Activities of Romana JERKOVIĆ
Plenary speeches (4)
Ensuring sustainable, decent and affordable housing in Europe - encouraging investment, private property and public housing programmes (debate)
World Mental Health Day - need for a comprehensive EU strategy on mental health (debate)
Guidelines for the employment policies of the Member States (debate)
One-minute speeches on matters of political importance
Oral questions (1)
The Commission’s plans to include the revision of the outstanding proposals on animal welfare in its work plan for 2025
Amendments (1588)
Amendment 10 #
2023/2110(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the EU is committed to improving its industrial and technological competitiveness in the global market and recognises the need to reinforce its position through sustained support for the growth of start-ups and scale-ups as those can foster innovation and further the objectives of green and digital transition;
Amendment 39 #
2023/2110(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission, in cooperation with the Member States, to assess how start-ups and a scale-ups respectively can contribute to the EU’s decarbonisation objectives and factor in their role in planning processes such as the National Energy and Climate plans
Amendment 40 #
2023/2110(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission and the Member States, as part of the upcoming SME relief package, to identify ways to introduce further financial incentives aimed at promoting the adoption of technology by start-ups and scale-upnd explore synergies between national and European initiatives aimed at promoting technology innovation and dissemination by start-ups and scale-ups in the private and the public sectors;
Amendment 51 #
2023/2110(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission and the Member States to develop comprehensive policies, regulations and strategies that are aligned with the European start-up and scale-up initiative and foster a favourable environment for start-ups and scale-ups, encompassing access to finance and technology, regulatory simplification, talent retention and acquisition, and support for internationalisation; through the Digital Single Market.
Amendment 74 #
2023/2110(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Welcomes the creation of the European Innovation Council Fund to support innovative start-ups; and bring new funding opportunities, ensuring that the processes to apply and the use of the EICF are startup-friendly
Amendment 76 #
2023/2110(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Emphasises the critical role of start-ups and scale-ups in fostering innovation and technological advancement across various sectors, including digital technologies, artificial intelligence, clean energy, biotechnology, and advanced manufacturing
Amendment 84 #
2023/2110(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Calls on the Commission and the Member States to assess the barriers which start-ups and scale-ups face in accessing finance and tailor funding application processes in a way that allows project developers to easily access finance.
Amendment 85 #
2023/2110(INI)
Motion for a resolution
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Calls on the Commission to explore ways in which start-ups and scale- ups can be supported in follow-up planning for implementing the innovations they have developed.
Amendment 87 #
2023/2110(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Notes the EU’s objectives concerning the Net Zero Industry Act2 and calls on the Commission to consider how additional fiscal incentives could be put forward forto increase the competitiveness of European start-ups and scale-ups, in order to encourage investments in net-zero technologies and participation in net-zero projects and facilitate the deployment of net-zero technologies in EU industrial green value chains; _________________ 2 Commission proposal of 16 March 2023 for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Europe’s net-zero technology products manufacturing ecosystem (Net Zero Industry Act) (COM(2023)0161).
Amendment 120 #
2023/2110(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Member States and the Commission, where applicable, to establish entrepreneur and angel investors-friendly tax regimes, incentives and simplified administrative procedures to attract and retain talent, incentivise investment and scalability, and encourage entrepreneurship;
Amendment 138 #
2023/2110(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Stresses the importance of safeguarding the principle of non- discrimination, promoting diversity and inclusivity within the start-up and scale up ecosystem, ensuring equal opportunities for all, including young people, established professionals and underrepresented groups
Amendment 150 #
2023/2110(INI)
Motion for a resolution
Paragraph 17 b (new)
Paragraph 17 b (new)
17b. Encourages the Commission and Member State to put in place measures and initiatives that foster an innovation ecosystem by enhancing the cooperation between academia, national labs, larger businesses, funding agencies and enabling consortia building.
Amendment 165 #
2023/2110(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Encourages the Commission to appoint start-up and scale-up contact points in relevant DGs to better coordinate dedicated policies
Amendment 169 #
2023/2110(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Implores the Commission to develop and adopt a ‘Start-up Test’, along the same lines as the SME Test that it adopted in 2021, in order to better assess the impact of legislation focusing on innovation, financing and competitiveness;, ensuring overregulation doesn’t disincentivise starting up in Europe.
Amendment 178 #
2023/2110(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Urges the Commission to accelerate the execution of its action plan for the Capital Markets Union to increase liquidity on European public markets and incentivise scale-ups to list on European stock exchanges.
Amendment 164 #
2023/0081(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) To achieve the 2030 objectives a particular focus is needed on some of the net-zero technologies, also in view their significant contribution towards the path to net zero by 2050. These technologies include solar photovoltaic and solar thermal technologies, onshore and offshore renewable technologies, battery/storage technologies, heat pumps and geothermal energy technologies, especially innovative applications of geothermal heating and cooling for public, private and industrial use, electrolysers and fuel cells, sustainable biogas/biomethane, carbon capture and storage technologies and grid technologies. These technologies play a key role in the Union’s open strategic autonomy, ensuring that citizens have access to clean, affordable, secure energy. Given their role, these technologies should benefit from even faster permitting procedures, facilitated access to data required for design, spatial planning and cost optimization, including subsurface data, obtain the status of the highest national significance possible under national law and benefit from additional support to crowd-in investments.
Amendment 173 #
2023/0081(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) To achieve the 2050 decarbonization objectives, all clean technologies that do not emit CO2 must be taken into account. In this respect, nuclear power is an energy source whose contribution to these objectives is recognized and undeniable. Currently supplying 50% of the low-carbon electricity produced in the Union, it is the leading low-carbon energy source in the EU. It is a high-performance sector and a source of employment, representing 1 million jobs. It also contributes to the European strategic autonomy and resilience.
Amendment 183 #
2023/0081(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) The development of carbon capture and storage solutions for industry is confronted with a coordination failure. On the one hand, despite the growing CO2 price incentive provided by the EU Emissions Trading System, for industry to invest into capturing CO2 emissions making such investments economically viable, they face a significant risk of not being able to access a permitted geological storage site. On the other hand, investors into first CO2 storage sites face upfront costs to identify develop and appraise them even before they can apply for a regulatory storage permit. Transparency about potential CO2 storage capacity in terms of the geological suitability of relevant areas and existing geological data, in particular from the exploration of hydrocarbon production sites, can support market operators to plan their investments. Member State should make such data publicly available and report regularly in a forward-looking perspective about progress in developing CO2 storage sites and the corresponding needs for injection and storage capacities above, in order to collectively reach the Union-wide target for CO2 injection capacity. The development and use of the CO2 injection and storage capacity must be subject to strict environmental standards, and ethical safeguards, in line with Directive 2009/31/EC, while extending them beyond the storage process and apply across the whole value chain, including capture, removal and transport, as well as the development of such infrastructure.
Amendment 215 #
2023/0081(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) To address security of supply issues and contribute to supporting the resilience of Union’s energy system and decarbonisation and modernisation efforts, the net-zero technology manufacturing capacity in the Union needs to expand. Union manufacturers of solar photovoltaic (PV) technologies need to increase their competitive edge and improve security of supply perspectives, by aiming to reach at least 30 gigawatt of operational solar PV manufacturing capacity by 2030 across the full PV value chain, in line with the goals set out in the European Solar Photovoltaic Industry Alliance, which is supported under the Union’s Solar Energy Strategy. 38 Union manufacturers of wind and heat pump technologies need to consolidate their competitive edge and maintain or expand their current market shares throughout this decade, in line with the Union’s technology deployment projections that meet its 2030 energy and climate targets. 39 This translates into a Union manufacturing capacity for wind of at least 36 GW and, respectively, for heat pumps of at least 31 GW in 2030. Union manufacturers of batteries and electrolysers need to consolidate their technology leadership and actively contribute to shaping these markets. For battery technologies this would mean contributing to the objectives of the European Battery Alliance and aim at almost 90% of the Union’s battery annual demand being met by the Union’s battery manufacturers, translating into a Union manufacturing capacity of at least 550 GWh in 2030. For EU electrolyser manufacturers, the REPowerEU plan projects 10 million tonnes of domestic renewable hydrogen production and a further up to 10 million tonnes of renewable hydrogen imports by 2030. To ensure EU’s technological leadership translates into commercial leadership, as supported under the Electrolyser Joint Declaration of the Commission and the European Clean Hydrogen Alliance, EU electrolyser manufacturers should further boost their capacity, such that the overall installed electrolyser capacity being deployed reaches at least 100 GW hydrogen by 2030. _________________ 38 Communication from the Commission to the European Parliament, the Council, the European EcTo improve EU’s strategic autonomicy and Social Committee and the Committee of the Regions: EU Solar Energy Strategy, SWD(2022) 148 final, 18.05.2022. 39 As perlessen its dependencies, the biomethane production should be scaled up in line with the REePowerEU objectives set out in the REPowerEU Plan, COM/2022/230 final, and accompanying Commission Staff Working Document Implementing the Repower EU Action Plan: Investment Needs, Hydrogen Accelerator and achieving the Bio-Methane Targets Accompanying the Document : Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions REPowerEU Plan, SWD/2022/230 final, 18.05.2022target to 35 bcm of by 2030. As a domestically available and stable energy source, it contributes to EU’s security of supply. The focus should be in sustainable production.
Amendment 263 #
2023/0081(COD)
Proposal for a regulation
Recital 27 a (new)
Recital 27 a (new)
(27a) In hard-to-abate sectors, including energy-intensive industries, the number of commercially available and scalable net zero technologies is currently limited. For those net zero technologies already in use or in the early stages of development, major reductions in cost and improvements in performance will be needed. Therefore, investments in research and innovation both at Union and national level continue to be important. Together with joint and coordinated efforts across the Member States notably through the Strategic Energy Technology Plan, research and innovation activities increase the resilience of the Union’s clean energy sector. Moreover, net zero technologies that are at demonstration or prototype stage today also make significant contributions in the long term to the achievement of net-zero industries in the Union and should be supported through the net zero industry act Financial support should be provided irrespective of the number of technologies implemented over time, as long as the costs associated with implementing these technologies remain additional and cannot be fully transferred to customers. Half of the greenhouse gas emissions reductions expected by 2050 will require technologies that are not yet ready for the market, so research and innovation activities are a crucial component to increase the EU’s technological sovereignty and global competitiveness.
Amendment 307 #
2023/0081(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) Several Union funding programmes, such as the Recovery and Resilience Facility, InvestEU, cohesion policy programmes or the Innovation Fund with the specific role of the European Hydrogen Bank acting as a one-stop-shop for EU funding supporting the entire renewable hydrogen value chain, are also available to fund investments in net-zero technology manufacturing projects.
Amendment 340 #
2023/0081(COD)
Proposal for a regulation
Recital 48 a (new)
Recital 48 a (new)
(48a) To provide long-term financing to the Green Industrial Plan and support the achievement of the goals and objectives set in this Act, the Commission should explore the possibility to set up a large climate investment plan at EU level with a broadened scope. Building on this act, the future climate investment plan should support on the implementation of the European Green Deal and cover other areas and sectors such as buildings insulation, charging infrastructure, electricity grids and support to demand- side measures and households.
Amendment 378 #
2023/0081(COD)
Proposal for a regulation
Recital 58 a (new)
Recital 58 a (new)
Amendment 389 #
2023/0081(COD)
Proposal for a regulation
Recital 64
Recital 64
(64) The scaling up of European net- zero technology industries requires significant additional skilled workers which implies important investment needs in re-skilling and upskilling, including in the field of vocational education and training. The creation of quality jobs should cover a wide range of sectors including both skilled and unskilled workers and as such contribute to a qualification of the entire workforce not leaving anyone behind. This should contribute to the creation of quality jobs in line with the targets for employment and training of the European Pillar of Social Rights. The energy transition will require a significant increase in the number of skilled workers in a range of sectors, including renewable energy and energy storage, and has a great potential for quality job creation. The skill needs for the fuel cell hydrogen sub-sector in manufacturing alone are estimated at 180.000 trained workers, technicians and engineers by the year 2030, according to the Commission’s European Strategic Energy Technology Plan65 . In the photo- voltaic solar energy sector, up to 66.000 jobs would be needed in manufacturing alone. The European network of employment services (EURES) is providing information, advice and recruitment or placement for the benefit of workers and employers, including across internal market borders. _________________ 65 European Commission, Directorate- General for Research and Innovation, Joint Research Centre, The strategic energy technology (SET) plan, Publications Office, 2019, https://data.europa.eu/doi/10.2777/04888.
Amendment 654 #
2023/0081(COD)
Proposal for a regulation
Article 4 – paragraph 8 a (new)
Article 4 – paragraph 8 a (new)
Amendment 763 #
2023/0081(COD)
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Amendment 766 #
2023/0081(COD)
Proposal for a regulation
Article 9 b (new)
Article 9 b (new)
Amendment 785 #
2023/0081(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point b – point i
Article 10 – paragraph 1 – point b – point i
(i) it adds significant manufacturing capacity in the Union for net-zero technologies or related components along their supply chain and fosters the ability to compete in increasingly global markets, both at home and abroad, and to build competitive advantage for the EU in key sectors;
Amendment 790 #
2023/0081(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point b – point ii
Article 10 – paragraph 1 – point b – point ii
(ii) it manufactures technologies with improved sustainability and performance, taking utmost account of cost-efficient energy efficiency technologies in line with the “energy efficiency first principle”;;
Amendment 809 #
2023/0081(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point b – point iv a (new)
Article 10 – paragraph 1 – point b – point iv a (new)
(iva) it contributes to increasing the competitiveness of SMEs
Amendment 903 #
2023/0081(COD)
Proposal for a regulation
Article 12 – paragraph 4 a (new)
Article 12 – paragraph 4 a (new)
4a. Member States shall ensure that the relevant administrative bodies are adequately resourced and staffed to respond within the applicable time limits to future requests.
Amendment 947 #
2023/0081(COD)
Proposal for a regulation
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1a. Member States may allocate resources and integrate measures supporting investments in strategic net- zero technologies manufacturing and industrial innovation under national Recovery and Resilience Plans, and their REPowerEU chapters, to pursue the objectives of this Regulation and to ensure that the targets set out in Article 1 are met.
Amendment 967 #
2023/0081(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. The Net-Zero Europe Platform as established in Article 28 shall discuss financial needs and bottlenecks of net-zero strategicprojects, the contribution to emissions saving, the social impact, the impacts on re- and upskilling of the workforce, the use of national ETS revenues to advance strategic net zero technology projects, potential best practices, in particular to develop EU cross-border supply chains, notably based on regular exchanges and reccomendations of the Net-Zero Industry Expert Group and with the relevant European industrial alliances.
Amendment 1045 #
2023/0081(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point c a (new)
Article 17 – paragraph 1 – point c a (new)
(ca) make publicly available data on areas where CO2 capture facilities and transportation pipelines can be permitted on their territory.
Amendment 1157 #
2023/0081(COD)
Proposal for a regulation
Article 18 – paragraph 7 a (new)
Article 18 – paragraph 7 a (new)
7a. To ensure a continuous and effective application over time of this contribution, the Commission shall: (a) three years after entry into force of the Regulation, assess the extension of the scope to other industry emitters operating in the EU, starting with oil and gas suppliers (b) three years after entry into force of this regulation, conduct an impact assessment to evaluate for which sources of carbon should be encouraged or precluded for the CO2 storage target, with the intention of aligning the permitted CO2 sources that will count towards fulfilling the obligations with the broader EU climate strategy. (c) on a rolling period basis, in line with reassessing the CO2 injection capacity target, recalculating the pro-rata contributions of oil and gas producers and suppliers based on their share in the Union’s crude oil and natural gas production.
Amendment 1180 #
2023/0081(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point a
Article 19 – paragraph 2 – point a
(a) social and environmental sustainability going beyond the minimum requirements in applicable legislation including job quality criteria, mechanisms to incentivise quality apprenticeship, measures to improve diversity at work as well as the respect of collective agreements and trade unions' right to negotiate;
Amendment 1192 #
2023/0081(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point b a (new)
Article 19 – paragraph 2 – point b a (new)
(ba) social sustainability aiming at ensuring high-quality jobs, incentivising quality apprenticeship and providing supporting measures to improve diversity at work as well as the respect of collective agreements and trade unions' right to negotiate;
Amendment 1195 #
2023/0081(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point b d (new)
Article 19 – paragraph 2 – point b d (new)
(bd) contribution to decent wages and working conditions including and where relevant inclusion of apprenticeships.
Amendment 1197 #
2023/0081(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point c
Article 19 – paragraph 2 – point c
(c) where applicable, the tender’s contribution to the energy system integration and energy efficiency;
Amendment 1322 #
2023/0081(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point b
Article 23 – paragraph 1 – point b
(b) enable and promote the use of the learning programmes, content and materials by public and private education and training providers in the Member States bridging research and innovation, possibly building on existing Horizon Europe projects, among others by training trainers, involving citizens and develop mechanisms to ensure the quality of the training offered by education and training providers in the Member States based on the above learning programmes, content and materials;
Amendment 1334 #
2023/0081(COD)
Proposal for a regulation
Article 23 – paragraph 2 a (new)
Article 23 – paragraph 2 a (new)
2a. provide dedicated training on upskilling and re-skilling of personnel from permitting bodies in so far as to support the growing needs of national or regional authorities for highly qualified workforce in order for them to deliver on the shortened deadlines listed in this regulation.
Amendment 1348 #
2023/0081(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point 6
Article 25 – paragraph 1 – point 6
(6) promote adequatecent wages and working conditions in jobs in net-zero technology industries, and the activation of youth, women and seniors to the labour market for net- zero technology industries, and the attraction of skilled workers from third countries, and thereby achieve a more diverse workforce;
Amendment 11 #
2022/2053(INI)
Motion for a resolution
Citation 18 f (new)
Citation 18 f (new)
— having regard to the Commission communication on the EU Soil Strategy for 2030 (COM(2021) 699),
Amendment 29 #
2022/2053(INI)
Motion for a resolution
Citation 18 a (new)
Citation 18 a (new)
— having regard to the Commission communication on a New EU Forest Strategy for 2030 (COM(2021)572),
Amendment 31 #
2022/2053(INI)
Motion for a resolution
Citation 18 b (new)
Citation 18 b (new)
— having regard to the Commission communication on the new EU Strategy on Adaptation to Climate Change (COM(2021) 82),
Amendment 32 #
2022/2053(INI)
Motion for a resolution
Citation 18 c (new)
Citation 18 c (new)
— having regard to the UN Human Rights Council resolution 48/13 on the right to healthy environment,
Amendment 33 #
2022/2053(INI)
Motion for a resolution
Citation 18 d (new)
Citation 18 d (new)
— having regard to the Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’), in particular Article 32,
Amendment 34 #
2022/2053(INI)
Motion for a resolution
Citation 18 e (new)
Citation 18 e (new)
— having regard to the UN 2030 Agenda for Sustainable Development and to the Sustainable Development Goals (SDGs),
Amendment 35 #
2022/2053(INI)
Motion for a resolution
Citation 18 g (new)
Citation 18 g (new)
Amendment 41 #
2022/2053(INI)
Motion for a resolution
Recital A
Recital A
A. whereas agriculture and food policies should facilitate the transition to sustainable food systems in line with the ambitions of the European Green Deal for a climate-neutral EU economy in 2050;
Amendment 55 #
2022/2053(INI)
Motion for a resolution
Recital B
Recital B
B. whereas sustainable carbon cycles must be considered in a holistic manner, as increasing carbon sinks and replacing fossil carbon as much as possible will require more biomass production, thuswill affecting the land sector; whereas carbon farming schemes can be part of an incentivising market- based toolbox for delivering on climate objectives;
Amendment 70 #
2022/2053(INI)
Motion for a resolution
Recital C
Recital C
C. whereas every tonne of fossil CO2 that is not emitted or is or will be sustainably stored in cycles is the best contribution tovery important in achieving climate targets; whereas storing CO2 from the atmosphere or other cycles should be used as one among many methods for achieving climate targets;
Amendment 103 #
2022/2053(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Amendment 108 #
2022/2053(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. whereas carbon sequestration practices such as carbon farming can contribute to the availability of new local job opportunities, rural development and to improved social inclusion of rural areas;
Amendment 226 #
2022/2053(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Stresses that carbon removal practices and efforts should not infringe on the right of people to live in healthy environments, which includes preserving healthy soils; calls on the Commission to devise clear safeguarding policies with the aim to protect this right;
Amendment 231 #
2022/2053(INI)
8b. Recognises the value of industrial solutions in carbon sequestration as well as their contribution in reducing carbon emissions; emphasizes that nature-based solutions such as diverse old-growth forests, rewetting of drained wetlands and peatlands, agroforestry and reforestation should be prioritised and incentivised as carbon farming initiatives should not only favour industrial farming models;
Amendment 235 #
2022/2053(INI)
Motion for a resolution
Paragraph 8 c (new)
Paragraph 8 c (new)
8c. Stresses that the impact of nature- based and industrial carbon removal solutions on balancing greenhouse gas emissions is limited, and should not come at the expense of ambitious climate mitigation goals, which require substantial reduction in emissions and not only offsetting;
Amendment 237 #
2022/2053(INI)
Motion for a resolution
Paragraph 8 d (new)
Paragraph 8 d (new)
8d. Welcomes the plan set out by the Commission on how carbon removals can contribute to achieving net negative emissions; calls on the Commission to define a list of practices with the highest absorption potential as an important input for farmers and to further invest in development of accessible and affordable carbon removing technologies;
Amendment 238 #
2022/2053(INI)
Motion for a resolution
Paragraph 8 e (new)
Paragraph 8 e (new)
Amendment 250 #
2022/2053(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Considers that carbon farming can be a new green business model which should be additional and voluntary, and whichrewards sustainable land management practices that aims to upscale climate mitigation by paying, and which incentivises farmers to implement climate-friendly farm or forest management practices, by tapping into the potential of blue carbon ecosystems and by streamlining the industrial use of carbon sequestered for different purposes;
Amendment 316 #
2022/2053(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that carbon farming must be regulated in line with the current CAP and be seen as a complementary and additional topping-up option; underlines, however, that in the longer term carbon farming should be market-basedto support the achievement of the objectives of the EU Soil Health Law and the EU Nature Restoration Law;
Amendment 344 #
2022/2053(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Considers that environmentally safe and permanent carbon capture and storage (CCS) and carbon capture and utilisation (CCU) can play a crucial role as future technologies for achieving climate neutrality in Europe and for creating a successful decarbonised economy in Europe;
Amendment 365 #
2022/2053(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Emphasizes the importance of encouraging and funding research aimed at technologies that neutralize carbon captured in geological natural resources, depleted oil and gas reservoirs and saline aquifers;
Amendment 385 #
2022/2053(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Underlines that the new certification framework for carbon farming should be as simple as possible in its design and not result in disproportionataim not to create undue administrative burdens for land and forestry managers and owners; emphasises that the future Union certification framework will need to take into account already existing national initiatives with the same objective;
Amendment 417 #
2022/2053(INI)
16a. Welcomes the Commission’s efforts to develop a transparent, bulletproof and scientifically backed EU framework for the certification of carbon removals, based on robust accounting rules; stresses that such framework should not undermine the policies that call for emissions reductions;
Amendment 448 #
2022/2053(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Stresses that carbon farming should be market-based and financed by public and/or private funds; calls on the Commission to create a genuinely new business model for farmers and foresters; notes that financing from the value chain or through the creation of a voluntary carbon market is possiblecould be explored; stresses that the CAP is not a viablecould be a source of funding, as the CAP is not a business model;
Amendment 479 #
Amendment 495 #
2022/2053(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Welcomes the proposal to setup an expert group and proposes to tap into the potential of digital solutions and to set up a knowledge sharing digital platform, which would enable easier stakeholder engagement, sharing knowledge, providing technical advice to the land managers, providing feedback to the Member States' authorities and facilitating establishing and sharing of best practices;
Amendment 67 #
2022/0219(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) This new instrument will be an important step towards to the creation of the EU Defence Union and shall contribute to enhance the Union’s open strategic autonomy, to strengthen its ability to protect its citizens and to reinforce the EU’s global position in the context of increasing security threats at the international level.
Amendment 68 #
2022/0219(COD)
Proposal for a regulation
Recital 5 b (new)
Recital 5 b (new)
(5b) The Instrument should also contribute to drive transformational change in the European Defence Technological and Industrial Base, simultaneous to improving security in the European Union. These changes include building more resilient supply chains, growing the advanced manufacturing sector and exports, and enhancing technological innovation.
Amendment 77 #
2022/0219(COD)
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) National regulations and increasing administrative burden in the defence sector of the Member States contributed to hindering competition and reducing economies of scale in the European defence industrial base.
Amendment 98 #
2022/0219(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) The Short Term Instrument should offset the complexity and risks associated with such joint actions, including common procurement, while allowing economies of scale in the actions undertaken by Member States to reinforce and modernise the European Technological and Industrial Base, increasing thereby the Union’s capacity resilience and security of supply. Incentivizing common procurement would also result into diminished costs in terms of administrative burdens, exploitation, maintenance and withdrawal of the systems.
Amendment 100 #
2022/0219(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) The instrument should be accompanied by measures aimed strengthening the European Defence Technological and Industrial Base European defence industry ensuring a level playing field for suppliers of all Member States and with particular attention to the involvement of SMEs, start-ups and mid-caps in the value chain.
Amendment 106 #
2022/0219(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) This Instrument will build on and take into account the work of the Defence Joint Procurement Task Force established by the Commission and the High Representative/Head of the European Defence Agency, in line with the Joint Communication ‘Defence Investment Gaps Analysis and Way Forward”, to coordinate very short-term defence procurement needs and engage with Member States and EU defence manufacturers to support joint procurement to replenish stocks, notably in light of the support provided to Ukraine.
Amendment 128 #
2022/0219(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) In certain circumstances, it should be possible to derogate from the principle that contractors and subcontractors involved in a common procurement supported by the Instrument are not subject to control by non-associated third countries or non -associated third-country entities. In that context, a legal entity established in the Union or in an associated third country and controlled by a non-associated third country or a non-associated third country entity may participate as contractor and subcontractor involved in the common procurement if strict conditions relating to the due diligence framework to identify, prevent, mitigate environmental and social risks, to the security and defence interests of the Union and its Member States, as established in the framework of the Common Foreign and Security Policy pursuant to Title V of the Treaty on European Union (TEU), including in terms of strengthening the European Defence Technological and Industrial Base, are fulfilled.
Amendment 160 #
2022/0219(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation establishes the short-term instrument for the European Defence Industry Reinforcement through common Procurement Act (the ‘Instrument’).
Amendment 180 #
2022/0219(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) to foster the competitiveness and efficiency of the European Defence Technological and Industrial Base (EDTIB), and opening the supply chains throughout the Union, including SMEs and mid-caps, for a more resilient Union, in particular by speeding up, in a collaborative manner, the adjustment of industry to structural changes, including ramp-up of its manufacturing capacities; , also through technological innovations;
Amendment 194 #
2022/0219(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point b a (new)
Article 3 – paragraph 1 – point b a (new)
(ba) to replenish stocks, in particular the most urgent and critical defence products needs by the Union, mainly those created by the disruption caused by the urgent transfer of defence products to Ukraine, taking into account the work of the Defence Joint Procurement Task Force.
Amendment 200 #
2022/0219(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The objectives shall be pursued with an emphasis on strengthening and developing the Union defence industrial base to allow it to address in particular the most urgent and critical defence products needs, especially those revealed or exacerbated by the response to the Russian aggression against Ukraine, taking into account the work of the Defence Joint Procurement Task Force, increasing the strategic autonomy of the Union and strengthen its ability to protect its citizens.
Amendment 243 #
2022/0219(COD)
Proposal for a regulation
Article 7 – paragraph 2 a (new)
Article 7 – paragraph 2 a (new)
2a. The minimum level of the Union contribution attributed to each action will be set out in the work programme referred to in Article 11 of the present regulation. The level of the Union contribution attributed to a given action will increase from its minimum level in the following cases, which indicate common procurement of higher value: a) At least 10% of the estimated value of the common procurement contract is allocated to SMEs, as contractors or subcontractors, that meet the funding conditions specified in Article 8 of the present regulation; b) At least 15% of the estimated value of the common procurement contract is allocated to mid-caps, as contractors or subcontractors, that meet the funding conditions specified in Article 8 of the present regulation.
Amendment 253 #
2022/0219(COD)
Proposal for a regulation
Article 8 – paragraph 6
Article 8 – paragraph 6
6. The participating Member States shall provide to the Commission a notification from the procurement agent on the guarantees provided by a contractor or subcontractor involved in the common procurement that is established in the Union or an associated third country and controlled by a non-associated third country or a non-associated third country entity. The guarantees and related provisions in the procurement contract shall be made available to the Commission upon request. The guarantees shall provide assurances that the involvement of the contractor or subcontractor involved in the common procurement fulfil strict conditions relating to the due diligence framework to identify, prevent, mitigate environmental and social risks and does not contravene the security and defence interests of the Union and its Member States as established in the framework of the CFSP pursuant to Title V of the TEU, or the objectives set out in Article 3.
Amendment 264 #
2022/0219(COD)
Proposal for a regulation
Article 8 – paragraph 8 a (new)
Article 8 – paragraph 8 a (new)
8a. When contractors and subcontractors involved in the common procurement use their assets, infrastructure, facilities and resources located or held outside the territory of the Member States or of the associated third countries, the commonly procured product shall meet the Union’s environmental, social, governance and ethics rules, as they are applied to the defence products manufactured in the European Union.
Amendment 317 #
2022/0219(COD)
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. The report shall build on consultations of Member States and key stakeholders and shall, in particular, assess the progress made towards the achievement of the objectives set out in Article 3 and evaluate the Instrument contribution to the following: a) participation of SMEs, start-ups and mid-caps in the action as contractors and subcontractors involved in the common procurement; b) reinforcement of the EDTIB throughout the Union; c) identification of the involvement of each Member States.
Amendment 331 #
2022/0219(COD)
Proposal for a regulation
Article 13 – paragraph 2 a (new)
Article 13 – paragraph 2 a (new)
2a. The Commission shall provide, in particular, SMEs and mid-caps the information needed to allow and facilitate their participation in the common procurement process, including supporting instruments to reduce administrative burdens.
Amendment 124 #
2022/0216(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) As regards Article 168(4), point (a), TFEU, standards for the safety and quality of organs and SoHOs, blood and blood derivatives should ensure a high level of human health protection. Therefore, this Regulation aims at setting high safety standards by ensuring, amongst others, the protection of SoHO donors, taking into consideration their fundamental role in the provision of SoHOs and for recipients, as well as measures to monitor and support the sufficiency of the supply of SoHOs that are critical for the health of patients.
Amendment 125 #
2022/0216(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) Directives 2002/98/EC16and 2004/23/EC17of the European Parliament and of the Council constitute the Union’s regulatory framework for blood and for tissues and cells, respectively. Although these Directives have harmonised to a certain degree the rules of Member States in the area of safety and quality of blood, tissues and cells, they include a significant number of options and possibilities for Member States to implement the rules they laid down. This results in divergences between national rules, which can create obstacles to cross-border sharing of these substances. A fundamental revision of those Directives is needed for a robust, transparent, up-to-date and sustainable regulatory framework for these substances, which achieves safety and quality for all parties involved, enhances legal certainty and supports continuous supply, whilst facilitating innovation for the benefit of public health and cross-border cooperation. In order to achieve a coherent application of the legal framework, it is appropriate to repeal Directives 2002/98/EC and 2004/23/EC and to replace them by a Regulation. _________________ 16 Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30). 17 Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
Amendment 128 #
2022/0216(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) Directives 2002/98/EC and 2004/23/EC are highly interconnected and contain very similar provisions for oversight and equivalent principles for safety and quality in the two sectors they regulate. In addition, many authorities and operators work across these sectors. As this Regulation aims to define high level principles that will be common to both the blood and of tissues and cells sectors, it would be appropriate that it replaces these Directives and merges the revised provisions into one legal act, taking into consideration the special characteristics of each type of substance.
Amendment 133 #
2022/0216(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) All SoHOs that are intended to be applied to humans fall within the scope of this Regulation. SoHOs can be prepared and stored in a variety of ways, becoming SoHO preparations, which can be applied to recipients. In these circumstances, this Regulation should apply to all activities from donor recruitment to human application and outcome monitoring. SoHOs or SoHO preparations can also be used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in particular on medical devices, regulated by Regulation (EU) 2017/745 of the European Parliament and of the Council19, on medicinal products, regulated by Directive 2001/83/EC of the European Parliament and of the Council20and by Regulation (EC) No 726/2004 of the European Parliament and of the Council21, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007 of the European Parliament and of the Council22, or on food, regulated by Regulation (EC) No 1925/2006 of the European Parliament and of the Council23. The criteria that define when SoHOs or SOHO preparations become products regulated under other Union legislation are not defined in this Regulation but are defined in those other acts. In case of products covered by other legislation of the Union, this Regulation shall only apply to those parts specified on it, without prejudice to other legislation of the Union.Inaddition, this Regulation should apply without prejudice to Union legislation on genetically modified organisms. _________________ 19 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 20 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 21 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 22 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121). 23 Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).
Amendment 136 #
2022/0216(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) When SoHOs are used in the autologous setting without any manipulation, processing or storage, the application of this Regulation would not be proportionate to the limited quality and safety risks arising in such a setting. When autologous SoHOs are collected and processed before being re-used in the same person, risks appear that should be mitigated. Thus, there needs to be an assessment and authorisation of the processes applied to ensure that they are demonstrated to be safe and effective for the recipient. When autologous SoHOs are collected to be processed and also stored, risks of cross-contamination, or environmental contamination, loss of traceability or damage to the biological properties inherent to the substance, and necessary for efficacy and/or functionality in the recipient, also appear. Thus, the requirements for SoHO establishment authorisation should apply. Furthermore, in case of substances meant for autologous but non-homologous application, this Regulation shall apply without prejudice to Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Or. en (Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004)
Amendment 142 #
2022/0216(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) When SoHOs are used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in order to ensure a high level of protection and contribute to legal clarity and certainty, this Regulation should apply to the extent that the activities to which they are subjected are not regulated by the other Union legislative framework. Without prejudice to other Union legislation, and in particular to Directive 2001/83/EC, Regulations (EC) No 726/2004, (EC) No 1925/2006, (EC) No 1394/2007 and (EU) 2017/745, this Regulation should at least apply to the recruitment and selection of donors, donation, collection and donor testing as well as to release, distribution, issuing, import and export when those activities concern SoHOs up to the point of their transfer to operators regulated by other Union legislation. This means that close interaction between this regulatory framework and other related frameworks is essential to ensure interplay and coherence between relevant legal frameworks, without gaps or overlaps.
Amendment 158 #
2022/0216(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Given the special nature of SoHOs, resulting from their human origin, and the increasing demands for these substances for human application or for the manufacture of products regulated by other Union legislation, or as the starting and raw material thereof, it is necessary to ensure a high level of health protection for donors as well as for recipients. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue on them as a result of the donation. This Regulation should therefore include principles and technical rules to monitor and protect donors. As different types of donation imply different risks for donors, with varying levels of significance, the monitoring of donor health should be proportionate to those levels of risk. This is particularly important when donation involves some risk to the donor’s health due to a need for pre-treatment with medicinal products, a medical intervention to collect the substance or a needthe possibility for donors to donate repeatedly. Donations of oocytes, bone marrow, peripheral blood stem cells and frequent donation of plasma should be considered to imply a significant risk.
Amendment 165 #
2022/0216(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law. Member States should notify the Commission of any such measures. More stringent protective measures put in place by Member States should be evidence- based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or its application is objectively justified by a legitimate aim, and where necessary supported by scientific evidence, and the means of achieving that aim are appropriate and necessary.
Amendment 172 #
2022/0216(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) This Regulation should not interfere with national legislation in the health area with objectives other than quality and safety of SoHOs that is compatible with Union law, in particular legislation concerning ethical aspects. Such aspects arise due to the human origin of the substances, which touches upon various sensitive and ethical concerns for Member States and citizens, such as access to particular services that use SoHOs. This Regulation should also not interfere with decisions of an ethical nature made by Member States, provided that they adhere to the Charter of Fundamental Rights of the European Union. Such ethical decisions might concern the use, or limitation of the use, of specific types of SoHOs or specific uses of SoHOs, including reproductive cells and embryonic stem cells. When a Member State allows the use of such cells, this Regulation should apply in full with a view to ensuring safety and quality and to protecting human health.
Amendment 173 #
2022/0216(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) This Regulation is not meant to cover research using SoHOs when that research does not involve application to the human body, for example in vitro research or research in animals. However, human substances used in research involving studies where they are applied to the human body should comply with the rules laid down in this Regulation, regarding clinical studies with SoHO.
Amendment 175 #
2022/0216(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) As a matter of principle, prticle 3 of the Charter of Fundamental Rights of the European Union prohibits the human body or parts of it from becoming a source of financial gain. Programmes promoting the donation of SoHOs shouldmust be founded on the principle of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient. Voluntary and unpaid SoHO donation is also a factor which can contributes to high safety standards for SoHOs and therefore to the protection of human health, and increases public trust in donation systems. It is also recognised, including by the Council of Europe Committee on Bioethics24, that while financial gain should be avoided, it may also be necessary to ensure that donors are not financially disadvantaged by their donation. Thus, financially neutralcompensation to remove any such risk is acceptable but should never produce a financial gain for the donor orconstitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate more frequently than is allowed,in any way that could posingerisks to their own health and to that of prospective recipients.Compensation and reimbursements should under no circumstances be an incentive or a claim to recruit donors, should not expose vulnerable persons in society to exploitation and should not promote competition among SoHO entities for the recruitment of donors. Such compensation should, therefore, be set by national authorities, at a level justified andappropriate in their Member State to reach such objectives. _________________ 24 Council of Europe Committee on Bioethics (DH-BIO). Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors (March 2018). Available at https://rm.coe.int/guide-financial- gain/16807bfc9a.
Amendment 189 #
2022/0216(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) In order to maintain public trust in SoHO donation and use programmes, information that is given to prospective donors, recipients or physicians regarding the likely use and benefits of particular SoHOs or SoHO preparations when applied to recipients should accurately reflect reliable scientific evidence and under no circumstances attribute or imply levels of safety or efficacy not supported by scientific methods. This should ensure that donors, or their families, are not coerced to donate by exaggerated descriptions of benefits and prospective patrecipients are not given false hopes when making decisions on their options for treatment. The verification of compliance with this Regulation through supervisory activities is of fundamental importance to ensure that, across the Union, the objectives of the Regulation are effectively achieved. The responsibility to enforce this Regulation lies with the Member States, whose competent authorities should monitor and verify, through the organisation of supervisory activities, that relevant Union requirements are effectively complied with and enforced.
Amendment 193 #
2022/0216(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities that act independently and impartially. It is therefore important that their function of oversight is separate and independent from the performance of SoHO activities. In particular, competent authorities should be free from undue political influence and from industry or other actors’ interference that might affect their operational impartiality.
Amendment 199 #
2022/0216(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult withe Clasification Advisory Council, defined in this Regulation and composed by representatives of the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, medical devices, organs or fooadvanced therapies, medical devices and the SoHO Coordination Board, with the aim of ensuring coherent procedures for the application of this Regulation. Competent authorities should inform the SoHO Coordination Board of the outcome of their consultations. When SoHOs or SoHO preparations are used to manufacture products regulated under other Union legislation, or as the starting and raw material thereof, competent authorities should cooperate with the relevant authorities on their territory. This cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for SoHO and for the other relevant sectors, as needed, regarding authorisation and monitoring of the SoHOs or the product manufactured from SoHOs. It should in principle be the responsibility of the Member States to decide on a case- by-case basis on the regulatory status of a substance, product or activity. However, in order to ensure consistent decisions across all Member States with regard to borderline cases, the Commission should be empowered to, on its own initiative or at the duly substantiated request of a Member State or the Classification Advisory Council, decide on the regulatory status of a particular substance, product or activity under this Regulation.
Amendment 208 #
2022/0216(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Since SoHO preparations are subjected to a series of SoHO activities prior to their release and, distribution and issuing, competent authorities should assess and authorise SoHO preparations to verify that a high level of safety, quality and efficacy is achieved consistently by the application of that specific series of activities, performed in that specific manner. When SoHOs are prepared with newly developed and validated collection, testing or processing methods, consideration should be given to the demonstration of safety and efficacy in recipients by means of requirements for clinical outcome data collection and review. The extent of such required clinical outcome data should correlate with the level of risk associated with the activities performed for that SoHO preparation and use. Where a new or modified SoHO preparation poses negligible risks for recipients (or offspring in the case of medically assisted reproduction), the vigilance reporting requirements provided for in this Regulation should be adequate to demonstrate safety and quality. This should apply for well-established SoHO preparations that are introduced in a new SoHO entity but have been robustly demonstrated as safe and effective by their use in other entities.
Amendment 210 #
2022/0216(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated, following the guidelines specified in this Regulation. The most up- to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive clinical follow-up for a defined number of patients. For moderate and high risk, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end- points. In case of high risk, these should include a comparison with standard treatments, ideally in a study with subjects allocated to test and control groups in a randomised manner. The competent authority should approve the plans before they are implemented and should assess the outcome data as part of a SoHO preparation authorisation. (Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 AprilIf a conventional treatment or a control group is based on a medicinal product for human use, these studies shall be considered clinical trials that are covered by Regulation 536/2014. Or. en 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC)
Amendment 213 #
2022/0216(COD)
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
Amendment 214 #
2022/0216(COD)
Proposal for a regulation
Recital 28 b (new)
Recital 28 b (new)
(28 b) The commitment to publish the clinical results obtained should be a mandatory requirement for clinical studies with SoHO. The existence of a registry of SoHO clinical studies at EU level is critical to facilitate patient participation in clinical studies, to boost multi-centre studies and to foster collaboration to generate more robust results and conclusions, and to make the generated knowledge available to other researchers, healthcare professionals, participants themselves and the general public.
Amendment 215 #
2022/0216(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) In the interests of efficiency, it should be permitted to conduct clinical outcome studies using the established framework in the pharmaceutical sector for clinical trials, as set out in Regulation (EU) No 536/2014 of the European Parliament and of the Council25, when operators wish to do so. Whilst applicants can choose to record the clinical data generated during the clinical outcome monitoring themselves, they should also be permitted to use existing clinical data registries as a means of such recording when those registries have been verified by the competent authority, or are certified by an external institution, in terms of the reliability of their data management procedures. _________________ 25 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
Amendment 216 #
2022/0216(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) In order to facilitate innovation and reduce administrative burden, competent authorities should share with each other information on the authorisation of new SoHO preparations and the evidence used for such authorisations, through the EU SoHO platform, including for the validation of certified medical devices used for SoHO collection, processing, storage or application to patients. Such sharing could allow authorities to accept previous authorisations granted to other entities, including in other Member States and to thus significantly reduce the requirements to generate evidence. Competent authorities should also share with each other information on clinical studies with SoHO, via the EU SoHO Platform.
Amendment 221 #
2022/0216(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) With regards to standards concerning donor, recipient and offspring protection, this Regulation should provide for a hierarchy of rules for their implementation. As risks and technologies change, this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this Regulation. As part of that hierarchy, in the absence of Union legislation describing particular procedures to be applied and followed to meet the standards set out in this Regulation, following the guidelines of the European Centre for Disease Prevention and Control (ECDC) and the EDQM should be considered as a means to demonstrate compliance with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. Member States should be involved in both the drafting and voting of these guidelines and should follow a transparent process of consultation with other relevant EU authorities and stakeholders. SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines are based on the most up-to-date scientific evidence and achieve the same level of quality, safety and efficacy. In cases of detailed technical issues for which neither Union legislation nor the ECDC and the EDQM have defined a technical guideline or rule, operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified.
Amendment 234 #
2022/0216(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) The EDQM is a structural part of the Council of Europe working under the European Pharmacopoeia Partial Agreement. The text of the Convention on the elaboration of a European Pharmacopoeia (ETS No. 050), accepted by Council Decision 94/358/EC26, is considered to be the text of the European Pharmacopoeia Partial Agreement. Member States of the Council of Europe that have signed and ratified the European Pharmacopoeia Convention are the member States of the European Pharmacopoeia Partial Agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement, including among others: the European Pharmacopoeia Commission, the European Committee on Organ Transplantation (CD-P-TO), the European Committee on Blood Transfusion (CD-P- TS) and the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The European Pharmacopoeia Convention has been signed and ratified by the European Union and all its Member States, all of whom are represented in their intergovernmental bodies. In this context, the work of the EDQM on developing and updating guidelines on safety and quality of blood, tissues and cells, should be considered an important contribution to the field of SoHOs in the Union and should be reflected in this Regulation. The guidelines address issues of quality and safety beyond the risks of communicable disease transmission, such as donor eligibility criteria for the prevention of the transmission of cancer and other non- communicable diseases and the assurance of safety and quality during collection, processing, storage and distribution. It should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this Regulation. The development of the guidelines should include stakeholder consultations to ensure their suitability and transparency.Member States should have an active role in the development of the guidelines, in cooperation with the EDQM. _________________ 26 Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).
Amendment 246 #
2022/0216(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) It is necessary to promote information and awareness campaigns at national and Union level on the importance of SoHOs. The aim of these campaigns should be to help European citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. As there is a need to ensure the availability of SoHOs for medical treatments, Member States and the Union should promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing self- sufficiency in the Unionthe autonomy of the Union, based on a wider donor base. Member States and the Union are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.
Amendment 257 #
2022/0216(COD)
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
Amendment 264 #
2022/0216(COD)
Proposal for a regulation
Recital 37 b (new)
Recital 37 b (new)
(37 b) On the other hand, it is essential to take steps to achieve, as soon as possible, an EU autonomy in the area of SoHO, especially in the case of plasma, which shows an increasing demand due to new therapeutic applications of plasma- derived medicines. Nowadays, the Union suffers from chronic shortages of plasma, resulting in its dependence on imports from third countries. It is necessary to specify the measures to be taken to increase the donor base, always in line with the principles of voluntary and unpaid donation, as well as to improve the infrastructure to enable efficient collection of SoHO, in order to ensure the continued, adequate and safe supply, also in times of crisis.
Amendment 266 #
2022/0216(COD)
Proposal for a regulation
Recital 37 c (new)
Recital 37 c (new)
(37 c) In order to reach an appropriate level of autonomy in the Union, it will be necessary to increase the collection of SoHO, but also to ensure its proper and efficient use. The factors and measures affecting SoHO’s demand play a critical role in ensuring the quality, safety and sustainability of the SoHO system. Suboptimal clinical practices and unnecessary use of SoHO compromises patient safety and limits the availability of SoHO for other patients in need. Member States should take measures to promote the optimal use of SoHO, taking into account alternatives that may reduce the demand, always following the most up-to- date scientific guidelines. The competent authorities should train healthcare professionals to make optimal use of SoHO. Member States should draw up national plans to ensure the supply of SoHO, as well as national emergency plans.
Amendment 267 #
2022/0216(COD)
Proposal for a regulation
Recital 37 d (new)
Recital 37 d (new)
(37 d) In cases where the availability of SoHO preparations or SoHO-derived products depend on profit-making entities, such as some plasma-derived products, there is a risk of altruistic donations turning into disproportionate profits and commercial interests taking precedence over the interests of patients and research. There could even be situations in which some low-profitable products are no longer produced, hampering their accessibility for patients. Similarly, investment in research and innovation for this type of products could be very small or non-existent. Prices of SoHO-derived products, which are obtained from altruistic and unpaid donations, should be fair and transparent. For certain low- profitable products, Member States should encourage research and innovation and should ensure, through negotiations, incentives or public service obligations, that they continue to be manufactured.
Amendment 271 #
2022/0216(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to promote a coordinated application of this Regulation, a SoHO Coordination Board (SCB) should be set up. The Commission should participate in its activities and chair it. The SCB should contribute to a coordinating the application of this Regulation throughout the Union, including by helping Member States to conduct SoHO supervisory activities. The SCB should be composed of persons designated by the Member States based on their role and expertise in their competent authorities, and should also involve experts that are not working for competent authorities, for specific tasks where access to necessary in-depth technical expertise in the field of SoHOs is required. In the latter case, appropriate consideration should be given to the possibility of involving European expert bodies such as the ECDC and the EDQM and existing professional, scientific, experts and donor and patrecipient representative groups at Union level in the field of SoHOs may also be invited.
Amendment 277 #
2022/0216(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) Some substances, products or activities have been subject to different legal frameworks with different requirements in the Member States. This causes confusion among operators in the field, and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use SoHOs. The SCB should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of SoHOs. The SCB should keep a compendium of the opinions issued by the SCB, the Classification Advisory Council or the competent authorities and of decisions made at Member State level, so that competent authorities considering the regulatory status under this Regulation of a particular substance, product or activity may inform their decision-making process by referring to that compendium. The SCB should also document agreed best practices to support a common Union approach. It should also cooperate with similar Union level bodies established in other Union legislation with a view to facilitating coordinated and coherent application of this Regulation between Member States and across bordering legislative frameworks. These measures should promote a coherent cross-sectoral approach and facilitate SoHO innovation.
Amendment 281 #
2022/0216(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) In order to limit administrative burden on competent authorities and the Commission, the latter should establish an online platform (the ‘EU SoHO Platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. and better communication, collaboration, coordination and exchange of SoHO between Member States. Member States should preferably use this new platform in their exchanges to limit the administrative burden.
Amendment 292 #
2022/0216(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular human dignity, the prohibition of making the human body and its parts a source of economic gain, the integrity of the person, the protection of personal data, the freedom of art and science and to conduct business, non-discrimination, the right to health protection and access to health care, and the rights of the child. To achieve these aims, all supervisory and SoHO activities should always be carried out in a manner that fully respects those rights and principles. The right for dignity and integrity of donors, recipients and of offspring born from medically assisted reproduction should always be taken into account, amongst others, by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material, that donor eligibility criteria are based on scientific evidence, that the use of SoHOs in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices, that activities are conducted in a transparent manner that prioritises the safety of donors and recipients, and that allocation and equitable and non-discriminatory access to SoHOs are defined in a transparent manner, on the basis of an objective evaluation of medical needs. This Regulation should therefore be applied accordingly.
Amendment 297 #
2022/0216(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) SoHOs, by definition, relate to persons, and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this Regulation, especially provisions relating to vigilance and communication between competent authorities. This Regulation should provide a legal basis under Article 6 and, where relevant, fulfil the conditions under Article 9(2), point (i), of Regulation (EU) 2016/679 for processing of such personal data. With respect to personal data processed by the Commission, this Regulation should provide a legal basis under Article 5 and, where relevant, fulfil the conditions under Article 10(2), point (i), of Regulation (EU) 2018/1725. Data on safety and efficacy of new SoHO preparations in recipients should also be shared, with appropriate protective measures and, where possible, anonymised, to allow aggregation at Union level for more robust evidence gathering on the clinical efficacy of SoHO preparations. For all data processing, such processing should be necessary and appropriate with a view to ensuring compliance with this Regulation in order to protect human health. Data on donors, recipients and offspring should hence be limited to the minimum necessary and pseudonymised, or anonymised, as appropiate in each case. dDonors, recipients and offspring should be informed of the processing of their personal data in line with the requirements of Regulations (EU) 2016/679 and (EU) 2018/1725, and in particular as provided for under this Regulation, including the possibility of exceptional cases where circumstances require such processing.
Amendment 303 #
2022/0216(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) The exchange of SoHOs between Member States is necessary for ensuring optimal patient access and sufficiency of supply, particularly in the case of local crises or shortages. For certain SoHOs that need to be matched between the donor and the recipient, such exchanges are essential to allow patients to receive the treatment they need. In this context, the objective of this Regulation, namely to ensure quality and safety of SoHOs and a high level of protection of donors, needs to be achieved at Union level, by establishing high standards of quality and safety for SoHOs, based on a common set of requirements that are implemented in a consistent manner across the Union. Thus, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objectiveThis Regulation will increase coordination between Member States and facilitate the cross-border exchange of SoHO.
Amendment 305 #
2022/0216(COD)
Proposal for a regulation
Recital 47 a (new)
Recital 47 a (new)
(47 a) The objective of this Regulation, namely to ensure quality and safety of SoHOs and a high level of protection of donors, needs to be achieved at Union level, by establishing high standards of quality and safety for SoHOs, based on a common set of requirements that are implemented in a consistent manner across the Union. Thus, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
Amendment 307 #
2022/0216(COD)
Proposal for a regulation
Recital 47 b (new)
Recital 47 b (new)
(47 b) In some cases such as bone marrow or haematopoietic stem cell transplants, the level of donor/recipient compatibility has to be extremely high. Therefore, excellent coordination is needed at a global level, beyond the Union level, so that each patient has more options of finding a compatible donor.
Amendment 310 #
2022/0216(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation establishes measures setting high standards of quality and safety for all substances of human origin (‘SoHOs’) intended for human application and for activities related to those substances in order to ensure a high level of human health protection, in particular for SoHO donors, SoHO recipients and offspring from medically assisted reproduction, and for enhanced coordination between Member States to improve the availability and accessibility of SoHO across the Union. This Regulation is without prejudice to national legislation which establishes rules relating to aspects of SoHOs other than their quality and safety and the safety of SoHO donors, recipients and offspring of medically assisted reproduction.
Amendment 318 #
2022/0216(COD)
(h a) issuing of SoHOs;
Amendment 321 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point m a (new)
Article 2 – paragraph 1 – point m a (new)
(m a) clinical studies with SoHO.
Amendment 323 #
2022/0216(COD)
Proposal for a regulation
Article 2 – paragraph 2 – introductory part
Article 2 – paragraph 2 – introductory part
2. In cases of autologous use of SoHOs, excluding cases where the processing involves a substantial modification or where its application is non-homologous, where:
Amendment 333 #
2022/0216(COD)
(1) ‘blood’ means the liquid that circulates in arteries and veins carrying oxygen to and carbon dioxide from the tissues of the body. It consists of a liquid part, plasma, and a solid consisting of red blood cells, leucocytes and platelets;
Amendment 338 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
(5) ‘substance of human origin’ (SoHO) means any substance collected from the human body in whatever manner, whether it contains cells or not and whether those cells are living or not. For the purposes of this Regulation, SoHO does not include organs in the sense of Article 3, point (h), of Directive 2010/53/EU, but does include substances which can be extracted from them;
Amendment 339 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘human application’ means inserted, implanted, injected, infused, transfused, transplanted, ingested, transferred (as in transfer to the uterus or fallopian tube of a woman), inseminated or otherwise added to the human body in order to create a biological, mechanical or physiological interaction with that body;
Amendment 340 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
(7) ‘SoHO activity’ means an action, or series of actions, that has a direct impact on the safety, quality or, efficacy or functionality of SoHOs, as listed in Article 2(1);
Amendment 343 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘SoHO donor’ means any person who has presented themselves to a SoHO entity with a view to making a donation of SoHOs, or a deceased person who has authorised, or on his/her behalf a family member or authorised person, the donation of parts of his/her body after death, whether that donation is successful or not;
Amendment 349 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8 a) ‘SoHO donation’ means a process by which a person – or on his/her behalf a relative or authorised person – voluntarily and altruistically gives parts of their own body to other people in need, or authorises their use after their death. It includes the necessary medical formalities, examinations and treatments and monitoring of the SoHO donor, whether that donation is successful or not;
Amendment 352 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8 b (new)
Article 3 – paragraph 1 – point 8 b (new)
(8 b) ‘living donor’ means any person who has presented themselves to a SoHO entity with a view to making a donation of SoHOs, whether that donation is successful or not;
Amendment 355 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
(10) ‘medically assisted reproduction’ means the facilitation of conception by intra-uterine insemination of sperm, in vitro fertilisation or any other laboratory or medical intervention that promotes conception and uses SoHOs for the preservation of fertility through collection and storage of SoHO substances for subsequent human application;
Amendment 361 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 11
Article 3 – paragraph 1 – point 11
(11) ‘offspring from medically assisted reproduction’ means fetuses and children that are born following medically assisted reproduction;
Amendment 362 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 11 a (new)
Article 3 – paragraph 1 – point 11 a (new)
(11 a) ‘unborn offspring from medically assisted reproduction’ means embryos and foetuses conceived by medically assisted reproduction;
Amendment 364 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point b
Article 3 – paragraph 1 – point 12 – point b
(b) meets a pre-defined specification; and
Amendment 366 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point c
Article 3 – paragraph 1 – point 12 – point c
(c) is intended for application to a recipient for a specific and homologous clinical indication or is intended for distribution for manufacture of a product regulated by other Union legislation, or as the starting and raw material thereof; and
Amendment 368 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point c a (new)
Article 3 – paragraph 1 – point 12 – point c a (new)
(c a) has not been substantially modified, such as to be considered as a medicinal product or advanced therapy, and is not intended to be applied in a non- homologous manner to the recipient.
Amendment 370 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 12 a (new)
Article 3 – paragraph 1 – point 12 a (new)
(12 a) ‘competent authority’ means the body or bodies responsible for SoHO’s activities at national level, designated by each Member State;
Amendment 374 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
(13) ‘donor recruitment’ means any activity aimed at informing and encouraging persons to become SoHO donors;
Amendment 378 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 15
Article 3 – paragraph 1 – point 15
(15) ‘processing’ means any operation involved in the handling of SoHOs, including washing, shaping, separation, fertilisation, decontamination, sterilisation, preservation and packaging. It does not include activities involving a substantial modification of SoHOs that would make it a medicinal product or an advanced therapy;
Amendment 383 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 16
Article 3 – paragraph 1 – point 16
(16) ‘quality control’ means severaldefined tests or checks to confirm that a SoHO activity or SoHO preparation meets pre- defined quality criteria;
Amendment 386 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 17
Article 3 – paragraph 1 – point 17
(17) ‘storage’ means the maintenance of SoHOs under appropriate controlled conditions until distribution or issuing;
Amendment 387 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 18
Article 3 – paragraph 1 – point 18
(18) ‘release’ means a process through which it is verified that a SoHO or a SoHO preparation meets defined safety and quality criteria and the conditions of any applicable authorisation before distribution, issuing, export or human application;
Amendment 393 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 21
Article 3 – paragraph 1 – point 21
(21) ‘export’ means distribution of SoHOs or SoHO preparations to third countries outside the Union;
Amendment 394 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 21 a (new)
Article 3 – paragraph 1 – point 21 a (new)
(21 a) ‘non-homologous use’ means a cell or tissue that, when applied to a recipient, ceases to have the same essential function, in the same anatomical or histological space as it had in its original environment in the donor;
Amendment 395 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 21 b (new)
Article 3 – paragraph 1 – point 21 b (new)
(21 b) ‘homologous use’ means a cell or tissue that when applied in a recipient mantains the same essential function, in the same anatomical or histological space as it had in its original environment in the donor;
Amendment 396 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 22
Article 3 – paragraph 1 – point 22
(22) ‘clinical outcome monitoring’ means evaluation of the health of a SoHO recipient for the purpose of monitoring the results of a SoHO preparation application, maintaining care and demonstrating safety and efficacy or functionality;
Amendment 397 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 23
Article 3 – paragraph 1 – point 23
(23) ‘autologous use’ means collection of SoHO from one individual for subequent application to the same individual, with or without further SoHO activities between collection and application;
Amendment 400 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 27
Article 3 – paragraph 1 – point 27
(27) ‘adverse occurrence’ means any incident associated with the donation or human application of SoHO that caused harm to a living SoHO donor, harm to a SoHO recipient or to offspring from medically assisted reproduction or that implied a risk of such harm;
Amendment 405 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 28 – point i a (new)
Article 3 – paragraph 1 – point 28 – point i a (new)
(i a) any other adverse ocurrence specified by the EDQM guidelines.
Amendment 407 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 29
Article 3 – paragraph 1 – point 29
(29) ‘SoHO rapid alert’ means a communication regarding a SAO, a communicable disease outbreakn adverse ocurrence or other information that might be of relevance to the safety and quality of SoHOs in more than one Member State and is to be transmitted rapidly between competent authorities and the Commission to facilitate the implementation of preventive or mitigating measures;
Amendment 408 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 31
Article 3 – paragraph 1 – point 31
(31) ‘EU SoHO Platform’ means the digital platform established and managed by the Commission tofor the exchange of information concerning SoHO activities at Union level, between competent authorities, the Commission, SoHO entities and other relevant entities, and to facilitate coordination and cross-border cooperation, between Member States, on SoHO;
Amendment 412 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 33
Article 3 – paragraph 1 – point 33
(33) ‘the compendium of SoHO’ means a list kept up-to-date by the SoHO Coordination Board of decisions, taken at Member State level, and opinions, issued by competent authorities and by the SCB and the Classification Advisory Council, on the regulatory status of specific substances, products or activities and published on the EU SoHO platform;
Amendment 414 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 38
Article 3 – paragraph 1 – point 38
(38) ‘Union training’ means training activities for the personnel of competent authorities and, where appropriate, for personnel of delegated bodies performing SoHO supervisory activities;
Amendment 416 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 41
Article 3 – paragraph 1 – point 41
(41) ‘critical SoHO’ means a SoHO for which an insufficient supply will result in serious harm or risk of harm to patrecipients;
Amendment 418 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 42
Article 3 – paragraph 1 – point 42
(42) ‘critical SoHO entity’ means a SoHO entity that carries out activities contributing to the supply of critical SoHOs and the scale of those activities is such that a failure to carry them out cannot be compensated by activities of other entities or alternative substances or products for patrecipients;
Amendment 420 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 42 a (new)
Article 3 – paragraph 1 – point 42 a (new)
(42 a) ‘Classification Advisory Council’ means a body composed of representatives of the SoHO Coordination Board, the European Medicines Agency and the Medical Device Coordination Group with the responsibility of assisting the Member States and the Commission in determining the regulatory status of a substance, product or activity covered by this Regulation;
Amendment 421 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 42 b (new)
Article 3 – paragraph 1 – point 42 b (new)
(42 b) ‘SoHO Coordination Board (SCB)’ means a body set up by this Regulation to promote coordination between Member States on SoHO;
Amendment 423 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 45
Article 3 – paragraph 1 – point 45
(45) ‘technical guidelines’ means a description of a series of methodological procedures and parameters, updated in accordance with the latest scientific evidence, that, if followed, achieve a level of quality and safety of a SoHO activity or a SoHO preparation that is considered to be acceptable as a means to comply with regulatory standards;
Amendment 424 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 47 – introductory part
Article 3 – paragraph 1 – point 47 – introductory part
(47) ‘traceability’ means the ability to locate and identify SoHOs during any step from collection through processing and storage to, distribution or issuing, to human application or disposal, including the ability to:
Amendment 427 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 51
Article 3 – paragraph 1 – point 51
(51) ‘imputability’ means the likelihood that a seriousn adverse occurrence, in a SoHO donor, is related to the donacollection process or, in a recipient, to the application of the SoHOs;
Amendment 433 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 61
Article 3 – paragraph 1 – point 61
(61) ‘SoHO for reproductive cellson’ means all cells intended to be used for the purpose of medically assisted reproduction and embryos resulting from fertilisation;
Amendment 434 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 62
Article 3 – paragraph 1 – point 62
(62) ‘third party donation’ means a donation of SoHO for reproductive cellson by a person to a personrecipient or a couple with whom the donor does not have an intimate physical relationship;
Amendment 436 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 63
Article 3 – paragraph 1 – point 63
(63) ‘within couple use’ means use of reproductive cells for medically assisted reproduction frombetween two persons with an intimate physical relationship, where one person supplies their own oocytes and the other person supplies their own sperm. Such gametes shall under no circumstances be applied to third parties;
Amendment 441 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 64
Article 3 – paragraph 1 – point 64
(64) ‘compensation’ means making good of any quantifiable losses associated with donation, without any net gain or loss;
Amendment 452 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 64 a (new)
Article 3 – paragraph 1 – point 64 a (new)
(64 a) ‘reimbursement’ means the reimbursement of costs incurred by the donor associated with the donation process;
Amendment 454 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 64 b (new)
Article 3 – paragraph 1 – point 64 b (new)
(64 b) ‘financial neutrality’ means a situation in which the donor does not experience net economic gains or losses associated with a donation;
Amendment 461 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 a (new)
Article 3 – paragraph 1 – point 70 a (new)
(70 a) ‘informed consent’ means consent by the donor to make a free and non- coercive donation or consent by the recipient to accept a treatment with a SoHO, after receiving clear, comprehensive and comprehensible information;
Amendment 465 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 b (new)
Article 3 – paragraph 1 – point 70 b (new)
(70 b) ‘European autonomy’ means the situation where the Union has the capacity to self-supply SoHO, being self- sufficient from third countries to cover most of the demand, with the exception of those SoHOs which require global management due to their intrinsic characteristics.
Amendment 468 #
2022/0216(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 70 c (new)
Article 3 – paragraph 1 – point 70 c (new)
(70 c) ‘SoHO clinical study’ means an experimental evaluation of a SoHO or a SoHO preparation in humans, with the objective of drawing conclusions regarding its efficacy and safety.
Amendment 470 #
2022/0216(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States may maintain or introduce within their territories measures that are more stringent than the ones provided for in this Regulation on condition that those national measures are compatible with Union law, and are proportionate to the risk to human health. In particular, Member States may introduce requirements for donations, including the prohibition or restriction of imports of SoHO, to ensure a high level of health protection and to achieve the objective defined in Article 54, provided that the conditions of the Treaties are met. Such measures shall not hinder coordination between Member States or European autonomy.
Amendment 491 #
2022/0216(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Without prejudice to Article 75, competent authorities shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions taken in cases where a SoHO entity has failed to comply with an obligation under this Regulation and where such failure causes or may cause a serious risk to human health. They shall also be transparent about the criteria used for the assessment and authorisation of SoHO preparations and SoHO entities.
Amendment 493 #
2022/0216(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Competent authorities shall be responsible for the SoHO supervisory activities referred to in Chapter III in order to verify the effective compliance of SoHO entities and SoHO preparations authorised in their territory with the requirements set out in this Regulation.
Amendment 495 #
2022/0216(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
(b) procedures to ensure the independence, impartiality, transparency, effectiveness, quality, suitability for purpose and consistency of their SoHO supervisory activities;
Amendment 496 #
2022/0216(COD)
Proposal for a regulation
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
(c) appropriate and properly maintained facilities and equipment to ensure that personnel can perform their SoHO supervisory activities efficiently, safely and effectively;
Amendment 499 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. In all cases where questions arise as to the regulatory status of a substance, product or activity, competent authorities shall consult with authorities established in other relevant Union legislation referred tothe Classification Advisory Council, defined in Aarticle 2(3), as relevant.67(a) In such cases, competent authorities shall also consult the compendium referred to Article 3 point (33).
Amendment 500 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 1
Article 14 – paragraph 2 – subparagraph 1
Amendment 502 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 2
Article 14 – paragraph 2 – subparagraph 2
Amendment 505 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The competent authorities shall inform the SCBClassification Advisory Council of the subsequent decision taken in their Member State, following the consultations referred to in paragraph 1 of this Article, regarding the regulatory status of the substance, product or activity concerned under this Regulation and on any consensus reached as a result of those consultations for publication in the compendium by the SCB. To the extent possible, Member States shall accept the opinion of the Classification Advisory Council. Otherwise, they shall inform the Classification Advisory Council as soon as possible of the decision taken and its justification.
Amendment 509 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1
Article 14 – paragraph 4 – subparagraph 1
The Commission may, upon a duly substantiated request of a Member State or the Classification Advisory Council, following the consultation referred to in paragraph 1, or on its own initiative, by means of implementing acts, determine the regulatory status of a substance, product or activity under this Regulation, in case questions arise in that respect, notably when these questions cannot be resolved at the Member State level, or in discussions between the SCB and the advisory bodies established in other relevant Union legislation, in accordance with Article 68(1), point (b)in the Classification Advisory Council. This decision shall be based on the most up-to- date scientific evidence.
Amendment 510 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
Amendment 513 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The consultation and cooperation referred to in paragraphs 1, 2 and 5 may also be initiated on the basis of a request for advice from a SoHO entity, as referred to in Article 40.
Amendment 515 #
2022/0216(COD)
Proposal for a regulation
Article 14 – paragraph 7 – subparagraph 1
Article 14 – paragraph 7 – subparagraph 1
The Commission may, by means of implementing acts, lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant Union legislation referred to in Article 2(3).
Amendment 524 #
2022/0216(COD)
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. SoHO preparation authorisations shall be valid throughout the Union for the period defined in the terms of the authorisation, when such a time period has been defined, or until a competent authority has suspended or withdrawn the authorisation. Where a Member State has adopted a more stringent measure, in accordance with Article 4, which relates to a specific SoHO preparation, that Member State may decline to recognise the validity of the SoHO preparation authorisation of another Member State pending verification that the more stringent measure has been met. This information shall be notified, without undue delay, in the EU SoHO Platform.
Amendment 525 #
2022/0216(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Competent authorities shall have procedures in place to allow that applications for the authorisation of SoHO preparations are submitted in accordance with Article 41. They shall provide guidelines and templates for the submission of applications for SoHO preparation authorisation. When developing these guidelines and templates, competent authorities shall consultfollow the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c). Competent authorities may establish simplified procedures for applications concerning modifications to previously authorised SoHO preparations.
Amendment 531 #
2022/0216(COD)
Proposal for a regulation
Article 21 a (new)
Article 21 a (new)
Article 21 a Conditional authorisation of SoHO preparations in exceptional situations 1. In exceptional cases, and subject to a medical prescription, the competent authorities may consult the best practices approved and documented by the SCB in accordance with Article 68(1)(c) and authorise the conditional and temporary use of certain SoHOs preparations in cases where: (a) the potential recipient of those SoHO preparations is at vital risk, has no available therapeutic alternatives and their treatment cannot be postponed; (b) available clinical data indicate that the SoHO preparation will be safe and effective. 2. The competent authorities shall, without undue delay, enter information on conditional authorisations of SoHO preparations into the EU SoHO Platform referred to in Chapter XI. 3. After receiving conditional and temporary authorisation for a SoHO preparation, the SoHO entity shall, in parallel, initiate a regular authorisation procedure for that SoHO preparation in accordance with Article 21.
Amendment 533 #
2022/0216(COD)
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
5. When assessing the SoHO preparation pursuant to paragraph 4, points (e) and (g), competent authorities shall consider, in the cases where the applicant has proposed to record, and recorded,verify that the clinical studies and their results of the clinical outcome monitoring in an existing clinical registry, that this is an acceptable method, provided that those competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of datahave been correctly recorded in the EU SoHO Platform.
Amendment 556 #
2022/0216(COD)
Proposal for a regulation
Article 28 – paragraph 9
Article 28 – paragraph 9
9. By derogation from paragraph 1, in case of emergencythe exceptional situations described in Article 21(a) or in case of emergency, as described in Article 64, competent authorities may authorise imports of SoHOs for immediate application to a specific recipient when justified by the clinical circumstances on a case-by-case basis.
Amendment 565 #
2022/0216(COD)
Proposal for a regulation
Article 32 – paragraph 1 – subparagraph 2
Article 32 – paragraph 1 – subparagraph 2
In exceptional cases, competent authorities may consider that a person’s considerable and relevant experience may exempt this person from the requirement set out in the first subparagraph. They shall also perform their duties impartially, transparently and free from conflicts of interest.
Amendment 567 #
2022/0216(COD)
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. Competent authorities shall provide inspectors with a specific induction training before inspectors take up their duties. For the specific induction training, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c). The designation criteria shall be clear and transparent.
Amendment 572 #
2022/0216(COD)
Proposal for a regulation
Article 34 – paragraph 2
Article 34 – paragraph 2
2. Competent authorities shall establish procedures for the unique identification of SoHO establishments that are subject to the provisions on the Single European Code in Article 46. Competent authorities shall ensure that such identification complies with the technical standards defined for that coding system. For this purpose, competent authorities may preferably use a SoHO establishment identification code generated by the EU SoHO Platform.
Amendment 573 #
2022/0216(COD)
Proposal for a regulation
Article 34 a (new)
Article 34 a (new)
Article 34 a Monitoring of SoHO availability and continuity of supply 1. As part of the national plans to ensure the continuity of SoHO supply referred to in Article 61(a), the competent authorities shall establish a digital platform through which they can exchange information on the availability of SoHO in the national territory in a fast and efficient manner. Through this system, competent authorities may request national SoHO entities to provide information on the availability of a certain SoHO product in specific situations of need. They shall also take into account alerts sent by national SoHO entities concerning the availability of SoHO and potential shortages. The competent authorities shall ensure that this digital platform is available no later than two years after the entry into force of this Regulation. 2. The competent authorities shall be responsible for monitoring the availability of SoHO at national level. They shall provide guidance to SoHO entities to facilitate the exchange of information on the availability of SoHO referred to in Article 46(a). 3. The competent authorities shall store and analyse information on the availability of SoHO and its fluctuations over time, as well as trends in demand and potential shortages of SoHO and shall draw up reports containing that information which may be made available to other Member States through the EU SoHO Platform as defined in Article 73 (Article 35).
Amendment 576 #
2022/0216(COD)
Proposal for a regulation
Article 36 a (new)
Article 36 a (new)
Amendment 577 #
2022/0216(COD)
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. The responsible person for release of SoHOs shall be in possession of a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned and shall have at least 2 years of experience in the relevant field. The SoHO entity shall ensure that the person responsible for the release of SoHO receives adequate and up-to-date training, appropriate to their job and responsibilities, including specific training on those SoHOs that require it.
Amendment 579 #
2022/0216(COD)
Proposal for a regulation
Article 40 – paragraph 3
Article 40 – paragraph 3
3. SoHO entities may request to their competent authorities a derogation from the requirement for a SoHO preparation authorisation in the exceptional circumstances referred to in Articles 21(a) 64.
Amendment 582 #
2022/0216(COD)
Proposal for a regulation
Article 41 – paragraph 4
Article 41 – paragraph 4
4. SoHO entities shall perform the clinical outcome monitoring once a conditional authorisation has been granted pursuant to Article 21(2), point (c), and submit the results to their competent authorities. In conducting the clinical investigation study as referred to in paragraph 3, points (b) and (c), for the SoHO preparation concerned, the applicant may use an existing clinical registry to record its results provided that their competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of datashall register that study and the results obtained in the SoHO EU Platform in accordance with Article 36 (a).
Amendment 585 #
2022/0216(COD)
Proposal for a regulation
Article 41 a (new)
Article 41 a (new)
Article 41 a Clinical studies with SoHO 1. SoHO entities may conduct clinical studies with SoHO, in the context of the monitoring plans defined in Article 41 or beyong it, with the aim of comparing or improving treatments. 2. Clinical studies shall always have the safety and well-being of the participants in the study as a priority and they shall respect the provisions of Articles 53, 54, 55, 56, 58 and 59 of this Regulation, concerning the protection of donors and recipients. SoHO entities intending to start a clinical study shall seek to obtain more robust and reliable data, through collaboration with other SoHO entities, if necessary. 3. SoHO entities must apply for a favorable opinion from the Research Ethics Committee before starting any clinical study. The Committee shall assess the ethical, legal and methodological aspects of the study, to determine the capacity of the study design to draw robust conclusions, as well as well-being and safety-related aspects of the participants, before issuing a favorable opinion for the study. 4. The person responsible for the clinical study shall be adequately trained. 5. Before starting the clinical study, SoHO entities shall register it on the EU SoHO Platform, where they shall also record the results after the end of the study, in accordance with Article 36 (a). 6. SoHO entities shall request approval of the clinical study to competent authorities before starting a clinical study with SoHO, in accordance with Article 36(a). SoHO entities may request assistance regarding administrative, technical and ethical aspects of the clinical study to the competent authorities, in accordance with Article 36(a).
Amendment 591 #
2022/0216(COD)
Proposal for a regulation
Article 46 a (new)
Article 46 a (new)
Amendment 592 #
2022/0216(COD)
Proposal for a regulation
Article 47 – paragraph 1
Article 47 – paragraph 1
1. SoHO entities shall maintain a system for detecting, investigating and recording information concerning adverse occurrences, including adverse occurrences detected during clinical outcome monitoring as part of a SoHO preparation authorisation application as referred to in Article 41 or as part of a clinical study with SoHO, as referred to in Article 41(a).
Amendment 595 #
2022/0216(COD)
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
1. SoHO establishments shall not carry out any SoHO activities without prior SoHO establishment authorisation. This shall apply whether all activities are carried out by the establishment itself or one or more are contracted to another SoHO entity.
Amendment 603 #
2022/0216(COD)
Proposal for a regulation
Article 52 – paragraph 2
Article 52 – paragraph 2
2. SoHO entities shall protect the physical and mental health of living donors before, during and after the donation.
Amendment 604 #
2022/0216(COD)
Proposal for a regulation
Article 52 – paragraph 2 a (new)
Article 52 – paragraph 2 a (new)
2 a. SoHOs from living donors shall be obtained from individuals whose state of health is such that no adverse effects on their health are expected/likely as a result of donation.
Amendment 607 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point a a (new)
Article 53 – paragraph 1 – point a a (new)
(a a) ensure that donors are not discriminated on grounds not specified in the technical guidelines listed in Article 56, based on scientific evidence, and intended to avoid potential risks to the health of SoHO recipients or donors;
Amendment 608 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point b
Article 53 – paragraph 1 – point b
(b) provide donors or their relatives or any persons granting authorisation on their behalf, in accordance with national legislation, with the information referred to in Article 55 and in a way that is adequate in view of their capacity to understand it, so that they can give free and informed consent;
Amendment 609 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point f
Article 53 – paragraph 1 – point f
(f) verify the eligibility of the donor on the basis of a donor health evaluation, including mental health-related aspects that could be altered by the donation process, that aims to minimise any risk that the donation might pose to the donor’s health;
Amendment 626 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – paragraph 2
2. In the course of the donor health evaluations referred to in paragraph 1, point (f), SoHO entities shall conduct interviews with the donors and gather information concerning the donors’ present and recent state of physical and mental health and their health histories to assure the safety of the donation process for those donors. SoHO entities may perform laboratory tests as part of the donor health evaluations. They shall perform such tests in cases where evaluations indicate that laboratory tests are necessary to establish the eligibility of those donors from the perspective of their own protection. The physician, as referred to in Article 51, shall approve the procedure and criteria for donor health evaluations.
Amendment 627 #
2022/0216(COD)
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. SoHO entities that collect SoHOs from donors that are subjected to a surgical procedure in order to donate, that are treated with hormones to facilitate donation, or that donate SoHO that can be donated on a frequent and repeated basis, shall register such donors and the results of their donor health evaluations in a cross- entity registry that allows interconnection with other such registries at Union level, as referred to in paragraph 1, point (j). SoHO entities that manage such registries shall ensure interconnectivity between them.
Amendment 643 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Member States may allow for the compensation or reimbursement from the SoHO entities to living donors for losses related to their participation in donations through fixed rate allowances. In such case, Member States shall establish the conditions for such allowances in national legislation, including the setting of an upper limit that ensures that allowances are transparent, financially neutral and consistent with the standards laid down in this Article. They may delegate the setting of conditions for such allowances to independent bodies that are established in accordance with national legislation.
Amendment 648 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
3. SoHO entities may compensate or reimburse living donors as provided for by their competent authorities pursuant to paragraph 2. SoHO entities shall report transparently to the competent authorities on the compensation used, and on any changes made in this respect.
Amendment 651 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 3 a (new)
Article 54 – paragraph 3 a (new)
3 a. Compensation may under no circumstances be used for promotion or as a claim for recruitment, shall not be an incentive to donate and shall not lead to exploitation of the most vulnerable persons in society or to situations of inappropriate competition for the recruitment of donors.
Amendment 653 #
2022/0216(COD)
Proposal for a regulation
Article 54 – paragraph 3 b (new)
Article 54 – paragraph 3 b (new)
3 b. The Commission shall assess the ethical aspects of voluntary and unpaid donation and verify that Member States’ compensation and reimbursement systems follow the guidelines specified in this Regulation. This assessment shall determine, inter alia, that such compensations and reimbursements under no circumstances constitute an incentive or a claim to recruit donors, that they do not expose vulnerable people in society to exploitation activities, that they do not undermine public confidence in the donation system or that they do not promote competition between SoHO entities for the recruitment of donors. Member States shall provide the Commission with the information requested to perform this assessment. By [one year after the entry into force of this Regulation], and every three years, the Commission shall submit a report to the Council and the European Parliament assessing the compensation and reimbursement systems in the Member States and, where appropriate, making recommendations to the Member States on how they can be improved. These reports shall be made available to the public.
Amendment 658 #
2022/0216(COD)
Proposal for a regulation
Article 55 – paragraph 3 – point d
Article 55 – paragraph 3 – point d
(d) the intended use of the donated SoHO, in particular covering proven benefits for the future recipients and any possible research or commercial uses to which the donor should give an informed consent;
Amendment 671 #
2022/0216(COD)
Proposal for a regulation
Article 56 – paragraph 6
Article 56 – paragraph 6
Amendment 676 #
2022/0216(COD)
Proposal for a regulation
Article 57 – paragraph 1
Article 57 – paragraph 1
SoHO entities shall protect the health of SoHO recipients and offspring from medically assisted reproduction from risks posed by SoHO preparations and their application. They shall do so by identifying, minimising or eliminating those risks.
Amendment 679 #
2022/0216(COD)
Proposal for a regulation
Article 57 – paragraph 1 a (new)
Article 57 – paragraph 1 a (new)
SoHO entities shall ensure that recipients are not discriminated on grounds not specified in the technical guidelines listed in Article 56, based on scientific evidence and intended to avoid potential risks to the health of donors or recipients;
Amendment 688 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 – introductory part
Article 58 – paragraph 2 – introductory part
2. In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of communicable disease transmission from SoHO donors to recipients by combining, at least,follow the scientific and technical specifications defined in Article 59 to mitigate the following measurerisks:
Amendment 690 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 – point a
Article 58 – paragraph 2 – point a
Amendment 692 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 – point b
Article 58 – paragraph 2 – point b
Amendment 695 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 – point c
Article 58 – paragraph 2 – point c
Amendment 699 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 a (new)
Article 58 – paragraph 2 a (new)
2 a. of communicable disease transmission from SoHO donors to recipients by combining, at least, the following measures: (i) reviewing and evaluating the donors’ current and past health, travel and relevant behavioural histories to allow the application of temporary or permanent deferrals when risks cannot be fully eliminated by donor testing; (ii) testing of donors for communicable diseases using certified and validated testing methods, or other methods considered appropriate in accordance with the guidelines defined in Article 59; (iii) when feasible and suitable according to the guidelines defined in Article 59, using processing technologies that reduce, inactivate or eliminate any potential communicable pathogens.
Amendment 701 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 b (new)
Article 58 – paragraph 2 b (new)
2 b. of non-communicable disease transmission, including genetic conditions and cancer, from donors to the recipients or to offspring from medically assisted reproduction by combining, at least, the following measures: (i) reviewing the donors’ current and past health to allow temporary or permanent deferral of donors that carry a risk of transmitting cancerous cells or other non- communicable diseases that might be passed to a recipient by SoHO application; (ii) where the transmission of genetic conditions is an identified risk, and in particular in the case of medically assisted reproduction with third party donation: - testing donors for those conditions, as indicated by prevalence or severity as presenting the highest risk;or - testing prospective recipients to identify any relevant genetic risk, combined with testing donors for such identified genetic conditions to ensure matching that will prevent the concerned condition in the offspring.
Amendment 702 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 c (new)
Article 58 – paragraph 2 c (new)
2 c. of communicable or non- communicable disease transmission to the recipients through cross-contamination of donations during collection, processing, storage and distribution by measures that ensure that physical contact between SoHOs from different donors is avoided or, in cases where combining donations is necessary for efficacy of the SoHO preparation, is minimised.
Amendment 703 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 d (new)
Article 58 – paragraph 2 d (new)
Amendment 704 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 e (new)
Article 58 – paragraph 2 e (new)
2 e. that any reagents and solutions added to SoHOs or coming in contact with SoHOs during collection, processing, storage and distribution might be transmitted to recipients and have a toxic, or other, detrimental effect on their health by combining, at least, the following measures: (i) specifying such reagents and solutions prior to their purchase; (ii) verifying any required certifications of such reagents and solutions; (iii) demonstrating the removal of such reagents and solutions, when necessary, prior to distribution.
Amendment 705 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 f (new)
Article 58 – paragraph 2 f (new)
Amendment 706 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 g (new)
Article 58 – paragraph 2 g (new)
2 g. that SoHOs cause an immune reaction in recipients by combining, at least, the following measures: (i) accurately typing and matching of patients to donors, when such matching is necessary; (ii) correctly distributing SoHOs to the correct recipients pursuant to Article 45.
Amendment 707 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 2 h (new)
Article 58 – paragraph 2 h (new)
Amendment 708 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 3
Article 58 – paragraph 3
Amendment 713 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 4
Article 58 – paragraph 4
Amendment 714 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 5
Article 58 – paragraph 5
Amendment 717 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 6
Article 58 – paragraph 6
Amendment 719 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 7
Article 58 – paragraph 7
Amendment 721 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 8
Article 58 – paragraph 8
Amendment 723 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 9
Article 58 – paragraph 9
Amendment 726 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 10 – point a
Article 58 – paragraph 10 – point a
(a) apply SoHO preparations to recipients without proven benefit, except in the context of a clinical investigation approved in the context of a conditional authorisation of the SoHO preparation by their competent authority pursuant to Article 41(4), or a clinical study referred to in Article 41(a);
Amendment 727 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 10 – point b
Article 58 – paragraph 10 – point b
(b) apply SoHO preparations to recipients unnecessarily. SoHO entities shall make an optimal use of SoHO, taking into account therapeutic alternatives, and following the most up-to- date scientific guides specified in Article 59 ;
Amendment 728 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 10 – point c a (new)
Article 58 – paragraph 10 – point c a (new)
(c a) prioritise cosmetic uses over clinical uses, especially in the event of a possible shortage of SoHO.
Amendment 730 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 11 – subparagraph 1
Article 58 – paragraph 11 – subparagraph 1
Amendment 732 #
2022/0216(COD)
Proposal for a regulation
Article 58 – paragraph 11 – subparagraph 2
Article 58 – paragraph 11 – subparagraph 2
For donors that donate repeatedly, the interviews referred to in the first subparagraph may be limited to aspects that might have changed and may be replaced with questionnaires.
Amendment 741 #
2022/0216(COD)
Amendment 742 #
2022/0216(COD)
Proposal for a regulation
Article -62 (new)
Article -62 (new)
Amendment 747 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
Amendment 773 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 3 – point f a (new)
Article 62 – paragraph 3 – point f a (new)
(f a) communication strategy for the general public.
Amendment 776 #
2022/0216(COD)
Proposal for a regulation
Article 62 – paragraph 6
Article 62 – paragraph 6
6. Member States shall review regularly their national SoHO emergency plans at least every 3 years and whenever necessary to take into account changes in the organisation of competent authorities and, experience gained from implementing the plans and simulation exercises and the recommendations issued by the Commission, as referred to in Article 62(a).
Amendment 786 #
2022/0216(COD)
Proposal for a regulation
Article 62 b (new)
Article 62 b (new)
Article 62 b European SoHO autonomy 1. By two years after the entry into force of this Regulation, the Commission shall submit a report to the Council and the European Parliament assessing the different measures applicable to secure the SoHO supply at national level, in the Member States, and at Union level. This report shall include measures to promote donation, in a manner compatible with the principles of voluntary and unpaid donation defined in paragraph 54 – such as informative and awareness-raising campaigns for citizens on the benefits of donation, as well as measures for the efficient use of SoHO. Based on the results of this report, the Commission shall develop a plan to promote European SoHO autonomy and give recommendations to Member States to implement measures in this regard in their national plans, described in Article 61 (a). 2. The plan for a European autonomy proposed by the Commission shall be reviewed every 5 years. 3. The Commission shall work with Member States to promote public participation in SoHO donation activities, in particular with regard to critical SoHO, with a view of ensuring resilient supply and a significant increase in donation rates where risks of shortages are identified. In doing so, it shall encourage the collection of SoHO through strong public and non-profit sector participation.
Amendment 787 #
2022/0216(COD)
Proposal for a regulation
Article 63 – paragraph 1
Article 63 – paragraph 1
1. Critical SoHO entities shall without undue delay launch a SoHO supply alert to their competent authorities in case of a significant interruption, indicating the underlying reason, the expected impact on patients and any mitigating actions taken including possible alternative supply channels if appropriate. Interruptions shall be considered significant when the application of critical SoHO is cancelled or postponed due to unavailability and this poses a serious risk to human health.
Amendment 788 #
2022/0216(COD)
Proposal for a regulation
Article 63 – paragraph 1 a (new)
Article 63 – paragraph 1 a (new)
Amendment 790 #
2022/0216(COD)
Proposal for a regulation
Article 63 – paragraph 3
Article 63 – paragraph 3
3. The SoHO National Authorities mayshall submit to the EU SoHO Platform the SoHO supply alert received, especially in cases where the supply interruption might affect other Member States or where such interruption might be addressed through cooperation between Member States pursuant to Article 62(3), point (d).
Amendment 791 #
2022/0216(COD)
Proposal for a regulation
Article 64 – title
Article 64 – title
Derogation from the obligations to authorise SoHO preparations in public health emergency situations
Amendment 794 #
2022/0216(COD)
Proposal for a regulation
Article 65 – paragraph 1
Article 65 – paragraph 1
Member States may take additional measures to the ones set out in their national SoHO emergency plans to ensure critical SoHOs suppontinuity of SoHO supply, as well as in the national SoHO emergency plans to secure SoHO supply, especially in case of shortages on their territory, on a case-by-case basis. Member States taking such measures shall inform the other Member States and the Commission without undue delay and give reasons for the measures taken.
Amendment 797 #
2022/0216(COD)
Proposal for a regulation
Article 65 a (new)
Article 65 a (new)
Article 65 a Plans to ensure continuity of supply to SOHO entities SoHO entities carrying out SoHO activities related to critical SoHOs shall have in place a plan to ensure continuity of supply of its own entity that supports the implementation of the national SoHO continuity of supply plan referred to in Article 61 (a).
Amendment 806 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. Each Member State shall nominate two permanent members and two alternates representing the SoHO National Authority and, where the Member State chooses, the Ministry of Health. The SoHO National Authority may nominate members from other competent authorities, but those members shall ensure that the views and suggestions they make are endorsed by the SoHO National Authority. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate, in order to ensure a multidisciplinary and diverse representation of stakeholders in the SoHO sector. Other Union institutions, bodies, offices and agencies shall have an observer role.
Amendment 812 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 4
Article 67 – paragraph 4
4. The Commission shall chair the meetings ofBoard shall be co-chaired by a representative of the Commission and by one rotating representative of the Member States, who shall be elected by and from among the representatives of the Member States in the SCB. The chair shall not take part in votes of the SCB.
Amendment 814 #
2022/0216(COD)
Proposal for a regulation
Article 67 – paragraph 6 – point k a (new)
Article 67 – paragraph 6 – point k a (new)
(k a) make available to the public a summary of the topics discussed at the meetings.
Amendment 819 #
2022/0216(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point a
Article 68 – paragraph 1 – point a
(a) in collaboration with other authorities designated in other relevant Union legislation, preparing opinions at the request of competent authorities in accordance with Article 14(2) first sub-paragraph1), on the regulatory status under this Regulation of a substance, product or activity and transmitting its opinions to the compendium;
Amendment 820 #
2022/0216(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point b
Article 68 – paragraph 1 – point b
(b) when preparing the opinions referred to in point (a) of this paragraph, initiating, at Union level, a consultation with equivalent advisory bodies establishedparticipate in other relevant Union legislation in accordance with Article 14(2) second sub-paragraph, and including in the compendium the opinions concerning the Union legislation to be applied in cases where there is agreement with the equivalent advisory bodies Classification Advisory Council as defined in Article 68 (a);
Amendment 822 #
2022/0216(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point d
Article 68 – paragraph 1 – point d
(d) recording information notified in accordance with Article 14(32), and including such information in the compendium;
Amendment 825 #
2022/0216(COD)
Proposal for a regulation
Article 68 – paragraph 1 – point g a (new)
Article 68 – paragraph 1 – point g a (new)
Amendment 826 #
2022/0216(COD)
Proposal for a regulation
Article 68 a (new)
Article 68 a (new)
Amendment 828 #
2022/0216(COD)
Proposal for a regulation
Article 69 – paragraph 1 – subparagraph 1
Article 69 – paragraph 1 – subparagraph 1
The Commission shall organise Union training in cooperation with the Member States concerned.
Amendment 832 #
2022/0216(COD)
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
The Commission shall establish and maintain cooperation with the EDQM in relation to the guidelines published by the EDQM. Such cooperation shall be based on the highest scientific standards, be proactive in identifying future needs and be transparent, involving the relevant stakeholders in consultations related to the development of the technical guidelines.
Amendment 837 #
2022/0216(COD)
Proposal for a regulation
Article 71 – paragraph 1 a (new)
Article 71 – paragraph 1 a (new)
The Commission shall evaluate the transparency in the procedures and development of the technical guidelines by the EDQM and their suitability to the needs and interests of the Member States.
Amendment 838 #
2022/0216(COD)
Proposal for a regulation
Article 72 – paragraph 1 – point a
Article 72 – paragraph 1 – point a
(a) providing secretariat and technical, scientific and logistic support to the SCB and its working groups and to the Classification Advisory Council;
Amendment 839 #
2022/0216(COD)
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
2. With regard to the support referred to in paragraph 1, point (a), the Commission shall, in particular, organise the meetings of the SCB and its working groups, the travel of members of the SCB, and of the Classification Advisory Council, the travel of members of the SCB and the Classification Advisory Council reimbursement and special allowances for scientific experts that participate in those meetings, and ensure the appropriate follow-up.
Amendment 840 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1
Article 73 – paragraph 1
1. The Commission shall establish, manage and maintain the EU SoHO Platform to facilitate effective and efficient exchange, registration and storage of information concerning SoHO activities in the Union, as provided for in this Regulation. To ensure optimal use of the EU SoHO Platform, the Commission shall:
Amendment 842 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point a (new)
Article 73 – paragraph 1 – point a (new)
(a) develop the technical and functional specifications of the EU SoHO Platform, including the data exchange mechanism for the exchange with existing national systems and the format for electronic submission;
Amendment 843 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point b (new)
Article 73 – paragraph 1 – point b (new)
Amendment 844 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point c (new)
Article 73 – paragraph 1 – point c (new)
(c) develop relevant guidance for reporting through the EU SoHO Platform;
Amendment 845 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point d (new)
Article 73 – paragraph 1 – point d (new)
(d) ensure data interoperability between the EU SoHO Platform, Member States’ IT systems and other relevant IT systems and databases, such as the EMA’s European Shortages Monitoring Platform or systems defined in the European Health Data Space, without duplication of reporting;
Amendment 846 #
2022/0216(COD)
(e) ensure that the Commission, national authorities and competent authorities, SoHO entities, SCB, ECDC, EMA, EDQM and other relevant bodies have adequate levels of access to the information contained in the EU SoHO Platform to carry out their tasks;
Amendment 847 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point f (new)
Article 73 – paragraph 1 – point f (new)
(f) ensure that confidential information sent to the system is protected from unjustified disclosure;
Amendment 848 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 – point g (new)
Article 73 – paragraph 1 – point g (new)
(g) ensure that the EU SoHO Platform is fully operational at the latest 2 years after the entry into force of this Regulation, and develop an implementation plan for the Platform.
Amendment 849 #
2022/0216(COD)
Proposal for a regulation
Article 73 – paragraph 1 a (new)
Article 73 – paragraph 1 a (new)
1 a. Information collected through the EU SoHO Platform on SoHO shortage alerts, SoHO shortages and demand trends, cross-border SoHO requests and resolutions, or import and export of SoHO to third countries outside the EU will be used for the monitoring, prevention and management of SoHO shortages in the EU, as well as to enhance the EU SoHO autonomy, as part of the plan defined in Article 62 (a).
Amendment 851 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 2
Article 74 – paragraph 2
2. The EU SoHO platform shall also provide a secure environment for the exchange of information between competent authorities and, the Commission and the EMA, the ECDC, the SCB and EDQM, in particular in relation to SAO and rapid alerts. It shall also provide public access to information regarding the registration and authorisation status of SoHO entities and shall indicate the applicable guidelines to be followed to meet the technical standards laid down in Articles 56 and 59.
Amendment 852 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 2 a (new)
Article 74 – paragraph 2 a (new)
2 a. The EU SoHO Platform shall also be the main intermediary for reporting SoHO shortages and for cross-border requests of SoHO. National authorities shall issue and receive shortage alerts that cannot be resolved at Member State level, as well as SoHO cross-border requests and shall be able to respond to them. National authorities, aware of the national availability of SoHO, as referred to in Article 34(a), shall use the EU SoHO Platform to report any SoHO shortages that may lead to a public health emergency or severe ocurrence.
Amendment 853 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 2 b (new)
Article 74 – paragraph 2 b (new)
2 b. In the event of a SoHO-related health emergency or for the purpose of preventing potential threats, alerts issued through the EU SoHO Platform shall allow for rapid situational awareness by the Commission, competent authorities and other relevant bodies so that action can be taken as soon as possible as set out in Regulation (EU) 2022/2371 on serious cross-border threats to health.
Amendment 854 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 2 c (new)
Article 74 – paragraph 2 c (new)
2 c. It shall also provide public access to information regarding the registration and authorisation status of SoHO entities and shall indicate the applicable guidelines to be followed to meet the technical standards laid down in Articles 56 and 59.
Amendment 855 #
2022/0216(COD)
Proposal for a regulation
Article 74 – paragraph 2 d (new)
Article 74 – paragraph 2 d (new)
2 d. The EU SoHO Platform shall contain a record of clinical studies with SoHO and their results, as referred to in Article 36 (a).
Amendment 28 #
2022/0210(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) Decision No 2022/591 of the European Parliament and of the Council of 6 April 2022 laying down a General Union Environment Action Programme to 203012 confirmed that sound information on the key trends, pressures and drivers for environmental change is essential for the development of effective policy, its implementation, and the empowerment of citizens. Instruments should be developed with a view to enhancing public awareness of the environmental effects ofrelationship and interconnection between the environment and economic activity. Environmental economic accounts is one such instruments. _________________ 12 OJ L 114, 12.4.2022, p. 22.
Amendment 34 #
2022/0210(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The new modules are to contribute directly to Union’s policy priorities of green growth and, resource efficiency and achieving climate neutrality at the latest by 2050, including its intermediate targets.
Amendment 38 #
2022/0210(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The United Nations Statistical Commission adopted the System of Environmental-Economic Accounting (‘SEEA’) central framework as an international statistical standard at its 43rd session in February 2012 and the SEEA Ecosystem Accounting (chapters 1 to 7 describing the accounting framework and the physical accounts) at its 52nd session in March 2021. The new modules set out by this Regulation are fully in line with the SEEA. Additionally, the SEEA has implemented the System of Environmental-Economic Accounts for Water (SEEA-Water), which supports the SEEA Central Framework. Revision of the regulation (EU) No 691/2011 does not include the water account module.
Amendment 39 #
2022/0210(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) Water is a crucial resource and integrating it into the European environmental economic accounts is a prerequisite for managing it sustainably as well as understanding its relationship with economic activity.
Amendment 43 #
2022/0210(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) In order to better monitor progress towards a green, just, competitive and resilient circular economy and to monitor progress towards the Sustainable Development Goals in a Union context, additional reliable data is required.
Amendment 49 #
2022/0210(COD)
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) Findings of the special report No 2019/16 of the European Court of Auditors suggest that a long-term strategy for the European environmental economic accounts is needed to ensure the most effective use of data and their contribution to the environmental policy- making.
Amendment 60 #
2022/0210(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) In order to take into account the current state of development of methodologies to value ecosystem services, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in order to supplement the Regulation by establishing for which of the ecosystem services already included in the reporting tables in section 5 of Annex IX monetary values should be reported, the first reference year as well as a list of acceptable methods for establishing those monetary values without undermining the invaluable social and ecological values of biodiversity, ecosystem services and by taking into account the risk of commercialization of nature and uncertainty. The aim of establishing monetary values should be in raising visibility on the cost of non-action. It is of particular importance that the Commission carry out appropriate consultations during the preparatory work, including at expert level, and that those consultations are conducted in accordance with the principles laid down in the Inter- institutional Agreement of 13 April 2016 on Better Law-Making17 . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 17 OJ L 123, 12.5.2016, p. 1.
Amendment 62 #
2022/0210(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) Member States and the Commission should strive for a more accurate and science-based use of environmental statistical data in order to provide the European Climate Dashboard with accurate indicators. The data should also be used for establishing facts regarding the cost of non-acting on environmental and climate challenges.
Amendment 63 #
2022/0210(COD)
Proposal for a regulation
Recital 15 b (new)
Recital 15 b (new)
(15b) In 2022 the General Assembly of the United Nations has adopted the resolution recognising a clean, healthy and sustainable environment as a human right. In its report on the EU Biodiversity Strategy for 2030: Bringing nature back into our lives, the European Parliament considers that the right to a healthy environment should be recognised in the EU Charter of Fundamental Rights.
Amendment 68 #
2022/0210(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) 691/2011
Article 2 – point 9a (new)
Article 2 – point 9a (new)
(9a) ‘planetary boundaries’ means a framework of safe environmental limits, the respecting of which reduces the possibility of altering the Earth to a much less hospitable state and is measured using “Extinctions per million species- years”. The framework is comprised of nine planetary boundaries: climate change, biosphere integrity (which covers functional and genetic diversity), land system changes, freshwater change, comprising blue water and green water, biogeochemical flows covering nitrogen and phosphorus, ocean acidification, atmospheric aerosol loading, stratospheric ozone depletion and novel entities;
Amendment 69 #
2022/0210(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EU) 691/2011
Article 2 – point 9b (new)
Article 2 – point 9b (new)
(9b) 'One Health approach’ means One Health approach as defined in Article 2, point (5), of Regulation (EU) 2021/522 of the European Parliament and of the Council (‘EU4Health Programme);
Amendment 80 #
2022/0210(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Regulation (EU) 691/2011
Article 3 – paragraph 4a (new)
Article 3 – paragraph 4a (new)
4a. The Commission (Eurostat) shall carry out a methodological and feasibility study on the monetary valuation of ecosystem services without undermining the invaluable social and ecological values of biodiversity, ecosystem services and by taking into account the risk of commercialization of nature and uncertainty. Based on the results of this study, the Commission may supple, Parliament and the Council may amentd this Regulation in order to define, by means of a delegated act, for which of the ecosystem services already included in the reporting tables in section 5 of Annex IX monetary values shall be reported, the first reference year as well as, a list of acceptable methods for establishing these monetary values., including value transfer techniques. This methodology shall support the transition to sustainable and circular economy and shall not clear the way for monetization of nature;
Amendment 91 #
2022/0210(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 3 a (new)
Article 1 – paragraph 1 – point 3 a (new)
Regulation (EU) 691/2011
Article 6a (new)
Article 6a (new)
(3a) The following Article is inserted: Article 6a By ... [18 months after the date of entry into force of this Regulation] the Commission (Eurostat) and the European Environmental Agency (EEA) shall develop and provide the European Climate Dashboard with a science-based and freely accessible state-of-play information on: (a) the GHG emission reduction path (including details on CO2, methane, nitrous oxyde and fluorianted gases) (b) the nine planetary boundaries (c) the forest accounts including information on the carbon sink and LULUCF pathway (d) other relevant data including information in line with aiming for the visibility of links of the One Health approach regarding human health, animal health and the environment, established by an delegated act;
Amendment 107 #
2022/0210(COD)
Proposal for a regulation
Annex I
Annex I
Regulation (EU) 691/2011
Annex VII – section 1
Annex VII – section 1
Forest accounts record and present data on forest resources and economic activity in the forestry and logging industry in a way that is fully compatible with the data reported under the European System of Accounts (ESA). Forest accounts provide complementary information and use concepts adapted to the particular nature of forests and of the forestry and logging industry. More information should be gathered on the carbon sinks of forests.
Amendment 159 #
2022/0140(COD)
Draft legislative resolution
Citation 2
Citation 2
— having regard to Article 294(2) and Articles 16, 114 and 11468 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9- 0167/2022),
Amendment 168 #
2022/0140(COD)
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16, 114 and 11468 thereof,
Amendment 171 #
2022/0140(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The aim of this Regulation is to establish the European Health Data Space (‘EHDS’) in order to improvegrant access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data), as well as for the improvement for other purposes that would benefit the society such as research, innovation, policy- making, health threats preparedness and control, patient safety, personalised medicine, official statistics or regulatory activities (secondary use of electronic health data). In addition, the goal is to improve the functioning of the internal market by laying down a uniform legal and technical framework in particular for the development, marketing and use of electronic health record systems (‘EHR systems’) in conformity with Union values.
Amendment 176 #
2022/0140(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1 a) The EHDS constitutes a key component for the creation of a strong and resilient European Health Union to better protect the health of European citizens, prevent and address future pandemics and improve resilience of Europe’s health systems.
Amendment 177 #
2022/0140(COD)
Proposal for a regulation
Recital 1 b (new)
Recital 1 b (new)
(1 b) This Regulation should work horizontally with other European programs such as the Digital Europe Programme, Connecting Europe Facility and Horizon Europe. The European Commission should ensure that other European programs complement and facilitate the implementation of the European Health Data Space.
Amendment 179 #
2022/0140(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The COVID-19 pandemic has highlighted the imperative of having timely access to quality electronic health data for health threats preparedness and response, as well as for prevention, diagnosis and treatment and secondary use of health data. Such timely access would have contributed, through efficient public health surveillance and monitoring, to a more effective management of the pandemic, to reduced costs and an improved response to health threats and ultimately would have helped to save more lives. In 2020, the Commission urgently adapted its Clinical Patient Management System, established by Commission Implementing Decision (EU) 2019/126941, to allow Member States to share electronic health data of COVID-19 patients moving between healthcare providers and Member States during the peak of the pandemic, but this was only an emergency solution, showing the need for a structural and systemicapproach at Member States and Union level. _________________ 41 Commission Implementing Decision (EU) 2019/1269 of 26 July 2019 amending Implementing Decision 2014/287/EU setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks (OJ L 200, 29.7.2019, p. 35).
Amendment 184 #
2022/0140(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The COVID-19 crisis strongly anchored the work of the eHealth Network, a voluntary network of digital health authorities, as the main pillar for the development of mobile contact tracing and warning applications and the technical aspects of the EU Digital COVID Certificates. It also highlighted the value of access to real time data to steer effective policy responses and the need for sharing electronic health data that are findable, accessible, interoperable and reusable (‘FAIR principles’), and ensuring that electronic health data are as open as possible and as closed as necessary. Synergies between the EHDS, the European Open Science Cloud42and the European Research Infrastructures should be ensured, as well as lessons learned from data sharing solutions developed under the European COVID-19 Data Platform. _________________ 42 EOSC Portal (eosc-portal.eu).
Amendment 188 #
2022/0140(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The processing of personal electronic health data is subject to the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council43and, for Union institutions and bodies, Regulation (EU) 2018/1725 of the European Parliament and of the Council44. References to the provisions of Regulation (EU) 2016/679 should be understood also as references to the corresponding provisions of Regulation (EU) 2018/1725 for Union institutions and bodies, where relevant. In addition, the Regulation should comply with Cyber Resilience Act. _________________ 43 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). 44 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
Amendment 196 #
2022/0140(COD)
Proposal for a regulation
Recital 5
Recital 5
(5) More and more Europeans cross national borders to work, study, visit relatives or to travel. To facilitate the exchange of health data, and in line with the need for empowering citizens, they should be able to access their health data in an electronic format that can be recognised and accepted across the Union. Such personal electronic health data could include personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about their health status, personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question, as well as data determinants of health, such as behaviour, environmental, physical influences, medical care, social or educational factors. Electronic health data also includes data that has been initially collected for research, statistics, threat assessment, policy making or regulatory purposes and may be made available according to the rules in Chapter IV. The electronic health data concern all categories of those data, irrespective to the fact that such data is provided by the data subject or other natural or legal persons, such as health professionals, or is processed in relation to a natural person’s health or well-being and should also include inferred and derived data, such as diagnostics, tests and medical examinations, as well as data observed and recorded by automatic means.
Amendment 200 #
2022/0140(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, and other complementary exams of diagnosis and therapeutics, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). To this end, Member States should ensure a common standard for health care data exchange to ensure and facilitate the data exchange and translation to the Union official languages. However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union action is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it. In this respect, appropriate funding and appropriate support at EU level should be considered as a means to reduce fragmentation, heterogeneity, and division and to achieve a system that is user-friendly and intuitive in all countries.
Amendment 209 #
2022/0140(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The right of access to data by a natural person, established by Article 15 of Regulation (EU) 2016/679, should be further developed in the health sector. Under Regulation (EU) 2016/679, controllers do not have to provide access immediately. While patient portals, mobile applications and other personal health data access services exist in many places, including national solutions in some Member States, the right of access to health data is still commonly implemented in many places through the provision of the requested health data in paper format or as scanned documents, which is time- consuming. This may severely impair timely access to health data by natural persons, and may have a negative impact on natural persons who need such access immediately due to urgent circumstances pertaining to their health condition. Appropriate Union funding should be granted to Member States transpose the information on Article 5(1) to electronic format. All health data prior to the implementation of this Regulation shall be inserted in electronic health records with the support of Member States and without additional burden to healthcare professionals.
Amendment 214 #
2022/0140(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) At the same time, it should be considered that immediate access to certain types of personal electronic health data may be harmful for the safety of natural persons, unethical or inappropriate. For example, it could be unethical to inform a patient through an electronic channel about a diagnosis with an incurable disease that is likely to lead to their swift passing instead of providing this information in a consultation with the patient first. Therefore, a possibility for limited exceptions in the implementation of this right should be ensured. Such an exception may be imposed by the Member States where this exception constitutes a necessary and proportionate measure in a democratic society, in line with the requirements of Article 23 of Regulation (EU) 2016/679. Such restrictions should be implemented by delaying the display of the concerned personal electronic health data to the natural person for a limited period. Where health data is only available on paper, if the effort to make data available electronically is disproportionate, there should be no obligation that such health data is converted until the moment of contact between the patient and the health professional. The availability of health data prior to the implementation of this regulation should happen in a timely manner into electronic format through a process facilitated by Member States. Any digital transformation in the healthcare sector should aim to be inclusive and benefit also natural persons with limited ability to access and use digital services. Natural persons should be able to provide an authorisation to the natural persons of their choice, such as to their relatives or other close natural persons, enabling them to access or control access to their personal electronic health data or to use digital health services on their behalf. Such authorisations may also be useful for convenience reasons in other situations. Proxy services should be established by Member States to implement these authorisations, and they should be linked to personal health data access services, such as patient portals on patient-facing mobile applications. The proxy services should also enable guardians to act on behalf of their dependent children; in such situations, authorisations could be automatic. In order to take into account cases in which the display of some personal electronic health data of minors to their guardians could be contrary to the interests or will of the minor, Member States should be able to provide for such limitations and safeguards in national law, as well as the necessary technical implementation. Personal health data access services, such as patient portals or mobile applications, should make use of such authorisations and thus enable authorised natural persons to access personal electronic health data falling within the remit of the authorisation, in order for them to produce the desired effect.
Amendment 221 #
2022/0140(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional data and does not have the same clinical or legal value as information provided by a healthcare professional. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural person should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on case by case basis, if necessary involving health professionals.
Amendment 225 #
2022/0140(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) Natural persons should be able to exercise control over the transmission of personal electronic health data to other healthcare providers. Healthcare providers and other organisations providing EHRs should facilitate the exercise of this right. Stakeholders such as healthcare providers, digital health service providers, manufacturers of EHR systems or medical devices should not limit or block the exercise of the right of portability because of the use of proprietary standards or other measures taken to limit the portability. Healthcare providers must follow data minimization principles when requesting personal health data, limiting it to the strictly necessary and justified data for a given service. For these reasons, the framework laid down by this Regulation builds on the right to data portability established in Regulation (EU) 2016/679 by ensuring that natural persons as data subjects can transmit their electronic health data, including inferred data, irrespective of the legal basis for processing the electronic health data. This right should apply to electronic health data processed by public or private controllers, irrespective of the legal basis for processing the data under in accordance with the Regulation (EU) 2016/679. This right should apply to all electronic health data.
Amendment 235 #
2022/0140(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Natural persons may not want to allow access to some parts of their personal electronic health data while enabling access to other parts. Such selective sharing of personal electronic health data should be supported. However, such restrictions may have life threatening consequences and, therefore, access to personal electronic health data should be possible to protect vital interests as an emergency override. According to Regulation (EU) 2016/679, vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person dependent on that information. Processing of personal electronic health data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law. Because the unavailability of the restricted personal electronic health data may impact the provision or quality of health services provided to the natural person, he/she should assume responsibility for the fact that the healthcare provider cannot take the data into account when providing health services.
Amendment 237 #
2022/0140(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Article 9(2), point (h), of Regulation (EU) 2016/679 provides for exceptions where the processing of senstitive data is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health care or treatment or the management of health care systems and services on the basis of Union or Member State law. This Regulation should provide conditions and safeguards for the processing of electronic health data by healthcare providers and health professionals in line with Article 9(2), point (h), of Regulation (EU) 2016/679 with the purpose of accessing personal electronic health data provided by the natural person or transmitted from other healthcare providers. However, this Regulation should be without prejudice to the national laws concerning the processing of health data, including the legislation establishing categories of health professionals that can process different categories of electronic health data.
Amendment 238 #
2022/0140(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and, avoiding duplications and errors and reducing costs. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format, which can be transmitted between healthcare providers can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as appropriate electronic and digital devices and health professional portals, to use personal electronic health data for the exercise of their duties. Moreover, the access to personal health records should be transparent to the natural persons and natural persons should be able to exercise full control over such access, including by limiting access to all or part of the personal electronic health data in their records. Health professionals should refrain from hindering the implementation of the rights of natural persons, such as refusing to take into account electronic health data originating from another Member State and provided in the interoperable and reliable European electronic health record exchange format. None of the provisions in this Regulation should be interpreted as limiting the obligation of healthcare professionals to conduct themselves in accordance with the applicable codes of conduct, deontological guidelines or other provisions governing ethical conduct with respect to sharing or accessing information, particularly in life- threatening or extreme situations.
Amendment 247 #
2022/0140(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity in standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category. Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of categories of electronic health data is needed. Categories of electronic health data such as patient summary, electronic prescription and dispensation, laboratory results and reports, hospitalealth units discharge reports, medical images and reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission. When further needs for the exchange of more categories of electronic health data are identified for healthcare purposes, the list of priority categories should be expanded. The Commission should be empowered to extend the list of priority categories, after analysing relevant aspects related to the necessity and possibility for the exchange of new datasets, such as their support by systems established nationally or regionally by the Member States. Particular attention should be given to the data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general.
Amendment 253 #
2022/0140(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format. This would also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, as referred to in the Policy Programme “Path to the Digital Decade”. In order to make electronic health data accesible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format, at least for certain categories of electronic health data, such as patient summaries, electronic prescriptions and dispensations, medical images and image reports, laboratory results and discharge reports, subject to transition periods. Where personal electronic health data is made available to a healthcare provider or a pharmacy by a natural person, or is transmitted by another data controller in the European electronic health record exchange format, the electronic health data should be read and accepted for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription. Commission Recommendation (EU) 2019/24345provides the foundations for such a common European electronic health record exchange format. The use of European electronic health record exchange format should become more generalised at EU and national level. While the eHealth Network under Article 14 of Directive 2011/24/EU of the European Parliament and of the Council46recommended Member States to use the European electronic health record exchange format in procurements, in order to improve interoperability, uptake was limited in practice, resulting in fragmented landscape and uneven access to and portability of electronic health data. _________________ 45 Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (OJ L 39, 11.2.2019, p. 18). 46 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 255 #
2022/0140(COD)
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19 a) The interoperability of the EHDS should contribute to high quality of European health data sets.
Amendment 259 #
2022/0140(COD)
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20 a) In order to support the successful implementation of the EHDS and the execution of an effective landscape of European health data cooperation, the European Commission and Member States should agree on time-based targets to implement improved health data interoperability across the European Union with a range of targets and milestones to be reviewed and assessed in an annual report.
Amendment 261 #
2022/0140(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) Under Article 168 of the Treaty Member States are responsible for their health policy, in particular for decisions on the services (including telemedicine) thatthat they provide and reimburse. Telemedicine and online pharmacy services have they provide and reimburseotential to reduce health inequalities and reinforce the free movement of european citizens across borders. Different reimbursement policies should, however, not constitute barriers to the free movement of digital health services such as telemedicine, including and online pharmacy services. When digital services accompany the physical provision of a healthcare service, the digital service should be included in the overall care provision.
Amendment 265 #
2022/0140(COD)
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) Telemedicine is becoming an increasingly important tool that can provide patients access to care and tackle inequities. Digital and other technological tools can minimize the circumstance of remote care, however, telemedicine should not be viewed as a replacement for in-person medicine, as there are certain conditions and procedures that require physical examination and intervention.
Amendment 271 #
2022/0140(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Digital health authorities should have sufficient technical skills, possibly bringing together experts from different organisations. The activities of digital health authorities should be well-planned and monitored in order to ensure their efficiency. Digital health authorities should take necessary measures to ensuring rights of natural persons by setting up national, regional, and local technical solutions such as national EHR, patient portals, data intermediation systems. When doing so, they should apply common standards and specifications in such solutions, promote the application of the standards and specifications in procurements and use other innovative means including reimbursement of solutions that are compliant with interoperability and security requirements of the EHDS. Digital health authorities should ensure that appropriate training initiatives are undertaken at the local level. In particular, health professionals should be informed and trained with respect to their rights and obligations under the present Regulation. To carry out their tasks, the digital health authorities should cooperate at national and Union level with other entities, including with insurance bodies, healthcare providers, healthcare professionals, manufacturers of EHR systems and wellness applications, as well as other stakeholders from health or information technology sector, entities handling reimbursement schemes, health technology assessment bodies, medicinal products regulatory authorities and agencies, medical devices authorities, procurers and cybersecurity or e-ID authorities.
Amendment 277 #
2022/0140(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Access to and transmission of electronic health data is relevant in cross- border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States in the digital infrastructure MyHealth@EU should become mandatory. All Member States should join the infrastructure and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data, and funding as well as other means of European level support should be considered.
Amendment 285 #
2022/0140(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) In the context of MyHealth@EU, a central platform should provide a common infrastructure for the Member States to ensure connectivity and interoperability in an efficient and secure way. In order to guarantee compliance with data protection rules and to provide a risk management framework for the transmission of personal electronic health data, the Commission should, by means of implementing acts, allocate specific responsibilities with time- based targets among the Member States, as joint controllers, and prescribe its own obligations, as processor.
Amendment 291 #
2022/0140(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme, as well as to instill the trust of citizens. To that end, a mandatory conformity assessment by notified bodies for EHR systems processing one or more priority categories of electronic health data should be establishconducted to overcome market fragmentation while ensuring a proportionate approach. Through this self- certification,compliance with robust security and data protection requirements. Through this conformity assessment, notified bodies should ascertain that EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48. _________________ 48 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15).
Amendment 299 #
2022/0140(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) While EHR systems specifically intended by the manufacturer to be used for processing one or more specific categories of electronic health data should be subject to a mandatory self-certificationconformity assessment by a notified body, software for general purposes should not be considered as EHR systems, even when used in a healthcare setting, and should therefore not be required to comply with the provisions of Chapter III.
Amendment 302 #
2022/0140(COD)
Proposal for a regulation
Recital 30
Recital 30
(30) To further support interoperability and security, Member States may maintain or define specific rules for the procurement, reimbursement, financing or use of EHR systems at national level in the context of the organisation, delivery or financing of health services. Such specific rules should not impede the free movement of EHR systems in the Union. Some Member States have introduced mandatory certification of EHR systems or mandatory interoperability testing for their connection to national digital health services. Such requirements are commonly reflected in procurements organised by healthcare providers, national or regional authorities. Mandatory certification of EHR systems at Union level via a conformity assessment procedure should establish a baseline that can be used in procurements at national level.
Amendment 303 #
2022/0140(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) Compliance with essential requirements on interoperability and security should be demonstrated by the manufacturers of EHR systems through the implementation of common specifications. To that end, implementing powers should be conferred on the Commission to determine such common specifications regarding datasets, coding systems, technical specifications, including standards, specifications and profiles for data exchange, as well as requirements and principles related to security, confidentiality, integrity, patient safety and protection of personal data as well as specifications and requirements related to identification management and the use of electronic identification. Digital health authorities should contribute to the development of such common specifications and base their discussion on previous debates.
Amendment 304 #
2022/0140(COD)
Proposal for a regulation
Recital 34
Recital 34
(34) In order to ensure an appropriate and effective enforcement of the requirements and obligations laid down in Chapter III of this Regulation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 should apply. Depending on the organisation defined at national level, such market surveillance activities could be carried out by the digital health authorities ensuring the proper implementation of Chapter II, notified bodies for EHR systems or a separate market surveillance authority responsible for EHR systems. While designating digital health authorities or national notified bodies as market surveillance authorities could have important practical advantages for the implementation of health and care, any conflicts of interest should be avoided, for instance by separating different tasks.
Amendment 311 #
2022/0140(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) Users of wellness applications, such as mobile applications, should be informed about the capacity of such applications to be connected and to supply data to EHR systems or to national electronic health solutions, in cases where data produced by wellness applications is useful for healthcare purposes. The capability of those applications to export data in an interoperable format is also relevant for data portability purposes. Where applicable, users should be informed about the compliance of such applications with interoperability and security requirements. However, given the large number of wellness applications and the limited relevance for healthcare purposes of the data produced by many of them, a certification scheme for these applications would not be proportionate. A voluntamandatory labelling scheme should therefore be established as an appropriate mechanism for enabling the transparency for the users of wellness applications regarding compliance with the requirements, thereby supporting users in their choice of appropriate wellness applications with high standards of interoperability and security. Such labelling schemes should also include information for users on data protection rights and an indication of whether the provider of the app or the browser operator has access to data generated by the app in any way. The Commission mayshould set out in implementing acts the details regarding the format and content of such label.
Amendment 324 #
2022/0140(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) For the secondary use of the clinical data for research, innovation, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically: for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, in this case it is this Regulation that provides the safeguardsthe necessary safeguards must be determined in accordance to this Regulation. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data.
Amendment 329 #
2022/0140(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In the context of the EHDS, the electronic health data already exists and is being collected by healthcare providers, professional associations, public institutions, regulators, researchers, insurers etc. in the course of their activities. Some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records, genetic data, claims data, etc.), others are collected also for other purposes such as research, statistics, health surveillance, patient safety, regulatory activities or policy making (e.g. disease registries, policy making registries, registries concerning the side effects of medicinal products or medical devices, etc.). For instance, European databases that facilitate data (re)use are available in some areas, such as cancer (European Cancer Information System) or rare diseases (European Platform on Rare Disease Registration, ERN registries, etc.). These data should also be made available for secondary use. However, much of the existing health- related data is not made available for purposes other than that for which they were collected. This limits the ability of researchers, innovators, policy- makers, regulators and doctors to use those data for different purposes, including research, innovation, policy-making, regulatory purposes, patient safety or personalised medicine. In order to fully unleash the benefits of the secondary use of electronic health data, all data holders should contribute to this effort in making different categories of electronic health data they are holding available for secondary use insofar as such effort is always conducted through effective and secured processes, such as aggregation and randomisations and with due respect to professional duties, including but not limited to, confidentiality duties.
Amendment 340 #
2022/0140(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) The categories of electronic health data that can be processed for secondary use should be broad and flexible enough to accommodate the evolving needs of data users, while remaining limited to data related to health or known to influence health. It can also include relevant data from the health system (electronic health records, claims data, disease registries, genomic data etc.), as well as data with an impact on health (for example consumption of different substances, homelessness, health insurance, minimum income, professional status, behaviour, including environmental factors (for example, pollution, radiation, use of certain chemical substances). They can also include person- generated data, such as data from medical devices, wellness applications or other wearables and digital health applications. The data user who benefits from access to datasets provided under this Regulation could enrich the data with various corrections, annotations and other improvements, for instance by supplementing missing or incomplete data, thus improving the accuracy, completeness or quality of data in the dataset for research and innovation activities. To support the improvement of the original database and further use of the enriched dataset, the dataset with such improvements and a description of the changes should be made available free of charge to the original data holder. The data holder should make available the new dataset, unless it provides a justified notification against it to the health data access body, for instance in cases of low quality of the enrichment. Secondary use of non-personal electronic data should also be ensured. In particular, pathogen genomic data hold significant value for human health, as proven during the COVID-19 pandemic. Timely access to and sharing of such data has proven to be essential for the rapid development of detection tools, medical countermeasures and responses to public health threats. The greatest benefit from pathogen genomics effort will be achieved when public health and research processes share datasets and work mutually to inform and improve each other.
Amendment 345 #
2022/0140(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) The data holders can be public, non for profit or private health or care providers, public, non for profit and private organisations, associations or other entities, public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. Health professionals contribute to the EHDS by registering the required categories of patient data in the EHR. Health professionals who are required to register data in an EHR system for primary use purposes should be exempt from providing the data again for secondary use purposes. In order to avoid a disproportionate burden on small entities, micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of EHDS. The public or private entities often receive public funding, from national or Union funds to collect and process electronic health data for research, statistics (official or not) or other similar purposes, including in area where the collection of such data is fragmented ofr difficult, such as rare diseases, cancer etc. Such data, collected and processed by data holders with the support of Union or national public funding, should be made available by data holders to health data access bodies, in order to maximise the impact of the public investment and support research, innovation, patient safety or policy making benefitting the society. In some Member States, private entities, including private healthcare providers and professional associations, play a pivotal role in the health sector. The health data held by such providers should also be made available for secondary use. At the same time, data benefiting from specific legal protection such as intellectual property from medical device companies or pharmaceutical companies often enjoy copyright protection or similar types of protection. However, public authorities and regulators should have access to such data, for instance in the event of pandemics, to verify defective devices and protect human health. In times of severe public health concerns (for example, PIP breast implants fraud) it appeared very difficult for public authorities to get access to such data to understand the causes and knowledge of manufacturer concerning the defects of some devices. The COVID-19 pandemic also revealed the difficulty for policy makers to have access to health data and other data related to health. Such data should be made available for public and regulatory activities, supporting public bodies to carry out their legal mandate, while complying with, where relevant and possible, the protection enjoyed by commercial data. Specific rules in relation to the secondary use of health data should be provided. Data altruism activities may be carried out by different entities, in the context of Regulation […] [Data Governance Act COM/2020/767 final] and taking into account the specificities of the health sector.
Amendment 356 #
2022/0140(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The secondary use of health data under EHDS should enable the public, private, not for profit entities, as well as individual researchers to have access to health data for research, innovation, policy making, educational activities, patient safety, regulatory activities or personalised medicine, in line with the purposes set out in this Regulation. Access to data for secondary use should contribute to the general interest of the society. Particularly, the secondary use of health data for research and development purposes should contribute to a return to society in the form of new medicines, medical devices, health care products and services at affordable and fair prices for European citizens, as well as enhancing access and availability of such in all Member States. Activities for which access in the context of this Regulation is lawful may include using the electronic health data for tasks carried out by public health bodies, such as exercise of public duty, including public health surveillance, planning and reporting duties, health policy making, ensuring patient safety, quality of care, and the sustainability of health care systems. Public bodies and Union institutions, bodies, offices and agenciesNational public health authorities and European Union agencies related to health may require to have regular access to electronic health data for an extended period of time, including in order to fulfil their mandate, which is provided by this Regulation. POther public sector bodies from Member States and European Union institutions, bodies, offices and agencies may carry out such research activities by using third parties, including sub- contractors, as long as the public sector body remain at all time the supervisor of these activities. The provision of the data should also support activities related to scientific research (including private research), development and innovation, producing goods and services for the health or care sectors, such as innovation activities or training of AI algorithms that could protect the health or care of natural persons. In some cases, the information of some natural persons (such as genomic information of natural persons with a certain disease) could support the diagnosis or treatment of other natural persons. There is a need for public bodies to go beyond the emergency scope of Chapter V of Regulation […] [Data Act COM/2022/68 final]. However, the public sector bodies may request the support of health data access bodies for processing or linking data. This Regulation provides a channel for public sector bodies to obtain access to information that they require for fulfilling their tasks assigned to them by law, but does not extend the mandate of such public sector bodies. Any attempt to use the data for any measures detrimental to the natural person, to increase insurance premiums, to advertise products or treatments, or develop harmful products should be prohibited.
Amendment 362 #
2022/0140(COD)
Proposal for a regulation
Recital 41 a (new)
Recital 41 a (new)
(41 a) Natural persons should be empowered to and have a right to control their electronic health data under this Regulation. Therefore the possibility for data subjects to decline the processing of all or parts of their health data for secondary use for some or all purposes should be provided. An easily understandable and accessible opt-out mechanism in a user-friendly format should be provided in this regard. Natural persons who opt-out of the processing of some or all of their health data for secondary use should not preclude their possibility to reconsider and provide some or all of their health data for secondary use at a later point.
Amendment 365 #
2022/0140(COD)
Proposal for a regulation
Recital 41 b (new)
Recital 41 b (new)
(41 b) Due to the highly sensitive nature of certain types of electronic health data, where full anonymisation is not possible and therefore the risk of re-identification of the data subject is high, additional safeguards should be provided for. An opt-in mechanism whereby data subjects explicitly consent or give their permission to the processing of part or all of such data for some or all secondary use purposes should be envisaged. This is particularly relevant for human genetic, genomic and proteomic data, as well as data from biobanks. Where data subjects explicitly consent to the use of parts or all of this data for some or all secondary use purposes, they should be made aware of the sensitive nature of the data they are sharing.
Amendment 366 #
2022/0140(COD)
Proposal for a regulation
Recital 41 c (new)
Recital 41 c (new)
(41 c) Different demographics have varying degrees of digital literacy which may hamper their ability to enact their rights to control their electronic health data. In addition to the right for natural persons to authorise another natural person of their choice to access or control their electronic health data on their behalf, Member States should charge digital health authorities with the creation of targeted national digital literacy programmes to maximise social inclusion and to ensure all natural persons can effectively exercise their rights under this Regulation.
Amendment 376 #
2022/0140(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) Considering the administrative burden for health data access bodies to inform the natural persons whose data are used in data projects within a secure processing environment, the exceptions provided for in Article 14(5) of Regulation (EU) 2016/679 should apply. Therefore, health data access bodies should provide general information concerning the conditions for the secondary use of their health data containing the information items listed in Article 14(1) and, where necessary to ensure fair and transparent processing, Article 14(2) of Regulation (EU) 2016/679, e.g. information on the purpose and the data categories processed. Exceptions from this rule should be made when the results of the research could assist in the treatment of the natural person concerned. In this case, the data user should inform the health data access body, which should inform the data subject or his health professional, with due regard for the stated wish of the data subject not to be contacted. Natural persons should be able to access the results of different research projects on the website of the health data access body, ideally in an easily searchable manner. The list of the data permits should also be made public. In order to promote transparency in their operation, each health data access body should publish an annual activity report providing an overview of its activities.
Amendment 380 #
2022/0140(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) In order to support the secondary use of electronic health data, the data holders should refrain from withholding the data, requesting unjustified fees that are not transparent nor proportionate with the costs for making data available (and, where relevant, with marginal costs for data collection), requesting the data users to co- publish the research or other practices that could dissuade the data users from requesting the data. Where ethical approval is necessary for providing a data permit, its evaluation should be based on its own merits. On the other hand, Union institutions, bodies, offices andnational public health authorities, European Union agencies, including EMA, ECDC and the Commission,EMCDDA have very important and insightful data. Access to data of such institutions, bodies, offices and agencies should be granted through the health data access body where the controller is located.
Amendment 387 #
2022/0140(COD)
Proposal for a regulation
Recital 48
Recital 48
(48) In order to strengthen the enforcement of the rules on the secondary use of electronic health data, appropriate measures that can lead to penalties or temporary or definitive exclusions from the EHDS framework ofr even fines directed to the data users or data holders that do not comply with their obligations. The health data access body should be empowered to verify compliance and give data users and holders the opportunity to reply to any findings and to remedy any infringement. The imposition of penalties should be subject to appropriate procedural safeguards in accordance with the general principles of law of the relevant Member State, including effective judicial protection and due process.
Amendment 389 #
2022/0140(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) Given the sensitivity of electronic health data, it is necessary to reduce risks on the privacy of natural persons by applying the data minimisation principle as set out in Article 5 (1), point (c) of Regulation (EU) 2016/679. Therefore, common standards for data anonymisation shall be further developed and the use of anonymised electronic health data which is devoid of any personal data should be made available, when possible and if the data user asks it, with data that cannot be anonymised or pseudonymized being excluded of reuse possibilities. Requests of pseudonymised data should be duly justified. When providing access to a pseudonymised or anonymised dataset, a Data Access Body should follow state-of- the-art anonymisation/pseudonymisation technology. If the data user needs to use personal electronic health data, it should clearly indicate in its request the justification for the use of this type of data for the planned data processing activity. The personal electronic health data should only be made available in pseudonymised format and the encryption key can only be held by the health data access body. Data users should not attempt to re-identify natural persons from the dataset provided under this Regulation, subject to administrative or possible criminal penalties, where the national laws foresee this. However, this should not prevent, in cases where the results of a project carried out based on a data permit has a health benefit or impact to a concerned natural person (for instance, discovering treatments or risk factors to develop a certain disease), the data users would inform the health data access body, which in turn would inform the concerned natural person(s)'s professional, with due regard for the stated wish of the data subject not to be contacted. Moreover, the applicant can request the health data access bodies to provide the answer to a data request, including in statistical form. In this case, the data users would not process health data and the health data access body would remain sole controller for the data necessary to provide the answer to the data request.
Amendment 411 #
2022/0140(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) As the COVID-19 crisis has shown, the Union institutions, bodies, offices and agencies, especially the Commission, need access to health data for a longer period and on a recurring basis. This is may be the case not only in specific circumstances in times of crisis but also to provide scientific evidence and technical support for Union policies on a regular basis. Access to such data may be required in specific Member States or throughout the whole territory of the Union.
Amendment 418 #
2022/0140(COD)
Proposal for a regulation
Recital 53
Recital 53
(53) For requests to access electronic health data from a single data holder in a single Member State and in order to alieviate the administrative burden for heath data access bodies of managing such request, the data user should be able to request this data directly from the data holder and the data holder should be able to issue a data permit while complying with all the requirements and safeguards linked to such request and permit. Multi- country requests and requests requiring combination of datasets from several data holders should always be channelled through health data access bodies. The data holder should report to the health data access bodies about any data permits or data requests they provide.
Amendment 431 #
2022/0140(COD)
Proposal for a regulation
Recital 57
Recital 57
(57) The authorisation process to gain access to personal health data in different Member States can be repetitive and cumbersome for data users. Whenever possible, synergies should be established to reduce the burden and barriers for data users. One way to achieve this aim is to adhere to the “single application” principle whereby, with one application, the data user obtains authorisation from multiple health data access bodies in different Member States.
Amendment 434 #
2022/0140(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) Cooperation and work is ongoing between different professional organisations, the Commission and other institutions to set up minimum data fields and other characteristics of different datasets (registries for instance). This work is more advanced in areas such as cancer, rare diseases, cardiovascular and metabolic diseases, risk factors assessment and statistics and shall be taken into account when defining new standards and disease-specific harmonised templates for structured data elements.. However, many datasets are not harmonised, raising comparability issues and making cross- border research difficult. Therefore, more detailed rules should be set out in implementing acts to ensure a harmonised provision, coding and registration of electronic health data. Member States should work towards delivering sustainable economic and social benefits of European electronic health systems and services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of healthcare and ensuring access to safe and high-quality healthcare. Existing health data infrastructures and registries put in place by institutions and stakeholders can contribute to defining and implementing data standards, to ensuring interoperability and must be leveraged to allow continuity and build on existing expertise.
Amendment 450 #
2022/0140(COD)
Proposal for a regulation
Recital 64 a (new)
Recital 64 a (new)
(64 a) Member States should consider criminalising unauthorised re- identification and disclosure of de- identified personal data to serve as a deterrent measure.
Amendment 459 #
2022/0140(COD)
Proposal for a regulation
Recital 65 a (new)
Recital 65 a (new)
(65 a) The EHDS Board should operate transparently with open publication of meeting dates and minutes of the discussion as well as an annual report elaborated together with the European Commission.
Amendment 462 #
2022/0140(COD)
Proposal for a regulation
Recital 70
Recital 70
(70) Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties and fines for their infringement. For certain specific infringements, Member States should take into account the margins and criteria set out in this Regulation.
Amendment 464 #
2022/0140(COD)
Proposal for a regulation
Recital 71
Recital 71
(71) In order to assess whether this Regulation reaches its objectives effectively and efficiently, is coherent and still relevant and provides added value at Union level the Commission should carry out an evaluation of this Regulation. The Commission should carry out a partial evaluation of this Regulation 53 years after its entry into force, on the self-certification of EHR systems, and an overall evaluation 75 years after the entry into force of this Regulation. The Commission should submit reports on its main findings following each evaluation to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions.
Amendment 474 #
2022/0140(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) strengthenoutlines the rights of natural persons in relation to the availability and control of their electronic health data;
Amendment 515 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) ‘non-personal electronic health data’ means data concerning health and genetic data in electronic formatrelevant for health research in electronic format that have been irreversibly anonymised and data that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;
Amendment 516 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point b
Article 2 – paragraph 2 – point b
(b) ‘non-personal electronic health data’ means data concerning mental and physical health and genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;
Amendment 534 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals, involving the exchange of information and knowledge without changing the content or quality of the data between these organisations, software applications or devices, through the processes they support, enabling data portability across data holders and health care providers for data recipients and data users;
Amendment 538 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
(g) ‘European electronic health record exchange format’ means a structured, commonly used and machine-readable format that allows transmission of personal electronic health data between different organisations, software applications, devices and healthcare providers;
Amendment 541 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point j
Article 2 – paragraph 2 – point j
(j) ‘health professional access service’ means a service, supported by an EHR system, that enables health professionals to access data of natural persons under their treatmentcare and with authorised permission to do so;
Amendment 548 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point l
Article 2 – paragraph 2 – point l
(l) ‘telemedicine’ means the provision of healthcare services, including remote care and online pharmacies, through the use of information and communication technologies, in situations where the health professional and the patient (or several health professionals) are not in the same location;
Amendment 549 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point m
Article 2 – paragraph 2 – point m
(m) ‘EHR’ (electronic health record) means any collection of electronicthe past or present electronic mental and physical health data related to a natural person and collected in the health system, processed for healthcarethe purpose of the provision of healthcare services or research purposes;
Amendment 555 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point n
Article 2 – paragraph 2 – point n
(n) ‘EHR system’ (electronic health record system) means any appliance or softwarother article whose primary purpose intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records or that can be reasonably expected by the manufacturer to be used for these purposes;
Amendment 564 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point o
Article 2 – paragraph 2 – point o
(o) ‘wellness application’ means any appliance or software intended by the manufacturer to be used by a natural person for processing electronic health data for other purposes than healthcare, such as well-being and pursuing healthy life- styla healthy lifestyle, well-being purposes or that can be reasonably expected by the manufacturer for these purposes;
Amendment 572 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point y
Article 2 – paragraph 2 – point y
(y) ‘data holder’ means any natural or legal person, which is an entity or a body controller as set out in Regulation (EU) 2016/679 in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies whoich are a controller as set out in Regulation (EU) 2018/1725 which hasve the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, to process personal electronic health data or in the case of non-personal health data, through control of the technical design of athe product and related services, the ability to make and as allowed by contract with natural or legal person owning, renting or leasing the product or related service, the ability to make the relevant and appropriate data pursuant to the relevant requirements laid down in this Regulation available, including to register, provide, restrict access or exchange certain data;
Amendment 594 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ac
Article 2 – paragraph 2 – point ac
(ac) ‘dataset catalogue’ means a collection of datasets descriptions, which is arranged in a systematic manner and consists of a user-oriented public part, where information concerning individual dataset parameters is accessible by electronic means through an online portal;
Amendment 603 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae a (new)
Article 2 – paragraph 2 – point ae a (new)
(ae a) "notified body’ means a conformity assessment body notified in accordance with Article 27f of this Regulation;
Amendment 607 #
2022/0140(COD)
(ae b) ‘conformity assessment’ means the process demonstrating whether the essential requirements of this Regulation relating to EHR systems have been fulfilled;
Amendment 612 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae c (new)
Article 2 – paragraph 2 – point ae c (new)
(ae c) ‘conformity assessment body’ means a body that performs conformity assessment activities, including testing, certification and inspection;
Amendment 615 #
2022/0140(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point ae d (new)
Article 2 – paragraph 2 – point ae d (new)
(ae d) ‘data sharing’ means the provision defined in Article 2 (10) of the Regulation (EU) 2022/868;
Amendment 633 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. In accordance with Article 23 of Regulation (EU) 2016/679, Member States may restrict the scope of thisese rights whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on his or her health.
Amendment 638 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. Where the personal health data have not been registered electronically prior to the application of this Regulation, Member States mayshall require that such data is made available in electronic format pursuant to this Article. This shall not affect the obligation to make personal electronic health data registered after the application of this Regulation available in electronic format pursuant to this Article.
Amendment 644 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 5 – subparagraph 1 – point b
Article 3 – paragraph 5 – subparagraph 1 – point b
(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf or to enable legal guardians to act on behalf of their dependents in accordance with the national law of the Member State.
Amendment 654 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. Natural persons may insert, access and export their electronic health data in and from their own EHR or in that of natural persons whose health information they can access, through electronic health data access services orand applications linked to these services. That information shall be marked as inserted by the natural person or by his or her representative as non-validated, and information shall only be considered as a clinical fact if validated by an identified, registered health professional with the relevant competence. Natural persons shall not have the possibility to directly change data inserted by healthcare professionals. The process must be secure.
Amendment 662 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 7
Article 3 – paragraph 7
7. Member States shall ensure that, when exercising the right to rectification under Article 16 of Regulation (EU) 2016/679, natural persons can easily request rectification online through the electronic health data access services referred to in paragraph 5, point (a), of this Article. The rectification of a clinical fact in the EHR must be validated by an identified, registered health professional with the appropriate competence. The process must be secure.
Amendment 668 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 1
Article 3 – paragraph 8 – subparagraph 1
Natural persons shall have the right to give access to or request a data holder from the health or social security sector to transmit partially or totally, their electronic health data to a data recipient of their choice from the health or social security sector, immediately, free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder.
Amendment 673 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 3
Article 3 – paragraph 8 – subparagraph 3
By way of derogation from Article 9 of Regulation […] [Data Act COM/2022/68 final], the data recipient shall not be required to compensate the data holder for making electronic health data available.
Amendment 674 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 4
Article 3 – paragraph 8 – subparagraph 4
Natural persons shall have the right that, where priority categories of personal electronic health data referred to in Article 5 are transmitted or made available by the natural person according to the European electronic health record exchange format referred to in Article 6, such data shall be read and accepterecognised as valid by other healthcare providers.
Amendment 680 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 9
Article 3 – paragraph 9
9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. Member StatesFor judicial reasons strictly related to medical liability of health professionals, the date and time of omitted information must be recorded and only visible to the health data access bodies under these circumstances. The European Commission shall establish the rules and specific safeguards regarding such restriction mechanisms through a delegated act.
Amendment 691 #
2022/0140(COD)
Proposal for a regulation
Article 3 – paragraph 10
Article 3 – paragraph 10
10. Natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. In order to demonstrate compliance with this right, all relevant entities shall maintain a system of automated recording showing unequivocally who, when and where had access to data, accessible to the patient. The information shall be provided immediately and free of charge through electronic health data access services in a commonly accepted, interoperable format.
Amendment 714 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) have access to the electronic health data of natural persons under their treatmentcare and restrict to their functions of action, irrespective of the Member State of affiliation and the Member State of treatment;
Amendment 718 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) ensure that the personal electronic health data of the natural persons they treatcare are updated with information related to the health services provided and, if not, update data concerning the health services provided by them.
Amendment 731 #
2022/0140(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals lawfully exercising their activities through health professional access services and that health professionals can easily select specific relevant information in the EHR. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge. To this end, they may cooperate, where appropriate, with professional associations under the terms provided for by national rules.
Amendment 763 #
2022/0140(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point f
Article 5 – paragraph 1 – subparagraph 1 – point f
(f) discharge reports.;
Amendment 765 #
2022/0140(COD)
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point f a (new)
Article 5 – paragraph 1 – subparagraph 1 – point f a (new)
(f a) medical directives.
Amendment 785 #
2022/0140(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) harmonised datasets containing electronic health data and defining structures, such minimum as data fields and data groups for the content representation of clinical content and other parts of the electronic health data, that can be enlarged to include disease-specific data;
Amendment 790 #
2022/0140(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. Member States shall ensure that the priority categories of personal electronic health data referred to in Article 5 are issued in the format referred to in paragraph 1 and such data shall be read and accepted by therecognised as valid by the data recipient including measures aimed at ensuring priority categories of personal electronic health data arecipient translated as necessary for the provision of healthcare to the language of the patient or the healthcare professional.
Amendment 796 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Member States shall ensure that, wWhere data is processed in electronic format, Member States shall facilitate health professionals to systematically register the relevant health data falling under at least the priority categories referred to in Article 5 concerning the health services provided by them to natural persons, in the electronic format in an EHR system.
Amendment 806 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 3 – subparagraph 1 – introductory part
Article 7 – paragraph 3 – subparagraph 1 – introductory part
The Commission shall, by means of implementingdelegated acts, determine the requirements for the registration of electronic health data by healthcare providers and natural persons, as relevant. Those implementingdelegated acts shall establish the following:
Amendment 816 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 3 a (new)
Article 7 – paragraph 3 a (new)
3 a. For the purpose of transparency and accountability, natural persons or their legal representatives must be able to see which healthcare professional accessed their electronic health record separately in each specific category and when.
Amendment 817 #
2022/0140(COD)
Proposal for a regulation
Article 7 – paragraph 3 b (new)
Article 7 – paragraph 3 b (new)
3 b. When health data is registered or updated, electronic health records must identify the time, person and location of the registry.
Amendment 826 #
2022/0140(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Where a Member State accepts the provision of telemedicine services, it shall, under the same conditions, accept the provision of the services of the same type by healthcare providers located in other Member States with the same rights and obligations to access and register electronic health data. Telemedicine services shall respect the national law of the Member State in which is being provided.
Amendment 835 #
2022/0140(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission shall, by means of implementingdelegated acts, determine the requirements for the interoperable, cross- border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final]. The mechanism shall facilitate the transferability of electronic health data in a cross-border context. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 836 #
2022/0140(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The Member States and the Commission shall implement services required by the interoperable, cross-border identification and authentication mechanism referred to in paragraph 2 of this Article at Union level, as part of the cross-border digital health infrastructure referred to in Article 12(3).
Amendment 839 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. Each Member State shall designate a digital health authority responsible for the implementation and enforcement of this Chapter at national level. Implementation shall be harmonised at national level and across Member States with the EHDS Board conducting an oversight and leadership role in achieving this. The Member State shall communicate the identity of the digital health authority to the Commission by the date of application of this Regulation. Where a designated digital health authority is an entity consisting of multiple organisations, the Member State shall communicate to the Commission a description of the separation of tasks between the organisations. The Commission shall make this information publicly available.
Amendment 843 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point b
Article 10 – paragraph 2 – point b
(b) ensure that complete and up to date information about the implementation of rights and obligations provided for in in Chapters II and III is made readily available to natural persons, health professionals and healthcare providers and that appropriate training initiatives are undertaken at the local level;
Amendment 853 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point k
Article 10 – paragraph 2 – point k
(k) offer, in compliance with national legislation, telemedicine services and ensure that such services are easy to use, accessible and equitable to different groups of natural persons and health professionals, including natural persons with disabilities, do not discriminate and offer the possibility of choosing between in person and digital services;
Amendment 855 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point k a (new)
Article 10 – paragraph 2 – point k a (new)
(k a) ensure a communication plan to the natural person, health professional and stakeholders to inform the rights and obligations of which element of the EHDS and inform the natural person the advantages and potential gains to science and society of the primary and secondary use of electronic health data;
Amendment 856 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point k b (new)
Article 10 – paragraph 2 – point k b (new)
(k b) offer, free of charge, accessible online training, to natural persons and health professionals on how to use electronic health data access service and health professional access service, respectively;
Amendment 882 #
2022/0140(COD)
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ and healthcare professionals’ representatives. Members of the digital health authority shall avoid any conflicts of interest. The Commission shall be empowered to adopt delegated acts setting out what is likely to constitute a conflict of interest together with the procedure to be followed in such cases.
Amendment 903 #
2022/0140(COD)
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. The digital health authority with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken and inform the legal authorities if applicable.
Amendment 918 #
2022/0140(COD)
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. The Commission shall, by means of implementing acts, adopt the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to MyHealth@EU and conditions for temporary or definitive exclusion from MyHealth@EU. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The implementing act shall include the agreement of target implementation dates, including for improved cross-border health data interoperability, in consultation with the EHDS board.
Amendment 953 #
2022/0140(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. EHR systems may be placed on the market or put into service only if theyafter a notified body has assessed and verified that the EHR system complyies with the provisions laid down in this Chapter.
Amendment 962 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) draw up the technical documentation of their EHR systems in accordance with Article 24 before placing their system on the market;
Amendment 965 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point d
Article 17 – paragraph 1 – point d
(d) draw up an EU declaration of conformitycarry out the relevant conformity assessment procedures as referred to in Article 267a;
Amendment 966 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point d a (new)
Article 17 – paragraph 1 – point d a (new)
Amendment 967 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point e
Article 17 – paragraph 1 – point e
Amendment 969 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point g
Article 17 – paragraph 1 – point g
(g) take without undue delay any necessary corrective action in respect of their EHR systems which are not or are no longer in conformity with the essential requirements laid down in Annex II, or recall or withdraw such systems;
Amendment 971 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point i
Article 17 – paragraph 1 – point i
(i) inform the market surveillance authorities and notified bodies of the Member States in which they made their EHR systems available or put them into service of the non- conformity and of any corrective action taken;
Amendment 975 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point j
Article 17 – paragraph 1 – point j
(j) upon request of a market surveillance authority or a notified body, provide it with all the information and documentation necessary to demonstrate the conformity of their EHR system with the essential requirements laid down in Annex II.
Amendment 976 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point k
Article 17 – paragraph 1 – point k
(k) cooperate with market surveillance authorities and notified bodies, at their request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.
Amendment 979 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. Manufacturers of EHR systems shall ensure that procedures are in place to ensure that the design, development and deployment of an EHR system continues to comply with the essential requirements laid down in Annex II and the common specifications referred to in Article 23. Changes in EHR system design or characteristics shall be adequately taken into account and reflected in the technical documentationfor EHR systems to remain in conformity with this Regulation. Changes in EHR system design or characteristics and changes in the harmonised standards or the technical specifications referred to in Annex II and III by reference to which the conformity of the EHR system is declared or by application of which its conformity is verified shall be adequately taken into account and reflected in the technical documentation. When deemed appropriate with regard to the risks presented by EHR systems, manufacturers shall, to protect the rights of natural persons, carry out sample testing or put into service, investigate, and, if necessary, keep a register of complaints, of non-conforming EHR systems and EHR systems recalls, and shall keep distributors informed of any such monitoring.
Amendment 980 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. Manufacturers of EHR systems shall keep the technical documentation and the EU declaration of conformity for 10 years after the last EHR system covered by the EU declaration of conformity has been placed on the market, where relevant, at the disposal of the market surveillance authorities for 10 years after the last EHR system conformity assessment. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from the competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in Annex II.
Amendment 982 #
2022/0140(COD)
3 a. Manufacturers who consider or have reason to believe that an EHR system, which they have placed on the market or put into service is not in conformity with the essential requirements set out in Annex II shall immediately take the corrective measures necessary to bring that EHR system into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the EHR system presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the EHR system available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.
Amendment 984 #
2022/0140(COD)
Proposal for a regulation
Article 17 – paragraph 3 b (new)
Article 17 – paragraph 3 b (new)
3 b. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EHR system with the essential requirements set out in Annex II, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any measures taken to eliminate the risks posed by the EHR system, which they have placed on the market or put into service.
Amendment 990 #
2022/0140(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point a
Article 18 – paragraph 2 – point a
(a) keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for the period referred to in Article 17(3);
Amendment 994 #
2022/0140(COD)
Proposal for a regulation
Article 18 – paragraph 2 – point c
Article 18 – paragraph 2 – point c
(c) cooperate with the market surveillancecompetent national authorities, at their request, on any corrective action taken in relation to the EHR systems covered by their mandate.
Amendment 999 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point a
Article 19 – paragraph 2 – point a
(a) the manufacturer has drawn up the technical documentation and the EU declaration of conformity;
Amendment 1000 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point a a (new)
Article 19 – paragraph 2 – point a a (new)
(a a) ensure that the appropriate conformity assessment procedures referred to in Article 27a have been carried out by the manufacturer
Amendment 1002 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point b
Article 19 – paragraph 2 – point b
(b) the EHR system bears the CE marking of conformity referred to in Article 27 ;
Amendment 1005 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. Where an importer considers or has reason to believe that an EHR system, which they have placed on the market, is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. In situations where the EHR system is already on the market, importers shall immediately take the corrective measures necessary to bring that EHR system into conformity, to withdraw it or recall it, as appropriate. The importer shall inform without undue delay the manufacturer of such EHR system and the market surveillancenational competent authorities of the Member State in which it made the EHR system available, to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in Annex II.
Amendment 1007 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 6
Article 19 – paragraph 6
6. Importers shall keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for the period referred to in Article 17(3) and ensure that the technical documentation can be made available to those authorities, upon request. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in Annex II.
Amendment 1010 #
2022/0140(COD)
Proposal for a regulation
Article 19 – paragraph 7
Article 19 – paragraph 7
7. Importers shall, further to a reasoned request from a market surveillancecompetent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official language of the Member State where the market surveillancecompetent national authority is located. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.
Amendment 1015 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 1 – point a
Article 20 – paragraph 1 – point a
Amendment 1016 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 1 – point a a (new)
Article 20 – paragraph 1 – point a a (new)
(a a) ensure that the appropriate conformity assessment procedures referred to in Article 27a have been carried out by the manufacturer;
Amendment 1018 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 1 a (new)
Article 20 – paragraph 1 a (new)
1 a. When making an EHR system available on the market, distributors shall act with due care in relation to the requirements of this Regulation.
Amendment 1021 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. Distributors shall, further to a reasoned request from a market surveillancecompetent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.
Amendment 1022 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 4 a (new)
Article 20 – paragraph 4 a (new)
4 a. Where a distributor considers or has reason to believe that an EHR system, which they have placed on the market, is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. In situations where the EHR system is already on the market, importers shall immediately take the corrective measures necessary to bring that EHR system into conformity, to withdraw it or recall it, as appropriate. The distributor shall inform without undue delay the manufacturer of such EHR system and the national competent authorities of the Member State in which it made the EHR system available, to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken.
Amendment 1024 #
2022/0140(COD)
Proposal for a regulation
Article 20 – paragraph 4 b (new)
Article 20 – paragraph 4 b (new)
4 b. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official language of the Member State where the competent national authority is located. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.
Amendment 1044 #
2022/0140(COD)
Proposal for a regulation
Article 25 a (new)
Article 25 a (new)
Article 25 a Presumption of conformity of EHR systems 1. An EHR system which is in conformity with harmonised standards as referred to in Article 23 shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those standards. 2. The Commission shall, as provided in Article 10(1) of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards for the essential requirements set out in Annex II. 3. The Commission is empowered to adopt implementing acts establishing technical specifications for the essential requirements set out in Annex II where the following conditions have been fulfilled: (a) no reference to harmonised standards covering the relevant essential health and safety requirements is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012; (b) the Commission has requested one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements and there are undue delays in the standardisation procedure or the request has not been accepted by any of the European standardisation organisations. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 68(2). 4. An EHR system which is in conformity with the technical specifications shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those technical specifications.
Amendment 1046 #
2022/0140(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. The EU declaration of conformity shall state that the manufacturer of the EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled.
Amendment 1049 #
2022/0140(COD)
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
4. By drawing upissuing the EU declaration of conformity, to the manufacturerhealth data access body, the notified body shall assume responsibility for the conformity of the EHR system.
Amendment 1057 #
2022/0140(COD)
Proposal for a regulation
Article 27 a (new)
Article 27 a (new)
Article 27 a Conformity assessment procedures for EHR systems 1. In order to certify the conformity of an EHR system with this Regulation, the manufacturer or its authorised representative, shall apply for EU type- examination procedure provided for in Annex IVa; 2. Notified bodies shall take into account the specific interests and needs of small and medium sized enterprises when setting the fees for conformity assessment and reduce those fees proportionately to their specific interests and needs.
Amendment 1058 #
2022/0140(COD)
Proposal for a regulation
Article 27 b (new)
Article 27 b (new)
Article 27 b Notification Member States shall notify the Commission and the other Member States of conformity assessment bodies authorised to carry out conformity assessments in accordance with this Regulation.
Amendment 1059 #
2022/0140(COD)
Proposal for a regulation
Article 27 c (new)
Article 27 c (new)
Article 27 c Notifying authorities 1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article 27j. 2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008. 3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body, which is not a governmental entity that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 27d. In addition, that body shall have arrangements to cover liabilities arising out of its activities. 4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.
Amendment 1060 #
2022/0140(COD)
Proposal for a regulation
Article 27 d (new)
Article 27 d (new)
Article 27 d Requirements relating to notifying authorities 1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs. 2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities. 3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment of the EHR system. 4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, or consultancy services on a commercial or competitive basis. 5. A notifying authority shall safeguard the confidentiality of the information it obtains. 6. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.
Amendment 1061 #
2022/0140(COD)
Proposal for a regulation
Article 27 e (new)
Article 27 e (new)
Article 27 e Information obligation on notifying authorities Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available.
Amendment 1062 #
2022/0140(COD)
Proposal for a regulation
Article 27 f (new)
Article 27 f (new)
Amendment 1063 #
2022/0140(COD)
Proposal for a regulation
Article 27 g (new)
Article 27 g (new)
Article 27 g Presumption of conformity of notified bodies Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 27f in so far as the applicable harmonised standards cover those requirements.
Amendment 1064 #
2022/0140(COD)
Proposal for a regulation
Article 27 h (new)
Article 27 h (new)
Article 27 h Subsidiaries of and subcontracting by notified bodies 1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 27f and shall inform the notifying authority accordingly. 2. A notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever those are established. 3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client. 4. A notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex IVa.
Amendment 1065 #
2022/0140(COD)
Proposal for a regulation
Article 27 i (new)
Article 27 i (new)
Article 27 i Notification procedure 1. A notifying authority shall notify only conformity assessment bodies which have satisfied the requirements laid down in Article 27f. 2. The notifying authority shall send a notification to the Commission and the other Member States of each conformity assessment body referred to in paragraph 1, using the electronic notification tool developed and managed by the Commission. 3. The notification referred to in paragraph 2 shall include the following: (a) full details of the conformity assessment activities to be performed; (b) the relevant attestation of competence. 4. Where a notification is not based on an accreditation certificate referred to in Article 27i(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 27f. 5. The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of the validation of the notification where it includes an accreditation certificate referred to in Article 27i(2), or within two months of the notification where it includes documentary evidence referred to in Article 27i(3). Only such a body shall be considered a notified body for the purposes of this Regulation. 6. The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification referred to in paragraph 2.
Amendment 1066 #
2022/0140(COD)
Proposal for a regulation
Article 27 i (new)
Article 27 i (new)
Article 27 i Application for notification 1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established. 2. The application for notification shall be accompanied by a description of the conformity assessment activities, of the conformity assessment procedures set out in Annex IVa as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 27f. 3. Where the conformity assessment body concerned cannot provide an accreditation certificate as referred to in paragraph 2, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 27f.
Amendment 1067 #
2022/0140(COD)
Proposal for a regulation
Article 27 k (new)
Article 27 k (new)
Article 27 k Identification numbers and lists of notified bodies 1. The Commission shall assign an identification number to a notified body. It shall assign a single such number even where the body is notified under several Union acts. 2. The Commission shall make publicly available the list of notified bodies including the identification numbers that have been assigned to them and the conformity assessment activities for which they have been notified. The Commission shall ensure that the list is kept up to date.
Amendment 1068 #
2022/0140(COD)
Proposal for a regulation
Article 27 l (new)
Article 27 l (new)
Article 27 l Changes to notifications 1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 27f, or that it is failing to fulfil its obligations as set out in Article 27m the notifying authority shall restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly. 2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.
Amendment 1069 #
2022/0140(COD)
Proposal for a regulation
Article 27 m (new)
Article 27 m (new)
Article 27 m Challenge of the competence of notified bodies 1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject. 2. The notifying authority shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned. 3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially. 4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying authority to take the necessary corrective measures, including the withdrawal of the notification if necessary. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 1070 #
2022/0140(COD)
Proposal for a regulation
Article 27 n (new)
Article 27 n (new)
Amendment 1071 #
2022/0140(COD)
Proposal for a regulation
Article 27 o (new)
Article 27 o (new)
Article 27 o Appeals against decisions of notified bodies A notified body shall ensure that a transparent and accessible appeals procedure against its decisions is available.
Amendment 1072 #
2022/0140(COD)
Proposal for a regulation
Article 27 p (new)
Article 27 p (new)
Article 27 p Information obligation on notified bodies 1. A notified body shall inform the notifying authority of the following: (a) any refusal, restriction, suspension or withdrawal of a certificate of conformity or approval decision; (b) any circumstances affecting the scope of, or the conditions for, its notification; (c) any request for information which it has received from market surveillance authorities regarding its conformity assessment activities; (d) on request, any conformity assessment activities performed within the scope of its notification and any other activity performed, including cross-border activities and subcontracting. 2. A notified body shall provide other notified bodies carrying out similar conformity assessment activities covering the same kinds of machinery product with relevant information on issues relating to negative and, on request, positive conformity assessment results.
Amendment 1073 #
2022/0140(COD)
Proposal for a regulation
Article 27 q (new)
Article 27 q (new)
Article 27 q Coordination of notified bodies The Commission shall ensure that appropriate coordination and cooperation between notified bodies are put in place and properly operated in the form of a sectoral group of notified bodies. A notified body shall participate in the work of that group, directly or by means of designated representatives.
Amendment 1074 #
2022/0140(COD)
Proposal for a regulation
Article 27 q (new)
Article 27 q (new)
Article 27 q Exchange of experience The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.
Amendment 1075 #
2022/0140(COD)
Proposal for a regulation
Chapter III – Section 3 a (new)
Chapter III – Section 3 a (new)
3a Section 3a Conformity assessment
Amendment 1079 #
2022/0140(COD)
Proposal for a regulation
Article 28 – paragraph 4 a (new)
Article 28 – paragraph 4 a (new)
4 a. Market surveillance authorities shall immediately inform Notified Bodies about manufacturers of EHR systems that no longer comply with the requirements on the declaration of conformity.
Amendment 1080 #
2022/0140(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Where a market surveillance authority findsof one Member State have sufficient reason to believe that an EHR system presents a risk to the health or, safety or rights of natural persons or to other aspects of public interest protection, ithey shall require the manufacturer of the EHR system concerned, icarry out an evaluation in relation to the EHR system concerned covering all relevant requirements laid down in this Regulation. Its authorised representatives and all other relevant economic operators toshall cooperate as necessary with the market surveillance authorities for that purpose and take all appropriate measures to ensure that the EHR system concerned no longer presents that risk when placed on the market to withdraw the EHR system from the market or to recall it within a reasonable period. Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the EHR system does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the EHR system into compliance with those requirements, to withdraw the machinery product from the market, or to recall it within a reasonable period which is commensurate with the nature of the risk referred to in the first subparagraph. The market surveillance authorities shall inform the relevant notified body accordingly.
Amendment 1083 #
2022/0140(COD)
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
1 a. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.
Amendment 1096 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 a (new)
Article 30 – paragraph 1 a (new)
1 a. Where the relevant economic operator does not take adequate corrective action within the period referred to in Article 29, paragraph 1, second subparagraph, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the EHR system being made available on their national market, to withdraw the machinery product from that market or to recall it. The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
Amendment 1097 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 b (new)
Article 30 – paragraph 1 b (new)
1 b. The information referred to in paragraph 1.a, second subparagraph, shall include all available details, in particular the data necessary for the identification of the noncompliant EHR system, the origin of that EHR system, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.In particular, the market surveillance authorities shall indicate whether the noncompliance is due to any of the following: (a) failure of the EHR system to meet the requirements relating to the essential requirements set out in Annex II; (b) shortcomings in the harmonised standards referred to in Article 25a(1); (c) shortcomings in the technical specifications referred to in Article 25a(4).
Amendment 1098 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 c (new)
Article 30 – paragraph 1 c (new)
1 c. Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the EHR system concerned, and, in the event of disagreement with the adopted national measure, of their objections.
Amendment 1099 #
2022/0140(COD)
Proposal for a regulation
Article 30 – paragraph 1 d (new)
Article 30 – paragraph 1 d (new)
1 d. Where, within three months of receipt of the information referred to in paragraph 1a, second subparagraph, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
Amendment 1100 #
2022/0140(COD)
Proposal for a regulation
Article 30 a (new)
Article 30 a (new)
Article 30 a Union safeguard procedure 1. Where, on completion of the procedure set out in Article 29(2) and Article 30(1a), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the form of a decision determining whether the national measure is justified or not. The Commission shall address its decision to all Member States and shall without delay communicate it to them and to the relevant economic operator or operators. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 68(2a). 2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant EHR system is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure. Where the national measure is considered justified and the non-compliance of the EHR system is attributed to shortcomings in the harmonised standards or technical specifications referred to in Article 30(1b), points (b) and (c), of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
Amendment 1106 #
2022/0140(COD)
Proposal for a regulation
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Where a manufacturer of a wellness application claims interoperability with an EHR system and therefore compliance with the essential requirements laid down in Annex II and common specifications in Article 23, such wellness application mayshall be accompanied by a label, clearly indicating its compliance with those requirements. The label shall be issued by the manufacturer of the wellness application and the health data access body shall be informed.
Amendment 1107 #
2022/0140(COD)
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
3. The Commission mayshall, by means of implementing acts, determine the format and content of the label. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 1142 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point a
Article 33 – paragraph 1 – point a
(a) electronic health data from EHRs;
Amendment 1151 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point b
Article 33 – paragraph 1 – point b
(b) data on factors impacting on health, including social, environmental behavioural determinants of health;
Amendment 1156 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point d
Article 33 – paragraph 1 – point d
(d) healthcare-related administrative data, including claims and reimbursement data;
Amendment 1166 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 1 – point e
Article 33 – paragraph 1 – point e
(e) extracts from human genetic, genomic and proteomic data, such as genetic markers;
Amendment 1220 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro and small enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59in the context of healthcare provision. _________________ 59 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
Amendment 1222 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 2 a (new)
Article 33 – paragraph 2 a (new)
2 a. The Commission, together with the Member States, will define measures to protect the personal data of healthcare professionals involved in the treatment of a natural person, in order to prevent the possibility of identifying which prescriptions doctors administer to their patients.
Amendment 1229 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 3 a (new)
Article 33 – paragraph 3 a (new)
3 a. The natural person shall receive information about the benefits of providing access to their health data for secondary use.
Amendment 1251 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 5
Article 33 – paragraph 5
Amendment 1265 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 5 a (new)
Article 33 – paragraph 5 a (new)
5 a. Natural persons shall have the right to decline the processing of parts or all of their electronic health data for secondary use. In this regard, health data access bodies shall provide an easily understandable and accessible opt-out mechanism in a user-friendly format whereby natural persons have the option to explicitly remove parts or all of their electronic health data to be processed for some or all secondary use purposes.
Amendment 1268 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 5 b (new)
Article 33 – paragraph 5 b (new)
5 b. For the categories of electronic health data referred to in (e) and (m) of the first paragraph, health data access bodies shall only provide this health data for secondary use processing after natural persons have explicitly consented to its use. Such an opt-in mechanism shall be easily understandable and accessible and provided for in a user-friendly format whereby data subjects are made aware of the sensitive nature of the data.
Amendment 1274 #
2022/0140(COD)
Proposal for a regulation
Article 33 – paragraph 7
Article 33 – paragraph 7
Amendment 1295 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point a
Article 34 – paragraph 1 – point a
(a) activities for reasons of public interest in the area of public and occupational health, such as protection against serious cross-border threats to health, public health surveillance, monitoring and evaluating health programmes or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices;
Amendment 1300 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, as well as, where national laws apply, professional associations, in the health or care sector to carry out their tasks defined in their mandates;
Amendment 1311 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point d
Article 34 – paragraph 1 – point d
(d) education oruniversity and post-university teaching activities in health or care sectors;
Amendment 1314 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point e
Article 34 – paragraph 1 – point e
(e) scientific research related to health or care sectors for prevention, early detection, diagnosis, treatment, rehabilitation or healthcare management, including fundamental, exploratory or applied healthcare research;
Amendment 1325 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point f
Article 34 – paragraph 1 – point f
(f) development and innovation activities for products or services contributing to public health or social security and intended for healthcare or long-term care purposes, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;
Amendment 1339 #
2022/0140(COD)
Proposal for a regulation
Article 34 – paragraph 1 – point g
Article 34 – paragraph 1 – point g
(g) training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, contributing to the public health or social security and intended for healthcare or long-term care purposes, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;
Amendment 1372 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point a
Article 35 – paragraph 1 – point a
(a) taking decisions detrimental to a natural person or a group of natural persons based on their electronic health data; in order to qualify as “decisions”, they must produce legal effects or similarly significantly affect those natural persons;
Amendment 1377 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point b
Article 35 – paragraph 1 – point b
(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance or credit contract or to modify their contributions and insurance premiums or conditions of loans or exclude them from the benefit of participating in clinical trials;
Amendment 1388 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point c
Article 35 – paragraph 1 – point c
(c) advertising or marketing activities towards health professionals, organisations in health or natural persons;
Amendment 1393 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e
Article 35 – paragraph 1 – point e
(e) developing products or services that may harm individuals and societies at large, including, but not limited to illicit drugs, alcoholic beverages, tobacco and nicotine products, weaponries or products, or goods or services which are designed or modified in such a way that they incite chemical, behavioural or any other type of addiction or that they contravene public order or morality.
Amendment 1404 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Article 35 – paragraph 1 – point e a (new)
(e a) automated individual decision- making, including profiling, in accordance with Article 22 of the Regulation (EU) 2016/679.
Amendment 1412 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e b (new)
Article 35 – paragraph 1 – point e b (new)
(e b) data of pharmaceutical prescriptions or medical devices by commercial name, with the exception of usage by public authorities.
Amendment 1415 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e c (new)
Article 35 – paragraph 1 – point e c (new)
(e c) national defense and security.
Amendment 1417 #
2022/0140(COD)
Proposal for a regulation
Article 35 – paragraph 1 – point e d (new)
Article 35 – paragraph 1 – point e d (new)
(e d) confidential data used by public bodies which are market regulators.
Amendment 1436 #
2022/0140(COD)
Proposal for a regulation
Article 36 – paragraph 2
Article 36 – paragraph 2
2. Member States shall ensure that each health data access body is provided with the human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers in a timely manner.
Amendment 1490 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 1 – point j
Article 37 – paragraph 1 – point j
(j) cooperate with and supervise data holders to enable them to enact their rights to opt-out of data processing for secondary use as referred to in Article 33(5a) and to opt-in for data processing for the specific categories of data referred to in Article 33(5b) ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;
Amendment 1532 #
2022/0140(COD)
Proposal for a regulation
Article 37 – paragraph 2 – point d a (new)
Article 37 – paragraph 2 – point d a (new)
(d a) cooperate with European institutions and agencies, where applicable in accordance with Union law.
Amendment 1543 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 1 – point c
Article 38 – paragraph 1 – point c
(c) the applicable rights of natural persons in relation to secondary use of electronic health data, including the right to opt-out referred to in Article 33(5a) and the right to opt-in for the categories of data referred to in Article 33(5b);
Amendment 1550 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 1 – point d a (new)
Article 38 – paragraph 1 – point d a (new)
(d a) the record on who has been granted access to the data, the legal basis and the purpose, in accordance with Union and national law;
Amendment 1558 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. HAt the request of a natural person or a group representing natural persons, health data access bodies shall not be obliged to provide the specific information under Article 14 of Regulation (EU) 2016/679 to each natural person concerning the use of their data for projects subject to a data permit and shall provide general public information on all the data permits issued pursuant to Article 46.
Amendment 1566 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 3
Article 38 – paragraph 3
3. Where a health data access body isData users shall inform the health data access bodies of conclusive findings that arise from the secondary use of natural persons’ health data. Health data access bodies shall provide an accessible and easily understandable mechanism for natural persons to express their explicit will to be informed by a data user of a finding that may impact on the health of athat natural person, the health data access body may inform the natural person and his or her treating health professional about. Electronic health records shall notify the health professionals with the appropriate competence to communicate to the natural person about that finding to better evaluate thate finding and its consequences.
Amendment 1571 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 4
Article 38 – paragraph 4
4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies, as well as the risks and consequences linked with individual and collective digital health data rights arising from this Regulation.
Amendment 1574 #
2022/0140(COD)
Proposal for a regulation
Article 38 – paragraph 4
Article 38 – paragraph 4
4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies, as well as the risks and consequences linked with individual and collective digital health data rights arising from this Regulation.
Amendment 1627 #
2022/0140(COD)
Proposal for a regulation
Article 41 – paragraph 4
Article 41 – paragraph 4
4. The data holder shall put the electronic health data at the disposal of the health data access body within 23 months from receiving the request from the health data access body. In exceptional cases, that period may be extended by the health data access body for an additional period of 2 months.
Amendment 1632 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 1
Article 42 – paragraph 1
1. Health data access bodies and single data holders may charge fees for making electronic health data available for secondary use. Any fees shall include and be derived from the costs related to set up, data enrichment, maintainance or updating of the dataset and conducting the procedure for requests, including for assessing a data application or a data request, granting, refusing or amending a data permit pursuant to Articles 45 and 46 or providing an answer to a data request pursuant to Article 47, in accordance with Article 6 of Regulation […] [Data Governance Act COM/2020/767 final]. No fees should be charged to public health authorities, at local, regional or national level or to address public health research, including but not limited to, epidemiological surveillance or monitoring of health projects and programmes.
Amendment 1646 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 4
Article 42 – paragraph 4
4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting, set up, data enrichment, maintainance or updating of the dataset and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The support received by the data holder from donations, public national or Union funds, to set up, develop or update that dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.
Amendment 1657 #
2022/0140(COD)
Proposal for a regulation
Article 42 – paragraph 6
Article 42 – paragraph 6
6. The Commission mayshall, by means of implementing acts, lay down principles and rules for the fee policies and fee structures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 1665 #
2022/0140(COD)
4. Health data access bodies shall have the power to revoke the data permit issued pursuant to Article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non- compliance referred to in paragraph 3, immediately or within a reasonable time limit, and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. In this regard, the health data access bodies shall be able, where appropriate, to revoke the data permit and to exclude the data user from any access to electronic health data for a period of up to 5 years, and fines shall be imposed in accordance with Article 83 of the Regulation (EU) 2016/679.
Amendment 1671 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 5
Article 43 – paragraph 5
5. Where data holders withhold the electronic health data from health data access bodies with the manifest intention of obstructing the use of electronic health data, or do not respect the deadlines set out in Article 41, the health data access body shall have the power to fine the data holder with fines for each day of delay, which shall be transparent and proportionate. The amount of the fines shall be established by the health data access body. In case of repeated breaches by the data holder of the obligation of loyal cooperation with the health data access body, that body can exclude the data holder from participation in the EHDS for a period of up to 5 years. Where a data holder has been excluded from the participation in the EHDS pursuant to this Article, following manifest intention of obstructing the secondary use of electronic health data, it shall not have the right to provide access to health data in accordance with Article 49.
Amendment 1677 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 5 a (new)
Article 43 – paragraph 5 a (new)
5 a. Any natural person affected by a breach of the data permit issued pursuant to Articles 35 and 46 should have the right to an effective judicial remedy before a tribunal in accordance with Article 47 of the Charter of Fundamental Rights of the European Union.
Amendment 1685 #
2022/0140(COD)
Proposal for a regulation
Article 43 – paragraph 10
Article 43 – paragraph 10
10. The Commission mayshall issues guidelines on penalties to be applied by the health data access bodies.
Amendment 1715 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access bodyholder. Data users shall not re- identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.
Amendment 1721 #
2022/0140(COD)
Proposal for a regulation
Article 44 – paragraph 3 a (new)
Article 44 – paragraph 3 a (new)
3 a. In providing anonymised and pseudonymised datasets, health data access bodies shall follow the state-of-the- art in anonymisation and pseudonymisation technologies. The European Health Data Space Board, together with the digital health authorities, shall discuss and create norms and standards for data holders to apply.
Amendment 1752 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point g
Article 45 – paragraph 2 – point g
(g) an justified estimation of the period during which the electronic health data is needed for processing;
Amendment 1756 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point h a (new)
Article 45 – paragraph 2 – point h a (new)
(h a) a communication plan defining audiences and tools to publicly inform on the results or outcomes of the access to the data in accordance with Article 46(11);
Amendment 1760 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point h b (new)
Article 45 – paragraph 2 – point h b (new)
(h b) provide the specified information under Article 14 of Regulation (EU) 2016/679 and facilitate the exercise of the rights of natural persons with Chapter III of Regulation (EU) 2016/67.
Amendment 1761 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 2 – point h c (new)
Article 45 – paragraph 2 – point h c (new)
(h c) information, such as but not limited to professional qualifications, which justify the data applicant's suitability to use the requested data for the intended purpose.
Amendment 1767 #
2022/0140(COD)
Proposal for a regulation
Article 45 – paragraph 4 – introductory part
Article 45 – paragraph 4 – introductory part
4. Where the applicant intends to access the personal electronic health data in a pseudonymised format or non- personal data, the following additional information shall be provided together with the data access application:
Amendment 1813 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 3
Article 46 – paragraph 3
3. A health data access body shall issue or refuse a data permit within 26 months of receiving the data access application. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final], the health data access body may extend the period for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay. Where a health data access body fails to provide a decision within the time limit, the data permit shall be issued.
Amendment 1843 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 9
Article 46 – paragraph 9
9. A data permit shall be issued for the duration necessary to fulfil the requested purposes which shall not exceed 5 years. This duration may be extended once, at the request of the data user, based on arguments and documents to justify this extension provided, 1 month before the expiry of the data permit, for a period which cannot exceed 5 years. By way of derogation from Article 42, the health data access body may charge increasing fees to reflect the costs and risks of storing electronic health data for a longer period of time exceeding the initial 5 years. In order to reduce such costs and fees, the health data access body may also propose to the data user to store the dataset in storage system with reduced capabilities. The data within the secure processing environment shall be deleted within 6 months followingimmediately after the expiry of the data permit. Upon request of the data user, the formula on the creation of the requested dataset shall be stored by the health data access body.
Amendment 1851 #
2022/0140(COD)
Proposal for a regulation
Article 46 – paragraph 11
Article 46 – paragraph 11
11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 182 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public in lay summaries on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.
Amendment 1877 #
2022/0140(COD)
Proposal for a regulation
Article 48 – title
Article 48 – title
Making data available for public sector bodies and Union institutions, bodies, offices andnational public health authorities and European Union public health agencies without a data permit
Amendment 1885 #
2022/0140(COD)
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
By derogation from Article 46 of this Regulation, a data permit shall not be required to access the electronic health data under this Article. When carrying out those tasks under Article 37 (1), points (b) and (c), the health data access body shall inform public sector bodies and the Union institutions, offices, agencies and bodnational public health authorities and the European Union health agencies, about the availability of data within 2 months of the data access application, in accordance with Article 9 of Regulation […] [Data Governance Act COM/2020/767 final]. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final ], the health data access body may extend the period by 2 additional months where necessary, taking into account the complexity of the request. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless it specifies that it will provide the data within a longer specified timeframe.
Amendment 1890 #
2022/0140(COD)
Proposal for a regulation
Article 49
Article 49
Access to electronic health data from a 1. access to electronic health data only from a single data holder in a single Member State, by way of derogation from Article 45(1), that applicant may file a data access application or a data request directly to the data holder. The data access application shall comply with the requirements set out in Article 45 and the data request shall comply with requirements in Article 47. Multi-country requests and requests requiring a combination of datasets from several data holders shall be addressed to health data access bodies. 2. issue a data permit in accordance with Article 46 or provide an answer to a data request in accordance with Article 47. The data holder shall then provide access to the electronic health data in a secure processing environment in compliance with Article 50 and may charge fees in accordance with Article 42. 3. 51, the single data provider and the data user shall be deemed joint controllers. 4. shall inform the relevant health data access body by electronic means of all data access applications filed and all the data permits issued and the data requests fulfilled under this Article in order to enable the health data access body to fulfil its obligations under Article 37(1) and Article 39.rticle 49 deleted single data holder Where an applicant requests In such case, the data holder may By way of derogation from Article Within 3 months the data holder
Amendment 1900 #
2022/0140(COD)
Proposal for a regulation
Article 50 – paragraph 1 – introductory part
Article 50 – paragraph 1 – introductory part
1. TSubject to the issuance of a data permit, the health data access bodies shall provide access to electronic health data only through a secure processing environment, with technical and organisational measures and security and interoperability requirements. In particular, they shall take the following security measures:
Amendment 1910 #
2022/0140(COD)
Proposal for a regulation
Article 50 – paragraph 3
Article 50 – paragraph 3
3. The health data access bodies shall ensure regular audits of the secure processing environments. and take immediate corrective action of any shortcomings, risks or vulnerabilities identified in the secure processing environments
Amendment 1917 #
Amendment 1921 #
2022/0140(COD)
Proposal for a regulation
Article 51 – paragraph 1
Article 51 – paragraph 1
1. The health data access bodies and the data users, including Union institutions, bodies, offices and agencies,In addition to data holders, the health data access bodies shall be deemed a controller for the processing of personal electronic health data in accordance with Article 37(1)(d). The data users shall be deemed joint controllers of electronic health data processed in accordance with data permi for the processing of personal electronic health data in pseudonymised form in the secure processing environment pursuant to the data permit. The health data access body shall act as a processor for the health data user´s processing pursuant to a data permit in the secure processing environment.
Amendment 1925 #
2022/0140(COD)
Proposal for a regulation
Article 51 – paragraph 2
Article 51 – paragraph 2
2. The Commission shall, by means of implementing acts, establish a template for the joint controllers’ arrangement. Those implementing acts shall be adopted in accordance with the advisory procedure set out in Article 68(2).
Amendment 1929 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 3
Article 52 – paragraph 3
3. Union institutions, bodies, offices and agencies involved in health research, health policy or analysis, shall be authorised participants of HealthData@EU.
Amendment 1934 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 5
Article 52 – paragraph 5
5. Third countries or international organisations may become authorised participants where they comply with the rules of Chapter IV of this Regulation and whereby the transfer of electronic health data is compliant with the provisions laid down in Chapter V of Regulation (EU) 2016/679 and provide access to data users located in the Union, on equivalent terms and conditions, to the electronic health data available to their health data access bodies. The Commission may adopt implementing acts establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of HealthData@EU for the purposes of secondary use of health data, is compliant with the Chapter IV of this Regulation and Chapter V of Regulation 2016/679 and provides access to data users located in the Union to the electronic health data it has access to on equivalent terms and conditions. The compliance with these legal, organisational, technical and security requirements, including with the standards for secure processing environments pursuant to Article 50 shall be checked under the control of the Commission. These implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68 (2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available.
Amendment 1945 #
2022/0140(COD)
The Commission mayshall, by means of implementing acts, set out:
Amendment 1947 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 – point a
Article 52 – paragraph 13 – subparagraph 1 – point a
(a) requirements, technical specifications, the IT architecture of HealthData@EU, conditions and compliance checks for authorised participants to join and remain connected to HealthData@EU and conditions for temporary or definitive exclusion from HealthData@EU which shall ensure state- of-the-art data security, confidentiality, and protection of electronic health data in the cross border infrastructure;
Amendment 1952 #
2022/0140(COD)
(aa) conditions and compliance checks for authorised participants to join and remain connected to HealthData@EU and conditions for temporary or definitive exclusion from HealthData@EU;
Amendment 1961 #
2022/0140(COD)
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 2
Article 52 – paragraph 13 – subparagraph 2
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The Commission shall consult with and involve the European Union Agency for Cyber Security (ENISA) in the aforementioned process.
Amendment 1975 #
2022/0140(COD)
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. AThe same data permit issued by one concerned health data access body mayshall benefit from mutual recognition by the other concerned health data access bodies.
Amendment 1976 #
2022/0140(COD)
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. AThe same data permit issued by one concerned health data access body mayshall benefit from mutual recognition by the other concerned health data access bodies.
Amendment 1981 #
2022/0140(COD)
Proposal for a regulation
Article 57 – paragraph 1
Article 57 – paragraph 1
1. The Commission shall establish an EU Datasets Catalogue connecting the national catalogues of datasets established by the health data access bodies and other authorised participants in HealthData@EU. taking into consideration the health interoperability resources already developed across the Union.
Amendment 2006 #
2022/0140(COD)
Proposal for a regulation
Article 61 – paragraph 2
Article 61 – paragraph 2
2. The protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization and pseudonymisation techniques and shall be detailed in the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final].
Amendment 2017 #
2022/0140(COD)
Proposal for a regulation
Article 63 – paragraph 1
Article 63 – paragraph 1
Amendment 2023 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor mayshall be invited to the meetings, where the issues discussed are of relevance for them. The Board shall also consult on a regular basis European level patient organisations and European level healthcare professional organisations and may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.
Amendment 2036 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 4
Article 64 – paragraph 4
4. Stakeholders and relevant third partieRelevant stakeholders, including patients’ ' and healthcare presentativesofessional's organisations and academia, shall be invited to attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity.
Amendment 2039 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 5
Article 64 – paragraph 5
5. The EHDS Board shall cooperate with other relevant bodies, entities and experts, such as the European Data Innovation Board referred to in Article 26 of Regulation […] [Data Governance Act COM/2020/767 final], competent bodies set up under Article 7 of Regulation […] [Data Act COM/2022/68 final], supervisory bodies set up under Article 17 of Regulation […] [eID Regulation], European Data Protection Board referred to in Article 68 of Regulation (EU) 2016/679 and cybersecurity bodies, in particular the European Agency for Cybersecurity (ENISA).
Amendment 2040 #
2022/0140(COD)
Proposal for a regulation
Article 64 – paragraph 5 a (new)
Article 64 – paragraph 5 a (new)
5a. The EHDS Board, in conjunction with the European Commission, shall publish an annual report covering the implementation status of the European Health Data Space and other relevant points of development, including with respect to cross-border health data interoperability, and implementation challenges.
Amendment 2066 #
2022/0140(COD)
Proposal for a regulation
Article 65 – paragraph 2 – point f
Article 65 – paragraph 2 – point f
(f) to facilitate the exchange of views on the secondary use of electronic health data with the relevant stakeholders, including representatives of patients, health professionals, researchers, regulators and policy makers in the health sector to support the design of aligned implementation strategies, guidance and standards and to assess the needs for further improvement.
Amendment 2076 #
2022/0140(COD)
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 5(2), 107(3), 25(3), 32(4), 33(7), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
Amendment 2081 #
2022/0140(COD)
Proposal for a regulation
Article 67 – paragraph 3
Article 67 – paragraph 3
3. The power to adopt delegated acts referred to in Articles 5(2), 107(3), 25(3), 32(4), 33(7), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 2083 #
2022/0140(COD)
Proposal for a regulation
Article 67 – paragraph 4
Article 67 – paragraph 4
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State and targeted stakeholders, including health professionals and patients’ organisations, in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making.
Amendment 2086 #
2022/0140(COD)
Proposal for a regulation
Article 68 – paragraph 2 a (new)
Article 68 – paragraph 2 a (new)
2a. In accordance with the Inter- Institutional Agreement of 13 April 2016 on Better Law-Making, the Commission shall make use of expert groups, consult targeted stakeholders and carry out public consultations to gather broader expertise in the early preparation of draft implementing acts.
Amendment 2091 #
2022/0140(COD)
Proposal for a regulation
Article 69 – paragraph 1
Article 69 – paragraph 1
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties shall be effective, proportionate and, dissuasive and encouraging corrective action to the infringements. Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them.
Amendment 2100 #
2022/0140(COD)
Proposal for a regulation
Article 70 – paragraph 1
Article 70 – paragraph 1
1. After 53 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapter III, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. The evaluation shall include an assessment of the self-certification of EHR systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies.
Amendment 2120 #
2022/0140(COD)
Proposal for a regulation
Article 72 – paragraph 3 – point b
Article 72 – paragraph 3 – point b
(b) from 32 years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (d), (e) and (f), and to EHR systems intended by the manufacturer to process such categories of data;
Amendment 2122 #
2022/0140(COD)
Proposal for a regulation
Article 72 – paragraph 4
Article 72 – paragraph 4
Chapter III shall apply to EHR systems put into service in the Union pursuant to Article 15(2) from 32 years after date of entry into application.
Amendment 2129 #
2022/0140(COD)
Proposal for a regulation
Annex II – point 2 – point 2.5
Annex II – point 2 – point 2.5
2.5. An EHR system shall not include features that prohibit, restrict or place undue burden on authorised exporting of personal electronic health data for the reasons of replacing the EHR system by another product. Authorised exporting of personal electronic health data shall be free of charge, without undue delay, or in in any event within one month from the request and in a structured, commonly used and machine-readable format, in line with the interoperability and security requirements to be developed according to Articles 23 and 50.
Amendment 2131 #
2022/0140(COD)
Proposal for a regulation
Annex II – point 3 – point 3.1
Annex II – point 3 – point 3.1
3.1. An EHR system shall be designed and developed in such a way that it ensures highly safe and secure processing of electronic health data, and that it prevents unauthorised access to such data.
Amendment 2133 #
2022/0140(COD)
Proposal for a regulation
Annex IV a (new)
Annex IV a (new)
Amendment 95 #
2022/0085(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) The Union institutions, bodies and agencies are attractive targets who face highly skilled and well-resourced threat actors as well as other threats. At the same time, the level and maturity of cyber resilience and the ability to detect and respond to malicious cyber activities varies significantly across those entities. It is thus necessary for the functioning of the European administration that the institutions, bodies and agencies of the Union achieve a high common level of cybersecurity through a cybersecurity baseline (a set of minimum cybersecurity rules with which network and information systems and their operators and users have to be compliant to minimise cybersecurity risks)the implementation of cybersecurity risk management measures commensurate to the respective risks posed, information exchange and collaboration.
Amendment 97 #
2022/0085(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) To reach a high common level of cybersecurity, it is necessary that each Union institution, body and agency establishes an internal cybersecurity risk management, governance and control framework that ensures an effective and prudent management of all cybersecurity risks, and takes account of business continuity and crisis management. The framework should lay down cybersecurity policies and priorities for the security of network and information systems encompassing the entirety of the ICT environment. The framework should be reviewed on a regular basis and at least every three years on the basis of key performance indicators to ensure that strategic objectives are met.
Amendment 99 #
2022/0085(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The differences between Union institutions, bodies and agencies require flexibility in the implementation since one size will not fit all. The measures for a high common level of cybersecurity should not include any obligations directly interfering with the exercise of the missions of Union institutions, bodies and agencies or encroaching on their institutional autonomy. Thus, those institutions, bodies and agencies should establish their own frameworks for cybersecurity risk management, governance and control, and adopt their own baselines and cybersecurity plans. cybersecurity risk management measures and cybersecurity plans. Union institutions, bodies, offices and agencies should continuously evaluate the effectiveness of the adopted risk management measures and their proportionality relative to the identified risks, and where necessary, adjust and revise accordingly their frameworks and plans on the basis of the results of the cybersecurity maturity assessments.
Amendment 105 #
2022/0085(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) A high common level of cybersecurity requires cybersecurity to come under the oversight of the highest level of management of each Union institution, body and agency, who should approve a cybersecurity baseline that shouldoversee the implementation of the provisions of this Regulation and approve the establishment, and any subsequent revisions thereof, of the risk management and control framework, the corresponding cybersecurity risk management measures addressing the risks identified underin the framework to be established by eachand the cybersecurity plans of each Union institution, body, office and agency. Addressing the cybersecurity culture, i.e. the daily practice of cybersecurity, is an integral part of a cybersecurity baselinerisk management, governance and control framework and the corresponding cybersecurity risk management measures in all Union institutions, bodies, offices and agencies.
Amendment 110 #
2022/0085(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) In May 2011, the Secretaries- General of the Union institutions and bodies decided to establish a pre- configuration team for a computer emergency response team for the Union’s institutions, bodies and agencies (CERT- EU) supervised by an inter-institutional Steering Board. In July 2012, the Secretaries-General confirmed the practical arrangements and agreed to maintain CERT-EU as a permanent entity to continue to help improve the overall level of information technology security of the Union’s institutions, bodies and agencies as an example of visible inter-institutional cooperation in cybersecurity. In September 2012, CERT-EU was established as a Taskforce of the European Commission with an interinstitutional mandate. In December 2017, the Union institutions and bodies concluded an interinstitutional arrangement on the organisation and operation of CERT-EU3 . This arrangement should continue to evolve to support the implementation of this Regulation and be evaluated on a regular basis in light of future negotiations of long-term budget frameworks allowing for further decisions to be made with respect to the functioning and institutional role of CERT-EU, including the possible establishment of CERT-EU as a Union office. _________________ 3 OJ C 12, 13.1.2018, p. 1–11.
Amendment 113 #
2022/0085(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Many cyberattacks are part of wider campaigns that target groups of Union institutions, bodies and agencies or communities of interest that include Union institutions, bodies and agencies. To enable proactive detection, incident response or mitigating measures, and recovery from significant incidents, Union institutions, bodies and agencies should notify CERT- EU of significant cyber threats, significant vulnerabilities and significant incidents and share appropriate technical details that enable detection or mitigation of, as well as response to, similar cyber threats, vulnerabilities and and recovery from similar incidents in other Union institutions, bodies and agencies. Following the same approach as the one envisaged in Directive [proposal NIS 2], where entitUnion institutions, bodies, offices and agencies become aware of a significant incident they should be required to submit an initial notificationearly warning to CERT- EU within 24 hours. Such information exchange should enable CERT-EU to disseminate the information to other Union institutions, bodies and agencies, as well as to appropriate counterparts, to help protect the Union IT environments and the Union’s counterparts’ IT environments against similar incidents, threats and vulnerabilities.
Amendment 114 #
2022/0085(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13 a) This Regulation lays down a multiple-stages approach to reporting of significant incidents in order to strike the right balance between, on the one hand, swift reporting hat helps mitigate the potential spread of incidents and allows entities to seek support, and, on the other hand, in-depth reporting that draws valuable lessons from individual incidents and improves over time the resilience of individual Union institutions, bodies, offices and agencies and contributes to increasing the overall cybersecurity posture of European administration. In this regard, the Regulation should also include reporting of incidents that, based on an initial assessment performed by the Union institution, body, office or agency, may be assumed to lead to severe operational disruption or financial losses or affect other natural or legal persons by causing considerable material or non- material losses. Such initial assessment should take into account, amongst other, the affected network and information systems and in particular their importance for the functioning and operations of the Union institution, body, office or agency, the severity and technical characteristics of a cyber threat and any underlying vulnerabilities that are being exploited as well as the Union institution, body, office or agency’s experience with similar incidents. Indicators such as the extent to which the functioning of Union institution, body, office or agency is affected, the duration of an incident or the number of affected users could play an important role in defining whether the operational disruption of the service is of severe nature.
Amendment 116 #
2022/0085(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14 a) The IICB’s function is aimed at supporting Union institutions, bodies, offices and agencies in elevating their respective cybersecurity postures by implementing the provisions of this Regulation. In order to support Union institutions, bodies, office and agencies, the IICB could adopt guidance and recommendations towards Union institutions, bodies, offices and agencies’ cybersecurity maturity assessments and cybersecurity plans, review possible interconnections between Union institutions, bodies, offices and agencies’ ICT environments and support the establishment of a Cybersecurity Officers Group under ENISA, gathering the Local Cybersecurity Officers of all Union institutions, bodies, offices and agencies with an aim to facilitate the sharing of best practices and experiences gained from the implementation of this Regulation.
Amendment 117 #
2022/0085(COD)
Proposal for a regulation
Recital 14 b (new)
Recital 14 b (new)
(14 b) In order to ensure alignment with Directive [proposal NIS 2], the IICB could adopt recommendations based on the results of EU coordinated risk assessments of critical supply chains referred to in Article19 of Directive [proposal NIS 2] to support Union institutions, bodies, offices and agencies in adopting effective and proportionate risk management measures relating to supply chain security and develop guidelines for information sharing arrangements of Union institutions, bodies, offices and agencies relating to the voluntary notification of cyber threats, near misses and incidents to CERT-EU.
Amendment 119 #
2022/0085(COD)
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16 a) Where the IICB finds that Union institutions, bodies, offices or agencies have not effectively applied or implemented this Regulation it could, without prejudice to the internal procedures of the relevant Union institution, body, office or agency, request relevant and available documentation relating to the effective implementation of the provisions of this Regulation, communicate a reasoned opinion with observed gaps in the implementation of this Regulation, invite the Union institution, body, office or agency concerned to provide a self-assessment on its reasoned and issue, in cooperation with CERT-EU, guidance to bring its respective risk management, governance and control framework, cybersecurity risk management measures, cybersecurity plans and reporting obligations incompliance with this Regulation.
Amendment 123 #
2022/0085(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) In supporting operational cybersecurity, CERT-EU should make use of the available expertise of the European Union Agency for Cybersecurity (ENISA) through structured cooperation as provided for in Regulation (EU) 2019/881 of the European Parliament and of the Council5 . Where appropriate, dedicated arrangements between the two entities should be established to define the practical implementation of such cooperation and to avoid the duplication of activities. CERT- EU should cooperate with the European Union Agency for CybersecurityENISA on threat analysis and share its threat landscape report with the Agency on a regular basis. _________________ 5 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15).
Amendment 132 #
2022/0085(COD)
Proposal for a regulation
Article 1 – paragraph -1 (new)
Article 1 – paragraph -1 (new)
-1 This Regulation lays down measures aiming to achieve a high common level of cybersecurity within Union institutions, bodies, offices and agencies;
Amendment 133 #
2022/0085(COD)
Proposal for a regulation
Article 1 – paragraph 1 – introductory part
Article 1 – paragraph 1 – introductory part
Amendment 136 #
2022/0085(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) obligations on Union institutions, bodies, offices and agencies to establish an internal cybersecurity risk management, governance and control framework;
Amendment 137 #
2022/0085(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point b a (new)
Article 1 – paragraph 1 – point b a (new)
(b a) rules underpinning information sharing obligations and the facilitation of voluntary information sharing arrangements for Union institutions, bodies, offices and agencies;
Amendment 138 #
2022/0085(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point c
Article 1 – paragraph 1 – point c
(c) rules on the organisation, tasks and operation of the Cybersecurity Centre for the Union institutions, bodies, offices and agencies (CERT-EU) and on the functioning, organisation and operation of the Interinstitutional Cybersecurity Board (IICB).
Amendment 140 #
2022/0085(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
This Regulation applies to the management, governance and control of cybersecurity risks by all Union institutions, bodies, offices and agencies and to the functioning, organisation and operation of CERT-EU and the Interinstitutional Cybersecurity BoardICB.
Amendment 141 #
2022/0085(COD)
Proposal for a regulation
Article 2 a (new)
Article 2 a (new)
Article 2 a Processing of Personal Data The processing of personal data under this Regulation by CERT-EU, the IICB and all Union institutions, bodies, offices and agencies shall be carried out in compliance with Regulation (EU) 2018/1725 of the European Parliament and of the Council.
Amendment 143 #
2022/0085(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) ‘network and information system’ means network and information system within the meaning ofas defined in Article 4(1) of Directive [proposal NIS 2];
Amendment 144 #
2022/0085(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 4
Article 3 – paragraph 1 – point 4
(4) ‘cybersecurity’ means cybersecurity within the meaning of Article 4(3) of Directive [proposal NIS 2]; as defined in Article 2(1) of Regulation (EU) 2019/881 of the European Parliament and of the Council7a; _________________ 7a Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p.15).
Amendment 147 #
2022/0085(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
(5) ‘highest level of management’ means a manager, management or coordination and oversight body at the most senior administrative level with a mandate to make or authorise decisions, taking account of the high-level governance arrangements in each Union institution, body or agency;
Amendment 149 #
2022/0085(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
Amendment 152 #
2022/0085(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘major attack’incident' means any incident requiring more resources than are available at whose disruption exceeds CERT-EU’s or any individual Union institution, body,office or agency’s capacity to respond to it or withe affected significant impact on at least two Union institutions, body or agency and at CERT-EUies, offices and agencies;
Amendment 155 #
2022/0085(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 11
Article 3 – paragraph 1 – point 11
(11) ‘significant cyber threat’ means a cyber threat with the intention, opportunity and capability to cause a significant incidentas defined in Article 4(7a) of Directive [proposal NIS 2];
Amendment 159 #
2022/0085(COD)
(14) ‘cybersecurity risk’ means any reasonably identifiable circumstance or event havisk as defined ing a potential adverse effect on the security of network and information systemsrticle 4(7b) of Directive [proposal NIS 2];
Amendment 163 #
2022/0085(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 14 a (new)
Article 3 – paragraph 1 – point 14 a (new)
(14 a) ‘ICT environment’ means any on- premise or virtual ICT product, ICT service and ICT process as defined in Article 2 of Regulation (EU) 2019/881, and any network and information system whether owned and operated by a Union institution, body, office or agency, or hosted or operated by a third party, including mobile devices, corporate networks, and business networks not connected to the internet and any devices connected to the ICT environment;
Amendment 172 #
2022/0085(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 16
Article 3 – paragraph 1 – point 16
Amendment 174 #
2022/0085(COD)
Proposal for a regulation
Article 4 – title
Article 4 – title
Risk management, governance and control framework
Amendment 178 #
2022/0085(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Each Union institution, body and agency shall establish its own internal cybersecurity risk management, governance and control framework (‘the framework’) in support of the entity’s mission and exercising its institutional autonomy. This work shall be overseen by the entity’s highest level of management to ensure an effective and prudent management of all cybersecurity risks. The framework shall be in place by …. at the latest [15 months after the entry into force of this Regulation].
Amendment 180 #
2022/0085(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The framework shall cover the entirety of the ICT environment of the concerned institution, body or agency, including any on-premise IT environment, outsourced assets and services in cloud computing environments or hosted by third parties, mobile devices, corporate networks, business networks not connected to the internet and any devices connected to the IT environmentUnion institution, body, office or agency. The framework shall take account of business continuity and crisis management and it shall consider supply chain security as well as the management of human risks and all other relevant technical, operational and organisational risks that could impact the cybersecurity of the concerned Union institution, body or agency.
Amendment 181 #
2022/0085(COD)
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2 a. The framework shall define strategic objectives to ensure a high level of cybersecurity in the Union institution, body, office or agency, The framework shall lay down cybersecurity policies and priorities for the security of network and information systems encompassing the entirety of the ICT environment, and define the roles and responsibilities of staff tasked with ensuring the effective implementation of the provisions of this Regulation.
Amendment 182 #
2022/0085(COD)
Proposal for a regulation
Article 4 – paragraph 2 b (new)
Article 4 – paragraph 2 b (new)
2 b. The framework shall be reviewed on a regular basis and at least every three years on the basis of key performance indicators. Where appropriate and upon request of the IICB, a Union institution, body, office or agency’s framework shall be updated following guidance from CERT-EU on observed incidents or possible gaps in the implementation of the provisions of this Regulation.
Amendment 186 #
2022/0085(COD)
3. The highest level of management of each Union institution, body, office and agency shall provide oversight oversee the compliance of theirits organisation with the obligations related to cybersecurity risk management, governance, and control, without prejudice to the formal responsibilities of other levels of management for compliance and risk management in their respective areas of responsibility.
Amendment 187 #
2022/0085(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Each Union institution, body and agency shall have effective mechanisms in place to ensure that an adequate percentage of the ICT budget is spent on cybersecurity.
Amendment 190 #
2022/0085(COD)
Proposal for a regulation
Article 5 – title
Article 5 – title
Cybersecurity baselinerisk management measures
Amendment 194 #
2022/0085(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The highest level of management of each Union institution, body and agency shall approve the entity’s own cybersecurity baselinerisk management measures to address the risks identified under the framework referred to in Article 4(1). It shall do so in support of its mission and exercising its institutional autonomy. The cybersecurity baseline shall be in place by …. at the latest [18 months after the entry into force of this Regulation] and shall address the domains listed in Annex I and the measures listed in Annex IIHaving regard to the state of the art and, where applicable, relevant European and international standards, or available European cybersecurity certificates as defined in Article 2 of Regulation (EU) 2019/881, those risk management measures shall ensure a level of security of network and information systems across the entirety of the ICT environment commensurate to the risks identified under the framework referred to in Article 4(1). When assessing the proportionality of those measures, due account shall be taken of the degree of the Union institution, body, office or agency’s exposure to risks, its size, the likelihood of occurrence of incidents and their severity, including their societal, economic and interinstitutional impact.
Amendment 197 #
2022/0085(COD)
Proposal for a regulation
Article 5 – paragraph 1 a (new)
Article 5 – paragraph 1 a (new)
1 a. Union institutions, bodies, offices and agencies shall include at least the following domains in the implementation of the cybersecurity risk management measures: (a) cybersecurity policy, including specification on the measures needed to reach objectives and priorities referred to in Article 4 and Article 5(2a); (b) policy objectives and priorities regarding the use of cloud computing services as defined in Article 4(19) of Directive [proposal NIS 2]) and technical arrangements to enable and sustain teleworking; (c) organisation of cybersecurity, including definition of roles and responsibilities; (d) management of the ICT environment, including ICT inventory and network cartography; (e) access control, identity management and privileged access management; (f) operations security and human resources security; (g) communications security; (h) system acquisition, development and maintenance; (i) supply chain security and supplier relationships between each Union institution, body, office and agency with its direct suppliers and service providers; (j) incident handling, including approaches to improve the prevention, detection, analysis, and containment of, response to, and recovery from an incident and cooperation with CERT-EU, such as the maintenance of security monitoring and logging; (k) business continuity management and crisis management; (l) cybersecurity skills, education, awareness-raising, training programmes and exercises.
Amendment 199 #
2022/0085(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. The senior management of each Union institution, body, office and agency as well as all relevant staff tasked with implementing the cybersecurity risks management measures and obligations of this Regulation shall follow specific trainings on a regular basis to gain sufficient knowledge and skills in order to apprehend and assess cybersecurity risk and management practices and their impact on the operations of the organisation.
Amendment 201 #
2022/0085(COD)
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
Amendment 202 #
2022/0085(COD)
Proposal for a regulation
Article 5 – paragraph 2 b (new)
Article 5 – paragraph 2 b (new)
2 b. The IICB may recommend technical and methodological requirements of the domains and risk management measures referred to in paragraphs 1(a) and 2(a) of this Article and, where necessary, recommend adaptations to reflect developments in attack methods, cyber threats and advances in technology, for the purposes of the review of this Regulation in accordance with Article 24.
Amendment 203 #
Amendment 207 #
2022/0085(COD)
Proposal for a regulation
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
The IICB, after consulting the European Union Agency for Cybersecurity (ENISA) and upon receiving guidance from CERT- EU, shall recommend guidelines to Union institutions, bodies, offices and agencies for the carrying out of cybersecurity maturity assessments.
Amendment 209 #
2022/0085(COD)
Proposal for a regulation
Article 6 – paragraph 1 b (new)
Article 6 – paragraph 1 b (new)
Upon request of the IICB, and with the explicit consent of the Union institution, body, office or agency concerned, the results of a cybersecurity maturity assessment may be discussed within the IICB configuration or within the established network of Local Cybersecurity Officers with a view to learning from experiences in the implementation of this Regulation and sharing best practices and results of use cases.
Amendment 210 #
2022/0085(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Following the conclusions derived from the maturity cybersecurity assessment and considering the assets and risks identified pursuant to Article 4, the highest level of management of each Union institution, body, office and agency shall approve a cybersecurity plan without undue delay after the establishment of the risk management, governance and control framework, and the cybersecurity baseline. Therisk management measures. The cybersecurity plan shall aim at increasing the overall cybersecurity of the concerned entity Union institution, body, office or agency and shall thereby contribute to the achievement or enhancement of a high common level of cybersecurity among all Union institutions, bodies, offices and agencies. To support the entity’Union institution, body, office or agency's mission on the basis of its institutional autonomy, the plan shall at least include the domains listed in Annex I, the measures listed in Annex II, as well ascybersecurity risk management measures relatferred to incident preparedness, response and recovery, such as security monitoring and logging. The plan shall be revised at least every three years, following the Article 5 (1a) and 5(2a). The cybersecurity plan shall be revised at least every three years, or where necessary, with any substantial revision of the framework referred to in Article 4, following the cybersecurity maturity assessments carried out pursuant to Article 6.
Amendment 213 #
2022/0085(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. The cybersecurity plan shall include relevant staff members’ roles and responsibilities for its implementation, including detailed job descriptions for technical and operational staff as well as all relevant processes underpinning performance evaluation.
Amendment 215 #
2022/0085(COD)
Proposal for a regulation
Article 7 – paragraph 2 a (new)
Article 7 – paragraph 2 a (new)
Amendment 216 #
2022/0085(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The cybersecurity plan shall consider any applicable guidance documents and recommendations issued by CERT-EU in accordance with Article 13 and another applicable or targeted recommendations issued by the IICB and CERT-EU.
Amendment 218 #
2022/0085(COD)
1. Upon completion of maturity assessments, the Union institutions, bodies and agencies shall submit these to the Interinstitutional Cybersecurity Board. Upon completion of security planstheir respective cybersecurity maturity assessments referred to in Article 6 and cybersecurity plans referred to in Article 7, the Union institutions, bodies, offices and agencies shall notify the Interinstitutional Cybersecurity Board of the completion. Upon request of the Board, they shall report on specific aspects of this Chaptersubmit these to the IICB.
Amendment 222 #
2022/0085(COD)
Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 1 – point k
Article 9 – paragraph 3 – subparagraph 1 – point k
(k) the European Union Agency for Cybersecurity (ENISA).
Amendment 233 #
2022/0085(COD)
Proposal for a regulation
Article 9 – paragraph 6
Article 9 – paragraph 6
6. The IICB shall meet at the initiative of its chair, and at least two times a year, at the request of CERT-EU or at the request of any of its members.
Amendment 240 #
2022/0085(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point -a (new)
Article 10 – paragraph 1 – point -a (new)
(-a) support Union institutions, bodies, offices and agencies in implementing this Regulation with the aim to raise their respective levels of cybersecurity;
Amendment 241 #
2022/0085(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point -a a (new)
Article 10 – paragraph 1 – point -a a (new)
(-a a) effectively monitor the implemenationof the obligations of this Regulation in Union institutions, bodies, offices and agencies without prejudice to their institutional autonomy and the overall institutional balance;
Amendment 242 #
2022/0085(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point a
Article 10 – paragraph 1 – point a
(a) review any reports requestedquest reports from CERT-EU on the state of implementation of this Regulation by the Union institutions, bodies and agencies;
Amendment 250 #
2022/0085(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point i a (new)
Article 10 – paragraph 1 – point i a (new)
(i a) review and where requested, following relevant guidance from CERT- EU. provide feedback to Union institutions, bodies, offices and agencies’ cybersecurity maturity assessments referred to in Article 6 and cybersecurity plans referred to in Article 7;
Amendment 252 #
2022/0085(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point i b (new)
Article 10 – paragraph 1 – point i b (new)
(i b) review possible interconnections between Union institutions, bodies, offices and agencies’ ICT environments and maintain an inventory of shared components of ICT products, ICT services andic processes;
Amendment 253 #
2022/0085(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point i c (new)
Article 10 – paragraph 1 – point i c (new)
(i c) where appropriate, adopt recommendations on the interoperability of Union institutions, bodies, offices and agencies’ ICT environments or components thereof;
Amendment 254 #
2022/0085(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point i d (new)
Article 10 – paragraph 1 – point i d (new)
(i d) support the establishment of a Cybersecurity Officers Group under ENISA, gathering the Local Cybersecurity Officers of all Union institutions, bodies, offices and agencies with an aim to facilitate the sharing of best practices and experiences gained from the implementation of this Regulation;
Amendment 255 #
2022/0085(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point i e (new)
Article 10 – paragraph 1 – point i e (new)
(i e) develop an incident and response plan for major incidents at Union level referred to in Article 3(8) and coordinate the adoption of individual Union institutions, bodies, offices and agencies’ cyber crisis management plans referred to in Article 7(2a);
Amendment 256 #
2022/0085(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point i f (new)
Article 10 – paragraph 1 – point i f (new)
(i f) adopt recommendations based on the results of EU coordinated risk assessments of critical supply chains referred to in Article 19 of Directive [proposal NIS 2] to support Union institutions, bodies, offices and agencies in adopting effective and proportionate risk management measures relating to supply chain security referred to in Article5(1ai);
Amendment 257 #
2022/0085(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point i g (new)
Article 10 – paragraph 1 – point i g (new)
(i g) develop guidelines for information sharing arrangements referred to in Article 19;
Amendment 258 #
2022/0085(COD)
Proposal for a regulation
Article 11 – paragraph -1 (new)
Article 11 – paragraph -1 (new)
-1 The IICB shall monitor the implementation of this Regulation and of adopted guidance documents, recommendations and calls for action by the Union institutions, bodies, offices and agencies.
Amendment 259 #
2022/0085(COD)
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
Amendment 261 #
2022/0085(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point -a (new)
Article 11 – paragraph 1 – point -a (new)
(-a) request relevant and available documentation of the Union institution, body, office or agency concerned relating to the effective implementation of the provisions of this Regulation or the application of guidance documents, recommendations and calls for action issued in accordance with Article 13;
Amendment 262 #
2022/0085(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point -a a (new)
Article 11 – paragraph 1 – point -a a (new)
(-a a) communicate a reasoned opinion to the Union institution, body, office or agency concerned with observed gaps in the implementation of this Regulation;
Amendment 263 #
2022/0085(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point -a b (new)
Article 11 – paragraph 1 – point -a b (new)
(-a b) invite the Union institution, body, office or agency concerned to provide a self-assessment on its reasoned opinion within a specified timeframe;
Amendment 264 #
2022/0085(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point -a c (new)
Article 11 – paragraph 1 – point -a c (new)
(-a c) issue, in cooperation with CERT- EU, guidance to the individual Union institution, body, office or agency to bring its respective risk management, governance and control framework, cybersecurity risk management measures, cybersecurity plans and reporting obligations in compliance with the provisions laid down in this Regulation in a specified manner and within a specified period;
Amendment 270 #
2022/0085(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The mission of CERT-EU, the autonomous interinstitutional Cybersecurity Centre for all Union institutions, bodies and agencies, shall be to contribute to the security of the unclassified ICT environment of all Union institutions, bodies and agencies by advising them on cybersecurity, by helping them to prevent, detect, mitigate and respond to and recover from incidents and by acting as their cybersecurity information exchange and incident response coordination hub.
Amendment 274 #
2022/0085(COD)
Proposal for a regulation
Article 12 – paragraph 2 – point c a (new)
Article 12 – paragraph 2 – point c a (new)
(c a) act as the designated coordinator for all Union institutions, bodies, offices and agencies for the purposes of coordinated vulnerability disclosure to the European vulnerability registry referred to in Article 6 of Directive [proposal NIS2];
Amendment 286 #
2022/0085(COD)
Proposal for a regulation
Article 12 – paragraph 6
Article 12 – paragraph 6
6. CERT-EU may organise cybersecurity exercises or recommend participation in existing exercises, in close cooperation with the European Union Agency for CybersecurityENISA whenever applicable, to test the level of cybersecurity of the Union institutions, bodies and agencies.
Amendment 287 #
2022/0085(COD)
Proposal for a regulation
Article 12 – paragraph 7
Article 12 – paragraph 7
7. CERT-EU may provide assistance to Union institutions, bodies and agencies regarding incidents in classified ICT environments if it is explicitly requested to do so by the constituent concerned. The provisions and obligations on all Union institutions, bodies, offices and agencies set out in Chapter V of this Regulation shall not apply to incidents in classified ICT environments unless an individual Union institution, body office or agency explicitly and voluntarily apply them in order to seek actionable assistance from CERT-EU or otherwise contribute to situational awareness at the Union level.
Amendment 290 #
2022/0085(COD)
Proposal for a regulation
Article 12 – paragraph 7 a (new)
Article 12 – paragraph 7 a (new)
7 a. CERT-EU shall cooperate with the European Data Protection Supervisor (EDPS) to support Union institutions, bodies, office and agencies in incidents entailing a personal data breach as defined in Article 3(16) of Regulation (EU) 2018/1725.
Amendment 296 #
2022/0085(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point a
Article 13 – paragraph 2 – point a
(a) modalities for or improvements to cybersecurity risk management and the cybersecurity baselinerisk management measures;
Amendment 298 #
2022/0085(COD)
Proposal for a regulation
Article 13 – paragraph 2 – point b
Article 13 – paragraph 2 – point b
(b) modalities for cybersecurity maturity assessments and cybersecurity plans; and
Amendment 303 #
2022/0085(COD)
Proposal for a regulation
Article 14 – paragraph -1 (new)
Article 14 – paragraph -1 (new)
-1 The Commission, after having obtained the unanimous approval of the IICB, shall appoint the Head of CERT- EU. The IICB shall be consulted at all stages of the procedure prior to the appointment of the Head of CERT-EU, in particular in drafting vacancy notices, examining applications and appointing selection boards in relation to this post.
Amendment 304 #
2022/0085(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
The Head of CERT-EU shall regularly submit reports to the IICB and the IICB Chair, and submit ad-hoc reports to the IICB upon its request, on the performance of CERT-EU, financial planning, revenue, implementation of the budget, service level agreements and written agreements entered into, cooperation with counterparts and partners, and missions undertaken by staff, including the reports referred to in Article 10(1).
Amendment 306 #
2022/0085(COD)
Proposal for a regulation
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
The Head of CERT-EU shall compose and submit to the IICB an annual report encompassing CERT-EU’s work programme, the financial planning of revenue and expenditure, including staffing, for CERT-EU activities, any updates of CERT-EU’s service catalogue and an assessment of the expected impact that such updates may have on its financial planning of revenue and expenditure, staffing and management of funds.
Amendment 308 #
2022/0085(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
Amendment 322 #
2022/0085(COD)
Proposal for a regulation
Article 18 – paragraph 3
Article 18 – paragraph 3
Amendment 326 #
2022/0085(COD)
Proposal for a regulation
Article 19 – title
Article 19 – title
19 SharingCybersecurity information sharing arrangements and obligations
Amendment 327 #
2022/0085(COD)
Proposal for a regulation
Article 19 – paragraph -1 (new)
Article 19 – paragraph -1 (new)
-1. Union institutions, bodies, offices and agencies may voluntarily notify CERT-EU on cyber threats, incidents, near misses and vulnerabilities that affect them. CERT-EU shall ensure that effective measures are adopted to ensure the confidentiality and appropriate protection of the information provided by the reporting Union institution, body, office or agency. When processing notifications, CERT-EU may prioritise the processing of mandatory notifications over voluntary notifications. Voluntary notification shall not result in the imposition of any additional obligations upon the reporting Union institution, body, office or agency to which it would not have been subject had it not submitted the notification.
Amendment 328 #
2022/0085(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. To enable CERT-EU to coordinate vulnerabileffectively perform itys management and incident responseission tasks in accordance with Article 12 of this Regulation, it may request Union institutions, bodies and agencies to provide it with information from their respective ICT system inventories that is relevant for the CERT- EU support. The requested institution, body or agency shall transmit the requested information, and any subsequent updates thereto, without undue delay.
Amendment 334 #
2022/0085(COD)
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. The sharingcybersecurity information sharing arrangements and obligations obligations shall not extend to EU Classified Information (EUCI) and to information that a Union institution, body or agency has received from a Member State Security or Intelligence Service or law enforcement agency under the explicit condition that it will not be shared with CERT-EU.
Amendment 336 #
Amendment 337 #
2022/0085(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1
Article 20 – paragraph 1 – subparagraph 1
Amendment 338 #
2022/0085(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1
Article 20 – paragraph 1 – subparagraph 1
All Union institutions, bodies, offices and agencies shall make an initial notification to CERT-EU of significant cyber threats, significant vulnerabilities and significreport, without undue delay to CERT-EU in accordance with paragraph 2(b) of anty incidents without undue delay and having any event no later than 24 hours after becoming aware of them significant impact.
Amendment 340 #
2022/0085(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 a (new)
Article 20 – paragraph 1 – subparagraph 1 a (new)
Amendment 341 #
2022/0085(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1 b (new)
Article 20 – paragraph 1 – subparagraph 1 b (new)
Where a significant incident or significant cyber threat referred to in paragraph 1(a) is affecting a network and information system, or a component of a Union institution, body, office or agency's ICT environment that is knowingly connected with another Union institution, body, office and agency's ICT environment, CERT-EU shall notify, without undue delay, the affected Union institution, body, office or agency.
Amendment 342 #
2022/0085(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 2
Article 20 – paragraph 1 – subparagraph 2
Amendment 348 #
2022/0085(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
Amendment 352 #
2022/0085(COD)
Proposal for a regulation
Article 20 – paragraph 2 a (new)
Article 20 – paragraph 2 a (new)
2 a. An incident shall be considered significant if: (a) the incident has caused or is capable of causing severe operational disruption to the Union institution, body, office or agency or financial losses thereto; (b) the incident has affected or is capable of affecting other natural or legal persons by causing considerable material or non- material losses.
Amendment 353 #
2022/0085(COD)
Proposal for a regulation
Article 20 – paragraph 2 b (new)
Article 20 – paragraph 2 b (new)
2 b. All Union institutions, bodies, offices and agencies shall submit to CERT-EU: (a) without undue delay and in any event within 24 hours after having become aware of the significant incident, an early warning, which, where applicable, shall indicate whether the significant incident is presumably caused by unlawful or malicious action and has any or could have a cross-border or cross-institutional impact; (b) without undue delay and in any event within 72 hours after having become aware of the significant incident, an incident notification, which, where applicable, shall update the information referred to in subparagraph (a) and indicate an initial assessment of the significant incident, its severity and impact, as well as where available, the indicators of compromise; (c) upon the request of CERT-EU, an intermediate report on relevant status updates; (d) a final report not later than one month after the submission of the significant incident notification under point (b), including at least the following: (i) a detailed description of the significant incident, its severity and impact; (ii) the type of threat or root cause that likely triggered the significant incident; (iii) applied and ongoing mitigation measures; (iv) where applicable, the cross-border or cross-institutional impact of the significant incident; (e) in cases of ongoing significant incidents at the time of the submission of the final report referred to in point (d), a progress report at that time and a final report within one month after the incident has been handled.
Amendment 356 #
2022/0085(COD)
Proposal for a regulation
Article 20 – paragraph 2 c (new)
Article 20 – paragraph 2 c (new)
2 c. In duly justified cases and in agreement with CERT-EU, the Union institution, body, office or agency concerned can deviate from the deadline laid down in paragraph 2(b).
Amendment 358 #
2022/0085(COD)
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. CERT-EU shall submit to ENISA on a monthly basis a summary report including anonymised and aggregated data on significant cyber threats, significant vulnerabilities and significant incidentincidents notified in accordance with paragraph 2(b) and cyber threats, incidents, near misses and vulnerabilities notified in accordance with paragraph 1Article 19(1).
Amendment 360 #
2022/0085(COD)
4. The IICB may issue guidance documents or recommendations concerning the modalities and content of the notification. When preparing such guidance documents or recommendations, the IICB shall take into account the specifications made by any implementing acts adopted by the Commission specifying the type of information, the format and the procedure of a notification submitted pursuant to Article 20 (11) of Directive [proposal NIS2]. CERT-EU shall disseminate the appropriate technical details to enable proactive detection, incident response or mitigating measures by Union institutions, bodies, offices and agencies.
Amendment 363 #
2022/0085(COD)
Proposal for a regulation
Article 20 – paragraph 5
Article 20 – paragraph 5
5. The notificationreporting obligations shall not extend to EUCI and to information that a Union institution, body or agency has received from a Member State Security or Intelligence Service or law enforcement agency under the explicit condition that it will not be shared with CERT-EU.
Amendment 366 #
2022/0085(COD)
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. CERT-EU, in cooperation with ENISA, shall support Union institutions, bodies and agencies regarding situational awareness of cyber threats, vulnerabilities and incidents.
Amendment 367 #
Amendment 370 #
2022/0085(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. CERT-EU shall coordinate among Union institutions, bodies and agencies responses to major attackincidents. It shall maintain an inventory of technical expertise that would be needed for incident response in the event of such attacksmajor incidents and assist the IICB in coordinating Union institutions, bodies, offices and agencies’ cyber crisis management plans for major incidents referred to in Article 10(if).
Amendment 375 #
2022/0085(COD)
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. With the approval of the concerned Union institutions, bodies and agencies, CERT-EU may also call on experts from the list referred to in paragraph 2 for contributing to the response to a major attackincident in a Member State, in line with the Joint Cyber Unit’s operating procedures.
Amendment 386 #
2022/0085(COD)
Proposal for a regulation
Article 24 – paragraph 3
Article 24 – paragraph 3
3. The Commission shall evaluate the functioning of this Regulation and report to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions no soonlater than five years after the date of entry into force.
Amendment 388 #
2022/0085(COD)
Proposal for a regulation
Annex I
Annex I
Amendment 394 #
2022/0085(COD)
Proposal for a regulation
Annex II
Annex II
Amendment 103 #
2022/0047(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) In order to respond to the needs of the digital economycontribute to the digital transition of the Union, a comprehensive harmonisation at Union level is needed to ensure fairness in the allocation of value from data among all actors in the data economy as well asto avoid fragmentation resulting from national legislation, and therefore to create trust in the data sharing environment. Moreover, to foster access to and use of data. and to remove barriers to a well-functioning internal market for data, it is necessary to lay down a harmonised framework specifying who, other than the manufacturer or other data holder is entitled to access the data generated by products or related services, under which conditions and on what basis. Accordingly, Member States should not adopt or maintain additional national requirements on those matters falling within the scope of this Regulation, unless explicitly provided for in this Regulation, since this would affect the direct and uniform application of this Regulation.
Amendment 130 #
2022/0047(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) Physical products that obtain, generate or collect, by means of their components or operating systems or embedded software, data concerning their performance, use or environment and that are able to communicate that data via a publicly available electronic communications service (often referred to as the Internet of Things) should be covered by this Regulation with the exception of prototypes. Electronic communications services include land- based telephone networks, television cable networks, satellite-based networks and near-field communication networks. Such products may include vehicles, home equipment and consumer goods, medical and health devices or agricultural and industrial machinery. The data represent the digitalisation of user actions and events and should accordingly be accessible to the user, while information derived or inferred from this data, where lawfully held, should not be considered within scope of this Regulation. Such data are potentially valuable to the user and support innovation and the development of digital and other services protecting the environment, health and the circular economy, in particular though facilitating the maintenance and repair of the products in question.This Regulation applies to products placed on the marketin the Union and thus does not apply to products in development stage such as prototypes.
Amendment 136 #
2022/0047(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) In contrast, certain products that are primarily designed to display or play content, or to record and transmit content, amongst others for the use by an online service should not be covered by this Regulation. Such products include, for example, personal computers, servers, tablets and smart phones, cameras, webcams, sound recording systems and text scanners. They require human input to produce various forms of content, such as text documents, sound files, video files, games, digital maps.
Amendment 140 #
2022/0047(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15 a) The use and access to sensitive data generated by a product regulated by a specific sectoral rules is without prejudice to those rules.
Amendment 148 #
2022/0047(COD)
(17) Data generated by the use of a product or related service include data recorded intentionally by the user. Such data include also data generated as a by- product of the user’s action, such as diagnostics data, and without any action by the user, such as when the product is in ‘standby mode’, and data recorded during periods when the product is switched off. Such data should include data in the form and format in which they are generated by the product, but not pertain to data resulting from any softwaincluding data pre -process that calculates derivative data from such data as such software process may be subject to intellectual property rights.ed using the product’s own computing capacity
Amendment 158 #
2022/0047(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The user of a product should be understood as the legal or natural person, such as a business or, consumer or public sector body , which has purchased, rented or leased the product. Depending on the legal title under which he uses it, such a user bears the risks and enjoys the benefits of using the connected product and should enjoy also the access to the data it generates. The user should therefore be entitled to derive benefit from data generated by that product and any related service.
Amendment 166 #
2022/0047(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) In case several persons or entities own a product or are party to a lease or rent agreement and benefit from access to a related service, reasonable efforts should be made in the design of the product or related service or the relevant interface so that all personeach user can have access to data they it generates can have access to data they generated only to such data. In case several manufacturers or related services providers have sold, rent out or leased products or services integrated together to the same user, the user should turn to each of the manufacturers or related service providers with who it has a contractual agreement. Users of products that generate data typically require a user account to be set up. This allows for identification of the user by the manufacturer as well as a means to communicate to exercise and process data access requests. Manufacturers or designers of a product that is typically used by several persons should put in place the necessary mechanism and joint consent that allow separate user accounts for individual persons, where relevant, or the possibility for several persons to use the same user account. Access should be granted to the user upon simple request mechanisms granting automatic execution, not requiring examination or clearance by the manufacturer or data holder. This means that data should only be made available when the user actually wants this. Where automated execution of the data access request is not possible, for instance, via a user account or accompanying mobile application provided with the product or service, the manufacturer should inform the user how the data may be accessed.
Amendment 170 #
2022/0047(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) Products may be designed to make certain data directly available from an on- device data storage or from a remote server to which the data are communicated. Where on-device access is technically supported, the manufacturer shall make this means of access also available to third-party service providers or the user. Access to the on-device data storage may be enabled via cable-based or wireless local area networks connected to a publicly available electronic communications service or a mobile network. The server may be the manufacturer’s own local server capacity or that of a third party or a cloud service provider who functions as data holder. TheyProducts may be designed to permit the user or a third party to process the data on the product or on a computing instance of the manufacturer or in an environment chosen by the user or the authorised. Where either option is available, the user or third party shall choose their preferred method.
Amendment 188 #
2022/0047(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) In sectors characterised by the concentration of a small number of manufacturers supplying end users, there are only limited options available to users with regard to sharing data with those manufacturers. In such circumstances, cContractual agreements may be insufficient to achieve the objective of user empowerment. The data tends to remain under the control of the manufacturers or other data holders, making it difficult for users to obtain value from the data generated by the equipment they purchase or lease. Consequently, there is limited potential for innovative smaller businesses to offer data-based solutions in a competitive manner and for a diverse data economy in Europe. This Regulation should therefore build on recent developments in specific sectors, such as the Code of Conduct on agricultural data sharing by contractual agreement. Sectoral legislation may be brought forward to address sector-specific needs and objectives. Furthermore, the data holder should not use any data generated by the use of the product or related service in order to derive insights about the economic situation of the user or its assets or production methods or the use in any other way that could undermine the commercial position of the user on the markets it is active on. This would, for instance, involve using knowledge about the overall performance of a business or a farm in contractual negotiations with the user on potential acquisition of the user’s products or agricultural produce to the user’s detriment, or for instance, using such information to feed in larger databases on certain markets in the aggregate (,e.g. databases on crop yields for the upcoming harvesting season) as such use could affect the user negatively in an indirect manner. The user should be given the necessary technical interface to manage permissions, preferably with granular permission options (such as “allow once” or “allow while using this app or service”), including the option to withdraw permission.
Amendment 190 #
2022/0047(COD)
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25 a) Data users should have the priority on benefitting from the value created by the use of the product. Data holders should ensure that non-personal they receive from the connected product are primarily used for the fulfilment of their contractual obligations to the user. This is without the prejudice of the data holders capability to use the non-personal data generated to improve the functioning of the connected product or related service, to develop new products or services or to enrich, manipulate or aggregate it with other data.
Amendment 202 #
2022/0047(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) The user should be free to use the data for any lawful purpose. This includes providing the data the user has received exercising the right under this Regulation to a third party offering an aftermarket service that may be in competition with a service provided by the data holder, or to instruct the data holder to do so. The request should also be valid regardless of whether the request is put forward by the user or an authorised third party acting on users behalf, such as authorised data intermediation service in the meaning of the Regulation (EU) 2022/868. The data holder should ensure that the data made available to the third party is as accurate, complete, reliable, relevant and up-to-date as the data the data holder itself may be able or entitled to access from the use of the product or related service. Any trade secrets or intellectual property rights should be respected in handling the data. It is important to preserve incentives to invest in products with functionalities based on the use of data from sensors built into that product. The aim of this Regulation should accordingly be understood as to foster the development of new, innovative products or related services, stimulate innovation on aftermarkets, but also stimulate the development of entirely novel services making use of the data, including based on data from a variety of products or related services. At the same time, it aims to avoid undermining the investment incentives for the type of product from which the data are obtained, for instance, by the use of data to develop a competing product.
Amendment 215 #
2022/0047(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) Data generated by the use of a product or related service should only be made available to a third party such as authorised data intermediation service in the meaning of the Regulation (EU) 2022/868 at the request of the user. This Regulation accordingly complements the right provided under Article 20 of Regulation (EU) 2016/679. That Article provides for a right of data subjects to receive personal data concerning them in a structured, commonly used and machine- readable format, and to port those data to other controllers, where those data are processed on the basis of Article 6(1), point (a), or Article 9(2), point (a), or of a contract pursuant to Article 6(1), point (b). Data subjects also have the right to have the personal data transmitted directly from one controller to another, but only where technically feasible. Article 20 specifies that it pertains to data provided by the data subject but does not specify whether this necessitates active behaviour on the side of the data subject or whether it also applies to situations where a product or related service by its design observes the behaviour of a data subject or other information in relation to a data subject in a passive manner. The right under this Regulation complements the right to receive and port personal data under Article 20 of Regulation (EU) 2016/679 in several ways. It grants users the right to access and make available to a third party to any data generated by the use of a product or related service, irrespective of its nature as personal data, of the distinction between actively provided or passively observed data, and irrespective of the legal basis of processing. Unlike the technical obligations provided for in Article 20 of Regulation (EU) 2016/679, this Regulation mandates and ensures the technical feasibility of third party access for all types of data coming within its scope, whether personal or non-personal. This Regulation also allows direct data sharing from users to third parties. This Regulation precludes the data holder or the third party from directly or indirectly charging consumers or data subjects a fee, compensation or costs for sharing data or for accessing it. This Regulation does not directly or indirectly incentivise the commercialisation or trade of personal data It also allows the data holder to set reasonable compensation to be met by third parties, but not by the user, for any cost incurred in providing direct access to the data generated by the user’s product. If a data holder and third party are unable to agree terms for such direct access, the data subject should be in no way prevented from exercising the rights contained in Regulation (EU) 2016/679, including the right to data portability, by seeking remedies in accordance with that Regulation. It is to be understood in this context that, in accordance with Regulation (EU) 2016/679, a contractual agreement does not allow for the processing of special categories of personal data by the data holder or the third party.
Amendment 278 #
2022/0047(COD)
Proposal for a regulation
Recital 56
Recital 56
(56) In situations of exceptional need, it may be necessary for public sector bodies or Union institutions, agencies or bodies to use data held by an enterprise to respond to public emergencies or in other exceptional casesPublic sector bodies are faced with several interrelated challenges spanning from pandemics and climate change to urban planning and mobility. Privately held data has a high potential to help solving these problems in the public interest. By informing decision making, providing for new scientific insights and resolving policy issues, private held data enablse more targeted interventions and improvement of public service delivery, bringing about significant savings for the public budget. This is why situations it may be necessary for public sector bodies or Union institutions, agencies or bodies to use data held by an enterprise to respond to public emergencies such as public health or climate emergencies, in other exceptional cases such as purposes of legitimate public interest explicitly provided by under Union or national law. Research-performing organisations and research-funding organisations could also be organised as public sector bodies or bodies governed by public law. To limit the burden on businesses, micro and small enterprises should be exempted from the obligation to provide public sector bodies and Union institutions, agencies or bodies data in situations of exceptional need.
Amendment 283 #
2022/0047(COD)
Proposal for a regulation
Recital 56 a (new)
Recital 56 a (new)
(56 a) The business-to-government data sharing should be driven by the over- arching principles outlined in the High Level Expert Group on Business-to- Government. These principles are: proportionality of the use of private-sector data, data use limitation, “do no harm”, compensation, non-discrimination, limitation mitigation, transparency and societal participation, accountability and fair and ethical data use.
Amendment 289 #
2022/0047(COD)
Proposal for a regulation
Recital 57
Recital 57
(57) In case of public emergencies, such as public health emergencies, emergencies resulting from environmental degradation and major natural disasters including those aggravated by climate change, as well as human-induced major disasters, such as major cybersecurity incidents, the public interest resulting from the use of the data will outweigh the interests of the data holders to dispose freely of the data they hold. In such a case, data holders should be placed under an obligation to make the data available to public sector bodies or to Union institutions, agencies or bodies upon their request. The existence of a public emergency ishould be determined according to the respective procedures in the Member States or of relevant international organisations.
Amendment 298 #
2022/0047(COD)
Proposal for a regulation
Recital 58
Recital 58
(58) An exceptional need may also arise when a public sector body can demonstrate that the data are necessary either to prevent a public emergency, or to assist recovery from a public emergency, in circumstances that are reasonably proximate to the public emergency in question. Where the exceptional need is not justified by the need to respond to, prevent or assist recovery from a public emergency, the public sector body or the Union institution, agency or body should demonstrate that the lack of timely access to and the use of the data requested prevents it from effectively fulfilling a specificor exercising a task in the legitimate public interest that has been explicitly provided in lawas provided for in national law. The tasks, aimed at improving the efficient provision of public services and evidence-based public policymaking as well as gaining enforcement of existing laws or regulations, can include but should not be limited to, improving traffic and mobility, environmental sustainability, affordable housing, city planning as well as facilitating the development, production and dissemination of official statistics. Such exceptional need may also occur in other situations, for example in relation to the timely compilation of official statistics when data is not otherwise available or when the burden on statistical respondents will be considerably reduced. At the same time, the public sector body or the Union institution, agency or body should, outside the case of responding to, preventing or assisting recovery from a public emergency, demonstrate that no alternative means for obtaining the data requested exists and that the data cannot be obtained in a timely manner through the laying down of the necessary data provision obligations in new legislation. This covers situations where the existence of a reporting obligation fort the provision of the data in scope of the request exists but is in itself insufficient to guarantee the availability of data of the necessary quality, granularity, and timeliness or where the said obligation is otherwise not fit for the specific use purpose sought.
Amendment 311 #
2022/0047(COD)
Proposal for a regulation
Recital 62 a (new)
Recital 62 a (new)
(62 a) The data made available to the public sector bodies should be in a structured and commonly used format, accompanied with a relevant metadata that facilitates the use of the data with only minimal adaptations necessary to make them useable by the public sector or Union institution body.
Amendment 320 #
2022/0047(COD)
Proposal for a regulation
Recital 66
Recital 66
(66) When reusing data provided by data holders, public sector bodies and Union institutions, agencies or bodies should respect both existing applicable legislation and contractual obligations to which the data holder is subject. . Public administration authorities should coordinate their requests for data and pursue best efforts to ensure that businesses are obliged to supply the same data only once. Where the disclosure of trade secrets of the data holder to public sector bodies or to Union institutions, agencies or bodies is strictly necessary to fulfil the purpose for which the data has been requested, confidentiality of such disclosure should be ensured to the data holder.
Amendment 328 #
2022/0047(COD)
Proposal for a regulation
Recital 69 a (new)
Recital 69 a (new)
(69 a) Unnecessarily high “data egress fees”, or data transfer costs have the potential to restrict competition and cause lock-in effects for the customers of data processing services, by reducing incentives to choose a different or additional service provider. Therefore, the gradual withdrawal of the charges associated with switching data processing services should specifically include withdrawing any “egress fees” charged by the data processing services to a customer.
Amendment 339 #
2022/0047(COD)
Proposal for a regulation
Recital 79
Recital 79
(79) Standardisation and semantic interoperability should play a key role to provide technical solutions to ensure interoperability. In order to facilitate the conformity with the requirements for interoperability, it is necessary to provide for a presumption of conformity for interoperability solutions that meet harmonised standards or parts thereof in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council. These standards should be developed in open, technology neutral and inclusive way line with Chapter II of the Regulation (EU) No 1025/2012. The Commission should adopt common specifications in areas where no harmonised standards exist or where they are insufficient in order to further enhance interoperability for the common European data spaces, application programming interfaces, cloud switching as well as smart contracts. Additionally, common specifications in the different sectors could remain to be adopted, in accordance with Union or national sectoral law, based on the specific needs of those sectors. Reusable data structures and models (in form of core vocabularies), ontologies, metadata application profile, reference data in the form of core vocabulary, taxonomies, code lists, authority tables, thesauri should also be part of the technical specifications for semantic interoperability. Furthermore, the Commission should be enabled to mandate the development of harmonised standards for the interoperability of data processing services in consultation with the European Data Innovation Board as outlined in the Article 30 of the Regulation (EU) No 2022/868.
Amendment 343 #
2022/0047(COD)
Proposal for a regulation
Recital 80 a (new)
Recital 80 a (new)
(80 a) The number of devices connected to the Internet, both in enterprise networks and consumer households, including machines, sensors, and cameras that make up the Internet of Things (IoT), continues to grow at a steady pace. Since it is expected that by the end of the decade a number of connected devices across the Union will be extremely high, providing for digital identity of IoT devices and their secure authentication is becoming an urgent priority. International Data Corporation estimates that the number of connected IoT devices is expected to reach 41.6 billion by 2025. While an increasing number of devices is connected to the internet, security and resilience are not sufficiently built in by design, leading to insufficient cybersecurity. Ensuring secure digital identities for IoT devices needs to be a continuous, automated process but this needs to start at the point of manufacture and continue throughout the device lifecycle. Connected devices create a data-rich network which means improved functionality and potential revenue growth for organisations, but they also come with significant business and compliance risks. These begin to outweigh the strategic benefits unless businesses and governments prioritise securing digital identities. By extending the concept of digital identity and attestation of attributes to IoT devices, the European Digital Identity Framework can help mitigate cybersecurity risks and add value to the data exchanged by adding a new trust layer to network and information systems, communications networks, digital products, services and devices used by citizens, organisations and businesses.
Amendment 345 #
2022/0047(COD)
Proposal for a regulation
Recital 81 a (new)
Recital 81 a (new)
(81 a) In order to further enhance coordination in thee nforcement of this Regulation, the European Data Innovation Board should foster the mutual exchange of information amongst competent authorities as well as advise and assist the Commission in matters falling under this Regulation that fall within the competences of Article 30 of Regulation (EU) 2022/868. A subgroup for stakeholder involvement referred to in Article 29(2)(c) of that Regulation should participate in the consultation on a continual basis.
Amendment 359 #
2022/0047(COD)
Proposal for a regulation
Article 1 – paragraph 1 a (new)
Article 1 – paragraph 1 a (new)
1 a. This Regulation covers personal and non-personal data, including the following types of data or in the following contexts: (a) Chapter II applies to data concerning the performance, use and environment of products and relatedservices. (b) Chapter III applies to anyprivate sector data subject to statutory data sharing obligations. (c) Chapter IV applies to any private sector data accessed and used on the basis of contractual agreements between businesses. (d) Chapter V applies to any privatesector data with a focus on non-personal data. (e) Chapter VI applies to any dataprocessed by data processing services. (f) Chapter VII applies to any non- personal data held in the Union by providers of data processing services.
Amendment 362 #
2022/0047(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) manufacturers of products and suppliers of related services placed on the market in the Union and the Union based users of such products or services;
Amendment 388 #
2022/0047(COD)
Proposal for a regulation
Article 1 – paragraph 4 a (new)
Article 1 – paragraph 4 a (new)
4 a. Dataholders shall not be obliged to provide access to data to any natural or legal person, entity or body outside the Union, unless otherwise provided by the Union law or the implementing national legislations.
Amendment 395 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1 a (new)
Article 2 – paragraph 1 – point 1 a (new)
(1 a) ‘personal data’ means personal data as defined in Article 4, point(1), of Regulation (EU) 2016/679;
Amendment 398 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1 b (new)
Article 2 – paragraph 1 – point 1 b (new)
(1 b) 'non-personal data' means data other than personal data;
Amendment 402 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1 a (new)
Article 2 – paragraph 1 – point 1 a (new)
(1 a) ‘metadata’ means a structured description of the contents of the data facilitating the discovery and use of this data such as configuration parameters, security settings, logs, and other information regarding the use of the product or related service by the final user. It should be as used by the data holder for its own purpose, without any obligation to register or store metadata additionally.
Amendment 417 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) ‘product’ means a tangible, movable item, including where incorporated in an immovable item, that obtains, generates or collects, data concerning its use or environment, and that is able to communicate data via a publicly availablen electronic communications service and whose primary function is not the storing and, processing of datar transmission of data nor is it primarily designed to display or play content, or to record and transmit content;
Amendment 443 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 6 a (new)
Article 2 – paragraph 1 – point 6 a (new)
(6 a) 'data subject' means data subject as referred to in Article 4, point (1), of Regulation (EU) 2016/679;
Amendment 455 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10
Article 2 – paragraph 1 – point 10
(10) ‘public emergency’ means an exceptional situation such as public health emergencies, emergencies resulting from environmental degradation and major natural disasters, including those exacerbated by climate change, and major man-made disasters, such as major cybersecurity incidents, negatively affecting the population of the Union, a Member State or part of it, with a risk of serious and lasting repercussions on living conditions or economic and financial stability, or the substantial degradation of economic assets in the Union or the relevant Member State(s); and which is determined according to the respective procedures under Union or national law.
Amendment 459 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10 a (new)
Article 2 – paragraph 1 – point 10 a (new)
(10 a) ‘official statistics’ means statistics within the meaning of ‘European statistics’ under Regulation (EC) No 223/2009’.
Amendment 465 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 15
Article 2 – paragraph 1 – point 15
(15) ‘'open interoperability specificationstandards’ mean ICT technical specifications, as defined in Regulation (EU) No 1025/2012, which are performance oriented towards achieving interoperability between data processing servicesfor repeated or continuous application, publicly available for implementation and use on reasonable terms (including for a reasonable fee or free of charge), adopted through an inclusive, collaborative, consensus-based and transparent process from which materially affected and interested parties cannot be excluded;
Amendment 469 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 16
Article 2 – paragraph 1 – point 16
Amendment 472 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 17
Article 2 – paragraph 1 – point 17
Amendment 478 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 20 a (new)
Article 2 – paragraph 1 – point 20 a (new)
(20 a) ‘common European data spaces’ mean purpose- or sector-specific or cross -sectoral interoperable frameworks of common standards and practices to share or jointly process data for, inter alia, development and provision of new products and services, scientific research or civil society initiatives.
Amendment 483 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 20 b (new)
Article 2 – paragraph 1 – point 20 b (new)
(20 b) ‘data intermediation service’ means data intermediation service as referred to in Article 2, point (8), of Regulation(EU) 2022/868;
Amendment 485 #
2022/0047(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 20 c (new)
Article 2 – paragraph 1 – point 20 c (new)
(20 c) 'operator within data spaces' mean legal persons, such as data holders, data users, and data intermediation service providers, that facilitate or engage in data sharing within and across the common European data spaces;
Amendment 492 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Products shall be designed and manufactured, and related services shall be provided, in such a manner that data generated by their use that are accessible to the data holder are free of charge and, are, by default, easily, securely and, where relevant and appropriate, directly accessible to the user in a structured, commonly used and machine-readable format. Data shall be provided in the form in which they have been generated by the product, with only the minimal adaptations necessary to make them useable by a third party, including related metadata necessary to interpret and use the data.
Amendment 495 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Products shall be designed and manufactured, and related services shall be provided, in such a manner that data generated by their use are, by default, easily, securely and, where relevant and appropriate, directly accessible to the user. This should be done without endangering their functionality nor going against data security requirements from Regulation 2016/679, product regulations or technical standardisation
Amendment 503 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1 a. Where on-device access is technically supported, the manufacturer shall make this means of access also available to third-party service providers in a non-discriminatory manner.
Amendment 504 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 1 a (new)
Article 3 – paragraph 1 a (new)
1 a. The data holder shall not be liable towards the user for any direct or indirect damages arising from, relating to and/or in connection with data made accessible.
Amendment 516 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point a a (new)
Article 3 – paragraph 2 – point a a (new)
(a a) the categories of data transmitted to the data holder by the use of a product or a related service
Amendment 521 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point c
Article 3 – paragraph 2 – point c
(c) how the user may access those data delivered in a usable format and in a simple, clear and free manner for the user ;;
Amendment 528 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point c b (new)
Article 3 – paragraph 2 – point c b (new)
(c b) (cb) The technical means to access the data, such as Software Development Kits or application programming interfaces , and their terms of use and quality of service shall be sufficiently described to enable the development of such means of access
Amendment 529 #
2022/0047(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point c a (new)
Article 3 – paragraph 2 – point c a (new)
(c a) the data holder shall provide information on the data structures, data formats, vocabularies, classification schemes, taxonomies and code lists, where available, which shall be described in a publicly available and consistent manner.
Amendment 558 #
2022/0047(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Where data cannot be directly accessed by the user from the product, the data holder shall make available to the user the data generated by itsthe use of a product or related service without undue delay easily, in a structured, commonly used and machine-readable format, free of charge and, where applicable, continuously and in real-time. accompanied with relevant metadata. Data shall be provided in the form in which they have been generated by the product including data generated by the use of a product, with only the minimal adaptations necessary to make them useable by a third party, including related metadata and support tools necessary to interpret and use the data in order to achieve the intended purpose- This shall be done on the basis of a simple request through electronic means where This shall be done on the basis of a simple request through electronic means where technically feasible.
Amendment 573 #
2022/0047(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Trade secrets shall only be disclosed provided that all specific necessary measures are taken to preserve the confidentiality of trade secrets in particular with respect to third parties. The data holder and the user can agree measures to preserve the confidentiality of the shared data, in particular in relation to third parties. Such measures shall be utilized in a limited manner and only when theshared data includes trade secrets as defined by the EU or national law. The data holder shall prove the existence of trade secrets when it invokes measures to preserve the confidentiality of the shared data.
Amendment 579 #
2022/0047(COD)
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Trade secrets shall only be disclosed provided that all specific necessary measures are taken to preserve the confidentialityData constitutive of trade secrets and data subject to intellectual property rights shall only be disclosed upon agreement of the trade secrets in particular with respect to third parties. T holder or IPR holder. The trade secret holder, the data holder and the user can agree measures to preserve the confidentiality of the shared data, in particular in relation to third parties. The trade secret holder or IPR holder shall identify the data which are protected.
Amendment 608 #
2022/0047(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. Upon request by a user, or by a party acting on behalf of a user such as authorised data intermediation service in the meaning of the Regulation (EU) 2022/868, the data holder shall make available the data generated by the use of a product or related service to a third party, without undue delay, free of charge to the user, of the same quality as is available to the data holder, free of charge to the user via a well-formed application programming interface and, where applicable, continuously and in real- time.
Amendment 650 #
2022/0047(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point a
Article 6 – paragraph 2 – point a
(a) make the exercise of the rights or choices of users unduly difficult including by offering choices to the end-users in a non-neutral manner, or coerce, deceive or manipulate the user in any way, by subverting or impairing the autonomy, decision-making or choices of the user, including by means of a digital interface with the user or a part thereof, including its structure, design, function or manner of operation;
Amendment 678 #
2022/0047(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. The obligations of this Chapter related to business-to-business data sharing shall not apply to data generated by the use of products manufactured or related services provided by enterprises that qualify as micro or small enterprises, as defined in Article 2 of the Annex to Recommendation 2003/361/EC, provided those enterprises do not have partner enterprises or linked enterprises as defined in Article 3 of the Annex to Recommendation 2003/361/EC which do not qualify as a micro or small enterprise.
Amendment 699 #
2022/0047(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Any compensation agreed between a data holder and a data recipient for making data available shall be reasonable and shall not exceed the costs directly related to making the data available.
Amendment 704 #
2022/0047(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Where the data recipient is a micro, small or medium enterprise, as defined in Article 2 of the Annex to Recommendation 2003/361/EC, aAny compensation agreed shall not exceed the costs directly related to making the data available to the data recipient and which are attributable to the request. Article 8(3) shall apply accordingly.
Amendment 740 #
2022/0047(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. A contractual term, concerning the access to and use of data or the liability and remedies for the breach or the termination of data related obligations which has been unilaterally imposed by an enterprise on a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Recommendation 2003/361/EC or which has been unilaterally imposed by an enterprise which is the sole source of crucial data they hold in some ecosystem shall not be binding on the latterrecipient enterprise if it is unfair.
Amendment 753 #
2022/0047(COD)
Proposal for a regulation
Article 13 – paragraph 8 a (new)
Article 13 – paragraph 8 a (new)
8 a. The Commission shall conduct a regular market investigation to review and, if necessary, revise the unfair contractual terms listed in paragraphs 3 and 4 of this Article.
Amendment 756 #
2022/0047(COD)
Proposal for a regulation
Chapter V – title
Chapter V – title
V MAKING DATA AVAILABLE TO PUBLIC SECTOR BODIES AND UNION INSTITUTIONS, AGENCIES OR BODIES BASED ON EXCEPTIONAL NEED
Amendment 758 #
2022/0047(COD)
Proposal for a regulation
Article 14 – title
Article 14 – title
Obligation to make data available based on exceptional need
Amendment 761 #
2022/0047(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Upon request, a data holder shall make data, including relevant metadata, available to a public sector body or to a Union institution, agency or body demonstrating an exceptional need or a legitimate public interest to use the data requested.
Amendment 769 #
Amendment 776 #
2022/0047(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point a
Article 15 – paragraph 1 – point a
(a) where the data requested is necessary to respond toprevent or respond to or recover from a public emergency;
Amendment 780 #
2022/0047(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point b
Article 15 – paragraph 1 – point b
Amendment 789 #
2022/0047(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point c – introductory part
Article 15 – paragraph 1 – point c – introductory part
(c) where the lack of available data prevents the public sector body or Union institution, agency or body from fulfilling a specificor exercising tasks in the public interest that hasve been explicitly provided by law; and
Amendment 791 #
2022/0047(COD)
Proposal for a regulation
Article 15 – paragraph 1 – point c – point 1
Article 15 – paragraph 1 – point c – point 1
(1) the public sector body or Union institution, agency or body has been unable to obtain such data by alternative means, including by purchasing the data on the market at market raton reasonable prices or by relying on existing obligations to make data available, and the adoption of new legislative measures cannot ensure the timely availability of the data; or
Amendment 802 #
2022/0047(COD)
Proposal for a regulation
Article 16 – paragraph 1 a (new)
Article 16 – paragraph 1 a (new)
1 a. This Chapter shall be without prejudice to further specific sectoral rules pertaining to the types of data for which rules have been laid down in Union or national law.
Amendment 803 #
2022/0047(COD)
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. The rights from this Chapter shall not be exercised to obtain information or take decisions concerning identifiable individuals. The rights from this Chapter shall not be exercised by public sector bodies and Union institutions, agencies and bodies in order to carry out activities for the prevention, investigation, detection or prosecution of criminal or administrative offences or the execution of criminal penalties, or for customs or taxation administration. This Chapter does not affect the applicable Union and national law on the prevention, investigation, detection or prosecution of criminal or administrative offences or the execution of criminal or administrative penalties, or for customs or taxation administration.
Amendment 845 #
2022/0047(COD)
Proposal for a regulation
Article 17 – paragraph 2 – point d
Article 17 – paragraph 2 – point d
(d) in case of requests made pursuant to Article 15, point (a), concern, insofar as possible, non- personal data;
Amendment 849 #
2022/0047(COD)
Proposal for a regulation
Article 17 – paragraph 2 – point d a (new)
Article 17 – paragraph 2 – point d a (new)
(d a) in case of requests made pursuant to Article 15, point (b), concern personal data only in case the dataprocessing has a specific basis in Union or Member State law;
Amendment 864 #
2022/0047(COD)
Proposal for a regulation
Article 17 – paragraph 4 – subparagraph 2 a (new)
Article 17 – paragraph 4 – subparagraph 2 a (new)
The third party shall not use the data it receives from a public sector body or a Union institution, agency or body as a result of the outsourcing of technical inspections or other functions pursuant to paragraph 4, to develop a product or a service that competes with the product or service from which the accessed data originate or share the data with another third party for that purpose
Amendment 887 #
2022/0047(COD)
Proposal for a regulation
Article 18 – paragraph 5
Article 18 – paragraph 5
5. Where compliance with the request to make data available to a public sector body or a Union institution, agency or body requires the disclosure of personal data, the data holder shall take reasonable efforts to anonymise or pseudonymise the data, insofar as the request can be fulfilled with pseudonymised data.
Amendment 891 #
2022/0047(COD)
Proposal for a regulation
Article 19 – paragraph 1 – introductory part
Article 19 – paragraph 1 – introductory part
1. A public sector body or a Union institution, agency or body having received data pursuant to a request made under Article 14 or statistical or research organisation receiving data pursuant to a request made under Article 21(1) shall:
Amendment 923 #
2022/0047(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. Where the data holder claims compensation for making data available in compliance with a request made pursuant to Article 15, points (b) or (c), such compensation shall not exceedcover the technical and organisational costs incurred to comply with the request including, where necessary, the costs of anonymisation and of technical adaptation, plus a reasonable margin. Upon request of the public sector body or the Union institution, agency or body requesting the data, the data holder shall provide information on the basis for the calculation of the costs and the reasonable margin.
Amendment 931 #
2022/0047(COD)
Proposal for a regulation
Article 20 – paragraph 2 a (new)
Article 20 – paragraph 2 a (new)
2 a. Where the public sector body or the Union institution, agency or body wishes to challenge the level of compensation requested by the data holder, the matter shall be brought to the competent authority referred to in Article 31 of the Member State where the data holder is established.
Amendment 934 #
2022/0047(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. A public sector body or a Union institution, agency or body shall be entitled to share data received under this Chapter with individuals or organisations in view of carrying out scientific research or analytics compatible with the purpose for which the data was requested, or to national statistical institutes, the members of the European System of Central Banks, and Eurostat for the compilation of official statistics.
Amendment 952 #
2022/0047(COD)
Proposal for a regulation
Article 22 – paragraph 4 a (new)
Article 22 – paragraph 4 a (new)
4 a. Where a public sector body intends to request data under Article 15 (b) of this Chapter from a data holder established in another Member State the request shall be evaluated in line by the competent authority of the Member State where the data holder is established.
Amendment 954 #
2022/0047(COD)
Proposal for a regulation
Article 23 – paragraph 1 – introductory part
Article 23 – paragraph 1 – introductory part
1. Providers of a data processing service shall take the measures provided for in Articles 24, 25 and 26 to ensure that customers of their service can switch to another data processing service, covering the same service type, which is provided by a different service provider. In particularorder to provide for effective services switching, providers of data processing service shall remove commercial, technical, contractual and organisational obstacles, which inhibitdiscourage customers from:
Amendment 990 #
2022/0047(COD)
Proposal for a regulation
Article 26 – title
Article 26 – title
Technical aspects of switching and interoperability
Amendment 994 #
2022/0047(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
2. For data processing services other than those covered by paragraph 1, providers of data processing services shall make open interfaces publicly available and free of charge for the purposes of portability and interoperability.
Amendment 997 #
2022/0047(COD)
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
4. Where the open interoperability specifications or European standards referred to in paragraph 3 do not exist for the service type concerned, the provider of data processing services shall, at the request of the customer, export all data generated or co-generated, including the relevant data formats and data structures, in a structured, commonly used and machine- readable format. The exporting data processing service shall ensure that the customer, after switching to a service covering the same service type offered by a different provider of data processing services, can enjoy functional equivalence in the use of the new service.
Amendment 1000 #
2022/0047(COD)
Proposal for a regulation
Article 26 – paragraph 4 a (new)
Article 26 – paragraph 4 a (new)
4 a. Where the open interoperability specifications or European standards referred to in paragraph 3 do not exist for the service type concerned, the provider of data processing services shall make APIs available for the purpose of interoperability. These APIs shall ensure, where technically feasible, that third-party services can enjoy the same functional equivalence as first-party services.
Amendment 1006 #
2022/0047(COD)
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. Providers of data processing services shall take all reasonable technical, legal and organisational measures, including contractual arrangements, in order to prevent international transfer orand governmental access to such non-personal data held in the Union where such transfer or access would create a conflict with Union law or the national law of the relevant Member State, without prejudice to paragraph 2 or 3.
Amendment 1011 #
2022/0047(COD)
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 3
Article 27 – paragraph 3 – subparagraph 3
The European Data Innovation Board established under Regulation [xxx – DGA](EU) 2022/868 shall advise and assist the Commission in developing guidelines on the assessment of whether these conditions are met.
Amendment 1017 #
2022/0047(COD)
Proposal for a regulation
Article 28 – paragraph 1 – subparagraph 1 – introductory part
Article 28 – paragraph 1 – subparagraph 1 – introductory part
Operators ofwithin data spaces shall comply with, the following essential requirements applicable to the services offered by the operator, to facilitate interoperability of data, data sharing mechanisms and services:
Amendment 1019 #
2022/0047(COD)
Proposal for a regulation
Article 28 – paragraph 1 – subparagraph 1 – introductory part
Article 28 – paragraph 1 – subparagraph 1 – introductory part
Operators ofwithin data spaces shall comply with, the following essential requirements, applicable to the services offered by the operator, to facilitate interoperability of data, data sharing mechanisms and services:
Amendment 1021 #
2022/0047(COD)
Proposal for a regulation
Article 28 – paragraph 1 – subparagraph 1 – introductory part
Article 28 – paragraph 1 – subparagraph 1 – introductory part
Amendment 1027 #
2022/0047(COD)
Proposal for a regulation
Article 28 – paragraph 1 – subparagraph 1 – point d
Article 28 – paragraph 1 – subparagraph 1 – point d
(d) the means to enable the interoperability of smart contracts for data sharing within their services and activities shall be provided.
Amendment 1030 #
2022/0047(COD)
Proposal for a regulation
Article 28 – paragraph 1 – subparagraph 1 – point d
Article 28 – paragraph 1 – subparagraph 1 – point d
(d) the means to enable the interoperability of smart contracts for data sharing within their services and activities shall be provided.
Amendment 1033 #
2022/0047(COD)
Proposal for a regulation
Article 28 – paragraph 2
Article 28 – paragraph 2
2. The Commission, in consultation with the European Data Innovation Board in line with the Articles 29and 30 (f)and 30(h) of the Regulation (EU)No 2022/868 is empowered to adopt delegated acts, in accordance with Article 38 to supplement this Regulation by further specifying the essential requirements referred to in paragraph 1.
Amendment 1036 #
2022/0047(COD)
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. OData holders and operators ofwithin data spaces that meet the harmonised standards or parts thereof published by reference in the Official Journal of the European Union shall be presumed to be in conformity with the essential requirements referred to in paragraph 1 of this Article, to the extent those standards cover those requirements.
Amendment 1037 #
2022/0047(COD)
Proposal for a regulation
Article 28 – paragraph 3 a (new)
Article 28 – paragraph 3 a (new)
Amendment 1041 #
2022/0047(COD)
Proposal for a regulation
Article 28 – paragraph 4
Article 28 – paragraph 4
4. The Commission may, in accordance with Article 10 of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards that satisfy the essential requirements under paragraph 1 of this Article and are developed inan and are developed in an open, transparent, technology-neutral, and inclusive manner in accordance with the Chapter II of Regulation (EU) No 1025/2012.
Amendment 1045 #
2022/0047(COD)
Proposal for a regulation
Article 28 – paragraph 6
Article 28 – paragraph 6
6. The Commission, in consultation with the European Data Innovation Board in line with the Articles 29 and 30(f)and 30(h) of the Regulation (EU) 2022/868 may adopt guidelines laying down interoperability specifications for the functioning of common European data spaces, such as architectural models and technical standards implementing legal rules and arrangements between parties that foster data sharing, such as regarding rights to access and technical translation of consent or permission.
Amendment 1046 #
2022/0047(COD)
Proposal for a regulation
Article 29 – title
Article 29 – title
Interoperability and portability for data processing services
Amendment 1048 #
2022/0047(COD)
Proposal for a regulation
Article 29 – paragraph 1 – introductory part
Article 29 – paragraph 1 – introductory part
1. Open interoperability specifications and European standards for the interoperability and portability of data processing services shall:
Amendment 1050 #
2022/0047(COD)
Proposal for a regulation
Article 29 – paragraph 1 – point a
Article 29 – paragraph 1 – point a
(a) be performance oriented towards achieving interoperability and portability between different data processing services that cover the same service type;
Amendment 1051 #
2022/0047(COD)
Proposal for a regulation
Article 29 – paragraph 1 – point b
Article 29 – paragraph 1 – point b
(b) enhance interoperability and portability of digital assets between different data processing services that cover the same service type;
Amendment 1057 #
2022/0047(COD)
Proposal for a regulation
Article 29 – paragraph 2 – introductory part
Article 29 – paragraph 2 – introductory part
2. Open interoperability specifications and European standards for the interoperability and portability of data processing services shall address:
Amendment 1063 #
2022/0047(COD)
Proposal for a regulation
Article 29 – paragraph 5
Article 29 – paragraph 5
5. For the purposes of Article 26(3) of this Regulation, the Commission in consultation with the European Data Innovation Board in line with the Articles 29 and 30(f) and 30(h) of Regulation (EU) 2022/868 shall be empowered to adopt delegated acts, in accordance with Article 38, to publish the reference of open interoperability specifications and European standards for the interoperability of data processing services in central Union standards repository for the interoperability of data processing services, where these satisfy the criteria specified in paragraph 1 and 2 of this Article.
Amendment 1065 #
2022/0047(COD)
Proposal for a regulation
Article 29 – paragraph 5
Article 29 – paragraph 5
5. For the purposes of Article 26(3) of this Regulation, the Commission shall be empowered to adopt delegated acts, in accordance with Article 38, to publish the reference of open interoperability specifications and European standards for the interoperability and portability of data processing services in central Union standards repository for the interoperability and portability of data processing services, where these satisfy the criteria specified in paragraph 1 and 2 of this Article.
Amendment 1067 #
2022/0047(COD)
Proposal for a regulation
Article 30 – title
Article 30 – title
30 Essential requirements regarding smart contracts for data sharing
Amendment 1069 #
2022/0047(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) robustness and access control: ensure that the smart contract has been designed to offer rigorous access control mechanisms and a very high degree of robustness to avoid functional errors and to withstand manipulation by third parties;
Amendment 1072 #
2022/0047(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
Amendment 1075 #
2022/0047(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point d
Article 30 – paragraph 1 – point d
Amendment 1082 #
2022/0047(COD)
Proposal for a regulation
Article 30 – paragraph 2
Article 30 – paragraph 2
Amendment 1085 #
2022/0047(COD)
Proposal for a regulation
Article 30 – paragraph 4
Article 30 – paragraph 4
Amendment 1087 #
2022/0047(COD)
Proposal for a regulation
Article 30 – paragraph 5
Article 30 – paragraph 5
Amendment 1089 #
2022/0047(COD)
Proposal for a regulation
Article 30 – paragraph 6
Article 30 – paragraph 6
Amendment 1093 #
2022/0047(COD)
Proposal for a regulation
Article 30 a (new)
Article 30 a (new)
Article 30 a Digital Identity of Internet of Things devices 1. Internet of Thing (IoT) data generating devices, such as machines, sensors, websites or cloud servers, can have a digital identity and electronic attestation of attributes within the meaning of the Regulation (EU) 910/2014 (European Digital Identity Framework). Digital identity of IoT devices shall allow for identification of a device, and for establishment of a relationship between a device and its owner. 2. The European Digital Identity Wallet (EDIW) within the meaning of Article 6a of the Regulation (EU) 910/2014 (European Digital Identity Framework) shall allow for issuing of electronic attestation of attributes of IoT devices that can be associated with the user of the EDIW at his/her request. 3. The Commission shall be empowered by delegated acts to adopt minimum data sets for the digital identity of certain categories of IoT devices and for their electronic attestation of attributes.
Amendment 1095 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 1
Article 31 – paragraph 1
1. Each Member State shall designate one or more competent authorities as responsible for the application and enforcement of this Regulation, with designated responsible competent authority coordinating the work of the competent authorities. Member States may establish one or more new authorities or rely on existing authorities.
Amendment 1104 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 2 – point c
Article 31 – paragraph 2 – point c
(c) the national competent authority responsible for the application and enforcement of Chapter VI of this Regulation shall have technical and human resources and experience in the field of data and electronic communications services.
Amendment 1105 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 3 – introductory part
Article 31 – paragraph 3 – introductory part
3. Member States shall ensure that the respective tasks and powers of the competent authorities designated pursuant to paragraph 1 of this Article are clearly defined and shall at least include:
Amendment 1107 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 3 – point b
Article 31 – paragraph 3 – point b
(b) handling complaints arising from alleged violations of this Regulation, and investigating, to the extent appropriate, the subject matter of the complaint and regularly and meaningfully informing the complainant of the progress and the outcome of the investigation swiftly within a reasonable period, in particular if further investigation or coordination with another competent authority is necessary;
Amendment 1110 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 3 – point d
Article 31 – paragraph 3 – point d
(d) imposing, through administrative or juridical procedures, dissuasive financial penalties which may include periodic penalties and penalties with retroactive effect, or initiating legal proceedings for the imposition of fines;
Amendment 1111 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 3 – point e
Article 31 – paragraph 3 – point e
(e) monitoring technological developments of relevance for the making available and use of data with a view of better enforcing this Regulation; ;
Amendment 1114 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 3 – point f
Article 31 – paragraph 3 – point f
(f) cooperating with competent authorities of other Member States to ensure the consistent swift and effective application of this Regulation, including the exchange of all relevant information by electronic means, in a timely manner without undue delay;
Amendment 1117 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 3 – point h
Article 31 – paragraph 3 – point h
(h) cooperating with all relevant competent authorities and the European Data the European Data Innovation Board to ensure that the obligations of Chapter VIthis Regulation are enforced consistently with other Union legislation and self-regulation applicable to providers of data processing service;ctor specific data governance rules and regulations
Amendment 1120 #
2022/0047(COD)
Proposal for a regulation
Article 31 – paragraph 4
Article 31 – paragraph 4
4. Where a Member State designates more than one competent authority, the competent authorities shall, in the exercise of the tasks and powers assigned to them under paragraph 3 of this Article, cooperate with each other, including, as appropriate, with the supervisory authority responsible for monitoring the application of Regulation (EU) 2016/679, to ensure the consistent application of this Regulation. In such cases, relevant Member States shall designate a coordinating, responsible competent authority.
Amendment 1126 #
2022/0047(COD)
Proposal for a regulation
Article 31 a (new)
Article 31 a (new)
Article 31 a Role of the European Data Innovation Board The European Data Innovation Board should foster the mutual exchange of information amongst competent authorities as well as advise and assist the Commission in matters of this Regulation falling under the competences of the Board in line with Article 30 of Regulation (EU) 2022/868
Amendment 1127 #
2022/0047(COD)
Proposal for a regulation
Article 32 – paragraph 1
Article 32 – paragraph 1
1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant , collectively, with the relevant competent authority in the Member State of their habitual residence, place of work or establishment if they consider that their rights or the obligations under this Regulation have been infringed.
Amendment 1129 #
2022/0047(COD)
Proposal for a regulation
Article 32 – paragraph 3
Article 32 – paragraph 3
3. Competent authorities shall cooperate early in the process to handle and resolve complaints, including by effectively and in a timely manner, including by setting reasonable deadlines for adopting formal decisions, ensuring equality of the parties, ensuring the right to be heard from complainants and access to the file throughout the process, exchanging all relevant information by electronic means, without undue delay. This cooperation shall not affect the specific cooperation mechanism provided for by Chapters VI and VII of Regulation (EU) 2016/679.
Amendment 1135 #
2022/0047(COD)
Proposal for a regulation
Article 33 – paragraph 1
Article 33 – paragraph 1
1. Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive, including administrative fines against enterprises of a minimum of 20 000 000EUR or 4 % of the total worldwide annual turnover of the preceding financial year, whichever is higher.
Amendment 1139 #
2022/0047(COD)
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. Member States shall by [date of application of the Regulation] notify the Commission , the European Data Protection Board and the European Data Innovation Boardof those rules and measures and shall notify it them without delay of any subsequent amendment affecting them. The Commission shall regularly update and maintain an easily accessible public register of those measures.
Amendment 1143 #
2022/0047(COD)
The Commission shall develop and recommend non-binding model contractual terms on data access and use to assist parties in drafting and negotiating contracts with balanced contractual rights and obligations. These non-binding contractual terms shall be openly freely available in easily usable electronic format.
Amendment 1147 #
2022/0047(COD)
Proposal for a regulation
Article 35 – paragraph 1 a (new)
Article 35 – paragraph 1 a (new)
The right of the maker of a databaseas provided for in Article 7(1) of Directive 96/9/EC shall not be exercised by data holders in such away that it prevents them from making data available to public sector bodies, or Union institutions, agencies or bodies, subsequent to a request made under Article 14 of this Regulation.
Amendment 1153 #
2022/0047(COD)
Proposal for a regulation
Article 41 – paragraph 1 – point e a (new)
Article 41 – paragraph 1 – point e a (new)
(e a) evaluation of the impacts of this Regulation to the development of business practices and monetisation practices of the European data economy and possible needs for reviewing the Regulation.
Amendment 19 #
2022/0033(NLE)
Proposal for a regulation
Recital -1 (new)
Recital -1 (new)
(-1) Reinforcing Europe's semiconductor capacity is key to achieve resilience and strategic autonomy, by reducing dependencies, enhancing digital sovereignty and contributing to the green and digital transitions.
Amendment 20 #
2022/0033(NLE)
Proposal for a regulation
Recital -1 a (new)
Recital -1 a (new)
(-1 a) Critical raw materials are a key element of the Union's chip ecosystem, and, therefore, a framework for increasing the Union’s resilience of critical raw materials supply should be established. Moreover, supporting research and innovation on materials and increasing cooperation between the Member States, the Commission, and like- minded partners will also be necessary.
Amendment 22 #
2022/0033(NLE)
Proposal for a regulation
Recital 2
Recital 2
(2) The Key Digital Technologies Joint Undertaking addresses clearly defined topics that enable European industries at large to research, innovate, design, manufacture and use the most innovative technologies in electronic components and systems.
Amendment 25 #
2022/0033(NLE)
Proposal for a regulation
Recital 3
Recital 3
(3) Regulation (EU) […]23 establishes a framework for increasing the Union’s resilience in the field of semiconductor technologies, stimulating public and private investment, strengthening the capabilities of the European semiconductor supply chain, and increasing cooperation among the Member States and the Commission. To create the conditions necessary to strengthen the Union’s industrial research and innovation capacity, the Chips for Europe Initiative (the ‘Initiative’) is established. In order to ensure a consistent implementation of the Initiative, the European Semiconductor Board should provide advice to the Public Authorities Board. _________________ 23 OJ L …, p…
Amendment 26 #
2022/0033(NLE)
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3 a) The Chips for Europe Initiative is a new strategic initiative of the Union, and requires fresh budgetary resources. The funding needs of the Initiative should be taken into consideration in the mid- term review of the Multiannual Financial Framework, with a view to ensuring the stability, coherence, ambition and long- term financing of the Initiative. Considering that new investments for advanced semiconductor design and manufacturing are extremely capital intensive, the mobilisation of Union funding should continue. Moreover, a framework to face exceptional crisis situations, such as inflation, should be envisaged.
Amendment 29 #
2022/0033(NLE)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4 a) The total financial resources allocated to the Horizon Europe programme, as a major priority of the Union, should not be reduced or re- purposed to fund activities outside of research and innovation and the reduction of the financial resources of the programme, aimed to reinforce the financial envelope of the Digital Europe programme with the aim of contributing to the Chips initiative, should be compensated by additional funding sources.
Amendment 30 #
2022/0033(NLE)
Proposal for a regulation
Recital 4 b (new)
Recital 4 b (new)
(4 b) The allocation of funds for the activities of the Chips for Europe Initiative should not detract from other research, development and innovation activities conducted under Horizon Europe and should ensure continuation of the envisaged Horizon Europe clusters projects.
Amendment 35 #
2022/0033(NLE)
Proposal for a regulation
Recital 5
Recital 5
(5) The Initiative aims to reinforce the competitiveness and resilience of the semiconductor technological and industrial base, whilst strengthening the research and innovation capacity of its semiconductor ecosystem, reducing dependence on a limited number of third country companies and geographies, and strengthening its capacity to design and produce advanced components. These aims should be supported by bridging the gap between the Union’s advanced research and innovation capabilities and their industrial exploitation. It should promote capacity building to enable design, production, packaging and systems integration in next-generation semiconductor technologies, enhance collaboration among key players across the Union, strengthening Europe’s semiconductor supply and value chains, serving key industrial sectors, and creating new markets.
Amendment 37 #
2022/0033(NLE)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5 a) Investing in talent and skills should be considered, with a view to bridging the gap between industry, research and education, as the availability of talent is critical to attracting semiconductor investments, by promoting human potential and skills through STEM education from primary stages of education up to the PhD level, with a specific focus on women, who are under- represented in these sectors.
Amendment 55 #
2022/0033(NLE)
Proposal for a regulation
Recital 11
Recital 11
(11) With a view to accelerating implementation of the actions of the Initiative and enhance cooperation between legal entities, particularly Research and Technology Organisations, certain proposals for actions should be eligible for funding only if the action is carried out by legal entities cooperating within a consortium of at least three legal entities from three different Members States from a broad geographical coverage. That consortium could be structured either as the European Chips Infrastructure Consortium as proposed in the ‘Chips Act’, or based on other available legal tools under Union law. Given that the activities supported under the Initiative and implemented by the Chips Joint Undertaking are financed from Horizon Europe programme and the Digital Europe programme, the Union financial contribution to the Chips Joint Undertaking indicated in Article 128 of Council Regulation (EU) 2021/2085 should be increased accordingly. The administrative costs of the Chips Joint Undertaking should also be increased in accordance with the increase of operational tasks. The private members should not contribute to the additional administrative costs.
Amendment 56 #
2022/0033(NLE)
Proposal for a regulation
Recital 13
Recital 13
(13) The Chips Joint Undertaking should facilitate cooperation between the Union and relevant international like- minded actors by defining a cooperation strategy building on complementarities and interdependencies along the semiconductor supply chain, including identifying and promoting areas for cooperation in research, innovation and development and skills development, and implementing actions where there is a mutual benefit, mainly based on reciprocity and in compliance with Horizon Europe rules and international obligations.
Amendment 68 #
2022/0033(NLE)
Proposal for a regulation
Article 1 – paragraph 1 – point 7 – point b
Article 1 – paragraph 1 – point 7 – point b
Regulation (EU) 2021/2085
Article 126 – Paragraph 1 – point d
Article 126 – Paragraph 1 – point d
(d) increase large-scale capacity throughout the Union in cutting-edge and next-generation semiconductor technologies to reinforce the Union’s advanced design, systems integration and semiconductor production and packaging capabilities and limit where possible the environmental footprint.
Amendment 73 #
2022/0033(NLE)
Proposal for a regulation
Article 1 – paragraph 1 – point 7 – point d
Article 1 – paragraph 1 – point 7 – point d
Regulation (EU) 2021/2085
Article 126 – Paragraph 2 – point i
Article 126 – Paragraph 2 – point i
(i) build advanced technology and engineering capacities for accelerating the development of quantum chips. and photonic semiconductors, while avoiding overlapping and duplication of efforts with the Quantum Technologies Flagship.
Amendment 84 #
2022/0033(NLE)
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EU) 2021/2085
Article 128 – Paragraph 1
Article 128 – Paragraph 1
1. The Union financial contribution to the Joint Undertaking including EEA appropriations shall be up toat least EUR 4 175 000 000, including up to EUR 50 174 000 for administrative costs distributed as follows:
Amendment 135 #
2021/0425(COD)
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9 a) The Union is not able to produce enough renewable and low-carbon hydrogen to meet its decarbonisation goals. Imports of renewable and low- carbon hydrogen are needed for the rapid availability of large quantities of hydrogen catering for the Union’s demand, especially from neighbouring countries and regions such as Norway, Ukraine, North Africa and the Middle East. The certification and life cycle assessment methodology of LCF should also apply to imports. This will ensure that partner countries can easily identify the requirements of the Union for LCF to be certified as such, ensure market confidence, and foster transparent imports of LCF. By developing such a methodology, the Union can also take a leading role in developing global standards for LCF certification and strengthen its role as a global climate leader, using its climate diplomacy to develop mutually beneficial cooperation with exporting partners.
Amendment 188 #
2021/0425(COD)
Proposal for a directive
Recital 35
Recital 35
(35) Recognising the role they can play in decarbonizing the energy system, certain categories of citizen energy initiatives should be recognised in the natural gas market at the Union level as ‘citizen energy communities’. These communities should facilitate the use of renewable gas in the natural gas systemand should contribute to the decarbonisation of the natural gas system, as well as contribute to the reduction of carbon footprint. In order to provide them with an enabling framework, fair treatment, a level playing field and a well- defined catalogue of rights and obligations should be laid down which generally reflects the membership structure, governance requirements and purpose of citizen energy communities in Directive (EU) 2019/944.
Amendment 1706 #
2021/0420(COD)
Proposal for a regulation
Annex 1 – part 18/23
Annex 1 – part 18/23
Add the following to the extended core network: - Zagreb (HR) - Maribor (SI) - Graz (AT) railfreight / passenger (conventional/new construction
Amendment 1708 #
2021/0420(COD)
Proposal for a regulation
Annex 1 – part 18/23
Annex 1 – part 18/23
Add the following to the comprehensive network: - Pula - Buzet (HR) - Divača (SI) - Trieste (IT) rail freight/passenger line Lupoglav – Buzet - state border (SI) - Prešnica (SI)
Amendment 1709 #
2021/0420(COD)
Proposal for a regulation
Annex 1 – part 18/23
Annex 1 – part 18/23
Add the following to the comprehensive network: - Čakovec - Varaždin - Lepoglava - Zabok Zagreb rail freight/passenger line
Amendment 1722 #
2021/0420(COD)
Add the following to the extended core network: Postojna (SI) - Rijeka - Žuta Lokva road (HR) Add the following to the core network: Zagreb (HR) - Maribor (SI) - Graz (AT) road
Amendment 1723 #
2021/0420(COD)
Proposal for a regulation
Annex 1 – part 19/23
Annex 1 – part 19/23
Add the following to the comprehensive network: Rijeka - Divača (SI) - Trieste (IT) road connection Kanfanar – Umag – State border - (SI) road connection
Amendment 1759 #
2021/0420(COD)
Proposal for a regulation
Annex 2 - table - section HR
Annex 2 - table - section HR
Node name: Ploče Maritime port: Comprehensivre
Amendment 1801 #
2021/0420(COD)
Proposal for a regulation
Annex 3 - part 7/14 and part 8/14
Annex 3 - part 7/14 and part 8/14
Add the following to the corridor Baltic Sea - Adriatic Sea: - Rijeka - Zagreb motorway - port of Rijeka (“core”) -Rijeka - Zagreb rail freight/passenger line
Amendment 1811 #
2021/0420(COD)
Proposal for a regulation
Annex 3 - part 10/14
Annex 3 - part 10/14
Amendment 80 #
2021/0218(COD)
Proposal for a directive
Recital 1
Recital 1
(1) The European Green Deal5 establishes the objective of the Union becoming climate neutral in 2050 at the latest in a manner that contributes to the European economy, growth and job creation. That objective, and the objective of a 55% reduction in greenhouse gas emissions by 2030 as set out in the 2030 Climate Target Plan6 that was endorsed both by the European Parliament7 and by the European Council8 ,sustainability of the European economy, environmental protection, social development, growth and job creation, while tackling climate change. That objective, and the objective of a 55% reduction in greenhouse gas emissions by 2030 as set out in Regulation (EU) 2021/1119 (‘European Climate Law’) requires an energy transition and significantly higher shares of renewable energy sources in an integrated energy system. __________________ 5 Communication from the Commission COM(2019) 640 final of 11.12.2019, The European Green Deal. 6 Communication from the Commission COM(2020) 562 final of 17.9.2020, Stepping up Europe’s 2030 climate ambition Investing in a climate-neutral future for the benefit of our people 7 European Parliament resolution of 15 January 2020 on the European Green Deal (2019/2956(RSP)) 8 European Council conclusions of 11 December 2020, https://www.consilium.europa.eu/media/4 7296/1011-12-20-euco-conclusions-en.pdf
Amendment 87 #
2021/0218(COD)
Proposal for a directive
Recital 2
Recital 2
(2) Renewable energy plays a fundamental role in delivering the European Green Deal and for achieving climate neutrality by 2050, given that the energy sector contributes over 75% of total greenhouse gas emissions in the Union. By reducing those greenhouse gas emissions, renewable energy also contributes to tackling environmental-related challenges such as biodiversity loss, reduces health damages and air pollution. Promoting domestic renewable energy reduces the Union’s need to import fossil fuels, increasing energy security.
Amendment 90 #
2021/0218(COD)
Proposal for a directive
Recital 2 a (new)
Recital 2 a (new)
(2a) The share of gross final energy consumption from renewable sources in EU reached 22% in 20201a, 2 percentage points (pp) above the target for the share of renewable energy in gross final energy consumption for 2020, as set out in Directive 2009/28/EC on the promotion of the use of energy from renewable sources. __________________ 1a https://ec.europa.eu/eurostat/web/product s-eurostat-news/-/ddn-20220119-1
Amendment 91 #
2021/0218(COD)
Proposal for a directive
Recital 2 b (new)
Recital 2 b (new)
(2b) At international level, at the 2021 United Nations Climate Change Conference (COP 26) the Commission, together with global partners, committed to end direct support for the international unabated fossil fuel energy and to use these funds for the deployment of renewable energy.
Amendment 92 #
2021/0218(COD)
Proposal for a directive
Recital 2 c (new)
Recital 2 c (new)
(2c) At COP26, the Commission together with global leaders elevated the global ambition level for the preservation and recovery of global forests, and for an accelerated transition to zero emissions transportation.
Amendment 93 #
2021/0218(COD)
Proposal for a directive
Recital 2 d (new)
Recital 2 d (new)
(2d) Since around 35 million Europeans are affected by energy poverty1a, renewable energy policies have an important role to play in any strategy to tackle energy poverty and consumer vulnerability. __________________ 1a Commission Recommendation (EU) 2020/1563 of 14 October 2020 on energy poverty
Amendment 94 #
2021/0218(COD)
Proposal for a directive
Recital 2 e (new)
Recital 2 e (new)
(2e) Member States should therefore ensure that incentives and proactive policies are put in place to facilitate the uptake of efficient renewable generation and heating and cooling not only in middle and high-income households but also in low-income households at risk of energy poverty or in social housing.
Amendment 97 #
2021/0218(COD)
Proposal for a directive
Recital 3
Recital 3
(3) Directive (EU) 2018/2001 of the European Parliament and of the Council9 sets a binding Union target to reach a share of at least 32 % of energy from renewable sources in the Union's gross final consumption of energy by 2030. Under the Climate Target Plan, the share of renewable energy in gross final energy consumption would need to increase to 40% by 2030 in order to achieve the Union’s greenhouse gas emissions reduction target10 . Therefore, the target set out in Article 3 of that Directive needs to be increased to 45% and be accompanied by national binding targets. __________________ 9 Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources, OJ L 328, 21.12.2018, p. 82–209 10 Point 3 of the Communication from the Commission COM(2020) 562 final of 17.9.2020, Stepping up Europe’s 2030 climate ambition Investing in a climate- neutral future for the benefit of our people
Amendment 104 #
2021/0218(COD)
Proposal for a directive
Recital 3 a (new)
Recital 3 a (new)
(3a) In its resolution of 15 January 2020 on "The European Green Deal”, the European Parliament called for the Renewable Energy Directive to be revised in line with net-zero emissions by 2050 at the latest, with designated binding national targets for each Member State. National binding targets of Directive 2009/28/EC have been the most important driver for renewable energy policies and investments in many Member States.
Amendment 114 #
2021/0218(COD)
Proposal for a directive
Recital 4
Recital 4
(4) There is a growing recognition of the need for alignment of bioenergy policies with the cascading principle of biomass use11 , with a view to ensuring fair access to the biomass raw material market for the development of innovative, high value- added bio-based solutions and a sustainable circular bioeconomy. When developing support schemes for bioenergy, Member States should therefore take into consideration the available sustainable supply of biomass for energy and non- energy uses and the maintenance of the national forest carbon sinks and ecosystems as well as ensuring protection of biodiversity and the enhancement of the principles of the circular economy and the biomass cascading use, and the waste hierarchy established in Directive 2008/98/EC of the European Parliament and of the Council12 . For this, they should grant no support to the production of energy from saw logs, veener logs, stumps and roots and avoid promoting the use of quality roundwood for energy except in well-defined circumstances, for example, to ensure wildfire prevention. In line with the cascading principle, woody biomass should be used according to its highest economic and environmental added value in the following order of priorities: 1) wood-based products, 2) extending their service life, 3) re-use, 4) recycling, 5) bio- energy and 6) disposal. Where no other use for woody biomass is economically viable or environmentally appropriate, energy recovery helps to reduce energy generation from non- renewable sources. Member States’ support schemes for bioenergy should therefore be directed to such feedstocks for which little market competition exists with the material sectors, and whose sourcing is considered positive for both climate and biodiversity, in order to avoid negative incentives for unsustainable bioenergy pathways, as identified in the JRC report ‘The use of woody biomass for energy production in the EU’13 . On the other hand, in defining the further implications of the cascading principle, it is necessary to recognise the national specificities which guide Member States in the design of their support schemesWaste prevention, reuse and recycling of waste should be the priority option. Member States should avoid creating support schemes which would be counter to targets on treatment of waste and which would lead to the inefficient use of recyclable waste. Moreover, in order to ensure a more efficient use of bioenergy, from 2026 on Member States should not give support anymore to electricity-only plants , unless the installations are in regions with a specific use status as regards their transition away from fossil fuels or if the installations use carbon capture and storage. __________________ 11 The cascading principle aims to achieve resource efficiency of biomass use through prioritising biomass material use to energy use wherever possible, increasing thus the amount of biomass available within the system. In line with the cascading principle, woody biomass should be used according to its highest economic and environmental added value in the following order of priorities: 1) wood-based products, 2) extending their service life, 3) re-use, 4) recycling, 5) bio-energy and 6) disposal. 12 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3). 13 https://publications.jrc.ec.europa.eu/reposit ory/handle/JRC122719
Amendment 121 #
2021/0218(COD)
Proposal for a directive
Recital 5
Recital 5
(5) The rapid growth and increasing cost-competitiveness of renewable electricity production can be used to satisfy a growing share of energy demand, for instance using heat pumps for space heating or low- and medium-temperature industrial processes, electric vehicles for transport, or electric furnaces in certain industries. Renewable electricity can also be used to produce synthetic fuels for consumption in hard-to-decarbonise transport sectors such as aviation and maritime transport. A framework for electrification needs to enable robust and efficient coordination and expand market mechanisms to match both supply and demand in space and time, stimulate investments in flexibility, energy storage and demand response, and help integrate large shares of variable renewable generation. Member States should therefore, while taking into account the energy first principle, ensure that the deployment of renewable electricity continues to increase at an adequate pace to meet growing demand. For this, Member States should establish a framework that includes market-compatible mechanisms to tackle remaining barriers to have secure and adequate electricity systems fit for a high level of renewable energy, as well as storage facilities, fully integrated into the electricity system. In particular, this framework shall tackle remaining barriers, including non-financial ones such as insufficient digital and human resources of authorities to process a growing number of permitting applications. The Commission should help Member States to bring down administrative barriers, in particular with a view to simplify and accelerate permitting procedures for renewable energy projects.
Amendment 131 #
2021/0218(COD)
Proposal for a directive
Recital 6
Recital 6
(6) When calculating the share of renewables in a Member State, renewable fuels of non-biological origin should be counted in the sector where they are consumed (electricity, heating and cooling, or transport). To avoid double-counting, the renewable electricity used to produce these fuels should not be counted. This would result in a harmonisation of the accounting rules for these fuels throughout the Directive, regardless of whether they are counted for the overall renewable energy target or for any sub-target. It would also allow to count the real energy consumed, taking account of energy losses in the process to produce those fuels. Moreover, it would allow for the accounting of renewable fuels of non- biological origin imported into and consumed in the Union. When renewable fuels of non-biological origin are consumed in a Member State other than the Member State where they were produced, in order to compensate the costs incurred by the producing Member State and to avoid discouraging investments, rules should be established to account for at least a minimum amount of the renewable fuels of non-biological origin consumed in a Member State towards the share of gross final consumption of energy from renewable sources in the Member State where they were produced.
Amendment 133 #
2021/0218(COD)
Proposal for a directive
Recital 7
Recital 7
(7) Member States’ cooperation to promote renewable energy can take the form of statistical transfers, support schemes or joint projects. It allows for a cost-efficient deployment of renewable energy across Europe and contributes to market integration. Despite its potential, cooperation has been very limited, thus leading to suboptimal results in terms of efficiency in increasing renewable energy. Member States should therefore be obliged to test cooperation through implementing atwo pilot projects. Projects financed by national contributions under the Union renewable energy financing mechanism established by Commission Implementing Regulation (EU) 2020/129414 would meet this obligation for the Member States involved. __________________ 14 Commission Implementing Regulation (EU) 2020/1294 of 15 September 2020 on the Union renewable energy financing mechanism (OJ L 303, 17.9.2020, p. 1).
Amendment 136 #
2021/0218(COD)
Proposal for a directive
Recital 8
Recital 8
(8) The Offshore Renewable Energy Strategy introduces an ambitious objective of 300 GW of offshore wind and 40 GW of ocean energy across all the Union’s sea basins by 2050. To ensure this step change, Member States will need to work together across borders at sea-basin level. Member States should therefore jointly define the amount of offshore renewable generation and related infrastructure to be deployed within each sea basin by 2050, with intermediate steps in 2030 and 2040. Should there be a possible gap between the potential amount of offshore renewable energy resources of the Member States and the planned amount of offshore renewable energy, the Commission should take additional measures to reduce that gap. These objectives should be reflected in the updated national energy and climate plans that will be submitted in 2023 and 2024 pursuant to Regulation (EU) 2018/1999. In defining the amount, Member States should take into account the offshore renewable energy potential of each sea basin, environmental protection and biodiversity, climate adaptation and other uses of the sea, especially the activities that already take place in the affected areas, the possible harm to the environment, the Article 2 of the Paris Agreement as well as the Union’s decarbonisation targets. In addition, Member States should increasingly consider the possibility of combining offshore renewable energy generation with transmission lines interconnecting several Member States, in the form of hybrid projects or, at a later stage, a more meshed grid. This would allow electricity to flow in different directions, thus maximising socio- economic welfare, optimising infrastructure expenditure and enabling a more sustainable usage of the sea. Member States bordering a sea basin should use the maritime spatial planning process to ensure a strong public participation approach so that the views of all stakeholders and coastal communities are taken into account, as well as the activities already taking place in the affected areas.
Amendment 143 #
2021/0218(COD)
Proposal for a directive
Recital 9
Recital 9
(9) The market for renewable power purchase agreements is rapidly growing and provides a complementary route to the market of renewable power generation in addition to support schemes by Member States or to selling directly on the wholesale electricity market. At the same time, these agreements provide the producer with the security of a certain income whilst the user can benefit from a stable electricity price. The market for renewable power purchase agreements is still limited to a small number of Member States and large companies, with significant administrative, technical and financial barriers remaining in large parts of the Union’s market. The existing measures in Article 15 to encourage the uptake of renewable power purchase agreements should therefore be strengthened further, by exploring the use of credit guarantees to reduce these agreements’ financial risks, taking into account that these guarantees, where public, should not crowd out private financing.
Amendment 155 #
2021/0218(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Buildings have a large untapped potential to the achievement of the renewable energy target and to contribute effectively to the reduction in greenhouse gas emissions in the Union. The decarbonisation of heating and cooling in this sector through an increased share in production and use of renewable energy will be needed to meet the ambition set in the Climate Target PlanEuropean Climate Law to achieve the Union objective of climate neutrality. However, progress on the use of renewables for heating and cooling has been stagnant in the last decade, largely relying on increased use of biomass. Without the establishment of targets to increase the production and use of renewable energy in buildings, there will be no ability to track progress and identify bottlenecks in the uptake of renewables. Furthermore, the creation of targets will provide a long-term signal to investors, including for the period immediately after 2030. This will complement obligations related to energy efficiency and the energy performance of buildings and comply with the energy efficiency first principle. Therefore, indicative targets for the use of renewable energy in buildings should be set to guide and incentivise Member States’ efforts to exploit the potential of using and producing renewable energy in buildings, encourage the development of and integration of technologies which produce renewable energy while providing certainty for investors and local level engagement.
Amendment 157 #
2021/0218(COD)
Proposal for a directive
Recital 11 a (new)
Recital 11 a (new)
(11a) The public sector is responsible for 5 to 10% of the Union’s total final energy consumption. This represents about 14% of the Union’s gross domestic product. For this reason, the public sector constitutes an important driver to stimulate market transformation to trigger behavioural changes in energy consumption by citizens and businesses. Public bodies at national, regional and local level have an exemplary role to play in increasing the share of renewable energy production and use. Therefore, binding targets for the use of renewable energy in public buildings should be set.
Amendment 159 #
2021/0218(COD)
Proposal for a directive
Recital 12
Recital 12
(12) Insufficient numbers of skilled workers, in particular installers and designers of renewable heating and cooling systems, slow down the replacement of fossil fuel heating systems by renewable energy based systems, including solar thermal photovoltaic systems, shallow geothermal systems and heat pumps and energy storage systems, and is a major barrier to integrating renewables in buildings, industry and agriculture. Member States should cooperate with social partners and renewable energy communities to anticipate the skills that will be needed. A sufficient number of high-quality training programmes and certification possibilities ensuring proper installation and reliable operation of a wide range of renewable heating and cooling systems should be made available and designed in a way to attract participation in such training programmes and certification systems. Training courses and qualifications already acquired by the operators on the basis of the previous legislation must be preserved. Member States should consider what actions should be taken to attract groups currently under- represented in the occupational areas in question. The list of trained and certified installers should be made public to ensure consumer trust and easy access to tailored designer and installer skills guaranteeing proper installation and operation of renewable heating and cooling.
Amendment 163 #
2021/0218(COD)
Proposal for a directive
Recital 13
Recital 13
(13) Guarantees of origin are a key tool for consumer information as well as for the further uptake of renewable power purchase agreements. In order to establish a coherent Union base for the use of guarantees of origin and to provide access to appropriate supporting evidence for persons concluding renewable power purchase agreements, all renewable energy producers should be able to receive a guarantee of origin without prejudice to Member States’ obligation to take into account the market value of the guarantees of origin if the energy producers receive financial support. Member States may introduce guarantees of origin subject to additional size granularity.
Amendment 168 #
2021/0218(COD)
Proposal for a directive
Recital 15
Recital 15
(15) With more than 30 million electric vehicles expected in the Union by 2030 it is necessary to ensure that they can fully contribute to the system integration of renewable electricity, and thus allow reaching higher shares of renewable electricity in a cost-optimal manner. The potential of electric vehicles to absorb renewable electricity at times when it is abundant and feed it back into a grid when there is scarcity has to be fully utilised. It is therefore appropriate, contributing to the system integration of variable renewable electricity while ensuring a secure and reliable supply of electricity. It is therefore necessary to introduce specific measures on electric vehicles and information about renewable energy and how and when to access it which complement those in Directive (EU) 2014/94 of the European Parliament and of the Council16 and the [proposed Regulation concerning batteries and waste batteries, repealing Directive 2006/66/EC and amending Regulation (EU) No 2019/1020]. __________________ 16 Directive 2014/94/EU of the European Parliament and of the Council of 22 October 2014 on the deployment of alternative fuels infrastructure (OJ L 307, 28.10.2014, p. 1)
Amendment 173 #
2021/0218(COD)
Proposal for a directive
Recital 16
Recital 16
(16) In order for flexibility and balancing services from the aggregation of distributed storage assets to be developed in a competitive manner, real-time access to basic battery information such as state of health, state of charge, capacity and power set point should be provided under non- discriminatory terms and free of charge to the owners or users of the batteries and the entities acting on their behalf through explicit consent, such as building energy system managers, mobility service providers and other electricity market participants. It is therefore appropriate to introduce measures addressing the need of access to such data for facilitating the integration-related operations of domestic batteries and, electric vehicles, smart heating and cooling systems, and other smart devices, complementing the provisions on access to battery data related to facilitating the repurposing of batteries in [the proposed Commission regulation concerning batteries and waste batteries, repealing Directive 2006/66/EC and amending Regulation (EU) No 2019/1020]. The provisions on access to battery data of electric vehicles should apply in addition to any laid down in Union law on type approval of vehicles.
Amendment 179 #
2021/0218(COD)
Proposal for a directive
Recital 19
Recital 19
(19) Distributed and decentralised generation, demand response and storage assets, such as domestic batteries and, batteries of electric vehicles, smart heating and cooling systems, and other smart devices have the potential to offer considerable flexibility and balancing services to the grid through aggregation. In order to facilitate the development of such services, the regulatory provisions concerning connection and operation of the decentralised generation and storage assets, such as tariffs, commitment times and connection specifications, should be designed in a way that does not hamper the potential of all storage assets, including small and mobile ones, to offer flexibility and balancing services to the system and to contribute to the further penetration of renewable electricity, in comparison with larger, stationary storage assets.
Amendment 184 #
2021/0218(COD)
Proposal for a directive
Recital 20
Recital 20
(20) Recharging points where electric vehicles typically park for extended periods of time, such as where people park for reasons of residence or employment, are highly relevant to energy system integration, therefore smart charging functionalities need to be ensured. In this regard, the operation of non-publicly accessible normal charging infrastructure, together with the publicly accessible, is particularly important for the integration of electric vehicles in the electricity system as it is located where electric vehicles are parked repeatedly for long periods of time, such as in buildings with restricted access, employee parking or parking facilities rented out to natural or legal persons.
Amendment 187 #
2021/0218(COD)
Proposal for a directive
Recital 21
Recital 21
(21) Industry accounts for 25% of the Union’s energy consumption, and is a major consumer of heating and cooling, which is currently supplied 91% by fossil fuels. However, 50% of heating and cooling demand is low-temperature (<200 °C) for which there are cost-effective renewable energy options, including through electrification. In addition, industry uses non-renewable sources as raw materials to produce products such as steel or chemicals. Industrial investment decisions today will determine the future industrial processes and energy options that can be considered by industry, so it is important that those investments decisions are future-proof. Therefore, benchmarks, avoiding lock-in of fossil fuel technologies and stranded assets in the future. Therefore, targets for the use of renewable energy should be put in place to incentivise industry to switch to a renewables-based production processes that not only are fueled by renewable energy, but also use renewable-based raw materials such as renewable hydrogen. Moreover, a common methodology for products that are labelled as having been produced partially or fully using renewable energy or using renewable fuels of non- biological origin as feedstock is required, taking into account existing Union product labelling methodologies and sustainable product initiatives. This would avoid deceptive practices and increase consumers trust. Furthermore, given consumer preference for products that contribute to environmental and climate change objectives, it would stimulate a market demand for those products.
Amendment 192 #
2021/0218(COD)
Proposal for a directive
Recital 22
Recital 22
(22) Renewable fuels of non-biological origin can be used for energy purposes, but also for non-energy purposes as feedstock or raw material in industries such as steel or chemicals. The use of renewable fuels of non-biological origin for both purposes exploits their full potential to replace fossil fuels used as feedstock and to reduce greenhouse gas emissions in industrial processes difficult to electrify and should therefore be included in a target for the use of renewable fuels of non- biological origin, while complying with the energy efficiency first principle. National measures to support the uptake of renewable fuels of non-biological origin in industry should not result in net pollution increases due to an increased demand for electricity generation that is satisfied by the most polluting fossil fuels, such as coal, diesel, lignite, oil peat and oil shale.
Amendment 194 #
2021/0218(COD)
Proposal for a directive
Recital 23
Recital 23
(23) Increasing ambition in the heating and cooling sector is key to delivering the overall renewable energy target given that heating and cooling constitutes around half of the Union's energy consumption, covering a wide range of end uses and technologies in buildings, industry and district heating and cooling. To accelerate the increase of renewables in heating and cooling, an annual 1.16 percentage point increase at Member State level should be made binding as a minimum for all Member States. For those Member States, which already have renewable shares above 50% in the heating and cooling sector, it should remain possible to only apply half of the binding annual increase rate and Member States with 60% or above may count any such share as fulfilling the average annual increase rate in accordance with points b) and c) of paragraph 2 of Article 23. In addition, Member State- specific top-ups should be set, redistributing the additional efforts to the desired level of renewables in 2030 among Member States based on GDP and cost- effectiveness. A longer list of different measures should also be included in Directive (EU) 2018/2001 to facilitate increasing the share of renewables in heating and cooling. Member States mayshould implement one or more measures from the list of measures. When adopting and implementing those measures, Member States should ensure their accessibility to all consumers, in particular those in low- income or vulnerable households and should require a significant share of measures to be implemented as a priority in low-income households at risk of energy poverty and in social housing.
Amendment 201 #
2021/0218(COD)
Proposal for a directive
Recital 25
Recital 25
(25) Modern renewable-based efficient district heating and cooling systems have demonstrated their potential to provide cost-effective solutions for integrating renewable energy, increased energy efficiency and energy system integration, facilitating the overall decarbonisation of the heating and cooling sector. To ensure this potential is harnessed, the annual increase of renewable energy and/or waste heat in district heating and cooling should be raised from 1 percentage point to 2.1 without changing the indicative nature of this increase,, but reflecting the uneven development of this type of network across the Union.
Amendment 207 #
2021/0218(COD)
Proposal for a directive
Recital 29
Recital 29
(29) The use of renewable fuels and renewable electricity in transport can contribute to the decarbonisation of the Union transport sector in a cost-effective manner, and improve, amongst other, energy diversification in that sector while promoting innovation, growth and jobs in the Union economy and reducing reliance on energy imports. With a view to achieving the increased target for greenhouse gas emission savings defined by the Union, the level of renewable energy supplied to all transport modes in the Union should be increased. Expressing the transport target as a greenhouse gas intensity reduction target would stimulate an increasing use of the most cost-effective and performing renewable fuels, in terms of greenhouse gas savings, in transport. In addition, a greenhouse gas intensity reduction target would stimulate innovation and set out a clear benchmark to compare across fuel types and renewable electricity depending on their greenhouse gas intensity. However, in order to ensure the achievement of the greenhouse gas emission savings target, Member States should have the possibility to do so by means of measures targeting volumes, energy content or greenhouse gas emissions, provided that it is demonstrated that the greenhouse gas intensity reduction and minimum shares are achieved. Complementary to this, increasing the level of the energy-based target on advanced biofuels and biogas and introducing a target for renewable fuels of non-biological origin would ensure an increased use of the renewable fuels with smallest environmental impact in transport modes that are difficult to electrify. The achievement of those targets should be ensured by obligations on fuel suppliers as well as by other measures included in [Regulation (EU) 2021/XXX on the use of renewable and low-carbon fuels in maritime transport - FuelEU Maritime and Regulation (EU) 2021/XXX on ensuring a level playing field for sustainable air transport], and complemented by additional incentives set out in this Directive. Dedicated obligations on aviation fuel suppliers should be set only pursuant to [Regulation (EU) 2021/XXX on ensuring a level playing field for sustainable air transport].
Amendment 215 #
2021/0218(COD)
Proposal for a directive
Recital 30
Recital 30
(30) Electromobility will play an essential role in decarbonising the transport sector. To foster the further development of electromobility, Member States should establish a credit mechanism enabling operators of charging points accessible to the public, as well as private charging points to contribute, by supplying renewable electricity, towards the fulfilment of the obligation set up by Member States on fuel suppliers. While supporting electricity in transport through such a mechanism, it is important that Member States continue setting a high level of ambition for the decarbonisation of their liquid fuel mix in transportmainly in hard-to- decarbonise transport sectors, such as maritime and aviation.
Amendment 221 #
2021/0218(COD)
Proposal for a directive
Recital 31
Recital 31
(31) The Union’s renewable energy policy aims to contribute to achieving the climate change mitigation objectives of the European Union in terms of the reduction of greenhouse gas emissions. In the pursuit of this goal, it is essential to also contribute to wider environmental objectives, and in particular the prevention of biodiversity loss, which is negatively impacted by the indirect land use change associated to the production of certain biofuels, bioliquids and biomass fuels. Contributing to these climate and environmental objectives constitutes a deep and longstanding intergenerational concern for Union citizens and the Union legislator. Extensive scientific evidence has demonstrated that biofuels and biogas produced from food and feed crops offer few if any carbon savings and are not appropriate for use in the energy sector. The European Union should instead promote fuels in quantities which balance the necessary ambition with the need to avoid contributing to direct and indirect land-use change. As a consequence, the changes in the way the transport target is calculated should not affect the limits established on how to account toward that target certain fuels produced from food and feed crops on the one hand and high indirect land-use change-risk fuels on the other hand. In addition, in order not to create an incentive to use biofuels and biogas produced from food and feed crops in transport, Member States should continue to be able to choose whether count them or not towards the transport target. If they do not count them, they may reduce the greenhouse gas intensity reduction target accordingly, assuming that food and feed crop-based biofuels save 50% greenhouse gas emissions, which corresponds to the typical values set out in an annex to this Directive for the greenhouse gas emission savings of the most relevant production pathways of food and feed crop-based biofuels as well as the minimum savings threshold applying to most installations producing such biofuels.
Amendment 229 #
2021/0218(COD)
Proposal for a directive
Recital 32
Recital 32
(32) Expressing the transport target as a greenhouse gas intensity reduction target makes it unnecessary to use multipliers to promote certain renewable energy sources. This is because different renewable energy sources save different amounts of greenhouse gas emissions and, therefore, contribute differently to a target. Renewable electricity should be considered to have zero emissions, meaning it saves 100% emissions compared to electricity produced from fossil fuels. This will create an incentive for the use of renewable electricity since renewable fuels and recycled carbon fuels are unlikely to achieve such a high percentage of savings. Electrification relying on renewable energy sources would therefore become the most efficient way to decarbonise road transport. In addition, in order to promote the use of advanced biofuels and biogas and renewable fuels of non-biological origin in the aviation and maritime modes, which are difficult to electrify, it is appropriate to keep the multiplier for those fuels supplied in those modes when counted towards the specific targets set for those fuels.
Amendment 258 #
2021/0218(COD)
Proposal for a directive
Recital 37
Recital 37
(37) In order to reduce the administrative burden for producers of renewable fuels and recycled carbon fuels and for Member States, where voluntary or national schemes have been recognised by the Commission through an implementing act as giving evidence or providing accurate data regarding the compliance with sustainability and greenhouse gas emissions saving criteria as well as other requirements set in this Directive, Member States should accept the results of the certification issued by such schemes within the scope of the Commission’s recognition. In order to reduce the burden on small installations, Member States should establish a simplified verification mechanism for installations of between 5 and 10MW.
Amendment 263 #
2021/0218(COD)
Proposal for a directive
Recital 38
Recital 38
(38) The Union database to be set up by the Commission aims at enabling the tracing of liquid and gaseous renewable fuels and recycled carbon fuels. Its scope should be extended from transport to all other end-use sectors in which such fuels are consumed. This should make a vital contribution to the comprehensive monitoring of the production and consumption of those fuels, mitigating risks of double-counting or irregularities along the supply chains covered by the Union database. In addition, to avoid any risk of double claims on the same renewable gas, a guarantee of origin issued for any consignment of renewable gas registered in the database should be cancelled.
Amendment 267 #
2021/0218(COD)
Proposal for a directive
Recital 47 a (new)
Recital 47 a (new)
(47a) Recital (81) is replaced by the following: While the level of greenhouse gas emissions caused by indirect land-use change cannot be unequivocally determined with the level of precision required to be included in the greenhouse gas emission calculation methodology, the highest risks of indirect land-use change have been identified for biofuels, bioliquids and biomass fuels produced from feedstock for which a significant expansion of the production area into land with high-carbon stock is observed. It is therefore appropriate, in general, to limit food and feed crops-based biofuels, bioliquids and biomass fuels promoted under this Directive and, in addition, to require Member States to set a specific and gradually decreasing limit for biofuels, bioliquids and biomass fuels produced from food and feed crops for which a significant expansion of the production area into land with high- carbon stock is observed. Low indirect land-use change-risk biofuels, bioliquids and biomass fuels should be exempted from the specific and gradually decreasing limit. The indirect land-use change-risk of biofuels, bioliquids and biomass fuels within the scope of this Directive should be assessed with the most recent data in relation to deforestation, and should address other high risk commodities and their by-products in the category of high indirect land use change risk .
Amendment 271 #
2021/0218(COD)
Proposal for a directive
Recital 47 b (new)
Recital 47 b (new)
(47b) Recital (21) is replaced by the following: When developing support schemes for renewable sources of energy, Member States should consider the available sustainable supply of biomass and take due account of the principles of the circular economy, the waste hierarchy established in Directive 2008/98/EC of the European Parliament and of the Council and the cascading principle in order to avoid unnecessary distortions of raw materials markets. Waste prevention and recycling of waste should be the priority option. Member States should avoid creating support schemes which would be counter to targets on treatment of waste and which would lead to the inefficient use of recyclable waste.
Amendment 346 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c – point 1 (new)
Article 1 – paragraph 1 – point 1 – point c – point 1 (new)
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 16 a (new)
Article 2 – paragraph 2 – point 16 a (new)
1) ‘renewable hybrid power plant’ means a combination of two or more renewable generation technologies which share the same grid connection, and can also integrate energy storage capacity;
Amendment 348 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c – point 2 (new)
Article 1 – paragraph 1 – point 1 – point c – point 2 (new)
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 16 b (new)
Article 2 – paragraph 2 – point 16 b (new)
2) ‘co-located energy storage facility’ means a project encompassing an energy storage facility and a facility producing renewable energy connected behind the same grid;
Amendment 350 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c – point 3 (new)
Article 1 – paragraph 1 – point 1 – point c – point 3 (new)
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 22 b (new)
Article 2 – paragraph 2 – point 22 b (new)
3) 'innovative storage technologies' means renewable energy storage technology based on a demonstration project as defined in Article 2, point (24) of Regulation (EU) 2019/943, or renewable energy storage technology, which can be part of co-located energy storage facility or a renewable hybrid power plant, with expected environmental benefit significantly higher than the improvement resulting from the general evolution of the state of the art in comparable technologies and when the innovative nature of the technology involves a clear degree of risk, in technological, market or financial terms, which is higher than the risk generally associated with comparable non- innovative technologies or activities;
Amendment 355 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c a (new)
Article 1 – paragraph 1 – point 1 – point c a (new)
Directive (EU) 2018/2001
Article 2 – paragraph 2 – point 22 c (new)
Article 2 – paragraph 2 – point 22 c (new)
(ca) ‘energy efficiency first’ means ‘energy efficiency first’ as defined in point (18) of Article 2 of Regulation(EU) 2018/1999.
Amendment 356 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point c b (new)
Article 1 – paragraph 1 – point 1 – point c b (new)
(cb) 'innovative renewable energy technologies: means renewable energy generation technologies based on demonstration projects as defined in Article 2, point (24) of Regulation (EU) 2019/943, or a renewable energy generation technology with expected environmental benefit significantly higher than the improvement resulting from the general evolution of the state of the art in comparable technologies and when the innovative nature of the technology involves a clear degree of risk, in technological, market or financial terms, which is higher than the risk generally associated with comparable non- innovative technologies or activities;
Amendment 358 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 a (new)
Article 1 – paragraph 1 – point 1 a (new)
Directive (EU) 2018/2001
Article 1
Article 1
(1a) Article 1 is replaced by the following: This Directive establishes a common framework for the promotion of energy from renewable sources. It sets mandatory national and Union targets for the overall share of energy from renewable sources in gross final consumption of energy in 2030. It also lays down rules on financial support for electricity from renewable sources, on self- consumption of such electricity, on the use of energy from renewable sources in the heating and cooling sector and in the transport sector, on regional cooperation between Member States, and between Member States and third countries, on guarantees of origin, on administrative procedures and on information and training. It also establishes sustainability and greenhouse gas emissions saving criteria for biofuels, bioliquid and biomass fuels.
Amendment 387 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point a
Article 1 – paragraph 1 – point 2 – point a
Directive (EU) 2018/2001
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Member States shall collectively ensure that the share of energy from renewable sources in the Union’s gross final consumption of energy in 2030 is at least 405%.;
Amendment 392 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point a a (new)
Article 1 – paragraph 1 – point 2 – point a a (new)
Directive (EU) 2018/2001
Article 3 – paragraph 2
Article 3 – paragraph 2
(aa) paragraph 2 is replaced by the following: Member States shall set binding national contributions to meet, collectively, the binding overall Union target set in paragraph 1 of this Article as part of their integrated national energy and climate plan sin accordance with Articles 3 to 5 and 9 to 14 of Regulation (EU) 2018/1999. In preparing their draft integrated national energy and climate plans, Member States shall consider the formula referred to in Annex II to that Regulation as a minimum target. Member States shall introduce measures effectively designed to ensure that the share of energy from renewable sources equals or exceeds this minimum binding contribution.
Amendment 396 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point a b (new)
Article 1 – paragraph 1 – point 2 – point a b (new)
Directive (EU) 2018/2001
Article 3 – paragraph 2a (new)
Article 3 – paragraph 2a (new)
(ab) In order to promote the production and use of renewable energy from innovative renewable energy technologies, Member States shall set an indicative target for the share of innovative renewables in total added energy capacity in 2030.
Amendment 403 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive (EU) 2018/2001
Article 3 – paragraph 3 – subparagraph 1
Article 3 – paragraph 3 – subparagraph 1
3. Member States shall take measures to ensure that energy from biomass is produced in a way that minimiseprevents undue distortive effects on the biomass raw material market and harmful impacts on biodiversity, climate and environment. To that end , they shall take into account the waste hierarchy as set out in Article 4 of Directive 2008/98/EC and the cascading principle referred to in the third subparagraph.
Amendment 447 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive (EU) 2018/2001
Article 3 – paragraph 3 – subparagraph 2 – point b – point i
Article 3 – paragraph 3 – subparagraph 2 – point b – point i
(i) it is produced in a region identified in a territorial just transition plan approved by the European Commission, in accordance with Regulation (EU) 2021/… of the European Parliament and the Council establishing the Just Transition Fund due to its reliance on solid fossil fuels, and meets the relevant requirements set in Article 29(11);
Amendment 473 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive (EU) 2018/2001
Article 3 – paragraph 3 – subparagraph 3
Article 3 – paragraph 3 – subparagraph 3
No later than one year after [the entry into force of this amending Directive], the Commission shall adopt a delegated act in accordance with Article 35 on how to apply the cascading principle for biomass, in particular on how to minimiseliminate the use of quality roundwood for energy production, with a focus on support schemes and with due regard to national specificities and while taking into account available volumes of feedstock and share of pre- existing competing industrial uses other than energy purposes, with a focus on support schemes and with due regard to national specificities. This delegated act shall consider the necessary forest management activities, aimed notably at ensuring wildfire prevention.
Amendment 490 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point b
Article 1 – paragraph 1 – point 2 – point b
Directive (EU) 2018/2001
Article 3 – paragraph 3 – subparagraph 4
Article 3 – paragraph 3 – subparagraph 4
By 2026 the Commission shall present a report on the impact of the Member States’ support schemes for biomass, including on biodiversity, climate, environment and possible market distortions, and will assess the possibility for further limitations regarding support schemes to forest biomass.;
Amendment 497 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point c
Article 1 – paragraph 1 – point 2 – point c
4a. Member States shall establish a framework, which may include support schemes and facilitating the uptake of renewable power purchase agreements, enabling the deployment of renewable electricity to a level that is consistent with the Member State’s national binding contribution referred to in paragraph 2 and at a pace that is consistent with the indicative trajectories referred to in Article 4(a)(2) of Regulation (EU) 2018/1999. In particular, that framework shall tackle remaining barriers, including those related to permitting procedures, and the development of the necessary power transmission networks, to a high level of renewable electricity supply. When designing that framework, Member States shall take into account the additional renewable electricity required to meet demand in the transport, industry, building and heating and cooling sectors and for the production of renewable fuels of non- biological origin. Member States shall endeavour to promote the most sustainable renewable energy generation technologies, for example by assessing the embodied carbon footprint of the projects, and applying sustainability best practices in the project development.;
Amendment 508 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 – point c a (new)
Article 1 – paragraph 1 – point 2 – point c a (new)
Directive (EU) 2018/2001
Article 3 – paragraph 5a (new)
Article 3 – paragraph 5a (new)
(ca) the following paragraph 5a is inserted: With a view to achieving the climate- neutrality objective set out in Article 2(1) and the intermediate Union climate targets set out in Article 4 of Regulation (EU) 2021/1119, a minimum target for energy from renewable sources for 2040 shall be set at Union and Member State level. By December 2025 the Commission shall submit a legislative proposal, as appropriate, based on a detailed impact assessment, to amend this Directive to include a minimum target for energy from renewable sources in 2040, both at Union and Member States level, taking into account the advice of the European Scientific Advisory Board on Climate Change, conclusions of the assessments referred to in Articles 6and 7 of Regulation (EU) 2021/1119 and the Long- term strategies set out in Article 15 of Regulation (EU) 2018/1999.
Amendment 516 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 2 a (new)
Article 1 – paragraph 1 – point 2 a (new)
(2a) Binding overall Union and national targets for 2030
Amendment 524 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Directive (EU) 2018/2001
Article 7 – paragraph 1– subparagraph 2
Article 7 – paragraph 1– subparagraph 2
With regard to the first subparagraph, point (a), (b), or (c), gas and electricity from renewable sources shall be considered only once for the purposes of calculating the share of gross final consumption of energy from renewable sources. Energy produced from renewable fuels of non-biological origin shall be accounted in the sector - electricity, heating and cooling or transport - where it is consumed. When renewable fuels of non-biological origin are consumed by a Member State different than the producing Member State, a minimum level of energy shall be accounted in the Member State where it is produced.
Amendment 525 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Directive (EU) 2018/2001
Article 7 – paragraph 1 – subparagraph 2a (new)
Article 7 – paragraph 1 – subparagraph 2a (new)
Member States may agree, via a specific cooperation agreement through the Union renewable development platform (URDP), to account the minimum level of the renewable fuels of non-biological origin consumed in one Member State towards the share of gross final consumption of energy from renewable sources in the Member State where those fuels were produced. In order to monitor that the same renewable fuels of non-biological origin are not accounted in both the Member State where they are produced and in the Member State where they are consumed and to record the amount claimed, the Commission shall be notified of any such agreement, including the amount of renewable fuels of non- biological origin to be counted in total and for each Member State and the date by which such an agreement will become operational.
Amendment 532 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 – point a
Article 1 – paragraph 1 – point 4 – point a
Directive (EU) 2018/2001
Article 9 – paragraph 1a
Article 9 – paragraph 1a
1a. By 31 December 2025, each Member State shall agree to establish at least one joint project with one or more other Member States for the production of renewable energy. By 2030 each Member State shall have at least two joint project agreements. The Commission shall be notified of such aneach agreement, including the date on which the project iss are expected to become operational. Projects financed by national contributions under the Union renewable energy financing mechanism established by Commission Implementing Regulation (EU) 2020/129425 shall be deemed to satisfy this obligation for the Member States involved.; __________________ 25 Commission Implementing Regulation (EU) 2020/1294 of 15 September 2020 on the Union renewable energy financing mechanism (OJ L 303, 17.9.2020, p. 1).
Amendment 541 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 – point b
Article 1 – paragraph 1 – point 4 – point b
7a. Member States bordering a sea basin shall cooperate to jointly define the amount of offshore renewable energy, including floating wind and solar farms, they plan to produce in that sea basin by 2050, with intermediate steps in 2030 and 2040, in accordance with [Revised Regulation (EU) No 347/2013]. They shall take into account the specificities and development in each region, especially the activities that already take place in the affected areas, the possible harm to the environment, Article 2 of the Paris Agreement, the offshore renewable potential of the sea basin and the importance of ensuring the associated integrated grid planning. Member States shall notify that amount in the updated integrated national energy and climate plans submitted pursuant to Article 14 of Regulation (EU) 2018/1999.;
Amendment 547 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 – point b a (new)
Article 1 – paragraph 1 – point 4 – point b a (new)
Directive (EU) 2018/2001
Article 9 – paragraph 7b (new)
Article 9 – paragraph 7b (new)
(ba) the following paragraph is added: Following the communication of the updated integrated national energy and climate plans, the Commission shall assess any possible gap between the potential amount of offshore renewable energy resources of the Member States and the amount of offshore renewable energy planned for 2030, 2040 and 2050. Where appropriate, the Commission shall take additional measures to reduce the gap.
Amendment 548 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 – point b b (new)
Article 1 – paragraph 1 – point 4 – point b b (new)
Directive (EU) 2018/2001
Article 9 – paragraph 7c (new)
Article 9 – paragraph 7c (new)
(bb) the following paragraph is added: When defining the amount of offshore renewable energy, Member States bordering a sea basin shall use the maritime spatial planning process ensuring a strong public participation approach so that the views of all stakeholders and affected coastal communities, as well as the impacts on the activities already taking place in the affected areas, are taken into account to ensure sustainable management of the maritime space;
Amendment 560 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5 – point c
Article 1 – paragraph 1 – point 5 – point c
Directive (EU) 2018/2001
Article 15 – paragraph 8 – subparagraph 1
Article 15 – paragraph 8 – subparagraph 1
8. Member States shall assess the regulatory and administrative barriers to long-term renewables power purchase agreements, including renewable hybrid plants and co-located facilities, and shall remove unjustified barriers to, and promote the uptake of, such agreements, including by exploring how to reduce the financial risks associated with them, in particular by using credit guarantees. Member States shall ensure that those agreements are not subject to disproportionate or discriminatory procedures or charges, and that any associated guarantees of origin can be transferred to the buyer of the renewable energy under the renewable power purchase agreement.
Amendment 564 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5 – point c
Article 1 – paragraph 1 – point 5 – point c
Directive (EU) 2018/2001
Article 15 – paragraph 8 – subparagraph 2
Article 15 – paragraph 8 – subparagraph 2
Member States shall describe their policies and measures promoting the uptake of renewables power purchase agreements and renewables heating and cooling purchase agreements in their integrated national energy and climate plans referred to in Articles 3 and 14 of Regulation (EU) 2018/1999 and progress reports submitted pursuant to Article 17 of that Regulation. They shall also provide, in those reports, an indication of the volume of renewable power generation supported by renewables powerand renewable heating and cooling supported by renewables power purchase agreements and renewables heating and cooling purchase agreements.;
Amendment 571 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5 – point c
Article 1 – paragraph 1 – point 5 – point c
Directive (EU) 2018/2001
Article 15 – paragraph 8 – subparagraph 2a (new)
Article 15 – paragraph 8 – subparagraph 2a (new)
8a. Following the assessment of Member States under the first subparagraph, the Commission shall analyse the barriers to long-term power purchase agreements and in particular to the deployment of cross-border renewable power purchase agreements and issue guidance on the removal of these barriers’;
Amendment 577 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 5 – point d
Article 1 – paragraph 1 – point 5 – point d
Directive (EU) 2018/2001
Article 15 – paragraph 9
Article 15 – paragraph 9
9. By six months after the entry into force of this amending Directive, the Commission shall revise the guidelines on permit granting to shorten and simplify the process for new and repowered projects, including renewable hybrid plants and co-located facilities, including recommendations to remove administrative barriers to renewable energy projects and the electricity transmission assets necessary for their connection and integration into the electricity system, present best practices on permitting and grid interconnection and key performance indicators on how to apply the rules on administrative procedures set out in this Directive. To this end, the Commission shall carry out appropriate consultations, including with relevant industry stakeholders. The Commission shall assess Member States’ current permitting practices and propose corrective measures to align them with the Commission’s guidelines. The Commission’s assessment shall be made public. In the absence of progress, the Commission may take additional measures to support Member States in their implementation by assisting them in reforming and streamlining their permitting procedures. By one year after the entry into force of this amending Directive, the Commission shall review, and where appropriate, propose modifications to, the rules on administrative procedures set out in Articles 15, 16 and 17 and their application, and may take additional measures to support Member States in their implementation.;
Amendment 608 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Directive (EU) 2018/2001
Article 15a – paragraph 1
Article 15a – paragraph 1
1. In order to promote the production and use of renewable energy in the building sector, Member States shall set an indicative target for the share of renewables in final energy consumption in their buildings sector in 2030 that is consistent with an indicative target of at least a 49 % share of energy from renewable sources in the buildings sector in the Union’s final consumption of energy in 2030. The national target shall be expressed in terms of share of national final energy consumption and calculated in accordance with the methodology set out in Article 7 including in the calculation of the share of final consumption the electricity from renewable sources comprising self-consumption, energy communities, the share of renewable in the electricity mix and the unavoidable waste heat and cold. Member States shall include their target in the updated integrated national energy and climate plans submitted pursuant to Article 14 of Regulation (EU) 2018/1999 as well as information on how they plan to achieve it.
Amendment 616 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Directive (EU) 2018/2001
Article 15a – paragraph 2
Article 15a – paragraph 2
2. Member States shall introduce measures in their building regulations and codes and, where applicable, in their support schemes, to increase the share of electricity and heating and cooling from renewable sources in the building stock, including national measures relating to substantial increases in renewables self- consumption, renewable energy communities and local energy storage, other flexibility services, such as demand response, in combination with energy efficiency improvements relating to cogeneration from renewable sources and passive, nearly zero-energy and zero- energy buildings. Those measures shall comply with the energy efficiency first principle referred to in Article 3 of [Energy efficiency Directive recast] including energy management solutions.
Amendment 623 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Directive (EU) 2018/2001
Article 15a – paragraph 2 – subparagraph 2
Article 15a – paragraph 2 – subparagraph 2
To achieve the indicative share of renewables set out in paragraph 1, Member States shall, in their building regulations and codes and, where applicable, in their support schemes or by other means with equivalent effect, require the use of minimum levels of energy from renewable sources in buildings, in line with the provisions of Directive 2010/31/EU and in accordance with the energy efficiency first principle. Member States shall allow those minimum levels to be fulfilled, among others, through efficient district heating and cooling and other flexibility services, such as demand response.
Amendment 629 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Directive (EU) 2018/2001
Article 15a – paragraph 3
Article 15a – paragraph 3
3. Member States shall ensure that public buildings at national, regional and local level, fulfil an exemplary role as regards the share of renewable energy used, in accordance with the provisions of Article 9 of Directive 2010/31/EU and Article 5 of Directive 2012/27/EU. Member States shall set a binding target for the share of renewables in final energy consumption in their public buildings at national, regional and local level in 2030 that is consistent with the indicative target referred to in paragraph 1. Member States may, among others, allow that obligation to be fulfilled by providing for the roofs or other compatible surfaces of public or mixed private- public buildings to be used by third parties for installations that produce energy from renewable sources.
Amendment 632 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Directive (EU) 2018/2001
Article 15a – paragraph 4
Article 15a – paragraph 4
4. In order to achieve the indicative share of renewable energy set out in paragraph 1 and 3, Member States shall promote the use of efficient renewable heating and cooling systems and equipment, including smart renewable-based heating and cooling systems, as well as the smart decentralised energy resources in buildings. To that end, Member States shall use all appropriate measures, tools and incentives, including, among others, energy labels developed under Regulation (EU) 2017/1369 of the European Parliament and of the Council26 , energy performance certificates pursuant to Directive 2010/31/EU, or other appropriate certificates or standards developed at national or Union level, and shall ensure the provision of adequate information and advice through one-stop shops on renewable, highly energy efficient alternatives in accordance with Article 21 of the [Energy efficiency Directive recast] as well as on financial instruments and incentives available to promote an increased replacement rate of old heating and cooling systems and an increased switch to solutions based on renewable energy.; __________________ 26 Regulation (EU) 2017/1369 of the European Parliament and of the Council of 4 July 2017 setting a framework for energy labelling and repealing Directive 2010/30/EU (OJ L 198, 28.7.2017, p. 1).
Amendment 640 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 6 a (new)
Article 1 – paragraph 1 – point 6 a (new)
Directive (EU) 2018/2001
Article 15b (new)
Article 15b (new)
(6a) the following Article is inserted: Article15b 'Integrated renewable energy resources assessment and planning Member States shall perform integrated mapping and planning for the deployment of renewable energy resources on their territory at NUTS 3 level in coordination with all relevant national, regional and local authorities. In doing so, Member States shall ensure the involvement of all relevant stakeholders, especially where pre-existing economic activities are affected. The integrated mapping and planning referred to in paragraph 1 shall also consider the flexibility needs and the energy storage facilities required to ensure a stable and resilient penetration of renewables, taking into account elements such as the differing energy shifting timescales, seasonal variations and energy scarcity periods. In identifying the most suitable areas for the deployment of renewables, Member States shall determine different levels of priority taking into account both the availability of the energy resource and the environmental and biodiversity protection and impacts on local communities and pre-existing activities. Member States may facilitate the deployment of projects in the areas identified as having the highest level of priority through the permit- granting process set out in Article 16(6), without prejudice to Article 16(7)'.
Amendment 650 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7 – introductory part
Article 1 – paragraph 1 – point 7 – introductory part
(7) in Article 18, paragraphs 3, 4 and 46 are replaced by the following:
Amendment 652 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive (EU) 2018/2001
Article 18 – paragraph 3 – subparagraph 1
Article 18 – paragraph 3 – subparagraph 1
3. Member States shall ensure that certification schemes are available for installers and designers of all forms of renewable heating and cooling systems in buildings, industry and agriculture, and for installers of solar thermal and photovoltaic systems, shallow geothermal systems and heat pumps, including storage and active demand respond systems. Those schemes may take into account existing schemes and structures as appropriate, and shall be based on the criteria laid down in Annex IV. Each Member State shall recognise the certification awarded by other Member States in accordance with those criteria.
Amendment 657 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive (EU) 2018/2001
Article 18 – paragraph 3 – subparagraph 2
Article 18 – paragraph 3 – subparagraph 2
Member States shall ensure that trained and qualified installers of renewable heating and cooling systems, solar thermal and photovoltaic systems, shallow geothermal systems, heat pumps and storage systems and active demand respond systems are available in sufficient numbers for the relevant technologies to service the growth of renewable heating and cooling required to contribute to the annual increase in the share of renewable energy in the heating and cooling sector as set out in Article 23, in buildings as set out in Article 15a and for renewable energy in transport as set out in article 25, as well as the overall renewable energy target as set out in Article 3.
Amendment 666 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 7
Article 1 – paragraph 1 – point 7
Directive (EU) 2018/2001
Article 18 – paragraph 6
Article 18 – paragraph 6
4a. By 31 December 2025 the Commission shall assess the availability of trained and qualified installers of renewable energy technologies needed to cover the demand for jobs at Member State level. Where necessary, the Commission shall make recommendations to Member States to reduce any gap in the availability of trained workers, which shall be made publicly available.
Amendment 685 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 8 – point a – point i
Article 1 – paragraph 1 – point 8 – point a – point i
Directive (EU) 2018/2001
Article 19 – paragraph 2 – subparagraph 1
Article 19 – paragraph 2 – subparagraph 1
To that end, Member States shall ensure that a guarantee of origin is issued in response to a request from a producer of energy from renewable sources. Member States may arrange for guarantees of origin to be issued for energy from non- renewable sources. Issuance of guarantees of origin may be made subject to a minimum capacity limit. A guarantee of origin shall be of the standard size of maximum 1 MWh. No more than one guarantee of origin shall be issued in respect of each unit of energy produced.;
Amendment 707 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 8 – point b a (new)
Article 1 – paragraph 1 – point 8 – point b a (new)
Directive (EU) 2018/2001
Article 19 – paragraph 13a (new)
Article 19 – paragraph 13a (new)
(ba) the following paragraph is inserted: The Commission shall assess, by 2025, necessary evolutions to the Guarantees of origin scheme towards finer time- granularity and location-based matching of consumption and propose, where appropriate, concrete measures that would enable their gradual implementation.
Amendment 720 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Directive (EU) 2018/2001
Article 20 – paragraph 3
Article 20 – paragraph 3
3. Subject to their assessment included in the integrated national energy and climate plans in accordance with Annex I to Regulation (EU) 2018/1999 on the necessity to build new infrastructure for district heating and cooling from renewable sources in order to achieve the Union target set in Article 3(1) of this Directive, Member States shall, where relevant, take the necessary steps with a view to developing efficient district heating and cooling infrastructure to promote heating and cooling from renewable energy sources, including solar energy, ambient energy, geothermal energy, biomass, biogas, bioliquids and waste heat and cold, in combination with thermal energy storage. and demand respond systems;
Amendment 728 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive (EU) 2018/2001
Article 20a – paragraph 1
Article 20a – paragraph 1
1. Member States shall require transmission system operators and distribution system operators in their territory to make available information on the share of renewable electricity and the greenhouse gas emissions content of the electricity supplied in each bidding zone, as accurately as possible and as close to real time as possible but in time intervals of no more than one hour, with forecasting where available. Member states shall require distribution system operators to assist transmission system operator to gather needed information, in case transmission operator does not have access to all information needed according the current national legislation. This information shall be made available digitally in a manner that ensures it can be used by electricity market participants, aggregators, consumers and end-users, and that it can be read by electronic communication devices such as smart metering systems, electric vehicle recharging points, heating and cooling systems and building energy management systems.
Amendment 739 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive (EU) 2018/2001
Article 20a – paragraph 2
Article 20a – paragraph 2
2. In addition to the requirements in [the proposal for a Regulation concerning batteries and waste batteries, repealing Directive 2006/66/EC and amending Regulation (EU) No 2019/1020], Member States shall ensure that manufacturers of domestic and industrial batteries enable real-time access to basic battery management system information, including battery capacity, state of health, state of charge and power set point, to battery owners and users as well as to third parties acting on their behalf through explicit consent and in compliance with the relevant provisions set out in Regulation (EU) 2016/679, such as building energy management companies and electricity market participants, under non- discriminatory terms and at no cost.
Amendment 742 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive (EU) 2018/2001
Article 20a – paragraph 2 – subparagraph 2
Article 20a – paragraph 2 – subparagraph 2
Member States shall ensure that vehicle manufacturers make available, in real-time, in-vehicle data related to the battery state of health, battery state of charge, battery power setpoint, battery capacity, as well as the location of electric vehicles to electric vehicle owners and users, as well as to third parties acting on the owners’ and users’ behalf through explicit consent and in compliance with the relevant provisions set out in Regulation (EU) 2016/679, such as electricity market participants and electromobility service providers, under non-discriminatory terms and at no cost, in addition to further requirements in the type approval and market surveillance regulation.
Amendment 745 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive (EU) 2018/2001
Article 20a – paragraph 2 – subparagraph 2a (new)
Article 20a – paragraph 2 – subparagraph 2a (new)
Member States shall ensure that manufacturers of smart heating and cooling systems, thermal energy storage units and other smart devices facilitating consumers to provide demand response to the energy system to enable real-time access to data relevant for demand response to users, as well as to third parties acting on the owners’ and users’ behalf through explicit consent and in compliance with the relevant provisions set out in Regulation (EU) 2016/679.
Amendment 750 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive (EU) 2018/2001
Article 20a – paragraph 3
Article 20a – paragraph 3
3. In addition to the requirements in [the proposal for a Regulation concerning the deployment of alternative fuel infrastructure, repealing Directive 2014/94/EU], Member States shall ensure that non–publicly accessible normal power recharging points installed in their territory from [the transposition deadline of this amending Directive] can support smart charging functionalities and, where appropriate based on assessment by the regulatory authority, bidirectional charging functionalities.
Amendment 760 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Directive (EU) 2018/2001
Article 20a – paragraph 4
Article 20a – paragraph 4
4. Member States shall ensure that the national regulatory framework does not discriminate against participation in the electricity markets, including congestion management and the provision of flexibility and balancing services, of small or mobile systems such as domestic batteries and, electric vehicles, smart heating and cooling systems, and other smart devices, both directly and through aggregation.;
Amendment 767 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
1. Member States shall endeavour to increase the share of renewable sources in the amount of energy sources used for final energy and non-energy purposes in the industry sector by an indicative average minimum annual increase of at least 1.1 percentage points by 2030. That increase shall be calculated as an average for the three-year periods 2024 to2027 and 2027 to 2030;
Amendment 829 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point a
Article 1 – paragraph 1 – point 12 – point a
Directive (EU) 2018/2001
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
1. In order to promote the use of renewable energy in the heating and cooling sector, each Member State shall, increase the share of renewable energy in that sector by at least 1.16 percentage points as an annual average calculated for the periods 2021 to 2025 and 2026 to 2030, starting from the share of renewable energy in the heating and cooling sector in 2020, expressed in terms of national share of gross final energy consumption and calculated in accordance with the methodology set out in Article 7.
Amendment 837 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point a
Article 1 – paragraph 1 – point 12 – point a
Directive (EU) 2018/2001
Article 23– paragraph 1 – subparagraph 2
Article 23– paragraph 1 – subparagraph 2
That increase shall be of 1.52 percentage points for Member States where waste heat and cold is used. In that case, Member States may count waste heat and cold up to 40 % of the average annual increase.
Amendment 844 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point a
Article 1 – paragraph 1 – point 12 – point a
Directive (EU) 2018/2001
Article 23– paragraph 1 – subparagraph 3
Article 23– paragraph 1 – subparagraph 3
Amendment 847 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point a
Article 1 – paragraph 1 – point 12 – point a
Directive (EU) 2018/2001
Article 23– paragraph 1 – subparagraph 3
Article 23– paragraph 1 – subparagraph 3
In addition to the minimum 1.16 percentage points annual increase referred to in the first subparagraph, each Member State shall endeavour to increase the share of renewable energy in their heating and cooling sector by the amount set out in Annex 1a.;
Amendment 855 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point b
Article 1 – paragraph 1 – point 12 – point b
Directive (EU) 2018/2001
Article 23 – paragraph 1a
Article 23 – paragraph 1a
1a. Member States shall carry out an assessment of their potential of energy from renewable sources and of the use of waste heat and cold in the heating and cooling sector including, where appropriate, an analysis of areas suitable for their deployment at low ecological risk and of the potential for small-scale household projects with the participation of local and regional authorities. The assessment shall set out milestones and measures to in increase renewables in heating and cooling and, where appropriate, the use of waste heat and cold through district heating and cooling and small-scale household and SMEs with a view of establishing a long- term national strategy to decarbonise heating and cooling. The assessment shall be in accordance with the energy efficiency first principle and part of the integrated national energy and climate plans referred to in Articles 3 and 14 of Regulation (EU) 2018/1999, and shall accompany the comprehensive heating and cooling assessment required by Article 14(1) of Directive 2012/27/EU.;
Amendment 859 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point c a (new)
Article 1 – paragraph 1 – point 12 – point c a (new)
Directive (EU) 2018/2001
Article 23– paragraph 2 – subparagraph 3 (new)
Article 23– paragraph 2 – subparagraph 3 (new)
(ca) the following subparagraph is inserted: Member States shall in particular provide information to the owners or tenants of buildings and SMEs on cost-effective measures, and financial instruments, to improve the use of renewable energy in the heating and cooling systems. Member States shall provide the information through accessible and transparent advisory tools based in one-stop shops;
Amendment 861 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point d
Article 1 – paragraph 1 – point 12 – point d
Directive (EU) 2018/2001
Article 23 – paragraph 4 – subparagraph 1 – introductory part
Article 23 – paragraph 4 – subparagraph 1 – introductory part
4. To achieve the average annual increase referred to in paragraph 1, first subparagraph, Member States mayshall implement one or mormore than one of the following measures:
Amendment 878 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point d
Article 1 – paragraph 1 – point 12 – point d
Directive (EU) 2018/2001
Article 23 – paragraph 4 – subparagraph 1 – point f
Article 23 – paragraph 4 – subparagraph 1 – point f
(f) promotion of renewable heat purchase agreements for corporate and collective small consumers;
Amendment 881 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point d
Article 1 – paragraph 1 – point 12 – point d
Directive (EU) 2018/2001
Article 23 – paragraph 4 – subparagraph 1 – point g
Article 23 – paragraph 4 – subparagraph 1 – point g
(g) planned replacement schemes of fossil heating and cooling systems or fossil phase-out schemes with milestones, with a view to a complete phase-out of fossil fuels in heating and cooling;
Amendment 893 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point d
Article 1 – paragraph 1 – point 12 – point d
(i) other policy measures, with an equivalent effect, including fiscal measures, support schemes or other financial incentives contributing to the installation of renewable heating and cooling equipment and the development of energy networks supplying renewable energy for heating and cooling in buildings and industry.
Amendment 897 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 12 – point d
Article 1 – paragraph 1 – point 12 – point d
Directive (EU) 2018/2001
Article 23– paragraph 4 – subparagraph 2
Article 23– paragraph 4 – subparagraph 2
When adopting and implementing those measures, Member States shall ensure their accessibility to all consumers including those who are tenants, in particular those in low-income or vulnerable households and shall require a significant share of measures to be implemented as a priority in households living in a condition of energy poverty as defined in the [Energy efficiency Directive recast] and in social housing, who would not otherwise possess sufficient up-front capital to benefit.;
Amendment 913 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 13 – point a
Article 1 – paragraph 1 – point 13 – point a
Directive (EU) 2018/2001
Article 24 – paragraph 1
Article 24 – paragraph 1
1. Member States shall ensure that information on the energy performance, the greenhouse gas emissions and the share of renewable energy in their district heating and cooling systems is provided to final consumers in an easily accessible manner, such at least on bills or on the suppliers' websites and on request. The information on the renewable energy share shall be expressed at least as a percentage of gross final consumption of heating and cooling assigned to the customers of a given district heating and cooling system, including information on how much energy was used to deliver one unit of heating to the customer or end-user.;
Amendment 942 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 13 – point e
Article 1 – paragraph 1 – point 13 – point e
Directive (EU) 2018/2001
Article 24 – paragraph 8 – subparagraph 1
Article 24 – paragraph 8 – subparagraph 1
8. Member States shall establish a framework under which electricity distribution system operators will assess, at least every four years, in cooperation with the operators of district heating and cooling systems in their respective areas, the potential for district heating and cooling systems to provide balancing and other system services, including demand response and thermal storage of excess electricity from centralized and decentralised renewable sources, and whether the use of the identified potential would be more resource- and cost-efficient than alternative solutions, in compliance with the energy efficiency first principle.
Amendment 949 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 13 – point e
Article 1 – paragraph 1 – point 13 – point e
Directive (EU) 2018/2001
Article 24 – paragraph 8 – subparagraph 3
Article 24 – paragraph 8 – subparagraph 3
Member States shall facilitate coordination between operators of district heating and cooling systems and electricity transmission and distribution system operators to ensure that balancing, storage and other flexibility services, such as demand response, provided by district heating and district cooling system operators, can participate in their electricity markets on a non-discriminatory basis.
Amendment 952 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 13 – point e
Article 1 – paragraph 1 – point 13 – point e
Directive (EU) 2018/2001
Article 24 – paragraph 8 – subparagraph 4
Article 24 – paragraph 8 – subparagraph 4
Member States mayshall extend the assessment and coordination requirements under the first and third subparagraphs to gas transmission and distribution system operators, including hydrogen networks and other energy networks.
Amendment 956 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 13 – point e
Article 1 – paragraph 1 – point 13 – point e
Directive (EU) 2018/2001
Article 24 – paragraph 10 – introductory part
Article 24 – paragraph 10 – introductory part
10. A Member State shall not be required to apply paragraphs 2 and 9 where at least one of the following conditions is met:
Amendment 965 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive (EU) 2018/2001
Article 25 – paragraph 1 – subparagraph 1 – point a
Article 25 – paragraph 1 – subparagraph 1 – point a
(a) the amount of renewable fuels and renewable electricity supplied to the transport sector leads to a greenhouse gas intensity reduction of at least 13 % by 2030, compared to the baseline set out in Article 27(1), point (b), in accordance with an indicative trajectory set by the Member State;
Amendment 978 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive (EU) 2018/2001
Article 25 – paragraph 1 – subparagraph 1 – point b
Article 25 – paragraph 1 – subparagraph 1 – point b
(b) the share of advanced biofuels and biogas produced from the feedstock listed in Part A of Annex IX in the energy supplied to the transport sector is at least 0,2 % in 2022, 0,5 % in 2025 and 2,2 % in 2030, and the share of renewable fuels of non-biological origin is at least 2,6 % in 2030.
Amendment 988 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive (EU) 2018/2001
Article 25 – paragraph 1 – subparagraph 2
Article 25 – paragraph 1 – subparagraph 2
For the calculation of the reduction referred to in point (a) and the share referred to in point (b), Member States shall take into account renewable fuels of non-biological origin also when they are used as intermediate products for the production of conventional transport fuels. For the calculation of the reduction referred to in point (a), Member States may take into account recycled carbon fuels.
Amendment 996 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive (EU) 2018/2001
Article 25 – paragraph 1 – subparagraph 3
Article 25 – paragraph 1 – subparagraph 3
When setting the obligation on fuel suppliers, Member States mayshall exempt fuel suppliers supplying electricity or renewable liquid and gaseous transport fuels of non-biological origin from the requirement to comply with the minimum share of advanced biofuels and biogas produced from the feedstock listed in Part A of Annex IX with respect to those fuels and shall exempt fuel suppliers supplying electricity from the requirement to comply with the minimum share of renewable liquid and gaseous transport fuels of non- biological origin.
Amendment 999 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive (EU) 2018/2001
Article 25 – paragraph 1 – subparagraph 3a (new)
Article 25 – paragraph 1 – subparagraph 3a (new)
When setting the obligation referred to in points (a) and (b) of the first subparagraph to ensure the achievement of the targets set out therein, Member States may do so by means of measures targeting volumes, energy content or greenhouse gas emissions, provided that it is demonstrated that the green house gas intensity reduction and minimum shares referred to in points (a) and (b) of the first subparagraph are achieved. Member States implementing the greenhouse gas intensity reduction target in Article 25 (1) by means of measures targeting volumes or energy content shall consider the share of renewable electricity to be four times its energy content;
Amendment 1003 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive (EU) 2018/2001
Article 25 – paragraph 1 – subparagraph 3b (new)
Article 25 – paragraph 1 – subparagraph 3b (new)
1a. The Commission shall assess that obligation laid down in paragraph 1 with a view to submitting a legislative proposal by 2025 to increase it where there are further substantial costs reductions in the production of renewable energy, where needed to meet the Union's international commitments for decarbonisation, or where a significant decrease in energy consumption in the Union justifies such an increase.
Amendment 1014 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive (EU) 2018/2001
Article 25 – paragraph 2
Article 25 – paragraph 2
2. Member States shall establish a mechanism allowing fuel suppliers in their territory to exchange credits for supplying renewable energy to the transport sector. Economic operators that supply renewable electricity to electric vehicles through public and private recharging stations shall receive credits, irrespectively of whether the economic operators are subject to the obligation set by the Member State on fuel suppliers, and may sell those credits to fuel suppliers, which shall be allowed to use the credits to fulfil the obligation set out in paragraph 1, first subparagraph.;
Amendment 1019 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Directive (EU) 2018/2001
Article 25 – paragraph 2a (new)
Article 25 – paragraph 2a (new)
2a. No later than [one year after the entry into force of this amending Directive], the Commission shall adopt a delegated act in accordance with Article 35 on how to apply the cascading principle for feedstock listed in Part A and B of Annex IX, while taking into account available volumes of feedstock and share of pre-existing competing industrial uses other than energy recovery with due regard to national specificities.
Amendment 1026 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15 – point a – point i
Article 1 – paragraph 1 – point 15 – point a – point i
Directive (EU) 2018/2001
Article 26 – paragraph 1 – subparagraph 1
Article 26 – paragraph 1 – subparagraph 1
For the calculation of a Member State's gross final consumption of energy from renewable sources referred to in Article 7 and of the greenhouse gas intensity reduction target referred to in Article 25(1), first subparagraph, point (a), the share of biofuels and bioliquids, as well as of biomass fuels consumed in transport, where produced from food and feed crops, shall be no more than one percentage point higher than the share of such fuels in the final consumption of energy in the road and rail transport sectors in 2020 in that Member State, with a maximum of 7 % of final consumption of energy in the road and rail transport sectors in that Member State.;
Amendment 1036 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15 – point a – point i a (new)
Article 1 – paragraph 1 – point 15 – point a – point i a (new)
Directive (EU) 2018/2001
Article 26 – paragraph 1 – subparagraph 2
Article 26 – paragraph 1 – subparagraph 2
(ia) the second subparagraph is deleted;
Amendment 1038 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15 – point a – point i b (new)
Article 1 – paragraph 1 – point 15 – point a – point i b (new)
Directive (EU) 2018/2001
Article 26 – paragraph 1 – subparagraph 3
Article 26 – paragraph 1 – subparagraph 3
(ib) Subparagraph 3 is replaced by the following: "Member States may set a lower limit and may distinguish, for the purposes of Article 29(1), between different biofuels, bioliquids and biomass fuels produced from food and feed crops, taking into account best available evidence on indirect land use change impact and the cascading principle. Member States may, for example, set a lower limit for the share of biofuels, bioliquids and biomass fuels produced from oil crops. "
Amendment 1045 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 15 – point b a (new)
Article 1 – paragraph 1 – point 15 – point b a (new)
Directive (EU) 2018/2001
Article 26 – paragraph 2 – subparagraph 2
Article 26 – paragraph 2 – subparagraph 2
(ba) in paragraph 2, second subparagraph is replaced by the following: From 31 December2023 until 31 December 2025 at the latest, that limit shall gradually decrease to 0 %.
Amendment 1060 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16 – point b
Article 1 – paragraph 1 – point 16 – point b
Directive (EU) 2018/2001
Article 27 – paragraph 1 – point a – point ii
Article 27 – paragraph 1 – point a – point ii
(ii) for renewable fuels of non- biological origin and recycled carbon fuels, by multiplying the amount of these fuels that is supplied to all transport modes by their emissions savings determined in accordance with delegated acts adopted pursuant to Article 29a(3);
Amendment 1062 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16 – point b
Article 1 – paragraph 1 – point 16 – point b
Directive (EU) 2018/2001
Article 27 – paragraph 1 –– point a – Point iii
Article 27 – paragraph 1 –– point a – Point iii
(iii) for renewable electricity, by multiplying the amount of renewable electricity that is supplied to all transport modes by the fossil fuel comparator ECF(e) set out in in Annex V. Member States implementing the greenhouse gas intensity reduction target in Article 25(1) by means of a national target for the share of renewable energy within the final consumption of energy in the transport sector shall consider the share of renewable electricity to be four times its energy content;
Amendment 1087 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16 – point b
Article 1 – paragraph 1 – point 16 – point b
Directive (EU) 2018/2001
Article 27 – paragraph 1– subparagraph 1 – point d
Article 27 – paragraph 1– subparagraph 1 – point d
(d) the greenhouse gas intensity reduction from the use of renewable energy is determined by dividing the greenhouse gas emissions saving from the use of biofuels, biogas, renewable fuels of non- biological origin and renewable electricity supplied to all transport modes by the baseline.
Amendment 1105 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 16 – point e – point ii
Article 1 – paragraph 1 – point 16 – point e – point ii
Directive (EU) 2018/2001
Article 27 – paragraph 3 – subparagraph 4
Article 27 – paragraph 3 – subparagraph 4
Where electricity is used for the production of renewable fuels of non-biological origin, either directly or for the production of intermediate products, the average share of electricity from renewable sources in the country of production, as measured two years before the year in question,in time intervals of no more than one hour as set out in Article 20a of this Directive shall be used to determine the share of renewable energy.;
Amendment 1138 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 17 – point b a (new)
Article 1 – paragraph 1 – point 17 – point b a (new)
Directive (EU) 2018/2001
Article 28 – paragraph 6 – subparagraph 3
Article 28 – paragraph 6 – subparagraph 3
(ba) In paragraph 6, subparagraph 3 is replaced by the following: Such delegated acts shall be based on an analysis of the potential of the raw material as feedstock for the production of biofuels and biogas for transport, taking into account all of the following: (a) the principles of the circular economy and of the waste hierarchy established in Directive 2008/98/EC, as well as the cascading use principle referred to in Articles 3 and 29 ; (b) the Union sustainability criteria laid down in Article 29(2) to (7); (c) the need to avoid significant distortive effects on markets for (by-)products, wastes or residues; (d) the potential for delivering substantial greenhouse gas emissions savings compared to fossil fuels based on a life- cycle assessment of emissions including emissions from the land sector and possible displacement effects, taking into account available volumes of feedstock and share of pre-existing competing industrial uses other than energy recovery with due regard to national specificities; (e) the need to avoid negative impacts on the environment and biodiversity; (f) the need to avoid creating an additional demand for land.
Amendment 1245 #
2021/0218(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 22
Article 1 – paragraph 1 – point 22
Directive (EU) 2018/2001
Article 31a – paragraph 1
Article 31a – paragraph 1
1. The Commission shall ensure that a Union database is set up to enable the tracing of liquid and gaseous renewable fuels and recycled carbon fuels.
Amendment 75 #
2021/0214(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7 a) Tackling climate change and keeping global warming below 1.5°C requires global action. The Union must not only lead by example, by eliminating its own emissions, including those embedded in the products it imports, but also cooperate with its partners, in accordance with WTO rules, to create an open, multilateral and cooperative global system, acting as a key enabler of the green transition.
Amendment 80 #
2021/0214(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) As long as a significant number of the Union’s international partners have policy approaches that do not result in the same level of climate ambition, there is a risk of carbon leakage. An effective CBAM implementation should ensure the creation of a level playing field while encouraging trade partners to decarbonize. Carbon leakage occurs if, for reasons of costs related to climate policies, businesses in certain industry sectors or subsectors were to transfer production to other countries or imports from those countries would replace equivalent but less GHG emissions intensive products. That could lead to an increase in their total emissions globally, thus jeopardising the reduction of GHG emissions that is urgently needed if the world is to keep the global average temperature to well below 2 °C above pre- industrial levels.
Amendment 101 #
2021/0214(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Innovation will be crucial to boost growth and competitiveness by empowering EU businesses, in particular SMEs to become global leaders in developing new and clean technology and to achieve the European Green Deal objectives. The Commission and the Member States should channelled incentives and policies for innovation, through a robust Innovation Fund to promote zero-carbon industrial processes.
Amendment 125 #
2021/0214(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) The CBAM seeks to replace these existing mechanisms by addressing the risk of carbon leakage in a different way, namely by ensuring equivalent carbon pricing for imports and domestic products. The CBAM should ensure an integrated approach between imports dynamics, the internal market development and the exports. To ensure a gradual transition from the current system of free allowances to the CBAM, the CBAM should be progressively phased in while free allowances in sectors covered by the CBAM are phased out. The combined and transitional application of EU ETS allowances allocated free of charge and of the CBAM should in no case result in more favourable treatment for Union goods compared to goods imported into the customs territory of the Union.
Amendment 147 #
2021/0214(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) As an instrument to prevent carbon leakage and reduce GHG emissions the CBAM should ensure that imported products are subject to a regulatory system that applies carbon costs equivalent to the ones that otherwise would have been borne under the EU ETS. The CBAM is a climate measure which should prevent the risk of carbon leakage and support the Union’s increased ambition o, resulting in a carbon cost equalization between national products and imported. The CBAM is a climate measure which should support increased ambition on the reduction of emissions in the Union in line with the European Green Deal and the European cClimate mitigationLaw and it should prevent the risk of carbon leakage, while ensuring WTO compatibility.
Amendment 199 #
2021/0214(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) The goods under this Regulation should be selected after a careful analysis of their relevance in terms of cumulated GHG emissions and risk of carbon leakage in the corresponding EU ETS sectors while limiting complexity and administrative burden. In particular, the actual selection should take into account basic materials and basic products covered by the EU ETS with the objective of ensuring that imports of energy intensive products into the Union are on equal footing with EU products in terms of EU ETS carbon pricing, and to mitigate risks of carbon leakage. Other relevant criteria to narrow the selection should be: firstly, relevance of sectors in terms of emissions, namely whether the sector is one of the largest aggregate emitters of GHG emissions; secondly, sector’s exposure to significant risk of carbon leakage, as defined pursuant to Directive 2003/87/EC; thirdly, the need to balance broad coverage in terms of GHG emissions while limiting complexity and administrative effort. Particular attention should also be paid to the risk of market distortions between the different sectors covered by the CBAM.
Amendment 227 #
2021/0214(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) The system should allow operators of production installations in third countries to register in a central database and to make their verified embedded GHG emissions from production of goods available to authorised declarants. An operator should be able to choose not to haveensure transparency in the access of information, namely indicating its name, address and contact details in the central database made accessible to the public.
Amendment 256 #
2021/0214(COD)
Proposal for a regulation
Recital 50 a (new)
Recital 50 a (new)
(50 a) The full effectiveness of the CBAM in tackling the carbon leakage risk both on the EU market and on export markets should be assessed and positively verified through a strong monitoring of the impacts on EU businesses, with a view to modify the present legislation, if necessary.
Amendment 262 #
2021/0214(COD)
Proposal for a regulation
Recital 51
Recital 51
(51) To facilitate and ensure a proper functioning of the CBAM, the Commission should ensure interoperability between the national and central databases. The Commission should also provide support to the competent authorities responsible for the application of this Regulation in carrying out their obligations. The Commission should assist enterprises, especially SMEs, in adapting to this Regulation and establish an expert group to share information and best practices with the competent authorities.
Amendment 269 #
2021/0214(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) The Commission should evaluate the application of this Regulation before the end of the transitional period and report to the European Parliament and the Council. The report of the Commission should in particular focus on the impact on competitiveness of EU downstream industry and its synchronisation with the technological perspectives and maturities, concerning namely the new clean energy alternatives such as the availability of cost-competitive green hydrogen. The report should also evaluate the possibilities to enhance climate actions towards the objective of a climate neutral Union by 2050. The Commission should, as part of that evaluation, initiate collection of information necessary to possibly extend the scope to indirect emissions, as well as to other goods and services at risk of carbon leakage, and to develop methods of calculating embedded emissions based on the environmental footprint methods47 . __________________ 47Commission Recommendation 2013/179/EU of 9 April 2013 on the use of common methods to measure and communicate the life cycle environmental performance of products and organisations (OJ L 124, 4.5.2013, p. 1).
Amendment 278 #
2021/0214(COD)
Proposal for a regulation
Recital 52 a (new)
Recital 52 a (new)
(52 a) At the end of the first year after the transition period of this Regulation, the Commission should present a report, with the possibility of being accompanied by a legislative proposal, and in accordance with WTO rules, to ensure the competitiveness of the products that are exported outside the EU.
Amendment 289 #
2021/0214(COD)
Proposal for a regulation
Recital 55 a (new)
Recital 55 a (new)
(55 a) To support least developed countries' efforts towards the decarbonisation of their manufacturing industries, financial support should be provided, including through reinforcing climate spending in the Union budget’s Instrument for Pre-Accession Assistance III established by Regulation (EU) 2021/1529 of the European Parliament and of the Council and the relevant geographic and thematic programmes of the Neighbourhood, Development and International Cooperation Instrument established by Regulation(EU) 2021/947 of the European Parliament and of the Council.
Amendment 292 #
2021/0214(COD)
Proposal for a regulation
Recital 55 b (new)
Recital 55 b (new)
(55 b) The implementation of CBAM will be key for achieving the climate targets of the Paris Agreement. In this context the Green Climate Fund (GCF) will also contribute to support developing countries raise and realize their Nationally Determined Contributions (NDC) ambitions towards low-emissions, climate- resilient pathways.
Amendment 301 #
2021/0214(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes a carbon border adjustment mechanism (the ‘CBAM’) for addressing greenhouse gas emissions embedded in the goods referred to in Annex I, upon their importation into the customs territory of the Union, in order to ensure a level playing field to preserve the competitiveness of EU industries, and thus to prevent the risk of carbon leakage.
Amendment 358 #
2021/0214(COD)
Proposal for a regulation
Article 2 – paragraph 12 a (new)
Article 2 – paragraph 12 a (new)
12a. The Union may pursue complementary approaches to CBAM through cooperation and dialogue with third countries, with a view to conclude agreements on open, multilateral and cooperative approaches to tackle carbon leakage and achieve the deep decarbonisation of energy intensive industries, including through non-pricing policies. The introduction of CBAM and the proposal to increase cooperation and dialogue with third countries may actively contribute to tackle climate challenges at international level.
Amendment 420 #
2021/0214(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The authorised declarant shall keep records of the documentation, certified by an independent person, verifier accredited pursuant article 18 of this Regulation. The accreditation will be required to demonstrate that the declared embedded emissions were subject to a carbon price in the country of origin of the goods and keep evidence of the proof of the actual payment for that carbon price which should not have been subject to an export rebate or any other form of compensation on exportation.
Amendment 461 #
2021/0214(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
The Commission shall assist the competent authorities, establishing clear and simplified rules and procedures, in carrying out their obligations under this Regulation and coordinate their activities.
Amendment 463 #
2021/0214(COD)
Proposal for a regulation
Article 12 – paragraph 1 a (new)
Article 12 – paragraph 1 a (new)
The Commission shall provide enterprises, especially SMEs, with technical advice and assistance in order to facilitate their adaptation to the obligations laid down in this Regulation.
Amendment 464 #
2021/0214(COD)
Proposal for a regulation
Article 12 – paragraph 1 b (new)
Article 12 – paragraph 1 b (new)
The Commission shall set up an expert group representing the competent authorities in order to exchange information and best practices on the application of this Regulation.
Amendment 466 #
2021/0214(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
All information acquired by the central and national competent authorityies in the course of performing its duty which is by its nature confidential or which is provided on a confidential basis shall be covered by an obligation of professional secrecy. Such information shall not be disclosed by the competent authority without the express permission of the person or authority that provided it. It may be shared with customs authorities, the Commission and the European Public Prosecutors Office and shall be treated in accordance with Council Regulation (EC) No 515/97.
Amendment 472 #
2021/0214(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The competent authority of each Member State shall establish a national registry of declarants authorised in that Member State in the form of a standardised electronic database in such a way to guarantee the interoperability with the central database referred to in paragraph 2. The national register shall containing the data regarding the CBAM certificates of those declarants, and to provide for confidentiality in accordance with the conditions set out in Article 13.
Amendment 482 #
2021/0214(COD)
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The information in the database referred to in paragraph 2 shall be confidentialmade available to the public, unless it is proven that it is business confidential according to the relevant EU legislation.
Amendment 485 #
2021/0214(COD)
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. The Commission shall establish a central database accessible to the public containing the names, addresses and contact details of the operators and the location of installations in third countries in accordance with Article 10(2). An operator may choose not to have its name, address and contact details accessible to the public.
Amendment 512 #
2021/0214(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point b a (new)
Article 17 – paragraph 1 – point b a (new)
(b a) the declarant has repeatedly failed to comply CBAM's obligations under article 26 and was not involved in practices of circumvention under Article 27.
Amendment 591 #
2021/0214(COD)
Proposal for a regulation
Article 24 a (new)
Article 24 a (new)
Article 24 a Revenues generated by the sale of CBAM certificates 1. The revenues generated by the sale of CBAM certificates shall constitute internal assigned revenue in accordance with Article 21(3) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council. 2. To meet Union objectives and international commitments, such as those under WTO agreements and the Paris Agreement, financial support shall be provided to support least developed countries' efforts towards the decarbonisation of their manufacturing industries, including through reinforcing climate spending in the Union budget’s Instrument for Pre-Accession Assistance III and the relevant geographic and thematic programmes of the Neighbourhood, Development and International Cooperation Instrument. The additional financial support shall be at least equivalent in financial value to the revenues generated by the sale of CBAM certificates. 3. To ensure transparency of the use of revenues generated by the sale of CBAM certificates the Commission shall, on a yearly basis, report to the European Parliament and to the Council on how the equivalent in financial value of those revenues from the previous year has been used and how this has contributed to tackling climate change in the least developed countries.
Amendment 657 #
2021/0214(COD)
Proposal for a regulation
Article 30 – paragraph 2
Article 30 – paragraph 2
2. Before the end of the transitional period, and every five years, the Commission shall present a report to the European Parliament and the Council on the application of this Regulation. The report shall contain, in particular, the assessment of the possibilities to further extend the scope of embedded emissions to indirect emissions and to other goods at risk of carbon leakage than those already covered by this Regulation, as well as an assessment of the governance system. It shall also contain the assessment of the possibility to further extend the scope to embedded emissions of transportation services as well as to goods further down the value chain and services that may be subject to the risk of carbon leakage in the future. An in-depth assessment should be made of the impact on competitiveness of the EU downstream industry and the maturity of new technologies that are crucial to ensure it.
Amendment 668 #
2021/0214(COD)
Proposal for a regulation
Article 30 – paragraph 2 a (new)
Article 30 – paragraph 2 a (new)
2a. At the end of the first year after the transitional period of this Regulation and to ensure a level playing field for the EU production destined to the export, of the sectors covered by the scope of Annex I of this Regulation, the Commission shall submit to the European Parliament and to the Council a report, if necessary accompanied by legislative measures, on the impact of EU exports of those sectors in the global markets and shell considering an export adjustment mechanism that equalize the costs of CO2 with the different pricing schemes of the third countries. Such measures shall comply the WTO rules.
Amendment 687 #
2021/0214(COD)
Proposal for a regulation
Article 31 – paragraph 1 a (new)
Article 31 – paragraph 1 a (new)
1a. The above-mentioned installations shall benefit from free allocation in reduced amounts, until the full effectiveness of the CBAM in tackling the carbon leakage risk both on the EU market and on export markets is assessed and positively verified.
Amendment 728 #
2021/0214(COD)
Proposal for a regulation
Annex I – subheading 1 a (new)
Annex I – subheading 1 a (new)
2523 30 00 – Aluminous cement | Carbon dioxide
Amendment 23 #
2021/0206(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) However, sufficient, stable and equitable resources are needed to finance those investments. In addition, before they have taken place, the cost supported by households and transport users for heating, cooling and cooking, as well as for road transport, is likely to increase as fuel suppliers subject to the obligations under the emission trading for buildings and road transport pass on costs on carbon to the consumers.
Amendment 30 #
2021/0206(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The increase in the price for fossil fuels may disproportionally affect vulnerable households, vulnerable micro- enterprises, vulnerable SMEs and vulnerable transport users who spend a larger part of their incomes on energy and transport, who, in certain regionsthus exacerbating inequalities, and who, in certain regions, especially in rural, peripheral and isolated areas, in less developed regions or territories, those suffering from severe handicaps and those in demographic decline, do not have access to alternative, affordable mobility and transport solutions and who may lack the financial capacity to invest into the reduction of fossil fuel consumption.
Amendment 42 #
2021/0206(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) This is even more relevant in view of the existing levels of energy poverty. Energy poverty is a situation in which households are unable to access essential energy services such as cooling, as temperatures rise, and heating. About 34 million Europeans reported an inability to keep their homes adequately warm in 2018, and 6.9% of the Union population have said that they cannot afford to heat their home sufficiently in a 2019 EU-wide survey32 . Overall, the Energy Poverty Observatory estimates that more than 50 million households in the European Union experience energy poverty. Energy poverty is therefore a major challenge for the Unionis essential and access to affordable energy services is a basic social right and essential for social inclusion. Energy poverty is a situation in which households are unable to access essential energy supply needs, so as to guarantee basic levels of comfort and health, such as cooling, as temperatures rise, and heating as a result of an insufficient level of income, high-energy prices and which, if applicable, may be aggravated by having an energy inefficient dwelling. About 34 million Europeans reported an inability to keep their homes adequately warm in 2018, and 6.9% of the Union population have said that they cannot afford to heat their home sufficiently in a 2019 EU-wide survey32 . Overall, the Energy Poverty Observatory estimates that more than 50 million households in the European Union experience energy poverty. Energy poverty is therefore a major challenge for the Union. Despite the increasing importance of this challenge having been acknowledged at EU-level through various initiatives, legislation and guidelines, there is no standard Union level definition of energy poverty and only one third of Member States have put in place a national definition of energy poverty. As a result, no transparent and comparable data on energy poverty in the Union is available. Therefore, a broad Union level definition should be established on energy poverty in order to properly collect data, including sex- disaggregated data, to target assistance and monitoring practices. While social tariffs or direct income support can provide immediate relief to households facing energy poverty, only targeted structural measures, in particular energy renovations, can provide lasting solutions. _________________ 32 Data from 2018. Eurostat, SILC [ilc_mdes01]).
Amendment 55 #
2021/0206(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) A Social Climate Fund (‘the Fund’) should therefore be established to provide funds to the Member States to support their policies to address the social impacts of the emissions trading for buildings and road transport on vulnerable households, vulnerable micro-enterprises, vulnerable SMEs and vulnerable transport users. This should be achieved notably through temporary income support and measures and investments intended to reduce reliance on fossil fuels through increased energy efficiency of buildings, decarbonisation of heating and cooling of buildings, including the integration of energy from renewable sources, and granting improved access to zero- and low-emission mobility and transport to the benefit of vulnerable households, vulnerable micro-enterprises, vulnerable SMEs and vulnerable transport users.
Amendment 61 #
2021/0206(COD)
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13 a) The implementation of the Fund should take into account ex ante impact provided by the European Commission, illustrating the unequal social impacts of the emissions trading for buildings and road transport in Member States and go hand in hand with an economic policy and governance that do not generate inequalities, poverty and social exclusion.
Amendment 67 #
2021/0206(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) For that purpose, each Member State should submit to the Commission a Social Climate Plan (‘the Plan’). Those Plans should pursue two objectives. Firstly, they should provide vulnerable households, vulnerable micro-enterprises, vulnerable SMEs and vulnerable transport users the necessary resources to finance and carry out investments in energy efficiency, decarbonisation of heating and cooling, in zero- and low-emission vehicles and mobility. Secondly, they should mitigate the impact of the increase in the cost of fossil fuels on the most vulnerable and thereby prevent energy and transport poverty during the transition period until such investments have been implemented. The Plans should have an investment component promoting the long-term solution of reduce fossil fuels reliance and could envisage other measures, including temporary direct income support to mitigate adverse income effects in the shorter term.
Amendment 68 #
2021/0206(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14 a) The Plans should also include measures to provide information support, capacity building and training necessary to implement the investments and measures intended to reduce reliance on fossil fuels through increased energy efficiency of buildings, decarbonisation of heating and cooling of buildings, including the integration of energy from renewable sources, and granting improved access to zero- and low-emission mobility and transport.
Amendment 71 #
2021/0206(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Member States, in consultation with regional, local level authorities and civil society organisations, are best placed to design and to implement Plans that are adapted and targeted to their local, regional and national circumstances as their existing policies in the relevant areas and planned use of other relevant EU funds. In that manner, the broad diversity of situations, the specific knowledge of local and regional governments, research and innovation and industrial relations and social dialogue structures, as well as national traditions, can best be respected and contribute to the effectiveness and efficiency of the overall support to the vulnerable.
Amendment 77 #
2021/0206(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Ensuring that the measures and investments are particularly targeted towards energy poor or vulnerable households, vulnerable micro-enterprises, vulnerable SMEs and vulnerable transport users is key for a just transition towards climate neutrality. Support measures to promote reductions in greenhouse gas emissions should help Member States to address the social impacts arising from the emissions trading for the sectors of buildings and road transport.
Amendment 89 #
2021/0206(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Women are particularly affected by carbon pricing as they represent 85% of single parent families. Single parent families have a particularly high risk of child poverty. Gender equality and equal opportunities for all, and the mainstreaming of those objectives, as well as questions of accessibility for persons with disabilities should be taken into account and promoted throughout the preparation and implementation of Plans to ensure no one is left behind. disproportionally affected by the consequences of climate change1a, by energy poverty and are particularly affected by carbon pricing due to the employment, income, pay and pension gaps. Moreover, they represent 85% of single parent families, which have a particularly high risk of child poverty and are under-represented as tenants. This, together with the fact that women are more affected by time poverty, limits women’s involvement in the energy transition, by not being able to afford energy efficiency investments to decrease their energy consumption and having limited access to energy efficiency retrofitting programs.2a Gender equality and equal opportunities for all, and the mainstreaming of those objectives, as well as questions of accessibility for persons with disabilities should be taken into account and promoted throughout the preparation and implementation of Plans to ensure no one is left behind. _________________ 1a EIGE, Area K - Women and the environment: climate change is gendered, 05 March 2020, available at: https://eige.europa.eu/publications/beijing -25-policy-brief-area-k-women-and- environment 2aEuropean Parliament, Directorate- General for Internal Policies of the Union, Feenstra, M., Clancy, J., Women, gender equality and the energy transition in the EU, Publications Office, 2019, https://data.europa.eu/doi/10.2861/989050
Amendment 93 #
2021/0206(COD)
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19 a) Women have different and more complex mobility patterns than those of men. They require more varied means of transport as they are the main responsible persons for care within households. They use more public transport and are more interested in the frequency and quality of service.1a Moreover, as transport is a factor that can reinforce poverty and social exclusion, mainstreaming gender into all transport-related legislation, policies, programmes and actions is paramount; _________________ 1a https://www.europarl.europa.eu/thinktank /nl/document/IPOL_STU(2021)701004
Amendment 93 #
2021/0206(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) The European Pillar of Social Rights Action Plan30a highlights that social rights and the European social dimension need to be strengthened across all policies of the Union as enshrined in the Treaties, in particular Article 3 TEU and Article 9 TFEU. _________________ 30a Endorsed by the European Council on 24 and 25 June 2021.
Amendment 101 #
2021/0206(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Those amendments have differing economic and social impacts on the different sectors of the economy, on the citizens, and the Member States. In particular, the inclusion of greenhouse gas emissions from buildings and road transport into the scope of Directive 2003/87/EC of the European Parliament and the Council31 should provide an additional economic incentive to invest into the reduction of fossil fuel consumption and thereby accelerate the reduction of greenhouse gas emissions. Combined with other measures, this should, in the medium to long term, reduce the costs for buildings and road transport, and provide new opportunities for job creation and investment. _________________ 31 Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a system for greenhouse gas emission allowance trading within the Union (OJ L 275, 25.10.2003, p. 32)The Commission will collect data on the social impact of the accompanying measures and how they affect different Member States, regions and vulnerable groups. The aspects of preventive approach, reduction of inequalities and social compensation are critical in order to avoid the worst effects on the most vulnerable households and self-employed persons while maintaining a high level of investment to ensure the success of the ecological transition.
Amendment 105 #
2021/0206(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) The financial envelope of the Fund should, in principle, be commensuris calculated to amounts correspondingbe equivalent to 25% of the expected revenues from the inclusion of buildings and road transport into the scope of Directive 2003/87/EC in the period 2026- 2032. Pursuant to Council Decision (EU, Euratom) 2020/205341 , Member States should make those revenues available to the Union budget as own resources. The revenue accruing to the Union budget shall respect the principle of universality in accordance with Article 7 of Council Decision (EU, Euratom) 2020/2053. Member States are to finance 540% of the total costs of their Plan themselves. For this purpose, as well as for investment and measures to accelerate and alleviate the required transition for citizens negatively affected, Member States should inter alia use their expected revenues from emissions trading for buildings and road transport under Directive 2003/87/EC for that purpose. The financing of the Fund should not come at the expense of other Union programmes. _________________ 41 Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom (OJ L 424, 15.12.2020, p. 1).
Amendment 111 #
2021/0206(COD)
Proposal for a regulation
Recital 9
Recital 9
Amendment 125 #
2021/0206(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The increase in the price for fossil fuels maytransition towards climate neutrality will disproportionaltely affect vulnerable households, vulnerable micro- enterpriseself- employed persons and vulnerable transport users who already spend a larger part of their incomes on energy and transport, who, in certain regions, do not have access to alternative, affordable mobility and transport solutions and who may lack the financial capacity to invest into the reduction of fossil fuel consumptionfurther deepening the existing inequalities.
Amendment 127 #
2021/0206(COD)
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
The measures and investments supported by the Fund shall benefit households, micro-enterprises, SMEs and transport users, which are vulnerable and particularly affected by the inclusion of greenhouse gas emissions from buildings and road transport into the scope of Directive 2003/87/EC, especially households in energy poverty and citizens without public transport alternative to individual cars (in remote and rural areas).
Amendment 136 #
2021/0206(COD)
Proposal for a regulation
Article 1 – paragraph 4
Article 1 – paragraph 4
The general objective of the Fund is to contribute to the transition towards climate neutrality by addressing the social impacts of the inclusion of greenhouse gas emissions from buildings and road transport into the scope of Directive 2003/87/EC. The specific objective of the Fund is to support vulnerable households, vulnerable micro-enterprises, vulnerable SMEs and vulnerable transport users through temporary direct income support and through measures and investments intended to increase energy efficiency of buildings, decarbonisation of heating and cooling of buildings, including the integration of energy from renewable sources, and granting improved access to zero- and low- emission mobility and transport.
Amendment 137 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1
Article 2 – paragraph 1 – point 1
(1) ‘building renovation’ means all kinds of energy-relatedholistic building renovation, includingwhich includes a comprehensive approach to the energy, accessibility, spatial and structural performance of the building, including in particular the insulation of the building envelope, that is to say walls, roof, floor, the replacement of windows, ventilation, the replacement of heating, cooling and cooking appliances, and the installation of on-site production of energy from renewable sourcesthe upgrade of electrical installations for more efficient ones, adaptation of housing for people with any type of disability and the installation of on-site production of energy from renewable sources, and including all kinds of safety-related renovation works undertaken at the same time, such as seismic protection, electrical safety, smoke detection and alarm, automatic fire suppression, smoke management and fire compartmentation;
Amendment 139 #
2021/0206(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) Therefore, a part of the revenues generated by the inclusion of building and road transport into the scope of Directive 2003/87/ECPreventive measures and compensation should be usprovided to address the social impacts arising from that inclusion, for thee transition towards climate neutrality to achieve a transition to behat is just and inclusive, and leavinges no one behind.
Amendment 145 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) ‘energy poverty’ means energy poverty as defined in point [(49)] of Article 2 of Directive (EU) [yyyy/nnn] of the of the European Parliament and of the Council50 ; _________________ 50[Directive (EU) [yyyy/nnn] of the of the European Parliament and of the Couna household’s inability to meet its basic energy supply needs and lack of access to essential energy services as to guarantee basic levels of comfort and health, a decent standard of living, including adequate heating and cooling, lighting, and energy to power appliances, in the relevant national context, existing social (OJ C […], […], p. […]).] [Proposal for recast of Directive 2012/27/EU on energy efficiency]policy and other relevant policies, as a result of an insufficient disposable income.
Amendment 148 #
2021/0206(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) This is even more relevant in view of the existing levels of energy poverty. Energy poverty is a situation in which households are unable to access essential energy services suchthe inability of a household to support an adequate level of energy supply so as to guarantee basic levels of comfort and health, due to as cooling, as temperatures rise, and heatingmbination of low income, high-energy prices and low quality, poor performing housing stock. About 34 million Europeans reported an inability to keep their homes adequately warm in 2018, and 6.9% of the Union population have said that they cannot afford to heat their home sufficiently in a 2019 EU-wide survey32 . Overall, the Energy Poverty Observatory estimates that more than 50 million households in the European Union experience energy poverty. Energy poverty is therefore a major challenge for the Union. While social tariffs or direct income support can provide immediate relief to households facing energy poverty, only targeted structural measures, in particular energy renovations, can provide lasting solutions. _________________ 32 Data from 2018. Eurostat, SILC [ilc_mdes01]).
Amendment 157 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9 a (new)
Article 2 – paragraph 1 – point 9 a (new)
(9 a) small or medium-sized enterprise or SME means a small or medium-sized enterprise as defined in Article 2 of the Annex of the Commission Recommendation 2003/361/EC
Amendment 173 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 12 a (new)
Article 2 – paragraph 1 – point 12 a (new)
(12 a) 'vulnerable SMEs' means SMEs that are significantly affected by the price impacts of the inclusion of buildings into the scope of Directive 2003/87/EC and lack the means to renovate the building they occupy;
Amendment 173 #
2021/0206(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) A Social Climate (‘the Fund’) should therefore be established to provide funds to the Member States to support their policies to address the social impacts of the emisstransitions trading for buildings and road transporto climate neutrality on vulnerable households, vulnerable micro-enterpriseself- employed persons and vulnerable transport users. This should be achieved notably through temporary income support and measures and investments intended to reduce reliance on fossil fuels through increased energy efficiency of buildings, decarbonisation of heating and cooling of buildings, including the integration of energy from renewable sources, and granting improved access to zero- and low-emission mobility and transport to the benefit of vulnerable households, vulnerable micro-enterpriseself- employed persons and vulnerable transport users.
Amendment 184 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Each Member State shall submit to the Commission a Social Climate Plan (‘the Plan’) together with the update to the integrated national energy and climate plan referred to in Article 14(2) of Regulation (EU) 2018/1999 in accordance with the procedure and timeline laid down in that Article, following, where relevant, a consultation with regional and local entities and civil society organisations working with population in situation of vulnerability. The Plan shall contain a coherent set of measures and investments to address the impact of carbon pricing on vulnerable households, vulnerable micro- enterprises, vulnerable SMEs and vulnerable transport users in order to ensure affordable heating, cooling and mobility while accompanying and accelerating necessary measures to meet the climate targets of the Union.
Amendment 195 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Plan mayshall include national measures providing temporary direct income support to vulnerable households and households that are vulnerable transport users to reduce the impact of the increase in the price of fossil fuels resulting from the inclusion of buildings and road transport into the scope of Directive 2003/87/EC.
Amendment 198 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point a
Article 3 – paragraph 3 – point a
(a) finance measures and investments to improve energy performance and increase energy efficiency of buildings, to implement and ensure their safety, through the implementation of active and passive energy efficiency improvement measures, to carry out building renovation, and to decarbonise heating and cooling of buildings, including the integration of energy production from renewable energy sources, to carry out electrical, fire and seismic safety inspection and renovation, and including information support, capacity building and training necessary to implement those measures and investments;
Amendment 201 #
2021/0206(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) For that purpose, each Member State should submit to the Commission a Social Climate Plan (‘the Plan’). Those Plans should pursue two objectives. Firstly, they should provide vulnerable households, vulnerable micro-enterpriseself-employed persons and vulnerable transport users the necessary resources, including in the form of financial support without an up-front or minimum contribution requirement, to finance and carry out investments in energy efficiency, decarbonisation of heating and cooling, in zero- and low-emission vehicles and mobility. Secondly, they should mitigate the impact of the increase in the cost of fossil fuels on the most vulnerable and thereby prevent energy and transport poverty during the transition period until such investments have been implemented. The Plans should have an investment component promoting the long- term solution of reduce fossil fuels reliance and could envisage other measures, including temporarycomplemented with direct income support to mitigate adverse income effects in the shorter term.
Amendment 208 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point b
Article 3 – paragraph 3 – point b
(b) finance measures and investments to increase the uptake of zero- and low- emission mobility and transport, including information support, capacity building and the training necessary to implement those measures and investments.
Amendment 226 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) an estimate of the likely effects of that increase in prices on households, and in particular on incidence of energy poverty, on micro-enterprises, on SMEs and on transport users, comprising in particular an estimate and the identification of vulnerable households, vulnerable micro- enterprises vulnerable SMEs and vulnerable transport users; these impacts are to be analysed with a sufficient level of regional disaggregation and sex- disaggregated data, taking into account elements such as access to public transport and basic services and identifying the areas mostly affected, particularly territories which are remote and rural;
Amendment 226 #
2021/0206(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Member States, in consultation with regional level authoritieswith a meaningful involvement of local and regional level authorities, social partners and civil society organisations working with vulnerable people, are best placed to design and to implement Plans that are adapted and targeted to their local, regional and national circumstances as their existing policies in the relevant areas and planned use of other relevant EU funds. In that manner, the broad diversity of situations, the specific knowledge of local and regional governments, research and innovation and industrial relations and social dialogue structures, as well as national traditions, can best be respected and contribute to the effectiveness and efficiency of the overall support to the vulnerable.
Amendment 234 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point d
Article 4 – paragraph 1 – point d
(d) where the Plan provides for measures referred to in Article 3(2), the criteria for the identification of eligible final recipients, the indication of the envisaged time limit for the measures in question and their justification on the basis of a quantitative estimate and a qualitative explanation of how the measures in the Plan are expected to reduce energy and transport poverty and the vulnerability of households, micro-enterprises, SMEs and transport users to an increase of road transport and heating fuel prices;
Amendment 235 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point e
Article 4 – paragraph 1 – point e
(e) envisaged milestones, targets to reduce the number of vulnerable households, vulnerable micro-enterprises, vulnerable SMEs and an indicative timetable for the implementation of the measures and investments to be completed by 31 July 2032;
Amendment 239 #
2021/0206(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Ensuring that the measures and investments are particularly targeted towards energy poor or vulnerable households, vulnerable micro-enterpriseself-employed persons and vulnerable transport users is key for a just transition towards climate neutrality. Support measures to promote reductions in greenhouse gas emissions should help Member States to address the social impacts arising from the emissions trading for the sectors of buildings and road transport.
Amendment 253 #
2021/0206(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) Pending the impact of those investments on reducing costs and emissions, well targeted direct income support for the most vulnerable would help the just transition. Such support should be understood to be a temporary measure accompanying the decarbonisation of the housing and transport sectors. It would not be permanent as it does not address the root causes of energy and transport poverty. Such support sreduce the existing social challenges associated with the energy transition, disproportionately affecting households suffering from energy poverty, vulnerable househould only concern direct ims spending larger pacrts of their inclusion of building and road transport into the scope of Directive 2003/87/EC, not electricity or heating costs related to the inclusion of power and heat production in the scope of that Directive. Eligibility for such direct income support should be limited in timeome on energy and transport, low- income families living in the worst performing buildings and in most deprived areas.
Amendment 263 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point e
Article 5 – paragraph 2 – point e
(e) reductions in the number of vulnerable households, especially households in energy poverty, of vulnerable micro-enterprises, vulnerable SMEs and of vulnerable transport users, including in rural and remote areas.
Amendment 266 #
2021/0206(COD)
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) Direct income support when combined with investment measures, including in the form of financial support without an up-front or minimum contribution requirement, targeting the same beneficiaries may lead to better results in reaching the objectives of the Fund.
Amendment 273 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. The Fund shall only support measures and investments respecting the principle of Energy Efficiency First as in article 3 of the Energy Efficiency Directive (EED) and the ‘do no significant harm’ referred to in Article 17 of Regulation (EU) 2020/852.
Amendment 275 #
2021/0206(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Taking into account the importance of tackling climate change in line with Paris Agreement commitments, and the commitment to the United Nations Sustainable Development Goals, the actions under this Regulation should contribute to the achievement of the target that 30% of all expenditure under the 2021- 2027 multiannual financial framework should be spent on mainstreaming climate objectives and should contribute to the ambition of providing 10% of annual spending to biodiversity objectives in 2026 and 2027, while considering the existing overlaps between climate and biodiversity goals. For this purpose, the methodology set out in Annex II of Regulation (EU) 2021/1060 of the European Parliament and of the Council33 should be used to tag the expenditures of the Fund. The Fund should support activities that fully respect thesocial, climate and environmental standards and priorities of the Union and comply with the principle of ‘do no significant harm’ within the meaning of Article 17 of Regulation (EU) 2020/852 of the European Parliament and of the Council34 . Only such measures and investments should be included in the Plans. Direct income support measures should as a rule be considered as having an insignificant foreseeable impact on environmental objectives, and as such be considered compliant with the principle of ‘do no significant harm’. The Commission intends to issue technical guidance to the Member States well ahead of the preparation of the Plans. The guidance will explain how the measures and investments must comply with the principle of ‘do no significant harm’ within the meaning of Article 17 of Regulation (EU) 2020/852. The Commission intends to present in 2021 a proposal for a Council Recommendation on how to address the social aspects of the green transition. _________________ 33 Regulation (EU) 2021/1060 of the European Parliament and of the Council of 24 June 2021 laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, the Just Transition Fund and the European Maritime, Fisheries and Aquaculture Fund and financial rules for those and for the Asylum, Migration and Integration Fund, the Internal Security Fund and the Instrument for Financial Support for Border Management and Visa Policy (OJ L 231, 30.6.2021, p. 159). 34 Regulation (EU) 2020/852 of the European Parliament and of the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 (OJ L 198, 22.6.2020, p. 13).
Amendment 281 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Member States may include the costs of measures providing temporary direct income support to vulnerable households and vulnerable households that are transport users to absorb the increase in road transport and heating fuel prices. Such support shall decrease over time and be limited to the direct impact of the emission trading for buildings and road transport. Eligibility for such direct income support shall cease within the time limits identified under Article 4(1) point (d).
Amendment 285 #
2021/0206(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Women are particularly affected by carbon pricing as they represent 85% of single parent families. Single parent families have a particularly high risk of child poverty. Gender equality and equal opportunities for all, and the mainstreaming of those objectives, as well as questions of accessibility forrights of persons with disabilities should be taken into accountupheld and promoted throughout the preparation and implementation of Plans to ensure no one is left behind.
Amendment 287 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – introductory part
Article 6 – paragraph 2 – introductory part
2. Member States may include the costs of the following measures and investments in the estimated total costs of the Plans, provided they principally benefit vulnerable households, vulnerable micro- enterprises, vulnerable SMEs or vulnerable transport users and intend to:
Amendment 291 #
2021/0206(COD)
(a) support building renovations, prioritising social housing and deprived areas, especially for those occupying worst- performing buildings, including in the form of financial support or fiscal incentives such as deductibility of renovation costs from the rent, independently of the ownership of the buildings concerned;
Amendment 298 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point b
Article 6 – paragraph 2 – point b
(b) contribute to the decarbonisation, including the electrification, of heating and cooling of, and of cooking in, buildings and the integration of energy from renewable sources that contribute to the achievements of energy savings;
Amendment 298 #
2021/0206(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Member States should submit their Plans together with the update of their integrated national energy and climate plans in accordance with Article 14 of Regulation (EU) 2018/1999 of the European Parliament and of the Council35 and the European Code of Conduct on Partnership in the framework of the European Structural and Investment Funds35a. The Plans should include the measures to be financed, their estimated costs and the national contribution. They should also include key milestones and targets to assess the effective implementation of the measures. _________________ 35 Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1). 35a Commission Delegated Regulation (EU) No 240/2014
Amendment 304 #
2021/0206(COD)
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) The Fund should only support such activities that respect applicable collective agreements, social and labour law, regarding inter alia wages, working conditions, health and safety of workers, collective bargaining rights and trade union participation.
Amendment 307 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point c a (new)
Article 6 – paragraph 2 – point c a (new)
(c a) provide targeted information, support, capacity building and training necessary to implement the energy efficiency renovation solutions and grant access to zero- and low-emission mobility and transport services;
Amendment 322 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point f
Article 6 – paragraph 2 – point f
(f) support public and private entities in developing and providing affordable zero- and low-emission mobility and transport services and the uptake of attractive active mobility options for rural, insular, mountainous, remote and less accessible areas or for less developed regions or territories, including less developed peri-urban areas.
Amendment 342 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The financial envelope for the implementation of the Fund for the period 20253-2027 shall be at least EUR 23 700 000 000 in current prices.
Amendment 348 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The financial envelope for the implementation of the Fund for the period 2028-2032 shall be at least EUR 48 500 000 000 in current prices, subject to the availability of the amounts under the annual ceilings of the applicable multiannual financial framework referred to in Article 312 TFEU.
Amendment 365 #
2021/0206(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Member States shall contribute at least to 540 percent of the total estimated costs of their Plans.
Amendment 375 #
2021/0206(COD)
Proposal for a regulation
Recital 29 a (new)
Recital 29 a (new)
Amendment 376 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a – point i
Article 15 – paragraph 2 – point a – point i
(i) whether the Plan represents a response to the social impact on and challenges faced by vulnerable households, vulnerable micro-enterprises, vulnerables SMEs and vulnerable transport users in the Member State concerned from establishing the emission trading system for buildings and road transport established pursuant to Chapter IVa of Directive 2003/87/EC, especially households in energy poverty, duly taking into account the challenges identified in the assessments of the Commission of the update of the concerned Member State’s integrated national energy and climate plan and of its progress pursuant to Article 9(3), and Articles 13 and 29 of Regulation (EU) 2018/1999, as well as in the Commission recommendations to Member States issued pursuant to Article 34 of Regulation (EU) 2018/1999 in view of the long-term objective of climate neutrality in the Union by 2050. This shall take into account the specific challenges and the financial allocation of the Member State concerned;
Amendment 387 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point b – point i
Article 15 – paragraph 2 – point b – point i
(i) whether the Plan is expected to have a lasting impact on the challenges addressed by that Plan and in particular on vulnerable households, vulnerable micro- enterprises, vulnerable SMEs and vulnerable transport users, especially households in energy poverty, in the Member State concerned;
Amendment 391 #
2021/0206(COD)
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
The measures and investments supportenvisaged by the Fund shall support a socially fair transition to climate neutrality, especially benefit households, micro-enterpriseself-employed persons and transport users, which are vulnerable, and particularly affected by the inclusion of greenhouse gas emissions from buildings and road transport into the scope of Directive 2003/87/EC, especially households in energy poverty and citizens without public transport alternative to individual cars (in remote and rural areas)distributional impact of the transition to climate neutrality, including by carbon pricing, especially households in energy poverty and without access to affordable and environmentally sustainable modes of transport.
Amendment 401 #
2021/0206(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. After the Commission has adopted a decision as referred to in Article 16, it shall in due time conclude an agreement with the Member State concerned constituting an individual legal commitment within the meaning of Regulation (EU, Euratom) 2018/1046 covering the period 20253-2027. That agreement may be concluded at the earliest one year before the year of the start of the auctions under Chapter IVa of Directive 2003/87/EC.
Amendment 406 #
2021/0206(COD)
Proposal for a regulation
Article 1 – paragraph 4
Article 1 – paragraph 4
The general objective of the Fund is to contribute to the transition towards climate neutrality by addressing the social impacts of the inclusion of greenhouse gas emissions from buildings and road transport into the scope of Directive 2003/87/EC. The specific objective of the Fund is to support vulnerable households, vulnerable micro-enterprises and vulnerat transition, and to ensure the ability of vulnerable households, self-employed and transport users to participate in and adapt to the transition, to reduce energy poverty and enlarge the access to affordable and sustainable green transport and mobility means. The specific objective of the Fund is to support vulnerable households, vulnerable self- employed and vulnerable transport users, especially those in energy poverty, and/or those in the lowest income deciles, or with low capacity to invest in, or limited access to, alternative and energy efficient heating, cooling and sustainable and affordable transport usersmodes, through temporary direct income support and through measures and investments intended to increase energy efficiency of buildings, decarbonisation of heating and cooling of buildings, including the integration of energy from renewable sources, and granting improved access to zero- and low-emission mobility and transportaffordable and sustainable zero emission mobility and transport, as well as to mitigate the negative impacts of the transition to climate neutrality on vulnerable households and tackle their social exclusion.
Amendment 426 #
2021/0206(COD)
Proposal for a regulation
Article 1 – paragraph 4 a (new)
Article 1 – paragraph 4 a (new)
The measures and investments supported by the Fund shall not provide any support which prolongs the use of fossil fuels.
Amendment 442 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
(2) ‘energy poverty’ means energy poverty as defined in point [(49)] of Article 2 of Directive (EU) [yyyy/nnn] of the of the European Parliament and of the Council50 ; _________________ 50 [Directive (EU) [yyyy/nnn] of the of the European Parliament and of the Council (OJ C […], […], p. […]).] [Proposal for recast of Directive 2012/27/EU on energy efficiency]the in ability of a household to support an adequate level of energy supply so as to guarantee basic levels of comfort and health, due to a combination of low income, high-energy prices and low quality, poor performing housing stock;
Amendment 454 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
(9) ‘micro-enterprise’ means an enterprise that employs fewer than 10 persons and whose annual turnover or annual balance sheet does not exceed EUR 2 million, calculated in accordance with Articles 3 to 6 of Annex I to Commission Regulation (EU) No 651/201453 ; _________________ 53 Commission Regulation (EU) No 651/2014 of 17 June 2014 declself-employed persons’ mean those who work in their own business, professional practice or farm for the purpose of earning certain categories of aid compatible with the internal market in application of Articles 107 and 108 of the Treaty Text with EEA relevance (OJ L 187, 26.6.2014, p. 1).a profit, and who employ no other persons;
Amendment 459 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10
Article 2 – paragraph 1 – point 10
(10) ‘transport users’ means households or micro-enterpriseself-employed persons that use various transport and mobility options;
Amendment 470 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 11
Article 2 – paragraph 1 – point 11
(11) ‘vulnerable households’ means households in energy poverty, or with lack of access to affordable sustainable transport or households, including lower middle- income ones, that are significantly affected by the pricesocial impacts of the inclusion of buildings into the scope of Directive 2003/87/EC and lack the means to renovate the building they occuptransition to climate neutrality;
Amendment 477 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 12
Article 2 – paragraph 1 – point 12
(12) ‘vulnerable micro-enterprises’ means micro-enterpriself-employed persons’ means thoses that are significantly affected by the pricesocial impacts of the inclusion of buildings into the scope of Directive 2003/87/EC and lack the means to renovate the building they occuptransition to climate neutrality;
Amendment 494 #
2021/0206(COD)
(13) ‘vulnerable transport users’ means transport users, including from lower middle-income households, that are significantly affected by the pricesocial impacts of the inclusion of road transport into the scope of Directive 2003/87/ECtransition to climate neutrality and lack the means to purchase zero- and low- emission vehicles or to switch to alternative sustainable modes of transport, including public transport, particularly in rural and remote areas.
Amendment 502 #
2021/0206(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 13 a (new)
Article 2 – paragraph 1 – point 13 a (new)
(13a) ‘most deprived persons’ means natural persons, whether individuals, families, households or groups of persons, including children in vulnerable situations and homeless people, whose need for assistance has been established according to the objective criteria which are set by the national competent authorities in consultation with relevant stakeholders while avoiding conflicts of interest, and which may include elements that allow for the targeting of the most deprived persons in certain geographical areas.
Amendment 509 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Each Member State shall submit to the Commission a Social Climate Plan (‘the Plan’) together with the update to the integrated national energy and climate plan referred to in Article 14(2) of Regulation (EU) 2018/1999 in accordance with the procedure and timeline laid down in that Article and following a meaningful consultation of local and regional level authorities, social partners and relevant civil society organisations. The Plan shall contain a coherent set of measures and investments to address the social impact of carbon pricingthe transition to climate neutrality on vulnerable households, vulnerable micro-enterpriseself- employed persons and vulnerable transport users in order to ensure affordable and energy efficient heating, and cooling and affordable and zero-emission mobility while accompanying and accelerating necessary measures to meet the climate targets of the Union.
Amendment 527 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. The Plan may include national measures providing temporary direct income support to vulnerable households and households that are vulnerable transport users to reduce the impact of the increase in the price of fossil fumeasures taken at Union and national levels, resulting from the inclusion of buildings and road transport into the scope of Directive 2003/87/ECpectively, to enable the collective achievement of the climate-neutrality objective set out in article 1, paragraph 1 of Regulation(EU) 2021/1119 (European Climate Law).
Amendment 551 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point a
Article 3 – paragraph 3 – point a
(a) finance measures and investments to increase energy efficiency of buildings, using a cost-effectiveness approach, such as life-cycle costing, to implement energy efficiency improvement measures, to carry out building renovation, and to decarbonise heating and cooling of buildings, including the integration of energy production from renewable energy sources;
Amendment 563 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point b
Article 3 – paragraph 3 – point b
(b) finance measures and investments to increase the uptake of zero- and low- emission mobility and transport.
Amendment 569 #
2021/0206(COD)
Proposal for a regulation
Article 3 – paragraph 3 – point b a (new)
Article 3 – paragraph 3 – point b a (new)
(ba) finance measures and investments to mitigate the negative impacts of the transition to climate neutrality on vulnerable households and tackle their social exclusion.
Amendment 588 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point b a (new)
Article 4 – paragraph 1 – point b a (new)
(ba) the coherence and mutual reinforcement of the accompanying measures to reduce the effects referred to in point (c)
Amendment 591 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) an estimate of the likely effects of that increase in pricese transition to climate neutrality on households, and in particular on incidence of energy poverty, on micro-enterpriseself-employed persons and on transport users, comprising in particular an estimate and the identification of vulnerable households, vulnerable micro- enterpriseself-employed persons and vulnerable transport users; these impacts are to be analysed with a sufficient level of regional disaggregation, taking into account elements such as access to public transport and basic services and identifying the groups and areas mostly affected, particularly territories which are remote and rural and those where the at risk of poverty rate is above the EU average;
Amendment 619 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point e a (new)
Article 4 – paragraph 1 – point e a (new)
(ea) the sustainability of the measures and investments, and their long-term impact on vulnerable households, vulnerable self-employed persons and vulnerable transport users beyond 2032;
Amendment 620 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point e b (new)
Article 4 – paragraph 1 – point e b (new)
Amendment 622 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point g a (new)
Article 4 – paragraph 1 – point g a (new)
(ga) an explanation of how the Plan contributes to the implementation of the European Pillar of Social Rights principles, in particular principle 20;
Amendment 625 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point g b (new)
Article 4 – paragraph 1 – point g b (new)
(gb) an explanation of how the Plan ensures that social and labour rights are respected and promoted, and relevant social indicators are improved;
Amendment 640 #
2021/0206(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point j
Article 4 – paragraph 1 – point j
(j) for the preparation and, where available, for the implementation, the implementation and the monitoring of the Plan, a summary of the consultation process, conducted in accordance with Article 10 of Regulation (EU) 2018/1999 and with the national legal frameworkEuropean Code of Conduct on Partnership, of local and regional authorities, social partners, civil society organisations, youth organisations and other relevant stakeholders, and how the input of the stakeholders is reflected in the Plan;
Amendment 673 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point e
Article 5 – paragraph 2 – point e
(e) reductions in the number of vulnerable households, especially households in energy poverty, of vulnerable micro-enterpriseself-employed persons and of vulnerable transport users, including in rural and remote areas.
Amendment 679 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point e a (new)
Article 5 – paragraph 2 – point e a (new)
(ea) creation of sustainable quality jobs by public and private entities receiving support as referred to in article 6(2) (c) and (f).
Amendment 684 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 2 – point e b (new)
Article 5 – paragraph 2 – point e b (new)
(eb) reduction of poverty.
Amendment 694 #
2021/0206(COD)
Proposal for a regulation
Article 5 – paragraph 3 a (new)
Article 5 – paragraph 3 a (new)
3a. Any activities financed by the Fund shall respect applicable collective agreements, social and labour law, regarding inter alia wages, working conditions, health and safety of workers, collective bargaining rights and trade union participation.
Amendment 706 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Member States may include the costs of measures providing temporary direct income support to vulnerable households and vulnerable households that are transport users to absorb the increase in road transport and heating fuel prices. Such support shall decrease over time and be limited to the direct impact of the emission trading for buildings and road, affected by the climate neutral transportition. Eligibility for such direct income support shall cease within the time limits identified under Article 4(1) point (d).
Amendment 716 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – introductory part
Article 6 – paragraph 2 – introductory part
2. Member States may include the costs of the following measures and investments in the estimated total costs of the Plans, provided they principally benefit vulnerable households, vulnerable micro- enterpriseself- employed persons or vulnerable transport users and intend to:
Amendment 721 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point -a (new)
Article 6 – paragraph 2 – point -a (new)
(-a) ensure access to affordable energy efficient housing, including by providing sufficient energy efficient housing stock in the social housing sector, building new green social housing and supporting moving into more efficient housing stock;
Amendment 728 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point a
Article 6 – paragraph 2 – point a
(a) support building renovations, especially for those occupying worst- performing buildings and in the social housing sector, including in the form of financial support, without an up-front or minimum contribution requirement, or fiscal incentives such as deductibility of renovation costs from taxation or the rent, independently of the ownership of the buildings concerned;
Amendment 740 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point b
Article 6 – paragraph 2 – point b
(b) contribute to the decarbonisation, including the electrification, of heating and cooling of, and cooking in, buildings, by ensuring access to affordable and energy efficient systems, and the integration of energy from renewable sources that contribute to the achievements of energy savings;
Amendment 760 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point d
Article 6 – paragraph 2 – point d
(d) provide access to zero- and low- emission vehicles and bikes, including financial support or fiscal incentives for their purchase as well as for appropriate public and private infrastructure, including for recharging and refuelling, without an up-front or minimum contribution requirement, or fiscal incentives for their purchase; for support concerning low-emission vehicles, a timetable for gradually reducing the support shall be provided;
Amendment 778 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point f
Article 6 – paragraph 2 – point f
(f) support public and private entities in developing and providing affordable zero- and low-emission mobility and transport services and the uptake of attractive active mobility options for rural, insular, mountainous, remote and less accessible areas or for less developed regions or territories, including less developed peri- urban areas.
Amendment 791 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point f a (new)
Article 6 – paragraph 2 – point f a (new)
(fa) combat discrimination of certain vulnerable groups in accessing measures and support linked to the transition, including through capacity building;
Amendment 794 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point f b (new)
Article 6 – paragraph 2 – point f b (new)
(fb) facilitate access to sustainable consumption and promote cost-saving opportunities linked to the circular economy;
Amendment 796 #
2021/0206(COD)
Proposal for a regulation
Article 6 – paragraph 2 – point f d (new)
Article 6 – paragraph 2 – point f d (new)
(fd) provide targeted and accessible information and awareness on risk reduction and cost-effective measures related to the transition to climate neutrality, as well as on the available support measures financed by the Fund.
Amendment 800 #
2021/0206(COD)
Proposal for a regulation
Article 7
Article 7
Amendment 815 #
2021/0206(COD)
Proposal for a regulation
Article 8 – title
Article 8 – title
Pass-on of benefits to households, micro- enterpriseself- employed persons and transport users
Amendment 818 #
2021/0206(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Member States may include into the estimated total costs financial support provided to public or private entities other than vulnerable households, vulnerable micro-enterpriseself-employed persons and vulnerable transport uses, if those entities carry out measures and investments ultimately benefitting vulnerable households, vulnerable micro- enterpriseself-employed persons and vulnerable transport users.
Amendment 823 #
2021/0206(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
Member States shall provide for the necessary statutory and contractual safeguards to ensure that the entire benefit is passed on to the households, micro- enterpriseself- employed persons and transport users.
Amendment 832 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The financial envelope for the implementation of the Fund for the period 20253-2027 shall be at least EUR 23 700 000 000 in current prices.
Amendment 849 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The financial envelope for the implementation of the Fund for the period 2028-2032 shall be at least EUR 48 500 000 000 in current prices, subject to the availability of the amounts under the annual ceilings of the applicable multiannual financial framework referred to in Article 312 TFEU.
Amendment 852 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 2 a (new)
Article 9 – paragraph 2 a (new)
2a. The Fund shall be endowed by: (a) 25 % from the total revenue from the allowances auctioned in accordance with Directive2003/87/EC [(COD)2021/0211] not allocated to the Modernisation or the Innovation Fund; (b) additional resources allocated in the Union budget, and by other resources in accordance with the applicable basic act.
Amendment 855 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 2 b (new)
Article 9 – paragraph 2 b (new)
2b. In the event that endowments to the Fund referred to in paragraph 2a of this Article are above the target amount of the financial envelope in accordance with paragraphs 1 and 2, the surplus shall remain in the Fund.
Amendment 859 #
2021/0206(COD)
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The amounts referred to in paragraphs 1 and 2 may also cover expenses pertaining to preparatory, monitoring, control, audit and evaluation activities which are required for the management of the Fund and the achievement of its objectives, in particular studies, meetings of experts, consultation of stakeholders, information and communication actions, including inclusive outreach actions, and corporate communication of the political priorities of the Union, insofar as they are related to the objectives of this Regulation, expenses linked to IT networks focusing on information processing and exchange, corporate information technology tools, and all other technical and administrative assistance expenses incurred by the Commission for the management of the Fund. Expenses may also cover the costs of other supporting activities such as quality control and monitoring of projects on the ground and the costs of peer counselling and experts for the assessment and implementation of the eligible actions. These costs shall not exceed 4 % of the financial total allocation for the Plan.
Amendment 906 #
2021/0206(COD)
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. Member States shall contribute at least to 540 percent of the total estimated costs of their Plans.
Amendment 914 #
2021/0206(COD)
Proposal for a regulation
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1a. By way of derogation from the paragraph 1, the contribution of Member States whose gross national income (GNI) per capita is below 90% of the EU average, shall be limited to a maximum of 20% of the total estimated costs of their Plans.
Amendment 917 #
2021/0206(COD)
Proposal for a regulation
Article 14 – paragraph 1 b (new)
Article 14 – paragraph 1 b (new)
1b. By way of derogation from paragraph 1, Member States shall contribute to 10% of the total estimated costs of the measures contributing to the eradication of energy poverty of and to ensuring access to sustainable transport for the most deprived persons.
Amendment 921 #
2021/0206(COD)
Proposal for a regulation
Article 14 – paragraph 2
Article 14 – paragraph 2
2. Member States shall inter alia use revenues from the auctioning of their allowances in accordance with Chapter IVa of Directive 2003/87/EC for their national contribution to the total estimated costs of their Plans.
Amendment 926 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a – point i
Article 15 – paragraph 2 – point a – point i
(i) whether the Plan represents a response to the social impact on and challenges faced by vulnerable households, vulnerable micro-enterpriseself-employed persons and vulnerable transport users in the Member State concerned from establishing the emission trading system for buildings and road transport established pursuant to Chapter IVa of Directive 2003/87/ECthe transition to climate neutrality, especially households in energy poverty, duly taking into account the challenges identified in the assessments of the Commission of the update of the concerned Member State’s integrated national energy and climate plan and of its progress pursuant to Article 9(3), and Articles 13 and 29 of Regulation (EU) 2018/1999, as well as in the Commission recommendations to Member States issued pursuant to Article 34 of Regulation (EU) 2018/1999 in view of the long-term objective of climate neutrality in the Union by 2050. This shall take into account the specific challenges and the financial allocation of the Member State concerned;
Amendment 938 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point a – point ii
Article 15 – paragraph 2 – point a – point ii
(ii) whether the Plan is expected to ensure that no measure ors and investments included in the Plan do not causes significant harm to environmental objectives within the meaning of Article 17 of Regulation (EU) 2020/852, respect applicable social and labour law, and contribute to the implementation of the European Pillar of Social Rights;
Amendment 955 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point b – point i
Article 15 – paragraph 2 – point b – point i
(i) whether the Plan is expected to have a lasting impact on the challenges addressed by that Plan and in particular on vulnerable households, vulnerable micro- enterpriseself- employed persons and vulnerable transport users, especially households in energy poverty, in the Member State concerned;
Amendment 956 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point b – point i a (new)
Article 15 – paragraph 2 – point b – point i a (new)
(ia) whether a meaningful involvement of local and regional authorities, social partners and relevant civil society organisations has been ensured during preparation, and whether such involvement is foreseen during the implementation and monitoring;
Amendment 963 #
2021/0206(COD)
Proposal for a regulation
Article 15 – paragraph 2 – point b – point iii a (new)
Article 15 – paragraph 2 – point b – point iii a (new)
(iiia) whether the Plan contributes to the creation of sustainable quality jobs.
Amendment 985 #
2021/0206(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. Where a Social Climate Plan, including relevant milestones and targets, is no longer achievable, either in whole or in part, by the Member State concerned because of objective circumstances, in particular because of the actual direct effects of the emission trading system for buildings and road transport established pursuant to Chapter IVa of Directive 2003/87/EC, the Member State concerned maythe Member State concerned may, following a meaningful consultation with regional and local authorities, social partners and relevant civil society organisations, submit to the Commission an amendment of its Plan to include the necessary and duly justified changes. Member States may request technical support for the preparation of such request.
Amendment 998 #
2021/0206(COD)
Proposal for a regulation
Article 17 – paragraph 5
Article 17 – paragraph 5
5. By 15 March 2027 each Member State concerned shall assess the appropriateness of its Plans in view of the actual direct effects of the emission trading system for buildings and road transport established pursuant to Chapter IVa of Directive 2003/087/ECtransition to climate neutrality. Those assessments shall be submitted to the Commission as part of the biennial progress reporting pursuant to Article 17 of Regulation (EU) 2018/1999.
Amendment 1002 #
2021/0206(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. After the Commission has adopted a decision as referred to in Article 16, it shall in due time conclude an agreement with the Member State concerned constituting an individual legal commitment within the meaning of Regulation (EU, Euratom) 2018/1046 covering the period 20253-2027. That agreement may be concluded at the earliest one year before the year of the start of the auctions under Chapter IVa of Directive 2003/87/EC.
Amendment 1025 #
2021/0206(COD)
Proposal for a regulation
Article 19 – paragraph 7 a (new)
Article 19 – paragraph 7 a (new)
7a. Where it is established that breaches of the principles of the rule of law in a Member State affect or seriously risk affecting the sound financial management of the Fund or the protection of the financial interests of the Union, the Commission shall take the appropriate measures in accordance with Regulation (EU, Euratom) 2020/2092 of the European Parliament and of the Council which may include, among others, a suspension of payments to the affected national authorities. In such cases, the Commission shall take all necessary steps to ensure that the intended final beneficiaries of the Fund continue to have access to EU assistance, with the Commission ensuring disbursement via regional and local authorities, non-governmental organisations, or other entities with a proven capacity to ensure the sound financial management of the Fund.
Amendment 1041 #
2021/0206(COD)
Proposal for a regulation
Article 21 – paragraph 1 – point a
Article 21 – paragraph 1 – point a
(a) ensure complementarity, synergy, coherence and consistency among different instruments at Union, national and, where appropriate, regional and local levels, both in the planning phase and during implementation;
Amendment 1045 #
2021/0206(COD)
Proposal for a regulation
Article 21 – paragraph 1 – point c
Article 21 – paragraph 1 – point c
(c) ensure close cooperation between those responsible for implementation and control at Union, national and, where appropriate, regional and local levels to achieve the objectives of the Fund.
Amendment 1055 #
2021/0206(COD)
Proposal for a regulation
Article 23 – paragraph 1 – introductory part
Article 23 – paragraph 1 – introductory part
1. Each Member State concerned shall, on a biennial basis and following a meaningful consultation with regional and local authorities, social partners and relevant civil society organisations, report to the Commission on the implementation of its Plan as part of its integrated national energy and climate progress report pursuant to Article 17 of Regulation (EU) 2018/1999 and in accordance with Article 28 thereof. The Member States concerned shall include in their progress report:
Amendment 1061 #
2021/0206(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point b
Article 23 – paragraph 1 – point b
(b) when applicable, detailed information on progress towards the national indicative objective to reduce the number of households in energy poverty, the access to affordable and zero- emission transport and mobility means, on progress regarding other relevant social indicators, and, where applicable, on the number of sustainable quality jobs created;
Amendment 1067 #
2021/0206(COD)
(f) in 2027, an assessment of the Plan referred to in Article 17(5) in view of the actual direct effects of the emission trading system for buildings and road transport established pursuant to Chapter IVa of Directive 2003/087/ECtransition to climate neutrality;
Amendment 1078 #
2021/0206(COD)
Proposal for a regulation
Article 23 – paragraph 4
Article 23 – paragraph 4
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 25 to supplement this Regulation in order to set out the common indicators to be used for reporting on the progress and for the purpose of monitoring and evaluation of the Fund towards the achievement of the objectives set out in Article 1 are stated in Annex XX of this Regulation.
Amendment 1082 #
2021/0206(COD)
Proposal for a regulation
Article 23 b (new)
Article 23 b (new)
Article 23 b Social Climate Dialogue 1. In order to enhance the dialogue between the Union institutions, in particular the European Parliament, the Council and the Commission, and to ensure greater transparency and accountability, the competent committee of the European Parliament may invite the Commission twice a year to discuss the following matters: (a) the plans of the Member States; (b) the assessment of the plans of the Member States; (c) the status of fulfilment of the milestones and targets of the plans of the Member States; (d) payment, suspension and termination procedures, including any observation presented and remedial measures taken by the Member States to ensure a satisfactory fulfilment of the milestones and targets; (e) any other relevant information and documentation provided by the Commission to the competent committee of the European Parliament in relation to the implementation of the SCF. 2. The European Parliament may express its views in resolutions as regards the matters referred to in paragraph 1. 3. The Commission shall take into account any elements arising from the views expressed through the social climate dialogue, including the resolutions from the European Parliament if provided.
Amendment 1085 #
2021/0206(COD)
1. By 1 July 2028No later than two years after the entry into force of the present regulation, the Commission shall provide the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions with an evaluation report on the implementation and functioning of the Fund.
Amendment 1100 #
2021/0206(COD)
Proposal for a regulation
Article 25
Article 25
Amendment 1105 #
2021/0206(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
Amendment 1109 #
Amendment 115 #
2021/0203(COD)
Proposal for a directive
Recital 7
Recital 7
(7) To achieve the increased climate ambition, the impact assessment accompanying the Climate Target Plan has shown that energy efficiency improvementsIncreased ambitions for energy efficiency are based on the compounding of crisis of climate emergency, a need for recovery process from the COVID-19 pandemic, a surge in fossil energy prices and a significant change in geopolitical reality. To achieve the increased climate ambition, the impact assessment accompanying the Climate Target Plan has shown, together with the acute geopolitical need to significantly reduce Union energy dependence, that energy efficiency improvements and speed of the clean energy transition will need to be significantly raiincreased from the current level of ambition of 32,5%. to 43% energy efficiency for final energy consumption and 45,5% for primary consumption in order to achieve a green and just transition for a sustainable wellbeing for all. According to the International Energy Agency more than 40% of the necessary GHG emission reductions will need to be delivered through energy efficiency measures. Investments in energy efficiency benefits the economy and for every EUR 1 million invested in buildings renovation, 18 jobs are created on average in the Union. Building renovation measures in line with the renovation wave objectives could cut energy bills of gas- heated households by over EUR 400 per year by 20301a. A crucial part of maximising the energy efficiency potential will be the deep renovation of the Union building stock. _________________ 1a https://www.camecon.com/what/our- work/the-renovation-wave-can-cut-eu- gas-imports-and-reduce-consumer-bills/#
Amendment 124 #
2021/0203(COD)
Proposal for a directive
Recital 10
Recital 10
(10) The higher level of ambition requires a stronger promotion of cost- effective energy efficiency measures in all areas of the energy system and in all relevant sectors where activity affects energy demand, such as the transport, water and agriculture sectors. Improving energy efficiency throughout the full energy chain, including energy generation, transmission, distribution and end-use, will benefit the environment, improve air quality and public health, reduce GHG emissions, including methane emissions and improve energy security, cut energy costs for households and companies, help alleviate energy poverty, and lead to increased competitiveness, more jobs and increased economic activity throughout the economy, thus improving citizens' quality of life. That complies with the Union commitments made in the framework of the Energy Union and global climate agenda established by the 2015 Paris Agreement.
Amendment 131 #
2021/0203(COD)
Proposal for a directive
Recital 11
Recital 11
(11) This Directive takes a step forward towards climate neutrality by 2050 , under which energy efficiency is to be treated as an energy source in its own right. The energy efficiency first principle is an overarching principle that should be taken into account across all sectors, going beyond the energy system, at all levels, including in the financial sector. Energy efficiency solutions should be considered as the first option in policy, planning and investment decisions, when setting new rules for the supply side and other policy areas. While the energy efficiency first principle should be applied without prejudice to other legal obligations, objectives and principles, they should also not hamper its application or exempt from applying the principle. The energy efficiency first principle should be applied at all decision-making levels: Union, national, regional and local. The Commission should ensure that energy efficiency and demand-side response can compete on equal terms with generation capacity. Energy efficiency improvements need to be made whenever they are more cost- effective than equivalent supply-side solutions. That should help exploit the multiple benefits of energy efficiency for the Union, in particular for citizens and businesses. Implementing energy efficiency improvement measures should also be a priority in alleviating energy poverty.
Amendment 136 #
2021/0203(COD)
(12) Energy efficiency should be recognised as a crucial element in decarbonising the Union's building stock, to reach climate neutrality by 2050 at the latest and the 2030 targets enshrined by Regulation (EU) 2021/1119 of the European Parliament and of the Council and a priority consideration in future investment decisions on the Union's energy infrastructure. The energy efficiency first principle should be applied taking primarily the system efficiency approach and societal perspective into consideration. Consequently, it should help increase the efficiency of individual end-use sectors and of the whole energy system. Application of the principle should also support investments in energy-efficient solutions contributing to environmental objectives listed in Regulation (EU) 2020/852 of the European Parliament and of the Council50 . _________________ 50 OJ L 198, 22.6.2020, p. 13–43. The IPCC outlines on “Energy System Transition” in its report of 28 February 2022 on “Climate change 2022: Impacts, Adaptation and Vulnerability” with high confidence that “energy generation diversification, including with renewable energy resources (e.g. wind, solar, small scale hydroelectric) and demand side management (e.g. storage, and energy efficiency improvements) can reduce vulnerabilities to climate change, especially in rural populations.
Amendment 142 #
2021/0203(COD)
Proposal for a directive
Recital 13
Recital 13
(13) The energy efficiency first principle was defined in the Regulation (EU) 2018/1999 of the European Parliament and of the Council51 and is at the core of the Energy System Integration Strategy52 and the Renovation Wave Strategy. While the principle is based on cost- effectiveness, its application has wider implications, which can vary depending on the circumstances. The Commission prepared dedicated guidelines for the operation and application of the principle, by proposing specific tools and examples of application in various sectors. The Commission has also issued a recommendation to Member States that builds on the requirements of this Directive and calls for specific actions in relation to the application of the principle. _________________ 51 Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council, PE/55/2018/REV/1, OJ L 328, 21.12.2018, p. 1–77. 52 An EU Strategy for Energy System Integration COM(2020) 299 final.
Amendment 169 #
2021/0203(COD)
Proposal for a directive
Recital 22
Recital 22
(22) The Union’s energy efficiency target was initially set and calculated using the 2007 Reference Scenario projections for 2030 as a baseline. The change in the Eurostat energy balance calculation methodology and improvements in subsequent modelling projections call for a change of the baseline. Thus, using the same approach to define the target, that is to say comparing it to the future baseline projections, the ambition of the Union’s 2030 energy efficiency target is set compared to the 2020 Reference Scenario projections for 2030 reflecting national contributions from the NECPs. With that updated baseline, the Union will need to further increase its energy efficiency ambition by at least 945.5% in 2030 compared to the level of efforts under the 2020 R2007 reference Sscenario. The new way of expressing the level of ambition for the Union’s targets does not affect the actual level of efforts needed and corresponds to a reduction of 36% for final and 39% for primary energy consumption respectively when compared to the 2007 Reference Scenario projectin order to reach climate neutrality by 2050 at the latest, the 2030 climate targets set in Regulation (EU) 2021/1119 and to reduce significantly the Union’s for 2030energy dependence.
Amendment 172 #
2021/0203(COD)
Proposal for a directive
Recital 24
Recital 24
(24) The need for the Union to improve its energy efficiency should be expressed in primary and final energy consumption, to be achieved in 2030, indicating additional level of efforts required when compared to the measures in place or planned measures in the national energy and climate plans. The 2020 Reference Scenario projects 864 Mtoe of final energy consumption and 1124 Mtoe of primary energy consumption to be reached in 2030 (excluding ambient heat and including international aviation). An additional reduction of 19% results in 78700 Mtoe and 1023911 Mtoe in 2030 respectively. Compared to 2005 levels, it means that final energy consumption in the Union should be reduced by some 23% and primary energy consumption should be reduced by some 32%. There are no binding targets at Member State level in the 2020 and 2030 perspective,This corresponds to a reduction of 43% for final and 45.5% for primary energy consumption respectively when compared to the 2007 Reference Scenario projections for 2030. There are no binding targets at Member State level in the 2020. For the 2030 target, national contributions should become binding and Member States should establish their contributions to the achievement of the Union’s energy efficiency target taking into account the formula provided in this Directive. Member States should be free to set their national objectives based either on primary or final energy consumption or primary or final energy savings, or on energy intensity. This Directive amends the way how Member States should express their binding national contributions to the Union´s binding target. Member States’ binding contributions to the Union’s target should be expressed in final and primary energy consumption to ensure consistency and monitoring of progress. A regular evaluation of progress towards the achievement of the Union's 2030 targets is necessary and is provided for in Regulation (EU) 2018/1999.
Amendment 179 #
2021/0203(COD)
Proposal for a directive
Recital 27
Recital 27
(27) To lead by example, the public sector should set its own decarbonisation and energy efficiency goals. Energy efficiency improvements in the public sector should reflect the efforts required at Union level. To comply with the final energy consumption target, the Union should decrease its final energy consumption by 19% by 2030 as compared to the average energy consumption in years 2017, 2018 and 2019. An obligation to achieve an annual reduction of the energy consumption in the public sector by at least 1,72% should ensure that the public sector fulfils its exemplary role. Member States retain full flexibility regarding the choice of energy efficiency improvement measures to achieve a reduction of the final energy consumption. Requiring an annual reduction of final energy consumption has a lower administrative burden than establishing measurement methods for energy savings.
Amendment 202 #
2021/0203(COD)
Proposal for a directive
Recital 32
Recital 32
(32) Buildings and transport, alongside industry, are the main energy users and main source of emissions.61 Buildings are responsible for about 40% of the Union’s total energy consumption and for 36% of its GHG from energy.62 The Commission Communication entitled Renovation Wave63 addresses the twin challenge of energy and resource efficiency and affordability in the building sector and aims at doubling the renovation rate. It focusses on the worst performing buildings, energy poverty and on public buildings. Moreover, buildings are crucial to achieving the Union objective of reaching climate neutrality by 2050. Buildings owned by public bodies account for a considerable share of the building stock and have high visibility in public life. It is therefore appropriate to set an annual rate of deep renovation of buildings owned by public bodies on the territory of a Member State to upgrade their energy performance. Member States are invited to set a higher renovation rate, where that is cost-effective in the framework of the renovation of their buildings stock in conformity with their Long Term Renovation Strategies or national renovation programmes. That renovation rate should be without prejudice to the obligations with regard to nearly- zero energy buildings (NZEBs) set in Directive 2010/31/EU of the European Parliament and of the Council.64 During the next review of Directive 2010/31/EU, the Commission should assess the progress Member States achieved regarding the renovation of public bodies’ buildings. The Commission should consider submitting a legislative proposal to revise the renovation rate, while taking into account the progress achieved by the Member States, substantial economic or technical developments, or where needed, the Union´s commitments for decarbonisation and zero pollution. The obligation to deeply renovate public bodies’ buildings in this Directive complements that Directive, which requires Member States to ensure that when existing buildings undergo majorsignificant renovation their energy performance is upgraded so that they meet the requirements on NZEBs. _________________ 61 COM/2020/562 final. 62 See IRP, Resource Efficiency and Climate Change, 2020, and UN Environment Emissions Gap Report, 2019. These figures refer to the use and operation of buildings, including indirect emissions in the power and heat sector, not their full life cycle. The embodied carbon in construction is estimated to account for about 10% of total yearly greenhouse gas emissions worldwide. 63 COM/2020/662 final. 64 Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings (OJ L 153, 18.6.2010, p. 13).
Amendment 206 #
2021/0203(COD)
Proposal for a directive
Recital 34
Recital 34
(34) In 2020, more than half of the world’s population lives in urban areas. That figure is expected to reach 68% by 205065 . In addition, half of the urban infrastructures by 2050 are still to be built66 . Green and blue infrastructure can contribute to the achievement of energy efficient targets and to more energy efficient performance of buildings. Green roofs can reduce the energy required for heating and cooling and contribute to biodiversity in urban areas creating important synergies and providing broad array of social services.1a Cities and metropolitan areas are centres of economic activity, knowledge generation, innovation and new technologies. Cities influence the quality of life of the citizens who live or work in them. Member States should support municipalities technically and financially. A number of municipalities and other public bodies in the Member States have already put into place integrated approaches to energy saving and energy supply, for example via sustainable energy action plans, such as those developed under the Covenant of Mayors initiative, and integrated urban approaches which go beyond individual interventions in buildings or transport modes. _________________ 1a https://ec.europa.eu/environment/nature/e cosystems/pdf/SWD_2019_193_F1_STAF F_WORKING_PAPER_EN_V4_P1_1024 680.PDF Cities 65 https://www.unfpa.org/world- population-trends 66 https://www.un.org/en/ecosoc/integration/p df/fact_sheet.pdf
Amendment 214 #
2021/0203(COD)
Proposal for a directive
Recital 45
Recital 45
(45) The energy savings obligation established by this Directive should be increased and should also apply after 2030 . That ensures stability for investors and thus encourage long-term investments and long-term energy efficiency measures, such as the deep renovation of buildings with the long-term objective of facilitating the cost effective transformation of existing buildings into NZEBs. Deep renovations that improve the energy performance of a building by at least 60% are currently annually carried out only in 0.2% of the building stock, and in only a fifth of the cases, energy efficiency is significantly improved. The energy savings obligation has an important role in the creation of local growth, jobs, competitiveness and alleviating energy poverty. It should ensure that the Union can achieve its energy and climate objectives by creating further opportunities and to break the link between energy consumption and growth. Cooperation with the private sector is important to assess the conditions on which private investment for energy efficiency projects can be unlocked and to develop new revenue models for innovation in the field of energy efficiency.
Amendment 217 #
2021/0203(COD)
Proposal for a directive
Recital 46
Recital 46
(46) Energy efficiency improvement measures also have a positive impact on air quality, as more energy efficient buildings contribute to reducing the demand for heating fuels, including solid heating fuels. Energy efficiency measures therefore contribute to improving indoor and outdoor air quality and help achieve, in a cost effective manner, the objectives of the Union's air quality policy, as established in particular by Directive (EU) 2016/2284 of the European Parliament and of the Council70 . Energy efficiency improvement measures pursuant to this Directive should also include a strategy to reduce the use of solid fuels and reduce indoor and outdoor pollution. Exposure reduction targets should be implemented at local and regional level where the use of solid heating fuels is part of the local or regional energy mix. Air pollution reduction measures pursuant to Article 23 should be implemented based on the assessment of real indoor and outdoor air quality measurements. _________________ 70 Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1).
Amendment 219 #
2021/0203(COD)
Proposal for a directive
Recital 47
Recital 47
(47) Member States are required to achieve cumulative end-use energy savings for the entire obligation period up to 2030, equivalent to new annual savings of at least 0,8% of final energy consumption up to 31 December 2023 and of at least 1,52% as of 1 January 2024 . That requirement could be met by new policy measures that are adopted during the obligation period from 1 January 2021 to 31 December 2030 or by new individual actions as a result of policy measures adopted during or before the previous period, provided that the individual actions that trigger energy savings are introduced during the following period. To that end, Member States should be able to make use of an energy efficiency obligation scheme, alternative policy measures, or both.
Amendment 220 #
2021/0203(COD)
(49) Where using an obligation scheme, Member States should designate obligated parties among transmission system operators, energy distributors, retail energy sales companies and transport fuel distributors or retailers on the basis of objective and non-discriminatory criteria. The designation or exemption from designation of certain categories of such distributors or retailers should not be understood to be incompatible with the principle of non-discrimination. Member States are therefore able to choose whether such transmission system operators, distributors or retailers or only certain categories thereof are designated as obligated parties. To empower and protect vulnerable customers, low-income households, people affected by energy poverty and people living in social housing, and to implement policy measures as a priority among those people, Member States can require obligated parties to achieve energy savings among vulnerable customers, low-income households, people affected by energy poverty and people living in social housing. For that purpose, Member States can also establish energy cost reduction targets. Obligated parties could achieve these targets by promoting the installation of measures that lead to energy savings and financial savings on energy bills, such as the installation of insulation and heating measures. Obligated parties should play an active role in the implementation of energy efficiency improvement measures as they have valuable knowledge and know how necessary for the cost-effective realisation of the energy savings targets.
Amendment 231 #
2021/0203(COD)
Proposal for a directive
Recital 50 a (new)
Recital 50 a (new)
(50a) Indoor Environmental Quality (IEQ) should be taken into account including Indoor Air Quality (IAQ) to positively affect the health, comfort, and well-being of building occupants in all forms of renovations and in particular with deep renovations.
Amendment 236 #
2021/0203(COD)
Proposal for a directive
Recital 53
Recital 53
(53) As an alternative to requiring obligated parties to achieve the amount of cumulative end-use energy savings required under Article 8(1) of this Directive, it should be possible for Member States, in their obligation schemes, to permit or require obligated parties to contribute to an Energy Efficiency National Fund , which could be used to implement policy measures as a priority among vulnerable customers, people affected by energy poverty and people living in social housing . Member state should commit to a target for the volume of Energy Efficiency National fund that corresponds to at least 50% of the value needed to realise the planned energy efficiency improvement measures for alleviation of energy poverty in line with the estimated national annual ring fencing targets pursuant to Article 8 of this Directive. Member States should quantify in their National Energy and Climate plans in line with Article 9 of Regulation (EU)2018/1999, cost estimates needed to realise the annual energy efficiency improvement measures with regards to the energy poverty alleviation targets. The Commission should give a recommendation on the adequacy of the cost estimates introduced by the Member States in meeting the annual ring fencing target for the alleviation of poverty.
Amendment 247 #
2021/0203(COD)
(60) In accordance with Article 9 of the Treaty , the Union's energy efficiency policies should be inclusive and should therefore ensure equal access to energy efficiency measures for all consumers affected by energy poverty. Improvements in energy efficiency should, be implemented as a priority among vulnerable customers and final users , people affected by energy poverty, and, where appropriate, among medium-income and low-income households and people living in social housing , elderly people and those living in rural and remote areas . In this context, specific attention should be paid to particular groups which are more at risk of being affected by energy poverty or more susceptible to the adverse impacts of energy poverty, such as women, persons with disabilities, elderly people, children, and persons with a minority racial or ethnic background. Member States can require obligated parties to include social aims in energy-saving measures in relation to energy poverty and this possibility had already been extended to alternative policy measures and Energy Efficiency National Funds. That should be transformed into an obligation to protect and empower vulnerable customers and final users and to alleviate energy poverty , while allowing Member States to retain full flexibility with regard to the type of policy measure, their size, scope and content. If an energy efficiency obligation scheme does not permit measures relating to individual energy consumers, the Member State may take measures to alleviate energy poverty by means of alternative policy measures alone. Within its policy mix, Member States should ensure that other policy measures do not have an adverse effect on vulnerable customers, final users, people affected by energy poverty and, where applicable, people living in social housing. Member States should make best possible use of public funding investments into energy efficiency improvement measures, including funding and financial facilities established at Union level.
Amendment 249 #
2021/0203(COD)
Proposal for a directive
Recital 62
Recital 62
(62) Around 34 million households in the Union were unable to keep their home adequately warm in 201974 . The European Green Deal prioritises the social dimension of the transition by committing to the principle that `no one is left behind´. The green and just transition, including the clean transition, affects women and men differently and may have a particular impact on some disadvantaged groups including people with disabilities. Energy efficiency measures must therefore be central to any cost-effective strategy to address energy poverty and consumer vulnerability and are complementary to social security policies at Member State level. To ensure that energy efficiency measures reduce energy poverty for tenants sustainably, the cost-effectiveness of such measures, as well as their affordability to property owners and tenants, should be taken into account, and adequate financial and technical support for such measures should be guaranteed at Member State level. Member States should support the local and regional level in identifying and alleviating energy poverty. The Union's building stock needs, in the long term, to be converted to NZEBs in accordance with the objectives of the Paris Agreement. Current building renovation rates are insufficient and buildings occupied by citizens on low incomes who are affected by energy poverty are the hardest to reach. The measures laid down in this Directive with regard to energy savings obligations, energy efficiency obligation schemes and alternative policy measures are therefore of particular importance. _________________ 74 COMMISSION RECOMMENDATION of 14.10.2020 on energy poverty, C(2020) 9600 final.
Amendment 257 #
2021/0203(COD)
Proposal for a directive
Recital 66
Recital 66
(66) The information and communications technology (ICT) sector another important sector which receives increasing attention. In 2018 the energy consumption of data centres in the EU was 76,8 TWh. This is expected to rise to 98.5 TWh by 2030, a 28% increase. This increase in absolute terms can as well be seen in relative terms: within the EU, data centres accounted for 2,7% of electricity demand in 2018 and will reach 3,21% by 2030 if development continues on the current trajectory75 . Europe’s Digital Strategy already highlighted the need for highly energy-efficient and sustainable data centres and calls for transparency measures for telecommunication operators on their environmental footprint. To promote sustainable development in the ICT sector, particularly of data centres, Member States should collect and publish data, based on common European standardised framework which is relevant for the energy performance and water footprint of data centres. Member States should collect and publish data only about data centres with a significant footprintn installed IT power demand equal to or greater than 100 kW, for which appropriate design or efficiency interventions, for new or existing installations respectively, can result in a considerable reduction of the energy and water consumption or in the reuse of waste heat in nearby facilities and heat networks. A data centre sustainability indicator can be established on the basis of that data collected _________________ 75 https://digital- strategy.ec.europa.eu/en/library/energy- efficient-cloud-computing-technologies- and-policies-eco-friendly-cloud-market
Amendment 261 #
2021/0203(COD)
Proposal for a directive
Recital 67
Recital 67
(67) The data centre sustainability indicators can be used to measure four basic dimensions of a sustainable data centre, namely how efficiently it uses energy, how much of that energy comes from renewable energy sources, the reuse of any waste heat that it produces and the usage of freshwater. The data centre sustainability indicators should raise awareness amongst data centre owners and operators, manufactures of equipment, developers of software and services, users of data centre services at all levels as well as entities and organisations that deploy, use or procure cloud and data centre services. It should also give confidence about the actual improvements following efforts and measures to increase the sustainability in new or existing data centres. Finally, it should be used as a basis for transparent and evidence-based planning and decision-making. Use of the data centre sustainability indicators should be optional for Member States. Use of the data centre sustainability indicator should be optionalmandatory for Member States.
Amendment 269 #
2021/0203(COD)
Proposal for a directive
Recital 72
Recital 72
(72) Taking advantage of new business models and technologies, Member States should endeavour to promote and facilitate the uptake of energy efficiency measures, including through innovative energy services for large and small customers. The capacity to innovate and evolve as a “first mover”, especially in the area of energy efficiency and climate change, provides the European industry and society with an important competitive advantage.
Amendment 274 #
2021/0203(COD)
Proposal for a directive
Recital 91
Recital 91
(91) Greater consumer protection should be guaranteed by the availability of effective, independent out-of-court dispute settlement mechanisms for all consumers, such as an energy ombudsperson including for vulnerable customers, a consumer body or a regulatory authority. Member States should, therefore, introduce speedy and effective complaint-handling procedures.
Amendment 277 #
2021/0203(COD)
Proposal for a directive
Recital 92
Recital 92
(92) The contribution of renewable energy communities, pursuant to Directive (EU) 2018/2001 of the European Parliament and of the Council80 , and citizen energy communities, according to Directive (EU) 2019/944 towards the objectives of the European Green Deal and the 2030 Climate Target Plan, should be recognised. Member States should, therefore, consider and promote the role of renewable energy communities and citizen energy communities. Those communities can help Member States to achieve the objectives of this Directive by advancing energy efficiency at local or household level. They can empower and engage consumers and enable certain groups of household customers, including in rural and remote areas to participate in energy efficiency projects and interventions. Energy communities can help fighting energy poverty through facilitation of energy efficiency projects, reduced energy consumption and lower supply tariffs by strengthening the spirit of solidarity. _________________ 80 Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82).
Amendment 278 #
2021/0203(COD)
Proposal for a directive
Recital 93
Recital 93
(93) The contribution of one-stop shops or similar structures as mechanisms that can enable multiple target groups, including citizens, SMEs and public authorities, to design and implement projects and measures related to the clean energy transition, should be recognised. That contribution can include the provision of technical, administrative and financial advice and assistance, facilitation of the necessary administrative procedures or of access to financial markets, or guidance with the national and European legal framework, including public procurement rules and criteria, and the EU Taxonomy on environmental and social minimum standards.
Amendment 279 #
2021/0203(COD)
Proposal for a directive
Recital 95
Recital 95
(95) A fair transition towards a climate- neutral Union by 2050 is central to the European Green Deal. The European Pillar of Social Rights, jointly proclaimed by the European Parliament, the Council and the Commission on 17 November 2017, includes energy among the essential services which everyone is entitled to access. Support for access to such services must be available for those in need81 . The realisation of principles of just transition depend also on the actions re-affirmed during the Porto summit. 81a _________________ 81 EPSR, Principle 20 “Access to essential services”: https://ec.europa.eu/commission/priorities/ deeper-and-fairer-economic-and-monetary- union/european-pillar-social- rights/european-pillar-social-rights-20- principles_en 81a https://www.consilium.europa.eu/en/press /press-releases/2021/05/08/the-porto- declaration/
Amendment 303 #
2021/0203(COD)
Proposal for a directive
Article 1 – paragraph 1 – subparagraph 1
Article 1 – paragraph 1 – subparagraph 1
This Directive lays down rules designed to implement energy efficiency as a priority across all sectors, remove barriers in the energy market and overcome market failures that impede efficiency in the supply and use of energy. It also provides for the establishment of indicative national energy efficiency contributions for 2030 in order to reduce energy dependence and to reach climate neutrality by 2050 at the latest and the 2030 climate targets as set in the Regulation (EU) 2021/1119.
Amendment 317 #
2021/0203(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 8 a (new)
Article 2 – paragraph 1 – point 8 a (new)
(8a) ‘deep renovation’ means deep renovation as defined in Article 2, point (19) of Directive (EU) .../...of the European Parliament and of the Council on the energy performance of buildings aiming for reaching the full potential of a building by reducing its energy demand, based on its typology and climatic zone, to a zero-emission building (ZEB) or a nearly zero-energy building (NZEB). It leads to a very high energy performance with the aim that the remaining minimal energy requirement can be covered by renewable energy. Deep renovation also delivers an optimal level of Indoor Environmental Quality (IEQ) to the Building occupants.
Amendment 319 #
2021/0203(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 8 b (new)
Article 2 – paragraph 1 – point 8 b (new)
(8b) ‘zero-emission building’ (ZEB) means a building with a very high energy performance as defined in Article 2, point (2) of Directive (EU) .../...of the European Parliament and of the Council on the energy performance of buildings;
Amendment 320 #
2021/0203(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 8 c (new)
Article 2 – paragraph 1 – point 8 c (new)
(8c) ‘nearly zero-energy building’ (NZEB) means a building with a very high energy performance as defined in Article 2, point (3) of Directive (EU) .../...of the European Parliament and of the Council on the energy performance of buildings;
Amendment 321 #
2021/0203(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 8 d (new)
Article 2 – paragraph 1 – point 8 d (new)
(8d) ‘indoor environmental quality’ (IEQ) means the Quality of a building’s environment in relation to the health and well being of those who occupy space within it. IEQ is determined by many factors, including lighting, indoor air quality in the meaning of Article 11(3) of Directive (EU) .../...of the European Parliament and of the Council on the energy performance of buildings, and damp conditions. IEQ refers to what we breathe, see, hear and feel inside a building.
Amendment 331 #
2021/0203(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 45
Article 2 – paragraph 1 – point 45
(45) ‘data centre’ means a structure, or group of structures, with the purpose of centralized accommodation, interconnection and transparent operation of information technology and network telecommunications equipment providing data storage, processing and transport services together with all the facilities and infrastructures for power distribution and environmental control and the necessary levels of resilience and security required to provide the desired service availability;
Amendment 332 #
2021/0203(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 48
Article 2 – paragraph 1 – point 48
(48) ‘'energy poverty’ means a household’s lack of access to essential energy services that underpininability due to non- affordability, to meet its basic energy supply needs and lack of access to essential energy services needed to guarantee basic levels of comfort and health, a decent standard of living and health, including adequate warmth,heating and cooling, lighting, and energy to power appliances, in the relevant national context, existing social policy and other relevant policies;, as a result of insufficient disposable income.
Amendment 335 #
2021/0203(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 50 a (new)
Article 2 – paragraph 1 – point 50 a (new)
(50a) 'best available techniques' (BAT) means the available techniques which are the best for preventing or minimising emissions and impacts on the environment.
Amendment 345 #
2021/0203(COD)
Proposal for a directive
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) energy systems, water sector, industry, buildings and
Amendment 350 #
2021/0203(COD)
Proposal for a directive
Article 3 – paragraph 1 – point b a (new)
Article 3 – paragraph 1 – point b a (new)
(ba) in the public and private financial sector, where financial services and instruments can contribute to support energy efficiency measures;
Amendment 361 #
2021/0203(COD)
Proposal for a directive
Article 3 – paragraph 3 a (new)
Article 3 – paragraph 3 a (new)
3a. Member States shall propose concrete plants to remove regulatory or non-regulatory barriers to energy efficiency in order to strengthen demand- side solutions and put them on an equal footing with supply side measures.
Amendment 367 #
2021/0203(COD)
Proposal for a directive
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States shall collectively ensure a reduction of energy consumption of at least 9 45.5% in 2030 compared to the projections of the 20207 Reference Scenario so that the Union’s final energy consumption amounts to no more than 78700 Mtoe and the Union’s primary energy consumption amounts to no more than 1023911 Mtoe in 2030.91 _________________ 91 The Union’s energy efficiency target was initially set and calculated using the 2007 Reference Scenario projections for 2030 as a baseline. The change in the Eurostat energy balance calculation methodology and improvements in subsequent modelling projections call for a change of the baseline. Thus, using the same approach to define the target, that is to say comparing it to the future baseline projections, the ambition of the Union’s 2030 energy efficiency target is set compared to the 2020 Reference Scenario projections for 2030 reflecting national contributions from the NECPs. With that updated baseline, the Union will need to further increase its energy efficiency ambition by at least 9 % in 2030 compared to the level of efforts under the 2020 Reference Scenario. The new way of expressing the level of ambition for the Union’s targets does not affect the actual level of efforts needed.
Amendment 372 #
2021/0203(COD)
Proposal for a directive
Article 4 – paragraph 2 – introductory part
Article 4 – paragraph 2 – introductory part
2. Each Member State shall set binding national energy efficiency contributions for final and primary energy consumption to meet, collectively, the binding Union target set in paragraph 1 . Member States shall notify those binding national contributions together with an bindicativeng linear trajectory with two reference points in 2025 and 2027 for those contributions to the Commission as part of the updates of their integrated national energy and climate plans in accordance with Article 14 of Regulation (EU) 2018/1999, and as part of their integrated national energy and climate plans as referred to in, and in accordance with, the procedure set out in Article 3 and Articles 7 to 12 of Regulation (EU) 2018/1999 . When doing soIn setting their binding national contributions, Member States shall use the formula defined in Annex I of this Directive and explain how, and on the basis of which data, the contributions have been calculated.
Amendment 380 #
2021/0203(COD)
Proposal for a directive
Article 4 – paragraph 2 – subparagraph 2 – point a
Article 4 – paragraph 2 – subparagraph 2 – point a
(a) that the Union’s 2030 energy consumption has to be no more than 78700 Mtoe of final energy or no more than 1023911 Mtoe of primary energy consumption ;
Amendment 392 #
2021/0203(COD)
Proposal for a directive
Article 2 – paragraph 1 – point 49 a (new)
Article 2 – paragraph 1 – point 49 a (new)
(49a) ‘support scheme’ means any instrument, scheme or mechanism applied by a Member State, or a group of Member States, to promote the energy efficiency improvement measures, including but not restricted to, investment aid, tax exemptions or reductions, tax refunds, energy efficiency obligation support schemes and direct price support schemes;
Amendment 401 #
2021/0203(COD)
Proposal for a directive
Article 4 – paragraph 3 – introductory part
Article 4 – paragraph 3 – introductory part
3. Where the Commission concludes, on the basis of its assessment pursuant to Article 29(1) and (3) of Regulation (EU) 2018/1999, that insufficient progress has been made towards meeting the binding energy efficiency contributions, Member States that are above their indicative trajectories referred to in paragraph 2 of this Article shall ensure that additional measures are implemented within one year following the date of reception of the Commission's assessment in order to ensure getting back on track to reach their energy efficiency contributions. Those additional measures shall include, but shall not be limited to, the following measures:
Amendment 408 #
2021/0203(COD)
Proposal for a directive
Article 4 – paragraph 3 – subparagraph 2
Article 4 – paragraph 3 – subparagraph 2
The Commission shall assess whether the national measures referred to in this paragraph are sufficient to achieve the Union's energy efficiency targets and the Member States binding contributions. Where national measures are deemed to be insufficient, the Commission shall, as appropriate, propose measures and exercise its power at Union level in order to ensure, in particular, the achievement of the Union's 2030 targets for energy efficiency.
Amendment 414 #
2021/0203(COD)
Proposal for a directive
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. Member States shall ensure that the total final energy consumption of all public bodies combined is reduced by at least 1,72% each year, when compared to the year X-2 (with X as the year when this Directive enters into force).
Amendment 432 #
2021/0203(COD)
Proposal for a directive
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
5a. Member States shall support and actively engage with regional and local authorities and their energy agencies in developing one-stop shops providing technical and financial advice and solutions to households, through an integrated process.
Amendment 435 #
2021/0203(COD)
Proposal for a directive
Article 6 – paragraph 1 – introductory part
Article 6 – paragraph 1 – introductory part
1. Without prejudice to Article 7 of Directive 2010/31/EU of the European Parliament and of the Council92 , each Member State shall ensure that at least 3 % of the total floor area of heated and/or cooled buildings owned by public bodies is renovated each year to at least be transformed into nearly zero-energy buildings in accordance with Article 9 of Directive 2010/31/EU. and into the highest standard for new buildings in accordance with [Article 2] of Directive (EU).../...of the European Parliament and of the Council on the energy performance of buildings. _________________ 92 Directive 2010/31/EU of the European Parliament and of the Council of 19 May 2010 on the energy performance of buildings (OJ L 153, 18.6.2010, p. 13).
Amendment 444 #
2021/0203(COD)
Proposal for a directive
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
Where public bodies occupy a building that they do not own, they shall exercise their contractual rights to the extent possible and encourage the building owner to renovate the building to a nearly zero-energy building in accordance with Article 9 of Directive 2010/31/EU. When concluding a new contract for occupying a building they do not own, public bodies shall aim for that building to fall into the top two energy efficiency classes on the energy performance certificate and may rent only buildings that are nearly zero-energy buildings, in accordance with Article 9 of Directive 2010/31/EU, and that are of the highest standard for new buildings in accordance with [Article 2.2] of Directive (EU).../...of the European Parliament and of the Council on the energy performance of buildings.
Amendment 462 #
2021/0203(COD)
Proposal for a directive
Article 6 – paragraph 3 a (new)
Article 6 – paragraph 3 a (new)
3a. Information on measured energy savings resulting from the renovation of public buildings shall also be included and made publicly available in the inventory, which should be linked to the national Energy Performance Certificates (EPC) databases.
Amendment 467 #
2021/0203(COD)
Proposal for a directive
Article 7 – paragraph 1 – subparagraph 1
Article 7 – paragraph 1 – subparagraph 1
Member States shall also ensure that in concluding the public contracts and concessions with a value equal to or greater than the thresholds referred to in the first subparagraph, contracting authorities and contracting entities, apply the energy efficiency first principle referred to in Article 3 of this Directive, including for those public contracts and concessions for which no specific requirements are provided in Annex IV. Contracting authorities may only make new rental agreements for buildings that are nearly- zero energy buildings (NZEB).
Amendment 483 #
2021/0203(COD)
Proposal for a directive
Article 8 – paragraph 1 – point c
Article 8 – paragraph 1 – point c
(c) new savings each year from 1 January 2024 to 31 December 2030 of 1,52 % of annual final energy consumption, averaged over the three-year period prior to 1 January 2020.
Amendment 497 #
2021/0203(COD)
Proposal for a directive
Article 8 – paragraph 3 – introductory part
Article 8 – paragraph 3 – introductory part
3. Member States shall implement energy efficiency obligation schemes, alternative policy measures, or a combination of both, or programmes or measures financed under an Energy Efficiency National Fund, as a priority among people affected by energy poverty, low-income households, vulnerable customers and, where applicable, people living in social housing. Member States shall ensure that policy measures implemented pursuant to this Article have no adverse effect on those persons. Where applicable, Member States shall make the best possible use of funding, including public funding, funding facilities established at Union level, and revenues from allowances pursuant to Article 22(3)(b) with the aim of removing adverse effects and ensuring a just and inclusive energy transition.
Amendment 500 #
2021/0203(COD)
Proposal for a directive
Article 8 – paragraph 3 – subparagraph 1
Article 8 – paragraph 3 – subparagraph 1
In designing such policy measures, Member States shall consider and promote the role of renewable energy communities and citizen energy communities in solidarity and the contribution to the implementation towards these policy measures. Member States shall aim to foster the development of citizen energy communities and encourage energy self-sufficiency at local level.
Amendment 501 #
2021/0203(COD)
Proposal for a directive
Article 8 – paragraph 3 – subparagraph 2 – introductory part
Article 8 – paragraph 3 – subparagraph 2 – introductory part
Member States shall achieve a minimum share of the required amount of cumulative end-use energy savings among people affected by energy poverty, low-income households, vulnerable customers and, where applicable, people living in social housing. This share shall at least equal the proportion of households in energy poverty as assessed in their National Energy and Climate Plan established in accordance with Article 3(3)(d) of the Governance Regulation 2018/1999. Member States shall in their assessment of the share of energy poverty in their National Energy and Climate Plan consider the indicators in points (a), (b),(c), and (ca) of this subparagraph. If a Member States NECP assessment results in a lower share of cumulative end-use energy savings among people affected by energy poverty, low- income households, vulnerable customers and, where applicable, people living in social housing the Commission shall examine the assessment with regards to the indicators referred to in this Article. If a Member State had not notified the share of households in energy poverty as assessed in their National Energy and Climate Plan, the share of the required amount of cumulative end-use energy savings among people affected by energy poverty low-income households, vulnerable customers and, where applicable, people living in social housing, shall at least equal the arithmetic average share of the following indicators for the year 2019 or, if not available for 2019, for the linear extrapolation of their values for the last three years that are available:
Amendment 503 #
2021/0203(COD)
Proposal for a directive
Article 8 – paragraph 3 – subparagraph 2 – point c
Article 8 – paragraph 3 – subparagraph 2 – point c
c) Structure of consumption expenditure by income quintile and COICOP consumption purpose (Eurostat, HBS, [hbs_str_t223], data for [CP045] Electricity, gas and other fuels).Total population living in a dwelling with a leaking roof, damp walls, floors or foundation, or rot in window frames or floor (Eurostat, SILC [ilc_mdho01]);
Amendment 504 #
2021/0203(COD)
Proposal for a directive
Article 8 – paragraph 3 – subparagraph 2 – point c a (new)
Article 8 – paragraph 3 – subparagraph 2 – point c a (new)
ca) At-risk-of-poverty rate (Eurostat, SILC and ECHP surveys [ilc_li02]) (cut- off point: 60% of median equivalised income after social transfers.
Amendment 523 #
2021/0203(COD)
Proposal for a directive
Article 9 – paragraph 4
Article 9 – paragraph 4
4. Member States mayshall require obligated parties to achieve a share of their energy savings obligation among people affected by energy poverty, vulnerable customers and, where applicable, people living in social housing. Member States mayshall also require obligated parties to achieve energy cost reduction targets and to achieve energy savings by promoting energy efficiency improvement measures, including financial support measures mitigating carbon price effects on SMEs and micro-SMEs.
Amendment 528 #
2021/0203(COD)
Proposal for a directive
Article 9 – paragraph 5
Article 9 – paragraph 5
5. Member States mayshall require obligated parties to work with local authorities or municipalities to promote energy efficiency improvement measures among people affected by energy poverty, vulnerable customers and, where applicable, people living in social housing. This includes identifying and addressing the specific needs of particular groups at risk of energy poverty or more susceptible to its effects. To protect people affected by energy poverty vulnerable customers and, where applicable, people living in social housing, Member States shall encourage obligated parties to carry out actions such as renovation of buildings, including social housing, replacement of appliances, financial support and incentives for energy efficiency improvement measures in conformity with national financing and support schemes, or energy audits.
Amendment 539 #
2021/0203(COD)
Proposal for a directive
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Member States shall ensure that enterprises with an average annual consumption higher than 1008TJ of energy over the previous three years and taking all energy carriers together, implement an energy management system. The energy management system shall be certified by an independent body according to the relevant European or International Standards.
Amendment 542 #
2021/0203(COD)
Proposal for a directive
Article 11 – paragraph 2 – introductory part
Article 11 – paragraph 2 – introductory part
2. Member States shall ensure that enterprises with an average annual consumption higher than 103.6TJ of energy over the previous three years and taking all energy carriers together that do not implement an energy management system are subject to an energy audit. Energy audits shall be carried out in an independent and cost-effective manner by qualified or accredited experts in accordance with requirements provided in Article 26 or implemented and supervised by independent authorities under national legislation. Energy audits shall be carried out at least every four years from the date of the previous energy audit.
Amendment 550 #
2021/0203(COD)
Proposal for a directive
Article 11 – paragraph 2 – subparagraph 1
Article 11 – paragraph 2 – subparagraph 1
The results of the energy audits including the water performance and recommendations from these audits shall be transmitted to the management of the enterprise. Member States shall ensure that the results and the implemented recommendations are published in the enterprise’s annual report, where applicable.
Amendment 556 #
2021/0203(COD)
Proposal for a directive
Article 11 – paragraph 10
Article 11 – paragraph 10
10. Without prejudice to paragraphs 1 to 9, Member States shall require, by 15 March 2024 and every year thereafter, owners and operators of every data centre in their territory with a significantn IT powered demand equal to or greater than 100 kW of energy consumption to make publicly available the information set out in Annex VI (`Minimum requirements for monitoring and publishing the energy performance of data centres´), which Member States shall subsequently report to the Commission.
Amendment 573 #
2021/0203(COD)
Proposal for a directive
Article 21 – paragraph 4 – introductory part
Article 21 – paragraph 4 – introductory part
4. Member States shall ensure that final customers, final users, vulnerable customers, people affected by energy poverty and, where applicable, people living in social housing, have access to simple, fair, transparent, independent, effective and efficient out-of-court mechanisms for the settlement of disputes concerning rights and obligations established under this Directive, through an independent mechanism such as an energy ombudsperson or a consumer body, or through a regulatory authority. Where the final customer is a consumer as defined in Article 4(1)(a) of Directive 2013/11/EU of the European Parliament and of the Council100 , such out-of-court dispute settlement mechanisms shall comply with the requirements set out therein. Special attention shall be given to energy poverty and vulnerable customers in line with Article 24(5). _________________ 100 Directive 2013/11/EU of the European Parliament and of the Council of 21 May 2013 on alternative dispute resolution for consumer disputes and amending Regulation (EC) No 2006/2004 and Directive 2009/22/EC (Directive on consumer ADR) (OJ L 165, 18.6.2013, p. 63).
Amendment 593 #
2021/0203(COD)
Proposal for a directive
Article 22 – paragraph 4 – subparagraph 1 – point a
Article 22 – paragraph 4 – subparagraph 1 – point a
a) to establish national definitions, indicators and criteria of energy poverty, energy poor and concepts of vulnerable customers as set out in Article 8(3), including final users;
Amendment 597 #
2021/0203(COD)
Proposal for a directive
Article 22 – paragraph 4 a (new)
Article 22 – paragraph 4 a (new)
4a. Member States shall establish obligations for energy service providers to fund and to set up within 18 months an energy efficiency ombudsperson centre at regional level in order to support vulnerable customers and contribute to the alleviation of energy poverty and to promote energy justice. The tasks of the centre will be the following: (a) to facilitate support and guidance from social workers in form of a “one stop shop” for social, administrative and financial possibilities at local, regional, national and Union level coordinating organisations such as social and job centres, debt advice centres or NGOs and national network of experts; (b) to provide technical support and energy efficiency advise by energy efficiency experts in line with national “one stop shop”; (c) enable and set up in a fair, reasonable and adequate manner financial support for energy efficiency investments by energy efficiency ombudsperson centre; Member States may use or combine in setting up such funding, existing tools such as the European Energy Efficiency Fund (EEEF), the National Energy Efficiency Fund (NEEF), Recovery and Resilience Facility (RRF), Next Generation EU (NGEU), Social Climate Fund, Cohesion Policy funds such as the European Regional and Development Fund and the Cohesion Fund (ERDF- CF) and the Just Transition Fund (JTF), a possible funding provided by energy service providers or any other existing or established funding at local, regional, national or Union level; (d) to provide an effective and independent out of court dispute settlement mechanism and an effective complaint handling procedure for consumers as referred to in Article 21(4).
Amendment 621 #
2021/0203(COD)
Proposal for a directive
Article 23 – paragraph 6 – point e a (new)
Article 23 – paragraph 6 – point e a (new)
(ea) include air pollution reduction measures for indoor and outdoor air quality control.
Amendment 656 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 1 – point c
Article 24 – paragraph 1 – point c
c. from 1 January 2035, a system using at least 50% renewable energy and waste heat, where the share of renewable energy is at least 205%;
Amendment 663 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 1 – point d
Article 24 – paragraph 1 – point d
d. from 1 January 2045, a system using at least 75 % renewable energy and waste heat, where the share of renewable energy is at least 405%;
Amendment 671 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 1 – point e
Article 24 – paragraph 1 – point e
e. from 1 January 2050, a system using only renewable energy and waste heat, where the share of renewable energy is at least 605%.
Amendment 678 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 2
Article 24 – paragraph 2
2. Member States shall ensure that where a district heating and cooling system is built or substantially refurbished it meets the criteria set out in paragraph 1 applicable at such time when it starts or continues its operation after the refurbishment. In addition, Member States shall ensure that when a district heating and cooling system is built or substantially refurbished, there is no increase in the use of fossil fuels other than natural gas in existing heat sources compared to the annual consumption averaged over the previous three calendar years of full operation before refurbishment, and that any new heat sources in that system do not use fossil fuels other than natural gas. Member States shall aim for the best available techniques (BAT).
Amendment 690 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 4 – point d
Article 24 – paragraph 4 – point d
(d) a data centre with a total rated energy input exceeding 1 MW level, to assess the cost and benefits of utilising the waste heat to satisfy economically justified demand, and of the connection of that installation to a district heating network or an efficient/RES-based district cooling system for local reuse of waste heat. The analysis shall consider cooling system solutions that allow removing or capturing the waste heat at useful temperature level with minimal ancillary energy inputs and connection of installation to a district heating network or any other projects economically feasible where waste heat could be reused.
Amendment 693 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 5 – point c
Article 24 – paragraph 5 – point c
(c) data centres whose waste heat is or will be used in a district heating network or directly for space heating, domestic hot water preparation or other uses in the building or group of buildings where it is located or other uses in the locality around the data centre.
Amendment 702 #
2021/0203(COD)
Proposal for a directive
Article 9 – paragraph 8
Article 9 – paragraph 8
8. Member States shall establish measurement, control and verification systems for carrying out documented verification on at least a statistically significant proportion and representative sample of the energy efficiency improvement measures put in place by the obligated parties. The measurement, control and verification shall be carried out independently of the obligated parties. Where an entity is an obligated party under a national energy efficiency obligation scheme under Article 9 and under the EU Emissions Trading System to buildings and road transport [COM(2021) 551 final, 2021/0211 (COD)96 ], the monitoring and verification system shall ensure that the carbon price passed through when releasing fuel for consumption [according to Article 1(21) of COM(2021) 551 final, 2021/0211 (COD)] shall be taken into account in the calculation and reporting of energy savings of the entity´s energy saving measures. _________________ 96 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Directive 2003/87/EC establishing a system for greenhouse gas emission allowance trading within the Union, Decision (EU) 2015/1814 concerning the establishment and operation of a market stability reserve for the Union greenhouse gas emission trading scheme and Regulation (EU) 2015/757, (Text with EEA relevance){SEC(2021) 551 final} - {SWD(2021) 557 final} - {SWD(2021) 601 final} -{SWD(2021) 602 final.
Amendment 711 #
2021/0203(COD)
Proposal for a directive
Article 27 – paragraph 7
Article 27 – paragraph 7
7. For the purpose of supporting the proper functioning of the energy services market, Member States mayshall establish an individual mechanism or designate an ombudsperson as outlined in Article 24(5), to ensure the efficient handling of complaints and out-of-court settlement of disputes arising from energy service and energy performance contracts.
Amendment 718 #
2021/0203(COD)
Proposal for a directive
Article 28 – paragraph 9
Article 28 – paragraph 9
9. Member States mayshall set up an National Energy Efficiency National Fund. The purpose of this fund shall be to implement energy efficiency measures, including measures pursuant to Article 8(3) and Article 22 as a priority among vulnerable customers, people affected by energy poverty and, where applicable, people living in social housing, and to implement n support of Member States’ national contributions pursuant to Article 4(2). Member States shall allocate to the fund at least 50% of the value needed to realize the planned energy efficiency improvement measures for the alleviation of poverty. Pursuant to Article 8(3) and Article 22, the National eEnergy eEfficiency measures to support Member States in meeting their national energy efficiency contributions and their indicative trajectories referred to in Article 4(2)Fund shall support the implementation of measures among vulnerable customers, people affected by energy poverty and, where applicable, people living in social housing. The Energy Efficiency National Fund may be financed with revenues from the allowance auctions pursuant to the EU Emission Trading System on buildings and transport sectors. The National Energy Efficiency Fund shall be operational as from the transposition deadline of this Directive.
Amendment 742 #
2021/0203(COD)
Proposal for a directive
Annex III – point a – paragraph 1 – indent 3
Annex III – point a – paragraph 1 – indent 3
— direct emissions of the carbon dioxide from cogeneration production that is fuelled with fossil fuels, are less than 27250 gCO2 per 1 kWh of energy output from the combined generation (including heating/cooling, power and mechanical energy).
Amendment 838 #
2021/0203(COD)
Proposal for a directive
Article 23 – paragraph 3 – introductory part
Article 23 – paragraph 3 – introductory part
3. For the purpose of the assessment referred to in paragraph 1, Member States shall carry out a cost-benefit analysis covering their territory and based on climate conditions, economic feasibility and technical suitability . The cost-benefit analysis shall be capable of facilitating the identification of the most resource- and cost-efficient solutions to meeting heating and cooling needs, taking into account overall system efficiency, power system adequacy and resiliency, as well as energy efficiency first. That cost-benefit analysis may be part of an environmental assessment under Directive 2001/42/EC of the European Parliament and of the Council101 . _________________ 101 Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (OJ L 197, 21.7.2001, p. 30).
Amendment 858 #
2021/0203(COD)
Proposal for a directive
Article 23 – paragraph 6 – point d a (new)
Article 23 – paragraph 6 – point d a (new)
(d a) consider energy affordability, security of supply, power system adequacy and resiliency;
Amendment 945 #
2021/0203(COD)
Proposal for a directive
Article 24 – paragraph 2 a (new)
Article 24 – paragraph 2 a (new)
2 a. Member States shall guarantee that incentives and financial support that covers up to 90 % of cost is put in place to ensure the uptake of efficient heating and cooling by households, including the low- income households at risk of energy poverty or in social housing. A stable legislative framework is key to ensure that investments are carried out in a timely and effective manner.
Amendment 969 #
2021/0203(COD)
Proposal for a directive
Article 24 a (new)
Article 24 a (new)
Article 24 a Financial support 1. In order to increase the uptake of energy efficiency improvement measures, building or substantially refurbishment of individual and district heating and cooling systems and replacement of old and inefficient heating and cooling appliances with efficient or high efficiency cogeneration and district heating, Member States shall adopt financial support schemes. 2. Member States shall ensure that the level of, and the conditions attached to, the support granted to the individual and district heating and cooling system and to efficient or high efficiency cogeneration projects are not revised in a way that negatively affects the rights conferred thereunder and undermines the economic viability of projects that already benefit from support. 3. Member States may adjust the level of support in accordance with objective criteria, provided that such criteria are established in the original design of the support scheme. 4. Member States shall publish a long- term schedule anticipating the expected allocation of support, covering, as a reference, at least the following five years, or, in the case of budgetary planning constraints, the following three years, including the indicative timing, the frequency of tendering procedures where appropriate, the expected capacity and budget or maximum unitary support expected to be allocated, and the expected eligible technologies, if applicable. That schedule shall be updated on an annual basis or, where necessary, to reflect recent market developments or expected allocation of support. 5. Member States shall, at least every five years, assess the effectiveness of their support schemes. That assessment shall take into account the effect of possible changes to the support schemes. The indicative long-term planning governing the decisions of the support and design of new support shall take into account the results of that assessment. Member States shall include the assessment in the relevant updates of their integrated national energy and climate plans and progress reports in accordance with Regulation (EU) 2018/1999.
Amendment 1095 #
2021/0203(COD)
Proposal for a directive
Annex V – point 2 – point e
Annex V – point 2 – point e
Amendment 127 #
2021/0106(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The purpose of this Regulation is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the developbased on ethical principles in particular for the design, development, deployment, marketing and use of artificial intelligence in conformity with Union values. This Regulation pursues a number of overriding reasons of public interest, such as a high level of protection of health, safety, environment and fundamental rights, and it ensures the free movement of AI- based goods and services cross-border, thus preventing Member States from imposing restrictions on the development, marketing and use of AI systems, unless explicitly authorised by this Regulation.
Amendment 133 #
2021/0106(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) Artificial intelligence systems (AI systems) can be easily deployed in multiple sectors of the economy and society, including cross border, and circulate throughout the Union. Certain Member States have already explored the adoption of national rules to ensure that artificial intelligence is trustworthy and safe and is developed and used in compliance with fundamental rights obligations. Differing national rules may lead to fragmentation of the internal market and decrease legal certainty for operators that develop or use AI systems. A consistent and high level of protection throughout the Union should therefore be ensured in order to achieve trustworthy AI, while divergences hampering the free circulation of AI systems and related products and services within the internal market should be prevented, by laying down uniform obligations for operators and guaranteeing the uniform protection of overriding reasons of public interest and of rights of persons throughout the internal market based on Article 114 of the Treaty on the Functioning of the European Union (TFEU). To the extent that this Regulation contains specific rules on the protection of individuals with regard to the processing of personal data concerning restrictions of the use of AI systems for ‘real-time’ remote biometric identification in publicly accessible spaces for the purpose of law enforcement, it is appropriate to base this Regulation, in as far as those specific rules are concerned, on Article 16 of the TFEU. In light of those specific rules and the recourse to Article 16 TFEU, it is appropriate to consult the European Data Protection Board.
Amendment 154 #
2021/0106(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) In order to ensure a consistent and high level of protection of public interests as regards health, safety and fundamental rights, common normative standards for all high-risk AI systems should be established. Those standards should be consistent with the Charter of fundamental rights of the European Union (the Charter), the European Green Deal (The Green Deal) and the Joint Declaration on Digital Rights of the Union (the Declaration) and should be non-discriminatory and in line with the Union’s international trade commitments.
Amendment 158 #
2021/0106(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) In order to introduce a proportionate and effective set of binding rules for AI systems, a clearly defined risk- based approach should be followed. That approach should tailor the type and content of such rules to the intensity and scope of the risks that AI systems can generate. It is therefore necessary to prohibit certain artificial intelligence practices, to lay down requirements for high-risk AI systems and obligations for the relevant operators, and to lay down transparency obligations for certain AI systems. With regard to transparency and human oversight obligations, Member States should be able to adopt further national measures to complement them without changing their harmonising nature.
Amendment 161 #
2021/0106(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) Without prejudice to tailoring rules to the intensity and scope of the risks that AI systems can generate, or to the specific requirements laid down for high-risk AI systems, all AI systems developed, deployed or used in the Union should respect not only Union and national law but also a specific set of ethical principles that are aligned with the values enshrined in Union law and that are in part, concretely reflected in the specific requirements to be complied with by high-risk AI systems. That set of principles should, inter alia, also be reflected in codes of conduct that should be mandatory for the development, deployment and use of all AI systems. Accordingly, any research carried out with the purpose of attaining AI-based solutions that strengthen the respect for those principles, in particular those of social responsibility and environmental sustainability, should be encouraged by the Commission and the Member States.
Amendment 162 #
2021/0106(COD)
Proposal for a regulation
Recital 14 b (new)
Recital 14 b (new)
(14b) AI literacy’ refers to skills, knowledge and understanding that allows both citizens more generally and developers, deployers and users in the context of the obligations set out in this Regulation to make an informed deployment and use of AI systems, as well as to gain awareness about the opportunities and risks of AI and thereby promote its democratic control. AI literacy should not be limited to learning about tools and technologies, but should also aim to equip citizens more generally and developers, deployers and users in the context of the obligations set out in this Regulation with the critical thinking skills required to identify harmful or manipulative uses as well as to improve their agency and their ability to fully comply with and benefit from trustworthy AI. It is therefore necessary that the Commission, the Member States as well as developers and deployers of AI systems, in cooperation with all relevant stakeholders, promote the development of AI literacy, in all sectors of society, for citizens of all ages, including women and girls, and that progress in that regard is closely followed.
Amendment 163 #
2021/0106(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) Aside from the many beneficial uses of artificial intelligence, that technology can also be misused and provide novel and powerful tools for manipulative, exploitative and social control practices. Such practices are particularly harmful and should be prohibited because they contradict Union values of respect for human dignity, freedom, equality, democracy and the rule of law and Union fundamental rights, including the right to non-discrimination, data protection and privacy, gender equality and the rights of the child.
Amendment 170 #
2021/0106(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) The placing on the market, putting into servicedevelopment, deployment or use of certain AI systems intendused to distort human behaviour, whereby physical or psychological harms are likely to occur, should be forbidden. Such AI systems deploy subliminal components individuals cannot perceive or exploit vulnerabilities of children and people due to their age, physical or mental incapacities. They do so with the intention toby materially distorting the behaviour of a person and in a manner that causes or is likely to cause harm to that or another person. The intention may not be presumed if the distortion of human behaviour results from factors external to the AI system which are outside of the control of the provider or the user. Research for legitimate purposes in relation to such AI systems should not be stifled by the prohibition, if such research does not amount to use of the AI system in human- machine relations that exposes natural persons to harm and such research is carried out in accordance with recognised ethical standards for scientific research.
Amendment 191 #
2021/0106(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) High-risk AI systems should only be placed on the Union market or put into servicedeveloped and deployed if they comply with certain mandatory requirements based on ethical principles. Those requirements should ensure that high-risk AI systems available in the Union or whose output is otherwise used in the Union do not pose unacceptable risks to important Union public interests as recognised and protected by Union law. AI systems identified as high-risk should be limited to those that have a significant harmful impact on the health, safety and fundamental rights of persons in the Union and such limitation minimises any potential restriction to international trade, if any.
Amendment 194 #
2021/0106(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) AI systems could produce adverse outcomes to health and safety of persons, in particular when such systems operate as components of products. Consistently with the objectives of Union harmonisation legislation to facilitate the free movement of products in the internal market and to ensure that only safe and otherwise compliant products find their way into the market, it is important that the safety risks that may be generated by a product as a whole due to its digital components, including AI systems, are duly prevented and mitigated. For instance, increasingly autonomous robots, whether in the context of manufacturing or personal assistance and care should be able to safely operate and performs their functions in complex environments. Similarly, in the health sector where the stakes for life and health are particularly high, increasingly sophisticated diagnostics systems and systems supporting human decisions should be reliable and accurate. The extent of the adverse impact caused by the AI system on the fundamental rights protected by the Charter is of particular relevance when classifying an AI system as high-risk. Those rights include the right to human dignity, respect for private and family life, protection of personal data, freedom of expression and information, freedom of assembly and of association, and non- discrimination, gender equality, education, consumer protection, workers’ rights, rights of persons with disabilities, right to an effective remedy and to a fair trial, right of defence and the presumption of innocence, right to good administration. In addition to those rights, it is important to highlight that children have specific rights as enshrined in Article 24 of the EU Charter and in the United Nations Convention on the Rights of the Child (further elaborated in the UNCRC General Comment No. 25 as regards the digital environment), both of which require consideration of the children’s vulnerabilities and provision of such protection and care as necessary for their well-being. The fundamental right to a high level of environmental protection enshrined in the Charter and implemented in Union policies should also be considered when assessing the severity of the harm that an AI system can cause, including in relation to the health and safety of persons or to the environment, due to the extraction and consumption of natural resources, waste and the carbon footprint.
Amendment 200 #
2021/0106(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) AI systems used in education or vocational training, notably for determining access or assigning persons to educational and vocational training institutions or to evaluate persons on tests as part of or as a precondition for their education should be considered high-risk, since they may determine the educational and professional course of a person’s life and therefore affect their ability to secure their livelihood. When improperly designed, developed and used, such systems may violate the right to education and training as well as the right to gender equality and to not to be discriminated against and perpetuate historical patterns of discrimination.
Amendment 201 #
2021/0106(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) AI systems used in employment, workers management and access to self- employment, notably for the recruitment and selection of persons, for making decisions on promotion and termination and for task allocation, monitoring or evaluation of persons in work-related contractual relationships, should also be classified as high-risk, since those systems may appreciably impact the health, safety and security rules applicable in their work and at their workplaces and future career prospects and livelihoods of these persons. Relevant work-related contractual relationships should involve employees and persons providing services through platforms as referred to in the Commission Work Programme 2021. Such persons should in principle not be considered users within the meaning of this Regulation. Throughout the recruitment process and in the evaluation, promotion, or retention of persons in work-related contractual relationships, such systems may perpetuate historical patterns of discrimination, for example against women, certain age groups, persons with disabilities, or persons of certain racial or ethnic origins or sexual orientation. AI systems used to monitor the performance and behaviour of these persons may also impact their rights to data protection and privacy. In this regard, specific requirements on transparency, information and human oversight should apply. Trade unions and workers representatives should be informed and they should have access to any documentation created under this Regulation for any AI system deployed or used in their work or at their workplace.
Amendment 214 #
2021/0106(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) Having comprehensible information on how high- risk AI systems have been developed and how they perform throughout their lifecycle is essential to verify compliance with the requirements under this Regulation and to allow users to make informed and autonomous decisions about their use. This requires keeping records and the availability of a technical documentation, containing information which is necessary to assess the compliance of the AI system with the relevant requirements. Such information should include the general characteristics, capabilities and limitations of the system, algorithms, data, training, testing and validation processes used as well as documentation on the relevant risk management system. The technical documentation should be kept up to date.
Amendment 215 #
2021/0106(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) To address the opacity that may make certain AI systems incomprehensible to or too complex for natural persons, a certainsufficient degree of transparency should be required for high-risk AI systems. Users should be able to interpret the system output and use it appropriately. High-risk AI systems should therefore be accompanied by relevant documentation and instructions of use and include concise and clear information, including in relation to possible risks to fundamental rights and discrimination, where appropriate. The same applies to AI systems with general purposes that may have high-risk uses that are not forbidden by their developer. In such cases, sufficient information should be made available allowing deployers to carry out tests and analysis on performance, data and usage. The systems and information should also be registered in the EU database for stand- alone high-risk AI systems foreseen in Article 60 of this Regulation.
Amendment 218 #
2021/0106(COD)
Proposal for a regulation
Recital 48
Recital 48
(48) High-risk AI systems should be designed and developed in such a way that natural persons can overseehave agency over them by being able to oversee and control their functioning. For this purpose, appropriate human oversight measures should be identified by the provider of the system before its placing on the market or putting into service. In particular, where appropriate and at the very least where decisions based solely on the automated processing enabled by such systems produce legal or otherwise significant effects, such measures should guarantee that the system is subject to in- built operational constraints that cannot be overridden by the system itself and is responsive to the human operator, and that the natural persons to whom human oversight has been assigned have the necessary competence, training and authority to carry out that role.
Amendment 221 #
2021/0106(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) High-risk AI systems should perform consistently throughout their lifecycle and meet an appropriate level of accuracy, robustness and cybersecurity in accordance with the generally acknowledged state of the art. The level of accuracy and accuracy metrics should be communicated to thein an intelligible manner to the deployers and users.
Amendment 229 #
2021/0106(COD)
(68) Under certain conditions, rapid availability of innovative technologies may be crucial for health and safety of persons and for society as a whole. It is thus appropriate that under exceptional and ethically justified reasons of public security or protection of life and health of natural persons and the protection of industrial and commercial property, Member States could authorise the placing on the market or putting into service of AI systems which have not undergone a conformity assessment.
Amendment 237 #
2021/0106(COD)
Proposal for a regulation
Recital 71
Recital 71
(71) Artificial intelligence is a rapidly developing family of technologies that requires novel forms of regulatory oversight and a safe space for experimentation, while ensuring responsible innovation and integration of appropriate and ethically justified safeguards and risk mitigation measures. To ensure a legal framework that is innovation-friendly, future-proof and resilient to disruption, national competent authorities from one or more Member States should be encouraged to establish artificial intelligence regulatory sandboxes to facilitate the development and testing of innovative AI systems under strict regulatory oversight before these systems are placed on the market or otherwise put into service.
Amendment 242 #
2021/0106(COD)
Proposal for a regulation
Recital 72
Recital 72
(72) The objectives of the regulatory sandboxes should be to foster AI innovation by establishing a controlled experimentation and testing environment in the development and pre-marketing phase with a view to ensuring compliance of the innovative AI systems with this Regulation and other relevant Union and Member States legislation; to enhance legal certainty for innovators and the competent authorities’ oversight and understanding of the opportunities, emerging risks and the impacts of AI use, and to accelerate access to markets, including by removing barriers for small and medium enterprises (SMEs) and start-ups; to contribute to the development of ethical, socially responsible and environmentally sustainable AI systems, in line with the ethical principles outlined in this Regulation. To ensure uniform implementation across the Union and economies of scale, it is appropriate to establish common rules for the regulatory sandboxes’ implementation and a framework for cooperation between the relevant authorities involved in the supervision of the sandboxes. This Regulation should provide the legal basis for the use of personal data collected for other purposes for developing certain AI systems in the public interest within the AI regulatory sandbox, in line with Article 6(4) of Regulation (EU) 2016/679, and Article 6 of Regulation (EU) 2018/1725, and without prejudice to Article 4(2) of Directive (EU) 2016/680. Participants in the sandbox should ensure appropriate safeguards and cooperate with the competent authorities, including by following their guidance and acting expeditiously and in good faith to mitigate any high-risks to safety and fundamental rights that may arise during the development and experimentation in the sandbox. The conduct of the participants in the sandbox should be taken into account when competent authorities decide whether to impose an administrative fine under Article 83(2) of Regulation 2016/679 and Article 57 of Directive 2016/680.
Amendment 246 #
2021/0106(COD)
Proposal for a regulation
Recital 73
Recital 73
(73) In order to promote and protect innovation, it is important that the interests of small-scale providers and users of AI systems are taken into particular account. To this objective, Member States should develop initiatives, which are targeted at those operators, including on AI literacy, awareness raising and information communication. Moreover, the specific interests and needs of small-scale providers shall be taken into account when Notified Bodies set conformity assessment fees. Translation costs related to mandatory documentation and communication with authorities may constitute a significant cost for providers and other operators, notably those of a smaller scale. Member States should possibly ensure that one of the languages determined and accepted by them for relevant providers’ documentation and for communication with operators is one which is broadly understood by the largest possible number of cross-border users.
Amendment 251 #
2021/0106(COD)
Proposal for a regulation
Recital 81
Recital 81
(81) The development of AI systems other than high-risk AI systems in accordance with the requirements of this Regulation may lead to a larger uptake of trustworthy socially responsible and environmentally sustainable artificial intelligence in the Union. Providers of non- high-risk AI systems should be encouraged to create codes of conduct intended to foster the voluntary application of the mandatory requirements applicable to high-risk AI systems. Providers should also be encouraged to apply on a voluntary basis additional requirements related, for example, to environmental sustainability, accessibility to persons with disability, stakeholders’ participation in the design and development of AI systems, and diversity of the development teams. The Commission may develop initiatives, including of a sectorial nature, to facilitate the lowering of technical barriers hindering cross-border exchange of data for AI development, including on data access infrastructure, semantic and technical interoperability of different types of data.
Amendment 256 #
2021/0106(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) harmonised rules for the placing on the market, the putting into servicedevelopment, deployment and the use of artificial intelligence systems (‘AI systems’) in the Union;
Amendment 259 #
2021/0106(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) providers‘developer’ placing on the market or putting into service AI systems in the Union, irrespective of whether those providers are established within the Union or in a third country or that adapts a general purpose AI system to a specific purpose and use;
Amendment 284 #
2021/0106(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 4 a (new)
Article 3 – paragraph 1 – point 4 a (new)
(4a) ‘end-user’ means any natural person who, in the context of employment or contractual agreement with the user, uses or deploys the AI system under the authority of the user;
Amendment 286 #
2021/0106(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘operator’ means the providdeveloper, the deployer, the user, the authorised representative, the importer and the distributor;
Amendment 287 #
2021/0106(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8a) ‘deployer’ means any natural or legal person, public authority, agency or other body putting into service an AI system developed by another entity without substantial modification, or using an AI system under its authority,
Amendment 291 #
2021/0106(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 14 a (new)
Article 3 – paragraph 1 – point 14 a (new)
(14a) ‘information security component of a product or system’ means a component of a product of a system which has been specifically designed to fulfil security function for that product or system against cyber incidents, disruptions and/ or attacks;
Amendment 292 #
2021/0106(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 14 b (new)
Article 3 – paragraph 1 – point 14 b (new)
(14b) ‘information security product or system’ means a product or of a system which has been specifically designed to fulfil a security function against cyber incidents, disruptions and/ or attacks;
Amendment 301 #
2021/0106(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 44 – point a
Article 3 – paragraph 1 – point 44 – point a
(a) the death of a person or serious damage to a person’s fundamental rights, health, to property or the environment, to democracy or the democratic rule of law,
Amendment 303 #
2021/0106(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 44 – point a a (new)
Article 3 – paragraph 1 – point 44 – point a a (new)
(aa) 'AI literacy' means the skills, knowledge and understanding regarding AI systems that are necessary for compliance with and enforcement of this Regulation
Amendment 379 #
2021/0106(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. High-risk AI systems shall comply with the requirements established in this Chapter, taking into account the generally acknowledged state of the art and industry standards, including as reflected in relevant harmonised standards or common specifications.
Amendment 401 #
2021/0106(COD)
Proposal for a regulation
Article 10 – paragraph 1 a (new)
Article 10 – paragraph 1 a (new)
1a. Providers of high-risk AI systems that utilise data collected and/or managed by third parties may rely on representations from those third parties with regard to quality criteria referred to in paragraph 2, points (a), (b) and (c).
Amendment 423 #
2021/0106(COD)
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. Training, validation and testing data sets shall be, to the best extent possible, relevant, representative, free of errors and complete. They shall have the appropriate statistical properties, including, where applicable, as regards the persons or groups of persons on which the high-risk AI system is intended to be used. These characteristics of the data sets may be met at the level of individual data sets or a combination thereof.
Amendment 461 #
2021/0106(COD)
Proposal for a regulation
Article 15 – paragraph 3 – introductory part
Article 15 – paragraph 3 – introductory part
3. Providers of High-risk AI systems shall btake appropriate technical and organizational measures to ensure that high-risk AI systems are resilient as regards to errors, faults or inconsistencies that may occur within the system or the environment in which the system operates, in particular due to their interaction with natural persons or other systemconsistent with industry best practices.
Amendment 496 #
2021/0106(COD)
Proposal for a regulation
Article 29 a (new)
Article 29 a (new)
Article 29 a Jurisdiction and territoriality Providers as defined in point 2 of Article 3 and within the meaning of Article 28, paragraph 1, shall be deemed to be under the jurisdiction of the Member State in which they have their main establishment in the Union.
Amendment 501 #
2021/0106(COD)
Proposal for a regulation
Article 38 – paragraph 2 a (new)
Article 38 – paragraph 2 a (new)
2a. Where a competent authority of a Member State requires obtaining an EU declaration of conformity of a provider which has its main establishment in another Member State, that request shall be made through the competent authority of the Member State where the provider has its main establishment. The information shall be transmitted by the provider in an official language of the Member State where it has its main establishment. The Commission is empowered to adopt delegated acts in accordance with this paragraph to further define the modalities for issuing and handling such requests.
Amendment 519 #
2021/0106(COD)
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
1. The provider shall draw up a written EU declaration of conformity for each AI system and keep it at the disposal of the national competent authorities for 10 years after the AI system has been placed on the market or put into service. The EU declaration of conformity shall identify the AI system for which it has been drawn up. A copy of the EU declaration of conformity shall be given to the relevant national competent authorities upony in the Member State of main establishment of the provider, upon the competent authority’s request.
Amendment 554 #
2021/0106(COD)
Proposal for a regulation
Article 53 – paragraph 1
Article 53 – paragraph 1
1. AI regulatory sandboxes established by one or more Member States competent authorities or the European Data Protection Supervisor, and in collaboration with SMEs, start-ups, enterprises and other innovators, shall provide a controlled environment that facilitates the development, testing and validation of innovative AI systems for a limited time before their placement on the market or putting into service pursuant to a specific plan. TFor Member States competent authorities or the European Data Protection Supervisor, this shall take place under the direct supervision and guidance by the competent authorities with a view to ensuring compliance with the requirements of this Regulation and, where relevant, other Union and Member States legislation supervised within the sandbox. SMEs, start-ups, enterprises and other innovators shall conduct live experiments for new business models in collaboration with the Member State competent authorities.
Amendment 558 #
2021/0106(COD)
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – paragraph 2
2. Member States shall ensure that to the extent the innovative AI systems involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the national data protection authorities and those other national authorities are associated to the operation of the AI regulatory sandbox. established by one or more Member States competent authorities or the European Data Protection Supervisor. Start-ups, SMEs, enterprises and other innovators may request access to personal data from relevant national authorities to be used in their AI sandbox while ensuring compliance with the requirements of this Regulation and, where relevant, other Union and Member States legislation supervised within the sandbox
Amendment 563 #
2021/0106(COD)
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. The AI regulatory sandboxes shall not affect the supervisory and corrective powers of the competent authorities. Any significant risks to health and safety and fundamental rights identified during the development and testing of suchAI systems shall result in immediate mitigation and, failing that, in the suspension of the development and testing process until such mitigation takes place.
Amendment 564 #
2021/0106(COD)
Proposal for a regulation
Article 53 – paragraph 5
Article 53 – paragraph 5
5. Member States’ competent authorities that have established AI regulatory sandboxes shall coordinate their activities and cooperate within the framework of the European Artificial Intelligence Board. They shall submit annual reports to the Board and the Commission on the results from the implementation of those scheme, including good practices, lessons learnt and recommendations on their setup and, where relevant, on the application of this Regulation and other Union legislation supervised within the sandbox. SMEs, start-ups, enterprises and other innovators are invited to share their good practices, lessons learnt and recommendations on their AI sandboxes with Member State competent authorities.
Amendment 571 #
2021/0106(COD)
Proposal for a regulation
Article 55 – paragraph 1 – point a
Article 55 – paragraph 1 – point a
(a) provide small-scale providers andSME providers, including start-ups with priority access to the AI regulatory sandboxes established by one or more Member States competent authorities or the European Data Protection Supervisor to the extent that they fulfil the eligibility conditions;
Amendment 590 #
2021/0106(COD)
Proposal for a regulation
Article 56 – paragraph 2 – point a
Article 56 – paragraph 2 – point a
(a) contribute to thepromote and support effective cooperation of the national supervisory authorities and the Commission with regard to matters covered by this Regulation;
Amendment 591 #
2021/0106(COD)
Proposal for a regulation
Article 56 – paragraph 2 – point c a (new)
Article 56 – paragraph 2 – point c a (new)
(ca) assist developers, deployers and users of AI systems to meet the requirements of this Regulation, including those set out in present and future Union legislation, in particular SMEs and start-ups.
Amendment 29 #
2021/0045(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) An internal telecommunications market cannot be said to exist while there are differences between domestic and roaming prices. Therefore the difference between domestic charges and roaming charges should be eliminated , thus establishing an internal market for mobile communication services. Specifities of IoT must be taken into consideration.
Amendment 30 #
2021/0045(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7 a) Takes note of increasing data consumption abroad and in this regard recalls the importance of European programmes such as WiFi4EU that should support high-speed connection in public spaces throughout the EU and guarantee accessibility especially in less developed countries and regions for students, lower income groups and vulnerable people. Therefore the Commission should further develop and invest in programmes such as WiFi4EU.
Amendment 31 #
2021/0045(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) The widespread use of internet- enabled mobile devices means that data roaming is of great economic significance. This is relevant for both users and providers of applications and content. In order to stimulate the development of this market, charges for data transport should not impede growth , in particular considering that the deployment of 5G networks and services is expected to grow steadily ncluding Internet of Things solutions is expected to grow steadily. Notes the increased level of uncertainty the COVID-19 pandemic brought to the predictability of future volumes of roaming traffic.
Amendment 35 #
2021/0045(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Roaming is relevant for facilitating innovation, and especially for benefiting users of connected objects. Recognises that in the future wholesale access should also cover Internet of Things in order to enable consumers to use their IoT devices seemingly across the EU Member States
Amendment 40 #
2021/0045(COD)
Proposal for a regulation
Recital new(14
Recital new(14
new(14) In order to allow for the development of a more efficient, integrated and competitive market for roaming services, there should be no restrictions preventing undertakings from effectively negotiating wholesale access for the purpose of providing roaming services. Obstacles to access to such wholesale roaming services, due to differences in negotiating power and in the degree of infrastructure ownership of undertakings, should be removed. To that end, wholesale roaming access agreements should respect the principle of technology neutrality and ensure all operators an equal and fair opportunity to accessing all networks and technologies available and be negotiated in good faithto the best knowledge allowing the roaming provider to offer retail roaming services equivalent to the services offered domestically. Mobile virtual network operators (MVNOs) and resellers of mobile communication services without their own network infrastructure typically provide roaming services based on commercial wholesale roaming agreements with their host mobile network operators in the same Member State. Commercial negotiations, however, may not leave enough margin to MVNOs and resellers for stimulating competition through lower prices. The removal of those obstacles and balancing the negotiation power between MVNOs/resellers and mobile network operators by an access obligation and wholesale caps should facilitate the development of alternative, innovative and Union-wide roaming services and offers for customers. Directive (EU) 2018/1972 does not provide for a solution to this problem via the imposition of obligations on operators with significant market powers.
Amendment 47 #
2021/0045(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) In accordance with Article 109 of Directive (EU) 2018/1972, all end-users should have access to emergency services, free of charge, through emergency communications to the most appropriate public safety answering point (PSAP). Member States are also required to ensure that access for end-users with disabilities to emergency services is available through emergency communications, especially while travelling abroad, and is equivalent to that enjoyed by other end- users. Takes into account the obligations imposed in Article 2 and 4 of the European Accessibility Act (Directive (EU) 2019/882) that Member States shall ensure that economic operators provide services that comply with the accessibility requirements of this Directive. It is for the Member States to determine the type of emergency communications that are technically feasible to ensure roaming customers access to emergency services. In order to ensure that roaming customers have access to emergency communications under the conditions laid down in Article 109 of Directive (EU) 2018/1972, visited network operators should inform the roaming provider through the wholesale roaming agreement about what type of emergency communications are mandated under national measures in the visited Member State. In addition, wholesale roaming agreements should include information on the technical parameters for ensuring access to emergency services, including for roaming customers with disabilities, as well as for ensuring the transmission of caller location information to the most appropriate PSAP in the visited Member State. Such information should allow the roaming provider to identify and provide the emergency communication and the transmission of caller location free of charge.
Amendment 51 #
2021/0045(COD)
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) In the long term, facilitating M2M roaming should be recognised as an important facilitator to digitise EU industry and build on related EU policies for sectors such as health, energy, environment, and transport. The Commission should assess the M2M and IoT connectivity market and provide recommendations in cooperation with BEREC and relevant stakeholders.
Amendment 58 #
2021/0045(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) Roaming customers should, to the greatest extent possible, be able to use the retail services that they subscribe to and benefit from the same level of quality of service as at home, when roaming in the Union. To that end, roaming providers should take the necessary measures to ensure that regulated retail roaming services are provided under the same conditions as if such services were consumed domestically. In particular, the same taking into account the obligations imposed in the Open Internet Regulation (Regulation(EU) 2015/2120, of the European Parliament and of the Council of 25 November 2015) to treat all traffic equally, without discrimination, restriction or interference. Similar quality of service should be offered to customers when roaming, if technically feasiavailable.
Amendment 73 #
2021/0045(COD)
Proposal for a regulation
Recital 36 a (new)
Recital 36 a (new)
(36 a) At a minimum, providers should clearly inform about specific pricing in timely manner, whenever consumers use value-added services. The Commission should introduce a rule that value-added services must cost the same for roaming consumers as nationals of that EU/EEA country.
Amendment 74 #
2021/0045(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) To ensure that roaming customers have uninterrupted and effective access to emergency services, free of charge, visited networks should not levy any wholesale charge related to suchall types of emergency communications on the roaming providers that are agreed between them and home networks or/and operators.
Amendment 83 #
2021/0045(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) There are considerable disparities between regulated roaming tariffs within the Union and roaming tariffs incurred by customers when they are travelling outside the Union, which are significantly higher than prices within the Union, where roaming surcharges are only exceptionally applied following the abolition of retail roaming charges . The Commission should consider including roaming provisions such as RLAH in future international agreements with 3rd countries especially those bordering with the EU and those being part of the pre-accession negotiations. The Commission should further assess such possible provisions in the relevant agreements with Western Balkan and Eastern Partnership countries. Due to the absence of a consistent approach to transparency and safeguard measures concerning roaming outside the Union, consumers are not confident about their rights and are therefore often deterred from using mobile services while abroad. Transparent information provided to consumers could not only assist them in the decision as to how to use their mobile devices while travelling abroad (both within and outside the Union), but could also assist them in the choice between roaming providers. It is therefore necessary to address the problem of the lack of transparency and consumer protection by applying certain transparency and safeguard measures also to roaming services provided outside the Union. Those measures should facilitate competition and improve the functioning of the internal market.
Amendment 85 #
2021/0045(COD)
Proposal for a regulation
Recital 50 a (new)
Recital 50 a (new)
(50 a) The Commission should work closely with the non-EU/EEA countries to reach roaming agreements or, at the very least, promote competition rules that bring down prices for consumers.
Amendment 88 #
2021/0045(COD)
Proposal for a regulation
Recital 57
Recital 57
(57) Where Union providers of mobile services find the benefits of interoperability and end-to-end connectivity for their customers jeopardised by the termination, or threat of termination, of their roaming arrangements with mobile network operators in other Member States, or are unable to provide their customers with service in another Member State as a result of a lack of agreement with at least one wholesale network provider, national regulatory authorities should make use, where necessary, of the powers under Article 61 of Directive (EU) 2018/1972 to ensure adequate access and interconnection , taking into account the objectives set out in Article 3 of that Directive , in particular the development of the internal market by favouring the provision, availability and interoperability of pan-European services, including of pan-European Internet of Things and end-to-end connectivity .
Amendment 90 #
2021/0045(COD)
Proposal for a regulation
Recital 59
Recital 59
(59) It is necessary to monitor and to review regularly the functioning of wholesale roaming markets and their interrelationship with the retail roaming markets, taking into account competitive and technological developments and traffic flows. The Commission should submit two reports to the European Parliament and to the Council. In its biennial reports, the Commission should, in particular, assess whether RLAH has any impact on the evolution of tariff plans available on the retail markets. That should include, on the one hand, an assessment of any emergence of tariff plans that include only domestic services and that exclude retail roaming services altogether, thus undermining the very objective of RLAH and, on the other, an assessment of any reduction in the availability of flat-rate tariff plans, which could also represent a loss for consumers and undermine the objectives of the digital single market. The Commission’s reports should, in particular, analyse the extent to which exceptional retail roaming surcharges have been authorised by national regulatory authorities, the ability of home network operators to sustain their domestic charging models and the ability of visited network operators to recover the efficiently incurred costs of providing regulated wholesale roaming services. In addition, the Commission’s reports should assess how, at wholesale level, access to the different network technologies and generations is ensured; the level of usage of trading platforms and similar instruments to trade traffic at wholesale level; the evolution of the machine-to- machine roaming; the persisting problems at retail level in relation to value added services and the application of the measures on emergency communications . Reports should include an assessment of the 5G rollout and any new technology implementation as well as effects of the COVID-19 pandemic on the market and end-user behaviour in terms of predictability of volumes. In order to enable such reporting with a view to assessing how the roaming markets adapt to RLAH rules, sufficient data should be gathered on the functioning of those markets after the implementation of those rules.
Amendment 96 #
2021/0045(COD)
Proposal for a regulation
Recital 60 a (new)
Recital 60 a (new)
(60 a) The Commission should provide relevant assessments of the M2M and IoT connectivity market in order to provide necessary recommendations in cooperation with BEREC and relevant stakeholders.
Amendment 111 #
2021/0045(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Mobile network operators shall meet all reasonable requests for wholesale roaming access , in particular allowing the roaming provider to replicate the retail mobile services offered domestically, when technically feasible according to technical capacities and availability.
Amendment 113 #
2021/0045(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. Wholesale roaming access shall cover access to all network elements and associated facilities, relevant services, software and information systems, necessary for the provision of regulated roaming services to customers , on any network technology and generation available in particular through equal and fair opportunity to accessing all networks and technologies available. Anomalous or abusive use shall not be covered by wholesale roaming access.
Amendment 116 #
2021/0045(COD)
Proposal for a regulation
Article 3 – paragraph 3 a (new)
Article 3 – paragraph 3 a (new)
3 a. BEREC shall, in close cooperation with the Commission and the relevant stakeholders, assess the possible future proof regulatory framework for consumers, businesses and operators to facilitate the access to next generation connectivity and modern technologies and to ensure the interoperability of key digital infrastructures, such as extensive 5G and future networks
Amendment 117 #
2021/0045(COD)
Proposal for a regulation
Article 3 – paragraph 3 b (new)
Article 3 – paragraph 3 b (new)
3 b. Commission shall provide assessments of the M2M and IoT connectivity market in timely manner in order to build on necessary recommendations in close cooperation with BEREC and relevant stakeholders.
Amendment 126 #
2021/0045(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Roaming providers shall ensure, when technically feasiavailable, that regulated retail roaming services are provided under the same conditions as if such services were consumed domestically, in particular in terms of quality of service. Roaming providers shall offer similar quality of service (same generation) where technically available. For no reason, providers shall not limit quality of service or the conditions of regulated retail roaming services.
Amendment 131 #
2021/0045(COD)
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Article 5 – paragraph 2 a (new)
2 a. In order to contribute to the consistent application of this Article, BEREC shall, by ...[6 months after the entry into force of this Regulation],after consulting stakeholders and in close cooperation with the Commission, update its retail guidelines regarding the implementation of the quality of service measures. Such guidelines shall also provide more clarity around data speed and other quality of service parameters provided while roaming
Amendment 135 #
2021/0045(COD)
Proposal for a regulation
Article 5 – paragraph 2 b (new)
Article 5 – paragraph 2 b (new)
2 b. BEREC shall closely monitor the market and provide follow up assessments. Special attention shall be brought to the assessment of the quality of service, including reports on the statistics about complaints received by consumers on the quality of services, the suitability of the existing regulatory approach/regulation and the adequacy of the different mechanisms as regards to characteristics of M2M and IoT.
Amendment 155 #
2021/0045(COD)
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. Implementing Regulation (EU) 2016/2286 shall continue to apply until the entry into force of a new implementing act adopted pursuant to paragraph 1. Providers shall gradually phase out the general application of fair use policy, which can only be applied when anomalous or abusive use of wholesale roaming access, permanent roaming or justified fraudulent practices are observed.
Amendment 158 #
2021/0045(COD)
Proposal for a regulation
Article 9 – paragraph 3 – point c
Article 9 – paragraph 3 – point c
(c) the quality of service that can reasonably be expected when roaming in the Union. Quality of service shall be recognized as an important element for consumers, and where appropriate for operators, consumers shall be offered available information on relevant factors that can affect the quality of service when using applications and services especially if they are primarily subject to certain QoS limitations. As an addition and where available, operators could provide consumers with links to reliable local sources related to the current weather conditions, traffic information and potential general/public health threads and restrictions.
Amendment 164 #
2021/0045(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The average wholesale charge that the visited network operator may levy on the roaming provider for the provision of regulated data roaming services by means of that visited network shall not exceed a safeguard limit of EUR 21,00 per gigabyte of data transmitted. That maximum wholesale charge shall gradually decrease to EUR 1,50 per gigabyte of data transmitted on 1 January 20250,90 per gigabyte of data transmitted on 1 January 2023 and to EUR 0,70 per gigabyte of data transmitted on 1 January 2024. On 1 January 2025 the maximum average wholesale charge shall decrease to EUR 0,60 per gigabyte and shall, without prejudice to Articles 21, 22 and 23 remain at EUR 1,50,60 per gigabyte of data transmitted until 30 June 2032 .
Amendment 173 #
2021/0045(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
Without prejudice to Articles 10, 11 and 12, the visited network operator shall not levy on the roaming provider any charge related to theall types of emergency communications initiated by the roaming customer and the transmission of caller location information.(calls and emergency SMS messages) agreed between the roaming provider and the visited network operator and initiated by the roaming customer and the transmission of caller location information. All clearly identifiable means of emergency services shall be provided without any additional charges
Amendment 179 #
2021/0045(COD)
Proposal for a regulation
Article 14 – paragraph 1 – subparagraph 2
Article 14 – paragraph 1 – subparagraph 2
Roaming providers shall, except when the roaming customer has notified the roaming provider that he does not require this service, provide the customer, automatically by means of a Message Service, without undue delay and free of charge, when the roaming customer enters a Member State other than that of his domestic provider, with information on the potential risk of increased charges due to the use of value added services including a link to a dedicated webpage hosted by BEREC providing information about the types of services that may be subject to increased costs and, if available, information on value added services number ranges.
Amendment 181 #
2021/0045(COD)
Proposal for a regulation
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
1 a. The Commission shall introduce a rule that value-added services must cost the same for roaming consumers as nationals of that EU/EEA country.
Amendment 196 #
2021/0045(COD)
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
An automatic message from the roaming provider shall inform the roaming customer that the latter may access emergency services free of charge by calling the single European emergency number ‘112’ and by alternative means of access to emergency services through emergency communications mandated in the visited Member State. The information shall be delivered to the roaming customer’s mobile device by an SMS message, every time the roaming customer enters a Member State other than that of his domestic provider. The SMS shall contain a link to a dedicated webpage serving as a central information point where BEREC would provide regularly updated database. It shall be provided free of charge at the moment the roaming customer initiates a roaming service, by an appropriate means adapted to facilitate its receipt and easy comprehension.
Amendment 210 #
2021/0045(COD)
Proposal for a regulation
Article 21 – paragraph new1 – introductory part
Article 21 – paragraph new1 – introductory part
new1. The Commission shall , after consulting BEREC, submit twobiennial reports to the European Parliament and to the Council. Where necessary, after submitting each report, the Commission shall adopsubmit a delegated act pursuant to Article 22 amending the maximum wholesale charges for regulated roaming services laid down inislative proposal to amend this Regulation. The first such report shall be submitted by 30 June 2025 and the second by 30 June 2029 .
Amendment 213 #
2021/0045(COD)
Proposal for a regulation
Article 21 – paragraph new1 – subparagraph 1 – point a
Article 21 – paragraph new1 – subparagraph 1 – point a
(a) the availability and quality of services, including those which are an alternative to regulated retail voice, SMS and data roaming services, in particular in the light of technological developments and of the access to the different network technologies and generations ; in particular the access to next generation connectivity and modern technologies;
Amendment 218 #
2021/0045(COD)
(b) the degree of competition in both the retail and wholesale roaming markets, in particular the actual wholesale rates paid by the operators and the competitive situation of small, independent or newly started operators, and MVNOs and providers of pan-European Internet of Things, including the competition effects of commercial agreements, of traffic traded on trading platforms and similar instruments and the degree of interconnection between operators;
Amendment 219 #
2021/0045(COD)
Proposal for a regulation
Article 21 – paragraph new1 – subparagraph 1 – point c
Article 21 – paragraph new1 – subparagraph 1 – point c
(c) the evolution of roaming for the machine-to- machine roamingand Internet of Things services ;
Amendment 232 #
2021/0045(COD)
Proposal for a regulation
Article 21 – paragraph 2 – introductory part
Article 21 – paragraph 2 – introductory part
2. In order to assess competitive developments in the Union-wide roaming markets, BEREC shall collect data regularly from national regulatory authorities on developments in retail and wholesale charges for regulated voice, SMS and data roaming services, including wholesale charges applied for balanced and unbalanced roaming traffic respectively , on the use of trading platforms and similar instruments, on the development of machine-to-machine roaming and Internet of Things, and on the extent to which wholesale roaming agreements cover quality of service and give access to different network technologies and generations. BEREC shall also collect data regularly from national regulatory authorities on the application of fair use policy by operators, the developments of domestic-only tariffs, the application of the sustainability mechanisms and complaints on roaming. When consulted pursuant to paragraph 1, BEREC shall collect and provide additional information on transparency, the application of measures on emergency communication and on value added services .
Amendment 235 #
2021/0045(COD)
Proposal for a regulation
Article 21 – paragraph 2 – subparagraph 2
Article 21 – paragraph 2 – subparagraph 2
Those data shall be notified to the Commission at least ontwice a year. The Commission shall make them public.
Amendment 236 #
2021/0045(COD)
Proposal for a regulation
Article 22
Article 22
Amendment 246 #
2021/0045(COD)
Proposal for a regulation
Article 23
Article 23
Amendment 254 #
2021/0045(COD)
Proposal for a regulation
Annex I
Annex I
Amendment 1 #
2020/2217(INI)
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
- having regard to the findings of the Digital Economy and Society Index 2020, published on the 11th of June 2020
Amendment 27 #
2020/2217(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas the EU requires the availability of flexible, scalable, reliable IT architecture, capable of supporting the most innovative applications;
Amendment 31 #
2020/2217(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the Union must urgently take action to reap the benefits of data by building an ethically sustainable, human- centric, trustworthy and secure data society that respects human rights and democracy and that aims to build a new open and inclusive knowledge economy, in connection with the education system and the cultural enterprises, that ensures the right to quality education and entrepreneurship, especially among the new generations, especially promoting forms of social innovation and new business models;
Amendment 43 #
2020/2217(INI)
Motion for a resolution
Recital D a (new)
Recital D a (new)
D a. whereas, according to Eurobarometer, the share of European citizens who would like to take a more active role in controlling the use of their personal data, including health, energy consumption and shopping habits (46%) is larger than those who would not like (38%);
Amendment 56 #
2020/2217(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
Amendment 57 #
2020/2217(INI)
Motion for a resolution
Recital E a (new)
Recital E a (new)
E a. whereas an adequate infrastructure is needed in the EU, through the use of high-performance hardware and storage to run applications and store data;
Amendment 59 #
2020/2217(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
E b. whereas investments in skills in cloud and big data can help companies distant from technology to turn their business; and whereas companies considered to be at the forefront must remain constantly updated on recent technology innovations in order not to lose their competitive advantage;
Amendment 60 #
2020/2217(INI)
Motion for a resolution
Recital E b (new)
Recital E b (new)
E b. whereas the European strategy for data will be instrumental, among other things, to achieve industrial policy objectives and will be beneficial to help European businesses, including SMEs, to successfully face the digital transition;
Amendment 65 #
2020/2217(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the Commission communication entitled ‘A European strategy for data’; believes that it is a prerequisite for the viability of European industries, the progress of universities and research centres and nascent AI, and a vital step towards a democratic data society, which will bring better services, growth and jobs;
Amendment 77 #
2020/2217(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Notes that the COVID-19 crisis highlights the role of real-time dataand high quality data and information;
Amendment 98 #
2020/2217(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Underlines that despite the high level of protection granted by the GDPR, individuals suffer from the lack of appropriate technical standards and tools empowering the simple exercise of those rights; emphasises that individuals should be supported in enforcing their rights granted by the GDPR with regard to the use of the data they generate;
Amendment 110 #
2020/2217(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Notes that a well-built data society benefits all, empowers workers instead of lowering their working conditions, and does not lead to inequality or digital gaps and also aims to improve the quality of life of the citizens;
Amendment 126 #
2020/2217(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Stresses that the Union’s data strategy must support sustainability, the Green Deal and, Union’s climate targets and social inclusion;
Amendment 137 #
2020/2217(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Supports the creation of a data governance framework for common European data spaces, covering interoperability, sharing, access and portability of data, to enhance the flow and reuse of industrial and public data; urges the governance framework to promote the “data for the public good” principle while always protecting the rights of EU citizens;
Amendment 149 #
2020/2217(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Insists that the data governance model be built on a decentralised data operating environment; believes that the EU should develop its own adequate capacity for cloud services and facilitate the emergence of a decentralised, interoperable ecosystem of data governance that enables efficient use of local infrastructures such as edge computing; supports the further uptake of decentralised digital technologies such as blockchain which enables individuals and organisations to manage data flows based on self-determination;
Amendment 155 #
2020/2217(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Believes that data management services and data architectures designed to store, use, re-use and curate data are critical components of the value chain of the European digital economy; stresses that costs related to access and storage of data determine the speed, depth and scale of the adoption of digital infrastructures and products, especially for SMEs and start-ups;
Amendment 187 #
2020/2217(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Recalls that personal and industrial data are not always separable; urges the Commission to define guidance on and practices in the utilisation of mixed data sets in industrial environments while guaranteeing privacy rules for personal data; calls on the Commission to consider creating a horizontal and cross-cutting personal data space alongside other data spaces to address the challenge of mixed data sets and empower citizens via, for example, trustworthy intermediators such as MyData operators, which store data with the consent of the owners; emphasises the need to further develop digital identities, which will enable individuals to retain ownership of their data and contribute to the establishment of safe and trustworthy data intermediation standards;
Amendment 189 #
2020/2217(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Recalls that personal and industrial data are not always separable; urges the Commission to define guidance on and practices in the utilisation of mixed data sets in industrial environments while guaranteeing privacy rules for personal data; calls on the Commission to consider creating a horizontal and cross-cutting personal data space alongside other data spaces to address the challenge of mixed data sets and empower citizens via, for example, trustworthy intermediators such as MyData operators, which store data with the consent of the owners; calls for further guidance by the Commission when it comes to the application of Regulation 2016/679 to mixed data sets, to ensure the full respect of data privacy;
Amendment 200 #
2020/2217(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Urges the Commission to present a data act to encourage and enable an increasing B2B, B2G, G2B and G2G flow of data in all sectors for exploiting the full potential of unused industrial data ensuring cybersecurity; when personal data is tapped consumer protection and safeguarding personal data must be ensured;
Amendment 206 #
2020/2217(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Encourages the Commission to facilitate voluntary data sharing schemes; urges the Commission to enact measures that would incentivise businesses to share their data, possibly through a reward system (win-win), with the objective of pooling vast sets of data, for it be equally accessed by EU businesses, in particular the less data rich, facilitating innovation; stresses the need for contracts to set clear obligations and liability for data aggregators when it comes to accessing, storing, sharing and processing data in order to limit the misuse of such data;
Amendment 214 #
2020/2217(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Notes that there are specific circumstances, such as systematic imbalances in B2B data value chains or specific circumstances of overriding public interest, where access to data should be compulsory e.g. via well-formed APIs; highlights that such imbalances are present in different sectors, such as e- commerce services, transport and tourism, where a small number of digital platforms, often from third countries, accumulate large amounts of sensitive data, while achieving an essential comparative advantage over EU businesses;
Amendment 215 #
2020/2217(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. NUnderlines that market imbalances resulting from the high concentration of information and provision of data-related services diminish wider data access and use, not only putting SMEs at a disadvantageous position but also increasing risks to competition in adjacent and emerging markets in the digital economy; notes that there are specific circumstances, such as systematic imbalances in B2B data value chains, where access to data should be compulsory e.g. via well-formed APIs;
Amendment 238 #
2020/2217(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Stresses the need to avoid service provider or technological lock-ins for publicly collected data; calls for public procurement processes and funding programmes to include data access and interoperability requirements based on technical standards;
Amendment 240 #
2020/2217(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Calls for improved coordination among Member States to facilitate the cross border flow of data across sectors, through government and stakeholder dialogue, with the objective of establishing a common way of collecting data based on the principles of findability, accessibility, interoperability, and reusability;
Amendment 248 #
2020/2217(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Calls for fair and transparent contractual conditions to be respected for all market players. Users and consumers should also have the right to always know the location of their data. In the event that an EU operator uses cloud services located in non-EU countries, it is important to ensure the application of as high level of legal protection as in EU in the event of disputes, including those relating to intellectual property;
Amendment 255 #
2020/2217(INI)
Motion for a resolution
Paragraph 22 b (new)
Paragraph 22 b (new)
22 b. Underlines the importance of defining a framework of rules capable of reconciling a broad and harmonised intellectual property protection with the sharing of data (original, derived and co- generated);
Amendment 270 #
2020/2217(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Recalls that the success of the Union’s data and AI strategies depends on the wider ICT ecosystem, closing the digital gap, developing the IoT, fibre, 5G, 6G, quantum, edge computing, block chain and high-performance computing; underlines that technological advancement based on data processing and the interconnectedness of digital products and services must be complemented with legally binding ethical standards to mitigate threats to privacy and data protection;
Amendment 278 #
2020/2217(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24 a. Welcomes the Commission infrastructure of High-Performance Computing; believes that it is an important instrument to exchange information and data between scientists and researcher and more broadly private and public actors;
Amendment 290 #
2020/2217(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25 a. Stresses that cloud infrastructures should be based on the principles of trust, openness, security, interoperability and portability;
Amendment 308 #
2020/2217(INI)
Motion for a resolution
Paragraph 27 a (new)
Paragraph 27 a (new)
27 a. Highlights that the gradual paradigm shift from physical centres of data storage to data architectures on the cloud and closer to the user, reinforces the need for a strengthened cybersecurity framework; underlines that the uptake and widespread use of products and services fuelled by data depend on cybersecurity standards, which will inspire trust and allow for safer data sharing mechanisms and better protocols to guarantee data protection;
Amendment 313 #
2020/2217(INI)
Motion for a resolution
Paragraph 27 b (new)
Paragraph 27 b (new)
27 b. Stresses that the safe and widespread uptake of both products and services in the data-fuelled consumer- facing IoT and industrial IoT European ecosystems must include trust by design in order to integrate privacy standards and security safeguards in all stages of the design process as well as the data processing protocols of devices and services;
Amendment 325 #
2020/2217(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Calls on the Commission to promote STEM education, with a specific focus on gender equality, as well as software engineering, ICT talent attraction, employment of women in tech and data literacy skills for all in order to build a European know-how focusing on next-generation and forefront technologies;
Amendment 329 #
2020/2217(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Calls for public and private funding for SMEs to fully capitalise on data economy’s potential; and to integrate digital technologies; reminds that only a minority of SMEs use customer relationship management (CRM) systems to analyse commercial information; underlines that the achievement of data equality for small and medium enterprises not only includes access to data, but also entails the skills to carry out analytics and to extract insights from such information;
Amendment 333 #
2020/2217(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
30. Calls for public and private funding for SMEs and Social economy enterprises to fully capitalise on data economy’s potential;
Amendment 336 #
2020/2217(INI)
Motion for a resolution
Paragraph 30 a (new)
Paragraph 30 a (new)
30 a. Welcomes the Digital Europe Programme and the role of the European Digital Innovation Hubs that will help European businesses, especially those still lagging behind, to keep up with the opportunities of the digital transition;
Amendment 342 #
2020/2217(INI)
31. Calls on social partners to explore the potential of digitalisation, data and AI to increase productivity, improve well- being of the workforce and invest in upskilling while respecting workers’ rights;
Amendment 346 #
2020/2217(INI)
Motion for a resolution
Paragraph 31 a (new)
Paragraph 31 a (new)
31 a. calls on the Commission to promote lifelong science-mathematics education in order to support the development of adequate digital skills and tools that adequately support processes related to artificial intelligence and cybersecurity;
Amendment 347 #
2020/2217(INI)
Motion for a resolution
Paragraph 31 b (new)
Paragraph 31 b (new)
31 b. Calls on the Commission and the Member States to also promote lifelong education in school systems and through information campaigns that aims to increase the awareness and responsibility of citizens as protagonists of the data economy society;
Amendment 350 #
2020/2217(INI)
Motion for a resolution
Paragraph 32
Paragraph 32
32. Believes that global rules governing the use of data are inadequate; calls on the Commission to work with like-minded third countries and international organisations to agree on new international standards to govern the use of new technologies, such as AI; highlights the need for international rules and standards to foster global cooperation aimed at strengthening data protection and establishing safe and appropriate data transfers;
Amendment 1 #
2020/2076(INI)
Motion for a resolution
Citation 3 a (new)
Citation 3 a (new)
- having regard to Article 3(3) TEU which refers to internal market, sustainable development and social market economy,
Amendment 2 #
2020/2076(INI)
Motion for a resolution
Citation 3 b (new)
Citation 3 b (new)
- having regard to the European Pillar of Social Rights,
Amendment 3 #
2020/2076(INI)
Motion for a resolution
Citation 3 c (new)
Citation 3 c (new)
- having regard to the Commission communication of 27 May 2020 entitled ‘Europe’s moment: Repair and Prepare for the Next Generation’ (COM(2020)456),
Amendment 4 #
2020/2076(INI)
Motion for a resolution
Citation 3 d (new)
Citation 3 d (new)
- having regard to the findings of the Digital Economy and Society Index 2020, published on the 11th of June 2020,
Amendment 5 #
2020/2076(INI)
Motion for a resolution
Citation 4 a (new)
Citation 4 a (new)
- having regard to the Commission communication of 27 May 2020 entitled ‘Adjusted Commission Work Programme 2020’ (COM(2020)440),
Amendment 38 #
2020/2076(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the Union requires a new industrial strategy that makes its industries more globally competitive, resilient, digital and environmentally sustainable driven by knowledge-based innovation and equality principles; whereas such a strategy should cover the transition of European industries to digitalisation and climate-neutrality, prioritising the ‘energy efficiency first’ principles, energy savings and renewable energy technologies;
Amendment 43 #
2020/2076(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the social market economy model has importantly contributed to the prosperity of Europe; whereas such an approach should be preserved in the policies dealing with the digital and environmental transition;
Amendment 57 #
2020/2076(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas in the European Union there are still “missing entrepreneurs”, such as youth, migrants, senior, women, whose entrepreneurial potential still needs to be fully developed; whereas the Union’s industrial strategy could represent an opportunity to foster the entrepreneurial culture of under- represented or disadvantaged categories and to enable them to fully contribute to the digital and environmental transition;
Amendment 59 #
2020/2076(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas according to the World Economic Forum’s Future of Jobs report, 65% of children entering primary school today will ultimately end up working in completely new types of jobs that do not yet exist today; whereas education systems have to put in a position to impart the universal knowledge and skills required for this new form of careers;
Amendment 76 #
2020/2076(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the COVID-19 pandemic and its fallout have created an unprecedented economic downturn in Europe, which risks to exacerbate inequalities and social tension in the European Union, especially among the most vulnerable citizens; whereas in this context any future- looking industrial strategy should start by addressing industrial recovery;
Amendment 80 #
2020/2076(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the COVID-19 pandemic and its fallout have created an unprecedented economic downturn in Europe; whereas in this context any future- looking industrial strategy should start by addressing industrial recovery, with a strong social and environmental approach;
Amendment 83 #
2020/2076(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the COVID-19 crisis has shown the crucial role of digital assets, including connectivity and networks, as well as of digital skills, as a tool enabling workers and companies to adapt the way they carry out their tasks and operations to the emergency situation; whereas the resilience of the digital infrastructure and the enhancement of the digital skills of the workforce are priority areas to boost the competitiveness of the European enterprises, especially SMEs;
Amendment 114 #
2020/2076(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Is of the opinion that digital and environmental transitions should be at the very core of all Unions strategies until 2050; in this context, calls on the Commission to define a comprehensive industrial strategy which manages these transitions, fosters transformation and guarantees the Union’s strategic autonomy, leaving no one behind;
Amendment 126 #
2020/2076(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Is aware that market dynamics alone do not bridge the fractures created during the transformation process if there is no proper management of the transitions and no strong industrial policies; is, furthermore, aware that while markets, competition and innovation push fast towards transformation, it is society and the environment that face the impact of these transformations; considers that balancing out the number of jobs lost in traditional industries with new jobs created in the digital and environmental sectors is not enough in itself as these new jobs are neither created in the same regions nor taken up by the same workers, specially taking into account the gender disparities in the labour market which have an effect on the mobility or relocation capacity of workers; calls on the Commission, therefore, to ensure that these transitions are fair and socially just, and that every action aimed at accelerating a transformation process (digital, environmental, etc.) is accompanied by a corresponding initiative to up-skill and reskill workers and to invest in alternative economic sectors specially in some regions with high unemployment and less diversified economies, with the aim of managing the effects produced by that accelerated process on both regions and people;
Amendment 129 #
2020/2076(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Is aware that market dynamics alone do not bridge the fractures created during the transformation process if there is no proper management of the transitions and no strong industrial policies; is, furthermore, aware that while markets, competition and innovation push fast towards transformation, it is society and the environment that face the impact of these transformations; considers that balancing out the number of jobs lost in traditional industries with new jobs created in the digital and environmental sectors is not enough in itself as these new jobs are neither created in the same regions nor taken up by the same workers; calls on the Commission, therefore, to ensure that these transitions are fair and socially just, and that every action aimed at accelerating a transformation process (digital, environmental, etc.) is accompanied by a corresponding initiative to up-skill and reskill workers, with the aim of managing the effects produced by that accelerated process on both regions and people; underlines in this regard the importance of lifelong learning to guarantee the permanence of workers in the labour market;
Amendment 140 #
2020/2076(INI)
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Considers the EU industrial policy of the Union can only succeed through integrated strategic planning, pooling the resources of European players, regional and local institutions, industrial clusters, social partners, universities and research groups; highlights in this context the importance of support structures such as SME networks, regional development agencies, innovation clusters and start-up counselling for the creation of local and regional industrial value chains;
Amendment 147 #
2020/2076(INI)
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Underlines that in order to gain or maintain global leadership in strategic industrial sectors and with regard to certain technologies, especially those with a high value-added, Europe needs to provide sufficient resources for research and innovation, including the Horizon Europe programme; recalls the positive spill-over effects of innovation efforts with regard to the quantity and especially the quality of jobs;
Amendment 155 #
2020/2076(INI)
Motion for a resolution
Paragraph 3
Paragraph 3
3. Considers, in the current context, that the Union requires a new, tailor-made industrial strategy that focuses on two distinct phases; the first aimed at recovery and the second aimed at reconstruction and transformation; calls on the Commission, therefore, to adapt the strategy published in March 2020 to the current situation and address both phases, while keeping the digital and environmental objectives as priorities throughout and ensuring synergies between the two to guarantee resource efficiency and achieve the circularity in industrial processes;
Amendment 163 #
2020/2076(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Believes that the new long-term strategy for Europe’s industrial future should contribute to combating the gender pay gap and the gender pension gap that still affect the European labour market and, more generally, the European society; calls on the Commission to take into due account the gender dimension in the implementation of the European industrial strategy - both in the recovery and in the reconstruction and transformation phases, including the use of gender budgeting tools in the definition of the financial instruments supporting the industrial and economic growth of the European Union;
Amendment 167 #
2020/2076(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Reiterates that, in order to ensure a long-term and sustainable industrial future for the European Union, it is key to focus on the enhancement of the skills and of the entrepreneurial capacity of the EU citizens as a powerful form to support their labour market participation;
Amendment 179 #
2020/2076(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Welcomes the Temporary State Aid framework as a way to promptly transfer liquidity where urgently needed; calls on the Commission nonetheless to ensure that the aid provided in the emergency phase does not lead to permanent distortions in the single market or generate inequalities between industrial enterprises from different Member States;
Amendment 185 #
2020/2076(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Stresses that the Union and the Member States must stand united to foster the position of the European industry in the world, creating a broad competitive industrial base in line with the 2050 climate neutrality target; underlines that quality job creation, social protection, well-functioning public services and the rule of law play an important role for thriving industrial activities in this context;
Amendment 199 #
2020/2076(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Underlines, moreover, that emergency assistance in the wake of a crisis situation, such as Covid-19, should only be provided to undertakings that respect applicable collective agreements and to companies that refrain from buying back shares, paying dividends to shareholders and giving bonuses to executives, and that are not registered in tax havens;
Amendment 216 #
2020/2076(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Calls on the Commission to include in the recovery plan a strategy to redeploy industries in Europe and to relocate industrial production in strategic sectors; calls, moreover, on the Commission to adopt a stronger stance on unfair global competition and predatory acquisitions by SOEs and sovereign funds; is of the opinion that, in this context, the Union should implement a provisional TDI scheme, also to ensure the level playing field within the European Single Market;
Amendment 280 #
2020/2076(INI)
Motion for a resolution
Paragraph 9 – point a
Paragraph 9 – point a
a. has sufficient financial capacity to offset the damage caused by the COVID- 19 crisis to European industries to mitigate the short-term working capital shortage and to push forward capital investment in the medium and long-term in order to support the transition to the green economy and catalyse the digital transformation;
Amendment 287 #
2020/2076(INI)
Motion for a resolution
Paragraph 9 – point a a (new)
Paragraph 9 – point a a (new)
aa. has a specific focus on small and medium enterprises, which have been hit the hardest by the COVID-19 crisis, and support their access to finance;
Amendment 295 #
2020/2076(INI)
Motion for a resolution
Paragraph 9 – point b a (new)
Paragraph 9 – point b a (new)
ba. takes into account the specificities of the Member States, which have been hit by the crisis in diverse ways;
Amendment 343 #
2020/2076(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Commission to carry out a detailed impact assessment of the potential costs and burdens for European companies and SMEs and the impact in employment before presenting new proposals for legislation or adopting new measures; calls on the Commission to propose commensurate support to the affected sectors whenever a negative impact cannot be avoided;
Amendment 384 #
2020/2076(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Highlights the potential of the circular economy for modernising the Union’s economy, reducing its energy and resource consumption and transforming whole industrial sectors and their value chains; underlines that the renovation wave will represent another relevant opportunity for many sectors and for the European society during its environmental transition due to the very high multiplier and leverage effect of the construction industry on other economic sectors;
Amendment 544 #
2020/2076(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Considers it imperative to digitalise the Union’s industries, including traditional ones; calls on the Commission to invest, inter alia, in the data economy, artificial intelligence, smart production, mobility, and resilient and secure very high-speed networks, paying special attention to encouraging women's participation as these are areas in which women are still under-represented; invites the Commission, in this respect, to assess the effectiveness of co- financed National Tax Credit schemes that could complement or replace traditional ‘on demand’ grants/tender-based support, especially for SMEs; highlights the importance of the European Regional Development Fund (ERDF) and the CohesionStructural and Investment Funds (CESIF) in supporting job creation, business competitiveness, economic growth and sustainable development as well as in enhancing the skills of European workers and in boosting the capacity of small and medium enterprises to make them able to successfully cope with the twin transitions so that no one will be left behind;
Amendment 558 #
2020/2076(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Regrets the still significant gap between large and small/medium enterprises with reference to the integration of digital technologies in their business operations, underlines that bridging this gap would constitute an improvement of the functioning of the internal market and would be beneficial for the overall European industrial competitiveness; calls on the Commission to assess and enhance the outreach of the European Digital Innovation Hubs, which - due to their knowledge of the local economic ecosystems - can represent an effective way to help SMEs digitalise;
Amendment 603 #
2020/2076(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Considers that industrial transformation requires the integration of new knowledge and innovation into existing markets and their use in the creation of new ones; regrets, in this respect, that the Union invests less in R&D as a percentage of GDP than its global competitors and that it suffers from a serious lack of innovative capacity in small and medium-sized enterprises due to a shortfall in the necessary risk capital; calls on the Commission to and to a shortage of adequate skills; calls on the Commission to enhance the pervasiveness of the innovation policies through the increase the budget for those programmes that underpin the transformation of the Union’s industry, including Horizon Europe, and to foster synergies between regional, national, European and private financial sources by taking advantage of synergies among all Union programmes;
Amendment 611 #
2020/2076(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Believes that social economy enterprises should be fully involved in the outcome of the industrial strategy since they create public value and leave an essential impact on the local communities they are grounded in; calls in this regard on the Commission to take into account the specificities of this category of enterprises in the design of the financial instruments under the Union investment programmes in order to support their access to finance;
Amendment 615 #
2020/2076(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Calls on the Commission to continue supporting the ability of European innovative companies to maintain effective protection for their R&D investments, secure fair returns, and in the longer term continue to develop open technology standards that support competition and choice; enhance Europe’s strategic autonomy and cybersecurity, as well as provide high- value employment;
Amendment 633 #
2020/2076(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Is of the opinion that ecosystems will be key components of the next industrial revolution, providing affordable and cleaner energy, transformative manufacturing and service-provision methods; believes, moreover, that supporting collaboration among industry, academia, SMEs, start-ups and scale-ups, trade unions, civil society, end-user organisations and all other stakeholders will be key to solving market failures and supporting efforts to cross the ‘valley of death’, including in areas not yet covered by industrial interests; recalls, in this regard, the importance of promoting the social dialogue and the consultation of workers in designing and implementing industrial policies, coherently with the European Pillar of Social Rights;
Amendment 658 #
2020/2076(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Considers public procurement to be a crucial driver of industrial transformation; calls on the Commission to study how to fully use the leverage of public expenditure and investment to achieve policy objectives, including by making environmental and social criteria mandatory in public procurement; calls also on the Commission to push for a more ambitious International Procurement Instrument that provides for reciprocity and mutual standards, promoting respect for intellectual property to encourage foreign trading partners committing to an equally high level of protection as the EU;
Amendment 664 #
2020/2076(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Is of the opinion that - in order to make the reconstruction and transformation phase truly effective - the public administration should play a key role to ensure a business-friendly economic environment and to reduce the administrative burden on enterprises while ensuring the highest standards of transparency and workers’ safety; believes that e-government tools, digital innovation policies and the enhancement of digital skills should be promoted within the public sector and among its employees; calls on the Commission to ensure the exchange of national and regional best practices in the field, with specific reference to the public management of economic competitiveness;
Amendment 666 #
2020/2076(INI)
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Calls on the Commission that in order to better support European research and innovation, to continue to support flexibility in licensing which enables innovators to license in a manner that reflects the many different uses made of their technology. In order for the EU to become front runners in 5G and 6G, European companies need fair compensation so they can maintain their R&D efforts; calls on the Commission to consider the impact that the IP Action Plan could have on European contributors to standards development;
Amendment 679 #
2020/2076(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to adopt a strong Key Performance Indicator (KPI) system to analyse the ex-ante impact of Union regulations and instruments, and to monitor progress and results; underlines that the KPI system should be based on objectives that are specific, measurable, achievable, relevant and time-oriented;
Amendment 680 #
2020/2076(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission to adopt a strong Key Performance Indicator (KPI) system to analyse the ex-ante impact of Union regulations and instruments on fact- based evidence, and to monitor progress and results;
Amendment 696 #
2020/2076(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Calls on the Commission to ensure a strong governance of the industrial strategy, focusing on the fourteen industrial ecosystems identified and should include relevant stakeholders and representatives of the fourteen industrial ecosystems, together with representatives from Member States and EU institutions;
Amendment 8 #
2020/2071(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas the Treaties and the European Charter of Fundamental Rights state that everyone shall have access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices; whereas this right should be enforced for all citizens, including those living in the smaller Member States and in the most peripheral areas of the Union;
Amendment 10 #
2020/2071(INI)
Draft opinion
Recital A a (new)
Recital A a (new)
A a. whereas uncoordinated initiatives at national level, such as stockpiling and penalties, could lead to an increased risk of medicines shortage, while a pan- European coordinated approach and a close dialogue among all actors concerned is crucial to mitigate and prevent medicines shortage, as the covid- 19 crisis has demonstrated;
Amendment 40 #
2020/2071(INI)
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas the Treaties and the European Charter of Fundamental Right state that everyone shall have access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices; whereas this right should be enforced for all citizens, including those living in the smaller Member States and in the most peripheral areas of the Union;
Amendment 48 #
2020/2071(INI)
Draft opinion
Paragraph -1 (new)
Paragraph -1 (new)
-1. Calls on the Commission to publish without any further delays the roadmap on EU Pharmaceutical Strategy which will identify root causes of medicine shortages; urges the Commission to propose ambitious and specific regulatory measures with an objective of making medicines available, affordable, sustainable and equally accessible; calls on the Commission to promote measures which will increase EU security of supply of medicines and reduce dependency on third countries;
Amendment 56 #
2020/2071(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Calls on the Commission to coordinate a Pan-European response, with European Medicines Agency (EMA), National Competent Authorities (NCAs), Member States, the pharmaceutical industry and all players in the pharmaceutical supply chain; a coordinated EU response is of utmost importance to coordinate Members States policy measures to individual and uncoordinated national measures to address medicines shortages root causes and prevent them in the long term as well as to ensure the right of patients to universal, equitable, affordable, effective, safe and timely access to essential medicines, as well as to guarantee the sustainability of the EU public healthcare systems;
Amendment 74 #
2020/2071(INI)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Calls on the Commission to preserve a competitive research-based pharmaceutical industry taking into account that EU remains by far the world leader manufacturing region of active ingredients for on patent medicines;
Amendment 90 #
2020/2071(INI)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Stresses the importance of ensuring the smooth functioning of the Internal Market in order to eliminate barriers to the access of medicines, medical devices and protective equipment to all citizens, especially those living in Member States that, due to their small size or to their remote position, heavily rely on imports and do not have easy access to the supply chain;
Amendment 93 #
2020/2071(INI)
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3 b. Whereas the coronavirus pandemic has highlighted Europe’s dependency on third countries for the production of essential medicines and medical devices, including active pharmaceutical ingredients(APIs), calls on the Commission to provide adequate financial resources under Horizon Europe and other EU programs to strengthen Union’s R&I activities supporting manufacturing in key industrial sectors, such as the pharmaceutical industry; calls on the Commission to reduce the R&I divide within the Union by ensuring broad geographical coverage and participation of low R&I performing Member States in collaborative projects; underlines that Horizon Europe and other EU programs need to support rare diseases through increased research, clinical trials, best practices sharing, and medication development; insists that research, best practices, clinical trials, and medication pertaining to rare diseases be made accessible for the benefit of citizens of all the Member States;
Amendment 107 #
2020/2071(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Having regard to the European Strategy for Data and the digital transformation of healthcare, urges the Commission to promote implementation of interoperable technologies in the Member State’s health sector which will facilitate delivery of innovative health solutions to patients; encourages the creation of a fully operational European Health Data Space with a governance framework which fosters creation of an innovative data-driven ecosystem and which encourages sharing of information and critical data across the Union; asks the Commission to promote next generation standards, tools and infrastructure to store and process data suitable for research and the development of innovative products and services, while ensuring processing of patients personal data is in compliance with European data protection framework;
Amendment 115 #
2020/2071(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
4 b. Calls on the Commission to take stock of the impact of coronavirus on industry and SMEs and to present a renewed EU industrial strategy; considers that the industrial recovery of Europe needs to prioritize twin digital and ecological transformation of our societies and building of resilience to external shocks; stresses the importance of promoting private-public partnerships in high value-added and innovative sectors, such as the pharmaceutical industry; stresses the importance of manufacturing for jobs, growth and competitiveness;
Amendment 127 #
2020/2071(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Notes with concern market failure in several Members States where patients' access to effective and affordable medicines and medical devices remains threatened by very high and often unsustainable price levels, market withdrawal of products that are out-of- patent or a failure to introduce new products to national markets due to business strategies; recognises that access to medicines and medical devices in the Member States with smaller markets requires particular consideration in the new EU Pharmaceutical Strategy;
Amendment 129 #
2020/2071(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. In order to support Member States in the prevention of medicine shortages, calls on the Commission to develop targeted EU Guidelines on procurement of medicines by putting in place the right economic framework, under the EU public procurement Directive 2014/24/EU, aimed at ensuring long term sustainability, competition, security of supply and stimulating investments in manufacturing;
Amendment 137 #
2020/2071(INI)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. Taking into account that timely notification of shortage of medicines is essential for ensuring alternative treatments for patient care and for mitigating negative effects on the security of supply, calls on the Commission to introduce obligation for marketing authorization holders to notify shortage of medicines to the competent authorities at a minimum two months in advance;
Amendment 144 #
2020/2071(INI)
Draft opinion
Paragraph 5 c (new)
Paragraph 5 c (new)
5 c. Calls on the Commission to expand its joint European response to include joint procurement actions for all developed vaccines, medication, medical equipment and medical technology; insists that this joint response be a priority post-pandemic, and be easily accessible for citizens in every Member State especially those that are particularly vulnerable from a public health and economical perspective due to their remote location or small size;
Amendment 294 #
2020/2071(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and to support local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential production sites in the EU;
Amendment 320 #
2020/2071(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Commission to publish without any further delays the EU Pharmaceutical Strategy which will identify root causes of medicine shortages; urges the Commission to propose ambitious and specific regulatory measures with an objective of making medicines available, affordable, sustainable and equally accessible; calls on the Commission to promote measures which will increase EU security of supply of medicines and reduce dependency on third countries;
Amendment 445 #
2020/2071(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Calls for links to be established between the pharmaceutical industry and other production sectors, such as farming, in a bid to develop the production of active ingredients in the EU; calls for efforts to counter over-specialisation in certain sectors and for substantial investment in research, the bioeconomy and biotechnology, for the purposes of resource diversification; considers that the industrial recovery of Europe needs to prioritize twin digital and ecological transformation of our societies and building of resilience to external shocks;
Amendment 703 #
2020/2071(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Calls for an electronic information notice to be drawn up in all the Union languages for every medicine on the EU m's Single Market, in order to facilitate sales of medicines between Member States; recommends the provision of more comprehensive information on the origin of medicines;
Amendment 705 #
2020/2071(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Stresses the importance of ensuring the smooth functioning of the Single Market in order to eliminate barriers to the access of medicines, medical devices and protective equipment to all citizens, especially those living in Member States that, due to their small size or to their remote position, heavily rely on imports and do not have easy access to the supply chain;
Amendment 1 #
2020/2070(INI)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the announcement of a renovation wave as part of the European Green Deal; urges the Commission to present it as planned, given that it is a key element of the post-COVID-19 recovery plan; calls on the Member States to step up large-scale renovation plans under the national energy and climate plans (NCEPs)highlights that the renovation wave and the post-Covid-19 recovery plan must be fully in line with the Union s climate and environmental objectives; calls on the Member States to step up large-scale renovation plans under the national energy and climate plans (NCEPs); recalls that buildings account for 40% of energy consumed and that according to the Communication on the European Green Deal, the current renovation rate will need at least to double to reach the EUs energy efficient and climate objectives; calls on the Member States to substantially increase their renovation rates from the current 0.4 to 1.2% emphasises that the buildings and construction sectors should full contribute to the achievement of the Unions revised climate objectives in line with the Climate Law;
Amendment 19 #
2020/2070(INI)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Emphasises the essential role of long-term renovation strategies (LTRSs) in achieving a decarbonised building stock with nearly zero-energy buildings, and in ensuring the readiness of Member States to increase renovation targets, consider that the LTRSs should be aligned with the increased climate ambitions and the objectives of achieving climate neutrality by 2050;
Amendment 24 #
2020/2070(INI)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Highlights that Covid-19 pandemic has recalled the importance of a stronger and a more coordinated Union action on health; believes that this should also be reflected in the building sector in areas such as air quality; recalls that the renovation wave can be an important tool in improving the health and wellbeing of people while reducing emissions of buildings;
Amendment 64 #
2020/2070(INI)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Underlines the importance of urgently replacing and phasing out the use of hazardous substances in construction materials and manufacturing in order to protect the health of occupants and workers as well as the environment.;
Amendment 68 #
2020/2070(INI)
Draft opinion
Paragraph 4 b (new)
Paragraph 4 b (new)
Amendment 70 #
2020/2070(INI)
Draft opinion
Paragraph 5
Paragraph 5
5. Notes that in addition to emission reduction and improved energy efficiency, building renovation projects should contribute to the potential for better health conditions; emphasiszes that the revision of ambient air quality standards canin line with WHO standards should be undertaken to also improve indoor air quality criteria and environment quality guidelines for buildings could protect human health lead to improvements in indoor environmental conditions and help tackle energy poverty;
Amendment 76 #
2020/2070(INI)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Stressed that the renovation wave and the related upcoming initiatives should have as one of the core objectives ending energy poverty and ensuring healthy and safe living conditions for all; welcomes the intention of the Commission to pay particular attention to the renovation of social housing, to help households who struggle to pay their energy bills; calls for the setting of a specific renovation target and funding measures in tackling energy poverty;
Amendment 85 #
2020/2070(INI)
Draft opinion
Paragraph 6
Paragraph 6
6. EmphasisRecognizes the potential, in terms of overcoming the current fragmentation in the market, of creating a common energy and environmental building passport; stresses further that it should include the circular capacity of materials of the "Building Renovation Passports" scheme in improving energy efficiency of the building stock and in providing owners with a long-term roadmap for deep renovations and deems such a scheme complementary to the energy performance certificate;
Amendment 96 #
2020/2070(INI)
Draft opinion
Paragraph 7
Paragraph 7
7. Stresses that all buildings should be made resilient and climate-proof; considers that vulnerable homeowners, and housing associations should be supported in climate-proofing their building stock, for example through grants or financial instruments based on the additionalitycombination of mMultiannual financial framework (MFF) funding, national budgets and private sector sources;
Amendment 105 #
2020/2070(INI)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Stresses the importance of independent, high quality one-stop-shop type of technical assistance for private home owners, the housing sector and public building owners, including municipalities, on decarbonisation and maximising energy-efficiency and sustainability of buildings;
Amendment 108 #
2020/2070(INI)
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
Amendment 1 #
2020/2012(INL)
Draft opinion
Recital A
Recital A
A. Whereas the Union is founded on the ethical values stated in Article 2 of the Treaty on European Union;
Amendment 3 #
2020/2012(INL)
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. Whereas rapid advances in contemporary scientific research and innovation in the fields of environment, health and food safety have raised a number of important ethical, legal and social issues that affect the relationship between science and society;
Amendment 4 #
2020/2012(INL)
Draft opinion
Recital A b (new)
Recital A b (new)
Ab. Whereas environment, health and food safety research and innovation activities carried out in Europe must comply with ethical principles and relevant national, Union and international legislation, including the Charter of Fundamental Rights of the European Union and the European Convention on Human Rights and its Supplementary Protocols1a; _________________ 1aArticle 19 of Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC Text with EEA relevance
Amendment 8 #
2020/2012(INL)
Draft opinion
Recital B
Recital B
B. Whereas the artificial intelligence (AI) global leadership race, which will determine the source of ethical values and standards shaping the sector worldwide, is picking up the pace and the Union should set an example for the rest of the world;
Amendment 11 #
2020/2012(INL)
Draft opinion
Recital B a (new)
Recital B a (new)
Amendment 17 #
2020/2012(INL)
Draft opinion
Recital C
Recital C
C. Whereas AI solutions may benefit society in the areas of green transition, environment protection,and biodiversity protection, circular economy and waste management, climate change, energy management and efficiency, water and air quality, e.g. smart grids and electro-mobilityarth observation and risk management, among others;
Amendment 20 #
2020/2012(INL)
Draft opinion
Recital C a (new)
Recital C a (new)
Ca. Whereas in its digital package published on 19 February 2020 the Commission states that ICT today accounts for between 5% and 9% of global electricity consumption and 2% of CO2 emissions and that the volume of data transferred and stored will continue to grow exponentially in the years to come; whereas the 2018 Joint Research Centre study “Artificial Intelligence/A European Perspective” estimates that data centres and data transmission could account for 3-4% of all power consumption of the Union;
Amendment 23 #
2020/2012(INL)
Draft opinion
Recital C b (new)
Recital C b (new)
Amendment 26 #
2020/2012(INL)
Draft opinion
Recital C c (new)
Recital C c (new)
Cc. Whereas properly regulated AI would help guide efforts to achieve the UN SDGs and help reach the climate objectives of the Paris Agreement;
Amendment 29 #
2020/2012(INL)
Draft opinion
Recital D
Recital D
D. Whereas AI can be applied to almost any field in medicine: biomedical research, exemplified by the AI-discovered antibiotic Halicin or AI contributions to new cancer prevention, more precise diagnosis and new therapies, medical education, clinical decision-making, personalized medicine, psychiatric diagnosis and treatment, in revolutionizing robotic prostheses and support systems, telemedicine, telesurgery and the overall efficiency of the health systems;
Amendment 40 #
2020/2012(INL)
Draft opinion
Recital E
Recital E
E. Whereas current policy and ethical guidelines for AI are lagging behind ethical challenges that must be identified and mitigated, since AI has tremendous capability to threaten patient preference, safety, and privacy; whereas the boundaries between the roles of physicianmedical professionals and carers and machines in patient care need to be outlined;
Amendment 48 #
2020/2012(INL)
Draft opinion
Recital F
Recital F
F. Whereas AI solutions may benefit society in the area of food safety and Farming 2.0, where the Union holds leadership in AI applications, especially in areas where water resources are scarce and climate change has severe impacts;
Amendment 63 #
2020/2012(INL)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Underlines the importance of the “right to explanation” of any decision taken by automated processing, this is the right to obtain human intervention on the part of the controller, to express his or her point of view and to contest the decision taken by an automated system4a; states, therefore, that ultimately, humans should keep the responsibility for decision making, especially in sectors where there are high stakes and risks such as health; _________________ 4a Article 22 GDPR Regulation
Amendment 75 #
2020/2012(INL)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Highlights that many of the proposals by countries which are not members of the Union and by international organizations revolve around common principles or concepts for AI, those being: human-centricness, trustworthiness, respect for human autonomy, harm prevention, equity and "no one left behind" and explicability; is of the opinion that an international ethical framework around these principles would be highly desirable; is concerned about AI progress and innovations leading to social inequality if no action is taken; calls therefore on the Commission and Member States to take the necessary measures to leave no one behind in the transition to a digital Europe, and to guarantee a fair, affordable and equal access to these innovations especially in areas such as healthcare;
Amendment 98 #
2020/2012(INL)
Draft opinion
Paragraph 4
Paragraph 4
4. Notes that, with the rapid development of AI and the uncertainty that lies ahead, a common Union AI ethical framework will expand an ecosystem of trust as defined in the Commission White Paper, whether in environment protection, healthcare or food safety applications, thus supporting the ecosystem of excellence in legal certainty and providing effective response to the challenges yet not defined in courtrooms, management meetings or scientific laboratories; points out that ethics is not made up of permanent principles, but has been changing over the course of various cultures and times; supports in this regard that the framework should be periodically reviewed to guarantee its applicability through time and new developments;
Amendment 115 #
2020/2012(INL)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Considers that in areas such as health, liability must ultimately lie with a natural or legal person; emphasizes the need for traceable and publicly available training data for algorithms;
Amendment 118 #
2020/2012(INL)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Emphasises that patients should know when and how they are interacting with a human professional and when they are not; insists that patients should have the freedom to decide about this interaction and should be offered an alternative of equal standard;
Amendment 123 #
2020/2012(INL)
Draft opinion
Paragraph 6
Paragraph 6
6. Calls for citizen and patient empowerment regarding their personal data and for securing the full enforcement of Union legal framework on data protection and privacy, relevant notably in the healthcare AI applications and related sensitive data, to strengthen the “Right to an explanation” foreseen in Article 22 of Regulation (EU) 2016/679 of the European Parliament and of the Council (General Data Protection Regulation, (GDPR))2 and higher interpretability requirements for high-risk AI; _________________ 2Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
Amendment 128 #
2020/2012(INL)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Highlights, in the healthcare sector, that data originated from patients using AI technologies should fulfil all the privacy requirements as stipulated in the GDPR, and that by no means, the data generated should contribute to any kind of discrimination (known or novel); calls on the Commission and Member States to guarantee that data accessibility to private companies, such as health or life insurance companies, is prevented and that the “right to be forgotten” of patients is fully respected;
Amendment 153 #
2020/2012(INL)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Points out that the use of tracking and contact tracing technologies by public authorities during the COVID 19 crisis and other potential health emergencies might conflict with data protection; recalls in this regard the Commission Guidance on applications supporting the fight against the COVID 19 pandemic in relation to data protection and the need for proportionality, limitation in time, alignment with European values and respect of human dignity and fundamental rights;
Amendment 156 #
2020/2012(INL)
Draft opinion
Paragraph 8 b (new)
Paragraph 8 b (new)
8b. Highlights that AI and robotics can bring numerous benefits to our environment, health and food safety as the dematerialisation of the economy makes the Union less dependent on raw materials or on the increased use of personalised medicine; underlines however, that their carbon footprint remains still high; calls on the Commission to carry out a study on the impact of AI technology’s carbon footprint and the positive and negative impacts of the transition to the use of AI technology by consumers; further calls on the Commission to include the footprint information in the common European Dataspace for Smart Circular Applications foreseen in the EU Action Plan on Circular Economy and to deal specifically with these technologies within the ICT key value chain of the above- mentioned plan;
Amendment 163 #
2020/2012(INL)
Draft opinion
Paragraph 9
Paragraph 9
9. Calls for securing sufficient financing for the Union AI transformation; supports the ambitions laid out in the Commission White Paper to attract €200 billion of AI public and private investment in the next 10 years in the Union; welcomes the attention granted to deficits of AI ecosystems in less-developed regions and to the needs of SMEs and start-ups; calls on the Commission to facilitate geographically balanced access to allidentify public infrastructure and promote the prioritization of AI funding, in cluding for SMEs and start- upsimate change mitigation and adaptation, renewable energies and health; stresses that the new Union objectives must not diminish Union engagement in its long standing priorities, like the CAP or, Cohesion Policy., the Green Deal and the COVID19 Recovery Plan;
Amendment 75 #
2020/0361(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) Therefore, in order to safeguard and improve the functioning of the internal market, a targeted set of uniform, clear, effective and proportionate mandatory rules should be established at Union level. This Regulation provides the conditions for innovative digital services to emerge and to scale up in the internal market. The approximation of national regulatory measures at Union level concerning the requirements for providers of intermediary services is necessary in order to avoid and put an end to fragmentation of the internal market and to ensure legal certainty, thus reducing uncertainty for developers and fostering interoperability. By using requirements that are technology neutral, innovation should not be hampered but instead be stimulated.
Amendment 78 #
2020/0361(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Such a substantial connection to the Union should be considered to exist where the service provider has an establishment in the Union or, in its absence, on the basis of the existence of a significant number of users in one or more Member States, orctivities or on the targeting of activities towards one or more Member States. The targeting of activities towards one or more Member States can be determined on the basis of all relevant circumstances, including factors such as the use of a language or a currency generally used in that Member State, or the possibility of ordering products or services, or using a national top level domain. The targeting of activities towards a Member State could also be derived from the availability of an application in the relevant national application store, from the provision of local advertising or advertising in the language used in that Member State, or from the handling of customer relations such as by providing customer service in the language generally used in that Member State. A substantial connection should also be assumed where a service provider directs its activities to one or more Member State as set out in Article 17(1)(c) of Regulation (EU) 1215/2012 of the European Parliament and of the Council27 . On the other hand, mere technical accessibility of a website from the Union cannot, on that ground alone, be considered as establishing a substantial connection to the Union. _________________ 27 Regulation (EU) No 1215/2012 of the European Parliament and of the Council of 12 December 2012 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters (OJ L351, 20.12.2012, p.1).
Amendment 85 #
2020/0361(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to achieve the objective of ensuring a safe, predictable and trusted online environment, for the purpose of this Regulation the concept of “illegal content” should be defined broadly and also covers information relating to illegal content, products, services and activities. In particular, that concept should be understood to refer to information, irrespective of its form, that under the applicable Union or national law is either itself illegal, such as illegal hate speech or terrorist content and unlawful discriminatory content, or that relates to activities that are illegal, such as the sharing of images depicting child sexual abuse, unlawful non- consensual sharing of private images, online stalking, the sale of non-compliant or counterfeit products, the non-authorised use of copyright protected material or activities involving infringements of consumer protection law. In this regard, it is immaterial whether the illegality of the information or activity results from Union law or from national law that is consistent with Union law and what the precise nature or subject matter is of the law in question.
Amendment 89 #
2020/0361(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Considering the particular characteristics of the services concerned and the corresponding need to make the providers thereof subject to certain specific obligations, it is necessary to distinguish, within the broader category of providers of hosting services as defined in this Regulation, the subcategory of online platforms. Online platforms, such as social networks or, online marketplaces or search engines, should be defined as providers of hosting services that not only store information provided by the recipients of the service at their request, but that also disseminate that information to the public, again at their request. However, in order to avoid imposing overly broad obligations, providers of hosting services should not be considered as online platforms where the dissemination to the public is merely a minor and purely ancillary feature of another service and that feature cannot, for objective technical reasons, be used without that other, principal service, and the integration of that feature is not a means to circumvent the applicability of the rules of this Regulation applicable to online platforms. For example, the comments section in an online newspaper could constitute such a feature, where it is clear that it is ancillary to the main service represented by the publication of news under the editorial responsibility of the publisher.
Amendment 98 #
2020/0361(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The exemptions from liability established in this Regulation should not apply where, instead of confining itself to providing the services neutrally, by a merely technical and, automatic and passive processing of the information provided by the recipient of the service, the provider of intermediary services plays an active role of such a kind as to give it knowledge of, or control over, that information. Those exemptions should accordingly not be available in respect of liability relating to information provided not by the recipient of the service but by the provider of intermediary service itself, including where the information has been developed under the editorial responsibility of that provider or where the provider of the service promotes and optimises the content.
Amendment 99 #
2020/0361(COD)
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18 a) The exemptions from liability should also not be available to providers of intermediary services that do not comply with the due diligence obligations set out in this Regulation. The conditionality should further ensure that the standards to qualify for those exemptions contribute to a high level of safety and trust in the online environment in a manner that promotes a fair balance of the rights of all stakeholders.
Amendment 104 #
2020/0361(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) In order to benefit from the exemption from liability for hosting services, the provider should, upon obtaining actual knowledge or awareness of illegal content, act expeditiously to remove or to disable access to that content. The removal or disabling of access should be undertaken in the observance of the principle of freedom of expressions enshrined in the Charter of Fundamental Rights, including freedom of expression. Where the illegal content can cause significant public harm, the provider should assess and, when necessary, remove or disable access to that content within 24 hours and, in any case, not more than one hour after receiving a removal order from the competent authority. The provider can obtain such actual knowledge or awareness through, in particular, its periodic own- initiative investigations or notices submitted to it by individuals or entities in accordance with this Regulation in so far as those notices are sufficiently precise and adequately substantiated to allow a diligent economic operator to reasonably identify, assess and where appropriate act against the allegedly illegal content.
Amendment 107 #
2020/0361(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) In order to ensure the effective protection of consumers when engaging in intermediated commercial transactions online, certain providers of hosting services, namely, online platforms that allow consumers to conclude distance contracts with traders, should not be able to benefit from the exemption from liability for hosting service providers established in this Regulation, unless they comply with a number of specific requirements set out in this Regulation, including the appointment of a legal representative in the Union, the implementation of notice and action mechanisms, the traceability of traders using their services, the provision of information on their online advertising and their recommender system practices and policy as well as transparency requirements towards the consumers as laid down in Directive 2011/83/EU. In addition, they should not be able to benefit from the exemption from liability for hosting service providers establishing in this Regulation, in so far as those online platforms present the relevant information relating to the transactions at issue in such a way that it leads consumers to believe that the information was provided by those online platforms themselves or by recipients of the service acting under their authority or control, and that those online platforms thus have knowledge of or control over the information, even if that may in reality not be the case. In that regard, is should be determined objectively, on the basis of all relevant circumstances, whether the presentation could lead to such a belief on the side of an average and reasonably well-informed consumer.
Amendment 113 #
2020/0361(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) In order to create legal certainty and not to discourage activities aimed at detecting, identifying and acting against illegal content that providers of intermediary services may undertake on a voluntary basis, it should be clarified that the mere fact that providers undertake such activities does not lead to the unavailability of the exemptions from liability set out in this Regulation, provided those activities are carried out in good faith and in a diligent mannera diligent manner and accompanied by additional safeguards. In addition, it is appropriate to clarify that the mere fact that those providers take measures, in good faith, to comply with the requirements of Union or national law, including those set out in this Regulation as regards the implementation of their terms and conditions, should not lead to the unavailability of those exemptions from liability. Therefore, any such activities and measures that a given provider may have taken should not be taken into account when determining whether the provider can rely on an exemption from liability, in particular as regards whether the provider provides its service neutrally and can therefore fall within the scope of the relevant provision, without this rule however implying that the provider can necessarily rely thereon.
Amendment 116 #
2020/0361(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) Since 2000, new technologies have emerged that improve the availability, efficiency, speed, reliability, capacity and security of systems for the transmission and storage of data online, leading to an increasingly complex online ecosystem. In this regard, it should be recalled that providers of services establishing and facilitating the underlying logical architecture and proper functioning of the internet, including technical auxiliary functions, can also benefit from the exemptions from liability set out in this Regulation, to the extent that their services qualify as ‘mere conduits’, ‘caching’ or neutral hosting services. Such services include, as the case may be, wireless local area networks, domain name system (DNS) services, top–level domain name registries, certificate authorities that issue digital certificates, or content delivery networks or providers of services deeper in the internet stack, such as IT infrastructure services (on-premise, cloud-based and or hybrid hosting solutions), that enable or improve the functions of other providers of intermediary services. Likewise, services used for communications purposes, and the technical means of their delivery, have also evolved considerably, giving rise to online services such as Voice over IP, messaging services and web-based e-mail services, where the communication is delivered via an internet access service. Those services, too, can benefit from the exemptions from liability, to the extent that they qualify as ‘mere conduit’, ‘caching’ or hosting service. Services deeper in the internet stack acting as online intermediaries could be required to take proportionate actions where the customer fails to remove the illegal content, unless technically impracticable.
Amendment 120 #
2020/0361(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) Providers of intermediary services should not be subject to a monitoring obligation with respect to obligations of a general nature. This does not concern monitoring obligations in a specific case and, in particular, does not affect orders by national authorities in accordance with national legislation, in accordance with the conditions established in this Regulation. Nothing in this Regulation should be construed as an imposition of a general monitoring obligation or active fact- finding obligation, or as a general obligation forimpeding upon the ability of providers to undertake proactive measures to relation to illegal contentidentify and remove illegal content and to prevent its reappearance.
Amendment 128 #
2020/0361(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) In order to facilitate smooth and efficient communications relating to matters covered by this Regulation, providers of intermediary services should be required to establish a single point of contact and to publish relevant information relating to their point of contact, including the languages to be used in such communications. The point of contact can also be used by trusted flaggers and, by professional entities and by users of services which are under a specific relationship with the provider of intermediary services. In contrast to the legal representative, the point of contact should serve operational purposes and should not necessarily have to have a physical location .
Amendment 130 #
2020/0361(COD)
Proposal for a regulation
Recital 37
Recital 37
(37) Providers of intermediary services that are established in a third country that offer services in the Union should designate a sufficiently mandated legal representative in the Union and provide information relating to their legal representatives, so as to allow for the effective oversight and, where necessary, enforcement of this Regulation in relation to those providers. It should be possible for the legal representative to also function as point of contact, provided the relevant requirements of this Regulation are complied with. Providers of intermediary services that qualify as small or micro enterprises within the meaning of the Annex to Recommendation 2003/361/EC, and who have been unsuccessful in obtaining the services of a legal representative after reasonable effort, shall be able to stablish collective representation under the guidance of the Digital Service Coordinator of the Member State where the enterprise intends to establish a legal representative.
Amendment 131 #
2020/0361(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) Providers of hosting services play a particularly important role in tackling illegal content online, as they store information provided by and at the request of the recipients of the service and typically give other recipients access thereto, sometimes on a large scale. It is important that all providers of hosting services, regardless of their size, put in place easy to access and user-friendly notice and action mechanisms that facilitate the notification of specific items of information that the notifying party considers to be illegal content to the provider of hosting services concerned ('notice'), pursuant to which that provider shall assess the illegality of the identified content and, based on that assessment, can decide whether or not it agrees with that assessme notification for illegal content and wishes to remove or disable access to that content ('action'). In the event that the provider of hosting services assesses the notice of illegal content to be positive and thus decides to remove or disable access to it, it shall ensure that such content remains inaccessible after take down. Provided the requirements on notices are met, it should be possible for individuals or entities to notify multiple specific items of allegedly illegal content through a single notice. The obligation to put in place notice and action mechanisms should apply, for instance, to file storage and sharing services, web hosting services, advertising servers and paste bins, in as far as they qualify as providers of hosting services covered by this Regulation.
Amendment 137 #
2020/0361(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) Where a hosting service provider decides to remove or disable information provided by a recipient of the service, for instance following receipt of a notice or acting on its own initiative, including through the use of automated means, that provider should prevent the reappearance of the notified illegal information. The provider should also inform the recipient of its decision, the reasons for its decision and the available redress possibilities to contest the decision, in view of the negative consequences that such decisions may have for the recipient, including as regards the exercise of its fundamental right to freedom of expression. That obligation should apply irrespective of the reasons for the decision, in particular whether the action has been taken because the information notified is considered to be illegal content or incompatible with the applicable terms and conditions. Available recourses to challenge the decision of the hosting service provider should always include judicial redress.
Amendment 140 #
2020/0361(COD)
Proposal for a regulation
Recital 43
Recital 43
Amendment 144 #
2020/0361(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) Recipients of the service should be able to easily and effectively contest certain decisions of online platforms that negatively affect them. Therefore, online platforms should be required to provide for internal complaint-handling systems, which must ensure human review and meet certain conditions aimed at ensuring that the systems are easily accessible and lead to swift and fair outcomes. In addition, provision should be made for the possibility of out-of-court dispute settlement of disputes, including those that could not be resolved in satisfactory manner through the internal complaint- handling systems, by certified bodies that have the requisite independence, means and expertise to carry out their activities in a fair, swift and cost- effective manner and within a reasonable period of time. The possibilities to contest decisions of online platforms thus created should complement, yet leave unaffected in all respects, the possibility to seek judicial redress in accordance with the laws of the Member State concerned.
Amendment 148 #
2020/0361(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) Action against illegal content can be taken more quickly and reliably where online platforms take the necessary measures to ensure that notices submitted by trusted flaggers through the notice and action mechanisms required by this Regulation are treated with priority, without prejudice to the requirement to process and decide upon all notices submitted under those mechanisms in a timely, diligent and objective manner. Such trusted flagger status should only be awarded to entities, and not individuals, that have demonstrated, among other things, that they have particular expertise and competence in tackling illegal content and are known to flag content frequently with a high rate of accuracy, that they represent collective interests and that they work in a diligent, objective and objeffective manner. Such entities can be public in nature, such as, for terrorist content, internet referral units of national law enforcement authorities or of the European Union Agency for Law Enforcement Cooperation (‘Europol’) or they can be non-governmental organisations and semi- public bodies, such as the organisations part of the INHOPE network of hotlines for reporting child sexual abuse material and organisations committed to notifying illegal racist and xenophobic expressions online. For intellectual property rights, organisations of industry representing collective interests and of right- holders specifically created for that purpose could be awarded trusted flagger status, where they have demonstrated that they meet the applicable conditions and ensure independent public interest representation. The rules of this Regulation on trusted flaggers should not be understood to prevent online platforms from giving similar treatment to notices submitted by entities or individuals that have not been awarded trusted flagger status under this Regulation, from otherwise cooperating with other entities, in accordance with the applicable law, including this Regulation and Regulation (EU) 2016/794 of the European Parliament and of the Council.43 _________________ 43 Regulation (EU) 2016/794 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Law Enforcement Cooperation (Europol) and replacing and repealing Council Decisions 2009/371/JHA, 2009/934/JHA, 2009/935/JHA, 2009/936/JHA and 2009/968/JHA, OJ L 135, 24.5.2016, p. 53
Amendment 153 #
2020/0361(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) The misuse of services of online platforms by frequently providing manifestly illegal content or by frequently submitting manifestly unfounded notices or complaints under the mechanisms and systems, respectively, established under this Regulation undermines trust and harms the rights and legitimate interests of the parties concerned. Therefore, there is a need to put in place appropriate and proportionate safeguards against such misuse. Information should be considered to be manifestly illegal content and notices or complaints should be considered manifestly unfounded where it is evident to a layperson, without any substantive analysis, that the content is illegal respectively that the notices or complaints are unfounded. Under certain conditions, online platforms should temporarily suspend their relevant activities in respect of the person engaged in abusive behaviour. This is without prejudice to the freedom by online platforms to determine their terms and conditions and establish stricter measures in the case of manifestly illegal content related to serious crimes. For reasons of transparency, this possibility should be set out, clearly and in sufficiently detail, in the terms and conditions of the online platforms. Redress should always be open to the decisions taken in this regard by online platforms and they should be subject to oversight by the competent Digital Services Coordinator. The rules of this Regulation on misuse should not prevent online platforms from taking other measures to address the provision of illegal content by recipients of their service or other misuse of their services, in accordance with the applicable Union and national law. Those rules are without prejudice to any possibility to hold the persons engaged in misuse liable, including for damages, provided for in Union or national law.
Amendment 162 #
2020/0361(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) To ensure an efficient and adequate application of that obligation, without imposing any disproportionate burdens, the online platforms covered should make reasonable efforts to verify the reliability of the information provided by the traders concerned and by other intermediaries, such as advertising services, webhosting, domain name registrations, in particular by using freely available official online databases and online interfaces, such as national trade registers and the VAT Information Exchange System45 , or by requesting the traders concerned to provide trustworthy supporting documents, such as copies of identity documents, certified bank statements, company certificates and trade register certificates. They may also use other sources, available for use at a distance, which offer a similar degree of reliability for the purpose of complying with this obligation. However, the online platforms covered should not be required to engage in excessive or costly online fact-finding exercises or to carry out verifications on the spot. Nor should such online platforms, which have made the reasonable efforts required by this Regulation, be understood as guaranteeing the reliability of the information towards consumer or other interested parties. Such online platforms should also design and organise their online interface in a way that enables traders to comply with their obligations under Union law, in particular the requirements set out in Articles 6 and 8 of Directive 2011/83/EU of the European Parliament and of the Council46 , Article 7 of Directive 2005/29/EC of the European Parliament and of the Council47 and Article 3 of Directive 98/6/EC of the European Parliament and of the Council48 . _________________ 45 https://ec.europa.eu/taxation_customs/vies/ vieshome.do?selectedLanguage=en 46Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council 47Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to- consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’) 48Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers
Amendment 168 #
2020/0361(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) Online advertisement plays an important role in the online environment, including in relation to the provision of the services of online platforms. However, online advertisement can contribute to significant risks, ranging from advertisement that is itself illegal content, to contributing to financial incentives for the publication or amplification of illegal or otherwise harmful content and activities online, or the discriminatory display of advertising withat can have both an impact on the equal treatment and opportunities of citizens and on the perpetuation of harmful stereotypes and norms. Therefore, more transparency in online advertising markets and independent research needs to be carried out to assess the effectiveness of behavioural advertisements which could pave the way for stricter measures or restriction of behavioural advertising. In addition to the requirements resulting from Article 6 of Directive 2000/31/EC, online platforms should therefore be required to ensure that the recipients of the service have certain individualised information necessary for them to understand when and on whose behalf the advertisement is displayed. In addition, recipients of the service should have information on the main parameters used for determining that specific advertising is to be displayed to them, providing meaningful explanations of the logic used to that end, including when this is based on profiling. The requirements of this Regulation on the provision of information relating to advertisement is without prejudice to the application of the relevant provisions of Regulation (EU) 2016/679, in particular those regarding the right to object, automated individual decision-making, including profiling and specifically the need to obtain consent of the data subject prior to the processing of personal data for targeted advertising. Similarly, it is without prejudice to the provisions laid down in Directive 2002/58/EC in particular those regarding the storage of information in terminal equipment and the access to information stored therein.
Amendment 171 #
2020/0361(COD)
Proposal for a regulation
Recital 52 a (new)
Recital 52 a (new)
(52 a) Advertising systems used by very large online platforms pose particular risks and require further public and regulatory supervision on account of their scale and ability to target and reach recipients of the service based on their behaviour within and outside that platform’s online interface. Very large online platforms should ensure public access to repositories of advertisements displayed on their online interfaces to facilitate supervision and research into emerging risks brought about by the distribution of advertising online, for example in relation to illegal advertisements or manipulative techniques and disinformation with a real and foreseeable negative impact on public health, public security, civil discourse, political participation and equality. Repositories should include the content of advertisements and related data on the advertiser and the delivery of the advertisement, in particular where targeted advertising is concerned.
Amendment 186 #
2020/0361(COD)
Proposal for a regulation
Recital 62
Recital 62
(62) A core part of a very large online platform’s business is the manner in which information is prioritised and presented on its online interface to facilitate and optimise access to information for the recipients of the service. This is done, for example, by algorithmically suggesting, ranking and prioritising information, distinguishing through text or other visual representations, or otherwise curating information provided by recipients. Such recommender systems can have a significant impact on the ability of recipients to retrieve and interact with information online. They also play an important role in the amplification of certain messages, the viral dissemination of information and the stimulation of online behaviour. Consequently, very large online platforms should ensure that recipients are appropriately informed, and can influence the information presented to them. They should clearly and separately present the main parameters for such recommender systems in an clear, concise, accessible and easily comprehensible manner to ensure that the recipients understand how information is prioritised for them. They should also ensure that the recipients enjoy alternative options for the main parameters, including options that are not based on profiling of the recipient, and shall not make the recipients of their services subject to recommender systems based on profiling by default.
Amendment 188 #
2020/0361(COD)
Proposal for a regulation
Recital 63
Recital 63
Amendment 213 #
2020/0361(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b a (new)
Article 1 – paragraph 2 – point b a (new)
(b a) promote innovation and facilitate competition for digital services, while protecting users and consumers rights.
Amendment 214 #
2020/0361(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b b (new)
Article 1 – paragraph 2 – point b b (new)
(b b) stimulate the level playing field of the online ecosystem by introducing interoperability requirements for very large platforms.
Amendment 218 #
2020/0361(COD)
Proposal for a regulation
Article 1 – paragraph 5 – point i a (new)
Article 1 – paragraph 5 – point i a (new)
(i a) Charter of Fundamental Rights of the European Union
Amendment 221 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point d – introductory part
Article 2 – paragraph 1 – point d – introductory part
(d) ‘to offer services in the Union’ means enabling legal or natural persons in one or more Member States to use the services of the provider of information society services which has a substantial connection to the Union; such a substantial connection is deemed to exist where the provider has an establishment in the Union;, or in the absence of such an establishment, the assessment of a substantial connection is based on specific factual criteria, such as: where the provider targets its activities towards one or more Member States.
Amendment 222 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point d – indent 1
Article 2 – paragraph 1 – point d – indent 1
Amendment 223 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point d – indent 2
Article 2 – paragraph 1 – point d – indent 2
Amendment 232 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point h
Article 2 – paragraph 1 – point h
(h) ‘online platform’ means a provider of a hosting service which, at the request of a recipient of the service, stores and disseminates to the public information, unless that activity is a minor and purely ancillary feature of another service and, for objective and technical reasons cannot be used without that other service, and the integration of the feature into the other service is not a means to circumvent the applicability of this Regulation and govern themselves under specific terms and conditions.
Amendment 240 #
2020/0361(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point o
Article 2 – paragraph 1 – point o
(o) ‘recommender system’ means a fully or partially automated system used by an online platform to suggest, rank and prioritise information in its online interface specific information to recipients of the service, including as a result of a search initiated by the recipient or otherwise determining the relative order or prominence of information displayed;
Amendment 246 #
2020/0361(COD)
Proposal for a regulation
Article 4 – paragraph 1 – introductory part
Article 4 – paragraph 1 – introductory part
1. Where an information society service is provided that consists of the transmission in a communication network of information provided by a recipient of the service, the service provider shall not be liable for the automatic, intermediate and temporary storage of that information, performed for the sole purpose of making more efficient the information's onward transmission to other recipients of the service upon their request, on condition that the provider:
Amendment 247 #
2020/0361(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point a
Article 4 – paragraph 1 – point a
(a) the provider does not modify the information;
Amendment 248 #
2020/0361(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) the provider complies with conditions on access to the information;
Amendment 249 #
2020/0361(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) the provider complies with rules regarding the updating of the information, specified in a manner widely recognised and used by industry;
Amendment 250 #
2020/0361(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point d
Article 4 – paragraph 1 – point d
(d) the provider does not interfere with the lawful use of technology, widely recognised and used by industry, to obtain data on the use of the information; and
Amendment 252 #
2020/0361(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point e
Article 4 – paragraph 1 – point e
(e) the provider acts expeditiously to remove or to disable access to the information it has stored upon obtaining actual knowledge of the fact that the information at the initial source of the transmission has been removed from the network, or access to it has been disabled, or that a court or an administrative authority has ordered such removal or disablement.
Amendment 262 #
2020/0361(COD)
Proposal for a regulation
Article 5 – paragraph 4 a (new)
Article 5 – paragraph 4 a (new)
4 a. Providers of intermediary services shall be deemed ineligible for the exemptions from liability referred to in Articles 3, 4 and 5 when they do not comply with the due diligence obligations set out in this Regulation.
Amendment 267 #
2020/0361(COD)
Proposal for a regulation
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
Providers of intermediary services shall ensure that voluntary investigations or activities are accompanied with appropriate safeguards, such as human oversight, to ensure they are transparent, fair and non-discriminatory.
Amendment 268 #
2020/0361(COD)
Proposal for a regulation
Article 7 – title
Article 7 – title
No general monitoring or active fact- finding obligations without undermining the obligation to implement appropriate technical and organisational measures to ensure a level of security appropriate to the risk
Amendment 284 #
2020/0361(COD)
Proposal for a regulation
Article 11 – paragraph 5 a (new)
Article 11 – paragraph 5 a (new)
5 a. Providers of intermediary services that qualify as small or micro enterprises within the meaning of the Annex to Recommendation2003/361/EC, and who have been unsuccessful in obtaining the services of a legal representative after reasonable effort, shall be able to stablish collective representation under the guidance of the Digital Service Coordinator of the Member State where the enterprise intends to establish a legal representative.
Amendment 288 #
2020/0361(COD)
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. Providers of intermediary services shall include information on any restrictions that they imposethe activities undertaken by them in relation to the use of their service in respect of information provided by the recipients of the service, in their terms and conditions. That information shall include information on any policies, procedures, measures and tools used for the purpose of content moderation, including algorithmic decision-making and human review. It shall be set out in clear and unambiguous language and shall be publicly available in an easily accessible format.
Amendment 291 #
2020/0361(COD)
Proposal for a regulation
Article 12 – paragraph 2
Article 12 – paragraph 2
2. Providers of intermediary services shall act in a diligent, objective, necessary and proportionate manner in applying and enforcing the restrictionactivities referred to in paragraph 1, with due regard to the rights and legitimate interests of all parties involved, including the applicable fundamental rights of the recipients of the service as enshrined in the Charter.
Amendment 317 #
2020/0361(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Paragraph 1 shall not apply to providers of intermediary services that qualify as micro or small enterprises within the meaning of the Annex to Recommendation 2003/361/EC.
Amendment 323 #
2020/0361(COD)
Proposal for a regulation
Article 14 – paragraph 2 – introductory part
Article 14 – paragraph 2 – introductory part
2. The mechanisms referred to in paragraph 1 shall be such as to facilitate the submission of sufficiently precise and adequately substantiated notices, on the basis of which a diligent economic operator can identify and assess the illegality of the content in question. To that end, the providers shall take the necessary measures to enable and facilitate the submission of notices containing all of the following elements:
Amendment 324 #
2020/0361(COD)
Proposal for a regulation
Article 14 – paragraph 2 – point a
Article 14 – paragraph 2 – point a
(a) where necessary, an explanation of the reasons why the individual or entity considers the information in question to be illegal content;
Amendment 330 #
2020/0361(COD)
Proposal for a regulation
Article 14 – paragraph 2 – point b
Article 14 – paragraph 2 – point b
(b) a clear indication of the electronic location of that information, in particular the exactsuch as the URL or URLs, andor, where necessary, additional information enabling the identification of the illegal content;
Amendment 332 #
2020/0361(COD)
Proposal for a regulation
Article 14 – paragraph 2 – point d
Article 14 – paragraph 2 – point d
(d) a statement confirming the good faith beliefbest knowledge of the individual or entity submitting the notice that the information and allegations contained therein are accurate and complete.
Amendment 345 #
2020/0361(COD)
Proposal for a regulation
Article 14 – paragraph 6 a (new)
Article 14 – paragraph 6 a (new)
6 a. Providers of hosting services shall ensure that content previously identified as illegal following the mechanisms in paragraphs 1 and 2, remain inaccessible after take down.
Amendment 379 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) decisions to remove or disable access to the information or not;
Amendment 380 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) decisions to suspend or terminate or not the provision of the service, in whole or in part, to the recipients;
Amendment 381 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 1 – point c
Article 17 – paragraph 1 – point c
(c) decisions to suspend or terminate the recipients’ account or not.
Amendment 382 #
2020/0361(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. Online platforms shall ensure that their internal complaint-handling systems are easy to access, user-friendly and enable and facilitate the submission of sufficiently precise and adequately substantiated complaints and include human review.
Amendment 401 #
2020/0361(COD)
Proposal for a regulation
Article 19 – paragraph 1 a (new)
Article 19 – paragraph 1 a (new)
1 a. Under certain cases such as cases based on existing internal systems or depending on urgencies, the regime of trusted flaggers should allow to exceptionally prioritise other notices in order to increase efficiency and involvement of all actors.
Amendment 403 #
2020/0361(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point a
Article 19 – paragraph 2 – point a
(a) it has particular expertise and competencdemonstrated particular competence, accuracy and expertise for the purposes of detecting, identifying and notifying illegal content;
Amendment 407 #
2020/0361(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point b
Article 19 – paragraph 2 – point b
(b) it represents collective interests, ensures independent public interest representation and is independent from any online platform;
Amendment 409 #
2020/0361(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point c
Article 19 – paragraph 2 – point c
(c) it carries out its activities for the purposes of submitting notices in a timely, diligent andn objective manner.
Amendment 410 #
2020/0361(COD)
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. Digital Services Coordinators shall communicate to the Commission and the Board the names, addresses and electronic mail addresses of the entities to which they have awarded the status of the trusted flagger in accordance with paragraph 2. Digital Services Coordinators shall engage in dialogue with platforms and rights holders for maintaining the accuracy and efficacy of a trusted flagger system.
Amendment 418 #
2020/0361(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Online platforms shall suspend, for a reasonable period of time and after having issued a prior warning, the provision of their services to recipients of the service that frequently provide manifestlyillegal content. A termination of the service can be issued in case the recipients fail to comply with the applicable provisions set out in this Regulation or in case the suspension has occurred at least 3 times following verification of the repeated provision of illegal content.
Amendment 426 #
2020/0361(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. Online platforms shall suspend, for a reasonable period of time and after having issued a prior warning, the processing of notices and complaints submitted through the notice and action mechanisms and internal complaints- handling systems referred to in Articles 14 and 17, respectively, by individuals or entities or by complainants that frequently submit notices or complaints that are manifestly unfounded.
Amendment 429 #
2020/0361(COD)
Proposal for a regulation
Article 20 – paragraph 3 – point a
Article 20 – paragraph 3 – point a
(a) the absolute numbers of items of manifestly illegal content or manifestly unfounded notices or complaints, submitted in the past year;
Amendment 432 #
2020/0361(COD)
Proposal for a regulation
Article 20 – paragraph 3 – point d
Article 20 – paragraph 3 – point d
Amendment 443 #
2020/0361(COD)
Proposal for a regulation
Article 22 – paragraph 1 – introductory part
Article 22 – paragraph 1 – introductory part
1. Where an online platform allows consumers to conclude distance contracts with traders, be it business-to-consumer or peer-to peer, it shall ensure that traders can only use its services to promote messages on or to offer products or services to consumers located in the Union if, prior to the use of its services, the online platform has obtained the following information:
Amendment 451 #
2020/0361(COD)
Proposal for a regulation
Article 22 – paragraph 1 – point f
Article 22 – paragraph 1 – point f
Amendment 479 #
2020/0361(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point b
Article 23 – paragraph 1 – point b
(b) the number of suspensions imposed pursuant to Article 20, distinguishing between suspensions enacted for the provision of manifestly illegal content, the submission of manifestly unfounded notices and the submission of manifestly unfounded complaints;
Amendment 487 #
2020/0361(COD)
Proposal for a regulation
Article 24 – paragraph 1 – point a
Article 24 – paragraph 1 – point a
(a) that the information displayed is anor parts thereof is an online advertisement;
Amendment 489 #
2020/0361(COD)
Proposal for a regulation
Article 24 – paragraph 1 – point b
Article 24 – paragraph 1 – point b
(b) the natural or legal person on whose behalf the advertisement is displayed and the natural or legal person who finances the advertisement;
Amendment 494 #
2020/0361(COD)
Proposal for a regulation
Article 24 – paragraph 1 – point c
Article 24 – paragraph 1 – point c
(c) clear meaningful information about the main parameters used to determine the recipient to whom the advertisement is displayed.
Amendment 496 #
2020/0361(COD)
Proposal for a regulation
Article 24 – paragraph 1 – point c a (new)
Article 24 – paragraph 1 – point c a (new)
(c a) whether the advertisement was selected using an automated system and, in that case, the identity of the natural or legal person responsible for the system.
Amendment 499 #
2020/0361(COD)
Proposal for a regulation
Article 24 – paragraph 1 a (new)
Article 24 – paragraph 1 a (new)
Providers of intermediary services shall inform the natural or legal person on whose behalf the advertisement is displayed where the advertisement has been displayed. They shall also inform public authorities, non-governmental organisations and researchers, upon their request.
Amendment 502 #
2020/0361(COD)
Proposal for a regulation
Article 24 – paragraph 1 b (new)
Article 24 – paragraph 1 b (new)
Online platforms shall favour advertising that do not require any tracking of user interaction with content.
Amendment 503 #
2020/0361(COD)
Proposal for a regulation
Article 24 – paragraph 1 c (new)
Article 24 – paragraph 1 c (new)
Online platforms shall offer the possibility to easily opt-out for micro-targeted tracking.
Amendment 504 #
2020/0361(COD)
Proposal for a regulation
Article 24 – paragraph 1 d (new)
Article 24 – paragraph 1 d (new)
Online platforms shall offer the possibility to opt-in for the use of behavioural data and political advertising.
Amendment 507 #
2020/0361(COD)
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
1. This Section shall apply to online platforms which provide their services to a number of average monthly active recipients of the service in the Union equal to or higher than 45 million, calculated in accordance with the methodology set out in the delegated acts referred to in paragraph 3, or with a turnover of over EUR 50 million per year.1a _________________ 1aCommission Staff Working Document. Impact Assessment Report. Annexes. (SWD(2020)348).
Amendment 514 #
2020/0361(COD)
Proposal for a regulation
Article 25 – paragraph 4 a (new)
Article 25 – paragraph 4 a (new)
4 a. Very large platforms shall allow business users and providers of ancillary services access to and interoperability with the same operating system, hardware or software features that are available or used in the provision by the gatekeeper of any ancillary services.
Amendment 515 #
2020/0361(COD)
Proposal for a regulation
Article 25 – paragraph 4 b (new)
Article 25 – paragraph 4 b (new)
4 b. Gatekeepers of very large platforms shall allow the installation and effective use of third party software applications or software application stores using, or interoperating with, operating systems of that gatekeeper and allow these software applications or software application stores to be accessed by means other than the core platform services of that gatekeeper. The gatekeeper shall not be prevented from taking proportionate measures to ensure that third party software applications or software application stores do not endanger the integrity of the hardware or operating system provided by the gatekeeper.
Amendment 516 #
2020/0361(COD)
Proposal for a regulation
Article 25 – paragraph 4 c (new)
Article 25 – paragraph 4 c (new)
4 c. Very large platforms shall refrain from technically restricting the ability of end users to switch between and subscribe to different software applications and services to be accessed using the operating system of the gatekeeper, including as regards the choice of Internet access provider for end users.
Amendment 517 #
2020/0361(COD)
Proposal for a regulation
Article 25 – paragraph 4 d (new)
Article 25 – paragraph 4 d (new)
4 d. Very large platforms shall allow consumers and developers in mobile application ecosystems to increase the number of applications available and ensure new functionalities across software applications and services to be accessed using the operating systems of the gatekeeper.
Amendment 528 #
2020/0361(COD)
Proposal for a regulation
Article 26 – paragraph 1 – introductory part
Article 26 – paragraph 1 – introductory part
1. Very large online platforms shall identify, analyse and assess, from the date of application referred to in the second subparagraph of Article 25(4), at least once a year thereafter, any significant systemic risks stemming from the functioning and use made of their services in the Union. This risk assessment shall be specific to their services and activities and shall include the following systemic risks:
Amendment 535 #
2020/0361(COD)
Proposal for a regulation
Article 26 – paragraph 1 – point b
Article 26 – paragraph 1 – point b
(b) any negative effects for the exercise of the fundamental rights, including the rights to respect for private and family life, freedom of expression and information, the prohibition of discrimination and the rights of the child, as enshrined in Articles 7, 11, 21 and 24 of the Charter respectively;
Amendment 552 #
2020/0361(COD)
Proposal for a regulation
Article 27 – paragraph 1 – introductory part
Article 27 – paragraph 1 – introductory part
1. Very large online platforms shall put in place reasonable, proportionate and effective mitigation measures, tailored toeasures to cease, prevent and mitigate the specific systemic risks identified pursuant to Article 26. Such measures may include, where applicable:
Amendment 554 #
2020/0361(COD)
Proposal for a regulation
Article 27 – paragraph 1 – point a
Article 27 – paragraph 1 – point a
(a) adapting content moderation or recommender systems, their decision- making processes, the features or functioning of their services and activities, or their terms and conditions;
Amendment 564 #
2020/0361(COD)
Proposal for a regulation
Article 27 – paragraph 2 – point b
Article 27 – paragraph 2 – point b
(b) best practices for very large online platforms to cease, prevent and mitigate the systemic risks identified.
Amendment 593 #
2020/0361(COD)
Proposal for a regulation
Article 29 – paragraph -1 (new)
Article 29 – paragraph -1 (new)
-1. Online platforms that use recommender systems shall indicate visibly to their recipients that the platform uses recommender systems.
Amendment 594 #
2020/0361(COD)
Proposal for a regulation
Article 29 – paragraph -1 a (new)
Article 29 – paragraph -1 a (new)
-1 a. Online platforms shall ensure that the option activated by default for the recipient of the service is not based on profiling within the meaning of Article 4(4) of Regulation (EU) 2016/679.
Amendment 598 #
2020/0361(COD)
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
1. Very large oOnline platforms that use recommender systems shall set out in their terms and conditions, in a clearseparately the information concerning the role and functioning of recommender systems, in a clear for average users, concise, accessible and easily comprehensible manner, the main parameters used in their recommender systems, as well as anyoffer controls with the available options for the recipients of the service to modifyin a user-friendly manner to modify, customize or influence those main parameters that they may have made available, including at least one option which is not based on profiling, within the meaning of Article 4 (4) of Regulation (EU) 2016/679. basic natural criteria such as time, topics of interest, etc.
Amendment 601 #
2020/0361(COD)
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
1 a. The parameters referred to in paragraph 1 shall include, at a minimum: (a) whether the recommender system is an automated system and, in that case, the identity of the natural or legal person responsible for the recommender system, if different from the platform provider; (b) clear information about the criteria used by recommender systems; (c) the relevance and weight of each criteria which leads to the information recommended; (e) what goals the relevant system has been optimised for, (d) if applicable, explanation of the role that the behaviour of the recipients of the service plays in how the relevant system produces its outputs.
Amendment 618 #
2020/0361(COD)
Proposal for a regulation
Article 30 – paragraph 2 – point c a (new)
Article 30 – paragraph 2 – point c a (new)
(c a) data regarding the amount of spending;
Amendment 619 #
2020/0361(COD)
Proposal for a regulation
Article 30 – paragraph 2 – point d a (new)
Article 30 – paragraph 2 – point d a (new)
(d a) whether one or more particular groups of recipients of the service have been explicitly excluded from the advertisement target group;
Amendment 627 #
2020/0361(COD)
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. Upon a reasoned request from the Digital Services Coordinator of establishment or the Commission, very large online platforms shall, within a reasonable period, as specified in the request, provide information and access to data to vetted researchers who meet the requirements in paragraphs 4 of this Article, for the sole purpose of conductingfacilitating and conducting public interest research that contributes to the identification and understanding of systemic risks as set out in Article 26(1). and to enable verification of the effectiveness and proportionality of the mitigation measures as set out in Article 27(1).
Amendment 631 #
2020/0361(COD)
Proposal for a regulation
Article 31 – paragraph 3 a (new)
Article 31 – paragraph 3 a (new)
3 a. Very large online platforms shall provide effective portability of data generated through the activity of a business user or end user and shall, in particular, provide tools for end users to facilitate the exercise of data portability, in line with Regulation EU 2016/679, including by the provision of continuous and real-time access;
Amendment 632 #
2020/0361(COD)
Proposal for a regulation
Article 31 – paragraph 3 b (new)
Article 31 – paragraph 3 b (new)
3 b. Very large online platforms shall provide business users, or third parties authorised by a business user, free of charge, with effective, high-quality, continuous and real-time access and use of aggregated or non-personal aggregated data, that is provided for or generated in the context of the use of the relevant core platform services by those business users and the end users engaging with the products or services provided by those business users; for personal data, provide access and use, in full compliance with GDPR, only where directly connected with the use effectuated by the end user in respect of the products or services offered by the relevant business user through the relevant core platform service, and when the end user opts in to such sharing with a consent in the sense of Regulation (EU) 2016/679; the functionalities for giving information and offering the opportunity to grant consent shall be as user-friendly as possible.
Amendment 633 #
2020/0361(COD)
Proposal for a regulation
Article 31 – paragraph 3 c (new)
Article 31 – paragraph 3 c (new)
3 c. The data provided to vetted researchers shall be as disaggregated as possible, unless the researcher requests it otherwise.
Amendment 634 #
2020/0361(COD)
Proposal for a regulation
Article 31 – paragraph 4
Article 31 – paragraph 4
4. In order to be vetted, researchers shall be affiliated with academic institutions, be independent from commercial interestscivil society organisations or think tanks representing the public interest, be independent from commercial interests, disclose the funding financing the research, have proven records of expertise in the fields related to the risks investigated or related research methodologies, and shall commit and be in a capacity to preserve the specific data security and confidentiality requirements corresponding to each request.
Amendment 681 #
2020/0361(COD)
Proposal for a regulation
Article 42 – paragraph 3
Article 42 – paragraph 3
3. Member States shall ensure that the maximum amount of penalties imposed for a failure to comply with the obligations laid down in this Regulation shall not exceed 6 % of the annual income or global turnover of the provider of intermediary services concerned. Penalties for the supply of incorrect, incomplete or misleading information, failure to reply or rectify incorrect, incomplete or misleading information and to submit to an on-site inspection shall not exceed 1% of the annual income or global turnover of the provider concerned.
Amendment 684 #
2020/0361(COD)
Proposal for a regulation
Article 42 – paragraph 4
Article 42 – paragraph 4
4. Member States shall ensure that the maximum amount of a periodic penalty payment shall not exceed 5 % of the average daily global turnover of the provider of intermediary services concerned in the preceding financial year per day, calculated from the date specified in the decision concerned.
Amendment 704 #
2020/0361(COD)
Proposal for a regulation
Article 59 – paragraph 1 – introductory part
Article 59 – paragraph 1 – introductory part
1. In the decision pursuant to Article 58, the Commission may impose on the very large online platform concerned fines not exceeding 6% of its total global turnover in the preceding financial year where it finds that thate platform, intentionally or negligently:
Amendment 705 #
2020/0361(COD)
Proposal for a regulation
Article 59 – paragraph 2 – introductory part
Article 59 – paragraph 2 – introductory part
2. The Commission may by decision impose on the very large online platform concerned or other person referred to in Article 52(1) fines not exceeding 1% of the total global turnover in the preceding financial year, where they intentionally or negligently:
Amendment 706 #
2020/0361(COD)
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
Article 60 – paragraph 1 – introductory part
1. The Commission may, by decision, impose on the very large online platform concerned or other person referred to in Article 52(1), as applicable, periodic penalty payments not exceeding 5 % of the average daily global turnover in the preceding financial year per day, calculated from the date appointed by the decision, in order to compel them to:
Amendment 95 #
2020/0359(COD)
Proposal for a directive
Recital 7
Recital 7
(7) With the repeal of Directive (EU) 2016/1148, the scope of application by sectors should be extended to a larger part of the economy in light of the considerations set out in recitals (4) to (6). The sectors covered by Directive (EU) 2016/1148 should therefore be extended to provide a comprehensive coverage of the sectors and services of vital importance for key societal and economic activities within the internal market. The ruleisk management requirements and reporting obligations should not be different according to whether the entities are operators of essential services or digital service providers. That differentiation has proven obsolete, since it does not reflect the actual importance of the sectors or services for the societal and economic activities in the internal market.
Amendment 97 #
2020/0359(COD)
Proposal for a directive
Recital 11
Recital 11
(11) Depending on the sector in which they operate or the type of service they provide, the entities falling within the scope of this Directive should be classified into two categories: essential and important. That categorisation should take into account the level of criticality of the sector or of the type of service, as well as the level of dependency of other sectors or types of services. Both essential and important entities should be subject to the same risk management requirements and reporting obligations. The supervisory and penalty regimes between these two categories of entities should be differentiated to ensure a fair balance between requirements and obligations on one hand, and the administrative burden stemming from the supervision of compliance on the other hand. The provisions of this Directive apply to entities with complex business models or operating environments, whereby an entity may simultaneously fulfil the criteria assigned to both essential and important entities. In order to enable the effective supervision and enforcement of risk management measures and reporting obligations for entities falling within the scope of this Directive, competent authorities or CSIRTs shall enforce the provisions of this Directive to a function or unit level within an entity, in order to appropriately and sufficiently address the level of criticality.
Amendment 102 #
2020/0359(COD)
Proposal for a directive
Recital 12
Recital 12
(12) Sector-specific legislation and instruments can contribute to ensuring high levels of cybersecurity, while taking full account of the specificities and complexities of those sectors. Sector- specific legislation and instruments that require essential or important entities to adopt cybersecurity risk management measures, or impose reporting obligations for significant incidents, shall, where possible, be consistent with the terminology, and refer to the definitions in Article 4 of this Directive. Where a sector–specific Union legal act requires essential or important entities to adopt cybersecurity risk management measures or to notify incidents or significant cyber threats of at least an equivalent effect to the obligations laid down in this Directive, and apply to the entirety of the security aspects of the operations and services provided by essential and important entities, those sector-specific provisions, including on supervision and enforcement, should apply. The Commission may issue guidelines in relation to the implementation of the lex specialis. This Directive does not preclude the adoption of additional sector- specific Union acts addressing cybersecurity risk management measures and incident notifications. This Directive is without prejudice to the existing implementing powers that have been conferred to the Commission in a number of sectors, including transport and energy.
Amendment 108 #
2020/0359(COD)
Proposal for a directive
Recital 15
Recital 15
(15) Upholding and preserving a reliable, resilient and secure domain name system (DNS) is a key factor in maintaining the integrity of the Internet and is essential for its continuous and stable operation, on which the digital economy and society depend. Therefore, this Directive should apply to all providers of DNS services along the DNS resolution chain, including operators of root name servers, top-level-domain (TLD) name servers, authoritative nametop-level- domain (TLD) name servers, public and open recursive domain name resolution services, and authoritative domain name resolution services. This Directive should not apply to decentralised servicers for domain names and recursive resolwhich centralised administration does not exist, such as the root name servers.
Amendment 111 #
2020/0359(COD)
Proposal for a directive
Recital 17 a (new)
Recital 17 a (new)
(17a) The edge ecosystem is an emerging vector susceptible to cyber threats and a growing trend with attacks targeting devices — such as routers, switches, and firewalls — is having a significant impact to both enterprises and to the connected digital ecosystem in its entirety. Edge computing ecosystems delivered in a highly distributed form are essential for the development of the Internet of Things (IoT), the Industrial Internet of Things (IIoT) and the sectoral ecosystems of connected devices such as connectivity infrastructure and autonomous vehicles. IoT devices may potentially offer additional attack surfaces and allow threats and attacks to trickle from the device to the network or the cloud. Poor security of IoT devices or IoT gateways can potentially hinder the security of the entire connectivity chain and the data flows towards the edge and the cloud, consequentially affecting the overall security of the ecosystem.
Amendment 112 #
2020/0359(COD)
Proposal for a directive
Recital 17 b (new)
Recital 17 b (new)
(17b) The continuous increase of computing power combined with the rising levels of maturity of exponential technologies such as machine learning (ML) and artificial intelligence (AI) enable the development of advanced cybersecurity capabilities for real-time detection, analysis, containment and response to cyber threats in a rapidly evolving threat landscape. AI tools and applications are used to develop security controls including, but not limited to, active firewalls, smart antivirus, automated CTI (cyber threat intelligence) operations, AI fuzzing, smart forensics, email scanning, adaptive sandboxing, and automated malware analysis.
Amendment 113 #
2020/0359(COD)
Proposal for a directive
Recital 17 c (new)
Recital 17 c (new)
(17c) Data-driven tools and applications powered by AI-enabled systems require the processing of large amounts of data, which may include personal data. Risks persist in the entire lifecycle of AI- enabled systems in cybersecurity- enhancing tools and applications, and in order to mitigate risks of unduly interference with the rights and freedoms of individuals, the requirements of data protection by design and by default laid down in Article 25 of Regulation (EU) 2016/679 shall be applied. Integrating appropriate safeguards such as pseudonymisation, encryption, data accuracy, and data minimisation in the design and use of AI-enabled systems deployed in cybersecurity applications and processes is essential to mitigate the risks that such systems may pose on personal data.
Amendment 114 #
2020/0359(COD)
Proposal for a directive
Recital 17 d (new)
Recital 17 d (new)
(17d) Member States should adopt policies on the promotion and integration of AI-enabled systems in the prevention and detection of cybersecurity incidents and threats as part of their national cybersecurity strategies. Such policies should emphasise the technological and operational measures including, but not limited to, workflow automation, streaming analytics, active monitoring, intelligent prediction and advanced network threat detection, in order to accelerate the analysis, validation and prioritisation of threats. ENISA’s National Capabilities Assessment Framework (NCAF) can assist in the evaluation and alignment of Member States’ policies building on available use cases and key performance indicators. Moreover, an assessment of Member States’ capabilities and overall level of maturity as regards the integration of AI- enabled systems in cybersecurity should be factored in the methodological construction of the cybersecurity index within the meaning of ENISA’s report on the state of cybersecurity in the Union under Article 15 of this Directive.
Amendment 115 #
2020/0359(COD)
Proposal for a directive
Recital 17 e (new)
Recital 17 e (new)
(17e) Open-source cybersecurity tools contribute to a higher degree of transparency and have a positive impact on the efficiency of industrial innovation. Open standards facilitate interoperability between security tools, benefitting the security of industrial stakeholders, enabling the diversification of reliance from a single supplier or vendor, and leading to a more comprehensive CTI framework. Semi-automation of CTI production is an important tool to reduce the number of manual steps underpinning the analysis of CTI. The use of AI and ML within CTI should be further explored to increase the value of machine learning functions within CTI activities.
Amendment 116 #
2020/0359(COD)
Proposal for a directive
Recital 17 f (new)
Recital 17 f (new)
(17f) Member States should develop a policy for the integration of open-source tools in public administration, and further explore measures to incentivise the wider adoption of open-source software by developing strategies to address and minimise the legal and technical risks that entities are faced with, as regards licensing and the necessary levels of technical support. Such policies are of particular importance for small and medium-sized enterprises (SMEs) facing significant costs for implementation, which can be minimised by reducing the need for specific applications or tools.
Amendment 121 #
2020/0359(COD)
Proposal for a directive
Recital 21 a (new)
Recital 21 a (new)
(21a) Public-Private Partnerships (PPPs) in the field of cybersecurity can provide the right framework for knowledge exchange, sharing of best practices and the establishment of a common level of understanding amongst all stakeholders. Goal-oriented and service outsourcing PPPs foster a culture of cybersecurity at the Member State level, and leverage the exchange and transfer of expertise, thus raising cybersecurity awareness and the overall level of reciprocal support between public and private entities. Hybrid PPPs enable governments to assign either the operation, or the delivery of service- specific functions, of a CSIRT to an experienced entity facilitating the access of public administrations to private sector resources, and increasing the levels of trust between stakeholders by establishing a proactive attitude in case of incidents or crises.
Amendment 122 #
2020/0359(COD)
Proposal for a directive
Recital 21 b (new)
Recital 21 b (new)
(21b) Member States should adopt policies underpinning the establishment of cybersecurity-specific PPPs as part of their national cybersecurity strategies. These policies should clarify, among others, the scope and stakeholders involved, the governance model, the available funding options, and the interaction among participating stakeholders. PPPs can leverage the expertise of private sector entities to support Member States’ competent authorities in developing state-of-the art services and processes including, but not limited to, information exchange, early warnings, cyber threat and incident exercises, crisis management, and resilience planning.
Amendment 130 #
2020/0359(COD)
Proposal for a directive
Recital 26 a (new)
Recital 26 a (new)
(26a) Cyber hygiene policies provide the foundations for protecting network and information system infrastructures, hardware, software and online application security, and business or end-user data which entities rely on. Cyber hygiene policies comprising a common baseline set of practices including, but not limited to, software and hardware updates, password changes, management of new installs, limitation of administrator-level access accounts, and backing up of data, enable a proactive framework of preparedness and overall safety and security in the event of incidents or threats.
Amendment 131 #
2020/0359(COD)
Proposal for a directive
Recital 26 b (new)
Recital 26 b (new)
(26b) Member States should adopt policies to promote cyber hygiene as part of their national cybersecurity strategies. Such policies should build on cyber hygiene controls and programmes that are affordable and accreditable in order to minimise the cost of implementation, especially for SMEs, and encourage wider compliance thereto by both public and private entities. ENISA should monitor and assess Member States’ cyber hygiene policies, and explore EU wide schemes to enable cross-border checks ensuring equivalence independent of Member State requirements.
Amendment 132 #
2020/0359(COD)
Proposal for a directive
Recital 28
Recital 28
(28) Since the exploitation of vulnerabilities in network and information systems may cause significant disruption and harm, swiftly identifying and remedying those vulnerabilities is an important factor in reducing cybersecurity risk. Entities that develop such systems should therefore establish appropriate procedures to handle vulnerabilities when they are discovered. Since vulnerabilities are often discovered and reported (disclosed) by third parties (reporting entities), the manufacturer or provider of ICT products or services should also put in place the necessary procedures to receive vulnerability information from third parties. In this regard, international standards ISO/IEC 30111 and ISO/IEC 29417 provide guidance on vulnerability handling and vulnerability disclosure respectively. As regards vulnerability disclosure, coordination between reporting entities and manufacturers or providers of ICT products or services is particularly important. CVoluntary coordinated vulnerability disclosure specifies a structured process through which vulnerabilities are reported to organisations in a manner allowing the organisation to diagnose and remedy the vulnerability before detailed vulnerability information is disclosed to third parties or to the public. Coordinated vulnerability disclosure should also comprise coordination between the reporting entity and the organisation as regards the timing of remediation and publication of vulnerabilities. Strengthening the coordination and timely exchange of relevant information between the manufacturer or provider of ICT products or services and the reporting entities is essential to facilitate the voluntary framework of vulnerability disclosure.
Amendment 133 #
2020/0359(COD)
Proposal for a directive
Recital 29
Recital 29
(29) Member States should therefore take measures to facilitate coordinated vulnerability disclosure by establishing a relevant national policy. In this regard, Member States should designate a CSIRT to take the role of ‘coordinator’, acting as an intermediary between the reporting entities and the manufacturers or providers of ICT products or services, where necessarythe reporting entity, or the manufacturer or the provider of ICT products or services, engages a third-party coordinator to assist with the disclosure process. The tasks of the CSIRT coordinator should, in particular, include identifying and contacting concerned entities, supporting reporting entities, negotiating disclosure timelines, and managing vulnerabilities that affect multiple organisations (multi- party vulnerability disclosure). Where vulnerabilities affect multiple manufacturers or providers of ICT products or services established in more than one Member State, the designated CSIRTs from each of the affected Member States should cooperate within the CSIRTs Network.
Amendment 139 #
2020/0359(COD)
Proposal for a directive
Recital 31
Recital 31
(31) Although similar vulnerability registries or databases do exist, these are hosted and maintained by entities which are not established in the Union. A European vulnerability registry maintained by ENISA would provide improved transparency regarding the publication process before the vulnerability is officially disclosed, and resilience in cases of disruptions or interruptions on the provision of similar services. To avoid duplication of efforts and seek complementarity to the extent possible, ENISA should explore the possibility of entering into structured cooperation agreements with similar registries in third country jurisdictions. ENISA could play a more central management role either by exploring the option of becoming a “Root CVE Numbering Authority” in the global Common Vulnerabilities and Exposures (CVE) registry, or setting up a database to leverage the existing CVE programme for vulnerability identification and registration to enable interoperability and reference between the European and third country jurisdiction registries.
Amendment 142 #
2020/0359(COD)
Proposal for a directive
Recital 35
Recital 35
(35) The competent authorities and CSIRTs should be empowered to participate in exchange schemes for officials from other Member States, within structured rules and mechanisms underpinning the scope and, where applicable, the required security clearance of officials participating in such exchange schemes, in order to improve cooperation. The competent authorities should take the necessary measures to enable officials from other Member States to play an effective role in the activities of the host competent authority or CSIRT.
Amendment 144 #
2020/0359(COD)
Proposal for a directive
Recital 38
Recital 38
Amendment 145 #
2020/0359(COD)
Proposal for a directive
Recital 39
Recital 39
Amendment 147 #
2020/0359(COD)
Proposal for a directive
Recital 40
Recital 40
(40) Risk-management measures should include measures to identify any risks of incidents, to prevent, detect and handle, respond to, attribute, and recover from incidents, and to mitigate their impact. The security of network and information systems should comprise the security of stored, transmitted and processed data.
Amendment 149 #
2020/0359(COD)
Proposal for a directive
Recital 43
Recital 43
(43) Addressing cybersecurity risks stemming from an entity’s supply chain and its relationship with its suppliers is particularly important given the prevalence of incidents where entities have fallen victim to cyber-attacks and where malicious actors were able to compromise the security of an entity’s network and information systems by exploiting vulnerabilities affecting third party products and services. Entities should thereforeevaluate their own cybersecurity capabilities and pursue the integration of cybersecurity enhancing technologies driven by AI or machine learning systems to automate their capabilities and the protection of network architectures. Entities should also assess and take into account the overall quality of products and cybersecurity practices of their suppliers and service providers, including their secure development procedures.
Amendment 153 #
2020/0359(COD)
Proposal for a directive
Recital 44
Recital 44
(44) Among service providers, managed security services providers (MSSPs) in areas such as incident response, penetration testing, security audits and consultancy play a particularly important role in assisting entities in their efforts to prevent, detect and respond to incidents. Those MSSPs have however also been the targets of cyberattacks themselves and through their close integration in the operations of operators pose a particular cybersecurity risk. Entities should therefore exercise increased diligence in selecting an MSSP, not only in terms of the close operational integration but also as regards the need for such outsourced activities involving personal data by a controller to be in full compliance with Regulation (EU) 2016/679, in particular the processing by a processor on behalf of a controller.
Amendment 156 #
2020/0359(COD)
Proposal for a directive
Recital 46
Recital 46
(46) To further address key supply chain risks and assist entities operating in sectors covered by this Directive to appropriately manage supply chain and supplier related cybersecurity risks, the Cooperation Group involving relevant national authorities, in cooperation with the Commission and ENISA, and in consultation with the European Data Protection Board (EDPB), should carry out coordinated sectoral supply chain risk assessments, as was already done for 5G networks following Recommendation (EU) 2019/534 on Cybersecurity of 5G networks21 , with the aim of identifying per sector which are the critical ICT services, systems or products, relevant threats and vulnerabilities. Particular emphasis should be placed on ICT services, systems or products subject to specific requirements, in particular in third country jurisdictions serving as the country of origin. _________________ 21Commission Recommendation (EU) 2019/534 of 26 March 2019 Cybersecurity of 5G networks (OJ L 88, 29.3.2019, p. 42).
Amendment 160 #
2020/0359(COD)
Proposal for a directive
Recital 47
Recital 47
(47) The supply chain risk assessments, in light of the features of the sector concerned, should take into account both technical and, where relevant, non- technical factors including those defined in Recommendation (EU) 2019/534, in the EU wide coordinated risk assessment of 5G networks security and in the EU Toolbox on 5G cybersecurity agreed by the Cooperation Group. To identify the supply chains that should be subject to a coordinated risk assessment, the following criteria should be taken into account: (i) the extent to which essential and important entities use and rely on specific critical ICT services, systems or products; (ii) the relevance of specific critical ICT services, systems or products for performing critical or sensitive functions, including the processing of personal data; (iii) the availability of alternative ICT services, systems or products; (iv) the resilience of the overall supply chain of ICT services, systems or products against disruptive events across the entire lifecycle of the service, system or product and (v) for emerging ICT services, systems or products, their potential future significance for the entities’ activities. Such risk assessments should identify best practices for managing risks associated with risks in the ICT supply chain and explore ways to further incentivise their wider adoption by entities within each sector under examination.
Amendment 164 #
2020/0359(COD)
Proposal for a directive
Recital 50
Recital 50
(50) Given the growing importance of number-independent interpersonal communications services, it is necessary to ensure that such services are also subject to appropriate security requirements in view of their specific nature and economic importance. Providers of such services should thus also ensure a level of security of network and information systems appropriate to the risk posed. Given that providers of number-independent interpersonal communications services normally do not exercise actual control over the transmission of signals over networks, the degree of risk to network security for such services can be considered in some respects to be lower than for traditional electronic communications services. The same applies to interpersonal communications services which make use of numbers and which do not exercise actual control over signal transmission. However, as the attack surface continues to expand, number-independent interpersonal communications services including, but not limited to, social media messengers, are becoming popular attack vectors. Malicious actors use platforms to communicate and attract victims to open compromised web pages, therefore increasing the likelihood of incidents involving the exploitation of personal data, and by extension, the security of information systems.
Amendment 173 #
2020/0359(COD)
Proposal for a directive
Recital 54
Recital 54
(54) In order to safeguard the security of electronic communications networks and services, the use of encryption, and in particular end-to-end encryption, should be promoted and, where necessary, should be mandatory for providers of such services and networks in accordance with the principles of security and privacy by default and by design for the purposes of Article 18. The use of end-to-end encryption should be reconciled with the Member State’ powers to ensure the protection of their essential security interests and public security, and to permit the investigation, detection and prosecution of criminal offences in compliance with Union law. Solutions for lawful access to information in end-to-end encrypted communications should maintain tThe effectiveness of encryption in protecting the privacy and security of communications, while provid must not be undermined ing an effective response to crimey circumstance, as any loophole in encryption is open to be explored or exploited by actors, regardless of their legitimacy or intent.
Amendment 175 #
2020/0359(COD)
Proposal for a directive
Recital 54 a (new)
Recital 54 a (new)
(54a) Any measures aimed at weakening encryption or circumventing the technology’s architecture may incur significant risks to the effective protection capabilities it entails, thus inevitably compromising the protection of personal data and privacy, resulting in an overall loss of trust in security controls. Any unauthorised decryption, reverse engineering of encryption code, or monitoring of electronic communications outside clear legal authorities should be prohibited to ensure the effectiveness of the technology and its wider use. The cases where encryption can be used to mitigate risks related to non-compliant data transfers as presented in EDPB Recommendations 01/2020 may enable stronger encryption, whether in transit or at rest, for providers of such services and networks for the purposes of Article 18.
Amendment 177 #
2020/0359(COD)
Proposal for a directive
Recital 55
Recital 55
(55) This Directive lays down a twohree- stage approach to incident reporting in order to strike the right balance between, on the one hand, swift reporting that helps mitigate the potential spread of incidents and allows entities to seek support, and, on the other hand, in-depth reporting that draws valuable lessons from individual incidents and improves over time the resilience to cyber threats of individual companies and entire sectors. Where entities become aware of an incident, theycompanies and entire sectors. In this regard, the Directive should also include reporting of incidents that, based on an initial assessment performed by the entity, may be assumed to lead to substantial operational disruption or financial losses or affect other natural or legal persons by causing considerable material or non- material losses. The initial assessment should take into account amongst others, the affected network and information systems and, in particular, their importance in the provision of the entity’s services, the severity and technical characteristics of the cyber threat, and any underlying vulnerabilities that are being exploited, as well as the entity’s experience with similar incidents. Where entities become aware of an incident, they should provide an early warning within 24 hours, without any obligation to disclose additional information. Entities should be required to submit an initial notification within 724 hours, followed by a finalcomprehensive report not later than one month after the incident has been handled. The initial incident notification should only include the information strictly necessary to make the competent authorities aware of the incident antimeline of 72 hours should not preclude entities from reporting incidents earlier, therefore allowing entities to seek support from competent authorities or CSIRTs swiftly, and enabling competent authorities or CSIRTs to mitigate the potential spread of the reported incident. Where an incident requires a longer period to be handled, an entity should be required to submit regular reports on the mitigation measures in place to contain, respond to, attribute and recover from the incident, and a comprehensive report not later than one month after the incident has been handled. The initial notification should allow the entity to seek assistance, if required. Such notification, where applicable, should indicate whether the incident is presumably caused by unlawful or malicious action. Member States should ensure that the requirement to submit this initial notification does not divert the reporting entity’s resources from activities related to incident handling that should be prioritised. To further prevent that incident reporting obligations either divert resources from incident response handling or may otherwise compromise the entities efforts in that respect, Member States should also provide that, in duly justified cases and in agreement with the competent authorities or the CSIRT, the entity concerned can deviate from the deadlines of 724 hours for the initial notification and one month for the finalcomprehensive report.
Amendment 183 #
2020/0359(COD)
Proposal for a directive
Recital 60
Recital 60
(60) The availability and timely accessibility of these data to public authorities, domain name registration data to legitimate access seekers is essential to protect the online ecosystem, prevent DNS abuse, detect and prevent crime and fraud, protect minors, protect intellectual property, and protect against hate speech. For the purposes of this Directive, legitimate access seekers are natural or legal persons making a justified request on the basis of a legitimate interest under Union or national law to access DNS data, and they may includinge competent authorities under Union or national law for the prevention, investigation or prosecution of criminal offences, CERTs, (CSIRTs, and as regards the data of their clients to, providers of electronic communications networks and services and providers of cybersecurity technologies and services acting on behalf of those clients, is essential to prevent and combat Domain Name System abuse, in particular to prevent, detect and respond to cybersecurity incidents. Such access should comply with Union data protection law insofar as it is related to personal data.
Amendment 185 #
2020/0359(COD)
Proposal for a directive
Recital 61
Recital 61
(61) In order to ensure the availability of accurate and complete domain name registration data, TLD registries and the entities providing domain name registration services for the TLD (so-called registrars) should collect and guarantee the integrity and availability of domain names registration data. In particular, TLD registries and the entities providing domain name registration services for the TLD should establish policies and procedures to collect and maintain accurate and complete registration data, as well as to prevent and correct inaccurate registration data in accordance with Union data protection rules.
Amendment 187 #
2020/0359(COD)
Proposal for a directive
Recital 62
Recital 62
(62) TLD registries and the entities providing domain name registration services for them shouldshould be required to make publically available domain name registration data that fall outside the scope of Union data protection rules, such as data that concernof legal persons25 . TLD registries and the entities providing domain name registration services for the TLD should also enable lawful access to specific domain name registration data concerning natural persons to legitimate access seekers, in accordance with Union data protection law. Member States should ensure that TLD registries and the entities providing domain name registration services for them should respond without undue delayin 72 hours to requests from legitimate access seekers for the disclosure of domain name registration data. TLD registries and the entities providing domain name registration services for them should establish policies and procedures for the publication and disclosure of registration data, including service level agreements to deal with requests for access from legitimate access seekers. The access procedure may also include the use of an interface, portal or other technical tool to provide an efficient system for requesting and accessing registration data. With a view to promoting harmonised practices across the internal market, the Commission may adopt guidelines on such procedures without prejudice to the competences of the European Data Protection Board. _________________ 25REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL recital (14) whereby “this Regulation does not cover the processing of personal data which concerns legal persons and in particular undertakings established as legal persons, including the name and the form of the legal person and the contact details of the legal person”.
Amendment 195 #
2020/0359(COD)
Proposal for a directive
Recital 69
Recital 69
(69) The processing of personal data, to the extent strictly necessary and proportionate for the purposes of ensuring network and information security by essential and important entities, public authorities, CERTs, CSIRTs, and providers of security technologies and services shoulis necessary to comply with a legal obligation under this Directive and constitutes a legitimate interest of the data controller concerned, as referred to in point (c) paragraph 1, and point (f) paragraph 1 respectively of Article 6 of Regulation (EU) 2016/679. That should include measures related to the prevention, detection, analysis and response to incidents, measures to raise awareness in relation to specific cyber threats, exchange of information in the context of vulnerability remediation and coordinated disclosure, as well as the voluntary exchange of information on those incidents, as well as cyber threats and vulnerabilities, indicators of compromise, tactics, techniques and procedures, cybersecurity alerts and configuration tools. Such measures may require the processing of the following types of personal data: IP addresses, uniform resources locators (URLs), domain names, and email addresses.
Amendment 199 #
2020/0359(COD)
Proposal for a directive
Recital 71
Recital 71
(71) In order to make enforcement effective, a minimum list of administrative sanctions for breach of the cybersecurity risk management and reporting obligations provided by this Directive should be laid down, setting up a clear and consistent framework for such sanctions across the Union. Due regard should be given to the nature, gravity and duration of the infringement, the actual damage caused or losses incurred or potential damage or losses that could have been triggered, the intentional or negligent character of the infringement, actions taken to prevent or mitigate the damage and/or losses suffered, the degree of responsibility or any relevant previous infringements, the degree of cooperation with the competent authority and any other aggravating or mitigating factor. The imposition of penalties including administrative fines should be subject to appropriate procedural safeguards in accordance with the general principles of Union law and the Charter of Fundamental Rights of the European Union, including effective judicial protection and due process.
Amendment 201 #
2020/0359(COD)
Proposal for a directive
Recital 76
Recital 76
(76) In order to further strengthen the effectiveness and dissuasiveness of the penalties applicable to infringements of obligations laid down pursuant to this Directive, the competent authorities should be empowered to apply sanctions consisting of the, where applicable, the temporary suspension of a certification or authorisation concerning part or all the services provided by an essential entity, and the imposition of a temporary ban from the exercise of managerial functions by a natural personagainst any person discharging managerial responsibilities at chief executive officer or legal representative level in that essential entity from exercising managerial functions in that entity. This provision shall not apply to public administration entities as referred to in this Directive. Given their severity and impact on the entities’ activities and ultimately on their consumers, such sanctions should only be applied proportionally to the severity of the infringement and taking account of the specific circumstances of each case, including the intentional or negligent character of the infringement, actions taken to prevent or mitigate the damage and/or losses suffered. Such sanctions should only be applied as ultima ratio, meaning only after the other relevant enforcement actions laid down by this Directive have been exhausted, and only for the time until the entities to which they apply take the necessary action to remedy the deficiencies or comply with the requirements of the competent authority for which such sanctions were applied. The imposition of such sanctions shall be subject to appropriate procedural safeguards in accordance with the general principles of Union law and the Charter of Fundamental Rights of the European Union, including effective judicial protection, due process, presumption of innocence and right of defence.
Amendment 206 #
2020/0359(COD)
Proposal for a directive
Recital 79
Recital 79
(79) A peer-review mechanism should be introduced, allowing the assessment by experts designated by the Member States and ENISA of the implementation of cybersecurity policies, including the level of Member States’ capabilities and available resources, and provide an effective path for the transfer of cybersecurity-enhancing technologies, mechanisms and processes between and among competent authorities or CSIRTs.
Amendment 231 #
2020/0359(COD)
Proposal for a directive
Article 2 – paragraph 5 a (new)
Article 2 – paragraph 5 a (new)
5a. As regards the processing of personal data, essential and important entities as well as competent authorities, CERTs, and CSIRTs, shall process personal data to the extent strictly necessary and proportionate for the purposes of ensuring network and information security in accordance with the obligations set out in this Directive. Where the processing of personal data is required for the purpose of cybersecurity and network and information security in accordance with the provisions set out in Article 18 and Article 20 of the Directive, including the provisions set out in Article 23, that processing is considered necessary for compliance with a legal obligation in accordance with paragraph1(c) of Article 6 of Regulation (EU) 2016/679.
Amendment 233 #
2020/0359(COD)
Proposal for a directive
Article 2 – paragraph 5 b (new)
Article 2 – paragraph 5 b (new)
5b. For the purposes of arrangements underpinning cybersecurity information- sharing and voluntary notification of information as set out in Articles 26 and 27 of this Directive, the processing of personal data constitutes a legitimate interest of the data controller concerned in accordance with paragraph 1(f) of Article 6 of Regulation (EU) 2016/679.
Amendment 235 #
2020/0359(COD)
Proposal for a directive
Article 2 – paragraph 5 c (new)
Article 2 – paragraph 5 c (new)
5c. As regards the processing of personal data from essential entities providing services of public electronic communications networks or publicly available electronic communications referred to in point 8 of Annex I and point (a)(i) of paragraph2(1), such processing of personal data required for the purposes of ensuring network and information security shall be in compliance with the provisions set out in Directive 2002/58/EC.
Amendment 238 #
2020/0359(COD)
Proposal for a directive
Article 2 – paragraph 6
Article 2 – paragraph 6
6. Sector-specific acts that require essential or important entities either to adopt cybersecurity risk management measures or to notify incidents or significant cyber threats, shall, where possible, refer to the definitions in Article 4 of this Directive. Where provisions of sector–specific acts of Union law require essential or important entities either to adopt cybersecurity risk management measures or to notify incidents or significant cyber threats, and where those requirements are at least equivalent in effect to the obligations laid down in this Directive, the relevant provisions of this Directive, including the provision on supervision and enforcement laid down in Chapter VI, shall not apply.
Amendment 243 #
2020/0359(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 4 a (new)
Article 4 – paragraph 1 – point 4 a (new)
(4a) ‘near miss’ means an event which could have caused harm, but was successfully prevented from fully transpiring;
Amendment 247 #
2020/0359(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 6
Article 4 – paragraph 1 – point 6
(6) ‘incident handling’ means all actions and procedures aiming at prevention, detection, analysis, attribution, and containment of and a response to an incident;
Amendment 248 #
2020/0359(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 7 a (new)
Article 4 – paragraph 1 – point 7 a (new)
(7a) ‘risk’ means the potential for loss or disruption caused by an incident and is to be expressed as a combination of the magnitude of such loss or disruption and the likelihood of occurrence of that incident;
Amendment 250 #
2020/0359(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 13
Article 4 – paragraph 1 – point 13
(13) ‘domain name system (DNS)’ means a hierarchical distributed naming system which allows end-users to reach services and resources on the internetenables the identification of internet services and resources, allowing end-user devices to utilise internet routing and connectivity services, to reach those services and resources;
Amendment 253 #
2020/0359(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 14
Article 4 – paragraph 1 – point 14
(14) ‘DNS service provider’ means an entity that provides recursive or authoritative domain name resolution services to internet end-users and other DNS service provider: a) open and public recursive domain name resolution services; or b) authoritative domain name resolution services as a service procurable by third-party entities;
Amendment 255 #
2020/0359(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 15
Article 4 – paragraph 1 – point 15
(15) ‘top–level domain name registry’ means an entity which has been delegated a specific TLD and is responsible for administering the TLD including the registration of domain names under the TLD and the technical operation of the TLD, including the operation of its name servers, the maintenance of its databases and the distribution of TLD zone files across name servers, irrespective of whether any of those operations are being performed by the entity or are outsourced;
Amendment 256 #
2020/0359(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 15 a (new)
Article 4 – paragraph 1 – point 15 a (new)
(15a) ‘legitimate access seekers’ means any natural or legal person, including competent authorities under Union or national law for the prevention, investigation or prosecution of criminal offences, CSIRTs, CERTs, providers of electronic communications networks and services, and providers of cybersecurity technologies and services, seeking DNS data upon a justified request on the basis of Union or national law for the purposes of preventing DNS abuse, detecting and preventing crime and fraud, protecting minors, protecting intellectual property, and protecting against hate speech;
Amendment 257 #
2020/0359(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 22
Article 4 – paragraph 1 – point 22
(22) ‘social networking services platform’ means a platform that enables end-users to connect, share, discover and communicate with each other via number- independent interpersonal communications services across multiple devices, and in particular, via chats, posts, videos and recommendations);
Amendment 272 #
2020/0359(COD)
Proposal for a directive
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
1. Each Member State shall adopt a national cybersecurity strategy defining the strategic objectives and, the required technical, organisational, and financial resources to achieve those objectives, and the appropriate policy and regulatory measures, with a view to achieving and maintaining a high level of cybersecurity. The national cybersecurity strategy shall include, in particular, the following:
Amendment 277 #
2020/0359(COD)
Proposal for a directive
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
(b) a governance framework to achieve those objectives and priorities, including the policies referred to in paragraph 2, and an appropriate framework defining the roles and responsibilities of public bodies and entities as well as other relevant actors, underpinning the cooperation and coordination, at the national level, between the competent authorities designated under Articles 7(1) and 8(1), the single point of contact designated under Article 8(3), and the CSIRTs designated under Article 9;
Amendment 284 #
2020/0359(COD)
Proposal for a directive
Article 5 – paragraph 2 – point a a (new)
Article 5 – paragraph 2 – point a a (new)
(aa) guidelines addressing cybersecurity in the supply chain for ICT products and services used by entities outside the scope of this Directive, and in particular supply chain challenges faced by SMEs;
Amendment 287 #
2020/0359(COD)
Proposal for a directive
Article 5 – paragraph 2 – point d a (new)
Article 5 – paragraph 2 – point d a (new)
(da) a policy on promoting the integration of open-source tools and applications;
Amendment 288 #
2020/0359(COD)
Proposal for a directive
Article 5 – paragraph 2 – point d b (new)
Article 5 – paragraph 2 – point d b (new)
(db) a policy to promote and support the development and integration of AI and other emerging technologies in cybersecurity-enhancing tools and applications;
Amendment 289 #
2020/0359(COD)
Proposal for a directive
Article 5 – paragraph 2 – point e
Article 5 – paragraph 2 – point e
(e) a policy on promoting and developing cybersecurity skills, awareness raising and research and development initiatives, including targeted policies addressing issues relating to gender representation and balance in the aforementioned areas;
Amendment 290 #
2020/0359(COD)
Proposal for a directive
Article 5 – paragraph 2 – point e a (new)
Article 5 – paragraph 2 – point e a (new)
(ea) a policy to promote cyber hygiene programmes comprising a baseline set of practices and controls;
Amendment 293 #
2020/0359(COD)
Proposal for a directive
Article 5 – paragraph 2 – point f a (new)
Article 5 – paragraph 2 – point f a (new)
(fa) a policy, including relevant procedures and governance frameworks, to support and promote the establishment of cybersecurity PPPs;
Amendment 301 #
2020/0359(COD)
3. Member States shall notify their national cybersecurity strategies to the Commission within three months from their adoption. Member States may exclude specific information from the notification where and to the extent that it is strictly necessary to preserve national security.
Amendment 302 #
2020/0359(COD)
Proposal for a directive
Article 5 – paragraph 4
Article 5 – paragraph 4
4. Member States shall assess their national cybersecurity strategies at least every four years on the basis of key performance indicators and, where necessary, amend them. The European Union Agency for Cybersecurity (ENISA) shall assist Member States, upon request, in the development of a national strategy and of key performance indicators for the assessment of the strategy. ENISA shall provide guidance to Member States in order to align their already formulated national cybersecurity strategies with the requirements and obligations set out in this Directive.
Amendment 311 #
2020/0359(COD)
Proposal for a directive
Article 6 – paragraph 2
Article 6 – paragraph 2
2. ENISA shall develop and maintain a European vulnerability registry. To that end, ENISA shall establish and maintain the appropriate information systems, policies and procedures, and the necessary technical and organisational measures to ensure the security and integrity of the registry, with a view in particular to enabling important and essential entities and their suppliers of network and information systems, as well as entities excluded from the scope of this Directive, and their suppliers, to disclose and register vulnerabilities present in ICT products or ICT services, as well as to provide access to the information on vulnerabilities contained in the registry to all interested parties, enabling all parties and in particular, the users of the ICT products or ICT services concerned to adopt appropriate mitigating measures. The registry shall, in particular, include information describing the vulnerability, the affected ICT product or ICT services and the severity of the vulnerability in terms of the circumstances under which it may be exploited, and the availability of related patches and, in the absence of available patches, guidance addressed to users of vulnerable products and services as to how the risks resulting from disclosed vulnerabilities may be mitigated.
Amendment 314 #
2020/0359(COD)
Proposal for a directive
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
1a. Where a Member State designates more than one competent authorities referred to in paragraph1, it should clearly indicate which of these competent authorities shall serve as the main point of contact for the management of large- scale incidents and crises.
Amendment 320 #
2020/0359(COD)
Proposal for a directive
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Member States shall ensure that each CSIRT has adequate resources and the technical capabilities necessary to carry out effectively their tasks as set out in Article 10(23).
Amendment 325 #
2020/0359(COD)
Proposal for a directive
Article 10 – paragraph 1 – point c
Article 10 – paragraph 1 – point c
(c) CSIRTs shall be equipped with an appropriate system for managclassifying, routing, and routtracking requests, in particular, to facilitate effective and efficient handovers;
Amendment 326 #
2020/0359(COD)
(ca) CSIRTs shall have appropriate codes of conduct in place to ensure the confidentiality and trustworthiness of their operations;
Amendment 327 #
2020/0359(COD)
Proposal for a directive
Article 10 – paragraph 1 – point e
Article 10 – paragraph 1 – point e
(e) CSIRTs shall be equipped with redundant systems and backup working space to ensure continuity of its services, including full-spectrum connectivity across networks, information systems and services, and devices;
Amendment 328 #
2020/0359(COD)
Proposal for a directive
Article 10 – paragraph 1 – point e a (new)
Article 10 – paragraph 1 – point e a (new)
(ea) CSIRTs shall have appropriate descriptions of the skillsets required by staff to meet the technical capabilities necessary to perform assigned tasks;
Amendment 329 #
2020/0359(COD)
Proposal for a directive
Article 10 – paragraph 1 – point e b (new)
Article 10 – paragraph 1 – point e b (new)
(eb) CSIRTs shall have appropriate internal training frameworks and, where suitable, relevant policies to support external technical training of staff in order to reinforce a culture of continuous improvement;
Amendment 330 #
2020/0359(COD)
Proposal for a directive
Article 10 – paragraph 1 a (new)
Article 10 – paragraph 1 a (new)
1a. CSIRTs shall develop the following technical capabilities to perform their tasks: (a) The ability to conduct real-time monitoring of networks and information systems, and anomaly detection; (b) The ability to support penetration prevention operations including, in particular, the detection and analysis of sophisticated cyber threats; (c) The ability to collect and conduct complex forensic data analysis, and reverse engineering of cyber threats; (d) The ability to filter harmful communication content including, but not limited to, malicious e-mails; (e) The ability to protect data, including personal and sensitive data, from unauthorised exfiltration; (f) The ability to enforce strong authentication and access privileges; (g) The ability to analyse and attribute cyber threats.
Amendment 352 #
2020/0359(COD)
Proposal for a directive
Article 13 – paragraph 3 – point a a (new)
Article 13 – paragraph 3 – point a a (new)
(aa) facilitating the transfer of technology and relevant measures, policies and frameworks among the CSIRTs;
Amendment 353 #
2020/0359(COD)
Proposal for a directive
Article 13 – paragraph 3 – point g – point v
Article 13 – paragraph 3 – point g – point v
(v) contribution to the national cybersecurity incident and crisis response plan referred to in Article 7 (34);
Amendment 364 #
2020/0359(COD)
Proposal for a directive
Article 15 – paragraph 1 – point a a (new)
Article 15 – paragraph 1 – point a a (new)
(aa) the general level of cybersecurity awareness amongst citizens and consumers, the security of consumer- facing connected devices, and the security of digital public services and the respective digital infrastructures through which such services are offered to citizens;
Amendment 368 #
2020/0359(COD)
Proposal for a directive
Article 15 – paragraph 1 – point c b (new)
Article 15 – paragraph 1 – point c b (new)
(cb) the alignment of Member States’ national cybersecurity strategies referred to in Article 5, including the level of convergence of key performance indicators for the assessment of the strategies.
Amendment 370 #
2020/0359(COD)
Proposal for a directive
Article 15 – paragraph 2 a (new)
Article 15 – paragraph 2 a (new)
2a. ENISA, in cooperation with the Commission and with guidance from the Cooperation Group and the CSIRTs network, shall prepare the methodological specifications, including the relevant variables underpinning the scoring and validation of the cybersecurity index referred to in paragraph 1(e).
Amendment 372 #
2020/0359(COD)
Proposal for a directive
Article 16 – paragraph 1 – introductory part
Article 16 – paragraph 1 – introductory part
1. The Commission shall establish, after consulting the Cooperation Group and ENISA, and at the latest by 18 months following the entry into force of this Directive, the methodology and content of a peer-review system for assessing the effectiveness of the Member States’ cybersecurity policies. ENISA shall develop templates for the self-assessment of the reviewed aspects, which Member States being reviewed shall complete and provide to designated experts prior to the commencement of the peer-review process. The reviews shall be conducted by cybersecurity technical experts drawn from ENISA and at least two Member States different than the one reviewed and shall cover at least the following:
Amendment 374 #
2020/0359(COD)
Proposal for a directive
Article 16 – paragraph 1 – point iii
Article 16 – paragraph 1 – point iii
(iii) the operationtechnical capabilities and effectiveness of CSIRTs; in executing their tasks;
Amendment 375 #
2020/0359(COD)
Proposal for a directive
Article 16 – paragraph 2
Article 16 – paragraph 2
2. The methodology shall include objective, non-discriminatory, fair and transparent criteria on the basis of which the Member States shall designate experts eligible to carry out the peer reviews. The Commission, supported by ENISA, shall develop appropriate codes of conduct underpinning the work methods of designated experts participating in peer- reviews to safeguard the confidentiality of information obtained through the peer- review process, and the non-disclosure of such information to any third parties. ENISA and the Commission shall designate experts to participate as observers in the peer-reviews. The Commission, supported by ENISA, shall establish within the methodology as referred to in paragraph 1 an objective, non-discriminatory, fair and transparent system for the selection and the random allocation of experts for each peer review.
Amendment 376 #
2020/0359(COD)
Proposal for a directive
Article 16 – paragraph 4
Article 16 – paragraph 4
4. Peer reviews shall entail actual or virtual on-site visits and off-site exchanges. In view of the principle of good cooperation, the designated experts tasked with carrying out the peer-review shall communicate the aspects under review as referred to in paragraph 1, including any additional targeted issues specific to the Member State or sectors referred to in paragraph 3, and request a corresponding self-assessment report from the Member States being reviewed. The Member States being reviewed shall provide the designated experts with the requested information necessary for the assessment of the reviewed aspects. Any information obtained through the peer review process shall be used solely for that purpose. The experts participating in the peer review shall not disclose any sensitive or confidential information obtained in the course of that review to any third parties.
Amendment 378 #
2020/0359(COD)
Proposal for a directive
Article 16 – paragraph 6
Article 16 – paragraph 6
6. Member States shall ensure that any risk of conflict of interests concerning the designated experts are revealed to the other Member States, the Commission and ENISA without undue delay, before the designation of experts referred to in paragraphs 1 and 2.
Amendment 379 #
2020/0359(COD)
Proposal for a directive
Article 16 – paragraph 7
Article 16 – paragraph 7
7. Experts participating in peer reviews shall draft reports on the findings and conclusions of the reviews. The reports shall include recommendations to enable improvement on the aspects covered by the peer-review process, including recommendations on the transfer of technologies, tools, measures, and processes from Member States carrying out the peer-review to the Member State being reviewed. The reports shall be submitted to the Commission, the Cooperation Group, the CSIRTs network and ENISA. The reports shall be discussed in the Cooperation Group and the CSIRTs network. The reports may be published on the dedicated website of the Cooperation Group.
Amendment 389 #
2020/0359(COD)
Proposal for a directive
Article 18 – paragraph 1
Article 18 – paragraph 1
1. Member States shall ensure that essential and important entities shall take appropriate and proportionate technical, operational and organisational measures to manage the risks posed to the security of network and information systems which those entities use infor their operations or for the provision of their services. Having regard to the state of the art, those measures shall ensure a level of security of network and information systems appropriate to the risk presented.
Amendment 391 #
2020/0359(COD)
Proposal for a directive
Article 18 – paragraph 2 – point b
Article 18 – paragraph 2 – point b
(b) incident handling (prevention, detection, andmitigation, response to, recovery from, and attribution of incidents);
Amendment 394 #
2020/0359(COD)
Proposal for a directive
Article 18 – paragraph 2 – point c
Article 18 – paragraph 2 – point c
(c) business continuity, disaster recovery and crisis management;
Amendment 399 #
2020/0359(COD)
Proposal for a directive
Article 18 – paragraph 2 – point f a (new)
Article 18 – paragraph 2 – point f a (new)
(fa) deployment of secured voice, video and text communications, and of secured emergency communications systems within the entity;
Amendment 424 #
2020/0359(COD)
Proposal for a directive
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Member States shall ensure that essential and important entities notify, without undue delay, the competent authorities or the CSIRT in accordance with paragraphs 32 and 43 of any incident having a significant impact on. Where the incident concerns the provisions of their services. Where appropriate, those entities shall notify, without undue delay, the recipientsentities’ services, those entities shall notify affected users about the unavailability or underlying risks of use of their services of incidents that are likely to adversely affect the provision of that service in order to mitigate the adverse effects of the incident. Essential and important entities may deviate from notifying affected users in case of overriding reasons inducing, but not limited to, that notification worsening the impact of an ongoing incident. Member States shall ensure that those entities report, among others, any information enabling the competent authorities or the CSIRT to determine any cross-border impact of the incident. The notification shall not make the notifying entity subject to increased liability.
Amendment 431 #
2020/0359(COD)
Proposal for a directive
Article 20 – paragraph 2 – subparagraph 1
Article 20 – paragraph 2 – subparagraph 1
Amendment 433 #
2020/0359(COD)
Proposal for a directive
Article 20 – paragraph 2 – subparagraph 2
Article 20 – paragraph 2 – subparagraph 2
Amendment 445 #
2020/0359(COD)
Proposal for a directive
Article 20 – paragraph 4 – subparagraph 1 – point -a (new)
Article 20 – paragraph 4 – subparagraph 1 – point -a (new)
(-a) an early warning within 24 hours after having become aware of an incident, without any obligations on the entity concerned to disclose additional information regarding the incident;
Amendment 448 #
2020/0359(COD)
Proposal for a directive
Article 20 – paragraph 4 – subparagraph 1 – point a
Article 20 – paragraph 4 – subparagraph 1 – point a
(a) without undue delay and in any event within 724 hours after having become aware of the incident, an initial notification, which, where applicable, shall indicate whether the incident is presumably caused by unlawful or malicious action;
Amendment 453 #
2020/0359(COD)
Proposal for a directive
Article 20 – paragraph 4 – subparagraph 1 – point c – introductory part
Article 20 – paragraph 4 – subparagraph 1 – point c – introductory part
(c) a finalcomprehensive report not later than one month after the submission of the report under point (a), including at least the following:
Amendment 463 #
2020/0359(COD)
Proposal for a directive
Article 20 – paragraph 5
Article 20 – paragraph 5
5. The competent national authorities or the CSIRT shall provide, within 24 hours after receiving the initial notification referred to in point (ab) of paragraph 43, a response to the notifying entity, including initial feedback on the incident and, upon request of the entity, guidance on the implementation of possible mitigation measures. Where the CSIRT did not receive the notification referred to in paragraph 1 , the guidance shall be provided by the competent authority in collaboration with the CSIRT. The CSIRT shall provide additional technical support if the concerned entity so requests. Where the incident is suspected to be of criminal nature, the competent national authorities or the CSIRT shall also provide guidance on reporting the incident to law enforcement authorities.
Amendment 471 #
2020/0359(COD)
Proposal for a directive
Article 20 – paragraph 8
Article 20 – paragraph 8
8. At the request of the competent authority or the CSIRT, the single point of contact shall forward notifications received pursuant to paragraphs 1 and 2 1 to the single points of contact of other affected Member States. In compliance with Union law, or in accordance with Member State legislation compliant with Union law, the single point of contact shall preserve the security and commercial interests of the essential or important entity reporting the incident, including the confidentiality of the information provided by the reporting entity in the notification of the incident, when forwarding the notification to the single points of contact of other affected Member States.
Amendment 475 #
2020/0359(COD)
Proposal for a directive
Article 20 – paragraph 9
Article 20 – paragraph 9
9. The single point of contact shall submit to ENISA on a monthly basis a summary report including anonymised and aggregated data on incidents, significant cyber threats and near misses notified in accordance with paragraphs 1 and 2 and in accordance withof this Article, and Article 27. In order to contribute to the provision of comparable information, ENISA may issue technical guidance on the parameters of the information included in the summary report.
Amendment 481 #
2020/0359(COD)
Proposal for a directive
Article 20 – paragraph 10 a (new)
Article 20 – paragraph 10 a (new)
10a. ENISA, in cooperation with the Cooperation Group, shall develop common incident notification templates by [date of transposition deadline of the Directive], to streamline the reporting obligations of essential and important entities, and simplify the sharing of relevant information referred to in point (b) of paragraph 1 of this Article.
Amendment 483 #
2020/0359(COD)
Proposal for a directive
Article 20 – paragraph 11
Article 20 – paragraph 11
11. The Commission, may adopt implementing acts further specifying the type of information, the format and the procedure of a notification submitted pursuant to paragraphs 1 and 2. The Commission may also adopt implementing shall be empowered to adopt delegated acts to further specifying the cases in which an incident shall be considered significant as referred to in paragraph 3. Those implementing acts shall be adopte2, and in accordance with the examination procedureercise of delegation power referred to in Article 37(2)6.
Amendment 488 #
2020/0359(COD)
Proposal for a directive
Article 21 – paragraph 1
Article 21 – paragraph 1
1. In order to demonstrate compliance with certain requirements of Article 18, Member States may requirand following guidance from ENISA, the Commission, and the Cooperation Group, Member States shall encourage essential and important entities to certify certain ICT products, ICT services and ICT processes, developed either by the essential and important entities or procured from third parties, under specific European cybersecurity certification schemes adopted pursuant to Article 49 of Regulation (EU) 2019/881. The products, services and processes subject to certification may be developed by an essential or important entity or procured from third parti, or under equivalent and internationally accepted certification schemes.
Amendment 502 #
2020/0359(COD)
Proposal for a directive
Article 23 – paragraph 1
Article 23 – paragraph 1
1. For the purpose of contributing to the security, stability and resilience of the DNS, Member States shall ensure that TLD registries and the entities providing domain name registration services for the TLD shall collect and maintain accurate and complete domain name registration data in a dedicated database facility with due diligence subject to Union data protection law as regards data which are personal data.
Amendment 505 #
2020/0359(COD)
Proposal for a directive
Article 23 – paragraph 4
Article 23 – paragraph 4
4. Member States shall ensure that the TLD registries and the entities providing domain name registration services for the TLD publish, without undue delaymake publicly available, within 72 hours after the registration of a domain name, domain registration data which are not personal dataof legal persons as registrants.
Amendment 507 #
2020/0359(COD)
Proposal for a directive
Article 23 – paragraph 5
Article 23 – paragraph 5
5. Member States shall ensure that the TLD registries and the entities providing domain name registration services for the TLD provide access to specific domain name registration data upon lawful and, including personal data, upon duly justified requests of legitimate access seekers, in compliance with Union data protection law. Member States shall ensure that the TLD registries and the entities providing domain name registration services for the TLD reply without undue delayreply within 72 hours to all requests for access. Member States shall ensure that policies and procedures to disclose such data are made publicly available. The Commission may adopt implementing acts laying out the requirements to be demonstrated by legitimate access seekers to TLD registries and entities providing domain name registration services before access to specific domain name registration data is granted. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 37(2).
Amendment 518 #
2020/0359(COD)
Proposal for a directive
Article 25 – paragraph 1 – introductory part
Article 25 – paragraph 1 – introductory part
1. ENISA shall create and maintain a registry for essential and important entities referred to in Article 24(1). ENISA shall establish appropriate information classification and management protocols to ensure the security and confidentiality of disclosed information, and restrict the access, storage, and transmission of such information to intended users. The entities shall submit the following information to ENISA by [12 months after entering into force of the Directive at the latest]:
Amendment 523 #
2020/0359(COD)
Proposal for a directive
Article 26 – paragraph 1 – introductory part
Article 26 – paragraph 1 – introductory part
1. Without prejudice to Regulation (EU) 2016/679, Member States shall ensure that essential and important entities may exchange relevant cybersecurity information among themselves including information relating to cyber threats, near misses, vulnerabilities, indicators of compromise, tactics, techniques and procedures, cybersecurity alerts and configuration tools, where such information sharing:
Amendment 528 #
2020/0359(COD)
Proposal for a directive
Article 26 – paragraph 2
Article 26 – paragraph 2
2. Member States shall ensure thfacilitate the exchange of information takes place withinby enabling the establishment of trusted communities of essential and important entities. Such exchange shall be implemented through information sharing arrangements in respect of the potentially sensitive nature of the information shared and in compliance with the rules of Union law referred to in paragraph 1.
Amendment 529 #
2020/0359(COD)
Proposal for a directive
Article 26 – paragraph 3
Article 26 – paragraph 3
3. Member States shall set out rules specifying the procedure,facilitate information sharing by making operational elements (including the use of dedicated ICT platforms), and content and conditionsvailable of the information sharing arrangements referred to in paragraph 2. Such rul, and may impose certain conditions on the information made available by competent authorities or CSIRTs. Member States shall also lay down the details of the involvement of public authorities in such arrangements, as well as operational elements, including the use of dedicated IT platforms. Member States shall offer support to the application of such arrangements in accordance with their policies referred to in Article 5(2) (g(l).
Amendment 546 #
2020/0359(COD)
Proposal for a directive
Article 29 – paragraph 2 – point c
Article 29 – paragraph 2 – point c
(c) targeted security audits based on risk assessments orperformed by the competent authorities, risk assessments performed by the audited entity, or in the absence thereof, risk-related available information;
Amendment 552 #
2020/0359(COD)
Proposal for a directive
Article 29 – paragraph 4 – point i
Article 29 – paragraph 4 – point i
Amendment 557 #
2020/0359(COD)
Proposal for a directive
Article 29 – paragraph 5 – subparagraph 1 – point a
Article 29 – paragraph 5 – subparagraph 1 – point a
(a) where applicable, temporarily suspend or request a certification or authorisation body to temporarily suspend a certification or authorisation concerning part or all the services or activities provided by an essential entity until the entity takes the necessary action to remedy the deficiencies or comply with the requirements of the competent authority for which such sanctions were applied;
Amendment 565 #
2020/0359(COD)
Proposal for a directive
Article 29 – paragraph 5 – subparagraph 1 – point b
Article 29 – paragraph 5 – subparagraph 1 – point b
(b) impose or request the imposition by the relevant bodies or courts according to national laws of a temporary ban against any person discharging managerial responsibilities at chief executive officer or legal representative level in that essential entity, and of any other natural person held responsible for the breach, from exercising managerial functions in that entity from exercising managerial functions in that entity. This provision shall not apply to public administration entities as referred to in point (23) of Article 4.
Amendment 566 #
2020/0359(COD)
Proposal for a directive
Article 29 – paragraph 5 – subparagraph 2
Article 29 – paragraph 5 – subparagraph 2
Amendment 570 #
2020/0359(COD)
Proposal for a directive
Article 29 – paragraph 7 – point c
Article 29 – paragraph 7 – point c
(c) the actual damage caused or losses incurred or potential damage or losses that could have been triggered, insofar as they can be determined. Where evaluating this aspect, account shall be taken, amongst others, of actual or potentialincluding financial or economic losses, effects on other services, and the number of users affected or potentially affected;
Amendment 574 #
2020/0359(COD)
Proposal for a directive
Article 30 – paragraph 2 – point b
Article 30 – paragraph 2 – point b
(b) targeted security audits based on risk assessments orperformed by the competent authority, risk assessments performed by the audited entity, or in the absence thereof, risk-related available information;
Amendment 575 #
2020/0359(COD)
Proposal for a directive
Article 30 – paragraph 2 – point c
Article 30 – paragraph 2 – point c
(c) security scans based on objective, non-discriminatory, fair and transparent risk assessment criteria;
Amendment 577 #
2020/0359(COD)
Proposal for a directive
Article 30 – paragraph 4 – point h
Article 30 – paragraph 4 – point h
Amendment 582 #
2020/0359(COD)
Proposal for a directive
Article 32 – paragraph 1
Article 32 – paragraph 1
1. Where the competent authorities have indications that the infringement by an essential or important entity of the obligations laid down in Articles 18 and 20 entails a personal data breach, as defined by Article 4(12) of Regulation (EU) 2016/679 which shall be notified pursuant to Article 33 of that Regulation, they shall inform the supervisory authorities competent pursuant to Articles 55 and 56 of that Regulation within a reasonable period of timeout undue delay.
Amendment 586 #
2020/0359(COD)
Proposal for a directive
Article 35 – paragraph 1 a (new)
Article 35 – paragraph 1 a (new)
As regards Digital Providers referred to in point (6) of Annex II, where platforms operated by such important entities are classified as very large online platforms within the meaning of Article 25 of Regulation (EU) XXXX/XXXX [Single Market For Digital Services (Digital Services Act) and amending Directive 2000/31/EC], or where the providers of core platform services are designated as gatekeepers within the meaning of Article 3 of Regulation (EU) XXXX/XXXX [Contestable and fair markets in the digital sector (Digital Markets Act)], these providers shall be designated as essential entities within the meaning of this Directive to adequately address the functioning of the economy and society in relation to cybersecurity, given the systemic risk stemming from the functioning and use made of their services in the Union, or the important gateway function that their core platform services serve for business users to reach end users.
Amendment 67 #
2020/0321(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The unprecedented experience of the COVID-19 pandemic has demonstrated that the Union should be more effective in managing the availability of medicinal products and medical devices and in developing medical countermeasures to address the threats posed to public health. The Union’s ability to do so has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, and also by the limited degree of Union preparedness in case of a public health emergency impacting a majority of Member States. The pandemic has also shown the necessity of having an innovative and research based pharmaceutical industry that works closely with EMA in order to be better prepared for future health crisis and disruptions in the supply chain. COVID- 19 also underlined the need for more transparency on medicines pricing and EU marketing authorisation.
Amendment 74 #
2020/0321(COD)
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4 a) The COVID-19 pandemic is a clear example of the need to reinforce the application of the One Health approach in the EU to achieve better public health outcomes, since, as stated in the EU4Health Programme, human health is connected to animal health and the environment and actions to tackle threats to health should take into account those three dimensions.
Amendment 83 #
2020/0321(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) The outbreak of COVID-19 and the subsequent health crisis revealed the need for a more coordinated European approach in crisis management. Although the emergency of the situation explains the lack of an impact assessment, sufficient allocation of resources in terms of staff and funding needs to be secured, taking into account the specificities of the health sector in the different Member States.
Amendment 84 #
2020/0321(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) In order to ensure a better functioning of the internal market of those products and contribute to a high level of human health protection, it is therefore appropriate to approximate the rules on monitoring of shortages of medicinal products and medical devices, and to facilitate the research and development of medicinal products, which may have the potential to treat, prevent, or diagnose diseases that cause public health crises. Highlights in this respect the necessity of developing analytics to predict emerging risks, including the use of alternative data sources.
Amendment 99 #
2020/0321(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) Individual research entities may agree together, or with another party, to act as a sponsor in order to prepare one harmonised Union-wide clinical trial protocol, yet experience during the COVID-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that can undertake all the responsibilities and activities of a sponsor within the Union, while interacting with multiple Member States. It is therefore appropriate for the Agency to identify and facilitate such initiatives by giving advice on the possibilities to act as a sponsor or, where applicable, to define respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) 536/2014. Such an approach would strengthen the research environment in the Union, andwhile encouraging the collaboration with external experts including academia, and target recruitment of data scientists, omics specialists, biostatisticians, epidemiologists, and experts in advanced analytics and AI, as well as to promote harmonisation and avoid subsequent delays in integrating the results of research to a marketing authorisation. A Union sponsor could benefit from Union research funding available at the time of the public health emergency as well as existing clinical trial networks to facilitate the development, application, submission, and running of the trial. This may be particularly valuable for trials established by Union or international public health or research organisations.
Amendment 106 #
2020/0321(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) In order to facilitate the work and the exchange of information under this Regulation, provision should be made through further implementing acts with a view to outlining the roles of the actors involved in the processing of personal data for the establishment and management of IT infrastructures and synergies with other existing IT systems or systems under development, including the EUDAMED IT platform for medical devices and Data Analysis and Real World Interrogation Network - DARWIN. That work should also be facilitated by, where appropriate, emerging digital technologies such as computational models and simulations for clinical trials, as well as data from the EU Space Programme such as the Galileo geolocation services, and Copernicus earth observation data, while enabling data discoverability.
Amendment 109 #
2020/0321(COD)
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25 a) Underlines the potential of Big Data to complement the evidence from clinical trials and fill knowledge gaps on medicines, as well as to help to better characterise diseases, treatments and the performance of medicines in individual healthcare systems. The global pandemic has also shown how High Performance Computing, in combination with Big Data and AI, can be of critical importance in the global fight against COVID-19.
Amendment 111 #
2020/0321(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) Rapid access and exchange of health data, including real world data i.e. health data generated outside of clinical studies, such as electronic health records, insurance claims data and data from patient registries, is essential to ensure effective management of public health emergencies and other major events. This Regulation should allow the Agency to use and facilitate such exchange and be part of the establishment and operation of the European Health Data Space infrastructure, while ensuring the applicability of the GDPR and EUDPR, and the respect of the principles relating to the processing of personal data (as per Article 5 GDPR and 4 EUDPR).
Amendment 116 #
2020/0321(COD)
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26 a) The handling of sensitive health data requires a high level of protection against cyber-attacks. The Agency was the target of a cyber-attack that resulted in some of the unlawfully accessed documents related to COVID-19 medicines and vaccines belonging to third parties. Highlights in this respect the need for a high level of security against cyber- attacks, and particularly cyber-espionage, at all times and especially during public health emergencies;
Amendment 117 #
2020/0321(COD)
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26 a) Calls for the swift implementation of binding rules on security information and cybersecurity in line with the Security Union Strategy. Urges the Member States to accelerate the work towards completing the implementation of the main 5G Toolbox measures by the second quarter of 2021;
Amendment 145 #
2020/0321(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the manufacturing, supply or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.
Amendment 167 #
2020/0321(COD)
Proposal for a regulation
Article 4 – paragraph 5 – point a
Article 4 – paragraph 5 – point a
(a) where the major event or public health emergency may affect the manufacturing, safety, quality, and efficacy of medicinal products, Article 5 shall apply;
Amendment 169 #
2020/0321(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Following the recognition of a public health emergency or a request for assistance referred to in Article 4(3), the Medicines Steering Group shall evaluate the information related to the major event or the public health emergency and consider the need for urgent and coordinated action with regard to the manufacturing safety, quality, and efficacy of the medicinal products concerned.
Amendment 195 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) specify the procedures and criteria for establishing the critical medicines lists;
Amendment 202 #
2020/0321(COD)
Proposal for a regulation
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) develop streamlined electronic monitoring and reporting systems in coordination with the national competent authorities;
Amendment 247 #
2020/0321(COD)
Proposal for a regulation
Article 14 – paragraph 2 – point f
Article 14 – paragraph 2 – point f
(f) cooperating with national competent authorities, Union bodies and agencies, the World Health Organization, third countries, and international scientific organisations on scientific and technical issues relating to the public health emergency and to medicinal products which may have the potential to address public health emergencies, as necessary.
Amendment 262 #
2020/0321(COD)
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
6. Where a developer is the recipient of scientific advice, the developer shall subsequently submit the data resulting from clinical trials to the Agency following a request made pursuant to Article 16. In order to ensure the protection of sensitive data a state-of-the-art pseudonymisation shall apply, including encryption.
Amendment 268 #
2020/0321(COD)
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. In preparation of the review, the Emergency Task Force may request information and data from marketing authorisation holders and from developers and engage with them in preliminary discussions. The Emergency Task Force may also, where available, make use of observational studies of health data generated outside of clinical studies taking into account their reliability, while applying state-of-the-art pseudonymisation, including encryption.
Amendment 275 #
2020/0321(COD)
Proposal for a regulation
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
(a) develop and maintain electronic tools for the submission of information and data, including electronic health data generated outside the scope of clinical studies, while ensuring processing of patients' personal data is in compliance with the European data protection framework;
Amendment 277 #
2020/0321(COD)
Proposal for a regulation
Article 18 – paragraph 1 – point b
Article 18 – paragraph 1 – point b
(b) coordinate independent vaccine effectiveness and safety monitoring studies using relevant data held by public authorities, while taking into consideration the priority recommendations of the HMA-EMA joint Big Data Task Force. Such coordination shall be conducted jointly with the European Centre for Disease Prevention and Control and notably through a new vaccine monitoring platform;
Amendment 278 #
2020/0321(COD)
Proposal for a regulation
Article 18 – paragraph 1 – point c
Article 18 – paragraph 1 – point c
(c) as part of its regulatory tasks, make use of digital infrastructures or tools, to facilitate the rapid access to or analysis of available electronic health data generated outside the scope of clinical studies, and the exchange of such data between Member States, the Agency, and other Union bodies; underlines in this regard the need to speed up the deployment of a secure quantum communication infrastructure (QCI), which would allow the transmission of sensitive information, using an ultra-secure form of encryption to shield against cyberattacks;
Amendment 279 #
2020/0321(COD)
Proposal for a regulation
Article 18 – paragraph 1 – point c a (new)
Article 18 – paragraph 1 – point c a (new)
(c a) The Agency shall be equipped with a high level of security against cyber- attacks and cyber-espionage at all times, especially during major events and public health emergencies at Union level. Binding rules on security information and cybersecurity shall apply in line with the Security Union Strategy.
Amendment 300 #
2020/0321(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point a
Article 23 – paragraph 1 – point a
(a) specify the procedures and criteria for establishing the public health emergency critical devices list;
Amendment 301 #
2020/0321(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point b
Article 23 – paragraph 1 – point b
(b) develop streamlined electronic monitoring and reporting systems in coordination with the national competent authorities;
Amendment 319 #
2020/0321(COD)
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) personal data in accordance with Article 32 and Article 4(1) of Regulation (EU) 2016/679 (‘GDPR’) and Article 3(1) EUDPR;
Amendment 321 #
2020/0321(COD)
Proposal for a regulation
Article 30 – paragraph 5
Article 30 – paragraph 5
5. The Commission, the Agency, and Member States may exchange commercially confidential information and, where necessary to protect public health, personal data, with regulatory authorities of third countries with which they have concluded bilateral or multilateral confidentiality arrangements. Recalls that transfers of personal data to third countries or international organisations must comply with Chapter V of the EUDPR, relevant provisions of the GDPR, the LED and the Charter of Fundamental Rights and take into account the recommendations and guidelines of the EDPB.