Activities of Beatrice COVASSI
Plenary speeches (27)
A Green Deal Industrial Plan for the Net-Zero Age (continuation of debate)
Implementation report on the Agreement on the withdrawal of the UK from the EU - The Windsor Framework (debate)
Adoption of the Cyber package proposals (debate)
IPCC report on Climate Change: a call for urgent additional action (debate)
EU Day for the victims of the global climate crisis (debate)
This is Europe - Debate with the President of Cyprus, Nikos Christodoulides (debate)
The water crisis in Europe (debate)
European Citizens’ Initiative ‘Save Cruelty Free Cosmetics – Commit to a Europe without animal testing’ (debate)
Ecodesign Regulation (debate)
Conclusions of the European Council meeting of 29-30 June 2023, in particular the recent developments in the war against Ukraine and in Russia (debate)
State of the SME Union (debate)
Geographical indication protection for craft and industrial products (debate)
Medicine shortages and strategic healthcare autonomy in the EU (debate)
Urban wastewater treatment (debate)
Establishing the Strategic Technologies for Europe Platform (‘STEP’) (debate)
A true geopolitical Europe now (topical debate)
European Citizens' Initiative 'Fur Free Europe' (debate)
Order of business
This is Europe - Debate with the Prime Minister of Bulgaria, Nikolay Denkov (debate)
EU-China relations (debate)
Transparency and accountability of non-governmental organisations funded from the EU budget (debate)
Geothermal energy (debate)
The fight against hate speech and disinformation: responsibility of social platforms within the Digital Services Act (topical debate)
Unitary supplementary protection certificate for plant protection products - Unitary supplementary certificate for medicinal products - Supplementary protection certificate for plant protection products (recast) - Supplementary protection certificate for medicinal products (recast) - Standard essential patents (joint debate - Patents)
Preventing work-related deaths following the Florence tragedy (debate)
Commission recommendation on secure and resilient submarine cables (debate)
Horizontal cybersecurity requirements for products with digital elements and amending Regulation (EU) 2019/1020 (debate)
Shadow reports (7)
REPORT on the proposal for a regulation of the European Parliament and of the Council on specific rules relating to the entry into Northern Ireland from other parts of the United Kingdom of certain consignments of retail goods, plants for planting, seed potatoes, machinery and certain vehicles operated for agricultural or forestry purposes, as well as non-commercial movements of certain pet animals into Northern Ireland
REPORT on the proposal for a regulation of the European Parliament and of the Council on specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland
REPORT on the proposal for a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements and amending Regulation (EU) 2019/1020
REPORT on the proposal for a regulation of the European Parliament and of the Council on measures to reduce the cost of deploying gigabit electronic communications networks and repealing Directive 2014/61/EU (Gigabit Infrastructure Act)
REPORT on the transparency and accountability of non-governmental organisations funded from the EU budget
REPORT on the nomination of Carlo Alberto Manfredi Selvaggi as a Member of the Court of Auditors
REPORT on the proposal for a directive of the European Parliament and of the Council on Soil Monitoring and Resilience (Soil Monitoring Law)
Shadow opinions (1)
Opinion on the Implementation reports 2021 and 2022 on the EU-UK Trade and Cooperation Agreement
Oral questions (1)
Medicine shortages and strategic healthcare autonomy in the EU
Written explanations (2)
Artificial Intelligence Act (A9-0188/2023 - Brando Benifei, Dragoş Tudorache)
. – Con il voto in Plenaria di oggi, il Parlamento europeo ha inviato un chiaro messaggio: siamo pronti a definire la prima normativa al mondo sull'Intelligenza Artificiale (IA). Il testo adottato mantiene gli esseri umani e i loro diritti fondamentali al centro della proposta, garantendo al contempo la certezza del diritto, evitando sovrapposizioni con la legislazione esistente e mirando a stimolare l'innovazione. È stato dato il giusto rilievo alla tutela dei cittadini e della loro privacy.In questo senso, ad esempio, abbiamo incluso nel testo il divieto di riconoscimento facciale in tempo reale per evitare qualsiasi rischio di sorveglianza di massa. Ho votato a favore di questa legge perché ritengo che adottare tempestivamente degli standard comuni a livello europeo sia di importanza cruciale per sviluppare le potenzialità di queste nuove tecnologie.Con l'approvazione del testo, l'Europa vuole essere, infatti, non solo regolatrice ma anche innovatrice. Si tratta di un passo importante, un'innovazione positiva e dalla parte delle persone.
Batteries and waste batteries (A9-0031/2022 - Achille Variati)
. – La proposta di legge sulle batterie è stata approvata oggi definitivamente al Parlamento europeo. Una grande rivoluzione per la nostra sostenibilità. Le batterie giocano un ruolo centrale per la decarbonizzazione dei trasporti e diventeranno le più sostenibili a livello globale grazie all'introduzione degli obblighi di design, riciclaggio e recupero.Si darà vita a una forma di economia circolare vera e propria attorno al mondo delle batterie, dalla produzione allo smaltimento. Ho sostenuto convintamente questo ulteriore passo importante verso una mobilità più sostenibile.
Written questions (22)
Activation of the Temporary Protection Directive in response to the devastating earthquake in Turkey
Italian decree-law on urgent provisions for the management of migratory flows
Syrian regime forces blockade of aid convoys of the Kurdish Red Crescent (KRC) directed to the North-West
Issuing of visas for Iranian women and girls
Issuing visas to Iranian women and girls
The situation of Turkish and Syrian children orphaned by the earthquake
Tragedy off the coast of Crotone
Systematic abuses at Greek borders
Financing of the project to redevelop the Artemio Franchi stadium in Florence
The case of Fatmata, a 23-year-old woman from Sierra Leone who was shot dead at the border between Greece and North Macedonia
Protection of the rights of children with same-sex parents
Italian National Recovery and Resilience Facility – monitoring gender impact: open data and conditionality
Media pluralism in Italy – the case of Roberto Saviano and RAI
State of affairs in Guatemala following the June 2023 presidential elections
EU response to the flooding in Tuscany and the increasing number of natural disasters caused by hydrogeological instability
Compliance of the Italy-Albania memorandum of understanding with international law and EU asylum rules
Hearing of the journalist Sigfrido Ranucci in the Parliamentary Committee for the General Orientation and Supervision of Radio and Television Services
Case of Ilaria Salis, detained in Hungary, and human rights in Hungarian prisons
Arbitrary conviction of Nobel Prize-winner Muhammad Yunus in Bangladesh
Protection of press freedom in Italy - possible amendment of the Consolidated Act on audio-visual and radio media services
The case of Filippo Mosca and prison conditions in Romania
Partnership agreement between the EU and Egypt
Amendments (445)
Amendment 9 #
2023/2122(INI)
Motion for a resolution
Recital B
Recital B
B. whereas only the funds directly awarded to NGOs have been subject to monitoring and reporting by the Commission so far;
Amendment 12 #
2023/2122(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
B a. whereas the Treaties require the EU institutions and EU Member States to maintain an open, transparent and regular dialogue with representative associations and civil society; stresses the importance for EU Members States and EU institutions to provide adequate funding to programmes aimed protecting and promoting rights and values enshrined in the EU Treaties; recognises the role NGOs and CSOs play in implementing these programmes;
Amendment 14 #
2023/2122(INI)
Motion for a resolution
Recital D
Recital D
D. whereas an analysis of FTS data shows that grants awarded from the EU budget to NGOs, after excluding EU programmes in the field of education and research, amounted to at least EUR 2.6 billion in 2022, under direct management, across all EU programmes and funds; whereas the total amount of grants awarded to NGOs is likely to be higher owing to the absence of a definition of an NGO or of clear differentiation between NGOs and not-for-profit organisations (NFPOs) in the FTS11 ; _________________ 11 Overall amount of grants awarded from the EU Budget to NGOs in 2022, based on FTS analysis – approx. EUR 3.7 billion.mounted to EUR 3,7 billion in 2022; whereas currently only NGOs have to publish their funding sources while all the interest groups have to provide an estimation of their lobbying budges;
Amendment 29 #
2023/2122(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Welcomes the vital role played by NGOs in linking civil society with political decision-making in all EU policy areas; highlights, in particular, their role in implementing the EU budget and reppromoting and defending human rights and democracy, combating any form of discrimination, fighting for a clean, healthy and sustainable environment, informing individuals and groups, especially the most vulnerable, about their rights and standing up for them when those rights are violated, denouncing human and civil rights violations, promoting intercultural dialogue, civic engagement and public participation, countering disinformation and hate speech, collecting public interest information and holding governments and elected representatives accountable to citizens, and fighting corruption and impunity for human rights abuses; stressenting civil societys, moreover, their crucial role in providing societal benefits and assistance for the most vulnerable groups, including women, LGBTIQ+ persons, persons with disabilities, minorities, migrants and refugees;
Amendment 49 #
2023/2122(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
Amendment 53 #
2023/2122(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Points out that laws and the legislative process often neglect the voices of local, regional and national NGOs, while favouring the priorities of large NGOs, that the priorities andshould take into consideration the different needs of smaller local and, regional NGOs are often ignored or have less attention paid to them, despite the fact that these smaller and regional groups often do the majority of the work; emphasises that the work of small and regional organisations is to be paid the highest respect, as they represent the true diversity and variety of volunteer work performed across Europe, and national and international NGOs;
Amendment 58 #
2023/2122(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Commends the crucial role of NGOs in the EU and elsewhere in defending the rule of law and promoting respect for human rightsaround the world in defending and promoting human rights, the rule of law and democracy; reiterates that in countries with authoritarian or non- democratic regimes, NGOs often represent the last line of defence of democracy; insists on the importance of adequate EU funding for NGOs active in these fieldswhose aim is to shrink civil society space and silence dissenting voices, NGOs often represent the last line of defence of democracy; is alarmed that some governments have adopted legislation based, inter alia, on security, counter-terrorism and the fight against foreign interference, that imposes discriminatory obligations on human rights NGOs and their workers, stigmatises, restricts or bans their activities, freeze their assets, deters their donors from contributing funds or deprives them from access to funding;
Amendment 64 #
2023/2122(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7 a. Remains deeply concerned by threats to and unjustified attacks on NGOs in some Member States, including by proposing and adopting legislation that imposes discriminatory obligations on NGOs that restrict or ban their activities, and through online and offline intimidation and harassment against their staff, negative public statements and smear campaigns, verbal threats, and legal and physical attacks; stresses that some NGOs also face excessive administrative controls or audits, politically motivated funding cuts and overly strict legal requirements for their formation and registration; insists that NGOs must be protected and should receive adequate funding and support;
Amendment 69 #
2023/2122(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Is convinced that public transparency is also vital for NGOs to showcase their valuable work, be recognised and build their credibility;
Amendment 74 #
2023/2122(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Is of the opinion that the alleged corruption case referred to as Qatargate and the role certain NGOs played in it could have been prevented through the consistent enforcement of existing transparency requirements and an obligation for NGOs to disclose their sources of funding and their internal structures; notes with concern that the relevant NGOs have profited from EU funding since 2015; considers it unacceptable that the use of funds and transfers to other organisations are not entirely traceable; warns of, through the consistent enforcement of existing transparency requirements, corruption, as well as the danger that EU taxpayers’ money could ultimately be used within corrupt circles; emphasises the importance of ‘final beneficiary transparency’ for EU NGO funds, can be avoided;
Amendment 81 #
2023/2122(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Recalls that the following findings and recommendations are based on the conclusions of the transparency and accountability study and address further weaknesses concerning the handling of EU funds by NGOsPoints out that strengthening the transparency requirements for interest representatives and entities, including NGOs, could serve the purpose of tracing of tracing foreign interferences; underlines that these requirements, however, should not create burdensome procedures and should not stigmatise legitimate foreign funding;
Amendment 87 #
2023/2122(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Reiterates the fundamental significance of public trust and support for NGOs; acknowledges that the terms used to describe these organisations are subject to different legal and public interpretations;
Amendment 93 #
2023/2122(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Emphasises that the term NGO is a broad umbrella term embracing many different kinds of organisation: from large international organisations to small regional or local ones, from organisations run mostly by professionalaid workers to those consisting mostly of volunteers; highlights that the subject matter covered by NGOs and the method of implementation can also vary substantially, for instance, some NGOs may do work that is highly theoretical (for example the work of some think-tanks), or political (for example politically affiliated NGOs) whereas others may be very hands-on (for example the daily work that firefighting NGOs engage in across Europe); emphasises, therefore, that different types of NGOs should be differentiated when analysing levels of transparency and efficiency, and that a bettera better harmonisation of the definition of NGOs should be established at the EU level;
Amendment 97 #
2023/2122(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
Amendment 105 #
2023/2122(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Highlights the advantages of establishing a common definition for EU engagement with NGOs, encompassing direct deliberative, political and financial interactions; acknowledges the advantage of enabling a common understanding of what these partners are in relation to the EU and its bodies in different contexts, beyond the question of financial support; believes that the added value of a common EU-wide definition lies inat establishing the above mentioned common harmonised definition can be an element of increased transparency, accountability and predictability for EU institutions, the Member States, NGOs and EU taxpayers;
Amendment 109 #
2023/2122(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
Amendment 119 #
2023/2122(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
Amendment 127 #
2023/2122(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Is concerned that public transparency requirements can be circumvented, especially when money is passed along a chain and used to fulfil the purposes of other donors; highlights that the FTS does not provide any information about how EU funding sub-granted under indirect and shared management is distributed among NGOs, on what basis or for what purpose; considers this highly problematic, as large amounts of funding are committed through indirect and shared management; calls on the Commission to verify the re-allocation of funds and their use by the final beneficiary by imposing appropriate reporting and publication requirements in line with annual reporting by the Member States and the Commission on the implementation of the European structural and investment fundHighlights that the FTS does not provide any information about how EU funding sub-granted under indirect and shared management is distributed among NGOs;
Amendment 142 #
2023/2122(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
Amendment 151 #
2023/2122(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls for national lobby registry laws to also require the disclosure of donors and their international financial chainEncourages Member States to establish national lobby registry laws;
Amendment 158 #
2023/2122(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Recalls that certain organisations that engage in illegal activities and act against the EU’s values have been registered and are operating in Member States; bBelieves that national administrations, which arebeing closer to the ground, must assume responsibility for being the first effective layer that could stop organisations that are acting illegally and against EU rulerepresent the first effective layer for control and monitoring of organisations and reporting to the EU in case of suspected fraud or misuse of funds;
Amendment 163 #
2023/2122(INI)
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on national authorities to take legal and administrative measures that facilitate action at EU level and make it easier and quicker for the Commission to include such organisations in the Early Detection and Exclusion System (EDES) and exclude them from EU funding; calls for such a requirement for Member States to be included in the proposal for an NGO regulation;
Amendment 170 #
2023/2122(INI)
Motion for a resolution
Paragraph 22
Paragraph 22
22. Regrets that public transparency is negatively impacted by the publication of data in the FTS with a delay of between 6 and 18 months; calls on the Commission to publish information about EU grants awarded to NGOs no later than 6 months after the date on which the grant was awarded15 , including funding received from other sources, such as foundations; calls on the Commission to develop and integrate data validation tools so that the FTS data validation process is automatic and continuous, is quicker and consumes fewer resources16 ; _________________ 15 See: transparency and accountability study, recommendation 5. 16 See: transparency and accountability study, recommendation 7.
Amendment 177 #
2023/2122(INI)
Motion for a resolution
Paragraph 23
Paragraph 23
Amendment 185 #
2023/2122(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
Amendment 187 #
2023/2122(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Regrets that the Commission’s systems are not very transparent and that their data differnd data are not user friendly, making it difficult to reconcile information from different publicly accessible Commission portals and databases, because they use different conventions to identify beneficiaries of projects and grants; recommends that the Commission establish harmonised rules and standardise the layout and functionalities of programme-specific databases;
Amendment 192 #
2023/2122(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Calls onRecognises that the Commission to uses a common unique entity, such as a unique participant identification code, and project identification keys across all portals and databases, including on beneficiaries’ websites, to facilitate the reconciliation of publicly available information provided by different systems and websites;, but calls onfor the Commission to provide all NGO grant beneficiaries with code that extracts five years of funding data directly from the FTS and includes links to the correspondingestablishment of a link between FTS and specific project entriesdata in the Commission’s programme databases17 ; _________________ 17 See: transparency and accountability study, recommendation 19.
Amendment 199 #
2023/2122(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Observes inconsistencies in the content and extent of the information displayed on project websites and notes NGOs’ insufficient clarity on grant distribution among partners and on the connection to pertinent Commission databases; calls for a more proactive approach from NGOs to public transparency that goes beythe lack of connection between the project websites and the related Commission databases; underlines that sometimes these differences could also depend on the fact that, in some countries ruled by authoritarian and illiberal regimes and with reduced civic spaces, the dissemination of such information may put NGOs at risk; calls all beneficiaries of EU funding to the best possible public transparency; calls the Commissiond the current minimal requirements for EU grant funding18 ; calls for a clearer and more systematic presentation of information on NGO and EU-funded project websites on the grant funding received from the EU and from other sources for both specific projects ando provide clear and consistent guidelines on project objectives, results and impact, building up on best practices, and to make them available on programme databases; calls for the establishment of harmonised but flexible approaches to make EU funding more visible to the public, while avoiding putting at risk NGOs that ovperall, and on project objectives, results and impact; _________________ 18 See: transparency and accountability study, recommendation 17.te in precarious contexts and face serious threats and reprisal for receiving EU funding;
Amendment 206 #
2023/2122(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Notes that, although the mainstreaming of the eGrants system as a common grants management tool and applicant registration system across Commission services has improved the quality and completeness of FTS data, more effort needs to be made to improve the reliability of such data; is concerned that there are still continuing shortcomings in terms of consistency in existing Commission transparency portals and systemsconsistency of such data; further calls for a more user- friendly FTS that is linked to the Transparency Register and compatible with specific programmes’ databases, and highlights that it should include final payments and a clear definitions of NGOs, making it possible to identify beneficiaries by categoryall categories of beneficiaries, including profit and non profit organisations; requests that the Commission prepare a proposal for further administrative action by 1 June 2024;
Amendment 216 #
2023/2122(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
Amendment 220 #
2023/2122(INI)
Motion for a resolution
Paragraph 30
Paragraph 30
Amendment 229 #
2023/2122(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
Amendment 231 #
2023/2122(INI)
Motion for a resolution
Paragraph 32
Paragraph 32
32. Notes that the coexistence of reporting obligations and accounting practices at the national and EU levels may lead to a disproportionate administrative burden for NGOs; calls on the Commission to ensure that reporting obligations at the EU and national levels are consistent in order to guarantee easier monitoring of the fulfilment of obligations, especially for smaller NGOs; calls on the Commission to develop a common monitoring system to identify final beneficiaries, as is already the case in regional policy; recommends that such a system should be based on the monitoring principles under shared management that apply to EU Member States;
Amendment 235 #
2023/2122(INI)
Motion for a resolution
Paragraph 33
Paragraph 33
33. Requests thatInvites the Commission to provide a comprehensive analysis of whether and by what financial means it provides training for lobbyists, including NGOs, on the Financial Regulation and on the EU budget; requests that this analysis be provided by 1 February 2024 with a listor intensify training for all its programmes officers and implementing agencies on the Financial Regulation and on the EU budget; call the Commission to provide all beneficiaries of EU funding training tools ofn relevant training events and the names of beneficiaries; requests, if applicable, that the content of the training be made public; requests that the content of these training courses be made available to members of the Committee on Budgetary Control on request; porting and financial rules; calls the Commission for the simplification of grants application and selection procedures, uniformity of approach and transparency of the process, reduction of administrative burden, and regular adaptation of these rules to changing circumstances and lessons learned; calls on the Commission to increase the ceiling for administrative expenses of NGOs and explore new models for full cost recovery of overhead costs;
Amendment 241 #
2023/2122(INI)
Motion for a resolution
Paragraph 34
Paragraph 34
34. Calls on the Commission to ensure that all applicants or beneficiaries of EU funding, including NGOs, are required to publish annually the number of lobbying contacts they have, along with their nature and their monetary value; reiterates in this context the need for a comprehensive financial pre-screening of these entities before they are listed in the EU transparency register;all EU institutions for far stricter implementation, enforcement and supervision of adherence to the current provisions on the EU transparency register; calls for allocating more resources to the Transparency Register Secretariat so that it is able to offer support to all applicants and registrants, especially small entities and NGOs, throughout the registration process and to verify the information they provided more thoroughly; in particular, calls for a transparency officer to be placed in all committee secretariats and relevant administrative units; recalls that, according to the transparency register guidelines, changes in the data provided should be communicated as soon as they occur and, in any case, within three months; insists that any changes in the board or leadership of EU-funded NGOsentities registered should also be recorded in the transparency register;
Amendment 252 #
2023/2122(INI)
Motion for a resolution
Paragraph 36
Paragraph 36
Amendment 258 #
2023/2122(INI)
Motion for a resolution
Paragraph 38
Paragraph 38
38. Recalls the recommendations from the 2021 Parliament discharge resolution22 calling for a revision of the EU transparency register and its guidelines to require the disclosure of details on all funding sources from registered organisations, including the shares held in other companies, and to allowtrace EU funds to be traced, as far as the existing rules allow it, from the direct recipient to the final beneficiary when funds are passed along a chain, including when funds from one NGO or stakeholder are transferred to another; _________________ 22 Texts adopted, P9_TA(2023)0138, paragraph 74.
Amendment 261 #
2023/2122(INI)
Motion for a resolution
Paragraph 39
Paragraph 39
Amendment 274 #
2023/2122(INI)
Motion for a resolution
Paragraph 40
Paragraph 40
40. Reiterates its call made in the 2021 Commission discharge resolution23 to adopt an NGO regulation by 1 June 2024 that includes harmonised minimum requirements for NGOs across all EU entities and a clear definition and categorisation of the fields of activity and size of NGOs and that provides for the necessary conditions for NGOs to receive EU funds; insists that there should befor a clear definition of NGOs in line with the financial rules proposal that can be applicable to all funding programmes and encompasses the different National legal frameworks, including a clear distinction between regular NGOs and ‘public utility NGOs’; calls on the Commission to establish simplified procedures for small NGOs; _________________ 23 Texts adopted, P9_TA(2023)0137, paragraph 20.ification of non profit organisations working for the public good;
Amendment 281 #
2023/2122(INI)
Motion for a resolution
Paragraph 41
Paragraph 41
41. Calls on the Commission to ensure that, when preparing its proposal for the NGO regulation, important questions on issues relating to, but not limited to, clear definitions, revolving doors, transparency in financing and donations, the fight against money launderingconsistency of financial policies and regulations with other current and future EU rules and policies that relate directly or indirectly to NGOs, such as the rule of law, limiting foreign interference, independence from political and economic influence, whistleblowing, and transparency in actual leadership and ownership are dealt with in a sufficiently transparent manneplementation of the Charter of fundamental rights, the anti- money laundering package, the EU Transparency Register; calls for the organisation of civil dialogue with the sector;
Amendment 288 #
2023/2122(INI)
Motion for a resolution
Paragraph 42
Paragraph 42
42. Reiterates its call in the 2021 Commission discharge resolution24 for the creation of a public blacklist of NGOs that have engaged in activities such as hate speech, incitement to terrorism, religious extremism, supporting or glorifying violence or spreading unfounded scientific statements or that have misused or misappropriated EU fundsensuring that all EU funding beneficiaries that have misused or misappropriated EU funds, have engaged in activities contrary to the EU values, and are listed in the EDES database in order to ensure that they are blocked from access to EU institutions and EU funding programmes; expects a proposal on this to be put forward by the Commission no later than 1 July 2024; _________________ 24 Texts adopted, P9_TA(2023)0137, paragraph 19.
Amendment 296 #
2023/2122(INI)
Motion for a resolution
Paragraph 43
Paragraph 43
Amendment 300 #
2023/2122(INI)
Motion for a resolution
Paragraph 44
Paragraph 44
44. Calls on the Commission and the ECA to systematically submit to Parliament, as the discharge authority, the information from the risk-based on-site reviews of NGOs that it conducts; calls on the Commission to go beyond the minimum requirementEU beneficiaries aund increase the number of NGOs it subjects to reviews; insists that such information be made publicly availableer direct management and their results;
Amendment 305 #
2023/2122(INI)
Motion for a resolution
Paragraph 45
Paragraph 45
Amendment 2 #
2023/2111(INI)
Motion for a resolution
Citation 1 a (new)
Citation 1 a (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’),
Amendment 30 #
2023/2111(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. Whereas Europe needs to increase energy security in line with the REPowerEU Plan of May 18, 2022, geothermal energy offers a renewable, always-on and local source of energy that can contribute in decreasing energy imports from third countries and have the potential to provide low-cost electricity and high-quality heat to citizens and industries;
Amendment 52 #
2023/2111(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Notes that the development of technologies has broadened the area suitable for cost-efficient geothermal projects and their scope; stresses that the potential of low-temperature, shallow geothermal resources that are available in all Member States; stresses the potential of deep geothermal energy that can contribute directly to heat and power generation;
Amendment 87 #
2023/2111(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Notes the potential for geothermal energy as a renewable and stable contribution to the decarbonisation of district heating and cooling as required under the Energy Efficiency Directive (EU) 2023/1791 and the Renewable Energy Directive (EU) 2023; underlines the need to modernise existing and build low-temperature district heating networks to enable the deployment of geothermal heat;
Amendment 92 #
2023/2111(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Notes the potential of geothermal energy for industrial de-carbonisation. Highlights the successful experiences already implemented in the agri-food sector in different European regions.
Amendment 96 #
2023/2111(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. HCalls on the Commission to present an EU geothermal strategy with the aim to create a European wide approach to enact geothermal energy; including an assessment of the geothermal district heating potential; highlights that 151 business and industries called on the Commission in 2022 to prepare a European strategy to unlock the potential of geothermal energy;
Amendment 100 #
2023/2111(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the European Commission to standardise definitions, applications, permitting rules and lifecycle emissions tools for geothermal in order to facilitate the growth of geothermal electricity, heating, cooling, storage uses in power grids, buildings, industry and agri-food sectors;
Amendment 110 #
2023/2111(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Calls on the Commission to come up with specific calls, also in the framework of the Strategic Energy Technologies Platform, to encourage pilot and commercial projects applying geothermal energy in industrial and agri- food sectors;
Amendment 116 #
2023/2111(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Commission to present guidelines to the Member States for the preparation of comprehensive heating and cooling assessments and of local heating and cooling plans as required under the Energy Efficiency Directive (EU) 2023/1791 including how a possible geothermal potential is assessed and processed;
Amendment 142 #
2023/2111(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Urges the Comission and Member States to explore methods of collecting different types of geological data from public and private entities with a view to organising, systematising and making it available to the public; notes that this should be achieved in compliance with necessary confidentiality requirements and data protection rules, and, where necessary, include incentives and compensation for data sharing by private entities;
Amendment 149 #
2023/2111(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Notes that easy access to data through public available and digitalised formats can de-risk investments in geothermal energy projects; calls on the European Commission and Member States to harmonise the legislation that gives access to subsurface data for both private and public actors;
Amendment 155 #
2023/2111(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses that for areas with insufficient subsurface data, there is a role for the European Commission to harmonise data collection rules; stresses the role for governments can play a role in funding geothermal resource mapping and exploratory drilling; welcomes the fact that some Member States have already taken steps in this direction; calls for EU funding to support this data collection with a view to creating an EU-wide atlas of geothermal potential;
Amendment 164 #
2023/2111(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Expresses its concern about the fragmented nature of statistics on geothermal energy; calls on the Member States, in cooperation with the industry and the Commission, to overhaul existing data collecting and access procedures for geothermal and to replicate best practices in the sector;
Amendment 167 #
2023/2111(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Takes notes that a more detailed register of geothermal energy potential would prevail local heat sources and support the adoption and implementation of the local heating and cooling plans as required under the Energy Efficiency Directive (EU) 2023/1791;
Amendment 168 #
2023/2111(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Stresses that the availability of existing district heating and cooling data to investors can help support local actors to evaluate the potential of geothermal energy in the local area; calls on the Commission to facilitate and coordinate that availability of existing district heating and cooling data;
Amendment 175 #
2023/2111(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Notes the great potential geothermal energy has as a local and low- cost source of energy if upfront costs and risks are mitigated; calls for the Commission and Member States to provide guidance to funding models as well as private and public funding opportunities;
Amendment 192 #
2023/2111(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. In line with the Renewable Energy Directive and in order to raise awareness among cosumer groups, stresses the importance to provide European Union guidance on Heat and Cold Purchase Agreements, as key tools for public- private partnerships financing geothermal projects at local level, in rural areas, in buildings and for industrial processes;
Amendment 207 #
2023/2111(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Notes that the requirements of mining laws designed for large-scale mining projects are difficult to uphold in muchnot necesarily suitable for smaller-scale geothermal projects; calls on the Member States to review and simplify existing mining laws, where necessary, or to develop dedicated permitting rules for geothermal; asks the Commission to provide guidelines to ensure the requisite level of coherence;
Amendment 210 #
2023/2111(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Expresses concerns that geothermal projects experience lengthy permitting processes; urges Member States to create streamlined, simplified and digital permitting processes by creating a single-point of contact for the whole permitting process across authorities;
Amendment 214 #
2023/2111(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Calls on Member States to lessen permitting times by giving permits by default ensuring nothing stands against it as practised in some Member States;
Amendment 227 #
2023/2111(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Recalls that "renewable go-to areas" outlined in the Renewable Energy Directive covers surface areas. Therefore, in order to support the developpment of geothermal energy, calls on the Commission’s guidance on their development to include the subsurface and facilitate the link with digalitsed one- stop permitting processes to standardise the geothermal market;
Amendment 282 #
2023/2111(INI)
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Notes that geothermal energy together with district heating can apply as a renewable and stable source of energy and therefore contribute to the just transition across Europe; calls for funds to be dedicated to the modernisation of existing district heating and cooling networks to secure the utilisation of the potential;
Amendment 287 #
2023/2111(INI)
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Draws attention to the fact that geothermal systems use limited land use and above-ground structure requirements; calls for Member States to consider access to urban plots for geothermal plants to secure faster adoption in permitting;
Amendment 295 #
2023/2111(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Notes that public resisacceptance remains a challenge for geothermal projects, particularly on the basis of environmental concerns such asis an important object also due to worries about environmental and visibility impacts: the possible contamination of ground waters, gas emissions or, water over-exploitation; expresses the opinion that maintaining high environmental standards and transparency standards can, address concerns and early stakeholder engagement could serve as anthe efficient way of overcoming distrust;
Amendment 10 #
2023/2010(INI)
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
— having regard to the SDG Acceleration Actions platform,
Amendment 12 #
2023/2010(INI)
Motion for a resolution
Citation 9 a (new)
Citation 9 a (new)
— having regard to the UNEA Resolution “5/10. The environmental dimension of a sustainable, resilient and inclusive post-COVID-19 recovery”, adopted by the United Nations Environment Assembly (UNEA) on 2 March 2022,
Amendment 14 #
2023/2010(INI)
Motion for a resolution
Citation 9 b (new)
Citation 9 b (new)
— having regard to the UN High Seas Treaty, the historic agreement to protect the world's oceans reached on 5 March 2023,
Amendment 55 #
2023/2010(INI)
Motion for a resolution
Recital A
Recital A
A. whereas, with less than seven years to go until the deadline for the implementation of the 2030 Agenda, the new geopolitical landscape and the multiple crises in various areas, including the triple planetary crisis of climate change, biodiversity loss and pollution, the Russian war of aggression against Ukraine, energy and food insecurity and soaring prices, fragile supply chains and rapid inflation, have hindered the achievement of the SDGs; whereas the 2030 Agenda and the 17 SDGs are key to addressing the current challenges and reorienting the global compass towards a socially and environmentally just transition that leaves no one and no place behind;
Amendment 149 #
2023/2010(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Stresses its commitment to the 2030 Agenda, especially in light of the new geopolitical landscape and the ongoing climate, biodiversity and health crises; warns against further polarisation in the distribution of wealth and income, which would lead to increased inequality and poverty; highlights, against this backdrop, the importance of the SDGs, which provide a universal compass for people’s prosperity and to protect the planet; recalls that a pledge to leave no one and no place behind lies at the heart of the 2030 Agenda and that the achievement of the SDGs should benefit all countries, people and segments of society;
Amendment 188 #
2023/2010(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Highlights the importance of the 2023 High-Level Political Forum on Sustainable Development and the SDG Summit, which are both due to take place in New York, as opportunities to review progress at the halfway point, which must be the starting point for an intensified effort and accelerated action to achieve the goals by 2030; acknowledges, in this regard, the SDGs being focused on in 2023 (SDGs 6, 7, 9, 11 and 17);
Amendment 217 #
2023/2010(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Calls urgently on the Commission to develop a comprehensive strategy accompanied by a structured SDGs implementation plan with clear, measurable, accountable and time-bound EU-wide targets; emphasises, in this regard, that successful implementation of the 2030 Agenda is contingent on stronger alignment between the EU’s governance systems in economic, social and environmental matters, such as the European Semester, the European Green Deal and the implementation of the European Pillar of Social Rights;
Amendment 227 #
2023/2010(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Commission to continue integrating the SDGs into the European Semester by better linking it to the monitoring of the NRRPs, and to use the country- specific recommendations to systematically measure Member States’ progress and set out concrete proposals for improvement;
Amendment 241 #
2023/2010(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Stresses Parliament’s important role in promoting the SDGs’ implementation through European policies and heightening the goals’ visibility in public discourse; underlines that coordination and regular structured dialogue within and between the EU institutions is essential in order to ensure the EU’s leadership and increase the effectiveness of its efforts to implement the 2030 Agenda;
Amendment 264 #
2023/2010(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Reiterates the call on the Commission to establish a new permanent platform, for a “whole of society” approach as an important innovation , for regular and structured engagement with civil society organisations in order to systematically involve them in a meaningful way in the SDG implementation process;
Amendment 266 #
2023/2010(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10 a. Highlights the necessity to develop and promote multiple solutions that any actor in society can implement to reduce the carbon footprint, such as: responsible consumption of resources (from water to food), transition to circular economy, investments in green energy, developing green value chains in the private sector, increasing the percentage of green public procurement, prioritizing and supporting investments in the research sector dedicated to bio-based solutions, increasing the percentage of green credits to support the transition to low-carbon businesses;
Amendment 297 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
Amendment 299 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12 b. Further calls on EU Member States and its global partners to share best practices and provide peer-to-peer learning and technical assistance, particularly to developing countries, to support efforts for resource mobilisation and for strengthening and scaling up country-level efforts on sustainable, resilient and inclusive recovery measures which promote a green and digital twin transition whilst considering odemographical issues and mainstreaming gender dimension;
Amendment 305 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 c (new)
Paragraph 12 c (new)
12 c. Stresses that women's contribution in green economic activities is essential to achieve equitable sustainable development and should be seen and valued; believes that women and girls can also benefit from the opportunities in the field of green entrepreneurship and become green employers rather than employees;
Amendment 306 #
2023/2010(INI)
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12 d. Encourages Member States to better engage local and regional authorities (LRAs) in the monitoring and implementation phases of NRRPs to ensure consideration of SGD indicators; recognises the potential of LRAs to drive a green and socially responsible recovery in their localities, to better encourage civic engagement and achieve sustainable growth in local economies;
Amendment 319 #
2023/2010(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. PCalls on the Member States to adopt SGD indicators and monitor their implementation in the NRRPs; points out that, in order to assess the Member States’ progress on the SDGs, the Eurostat sustainable development indicators must be improved by filling the gaps for some SDGs and better measuring policies’ impact on territories and specific vulnerable groups;
Amendment 380 #
2023/2010(INI)
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18 a. Calls on the Commission to consider extending the SDGs beyond the cohesion policy funds to address the financing gap and explore synergies with Horizon Europe, LIFE+, InvestEU, Digital Europe Programme, as well as the financial support of the European Investment Bank to mainstream sustainable development and scale up policies and projects;
Amendment 384 #
2023/2010(INI)
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18 b. Calls on Member States and the EU's global partners to bolster efforts to curb illicit financial flows and cross- border tax evasion, which undermine taxation systems and inhibit domestic resource mobilisation towards the achievement of the 2030 Agenda;
Amendment 413 #
2023/2010(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20 a. Encourages the private sector and multilateral financial institutions to continue to support countries whose economies have been affected by the COVID-19 pandemic to achieve a sustainable, resilient and inclusive recovery;
Amendment 150 #
2023/0232(COD)
Proposal for a directive
Recital 23
Recital 23
(23) The long-term objective of the Directive is to achieve healthy soils by 2050. As an intermediate step, in light of the limited knowledge about the condition of soils and about the effectiveness and costs of the measures to regenerate their health, the directive takes a staged approach. In the first stage the focus will be on setting up the soil monitoring framework and assessing the situation of soils throughout the EU. It also includes requirements to lay down measures to manage soils sustainably and regenerate unhealthy soils once their condition is established, but without imposing an obligation toin the aim of achieveing healthy soils by 2050 ne, wither intermediate targets. This proportionate approach will allow sustainable soil management and regeneration of unhealthy soils to be well prepared, incentivised and set in motion. In a second stage, as soon as the results of the first assessment of soils and trends analysis are available, the Commission will take stock of the progress towards the 2050 objective and the experience thereof, and will propose a review of the directive if necessary to accelerate progress towards 2050.
Amendment 158 #
2023/0232(COD)
Proposal for a directive
Recital 27
Recital 27
(27) In order to describe soil degradation it is necessary to establish soil descriptors that can be measured or estimated. Even if there is significant variability between soil types, climatic conditions and land uses, the current scientific knowledge allows to set criteria at Union level for some of those soil descriptors. However, Member States should be able to adapt the criteria for some of these soil descriptors based on specific national or local conditions and define the criteria for other soil descriptors for which common criteria at EU level cannot be established at this stage. For those descriptors for which clear criteria that would distinguish between healthy and unhealthy condition cannot be identified now, only monitoring and assessment are required. This will facilitate the development of such criteria in future.
Amendment 177 #
2023/0232(COD)
(36) In order to make the widest possible use of soil health data generated by the monitoring carried out under this Directive, Member States should be required to collect interoperable data and facilitate the access to such data for relevant stakeholders such as farmers, foresters, land owners and local authorities.
Amendment 183 #
2023/0232(COD)
Proposal for a directive
Recital 38
Recital 38
(38) Economic instruments, including those under the Common Agricultural Policy (CAP) that provide support to farmers, have a crucial role in the transition to the sustainable management of agricultural soils and, to a lesser extent, forest soils. The CAP aims to support soil health through the implementation of conditionality, eco-schemes and rural development measures. Financial support for farmers and foresters who apply sustainable soil management practices can also be generated by the private sector. Voluntary sustainability labels in the food, wood, bio-based, and energy industry, for example, established by private stakeholders, can take into account the sustainable soil management principles set out in this Directive. This can enable food, wood, and other biomass producers that follow those principles in their production to reflect these in the value of their products. Additional funding for a network of real-life sites for testing, demonstrating and upscaling of solutions, including on carbon farming, will be provided through the Soil Mission’s living labs and lighthouses. Without prejudice to the polluter pays principle, support and advice should be provided by Member States to help landowners and land users affected by action taken under this Directive taking into account, in particular, the needs and limited capacities of small and medium sized enterprises. Considering the heavy financial burden for risk assessment and remediation action, it would be proper to foresee in the next MFF a dedicated Fund for Soil.
Amendment 189 #
2023/0232(COD)
Proposal for a directive
Recital 43
Recital 43
(43) Contaminated sites are the legacy of decades of industrial activity in the EU and may lead to risks for human health and the environment now and in the future. IBuilding on the existing knowledge it is therefore necessary first to identify and investigate new potentially contaminated sites and then, in case of confirmed contamination, to assess the risks and take measures to address unacceptable risksthem. Soil investigation may prove that a potentially contaminated site is in fact not contaminated. In that case, the site should no longer be labelled by the Member State as potentially contaminated, unless contamination is suspected based on new evidence.
Amendment 192 #
2023/0232(COD)
Proposal for a directive
Recital 44
Recital 44
(44) To identify potentially contaminated sites, Member States should collect evidence among others through historical research, past industrial incidents and accidents, environmental permits, health surveys, and notifications by the public or authorities.
Amendment 193 #
2023/0232(COD)
(46) Flexibility for the management of potentially contaminated sites and contaminated sites is needed to take account of costs, benefits and local specificities. Member States should therefore at least adopt a risk-based approach for managing potentially contaminated sites and contaminated sites, taking into account the difference between these two categories, and which allows to allocate resources taking account of the specific environmental, economic and social context. Decisions should be taken based on the nature and extent of potential risks for human health and the environment resulting from exposure to soil contaminants (e.g. exposure of vulnerable populations such as pregnant women, persons with disabilities, elderly people and children). The cost-benefit analysis of undertaking remediation should be positivebalanced, taking into account the advantages for future generations. The optimum remediation solution should be sustainable and selected through a balanced decision-making process that takes account of the environmental, economic and social impacts. The management of potentially contaminated sites and contaminated sites should respect the polluter-pays, precautionary and proportionality principles. Member States should lay down the specific methodology for determining the site-specific risks of contaminated sites. Member States should also define what constitutes an unacceptable risk from a contaminated site based on scientific knowledge, the precautionary principle, local specificities, and current and future land use. In order to reduce the risks of contaminated sites to an acceptable level for human health and the environment, Member States should take adequate risk reduction measures including remediation. It should be possible to qualify measures taken under other Union legislation as risk reduction measures under this Directive when those measures effectively reduce risks posed by contaminated sites.
Amendment 200 #
2023/0232(COD)
Proposal for a directive
Recital 48
Recital 48
(48) Transparency is an essential component of soil policy and ensures public accountability and awareness, fair market conditions and the monitoring of progress. Therefore, Member States should set up and maintain a national register of contaminated sites and potentially contaminated sites which contains site- specific information that should be made publicly accessible in an online georeferenced spatial database. The register should contain the information that is necessary for the public to be informed on the existence and on the management of potentially contaminated sites and contaminated sites. BecauseIf the presence of soil contamination is not yet confirmed but only suspected on potentially contaminated sites, the difference between contaminated sites and potentially contaminated sites has to be communicated and explained well to the public to avoid raising unnecessary concern.
Amendment 209 #
2023/0232(COD)
Proposal for a directive
Recital 50
Recital 50
(50) Directive (EU) 2019/1024 of the European Parliament and of the Council69 mandates the release of public sector data in free and open formats. The overall objective is to continue the strengthening of the EU’s data economy by increasing the amount of interoperable public sector data available for re-use, ensuring fair competition and easy access to public sector information, and enhancing cross- border innovation based on data. The main principle is that government data should be open by default and design. Directive 2003/4/EC of the European Parliament and of the Council70 is aimed at guaranteeing the right of access to environmental information in the Member States in line with the Aarhus Convention. The Aarhus Convention and Directive 2003/4/EC encompass broad obligations related both to making environmental information available upon request and actively disseminating such information. Directive 2007/2/EC of the European Parliament and of the Council71 is also of broad scope, covering the sharing of spatial information, including data sets on different environmental topics. It is important that provisions of this Directive related to access to information and data- sharing arrangements complement those Directives and do not create a separate legal regime. Therefore, the provisions of this Directive regarding information to the public and information on monitoring of implementation should be without prejudice to Directives (EU) 2019/1024, 2003/4/EC and 2007/2/EC. _________________ 69 Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (OJ L 172, 26.6.2019, p. 56). 70 Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information and repealing Council Directive 90/313/EEC (OJ L 41, 14.2.2003, p. 26). 71 Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1).
Amendment 213 #
2023/0232(COD)
Proposal for a directive
Recital 53
Recital 53
(53) The Commission should carry out an evidence-based evaluation and, where relevant, a revision of this Directive, 6 years after its entry into force on the basis of the results of the soil health assessment. The evaluation should assess in particular the need to set more specific requirements and binding intermediate targets to make sure unhealthy soils are regenerated and the objective to achieve healthy soils by 2050 is achieved. The evaluation should also assess the need to adapt the definition of healthy soils to scientific and technical progress by adding provisions on certain descriptors or criteria based on new scientific evidence relating to the protection of soils or on the grounds of a problem specific to a Member State arising from new environmental or climatic circumstances. Pursuant to paragraph 22 of the Interinstitutional Agreement on Better Law-Making, that evaluation should be based on the criteria of efficiency, effectiveness, relevance, coherence and EU value added and should provide the basis for impact assessments of possible further measures.
Amendment 221 #
2023/0232(COD)
Proposal for a directive
Article 1 – paragraph 1
Article 1 – paragraph 1
1. The objective of the Directive is to put in place a solid and coherent soil monitoring, assessment, and sustainable management framework for all soils across the EU and to continuously improve soil health in the Union with the view to achieve healthy soils by 2050 and maintain soils in healthy condition, so that they can supply multiple ecosystem services at a scale sufficient to meet environmental, societal and economic needs, prevent and mitigate the impacts of climate change and biodiversity loss, increase the resilience against natural disasters and for food security and that soil contamination is reduced to levels no longer considered harmful to human health and the environment.
Amendment 226 #
2023/0232(COD)
Proposal for a directive
Article 1 – paragraph 2 – introductory part
Article 1 – paragraph 2 – introductory part
2. This Directive lays down measures on:
Amendment 228 #
2023/0232(COD)
Proposal for a directive
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) measures on monitoring and, assessment, and improvement of soil health;
Amendment 231 #
2023/0232(COD)
Proposal for a directive
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
(b) measures on sustainable soil management;
Amendment 232 #
2023/0232(COD)
Proposal for a directive
Article 1 – paragraph 2 – point c
Article 1 – paragraph 2 – point c
(c) measures on contaminated sites.
Amendment 233 #
2023/0232(COD)
Proposal for a directive
Article 1 – paragraph 2 – point c a (new)
Article 1 – paragraph 2 – point c a (new)
(c a) - binding healthy soils targets;
Amendment 238 #
2023/0232(COD)
Proposal for a directive
Article 1 a (new)
Article 1 a (new)
Article 1a Targets 1. In order to reach the healthy soils objective set out in Article 1, this Directive sets a binding target of 100% healthy soils across the Union by 2050. 2. This Directive also sets the following intermediate binding soil health targets: (a) a target of achieving 55 % healthy soils across the Union by 2035; (b) a target of achieving 70 % healthy soils across the Union by 2040; 3. The Union and its Member States shall take the necessary measures at Union, national and regional level, respectively, to enable the collective achievement of the healthy soils target set out in paragraph 1 and the soil health intermediate targets set out in paragraph 2 of this Article.
Amendment 248 #
2023/0232(COD)
(3) ‘ecosystem services’ means direct and indirect contributions of ecosystems to the economic, social, cultural and other benefits that people derive from those ecosystems;
Amendment 261 #
2023/0232(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
(5) ‘sustainable soil management’ means soil management practices that maintain or enhance the biodiversity and the ecosystem services provided by the soil without impairing the functions enabling those services, or being detrimental to other properties of the environment;
Amendment 265 #
2023/0232(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 9
Article 3 – paragraph 1 – point 9
(9) ‘soil health assessment’ means the evaluation of the health of the soil based on the measurement or estimation of soil descriptors;, based on three general categories: -healthy soil -moderately unhealthy soil -unhealthy soil
Amendment 280 #
2023/0232(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 20
Article 3 – paragraph 1 – point 20
(20) ‘soil contamination’ means the presence of a chemical or substancesubstance or material in the soil in a concentration that may be harmful tolead, directly or indirectly, to harmful effects on human health or the environment;
Amendment 290 #
2023/0232(COD)
Proposal for a directive
Article 3 – paragraph 1 – point 26
Article 3 – paragraph 1 – point 26
(26) ‘soil remediation’ means a regeneration action that reduces, isolates or immobilizes contaminant concentrations in the soil below a toxicity threshold for which significant dangers for organisms in contact with that soil can be excluded, with the aim of achieving the status of healthy or moderately healthy soil.
Amendment 304 #
2023/0232(COD)
Proposal for a directive
Article 4 – paragraph 1 – subparagraph 2
Article 4 – paragraph 1 – subparagraph 2
The number of soil districts for each Member State shall as a minimum correspond to the number of NUTS 12 territorial units established under Regulation (EC) No 1059/2003.
Amendment 318 #
2023/0232(COD)
Proposal for a directive
Article 4 – paragraph 2 – subparagraph 1 (new)
Article 4 – paragraph 2 – subparagraph 1 (new)
Member States shall ensure that any water body used for abstraction of water intended for human consumption as defined in Directive (EU) 2020/2184 is covered in its entirety by a single soil district.
Amendment 350 #
2023/0232(COD)
Proposal for a directive
Article 6 – paragraph 4
Article 6 – paragraph 4
4. The Commission shall, subject to agreement from Member States concerned, carry out regular soil measurements on soil samples taken in- situ, based on the relevant descriptors and methodologies referred to in Articles 7 and 8, to support Member States’ monitoring of soil health. Where a Member State provides agreement in accordance with this paragraph, it shall ensure that the Commission can carry out such in-situ soil sampling.
Amendment 373 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Member States may adapt theintegrate new soil descriptors and the soil health criteria referred to in part A of Annex I, provided they are in accordance with the specifications referred to in the second and third columns in part A of Annex I.
Amendment 376 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 2 a (new)
Article 7 – paragraph 2 a (new)
2 a. The Commission is empowered to adopt delegated acts in accordance with Article 20 to amend Part A of Annex I with a list of key contaminants with thresholds set at EU-level, including substances identified as persistent, bioaccumulative, mobile and toxic, in accordance with relevant EU legislation. This list is to be included in part A of Annex I, at the latest during the first evaluation of this Directive.
Amendment 387 #
2023/0232(COD)
Proposal for a directive
Article 7 – paragraph 6 a (new)
Article 7 – paragraph 6 a (new)
6 a. The Commission is empowered to adopt delegated acts in accordance with Article 20 to amend Annex I in order to adapt its descriptors, indicators and criteria to scientific and technical progress to support the achievement of the overarching objective of this Directive.
Amendment 394 #
2023/0232(COD)
Proposal for a directive
Article 8 – paragraph 4
Article 8 – paragraph 4
4. Member States shall ensure that the first soil measurements are performed at the latest by… (OP: please insert the date = 43 years after date of entry into force of the Directive).
Amendment 396 #
2023/0232(COD)
Proposal for a directive
Article 8 – paragraph 5 – subparagraph 1
Article 8 – paragraph 5 – subparagraph 1
Member States shall ensure that new soil measurements are performed at least every 5 years or earlier, whenever soil status modification is suspected..
Amendment 410 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 1 – subparagraph 1
Article 9 – paragraph 1 – subparagraph 1
Member States shall assess the soil health in all their soil districts based on the data collected in the context of the monitoring referred to in Articles 6, 7 and 8 for each of the soil descriptors referred to in Parts A and BAnnex I. For the first assessment of soil health in line with paragraph 1 of this Article, Member States shall include at least one of the two soil biodiversity descriptors set out in part C of Annex I.
Amendment 419 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 1 – subparagraph 3
Article 9 – paragraph 1 – subparagraph 3
Member States shall ensure that soil health assessments are performed at least every 5 years and that the first soil health assessment is performed by … (OP: please insert the date = 54 years after date of entry into force of the Directive).
Amendment 441 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 1 – point b
Article 9 – paragraph 2 – subparagraph 1 – point b
(b) the values for all soil descriptors listed in part B and C of Annex I meet the criteria set in accordance with Article 7 (‘healthy soil’).
Amendment 448 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 2 – subparagraph 3
Article 9 – paragraph 2 – subparagraph 3
Soil is moderately unhealthy where at least one of the criteria referred to in subparagraph 1 is not met (‘unhealthy soil’). n at least one of the criteria referred to in subparagraph 1 is not met but: a) an analysis of the values of soil descriptors listed in part C of Annex I does not indicate a critical loss of ecosystem services, taking into account the relevant data and available scientific knowledge b) an analysis of the values of land take and soil sealing indicators listed in part D of Annex I does not indicate critical impacts on the loss of ecosystem services and on objectives and targets established under Regulation (EU) 2018/841. (‘ moderately unhealthy soil’). Soil is unhealthy where: a) at least one of the criteria referred to in subparagraph 1 is not met (‘unhealthy soil’). ; b) an analysis of the values of soil descriptors listed in part C of Annex I indicates a critical loss of ecosystem services, taking into account the relevant data and available scientific knowledge or c) an analysis of the values of land take and soil sealing indicators listed in part D of Annex I indicates critical impacts on the loss of ecosystem services and on objectives and targets established under Regulation (EU) 2018/841.
Amendment 469 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 4 a (new)
Article 9 – paragraph 4 a (new)
4 a. Competent authorities shall establish for each soil district a soil district plan that sets out short- and long- term measures, policy actions and targets to achieve measurable improvement of soil health condition, a the latest by (OP: please insert the date = 5 years after the date of entry into force of this Directive) in accordance with Annex VIIa (new), taking into account soil classification and obligations referred to in Article 7. Soil district plans shall be reviewed and updated at least every 5 years in accordance with Annex VIIa (new). When preparing the soil district plans competent authorities shall ensure that all relevant stakeholders can duly participate in the process. The soil district plans shall be made available to the public free of charge by means of easily accessible media and communication channels. online by the respective Member State.
Amendment 475 #
2023/0232(COD)
Proposal for a directive
Article 9 – paragraph 5 – subparagraph 1
Article 9 – paragraph 5 – subparagraph 1
Member States shall set up a mechanism for a voluntary soil health certification for land owners and managers pursuant to the conditions in paragraph 2 of this Article.
Amendment 494 #
2023/0232(COD)
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1 – introductory part
Article 10 – paragraph 1 – subparagraph 1 – introductory part
From (OP: please insert the date = 42 years after date of entry into force of the Directive), Member States shall take at least the following measures, taking into account the type, use and condition of soil:
Amendment 503 #
2023/0232(COD)
Proposal for a directive
Article 10 – paragraph 1 – subparagraph 1 – point a a (new)
Article 10 – paragraph 1 – subparagraph 1 – point a a (new)
(a a) use of the Good Agricultural and Environmental Conditions (GAECs) as referred to in Regulation (EU) 2021/2115, on sustainable soil management practices (GAECs 5, 6 & 7), on climate change (GAECs 1, 2 & 3), on water (GAEC 4) and on biodiversity (GAECs 8 & 9) as a basis for the definition of sustainable soil management practices by each Member State in accordance with this paragraph;
Amendment 536 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
Member States shall reduce land take in order to achieve the target of zero net land take by 2050. For that purpose, Member States shall ensure that the following principles are respected in case of land take:
Amendment 540 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – point a – introductory part
Article 11 – paragraph 1 – point a – introductory part
(a) avoid or reduce as much as technically and economically possible the loss of the capacity of the soil to provide multiple ecosystem services, including food production, by:
Amendment 545 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – point a – point i
Article 11 – paragraph 1 – point a – point i
(i) reducing the area affected by the land take to the extent possible and
Amendment 558 #
2023/0232(COD)
Proposal for a directive
Article 11 – paragraph 1 – point b
Article 11 – paragraph 1 – point b
(b) compensate as much as possible the loss of soil capacity to provide multiple ecosystem services.
Amendment 595 #
2023/0232(COD)
Proposal for a directive
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Member States shall ensure that all potentially contaminated sites are identified by (OP: please insert date = 75 years after date of entry into force of the Directive) and are duly recorded in the register referred to in Article 16 by that date.
Amendment 599 #
2023/0232(COD)
Proposal for a directive
Article 14 – paragraph 2 – subparagraph 1
Article 14 – paragraph 2 – subparagraph 1
Member States shall lay down the rules concerning the deadline, content, form and the prioritisation of the soil investigations. Those rules shall be established in accordance with the risk-based approach referred to in Article 12 and the list of potentially contaminating risk activities referred to in Article 13(2), second subparagraph.` Potentially contaminated sites located in areas used for the abstraction of water for human consumption shall be prioritised for investigation.
Amendment 617 #
2023/0232(COD)
Proposal for a directive
Article 15 – paragraph 5 – subparagraph 1 (new)
Article 15 – paragraph 5 – subparagraph 1 (new)
Amendment 622 #
2023/0232(COD)
Proposal for a directive
Article 16 – paragraph 1
Article 16 – paragraph 1
1. By … (OP : please insert date = 43 years after entry into force of the Directive), Member States shall, in accordance with paragraph 2, draw up a register of contaminated sites and potentially contaminated sites.
Amendment 641 #
2023/0232(COD)
Proposal for a directive
Article 18 – paragraph 1 – subparagraph 1 – point c – point ii a (new)
Article 18 – paragraph 1 – subparagraph 1 – point c – point ii a (new)
(ii a) improving soil health within Member State in accordance with Article 9(4a)
Amendment 644 #
2023/0232(COD)
Proposal for a directive
Article 18 – paragraph 3 – point a
Article 18 – paragraph 3 – point a
(a) an up-to-date list and spatial data of their soil districts referred to in Article 4 by … (OP: please insert the date = 2 years and 3 months after date of entry into force of the Directive) and their respective district plans;
Amendment 662 #
2023/0232(COD)
Proposal for a directive
Article 20 – paragraph 2
Article 20 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 7, 8, 10, 15 and 16 shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Directive.
Amendment 665 #
2023/0232(COD)
Proposal for a directive
Article 20 – paragraph 3
Article 20 – paragraph 3
3. The delegation of power referred to in Articles 7, 8, 10, 15 and 16 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 670 #
2023/0232(COD)
Proposal for a directive
Article 20 – paragraph 6
Article 20 – paragraph 6
6. A delegated act adopted pursuant to Articles 7, 8, 10, 15 and 16 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Amendment 714 #
2023/0232(COD)
Proposal for a directive
Article 24 – paragraph 1 – point e – point i
Article 24 – paragraph 1 – point e – point i
(i) the definition of healthy and moderately unhealthy soils;
Amendment 750 #
2023/0232(COD)
Proposal for a directive
Annex VII a (new)
Annex VII a (new)
Annex VII a (new) Soil district plans A.Soil district plans shall include at least he following: 1.The results of the monitoring activities and of the assessment of the soil health in accordance with Article 9; 2.Short-, medium and long-term measures and policy actions to achieve the objective of healthy soils within the relevant soil district; 3.Sustainable soil management practices and the regeneration practices defined by the relevant Member State in accordance with Article 10(1)(a) and a timetable for their implementation; 4.The practices negatively affecting soil health defined by the relevant Member State in accordance with Article 10(1)(b) to be avoided within the soil district and a timetable for their cessation; 5.A a summary of the process for establishing the soil district plan, the public information and consultation measures taken, including an explanation of how the outcome of the public participation was taken into account. B.The first update of the soil district plan and all subsequent updates shall also include: 1.An assessment of the progress made within the soil district towards achieving its objectives in accordance with Article 1a and 9(4a); 2. Any significant changes in the practices and measures or their implementation timetable.
Amendment 757 #
2023/0232(COD)
Proposal for a directive
Annex I – Part A – Row 5a
Annex I – Part A – Row 5a
Part A: soil descriptors with criteria for healthy soil condition established at Union level Subsoil Bulk density In case a Member State Non-managed soils in compaction in subsoil replaces the soil descriptor natural land areas (upper part of “bulk density in subsoil” with B or E with an equivalent parameter, it horizon45); parameter, it shall adopt ashall adopt a criterion for Member criterhealthy soil condition for thealthy soil States may condition for the chosen soilchosen soil descriptor that is replace this descripequivalent tor that is equivalente criterion set descriptor to the criterion set for “bulkfor “bulk density in subsoil”. with an density in subsoil”. equivalent parameter (g per cm3) 4 As defined in the FAO Guidelines for Soil Description, Chapter 5 (https://www.fao.org/3/a0541e/a0541e.pdf ) Groundwater Chemical Good chemical status Land areas where it can be status status of established that seepage groundwater into a groundwater body or bodies as bodies does not occur assessed pursuant to Directives 2000/60/EC (Water Framework Directive) and 2006/118/EC (Groundwate r Directive)
Amendment 762 #
2023/0232(COD)
Part B: soil descriptors with criteria for healthy soil condition established at Member States level Soil - 12 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7). Soil - concentration Reasonable assurance, No exclusion contamination concentrationof heavy metals obtained from soil point of heavy in soil: As, Sb, sampling, identification and metals in soil:Cd, Co, Cr investigation of contaminated As, Sb, Cd, (total), Cr (VI), sites and any other relevant Co, Cr (total)Cu, Hg, Pb, Ni, information, that no Cr (VI), Cu,Tl, V, Zn (µg unacceptable risk for human Hg, Pb, Ni,per kg) health and the environment Tl, V, Zn (µgpesticide from soil contamination exists. per kg) Habitats with naturally high residues Habitats with naturally high concentration concentration of heavy metals of a selection of that are included in Annex I of contaminants Council Directive 92/43/EEC13 - concentration of heavy established by shall remain protected. Member States and taking into account existing concentration limits e.g. for metals that are includedwater quality and air emissions in Union of a selec legislation - Annex I of Council of organic Directive 92/43/EEC12 shall contaminants remain protected. established by Member States and taking into account existing concentration limits e.g. for water quality and air emissions in Union legislationFor priority substances and concentratio priority hazardous substances, reasonable assurance n of priority obtained from soil point substances and priority sampling, identification and hazardous investigation of contaminated sites and monitoring of substances relevant groundwater and listed in Directive surface water bodies that the 2000/60/EC soil does not risk causing non- compliance of these water (the Water bodies with Environmental Framework Quality Standards laid down Directive) and its in Directives 2006/118/EC and 2008/105/EC. daughter Directives Or. en 13 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7).
Amendment 769 #
2023/0232(COD)
Proposal for a directive
Annex I – Part C – Row 5
Annex I – Part C – Row 5
Part C: soil descriptors without criteria Loss of soil biodiversity Soil basal respiration ((mm3 O2 g-1 hr-1) in dry soil for healthy soil condition established at Member States level Loss of soil biodiversity Member States shall select at least one of the following soil descriptors: - Community-level physiological profiling (CLPP) to analyse the metabolic activity of microorganisms in a mixed microbial community. Shifts in microbial populations often indicate upcoming changes in the overall health of the environment. - Metabarcoding (eDNA) to characterise biodiversity, establish diversity thresholds and monitor community changes. Member States mayshall also select other optional soil descriptors for biodiversity such as: - metabarcoding of bacteria, fungi, protists and animals; - abundance and diversity of nematodes; - microbial biomass; - abundance and diversity of earthworms (in cropland); - invasive alien species and plant pests
Amendment 96 #
2023/0199(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) There is a need to support critical technologies in the following fields: deep and digital technologies, clean technologies, and biotechnologies (including the respective critical raw materials value chains), in particular projects, companies and sectors with a critical role for EU’s competitiveness and resilience and its value chains. By way of example, deep technologies and digital technologies should include microelectronics, high-performance computing, quantum technologies (i.e., computing, communication and sensing technologies), cloud computing, edge computing, and artificial intelligence, cybersecurity technologies, robotics, 5G and advanced connectivity (e.g. fiber-to- the-home/fiber-to-the-building technologies) and virtual realities, including actions related to deep and digital technologies for the development of defence and aerospace applications. Clean technologies should include, among others, renewable energy; electricity and heat storage; heat pumps; electricity grid; renewable fuels of non- biological origin; sustainable alternative fuels, including biofuels; electrolysers and fuel cells; carbon capture, utilisationinfrastructure and storage; energy efficiency; biolubricants; hydrogen and its related infrastructure; smart energy solutions; technologies vital to sustainability such as water purificationcutting-edge solutions implemented for leak detection and repair inspections carried out along renewable gases and water transport and distribution networks; technologies vital to sustainability such as water storage, smart use, purification, (decentralized) water recycling solutions and desalination; advanced materials such as nanomaterials, composites and future clean construction materials, and technologies for the sustainable extraction and processing of critical raw materials. Biotechnology should be considered to include technologies such as biomolecules and its applications, pharmaceuticals and medical technologies vital for health security, crop biotechnology, and industrial biotechnology, such as for waste disposal, and biomanufacturing. The Commission may issue guidance to further specify the scope of the technologies in these three fields considered to be critical in accordance with this Regulation, in order to promote a common interpretation of the projects, companies and sectors to be supported under the respective programmes in light of the common strategic objective. Moreover, technologies in any of these three fields which are subjects of an Important Project of Common European Interest (IPCEI) approved by the Commission pursuant to Article 107(3), point (b) TFEU should be deemed to be critical, and individual projects within the scope of such an IPCEI should be eligible for funding, in accordance with the respective programme rules, to the extent that the identified funding gap and the eligible costs have not yet been completely covered.
Amendment 132 #
2023/0199(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) To that end, it should be possible to rely on assessments made for the purposes of other Union programmes in accordance with Articles 126 and 127 of Regulation (EU, Euratom) 2018/1046,52 in order to reduce administrative burden for beneficiaries of Union funds and encourage investment in priority technologies. Provided they comply with the provisions of the RRF Regulation,53 Member States should consider including actions awarded the Sovereignty Seal when preparing their recovery and resilience plans and when proposing their Recovering and Resilience Plans and when deciding on investment projects to be financed from its share of the Modernisation Fund. The Sovereignty Seal should also be taken into account by the Commission in the context of the procedure provided for in Article 19 of the EIB Statute and of the policy check laid down in Article 23 of the InvestEU Regulation by ensuring a simplified approval procedure. In addition, the implementing partners should be requirencouraged to examine projects having been awarded the Sovereignty Seal in case they fall within their geographic and activity scope in accordance with Article 26(5) of that Regulation and taking into account the mode of operation of the implementing partners. Authorities in charge of programmes falling under STEP should also be encouraged to consider support for strategic projects identified in accordance with the Net Zero Industry and the Critical Raw Materials Acts that are within the scope of Article 2 of the Regulation and for which rules on cumulative funding may apply. _________________ 52 Regulation (EU, Euratom) 2018/1046 on the financial rules applicable to the general budget of the Union (OJ L 193, 30.7.2018, p. 1). 53 Regulation (EU) 2021/241 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17).
Amendment 133 #
2023/0199(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) To that end, it should be possible to rely on assessments made for the purposes of other Union programmes in accordance with Articles 126 and 127 of Regulation (EU, Euratom) 2018/1046,52 in order to reduce administrative burden for beneficiaries of Union funds and encourage investment in priority technologies. Provided they comply with the provisions of the RRF Regulation,53 Member States should consider including actions awarded the Sovereignty Seal when preparing their recovery and resilience plans and when proposing their Recovering and Resilience Plans and when deciding on investment projects to be financed from its share of the Modernisation Fund. The Sovereignty Seal should also be taken into account by the Commission in the context of the procedure provided for in Article 19 of the EIB Statute and of the policy check laid down in Article 23 of the InvestEU Regulation. In addition, the implementing partners should be required to examine projects having been awarded the Sovereignty Seal in case they fall within their geographic and activity scope in accordance with Article 26(5) of that Regulation. Authorities in charge of programmes falling under STEP should also be encouraged to consider to support for strategic projects identified in accordance with the Net Zero Industry and the Critical Raw Materials Acts that are within the scope of Article 2 of the Regulation and for which rules on cumulative funding may apply. The Sovereignty Seal should facilitate access to dedicated funds without replicating existing EU instruments. _________________ 52 Regulation (EU, Euratom) 2018/1046 on the financial rules applicable to the general budget of the Union (OJ L 193, 30.7.2018, p. 1). 53 Regulation (EU) 2021/241 establishing the Recovery and Resilience Facility (OJ L 57, 18.2.2021, p. 17).
Amendment 138 #
2023/0199(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) A new publicly available website (the ‘Sovereignty Portal’) should be set up by the Commission in coordination with already existing InvestEU Portal for InvestEU eligible transactions to provide information on available support to companies and project promoters seeking funds for STEP investments. To that end, it should display in an accessible and user- friendly manner the funding opportunities for STEP investments available under the EU budget. This should include information about directly managed programmes, such as Horizon Europe, the Digital Europe programme, the EU4Health programme, and the Innovation Fund, and also other programmes such as InvestEU, the RRF, and cohesion policy funds. Moreover, the Sovereignty Portal should help increase the visibility for STEP investments towards investors, by listing the projects that have been awarded a Sovereignty Seal. The Portal should also list the national competent authorities responsible for acting as contact points for the implementation of the STEP at national level.
Amendment 143 #
2023/0199(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) While the STEP relies on the reprogramming and reinforcement of existing programmes for supporting strategic investments, it is also an important element for testing the feasibility and preparation of new interventions as a step towards a European Sovereignty Fund. TAlso in order to path the way towards a Sovereignty Fund that eventually contributes to shaping and strengthening a European industrial policy, the evaluation in 2025 will assess the relevance of the actions undertaken and serve as basis for assessing the need for an upscaling of the support towards strategic sectors.
Amendment 171 #
2023/0199(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) InvestEU is the EU flagship programme to boost investment, especially the green and digital transition, by providing demand-driven financing, including through blending mechanisms, and technical assistance. Such approach contributes to crowd in additional public and private capital. Given the high market demand of InvestEU guarantee, the EU compartment of InvestEU should be reinforced to correspond to the objectives of the STEP. This will, among other things, reinforce InvestEU’s existing possibility to invest in projects forming part of an IPCEI, within the identified critical technology sectors. In addition, Member States are encouraged to contribute to the InvestEU Member State compartment to support financial products in line with the STEP objectives, without prejudice to applicable State aid rules. It should be possible for Member States to include as a measure in their recovery and resilience plans a cash contribution for the purpose of the Member State compartment of InvestEU to support objectives of the STEP. That additional contribution to support objectives of the STEP could reach up to 6% of their recovery and resilience plan’s total financial allocation to the Member State compartment of InvestEU. It should be possible to grant a relatively larger share of the EU guarantee under the EU compartment to the EIB Group. Any additional allocation to the EIB Group above the 75% original threshold should come from the portion of the EU guarantee under the InvestEU EU compartment that will not be absorbed by the Implementing Partners other than the EIB Group. In this context, the Commission should encourage and assist the Implementing Partners other than the EIB Group to absorb in full the remaining 25% under open access conditions Additional flexibility and clarifications should also be introduced to better pursue the objectives of the STEP.
Amendment 200 #
2023/0199(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point a – point ii
Article 2 – paragraph 1 – point a – point ii
(ii) cleannet-zero technologies as defined in the Net-Zero-Industry Act
Amendment 247 #
2023/0199(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Commission shall award a Sovereignty Seal to any action contributing to any of the Platform objectives, provided the action has been assessed and complies with the minimum quality requirements, in particular eligibility, exclusion and award criteria, provided by a call for proposals under Regulation (EU) 2021/695, Regulation (EU) 2021/694, Regulation (EU) 2021/697, Regulation (EU) 2021/522, or Commission Delegated Regulation (EU) 2019/856. Projects that have been identified as "strategic project" under NZIA or CRMA shall automatically be awarded a Sovereignty Seal.
Amendment 265 #
2023/0199(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. When deciding on investment projects to finance from their respective shares of the Modernisation Fund in accordance with Article 10d of Directive 2003/87/EC, Member States shall consider as a priority project for critical clean technologiesnet-zero technologies as defined in the NZIA which have received the Sovereignty Seal in accordance with paragraph 1. In addition, Member States may decide to grant national support to projects with a Sovereignty Seal contributing to the Platform objective referred to in Article 2(1), point (a)(ii).
Amendment 268 #
2023/0199(COD)
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
5. Under Regulation (EU) 2021/523, the Sovereignty Seal shall be taken into account in the context of the procedure provided for in Article 19 of the European Investment Bank Statute and of the policy check as laid down in Article 23(3) of that Regulation by ensuring a simplified approval procedure. In addition, the implementing partners shallould be encouraged to examine projects having been awarded the Sovereignty Seal in case they fall within their geographic and activity scope as laid down in Article 26(5) of that Regulation. and taking into account their mode of operation.”
Amendment 297 #
2023/0199(COD)
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. Where appropriate, and in the light of the foreseen European Sovereignty Fund that will help shaping and strengthening a European industrial policy, the evaluation shall be accompanied by a proposal for amendments of this Regulation.
Amendment 352 #
2023/0199(COD)
Proposal for a regulation
Article 16 – paragraph 1 – point 6
Article 16 – paragraph 1 – point 6
Regulation 2021/523
Article 13 – paragraph 4
Article 13 – paragraph 4
4. At least 75 % of the EU guarantee under the EU compartment as referred to in Article 4(1), first subparagraph, amounting to at least EUR 25 239 232 554, shall be granted to the EIB Group. Any additional allocation to the EIB Group above the 75% should come from the portion of the EU guarantee that will not be allocated before 31 December 2026 by the Implementing Partners other than the EIB Group following the next Calls for Expression of Interest. The EIB Group shall provide an aggregate financial contribution amounting to at least EUR 6 309 808 138. That contribution shall be provided in a manner and form that facilitates the implementation of the InvestEU Fund and the achievement of the objectives set out in Article 15(2).;”
Amendment 358 #
2023/0199(COD)
Proposal for a regulation
Article 16 – paragraph 1 – point 6 a (new)
Article 16 – paragraph 1 – point 6 a (new)
Regulation EU 2021/523
Article 13 – paragraph 77 – subparagraph 2
Article 13 – paragraph 77 – subparagraph 2
(6a) Article 13(7) subparagraph 2 is replaced by the following: Contracts between the implementing partner and the final recipient or the financial intermediary or other entity referred to in point (a) of Article 16(1) under the EU guarantee referred to in the first subparagraph of Article 4(2) shall be signed at the latest by 31 August 2026. In other cases, contracts between the implementing partner and the final recipient or the financial intermediary or other entity referred to in point (a) of Article 16(1) shall be signed by 31 December 2028.
Amendment 366 #
2023/0199(COD)
Proposal for a regulation
Article 16 – paragraph 1 – point 8 a (new)
Article 16 – paragraph 1 – point 8 a (new)
Regulation 2021/523
Article 24 – paragraph 6 a (new)
Article 24 – paragraph 6 a (new)
(8a) In Article 24, the following para 6a (new) is added: With reference to eligible type of financing as set in Article 16(1)b of the InvestEU Regulation, for intermediated financing and investment operations, in particular for SME support, the Investment Committee shall verify additionality at the level of the financial product during the negotiations of the guarantee agreement or an amendment to it with the implementing partners.
Amendment 370 #
2023/0199(COD)
Proposal for a regulation
Article 16 – paragraph 1 – point 10
Article 16 – paragraph 1 – point 10
Regulation 2021/523
Article 26 – paragraph 5
Article 26 – paragraph 5
5. In addition to paragraph 4, implementing partners shall alsould also be encouraged to examine projects having been awarded the Sovereignty Seal under Article 4 of Regulation .../... [STEP Regulation] whenever those projects fall within their geographic and activity scope., taking into account their mode of operation
Amendment 377 #
2023/0199(COD)
Proposal for a regulation
Article 16 – paragraph 1 – point 14 a (new)
Article 16 – paragraph 1 – point 14 a (new)
Regulation (EU) 2021/523
Annex V – letter A – subparagraph 4
Annex V – letter A – subparagraph 4
(14a) Annex V, letter A, subpara 4 is replace by the following: Only for intermediated financing and investment operations, in particular for SME support, additionality shall be verified by the Investment Committee at the level of the financial product during the negotiations of the guarantee agreement (or an amendment to it) with the implementing partners
Amendment 30 #
2023/0132(COD)
Proposal for a directive
Recital 8
Recital 8
(8) This revision should maintains the level of harmonisation that has been achieved. Where necessary and appropriate, it further reduces the remaining disparities, by laying down rules on the supervision and control of medicinal products and the rights and duties incumbent upon the competent authorities of the Member States with a view to ensuring compliance with legal requirements. In the light of experience gained on the application of the Union pharmaceutical legislation and the evaluation of its functioning, the regulatory framework need to be adapted to scientific and technological progress, the current market conditions and economic reality within the Union. Scientific and technological developments induce innovation and development of medicinal products, including for children and patients affected by rare diseases in all therapeutic areas where there is still unmet medical need. To harness these developments, the Union pharmaceutical framework should be adapted to meet scientific developments such as genomics, accommodate cutting edge medicinal products, e.g. personalised medicinal products and technological transformation such as data analytics, digital tools and the use of artificial intelligence. These adaptations also contribute to competitiveness of the Union pharmaceutical industry.
Amendment 33 #
2023/0132(COD)
Proposal for a directive
Recital 11
Recital 11
(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs. In this respect a balanced system of incentives is proposed that rewards innovation especially infor paediatric and orphan medicinal products and in other areas of unmet medical need and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation- friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.
Amendment 66 #
2023/0132(COD)
Proposal for a directive
Recital 49
Recital 49
(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare andpaediatric, rare as well as chronic diseases. _________________ 47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65). 48 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU. 49 COM/2022/223 final.
Amendment 234 #
2023/0132(COD)
Proposal for a directive
Article 4 – paragraph 1 – point 38 a (new)
Article 4 – paragraph 1 – point 38 a (new)
(38 a) ‘medicinal product authorised for a paediatric indication’ means a medicinal product which is authorised for use in part or all of the paediatric population and in respect of which the details of the authorised indication are specified in the summary of the product characteristics
Amendment 269 #
2023/0132(COD)
Proposal for a directive
Article 18 – paragraph 1 – subparagraph 2
Article 18 – paragraph 1 – subparagraph 2
As part of the assessment, in accordance with Article 29, of the integral combination of a medicinal product and a medical device the competent authorities shall assess the benefit-risk balance of the integral combination of a medicinal product and a medical device, taking into account the suitability of the use of the medicinal product together with the medical device. In case of combined products intended for paediatric use, a risk/benefit analysis should be taken into account following the opinion of the Paediatric Working Party of the Agency, established in accordance with Article 142 of the Regulation
Amendment 354 #
2023/0132(COD)
Proposal for a directive
Article 30 – paragraph 1
Article 30 – paragraph 1
Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 1820 days after the submission of a valid application from the date of validation of a marketing authorisation application.
Amendment 354 #
2023/0132(COD)
Proposal for a directive
Article 30 – paragraph 1
Article 30 – paragraph 1
Member States shall take all appropriate measures to ensure that the procedure for granting a marketing authorisation for medicinal products is completed within a maximum of 1820 days after the submission of a valid application from the date of validation of a marketing authorisation application.
Amendment 355 #
2023/0132(COD)
Proposal for a directive
Article 30 – paragraph 1 a (new)
Article 30 – paragraph 1 a (new)
Without prejudice to national provisions regarding the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, where a marketing authorisation has been granted in accordance with [revised Regulation (EC) No 726/2004], Member States shall ensure that the medicinal product is made available on the market within 90 days from the date of the issuing of the marketing authorisation as referred to in Article 16 of the [revised Regulation (EC) No 726/2004]
Amendment 355 #
2023/0132(COD)
Proposal for a directive
Article 30 – paragraph 1 a (new)
Article 30 – paragraph 1 a (new)
Without prejudice to national provisions regarding the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, where a marketing authorisation has been granted in accordance with [revised Regulation (EC) No 726/2004], Member States shall ensure that the medicinal product is made available on the market within 90 days from the date of the issuing of the marketing authorisation as referred to in Article 16 of the [revised Regulation (EC) No 726/2004]
Amendment 366 #
2023/0132(COD)
Proposal for a directive
Article 38 – paragraph 3
Article 38 – paragraph 3
3. Within the coordination group, all disagreeing Member States concerned shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make its point of view known orally or in writing. If, within 630 days of the communication of the points of disagreement, the Member States reach an agreement by consensus, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. The procedure laid down in Articles 34(7) or 36(8) shall apply.
Amendment 366 #
2023/0132(COD)
Proposal for a directive
Article 38 – paragraph 3
Article 38 – paragraph 3
3. Within the coordination group, all disagreeing Member States concerned shall use their best endeavours to reach agreement on the action to be taken. They shall allow the applicant the opportunity to make its point of view known orally or in writing. If, within 630 days of the communication of the points of disagreement, the Member States reach an agreement by consensus, the reference Member State shall record the agreement, close the procedure and inform the applicant accordingly. The procedure laid down in Articles 34(7) or 36(8) shall apply.
Amendment 367 #
2023/0132(COD)
Proposal for a directive
Article 38 – paragraph 4
Article 38 – paragraph 4
4. If within the 630-day period laid down in paragraph 3, an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission, which shall apply the procedure laid down in Articles 41 and 42.
Amendment 367 #
2023/0132(COD)
Proposal for a directive
Article 38 – paragraph 4
Article 38 – paragraph 4
4. If within the 630-day period laid down in paragraph 3, an agreement by consensus cannot be reached, the position of the majority of the Member States represented within the coordination group shall be forwarded to the Commission, which shall apply the procedure laid down in Articles 41 and 42.
Amendment 368 #
2023/0132(COD)
Proposal for a directive
Article 40 – paragraph 2
Article 40 – paragraph 2
2. The coordination group shall lay down a list of medicinal products for which a harmonised summary of product characteristics is to be drawn up, including the harmonisation of the approved paediatric indications, dosages and ages for which the product is recommended, taking into account the proposals from the competent authorities of all Member States, and shall forward that list to the Commission.
Amendment 368 #
2023/0132(COD)
Proposal for a directive
Article 40 – paragraph 2
Article 40 – paragraph 2
2. The coordination group shall lay down a list of medicinal products for which a harmonised summary of product characteristics is to be drawn up, including the harmonisation of the approved paediatric indications, dosages and ages for which the product is recommended, taking into account the proposals from the competent authorities of all Member States, and shall forward that list to the Commission.
Amendment 369 #
2023/0132(COD)
Proposal for a directive
Article 41 – paragraph 1 – subparagraph 1
Article 41 – paragraph 1 – subparagraph 1
When reference is made to the procedure laid down in this Article, the Committee for Medicinal Products for Human Use referred to in Article 148 of [revised Regulation (EC) No 726/2004] shall consider the matter concerned and shall issue a reasoned opinion within 630 days from the date when the matter was referred to it.
Amendment 369 #
2023/0132(COD)
Proposal for a directive
Article 41 – paragraph 1 – subparagraph 1
Article 41 – paragraph 1 – subparagraph 1
When reference is made to the procedure laid down in this Article, the Committee for Medicinal Products for Human Use referred to in Article 148 of [revised Regulation (EC) No 726/2004] shall consider the matter concerned and shall issue a reasoned opinion within 630 days from the date when the matter was referred to it.
Amendment 608 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, including studies covering the paediatric population conducted according to a PIP and
Amendment 608 #
2023/0132(COD)
Proposal for a directive
Article 84 – paragraph 1 – point a
Article 84 – paragraph 1 – point a
(a) adequate non-clinical or clinical studies were carried out in relation to the therapeutic indication demonstrating that it is of significant clinical benefit, including studies covering the paediatric population conducted according to a PIP and
Amendment 624 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is usstudies, trials and other activities are conducted for the purposes of:
Amendment 624 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – introductory part
Article 85 – paragraph 1 – introductory part
Patent rights, or supplementary protection certificates under the [Regulation (EC) No 469/2009 - OP please replace reference by new instrument when adopted] shall not be regarded as infringed when a reference medicinal product is usstudies, trials and other activities are conducted for the purposes of:
Amendment 633 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, innovative, hybrid or bio-hybrid medicinal products and for subsequent variations;
Amendment 633 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point i
Article 85 – paragraph 1 – point a – point i
(i) obtaining a marketing authorisation of generic, biosimilar, innovative, hybrid or bio-hybrid medicinal products and for subsequent variations;
Amendment 637 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point ii
Article 85 – paragraph 1 – point a – point ii
(ii) conducting a health technology assessment as defined in Regulation (EU) 2021/2282;
Amendment 646 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii
Article 85 – paragraph 1 – point a – point iii
(iii) obtaining pricing and reimbursement. approval
Amendment 650 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii a (new)
Article 85 – paragraph 1 – point a – point iii a (new)
(iii a) enabling public and private procurement of medicinal products after expiry of the relevant patents or supplementary protection certificate
Amendment 654 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii b (new)
Article 85 – paragraph 1 – point a – point iii b (new)
(iii b) complying with any other regulatory or administrative requirement in the Union or elsewhere;
Amendment 656 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point a – point iii c (new)
Article 85 – paragraph 1 – point a – point iii c (new)
(iii c) ensuring the subsequent practical requirements associated with the abovementioned activities
Amendment 658 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 – point b
Article 85 – paragraph 1 – point b
Amendment 664 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 1 a (new)
Article 85 – paragraph 1 a (new)
The activities falling within the first paragraph include the offering, manufacture, sale, supply, storage, import, export, use and purchase of products or processes, including by third party suppliers and service providers.
Amendment 666 #
2023/0132(COD)
Proposal for a directive
Article 85 – paragraph 2
Article 85 – paragraph 2
This exception shall not cover the placing on the market of the medicinal products resulting from such activities.in a Member State, while relevant patent rights or supplementary protection certificates are in force in that Member State, of the medicinal products manifactured for the purposes set out in point a
Amendment 683 #
2023/0132(COD)
Proposal for a directive
Article 101 – paragraph 1
Article 101 – paragraph 1
1. The management of funds intended for activities connected with pharmacovigilance, the operation of communication networks and market surveillance shall be under the permanent control of the competent authorities of the Member States in order to guarantee their independence in the performance of those pharmacovigilance activities. The competent authorities should guarantee that not less than 10% of these activities and funds are focused on paediatric populations
Amendment 716 #
2023/0132(COD)
Proposal for a directive
Article 167 – paragraph 2
Article 167 – paragraph 2
2. The wholesale distributors of a medicinal product placed on the market in a Member State shall, within the limits of their responsibilities, ensure appropriatethat medicinal products are released and continuedously supplies of that medicinal productd to pharmacies and persons authorised to supply medicinal products in a sufficient quantity so that the needs of patients in the Member State in question are covered.
Amendment 55 #
2023/0131(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) The expertise of the Committee for Advanced Therapies (CAT), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and Committee for Herbal Medicinal Products (HMPC) is retained through working groups, working parties and a pool of experts who are organised based on different domains and who are giving input to the CHMP and PRAC. The CHMP and PRAC consists of experts from all Member States while working parties consist in majority of experts appointed by the Member States, based on their expertise, and of external experts. In addition, the Paediatric Committee’s competences and expertise with reference to the scientific assessment and agreement of paediatric investigation plans and other matters of paediatric interest not falling under the PRAC and CHMP responsibilities, will be retained into a Paediatric Working Party, composed of experts in different medical areas, which should provide scientific support and expertise to all Bodies of the Agency on matters related to paediatric medicinal products development and use. The model of rapporteurs remains unchanged. Representation of patients and health care professionals, with expertise in all areas, including rare and paediatric diseases, is increased at the CHMP and PRAC, in addition to the dedicated working groups representing patients and health care professionals.
Amendment 128 #
2023/0131(COD)
Proposal for a regulation
Recital 136
Recital 136
(136) Shortages of medicinal products represent a growing threat to public health, with potential serious risks to the health of patients in the Union and impacts on the right of patients to access appropriate medical treatment. The root causes of shortages are multifactorial, with challenges identified along the entire pharmaceutical value chain, from quality and manufacturing problems. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. Therefore, all marketing authorisation holders should have shortage prevention plans in place, to prevent shortages. The Agency should provide guidance to marketing authorisation holders on approaches to streamline the implementation of those plans.Preventing and monitoring shortages should also go through better use of data, including from existing IT systems such as the European Medicines Verification System which can aid in the monitoring and timely response to supply shortages, and has the potential to detect supply issues through predictive models.
Amendment 133 #
2023/0131(COD)
Proposal for a regulation
Recital 138
Recital 138
(138) The national competent authorities and the Agency should be empowered to monitor shortages of medicinal products that are authorised through both national and centralised procedures, based on notifications of marketing authorisation holders. in a centralised, digitalised and automated system.The Agency should be empowered to monitor shortages of medicinal products that are authorised through the centralised procedure, also based on notifications of marketing authorisation holders. When critical shortages are identified, both national competent authorities and the Agency should work in a coordinated manner to manage those critical shortages, whether the medicinal product concerned by the critical shortage is covered by a centralised marketing authorisation or a national marketing authorisation. Marketing authorisation holders and other relevant entities must provide the relevant information to inform the monitoring. Wholesale distributors and other persons or legal entities, including patient organisations or health care professionals, may also report a shortage of a given medicinal product marketed in the Member State concerned to the competent authority or the Agency. The Executive Steering Group on Shortages and Safety of Medicinal Products (‘the Medicines Shortages Steering Group’ (MSSG)) already established within the Agency pursuant to Regulation (EU) 2022/123 of the European Parliament and of the Council56 , should adopt a list of critical shortages of medicinal products and ensure monitoring of those shortages by the Agency. The MSSG should also adopt a list of critical medicinal products authorised in accordance with [revised Directive 2001/83/EC] or this Regulation to ensure monitoring of the supply of those products. The MSSG may provide recommendations on measures to be taken by marketing authorisation holders, the Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. Implementing acts can be adopted by the Commission to ensure that appropriate measures, including the establishment or maintenance of strategic contingency stocks, are taken by marketing authorisation holders, wholesale distributors or other relevant entities. In case of emergencies and on the basis of the notifications received, the Agency should be empowered to redirect medicinal products available in strategic contingency stocks for quick access and agile mobilization of medicines, medical supplies, and equipment in order to facilitate the response to health emergencies of any kind and to support the health network _________________ 56 Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
Amendment 148 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 8 a (new)
Article 2 – paragraph 2 – point 8 a (new)
(8 a) ‘paediatric population’ means that part of the population aged between birth and 18 years;
Amendment 149 #
2023/0131(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 9 a (new)
Article 2 – paragraph 2 – point 9 a (new)
(9 a) paediatric investigation plan’ means a research and development programme aimed at ensuring that the necessary data are generated determining the conditions in which a medicinal product may be authorised to treat the paediatric population
Amendment 397 #
2023/0131(COD)
Proposal for a regulation
Article 73 a (new)
Article 73 a (new)
Article 73a Joint procurement of orphan medicinal products 1. Upon request by one or more Member States, the Commission and any of the Member States may engage, as contracting parties, in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 with a view to the advance purchase of orphan medicinal products. 2. Provisions referred to in Directive 2014/24/UE, Article 12(2) and Article 12(3) of Regulation (EU) 2022/2371 shall apply for the joint procurement procedure as referred to in paragraph 1. 3. The Commission shall set up a coordination mechanism between the entities organising and participating in any action of the joint procurement, providing technical expertise and assistance at all stages of the procedure. 4. In order to provide incentives to encourage the uptake of the joint procurement procedure, a dedicated fund is made available. 5. The Commission shall, by means of implementing acts, set up the Fund as referred to in paragraph 4, where operating procedures and financial resources to be allocated are specified.
Amendment 402 #
2023/0131(COD)
Proposal for a regulation
Article 77 – paragraph 1
Article 77 – paragraph 1
1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency, after receiving the opinion of its Paediatric Working Party, shall adopt within 90 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.
Amendment 404 #
2023/0131(COD)
Proposal for a regulation
Article 84 – paragraph 2 – subparagraph 3
Article 84 – paragraph 2 – subparagraph 3
Within 30 days and after receiving the opinion of its Paediatric Working Party, the Agency shall review these changes and adopt a decision on their refusal or acceptance.
Amendment 431 #
2023/0131(COD)
Proposal for a regulation
Article 116 – paragraph 1 – point d
Article 116 – paragraph 1 – point d
(d) a temporary disruption in supply of a medicinal product in a given Member State, of an expected duration of in excess of two weeks or, based on the demand forecast of the marketing authorisation holder no less than sixtwo months before the start of such temporary disruption of supply or, if this is not possible and where duly justified, as soon as they become aware of such temporary disruption, to allow the Member State to monitor any potential or actual shortage in accordance with Article 118(1).
Amendment 466 #
2023/0131(COD)
Proposal for a regulation
Article 122 – paragraph 6
Article 122 – paragraph 6
6. For the purposes of implementing this Regulation, the Agency shall expand the scope of the ESMP. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT regulatory and shortages reporting systems and other relevant IT systems and databases, including the repositories system containing information on safety features referred to in Article 67, paragraph 2, second subparagraph, point (e) of the Directive without duplication of reporting.
Amendment 490 #
2023/0131(COD)
Proposal for a regulation
Article 130 – paragraph 1 – subparagraph 1 – point a
Article 130 – paragraph 1 – subparagraph 1 – point a
(a) develop a common methodology to identify critical medicinal products, including the evaluation of vulnerabilities and availability of alternatives with respect to the supply chain of those medicines, in consultation, where appropriate, with relevant stakeholders;
Amendment 504 #
2023/0131(COD)
Proposal for a regulation
Article 142 – paragraph 1 – point d a (new)
Article 142 – paragraph 1 – point d a (new)
(d a) the Paediatric Working Party
Amendment 513 #
2023/0131(COD)
Proposal for a regulation
Article 150 – paragraph 2 – subparagraph 1
Article 150 – paragraph 2 – subparagraph 1
The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non-clinical and clinical evaluations., rare diseases and paediatric medicines with mandatory involvement of patients representatives
Amendment 515 #
2023/0131(COD)
Proposal for a regulation
Article 150 – paragraph 3 – subparagraph 2
Article 150 – paragraph 3 – subparagraph 2
The majority of the members of the working parties shall consist of experts from the competent authorities of the Member States. and patient representatives.Where appropriate, the Committee for Human Medicinal Products may, following consultation with the Management Board, set a minimum number of experts from the competent authorities in a working party.
Amendment 66 #
2023/0085(COD)
Proposal for a directive
Recital 9 a (new)
Recital 9 a (new)
(9 a) Within the context of the European Green Deal, the EU Action Plan Towards Zero Pollution for Air, Water and Soil (COM 2021/400, the European Chemicals Strategy for Sustainability (COM/2020/667) and the European Union Strategic Approach to Pharmaceuticals in the Environment (COM/2019/128), the healthcare sector plays a relevant role for environmental pollution reduction. In this perspective, establishing a proper regulatory framework for using green claims relating to sustainability, biodegradability, circularity and origin of the product’s components both for medicinal products (according to Directive 2001/83) and medical devices (according to Regulations 2017/745), would be crucial to encourage companies contribution to environmental objectives and guarantee reliable communication to consumers.
Amendment 508 #
2023/0085(COD)
Proposal for a directive
Article 5 – paragraph 8 a (new)
Article 5 – paragraph 8 a (new)
8 a. Environmental claims are communicated in a language that can be undestood by consumers in the Member States where the product or service is marketed.
Amendment 112 #
2023/0081(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) Any additional mobilisation of state aid should be targeted and temporary, and should be consistent with EU policy objectives such as the Green Deal and the Pillar of Social Rights. Projects of strategic common European interest should also be aligned with these goals, and should have genuine European added value. Such financing should have an equal positive impact in all Member State and shall not lead to aditional desparities among Member States in line with the EU's competition and cohesion policies.
Amendment 115 #
2023/0081(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) Regarding external aspects, in particular regarding emerging markets and developing economies, the EU will seek win-win partnerships in the framework of its Global Gateway strategy, which contribute to the diversification of its raw materials supply chain, to the achievement of global climate objectives as well as to partner countries’ efforts to pursue twin transition and develop local value addition.
Amendment 138 #
2023/0081(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) The net-zero transformation is already causing huge industrial, economic, and geopolitical shifts across the globe, which will become ever more pronounced as the world advances in its decarbonisation efforts. The road to net zero translates into strong opportunities for the expansion of Union’s net-zero industry, making use of the strength of the Single Market, by promoting investment in technologies in the field of renewable energy technologies , electricity and heat storage technologies, heat pumps, grid technologies, renewable fuels of non- biological origin technologies, electrolysers and fuel cells, fusion, small modular reactors and related best-in-class fuels, carbon capture, utilisation, and storage technologies, and energy-system related energy efficiency technologies and their supply chains, allowing for the decarbonisation of our economic sectors, from energy supply to transport, buildings, and industry. A strong net zero industry within the European Union can help significantly in reaching the Union’s climate and energy targets effectively, as well as in supporting other Green Deal objectives, while creating jobs andquality jobs and sustainable growth.
Amendment 148 #
2023/0081(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) The Union’s decarbonisation objectives, security of energy supply, digitalisation of the energy system and electrification of demand, for example in mobility and the need for fast recharging points, require an enormous expansion of electricity grids in the European Union, both at transmission level and at distribution level. At transmission level, high-voltage direct current (HVDC) systems are needed to connect offshore renewable energies; while at distribution level, connecting electricity providers and managing demand-side flexibility builds on investments in innovative grid technologies, such as electric vehicles smart charging (EVSC), energy efficiency building and industry automation and smart controls, advanced meter infrastructure (AMI) and home energy management systems (HEMS). The electricity grid needs to interact with many actors or devices based on a detailed level of observability, and hence availability of data, to enable flexibility, smart charging and smart buildings with smart electricity grids and small-scale flexibility services enabling demand -side response from consumers and the uptake of renewables. Connecting the net-zero technologies to the network of the European Union requires the substantial expansion of manufacturing capabilities for electricity grids in areas such as offshore and onshore cables, substations and transformers.
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 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 211 #
2023/0081(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) The Union has helped buildshould promote a global economic system based on open and rules- based trade, providing quality jobs, including a living wage, job security and access to social protection, lifelong learning opportunities, good working conditions in safe and healthy workplaces, reasonable working time with a good work-life balance, as well as trade union representation and bargaining rights, pushed for respecting and advancing social and environmental sustainability standards, and is fully committed to those values.
Amendment 213 #
2023/0081(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) The Union has helped build a global economic system based on open and rules-based trade, pushed for respecting and advancing social and environmental sustainability and climate transition standards, and is fully committed to those values.
Amendment 234 #
2023/0081(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) In order to maintain competitiveness and reduce current strategic import dependencies in key net- zero technology products and their supply chains, while avoiding the formation of new ones, the Union needs to continue strengthening its net zero industrial base and become more competitive and innovation friendly. The Union needs to enable the development of manufacturing capacity faster, simpler and in a more predictable way. Union policies should ensure regional and social cohesion in view of overcoming structural differences between regions as well as social inequalities, including inequalities between women and men.
Amendment 236 #
2023/0081(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) In order to maintain competitiveness and reduce current strategic import dependencies in key net- zero technology products and their supply chains, while avoiding the formation of new ones, the Union needs to continue strengthening its net zero industrial base and become more competitive and innovation friendly. The Union needs to enable the development of manufacturing capacity faster, simpler and in a more predictable way, reducing administrative burden and levelling the playing field with international competitors.
Amendment 250 #
2023/0081(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) In addition, the Communication on the Green Deal Industrial Plan for the Net- Zero Age42 sets out a comprehensive approach to support a clean energy technology scale up based on four pillars. The first pillar aims at creating a regulatory environment that simplifies and fast-tracks permitting for new net-zero technology manufacturing and assembly sites and facilitates the scaling up of the net-zero industry of the Union. The second pillar of the plan is to boost investment in and financing of net-zero technology production, through the revised Temporary Crisis and Transition Framework adopted in March 2023 and the creation of a European Sovereignty fund to preserve the European edge on critical and emerging technologies relevant to the green and digital transitions. The third pillar relates to developing the skills and quality jobs needed to make the transition happen and increase the number of skilled workers in the clean energy technology sector. The fourth pillar focuses on trade and the diversification of the supply chain of critical raw materials. That includes creating a critical raw materials club, working with like-minded partners, in full compliance with social and labour standards, to collectively strengthen supply chains and diversifying away from single suppliers for critical input. _________________ 42 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: A Green Deal Industrial Plan for the Net-Zero Age, COM/2023/62 final, 01.02.2023.
Amendment 257 #
2023/0081(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) Directives 2014/23/EU, 2014/24/EU and 2014/25/EU already allow contracting authorities and entities awarding contracts through public procurement procedures to rely, in addition to price or cost, on additional criteria for identifying the most economically advantageous tender. Such criteria concern for instance the quality of the tender including social, environmental, governance and innovative characteristics. When awarding contracts for net-zero technology through public procurement, contracting authorities and contracting entities should duly assess the tenders’ contribution to sustainability and resilience in relation to a series of criteria relating to the tender’s environmental sustainability, compliance with human rights laws, EU governance rules and reporting obligations, innovation, system integration and to resilience.
Amendment 259 #
2023/0081(COD)
Proposal for a regulation
Recital 26
Recital 26
(26) (26) Social sustainability criteria can already be applied under existing legislation and can include working conditions and collective bargaining in line with the European Pillar of Social Rights in line with Articles, 30 (3) of Directive 2014/23/EU, 18 (2) of Directive 2014/24/EU and 36 (2) of Directive 2014/25/EU. Contracting authorities should contribute to social sustainability by taking the appropriate measures to ensure that in the performance of public contracts economic operators comply with applicable obligations in the fields of social and labour law established by Union law, national law, collective agreements or by the international environmental, social and labour law provisions listed in Annex X of Directive 2014/23/EU, Annex X of Directive 2014/24/EU and Annex XIV of Directive 2014/25/EU43 . Public procurement contracts must include social clauses and where relevant apprenticeship clauses. _________________ 43 Commission Notice "Buying Social - a guide to taking account of social considerations in public procurement (2nd edition)", C(2021) 3573 final.
Amendment 260 #
2023/0081(COD)
(26a) Member States should use their purchasing power to promote Sustainable Public Procurement (SPP), including gender equality, in order to ensure a good balance between the three pillars of sustainable development - economic, social and environmental - when procuring goods, services or works.
Amendment 293 #
2023/0081(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) As indicated in the Communication on the Green Deal Industrial Plan for the Net-Zero Age, published on 1 February 2023, the Union’s industry’s market shares are under strong pressure, due to subsidies in third countries which undermine a level playing field. This translates in a need for a rapid and ambitious reaction from the Union in modernising its legal framework and promoting European standards for key net zero technologies.
Amendment 295 #
2023/0081(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) Access to finance is key for ensuring the Union’s open strategic autonomy and for establishing a solid manufacturing base for net-zero technologies and their supply chains across the Union. The majority of investments necessary to reach the Green Deal objectives will come from private capital53 attracted by the growth potential of the net- zero ecosystem. Well-functioning, deep and integrated capital markets will therefore be essential to raise and channel the funds needed for the green transition and net-zero manufacturing projects. Swift progress towards the Capital Markets Union is thus necessary for the EU to deliver on its net-zero objectives. The sustainable finance agenda (and blended finance) also plays a crucial role in scaling up investments into the net-zero technologies, while guaranteeing the competitiveness of the sector by giving investors and investee companies more harmonised information on what investments qualify as sustainable under the Taxonomy Regulation and the Sustainable Finance Disclosure Regulation, and by requiring financial institutions to exercise due diligence over their value chain. _________________ 53 Commission Staff Working Document Identifying Europe's recovery needs 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 - Europe's moment: Repair and Prepare for the Next Generation, SWD(2020) 98 final, Identifying Europe's recovery needs, 27.05.2020.
Amendment 330 #
2023/0081(COD)
Proposal for a regulation
Recital 47
Recital 47
(47) A European Sovereignty Fund wshould provide a structural answer to the investment needs. It will help preserving a European edge on critical and emerging technologies relevant to the green and digital transitions, including strategic net- zero technologies. This structural instrument will build on experience of coordinated multi-country projects under the IPCEIs and seek to enhance all Member States’ access to such projects, thereby safeguarding cohesion and the Single Market against risks caused by unequal availability of State Aids. seek to safeguard cohesion and the Single Market against risks caused by unequal availability of State Aids. The European Sovereignty Fund should be based on additional funding under the mid-term review of the EU Multiannual Financial Framework. In addition, the Commission should explore the development of a new bond issuance program at EU level. The European Sovereignty Fund shall offer a toolbox of financial instruments (loans, guarantees, equity, etc) to support capital and operational expenditures of clean technology manufacturing in the EU in order to overcome barriers to production scale-up.
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 348 #
2023/0081(COD)
Proposal for a regulation
Recital 50
Recital 50
(50) At the same time, the unpredictability, complexity and at times, excessive length of national permit- granting processes undermines the investment security needed for the effective development of net-zero technologies manufacturing projects. Therefore, in order to ensure and speed up their effective implementation, Member States should apply streamlined and predictable permitting procedures. In addition, Net-Zero Strategic Projects should be given priority status at national level to ensure rapid administrative treatment and urgent treatment in all judicial and dispute resolution procedures relating to them, without preventing competent authorities to streamline permitting for other net-zero technologies manufacturing projects that are not Net- Zero Strategic Projects or more generally. In order to ensure that net-zero manufacturing projects and Net-Zero Projects can be treated with priority, Member States shall ensure that the competent authorities are adequately equipped and staffed.
Amendment 378 #
2023/0081(COD)
Proposal for a regulation
Recital 58 a (new)
Recital 58 a (new)
Amendment 388 #
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. ThisA regular mapping exercise focussing on the development of quality jobs at regional level as well as the collective bargaining coverage rate should contribute to the creationincrease the number of quality jobs in line with the targets for employment and training of the European Pillar of Social Rights. Labour shortages are particularly prevalent in sectors with challenging working conditions, and skills alone will not solve this problem.1a The poor quality of jobs, bad working conditions and a lock of investment in VET at company level are some of the reasons for the lack of skilled workers.2a Tackling those issues by means of decent working conditions and retention policies is therefore important for a well- functioning labour market fit for the digital and green transitions. Improving job quality in sectors and companies with poor working conditions is also an important element for addressing the issue of brain drain which results in growing inequalities between regions, unequal development as well as unequal capacity to drive innovation and create jobs. 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. _________________ The same information regarding decent working conditions, social protection and access to the labour market should be provided for migrants, asylum seekers and refugees, whereby advise and support for the validation of skills and competences and the recognition of qualifications is essential in this context. _________________ 1a https://www.eurofound.europa.eu/news/ne ws-articles/skills-alone-will-not-solve- labour-shortages-in-europe 2a 2a https://www.cedefop.europa.eu/files/3092_ en.pdf https://www.cedefop.europa.eu/files/3075_ en.pdf 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 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 390 #
2023/0081(COD)
Proposal for a regulation
Recital 65
Recital 65
(65) Since strengthening the manufacturing capacity of key net-zero technologies in the Union will not be possible without a sizeable skilled workforce, it is necessary to introduce measures to boost the activation of more people to the labour market, notably women and young people not in employment, education or training (NEETs), including via skills first approaches as a complement to qualifications-based recruitment. In addition, in line with the objectives of the Council Recommendation on ensuring a fair transition towards climate-neutrality, specific support for job-to-job transition for workers in redundant and declining sectors are important. This means investing in skills and in quality job creation, including a living wage, job security and access to social protection, lifelong learning opportunities, good working conditions in safe and healthy workplaces, reasonable working time with a good work-life balance, as well as trade union representation and bargaining rights, required for net-zero technologies in the Union. Building on and fully taking into account existing initiatives such as the EU Pact for Skills, EU level activities on skills intelligence and forecasting, such as by the European Centre for the Development of Vocational Training (Cedefop) and the European Labour Authority, and the Blueprints for sectoral cooperation on skills, the objective is to mobilise all actors: Member States authorities, including at regional and local levels, education and training providers, social partners and industry, in particular SMEs, to identify skills needs, develop education and training programmes and deploy these at large scale in a fast and operational manner. Net-zero strategic projects have a key role to play in this regard. Member States and the Commission may ensure financial support including by leveraging the possibilities of the Union budget through instruments such as the European Social Fund Plus, Just Transition Fund, European Regional Development Funds, the Recovery and Resilience Facility, the Modernisation Fund, REPowerEU and the Single Market Programme.
Amendment 440 #
2023/0081(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b a (new)
Article 1 – paragraph 2 – point b a (new)
ba) that by 2030, at least a 50% of the existing industrial manufacturing companies, have undertaken a project to adopt, install or use strategic net-zero technologies in their installations, in order to reduce CO2 emissions or energy consumption.
Amendment 447 #
2023/0081(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b a (new)
Article 1 – paragraph 2 – point b a (new)
Amendment 450 #
2023/0081(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b b (new)
Article 1 – paragraph 2 – point b b (new)
Amendment 451 #
2023/0081(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b b (new)
Article 1 – paragraph 2 – point b b (new)
bb) The creation of quality jobs.
Amendment 452 #
2023/0081(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b c (new)
Article 1 – paragraph 2 – point b c (new)
bc) international competitiveness of the range of of net-zero technologies and related value chains and activities contributing to them;
Amendment 500 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) ‘net-zero technologies’ means renewable energy technologies66 ; electricity and heat storage technologies; heat pumps; grid technologies; renewable fuels of non-biological origin technologies; sustainable alternative fuels technologies67 ; electrolysers and fuel cells; advanced technologies to produce energy from nuclear processes with minimal waste from the fuel cycle, small modular reactors, and related best-in-class fuels; carbon capture, utilisation, and storage technologies; and energy-system related energy efficiency technologies. They refer to the final products, specific components and specific machinery primarily used for the production of those products, as well as the existing industrial processes that could use and install this products. They shall have reached a technology readiness level of at least 8. _________________ 66 ‘renewable energy' means ‘renewable energy’ as defined in 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 67 ‘sustainable alternative fuels’ means fuels covered by the Proposal for a Regulation of the European Parliament and of the Council on ensuring a level playing field for sustainable air transport, COM/2021/561 final and by the Proposal for a Regulation of the European Parliament and Council on the use of renewable and low-carbon fuels in maritime transport COM/2021/562 final.
Amendment 530 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point c
Article 3 – paragraph 1 – point c
(c) ‘innovative net-zero technologies’ means technologies which satisfy the definition of ‘net-zero technologies’, except that they have not reached a technology readiness level of at least 8, and that comprise genuine innovation which helps achieve the objectives of this Regulation through improved energy or resource efficiency, sustainability, circularity or reduced carbon impact, and which are not currently available on the market and are advanced enough to be tested in a controlled environment.
Amendment 545 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point d
Article 3 – paragraph 1 – point d
(d) ‘net-zero technology manufacturing project’ means a planned industrial facility or extension or repurposing of an existing facility manufacturing net-zero technologies, or projects in existing industrial facilities devoted to adopt, include or use net-zero technologies;
Amendment 572 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point i
Article 3 – paragraph 1 – point i
(i) ‘net-zero regulatory sandbox’ means a scheme that enables undertakings to test innovative net-zero technologies in a controlled real-world environment, under a specific plan, developed and monitored by a competent authority, including the innovation in existing industrial facilities in projects to adopt or use net-zero technologies.
Amendment 592 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point s a (new)
Article 3 – paragraph 1 – point s a (new)
(sa) 'quality jobs' means a work providing good wages, ensuring work security via standard employment contract and access to social protection, giving access to good quality lifelong learning opportunities, securing good working conditions in safe and healthy workplaces, including a reasonable working time with good work-life balance, while ensuring trade union representation and bargaining rights.
Amendment 596 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point s b (new)
Article 3 – paragraph 1 – point s b (new)
(sb) 'hydrogen compressors' means a technology for compressed hydrogen transport via pipelines as well as for hydrogen liquefaction facilities
Amendment 598 #
2023/0081(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point s d (new)
Article 3 – paragraph 1 – point s d (new)
(sd) “value chain” means activities related to the production of goods or the provision of services by a company, including the development of the product or the service and the use and disposal of the product as well as the related activities of upstream and downstream established business relationships of the company.
Amendment 615 #
2023/0081(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The national competent authority referred to in paragraph 1 shall be the sole point of contact for the project promoter in the permit-granting process leading to a comprehensive decision for a given project and shall coordinate the submission of all relevant documents and information, without prejudice to the existing distribution of competences between administrative levels and the restrictions that may derive from such distribution. .
Amendment 647 #
2023/0081(COD)
Proposal for a regulation
Article 4 – paragraph 7
Article 4 – paragraph 7
7. Member States shall ensure that the national competent authority responsible for the entire permit-granting processes, including all procedural steps, and without prejudice to the existing distribution of competences between administrative levels with regard to the final permits award, has a sufficient number of qualified staff and sufficient financial, technical and technological resources necessary, including for up- and re-skilling, for the effective performance of its tasks under this Regulation.
Amendment 655 #
2023/0081(COD)
Proposal for a regulation
Article 4 – paragraph 8 b (new)
Article 4 – paragraph 8 b (new)
8b. The European Commission and the InvestEU Advisory Hub shall provide technical and financial support to the national competent authorities and Member States to carry out the permit- granting process.
Amendment 656 #
2023/0081(COD)
Proposal for a regulation
Article 4 – paragraph 8 c (new)
Article 4 – paragraph 8 c (new)
8c. Member States shall consider increasing direct support to the national competent authority under national Recovery and Resilience Plans.
Amendment 657 #
2023/0081(COD)
Proposal for a regulation
Article 4 – paragraph 8 d (new)
Article 4 – paragraph 8 d (new)
8d. The national competent authority shall specify and make available the detailed requirements and extent of information requested of a project developer before the permit-granting process commences. It shall also specify the maximum time required to come to a final decision.
Amendment 659 #
2023/0081(COD)
Proposal for a regulation
Article 5 – paragraph 1 – introductory part
Article 5 – paragraph 1 – introductory part
Member States and the European Commission, when competent, shall provide the following information on administrative processes relevant to net- zero technology manufacturing projects, including net zero strategic projects, online and in a centralised and easily accessible manner:
Amendment 805 #
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 respects collective agreements and workers' right to organise, take collective action and to bargain collectively as well as the right to be informed and consulted, also on mergers and investment decisions;
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 813 #
2023/0081(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point b – point iv b (new)
Article 10 – paragraph 1 – point b – point iv b (new)
(ivb) its workers are covered by a collective agreement negotiated with trade unions;
Amendment 815 #
2023/0081(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point b – point iv c (new)
Article 10 – paragraph 1 – point b – point iv c (new)
(ivc) it provides quality jobs including a living wage, job security and access to social protection, lifelong learning opportunities, good working conditions in safe and healthy workplaces, reasonable working time with a good work-life balance as well as trade union representation and bargaining rights;
Amendment 817 #
2023/0081(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point b – point iv d (new)
Article 10 – paragraph 1 – point b – point iv d (new)
(ivd) it reinvests a large share of its profits, shares profits equitably with workers and does not pay extraordinary dividends and bonuses to managers while receiving public funding;
Amendment 819 #
2023/0081(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point b – point iv e (new)
Article 10 – paragraph 1 – point b – point iv e (new)
(ive) it applies pay transparency in line with Union legislation and ensures diversity at work;
Amendment 858 #
2023/0081(COD)
4a. Companies responsible for net- zero manufacturing projects shall fulfil the following conditions: (a) they make substantial invests in employees’ reskilling and upskilling; (b) they allocate a minimum percentage of capital expenditure to Research and Development; (c) they demonstrate compliance with ILO conventions, including on forced labour, and have efficient due diligence procedures in line with Union legislation in place; (d) they offer decent wages and engage in collective bargaining; (e) they limit stock buybacks, dividend payments and executive pay.
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 952 #
2023/0081(COD)
Proposal for a regulation
Article 14 – paragraph 2 – introductory part
Article 14 – paragraph 2 – introductory part
2. Member States may provide administrative support to net-zero strategic projectsprojects, in particular involving SMEs, to facilitate their rapid and effective implementation, including by providing:
Amendment 965 #
2023/0081(COD)
Proposal for a regulation
Article 14 – paragraph 2 a (new)
Article 14 – paragraph 2 a (new)
2a. The European Commission may mobilise the InvestEU Advisory Hub to provide technical assistance to net-zero projects in order to reinforce their technical, economic, environmental and social viability.
Amendment 1166 #
2023/0081(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. Contracting authorities or contracting entities shall base the award of contracts for net-zero technology listed in the Annex in a public procurement procedure on the most economically advantageous tender, which shall include the best price- quality ratio, comprising at least the social and environmental sustainability and resilience contribution of the tender, in compliance with Directives 2014/23/EU, 2014/24/EU, or 2014/25/EU and applicable sectoral legislation, as well as with the Union’s international commitments, including the GPA and other international agreements by which the Union is bound.
Amendment 1181 #
2023/0081(COD)
Proposal for a regulation
Article 19 – paragraph 2 – point a
Article 19 – paragraph 2 – point a
(a) environmental and social sustainability going beyond the minimum requirements in applicable legislation, including job quality, measures to improve diversity at work, as well as respect of collective agreements and trade union rights 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 1251 #
2023/0081(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. Without prejudice to Article 4 of Directive (EU) 2018/2001 and Articles 107 and 108 the Treaty, and to the Union’s international commitments including the GPA and other international agreements by which the Union is bound, Member States, regional or local authorities, bodies governed by public law or associations formed by one or more such authorities or one or more such bodies governed by public law, shall assess the sustainability, job quality and resilience contribution as referred to in Article 19(2) of this Regulation when designing the criteria used for ranking bids in the framework of auctions, the aim of which is to support the production or consumption of energy from renewable sources as defined in Article 2, point (1) of Directive (EU) 2018/2001.
Amendment 1279 #
2023/0081(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Without prejudice to Articles 107 and 108 of the Treaty and Article 4 of Directive 2018/200173 and in line with the Union’s international commitments, when deciding to set up schemes benefitting households or consumers which incentivise the purchase of net-zero technology final products listed in the Annex, Member States, regional or local authorities, bodies governed by public law or associations formed by one or more such authorities or one or more such bodies governed by public law, shall design them in such a way as to promote the purchase by beneficiaries of net-zero technology final products with a high environmental and social sustainability and resilience contribution as referred in Article 19(2), by providing additional proportionate financial compensation. _________________ 73 Directive 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
Amendment 1324 #
2023/0081(COD)
Proposal for a regulation
Article 23 – paragraph 1 – point c
Article 23 – paragraph 1 – point c
(c) develop and deploy credentials, including micro-credentials, to facilitate the transparency of skills acquired and enhance the transferability between jobs andquality jobs to facilitate the cross-border mobility of the workforce, and to promote matching with relevant quality jobs through tools such as the European Employment Services (EURES) network and EURAXESS.
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 1344 #
2023/0081(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point 4
Article 25 – paragraph 1 – point 4
(4) assist the uptake and recognition of learning credentials of the European Net- Zero Industry Academies in the Member States to promote the recognition of skills and the matching of skills and quality jobs, inter alia by promoting the validity and acceptance of the credentials throughout the labour market of the European Union;
Amendment 1346 #
2023/0081(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point 5
Article 25 – paragraph 1 – point 5
(5) facilitate the development of European occupation profiles consisting of a common set of knowledge, skills and competences for key professions in the net- zero technologies, drawing inter alia upon the learning programmes developed by the European Net-Zero Industry Academies, and, where appropriate, using the terminology provided by the European Skills, Competences, Qualifications and Occupations (ESCO) classification to facilitate transparency and mobility between quality jobs and across internal market borders;
Amendment 1349 #
2023/0081(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point 6
Article 25 – paragraph 1 – point 6
(6) promote adequate working conditions in quality jobs in net-zero technology industries, 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 1350 #
2023/0081(COD)
Proposal for a regulation
Article 25 – paragraph 1 – point 7
Article 25 – paragraph 1 – point 7
(7) facilitate closer coordination and the exchange of best practices between Member States to enhance the availability of skills in the net-zero technologies, including by contributing to Union and Member States policies to attract new talents from third countries by providing information regarding decent working conditions, social protection and access to the labour market as well as support for the validation of skills and competences and the recognition of qualifications.
Amendment 1393 #
2023/0081(COD)
Proposal for a regulation
Article 27 – paragraph 2 a (new)
Article 27 – paragraph 2 a (new)
2a. The InvestEU Advisory Hub should be mobilised to provide assistance to small and medium enterprises in benefiting from the permitting and financing conditions necessary to contribute to the achievements of the objectives set in Article 1.
Amendment 1427 #
2023/0081(COD)
Proposal for a regulation
Article 28 – paragraph 4 – point c – point i a (new)
Article 28 – paragraph 4 – point c – point i a (new)
ia) decent working conditions and social conditionalities.
Amendment 1445 #
2023/0081(COD)
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. Each Member State shall appoint a high-level representative to the Platform. Where relevant as regards the function and expertise, a Member State may have more than one representative in relation to different tasks related to the work of the Platform. Each member of the Platform shall have an alternate. Cross-industry social partners may designate four representatives as observers to the Platform with an equal representation of trade unions and employer organisations.
Amendment 1476 #
2023/0081(COD)
Proposal for a regulation
Article 29 – paragraph 11
Article 29 – paragraph 11
11. The Platform shall coordinate and cooperate with existing industrial alliances, as well as national sectorial social partners.
Amendment 1494 #
2023/0081(COD)
Proposal for a regulation
Article 31 – paragraph 2 – point c a (new)
Article 31 – paragraph 2 – point c a (new)
(ca) the participation of SMEs in net- zero projects and net-zero technology manufacturing
Amendment 1497 #
2023/0081(COD)
Proposal for a regulation
Article 31 – paragraph 2 – point h a (new)
Article 31 – paragraph 2 – point h a (new)
Amendment 2 #
2023/0064(COD)
Proposal for a regulation
Recital 8
Recital 8
The specific rules should include the prohibition to display the safety features referred to in Directive 2001/83/EC on the outer packaging or, where there is no outer packaging, on the immediate packaging of medicinal products for human use intended to be placed on the market in Northern Ireland, with the exception of the anti- tampering device measures set out in Directive 2011/62/EU which should remain in place. The specific rules should also include and the prohibition to place on the market in Northern Ireland new and innovative medicinal products that have been granted a marketing authorisation in accordance with Regulation (EC) No 726/2004. Furthermore, the specific rules should include certain labelling requirements for medicinal products for human use intended to be placed on the market in Northern Ireland. As a consequence, Commission Delegated Regulation (EU) 2016/1616 should not apply to medicinal products for human use intended to be placed on the market in Northern Ireland.
Amendment 4 #
2023/0064(COD)
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
The safety features referred to in Article 54, point (o) with the exception of the anti-tampering device measures, of Directive 2001/83/EC shall not appear on the outer packaging or, where there is no outer packaging, on the immediate packaging of medicinal products referred to in Article 1(1) of this Regulation
Amendment 5 #
2023/0064(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
Where a medicinal product referred to in Article 1(1) of this Regulation bears the safety feature referred to in Article 54, point (o) with the exception of the anti- tampering device measures, of Directive 2001/83/EC, it shall be fully removed or covered.
Amendment 6 #
2023/0064(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
The qualified person referred to in Article 48 of Directive 2001/83/EC shall, in the case of medicinal products referred to in Article 1(1) of this Regulation, ensure that the safety features referred to in Article 54, point (o) with the exception of the anti- tampering device measures, of Directive 2001/83/EC have not been affixed on the packaging of the medicinal product.
Amendment 64 #
2023/0046(COD)
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) Digitalisation has a profound impact on the daily social, economic, political and cultural life of citizens, workers and consumers and concerns all areas of society. For this reason, limited access and insufficient network expansion can deepen social inequalities, thus creating a new digital divide, not only between well-connected urban areas and rural and remote areas, but also between those people who can fully benefit from an efficient and secure digital connectivity allowing them to access a wide range of services, and those who cannot do so. In this regard, the inclusion of social housing in the rolling-out of high capacity networks should be a relevant priority for public and private investment projects, as broadband connectivity is a key aspect for social inclusion.
Amendment 65 #
2023/0046(COD)
Proposal for a regulation
Recital 1 b (new)
Recital 1 b (new)
(1b) In order to close the Digital Divide across the Union, and in line with the EU Decision "Establishing the Digital decade policy programme 2030", investments in digital infrastructure should aim to ensure connectivity accessible and affordable to all and everywhere in the Union, with available internet access, with a particular focus on the divide between different geographical areas. In particular, by 2030, networks with gigabit speeds should become available to those who need or wish to have such capacity.
Amendment 66 #
2023/0046(COD)
Proposal for a regulation
Recital 1 c (new)
Recital 1 c (new)
(1c) Recalling that EU's rural areas are home to 137 million people, 30.6% of the EU's population, and cover about 83% of EU's land, adequate coverage of networks with gigabit speeds, digital capacity building and enabling environment for rural and remote areas' digital innovation, are key conditions for those areas to be able to benefit from the new opportunities that the digital transition. Such coverage could provide significant potential to improve people's lives and mitigate the negative impact of reduced connectivity, insularity and remoteness, by enabling the application of new technologies such as e-health, e- government and education services.
Amendment 85 #
2023/0046(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) Measures aiming to make using public and private existing infrastructures more efficient and reduce costs and obstacles in carrying out new civil engineering works should contribute substantially to ensuring a fast and extensive deployment of very high capacity networks in all areas, including rural and remote areas. These measures should maintain effective competition without harming the safety, security and smooth operation of the existing infrastructure.
Amendment 88 #
2023/0046(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) This Regulation aims to strengthen and harmonise rights and obligations applicable across the Union to accelerate the roll-out of very high capacity networks and cross-sector coordination. Due to the persistent fragmentation of electronic communications markets in individual national markets, undertakings providing or authorised to provide electronic communications networks are unable to achieve economies of scale. This can have a strong downstream effect on cross-border trade and services provision, since many services can only be provided where an adequately performant network is in place across the Union. While ensuring an improved level playing field, this Regulation does not prevent national measures in compliance with Union law that serve to promote the joint use of existing physical infrastructure or enable a more efficient and/or rapid deployment of new physical infrastructure by complementing the rights and obligations laid down in this Regulation. For example, Member States could extend provisions on civil works coordination also to privately funded projects or require that more information on physical infrastructure or planned civil works is provided to a single information point in electronic format, provided that they do not violate Union law including the provisions of this Regulation. On the same note, Member States could introduce stricter cost-oriented price obligations regarding the terms and conditions under which access requests should be met. Member States could also introduce supplementary permit exemptions or impose more stringent timeframes for granting or denying permits, provided that they do not violate Union law including the provisions of this Regulation.
Amendment 96 #
2023/0046(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) To improve the deployment of very high capacity networks in the internal market, this Regulation should lay down rights for undertakings providing public electronic communications networks or associated facilities (including undertakings of a public nature) to access physical infrastructure regardless of its location under fair and reasonable terms consistent with the normal exercise of property rights. A fair return of investment should be granted to access providers, such return should reflect the relevant market conditions and different business models, such as those of providers of associated facilities. In this case, the access price offered may be considered fair and reasonable when providers offer only passive access to more than one electronic communications operators at comparable conditions. The obligation to give access to the physical infrastructure should be without prejudice to the rights of the owner of the land or of the building in which the infrastructure is located.
Amendment 119 #
2023/0046(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Public sector bodies that own or control physical infrastructure may lack sufficient resources, experience or the necessary technical knowledge to engage in negotiations with operators on access. TIn such case, in order to facilitate access to these public sector bodies’ physical infrastructure, a body cshould be appointed to coordinate the access requests, provide legal and technical advice for negotiating access terms and conditions, and make relevant information on such physical infrastructure available via a single information point. The coordinating body could also support public sector bodies in preparing model contracts and monitor the outcome and the length of time of the access requests process. The body could also help if disputes arise on access to physical infrastructure that public sector bodies own or control.
Amendment 120 #
2023/0046(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) To ensure consistency of approaches among Member States, the Commission, in close cooperation with the Body of European Regulators for Electronic Communications (BEREC), cshould provide guidance, by at least six months before the date of application of this Regulation, on applying the provisions on access to physical infrastructure, including but not only on the application of fair and reasonable conditions. The views of stakeholders, national authorities and national dispute settlement bodies should be duly taken into account in the preparation of the guidance. With a view to limit market disruption and an unintended reduction of a potential investment, the Commission, when formulating the guidelines on fair and reasonable price, should take into account the characteristics of the network operators and their business model, such as providers of associated facilities. Considering the level of flexibility recognised to Member States in the application of these provisions, and in order to be efficient, the European Commission guidance should provide the appropriate level of granularity.
Amendment 134 #
2023/0046(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) To ensure consistency of approaches, the Commission, in close cooperation with the Body of European Regulators (BEREC), cshould provide guidance, by at least six months before the date of application of this Regulation, on applying the provisions on civil work coordination, including but not only on apportioning of costs. The views of stakeholders and national dispute settlement bodies should be duly taken into account in the preparation of the guidance. Considering the level of flexibility recognised to Member States in the application of these provisions, and in order to be efficient, such guidance should provide an appropriate level of granularity.
Amendment 139 #
2023/0046(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) A number of different permits for deploying elements of electronic communications networks or associated facilities may be necessary in order to protect national and Union general interests. These can include digging, building, town planning, environmental and other permits as well as rights of way. The number of permits and rights of way required for deploying different types of electronic communications networks or associated facilities and the local character of the deployment could involve applying different procedures and conditions, which can cause difficulties in the network deployment. Therefore, to facilitate deployment, all rules on the conditions and procedures applicable to granting permits and rights of way should be streamlined and consis, consistent and harmonized, to the possible extent, at national level. While preserving the right of each competent authority to be involved and maintain its decision-making prerogatives in accordance with the subsidiarity principle, all information on the procedures and general conditions applicable to granting permits for civil works and rights of way should be available via single information points. This could reduce complexity and increase efficiency and transparency for all operators and particularly new entrants and smaller operators not active in that area. Moreover, operators should have the right to submit their requests for permits and rights of way in electronic format via a single information point. Those undertakings should also be able to retrieve information in electronic format about the status of their requests and whether they have been granted or refused.
Amendment 144 #
2023/0046(COD)
Proposal for a regulation
Recital 39
Recital 39
(39) Permit-granting procedures should not be barriers to investment or harm the internal market. Member States should therefore ensure that a decision on whether or not to grant permits on the deployment of elements of very high capacity networks or associated facilities is made available within 4 months from the receipt of a complete permit request. This is without prejudice to other specific deadlines or obligations laid down for the proper conduct of the procedure, which are applicable to the permit-granting procedure in accordance with national or Union law, such as the provisions set out in Article 57 of the Directive (EU) 2018/1972. Competent authorities should not restrict, hinder or make the deployment of very high capacity networks or associated facilities economically less attractive. Specifically, they should not prevent procedures for granting permits and rights of way from proceeding in parallel, where possible, or require operators to obtain one type of authorisation before they can apply for other types of authorisations. Competent authorities should justify any refusal to grant permits or rights of way under their competence, based on objective, transparent, non-discriminatory and proportionate conditions.
Amendment 154 #
2023/0046(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) In order to ensure uniform conditions for the implementation of Article 7 of this Regulation, implementingdelegated powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council39 . The exemptions from the requirement for permits set out at Union level by way of an implementing acte minimum list of exemptions from the requirement for permits set out at Union level by way of a delegated act, without prejudice to additional exemptions that may be introduced by Member States, could be applied to different categories of infrastructure (such as masts, antennae, poles and underground cables) under certain specified conditions, for which building permits, digging permits or other types of permits may be initially required. They could also be applied to technical upgrades of existing maintenance works or installations, small- scale civil works, such as trenching, and renewals of permits. _________________ 39 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 156 #
2023/0046(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) In order to ensure that the procedures for granting such permits and rights of way are completed within reasonable deadlines, as appears from certain modernising and good administrative practices at national level, it is necessary to draw up principles for administrative simplification. This should include inter alia limiting the obligation of prior authorisation to cases in which it is essential and introducing tacit approval by the competent authorities after a certain period of time has elapsedAdditionally, Member States should be able to maintain or introduce simplified authorization procedure or prior communication procedures that may exist under national law, applicable to the deployment of any element of very high capacity networks or associated facilities. Moreover, the categories of deployments exempted from permits under Union law should no longer be subject to permits under national law.
Amendment 158 #
2023/0046(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) Achieving the targets set out in Decision (EU) 2022/2481 requires that, by 2030, all end users at fixed locations are covered by a gigabit network up to a network termination point and all populated areas are covered by next- generation wireless high-speed networks with at least 5G-equivalent performance, in accordance with the principle of technological neutrality. Providing gigabit networks up to the end user should be facilitated, in particular through fibre-ready in-building physical infrastructure. Providing for mini-ducts during the construction of a building has only a limited incremental cost, while equipping buildings with gigabit infrastructure may represent a significant part of the cost of deploying a gigabit network. Therefore, all new buildings or buildings subject to reconstruction or a major renovation should be equipped with physical infrastructure and in-building fibre wiring, enabling the connection of end users to gigabit speeds. New multi- dwelling buildings and multi-dwelling buildings subject to major renovation should also be equipped with an access point, accessible to one or more undertakings providing or authorised to provide public electronic communications networks. Moreover, building developers should provide for empty ducts from every dwelling to the access point, located in or outside the multi-dwelling building. Major renovations of existing buildings at the end user’s location to enhance energy performance (pursuant to Directive 2010/31/EU of the European Parliament and of the Council40 ) provide an opportunity to also equip those buildings with fibre-ready in-building physical infrastructure, in-building fibre wiring and, for multi-dwelling buildings, an access point. _________________ 40 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 167 #
2023/0046(COD)
Proposal for a regulation
Recital 52
Recital 52
(52) To ensure consistency of approaches, the Commission, in close cooperation with BEREC, cshould provide guidance, by at least six months before the date of application of this Regulation, on the applications of provisions on access to in-building physical infrastructure, including but not only on the terms and conditions thereof. The views of stakeholders and national dispute settlement bodies should be duly taken into account in the preparation of the guidance. Considering the level of flexibility recognised to Member States in the application of these provisions, and in order to be efficient, such guidance should provide an appropriate level of granularity.
Amendment 174 #
2023/0046(COD)
Proposal for a regulation
Article 1 – paragraph 2
Article 1 – paragraph 2
2. If any provision of this Regulation conflicts with a more detailed or stringent relevant provision of Directive (EU) 2018/1972 or Directive 2002/77/EC, the relevant provision of those Directiveslatter shall prevail.
Amendment 175 #
2023/0046(COD)
Proposal for a regulation
Article 1 – paragraph 3
Article 1 – paragraph 3
3. Member States may maintain or introduce measures in conformity with Union law which contain more detailed and/or stringent provisions than those set out in this Regulation, such as cost- oriented prices, permit exemptions or other legal measures deriving from national law, where they serve to promote the joint use of existing physical infrastructure or enable a more efficient deployment of new physical infrastructure.
Amendment 186 #
2023/0046(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 1 a (new)
Article 2 – paragraph 2 – point 1 a (new)
(1a) 'Very high capacity network' means a fixed or wireless network as defined in Article 2, point (2) of Directive (EU) 2018/1972;
Amendment 193 #
2023/0046(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point 2 – paragraph 1 – point b
Article 2 – paragraph 2 – point 2 – paragraph 1 – point b
(b) where they are not part of a network and are owned or controlled by public sector bodies: buildings or, including rooftops, and entries to buildings, and any other asset including street furniture, such as light poles, street signs, traffic lights, billboards, bus and tramway stops and metro stations.
Amendment 217 #
2023/0046(COD)
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. Upon written request of anNetwork operator,s or public sector bodies owning or controlling physical infrastructure or network operators shall meet all reasonable requestwritten requests of operators for access to that physical infrastructure under fair and reasonable terms and conditions, including price, with a view to deploying elements of very high capacity networks or associated facilities. Public sector bodies owning or controlling physical infrastructure shall meet all reasonable requests for access also under non-discriminatory terms and conditions. Such written requests shall specify the elements of the physical infrastructure for which the access is requested, including a specific time frame.
Amendment 226 #
2023/0046(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point a
Article 3 – paragraph 2 – point a
(a) the need to ensure that the access provider has a fair opportunity to recover the costs it incurs in order to provide access to its physical infrastructure, taking into account specific national conditions, different business models, and any tariff structures put in place to provide a fair opportunity for cost recovery; in the case of electronic communications networks, any remedies imposed by a national regulatory authority shall also be taken into account.
Amendment 230 #
2023/0046(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
(b) the impact of the requested access on the access provider’s business plan, including investments in the physical infrastructure to which the access has been requested; additionally, a fair return of investment should be granted to the access providers. Such return should reflect the relevant market conditions and the different business models, such as those of providers of associated facilities. In this case, the access price offered may be considered fair and reasonable when providers offer only passive access to more than one electronic communications operator at comparable conditions.
Amendment 237 #
2023/0046(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point c a (new)
Article 3 – paragraph 2 – point c a (new)
(ca) any additional maintenance and adaptation costs deriving from providing access to the relevant infrastructure;
Amendment 253 #
2023/0046(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
4. Where public sector bodies that own or control physical infrastructure lack sufficient resources, experience or the necessary technical knowledge to engage in negotiations with operators on access, Member States mayshall establish a body to coordinate access requests to physical infrastructure owned or controlled by public sector bodies, provide legal and technical advice through the negotiation of access terms and conditions, and facilitate the provision of information via a single information point referred to in Article 10.
Amendment 265 #
2023/0046(COD)
Proposal for a regulation
Article 3 – paragraph 9
Article 3 – paragraph 9
9. After having consulted stakeholders, the national dispute settlement bodies and other competent Union bodies or agencies in the relevant sectors as appropriate, the Commission mayshall, in close cooperation with BEREC, provide guidance on the application of this Article by 6 months before the date of application of this Regulation. Such guidance should provide the appropriate level of granularity, including relevant specifities introduced at Member State level.
Amendment 286 #
2023/0046(COD)
Proposal for a regulation
Article 4 – paragraph 5
Article 4 – paragraph 5
5. Operators that obtain access to information pursuant to this Article shall take appropriate measures to ensure respect for confidentiality and operating and business secrets. Operators, to such purpose, shall sign a declaration to keep this information confidential and to use it only for the purpose of deploying its network.
Amendment 316 #
2023/0046(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Competent authorities shall not unduly restrict, hinder or make economically less attractive the deployment of any element of very high capacity networks or associated facilities. Member States shall ensure that any rules governing the conditions and procedures applicable for granting permits, including rights of way, required for the deployment of elements of very high capacity networks or associated facilities are consistent and, where applicable, harmonized across the national territory.
Amendment 336 #
2023/0046(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 1
Article 7 – paragraph 5 – subparagraph 1
The competent authorities shall grant or refuse permits, other than rights of way, within 42 months from the date of the receipt of a complete permit application.
Amendment 349 #
2023/0046(COD)
Proposal for a regulation
Article 7 – paragraph 5 – subparagraph 4
Article 7 – paragraph 5 – subparagraph 4
By way of exception and based on a justified reason set out by a Member State, the 42 month deadline referred to in the first subparagraph and in paragraph 6 may be extended by the competent authority on its own motion. Any extension shall be the shortest possible. Member States shall set out the reasons justifying such an extension, publish them in advance via single information points and notify them to the Commission.
Amendment 352 #
2023/0046(COD)
Proposal for a regulation
Article 7 – paragraph 6
Article 7 – paragraph 6
6. By way of derogation from Article 43(1), point (a) of Directive (EU) 2018/1972, where rights of way over or under public or private property are required for the deployment of elements of very high capacity networks or associated facilities in addition to permits, competent authorities shall grant or refuse such rights of way within the 42 month period from the date of receipt of the application.
Amendment 359 #
2023/0046(COD)
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
Amendment 367 #
2023/0046(COD)
Proposal for a regulation
Article 7 – paragraph 8
Article 7 – paragraph 8
8. The Commission shall, by means of an implementing act, specifyis empowered to adopt a delegated act in accordance with Article 13 to supplement this Regulation by specifying the minimum list of categories of deployment of elements of very high capacity networks or associated facilities that shall not be subject to any permit- granting procedure within the meaning of this Article. This implementing act shall be adopted in accordance with the examination procedure referred to in Article 13, without prejudice to additional exemptions that may be introduced by Member States. This delegated act shall be adopted by 6 months from the entry into force of this Regulation.
Amendment 381 #
2023/0046(COD)
Proposal for a regulation
Article 7 – paragraph 11 a (new)
Article 7 – paragraph 11 a (new)
11a. The procedure established in this article shall apply without prejudice to the provisions set out in Article 57 of the Directive (EU) 2018/1972.
Amendment 382 #
2023/0046(COD)
Proposal for a regulation
Article 7 – paragraph 11 b (new)
Article 7 – paragraph 11 b (new)
11b. Member States may maintain or introduce simplified authorization procedures or prior communications procedures, in accordance with Union legislation, where they serve to enable a more efficient deployment of new physical infrastructure for very high capacity network or associated facilities.
Amendment 444 #
2023/0046(COD)
Proposal for a regulation
Article 13 – title
Article 13 – title
13 CDelegated powers and committee procedure
Amendment 445 #
2023/0046(COD)
Proposal for a regulation
Article 13 a (new)
Article 13 a (new)
Article 13a Exercise of the delegation The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. The power to adopt delegated acts referred to in Article 7(8) shall be conferred on the Commission. The delegation of power referred to in Article 7(8) 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. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. A delegated act adopted pursuant to Article 7(8) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Amendment 449 #
2023/0046(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. By [DATE OF ENTRY INTO FORCE + 53 YEARS], the Commission shall present a report to the European Parliament and the Council on the implementation of this Regulation. The report shall include a summary of the impact of the measures set out in this Regulation and an assessment of the progress towards achieving its objectives, including whether and how the Regulation could further contribute to achieving the connectivity targets set out in the Decision establishing the Digital Decade Policy Programme 2030.
Amendment 111 #
2022/0396(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In line with the waste hierarchy set out in Article 4(2) of Directive 2008/98/EC, and in line with life-cycle thinking to deliver the best overall environmental outcome, the measures provided for under this Regulation aim at reducing the amount of packaging placed on the market in terms of its volume and weight, and preventing the generation of packaging waste, especially through packaging minimisation, avoiding packaging where it is not needed, and increased re-use of packaging, when it can be demonstrated that re-usable packaging achieves higher environmental benefits compared to single-use packaging. In addition, the measures aim at increasing the use of recycled content in packaging, especially in plastic packaging where the uptake of recycled content is very low, as well as higher recycling rates for all packaging and high quality of the resulting secondary raw materials while reducing other forms of recovery and final disposal.
Amendment 134 #
2022/0396(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) In order to prevent barriers to the internal market and ensure the efficient implementation of the obligations, economic operators should ensure that the plastic part of each unitbatch of packaging contains a certain minimum percentage of recycled content recovered from post- consumer plastic waste.
Amendment 142 #
2022/0396(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) For limited packaging applicationsThere is a demonstrable environmental benefit of using compostable packaging for specific packaging applications, in particular those strictly linked to food and food waste prevention, made of biodegradable plastic polymers, there is a demonstrable environmental benefit of using compostable packaging, which enters composting plants, including anaerobic digestion facilities under controlled conditions. Furthermore, where appropriate waste collection schemes and waste treatment infrastructures are available in a Member State, there should be a limited flexibility in deciding whether to mandate the use of compostable plastics for lightweight plastic carrier bags on its territory. In order to avoid consumer confusion about the correct disposal and considering the environmental benefit of circularity of the carbon, all other plastic packaging should go into material recycling and the design of such packaging should ensure that it does not affect the recyclability of other waste streams.
Amendment 163 #
2022/0396(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) In orderPackaging should contribute to ensure a high level of environmental protection in the internal market, as well as a high level of food safety and hygiene, food waste prevention and comply with the EU food traceability requirements and facilitate the achievement of the packaging waste prevention targets, u. Unnecessary or avoidable packaging that do not contribute to these aims should not be allowed to be placed on the market. The list of such packaging formats is provided in Annex V of this Regulation. In order to adapt the list to the technical and scientific progress the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the list.
Amendment 182 #
2022/0396(COD)
Proposal for a regulation
Recital 90
Recital 90
(90) Waste prevention is the most efficient way to improve resource efficiency and to reduce the environmental impact of waste. It is important therefore that economic operators take appropriate measures to reduce the waste generation by eliminating excessive packaging and restrict the uses of certain packaging formats, extending the life span of packaging, re-designing products so that no packaging or less packaging can be used, including bulk sales, and by shifting from single use packaging to reusable packaging. The Commission should assess the link between these measures and the setting of EU food waste reduction targets.
Amendment 187 #
2022/0396(COD)
Proposal for a regulation
Recital 100
Recital 100
(100) Member States shouldmay set up return and collection systems for packaging waste, so that they are channelled to the most appropriate waste management alternative, according to the waste hierarchy. The systems should be open for participation for all interested parties, in particular for economic operators and public authorities and be established taking into account the environment and consumer health, safety and hygiene. Return and collection systems should also be applicable for packaging of imported products under non-discriminatory provisions.
Amendment 191 #
2022/0396(COD)
Proposal for a regulation
Recital 102
Recital 102
(102) It has been shown that well- functioning dDeposit and return systems may ensure a very high collection rate, especially of beverage bottles and cans. In order to support the achievement of the separate collection target for single use plastic beverage bottles laid down in Directive (EU) 2019/904 and to further drive high collection rates of metal beverages containers, it is appropriate that Member States may establish deposit and return systems. Those systems willmay contribute to the increase of the supply of good quality secondary raw material suitable for closed loop recycling and reduce beverage containers litter.
Amendment 193 #
2022/0396(COD)
Proposal for a regulation
Recital 103
Recital 103
(103) Deposit and return systems should be obligatory for single use plastic beverage bottles and metal beverage containers. Member States might also decide to include other packaging in these systems, in particular single use glass bottles, and should ensure that deposit and return systems for single-use packaging formats, in particular for single use glass beverage bottles, are equally available for reusable packaging, where technically and economically feasible. They should consider establishing deposit and return systems also for reusable packaging. In such situations, a Member State should be allowed, while observing the general rules laid down in the Treaty and complying with the provisions set out in this Regulation, adopt provisions which go beyond the minimum requirements set out in this Regulation.
Amendment 204 #
2022/0396(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes requirements for the entire life cycle of packaging as regards environmental sustainability and labelling, to allow its placing on the market, as well as for the extended producer responsibility, prevention, collection, treatment and recycling of packaging waste.
Amendment 227 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 29 a (new)
Article 3 – paragraph 1 – point 29 a (new)
(29a) 'traceability' means the ability to trace and follow a food, feed, food- producing animal or substance intended to be , or expected to be incorporated into a food or feed, through all stages of production, processing and distribution;
Amendment 250 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 41
Article 3 – paragraph 1 – point 41
(41) ‘compostable packaging’ means packaging capable of undergoing physical, chemical, thermal or biological decomposition such that most of the finished compost ultimately decomposes into carbon dioxide, mineral salts, biomass and water, according to Article 47(4), and does not hinder the separate collection and the composting process or activity into which it is introduced in industrially controlled conditions in accordance with European harmonised standards for packaging recoverable through composting and anaerobic digestion;
Amendment 252 #
2022/0396(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In line with the waste hierarchy set out in Article 4(2) of Directive 2008/98/EC, and in line with life-cycle thinking to deliver the best overall environmental outcome, the measures provided for under this Regulation aim at reducing the amount of packaging placed on the market in terms of its volume and weight, and preventing the generation of packaging waste, especially through packaging minimisation, avoiding packaging where it is not needed, and increased re-use of packaging, when it can be demonstrated that re-usable packaging achieves higher environmental benefits compared to single-use packaging . In addition, the measures aim at increasing the use of recycled content in packaging, especially in plastic packaging where the uptake of recycled content is very low, as well as higher recycling rates for all packaging and high quality of the resulting secondary raw materials while reducing other forms of recovery and final disposal.
Amendment 273 #
2022/0396(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) Food packaging materials represent a positive contribution to the prevention of food loss and food waste along the supply chain, for example packaging that reduces food loss in transport, storage and distribution, and that preserves the quality and hygiene of food for longer, or that extends shelf life.
Amendment 278 #
2022/0396(COD)
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) Fostering a sustainable bio- economy can contribute to decreasing Europe's dependence on imported raw materials. Improving market conditions for bio-based recyclable packaging and compostable biodegradable packaging and reviewing existing law hampering the use of those materials offers the opportunity to stimulate further research and innovation and to substitute fossil fuel-based feedstocks with renewable sources for the production of packaging, where beneficial from a lifecycle perspective, and support further organic recycling.
Amendment 288 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. All packagingFrom 1st January 2030, all packaging placed on the market shall be recyclable.
Amendment 291 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point a
Article 6 – paragraph 2 – subparagraph 1 – point a
(a) it is designed for recycling or for compostable packaging is compliant with point a), b), c) of Annex III;
Amendment 308 #
2022/0396(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) In order to establish harmonised rules on packaging design to ensure its recyclability, without compromising its functionality, the power to adopt delegated acts should be delegated to the Commission to set out detailed criteria for packaging design for recycling per packaging materials and categories, as well as for the assessment of the packaging recyclability at scale including for categories of packaging not listed in this Regulation. In order to give economic operators and Member States sufficient time to collect and report the necessary data to establish the “at scale” recycling methodology, the manufacturers should ensure that packaging is recycled at scale as of 2035. That should ensure that packaging complies with the design for recycling criteria, and is also recycled in practice on the basis of the state of the art processes for separate collection, sorting and recycling.
Amendment 343 #
2022/0396(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) In order to prevent barriers to the internal market and ensure the efficient implementation of the obligations, economic operators should ensure that the plastic part of each unitbatch of packaging contains a certain minimum percentage of recycled content recovered from post- consumer plastic waste.
Amendment 356 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. From 1 January 2030, the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unitbatch of packaging:
Amendment 362 #
2022/0396(COD)
Proposal for a regulation
Recital 35
Recital 35
(35) The bio-waste waste stream is often contaminated with conventional plastics and the material recycling streams are often contaminated with compostable plastics. This cross-contamination leads to waste of resources, lower quality secondary raw materials and should be prevented at source. As the proper disposal route for compostable plastic packaging is becoming increasingly confusing for consumers, it is justified and necessary to lay down clear and common rules on the use of compostable plastic packaging, mandating it only when its use brings a clear benefit for the environment or for human health. This is particularly the case when the use of compostable packaging helps collect or dispose of bio-waste. This contamination leads to environmental and economic impacts and waste of resources and should be prevented at source. Mandating compostable plastic packaging for applications strictly linked to food and food waste, may help to reduce this contamination. Therefore, , it is justified and necessary to lay down clear and common rules on the use of compostable plastic packaging, mandating it only when its use brings a clear benefit for the environment or for human health. This is particularly the case when the use of compostable packaging helps collect or dispose of bio-waste. The EN 13432 standard “Packaging - Requirements for packaging recoverable through composting and biodegradation" specifies requirements and procedures to determine the compostability and anaerobic treatability of packaging and packaging materials in industrial controlled conditions and should represent the harmonised specification of what packaging can be considered compostable and biodegradable across Member States.
Amendment 371 #
2022/0396(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) For limited packaging applications made of biodegradable plastic polymersThere is a demonstrable environmental benefit of using compostable packaging for specific packaging applications, in particular those strictly linked to food and food waste prevention, , there is a demonstrable environmental benefit of using compostable packaging, which enters composting plants, including anaerobic digestion facilities under controlled conditions. Furthermore, where appropriate waste collection schemes and waste treatment infrastructures are available in a Member State, there should be a limited flexibility in deciding whether to mandate the use of compostable plastics for lightweight plastic carrier bags on its territory. In order to avoid consumer confusion about the correct disposal and considering the environmental benefit of circularity of the carbon, all other plastic packaging should go into material recycling and the design of such packaging should ensure that it does not affect the recyclability of other waste streams.
Amendment 375 #
2022/0396(COD)
2. From 1 January 2040, the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unitbatch of packaging:
Amendment 392 #
2022/0396(COD)
Proposal for a regulation
Recital 40
Recital 40
(40) Packaging should be designed so as to minimise its volume and weight while maintaining its ability to perform the packaging functions. The manufacturer of packaging should assess the packaging against the performance criteria, as listed in Annex IV of this Regulation. In view of the objective of this Regulation to reduce packaging and packaging waste generation and to improve circularity of packaging across the internal market, it is appropriate to further specify the existing criteria and to make them more stringent. The list of the packaging performance criteria, as listed in the existing harmonised standard EN 13428:200057, should therefore be modified. While marketing and consumer acceptance remain relevant for packaging design, they should not be part of performance criteria justifying on their own additional packaging weight and volume. However, this should not compromise product and packagingspecifications for craft and industrial products and food and agricultural products that are registered andEU geographical indications, and or otherwiseprotected byunder the Union intellectual property law or agreements between the EU and third countries which recogniseEU geographical indication protection schemes, as part of the Union’s objective to protect intellectual property,cultural heritage and traditional know-how. On the other hand, recyclability, the use of recycled content, and re-use may justify additional packaging weight or volume, and should be added to the performance criteria. Packaging with double walls, false bottoms and other characteristics only aimed to increase the perceived product volume should not be placed on the market, as it does not meet the requirement for packaging minimisation. The same rule should apply to superfluous packaging not necessary for ensuring packaging functionality. _________________ 57 Packaging – Requirements specific to manufacturing and composition – Prevention by source reduction.
Amendment 398 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 6
Article 7 – paragraph 6
6. By 1 January 2030, the financial contributions paid by producers to comply with their extended producer responsibility obligations as laid down in Article 40 shall be modulated based on the percentage of recycled content or bio-based content used in the packaging.
Amendment 408 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. By 31 December 2026, the Commission is empowered to adopt implementing acts establishing the methodology for the calculation and verification of the percentage of recycled content recovered from post-consumer plastic waste, per unitbatch of plastic packaging, and the format for the technical documentation referred to in Annex VII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 423 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 11 a (new)
Article 7 – paragraph 11 a (new)
11a. By 31 December 2026, the Commission shall publish a report assessing: (a) the possibility to introduce bio-based feedstock targets for plastic packaging, considering their potential contribution to meet the targets set out in Art. 7 (1) and (2); (b) sustainability requirements for bio- based feedstock; the Commission shall consider the existing sustainable criteria laid down in Art. 29 of Directive (EU) 2018/2001 - when assessing requirements for non fossil bio-based feedstock. 2. Based on the assessment set out in the report referred to in paragraph 1, the Commission is empowered to adopt delegated acts in accordance with Art. 58 to supplement this regulation in order to: (a) establish bio-based targets used in plastic packaging towards achievements of the recycled content targets under Art. 7 (1) and (2); (b) establish sustainability requirements for bio-based feedstock to be eligible to contribute towards the targets.
Amendment 425 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. By [OP: please insert the date = 24 months from the entry into force of this Regulation], packaging referred to in Article 3(1), points (f) and (g), sticky labels attached to fruit and vegetables and, very lightweight plastic carrier bags, bags for fruits and vegetables or for other food sold loose, required for hygiene reasons or where it is demonstrated that contribute to prevent food waste, shall be compostable in industrially controlled conditions in bio-waste treatment facilities.
Amendment 442 #
2022/0396(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) In orderPackaging should contribute to ensure a high level of environmental protection in the internal market, as well as a high level of food safety and hygiene, food waste prevention and comply with the EU food treceability requirements and facilitate the achievement of the packaging waste prevention targets, u. Unnecessary or avoidable packaging that do not contribute to these aims, should not be allowed to be placed on the market. The list of such packaging formats is provided in Annex V of this Regulation. In order to adapt the list to the technical and scientific progress the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the list.
Amendment 443 #
2022/0396(COD)
Proposal for a regulation
Recital 61 a (new)
Recital 61 a (new)
Amendment 488 #
2022/0396(COD)
Proposal for a regulation
Recital 90
Recital 90
(90) Waste prevention is the most efficient way to improve resource efficiency and to reduce the environmental impact of waste. It is important therefore that economic operators take appropriate measures to reduce the waste generation by eliminating excessive packaging and restrict the uses of certain packaging formats, extending the life span of packaging, re-designing products so that no packaging or less packaging can be used, including bulk sales, and by shifting from single use packaging to reusable packaging. The Commisison should assess the link between these measures and the setting of EU food waste reduction targets.
Amendment 518 #
2022/0396(COD)
Proposal for a regulation
Recital 100
Recital 100
(100) Member States shouldmay set up return and collection systems for packaging waste, so that they are channelled to the most appropriate waste management alternative, according to the waste hierarchy. The systems should be open for participation for all interested parties, in particular for economic operators and public authorities and be established taking into account the environment and consumer health, safety and hygiene. Return and collection systems should also be applicable for packaging of imported products under non-discriminatory provisions.
Amendment 525 #
2022/0396(COD)
Proposal for a regulation
Recital 102
Recital 102
(102) It has been shown that well- functioning dDeposit and return systems may ensure a very high collection rate, especially of beverage bottles and cans. In order to support the achievement of the separate collection target for single use plastic beverage bottles laid down in Directive (EU) 2019/904 and to further drive high collection rates of metal beverages containers, it is appropriate that Member States may establish deposit and return systems. Those systems willmay contribute to the increase of the supply of good quality secondary raw material suitable for closed loop recycling and reduce beverage containers litter.
Amendment 533 #
2022/0396(COD)
Proposal for a regulation
Recital 103
Recital 103
(103) Deposit and return systems should be obligatory for single use plastic beverage bottles and metal beverage containers. Member States might also decide to include other packaging in these systems, in particular single use glass bottles, and should ensure that deposit and return systems for single-use packaging formats, in particular for single use glass beverage bottles, are equally available for reusable packaging, where technically and economically feasible. They should consider establishing deposit and return systems also for reusable packaging. In such situations, a Member State should be allowed, while observing the general rules laid down in the Treaty and complying with the provisions set out in this Regulation, adopt provisions which go beyond the minimum requirements set out in this Regulation.
Amendment 554 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
Amendment 573 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
Amendment 575 #
2022/0396(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes requirements for the entire life cycle of packaging as regards environmental sustainability and labelling, to allow its placing on the market, as well as for the extended producer responsibility, prevention, collection, treatment and recycling of packaging waste.
Amendment 597 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 4 – introductory part
Article 26 – paragraph 4 – introductory part
4. The manufacturer and the final distributor making available on the market within the territory of a Member State in sales packaging alcoholic beverages in the form of beer, carbonated alcoholic beverages, fermented beverages other than wine, aromatised wine products and fruit wine, products based on spirit drinks, wine or other fermented beverages mixed with beverages, soda, cider or juice, shall ensure that:
Amendment 606 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 5
Article 26 – paragraph 5
Amendment 626 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 6 – introductory part
Article 26 – paragraph 6 – introductory part
6. The manufacturer and the final distributor making available on the market within the territory of a Member State in sales packaging non- alcoholic beverages in the form of water, water with added sugar, water with other sweetening matter, flavoured water, soft drinks, soda lemonade, iced tea and similar beverages which are immediately ready to drink, pure juice, juice or must of fruits or vegetables and smoothies without milk and non- alcoholic beverages containing milk fat, shall ensure that:
Amendment 668 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 29 a (new)
Article 3 – paragraph 1 – point 29 a (new)
(29a) 'traceability’ means the ability to trace and follow a food, feed, food- producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution;
Amendment 726 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 15 a (new)
Article 26 – paragraph 15 a (new)
15a. Member states will be exempted from the obligation under Paragraph 2, 3, 4 and 6 under the following conditions: (a) the rate of separate collection as required under Art. 43 (3), (4), (4b) of the respective packaging format as reported to the Commission under Art. 50 (1) point (c) is above 90% by weight of such packaging placed on the market on the territory of that Member State in the calendar years 2026 and 2027. Where such reporting has not yet been submitted to the Commission, the Member State shall provide a reasoned justification, based on validated national data, and description of the implemented measures, that the condition for the exemption set out in this paragraph are fulfilled; (b) at the latest 24 months before the deadline laid down in paragraph 2 and 3 of this article, the Member State notifies the Commission of its request for exemption and submits an implementation plan showing a strategy with concrete actions, including timeline that ensures the achievement of the 90% separate collection rate by weight of packaging
Amendment 753 #
2022/0396(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 41
Article 3 – paragraph 1 – point 41
(41) ‘compostable packaging’ means packaging capable of undergoing physical, chemical, thermal or biological decomposition such that most of the finished compost ultimately decomposes into carbon dioxide, mineral salts, biomass and water, according to Article 47(4), and does not hinder the separate collection and the composting process or activity into which it is introduced in industrially controlled conditions in accordance with European harmonised standards for packaging recoverable through composting and anaerobic digestion;
Amendment 861 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. All packagingFrom 1 January 2030, all packaging placed on the market shall be recyclable.
Amendment 872 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
1a. Member States shall endeavour to phase out the disposal of packaging waste compliant with Article 6(2).
Amendment 876 #
2022/0396(COD)
Proposal for a regulation
Article 6 – paragraph 2 – subparagraph 1 – point a
Article 6 – paragraph 2 – subparagraph 1 – point a
(a) it is designed for recycling; or for compostable packaging, is compliant with point a), b) and c) of Annex III
Amendment 1105 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. From 1 January 2030, the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unitbatch of packaging:
Amendment 1164 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 2 – introductory part
Article 7 – paragraph 2 – introductory part
2. From 1 January 2040, the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unitbatch of packaging:
Amendment 1243 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 6
Article 7 – paragraph 6
6. By 1 January 2030, the financial contributions paid by producers to comply with their extended producer responsibility obligations as laid down in Article 40 shall be modulated based on the percentage of recycled content or bio-based content used in the packaging.
Amendment 1265 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. By 31 December 2026, the Commission is empowered to adopt implementing acts establishing the methodology for the calculation and verification of the percentage of recycled content recovered from post-consumer plastic waste, per unitbatch of plastic packaging, and the format for the technical documentation referred to in Annex VII. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
Amendment 1331 #
2022/0396(COD)
Proposal for a regulation
Article 7 – paragraph 11 a (new)
Article 7 – paragraph 11 a (new)
11a. By 31 December 2026, the Commission shall publish a report assessing: (a) the possibility to introduce bio-based feedstock targets for plastic packaging, considering their potential contribution to meet the targets set out in Article 7(1) and (2); (b) sustainability requirements for bio- based feedstock;the Commission shall consider the existing sustainable criteria laid down in Article 29 of Directive (EU) 2018/2001 when assessing requirements for non-fossil bio-based feedstock. 2. Based on the assessment set out in the report referred to in paragraph 1, the Commission is empowered to adopt delegated acts in accordance with Article 58 to supplement this Regulation in order to: (a) establish bio-based targets used in plastic packaging towards achievements of the recycled content targets under Article 7(1) and (2); (b) establish sustainability requirements for bio-based feedstocks to be eligible to contribute towards the targets.
Amendment 1343 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. By [OP: please insert the date = 24 months from the entry into force of this Regulation], packaging referred to in Article 3(1), points (f) and (g), sticky labels attached to fruit and vegetables and, very lightweight plastic carrier bags, bags for fruits and vegetables or for other food sold loose, required for hygiene reasons or where it is demonstrated that contribute to prevent food waste, shall be compostable in industrially controlled conditions in bio-waste treatment facilities.
Amendment 1388 #
2022/0396(COD)
Proposal for a regulation
Article 8 – paragraph 5 a (new)
Article 8 – paragraph 5 a (new)
5a. The Commission shall, no later than 31 May 2026, request the European standardisation organisations to update the harmonised standard on the requirements for packaging recoverable through composting and biodegradation - test schemes and evaluation criteria. This standard shall consider the composting times, admissible levels of visual contamination and other requirements needed to reflect the actual conditions in the bio-waste treatment facilities, including anaerobic digestion processes, in line with the scientific and technological developments.
Amendment 1407 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Packaging shall be designed so that its weight and volume is reduced to the minimum necessary for ensuring its functionalitys, as laid down in Article 3 paragraph 1, taking account of the material that the packaging is made of.
Amendment 1418 #
2022/0396(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. Packaging not necessary to comply with any of the performance criteria set out in Annex IV and packaging with characteristics that are only aimed to increase the perceived volume of the product, including double walls, false bottoms, and unnecessary layers, shall not be placed on the market, unless the packaging design is subject to geographical indications of origin and/or intellectual property right protected under Union legislation.
Amendment 1703 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. EWithout prejudice to traceability requirements laid down in Article 18 of the Regulation n. 178/2002 1a,economic operators shall not place on the market packaging in the formats and for the purposes listed in Annex V. _________________ 1a Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002).
Amendment 1725 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 2 a (new)
Article 22 – paragraph 2 a (new)
2a. Without prejudice to Article 8 of this Regulation, economic operators shall not place on the market packaging in the formats and for the purposes listed in point 2 of Annex V as of 18 months after the adoption of the delegated act laid down in paragraph 2b
Amendment 1726 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 2 b (new)
Article 22 – paragraph 2 b (new)
Amendment 1741 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 3 a (new)
Article 22 – paragraph 3 a (new)
3a. By way of derogation from paragraph 1, economic operators are allowed to place on the market packaging in the formats and for the purposes listed in Annex V when such packaging corresponds to performance grade B or above, under the design for recycling criteria established for the packaging category to which it belongs
Amendment 1752 #
2022/0396(COD)
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
4. The Commission shall be empowered to adopt delegated acts in accordance with Article 58 to amend Annex V in order to adapt it to technical and scientific progress with the objective to reducing packaging waste. When adopting those delegated acts,By [OP: Please insert the date = 8 years after the date of entry into force of this Regulation] the Commission shall consider the potential of the restrictions on the use of specific packaging formats to reduce the packaging waste generated while ensuring an overall positive environmental impact, and shall take into account the availability of alternative packaging solutions that meet requirements set out in legislation applicable to contact sensitive packaging, as well as their capability to prevent microbiological contamination of the packaged product. To that end, the Commission shall submit a report to the European Parliament and to the Council, accompanied, if the Commission finds it appropriate, by a legislative proposal.
Amendment 1807 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
Amendment 1837 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
Amendment 1873 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 4 – introductory part
Article 26 – paragraph 4 – introductory part
4. The manufacturer and the final distributor making available on the market within the territory of a Member State in sales packaging alcoholic beverages in the form of beer, carbonated alcoholic beverages, fermented beverages other than wine, aromatised wine products and fruit wine, products based on spirit drinks, wine or other fermented beverages mixed with beverages, soda, cider or juice, shall ensure that:
Amendment 1887 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 5
Article 26 – paragraph 5
Amendment 1922 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 6 – introductory part
Article 26 – paragraph 6 – introductory part
6. The manufacturer and the final distributor making available on the market within the territory of a Member State in sales packaging non- alcoholic beverages in the form of water, water with added sugar, water with other sweetening matter, flavoured water, soft drinks, soda lemonade, iced tea and similar beverages which are immediately ready to drink, pure juice, juice or must of fruits or vegetables and smoothies without milk and non- alcoholic beverages containing milk fat, shall ensure that:
Amendment 2061 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 12 a (new)
Article 26 – paragraph 12 a (new)
12a. The packaging design subject to geographical indications of origin protected under Union legislation shall not comply with paragraphs 4 and 6 of this Article.
Amendment 2110 #
2022/0396(COD)
Proposal for a regulation
Article 26 – paragraph 15 a (new)
Article 26 – paragraph 15 a (new)
15a. Member States will be exempted from the obligation under paragraph 2, 3, 4 and 6 under the following conditions: (a) the rate of separate collection as required under Article 43(3), (4) (4b) of the respective packaging format as reported to the Commission under Article 50(1) point (c) is above 90 % by weight of such packaging placed on the market on the territory of that Member State in the calendar years 2026 and 2027. Where such reporting has not yet been submitted to the Commission, the Member State shall provide a reasoned justification, based on validated national data, and description of the implemented measures, that the conditions for the exemption set out in this paragraph are fulfilled; (b) at the latest 24 months before the deadline laid down in paragraphs 2 and 3 of this Article, the Member State notifies the Commission of its request for exemption and submits an implementation plan showing a strategy with concrete actions, including timeline that ensure the achievement of the 90 % separate collection rate by weight of the packaging
Amendment 125 #
2022/0272(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) It is necessary toCybersecurity is a key challenge for the European Union as the diffusion of products with digital elements is constantly rising. In this regard, cyberattacks are a matter of public interest as they can have a critical impact not only for the economy but also for consumers safety and health. It is therefore necessary to address cyber resilience at Union level and improve the functioning of the internal market by laying down a uniform legal framework for essential cybersecurity requirements for placing products with digital elements on the Union market. Two major problems adding costs for users and society should be addressed: a low level of cybersecurity of products with digital elements, reflected by widespread vulnerabilities and the insufficient and inconsistent provision of security updates to address them, and an insufficient understanding and access to information by users, preventing them from choosing products with adequate cybersecurity properties or using them in a secure manner.
Amendment 126 #
2022/0272(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) While the existing Union legislation applies to certain products with digital elements, there is no horizontal Union regulatory framework establishing comprehensive cybersecurity requirements for all products with digital elements. The various acts and initiatives taken thus far at Union and national levels only partially address the identified cybersecurity-related problems and risks, creating a legislative patchwork within the internal market, increasing legal uncertainty for both manufacturers and users of those products and adding an unnecessary burden on companies to comply with a number of requirements for similar types of products. The cybersecurity of these products has a particularly strong cross-border dimension, as products manufactured in one country are often used by organisations and consumers across the entire internal market. This makes it necessary to regulate the field at Union level. The Union regulatory landscape should be harmonised by introducing cybersecurity requirements for products with digital elements. In addition, certainty for operators and users should be ensured across the Union, as well as a better harmonisation of the single market, proportionality for micro, small and medium sized enterprises, thus creating more viable conditions for operators aiming at entering the Union market.
Amendment 135 #
2022/0272(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) In order not to hampeAs a crucial tool for innovation orand research, free and open-source software developed or supplied outside the course of a commercial activity should not be covered by this Regulation. This is in particular the case for software, including its source code and modified versions, that is openly shared and freely accessible, usable, modifiable and redistributable. In the context of software, a commercial activity might be characterized not only by: charging a price for a product, but also by; charging a price for technical support services, bywhen this does not serve only the recuperation of actual costs; providing a software platform through which the manufacturer monetises other services, or by; the use of personal data for reasons other than exclusively for improving the security, compatibility or interoperability of the software. The circumstances under which the product has been developed, or how the development has been financed should not be taken into account when determining the commercial or non- commercial nature of that activity. When free and open-source software, supplied outside of the course of a commercial activity, is integrated into a final product with digital elements made available on the market, the economic operator that has placed the relevant product on the market shall be responsible for the compliance both of the product and of the integrated open-source software, according to this Regulation.
Amendment 142 #
2022/0272(COD)
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) The lack of professional skills in the field of cybersecurity is a key issue to be tackled for the succesful application of this Regulation. Therefore, in line with the European Commission Communication "Closing the cybersecurity talent gap to boost the EU's competitiveness, growth and resilience ('The Cybersecurity Skills Academy')", specific measures both at EU and Member States level should be put in place to assess the state and the evolution of cybersecurity labour market and create a single point of entry and synergies for cybersecurity education and training offers with the aim of establishing a common EU approach to cybersecurity training.
Amendment 144 #
2022/0272(COD)
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) This Regulation should not apply to spare parts that are exclusively manufactured in order to repair and update products with digital elements that have been placed on the market before the application date of this Regulation.
Amendment 146 #
2022/0272(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) Certain tasks provided for in this Regulation should be carried out by ENISA, in accordance with Article 3(2) of Regulation (EU) 2019/881. In particular, ENISA should receive notifications from manufacturers of actively exploited vulnerabilities contained in products with digital elements, as well as incidents having an impact on the security of those products. ENISA should also forward these notifications to the relevant Computer Security Incident Response Teams (CSIRTs) or, respectively, to the relevant single points of contact of the Member States designated in accordance with Article [Article X] of Directive [Directive XXX / XXXX (NIS2)], and inform the relevant market surveillance authorities about the notified vulnerability. ENISA should ensure the confidentiality of these notifications with particular regard to vulnerabilities for which a security update is not yet available. On the basis of the information it gathers, ENISA should prepare a biennial technical report on emerging trends regarding cybersecurity risks in products with digital elements and submit it to the Cooperation Group referred to in Directive [Directive XXX / XXXX (NIS2)]. Furthermore, considering its expertise and mandate, ENISA should be able to support the process for implementation of this Regulation. In particular, it should be able to propose joint activities to be conducted by market surveillance authorities based on indications or information regarding potential non-compliance with this Regulation of products with digital elements across several Member States or identify categories of products for which simultaneous coordinated control actions should be organised. In exceptional circumstances, at the request of the Commission, ENISA should be able to conduct evaluations in respect of specific products with digital elements that present a significant cybersecurity risk, where an immediate intervention is required to preserve the good functioning of the internal market.
Amendment 174 #
2022/0272(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to facilitate assessment of conformity with the requirements laid down by this Regulation, there should be a presumption of conformity for products with digital elements which are in conformity with harmonised horizontal or domain specific standards, which translate the essential requirements of this Regulation into detailed technical specifications, and which are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council29. Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised standards where those standards do not entirely satisfy the requirements of this Regulation. _________________ 29 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
Amendment 180 #
2022/0272(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) Where no harmonised standards are adopted, and after taking in due consideration widely accepted international standards, or where the harmonised standards do not sufficiently address the essential requirements of this Regulation, the Commission should be able to adopt common specifications by means of implementingdelegated acts. Reasons for developing such common specifications, instead of relying on harmonised standards, might include a refusal of the standardisation request by any of the European standardisation organisations, undue delays in the establishment of appropriate harmonised standards, or a lack of compliance of developed standards with the requirements of this Regulation or with a request of the Commission. In order to facilitate assessment of conformity with the essential requirements laid down by this Regulation, there should be a presumption of conformity for products with digital elements that are in conformity with the common specifications adopted by the Commission according to this Regulation for the purpose of expressing detailed technical specifications of those requirements.
Amendment 183 #
2022/0272(COD)
Proposal for a regulation
Recital 53
Recital 53
(53) In the interests of competitiveness, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burden for economic operators, in particular for micro, small, medium sized enterprises. In this regard, Member States, with the support of the Commission, should ensure that there is an adequate availability of cybersecurity skilled professionals in order to ensure that notified bodies can carry out their activities efficiently thus facilitating economic operators' compliance to this Regulation. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That should be best achieved through appropriate coordination and cooperation between notified bodies.
Amendment 187 #
2022/0272(COD)
Proposal for a regulation
Recital 57 a (new)
Recital 57 a (new)
(57a) In this framework, in order to provide updated information on the cyber security of critical products with digital elements, as defined in Annex III, the Commission should consider the adoption of measures aimed at informing the market on products that, according to Article 10 (6) of this Regulation, will not receive any further cyber security management.
Amendment 188 #
2022/0272(COD)
Proposal for a regulation
Recital 61
Recital 61
(61) Simultaneous coordinated control actions (‘sweeps’) are specific enforcement actions by market surveillance authorities that can further enhance product security. Sweeps should, in particular, be conducted where market trends, consumer complaints or other indications suggest that certain product categories are often found to present cybersecurity risks. ENISA should submit proposals for categories of products for which sweeps could be organised to the market surveillance authorities, based, among others, on the notifications of product vulnerabilities and incidents it receives. ENISA should also coordinate national market surveillance authorities for regular checks of products with digital elements placed on the market by manufacturers that might present a security risk for the EU, with particular regard to identifying exploitable vulnerabilities.
Amendment 189 #
2022/0272(COD)
Proposal for a regulation
Recital 62
Recital 62
(62) In order to ensure that the regulatory framework can be adapted where necessary, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of updates to the list of critical products in Annex III and specifying the definitions of the these product categories. Power to adopt acts in accordance with that Article should be delegated to the Commission to identify products with digital elements covered by other Union rules which achieve the same level of protection as this Regulation, specifying whether a limitation or exclusion from the scope of this Regulation would be necessary as well as the scope of that limitation, if applicable. Power to adopt acts in accordance with that Article should also be delegated to the Commission in respect of the potential mandating of certification of certain highly critical products with digital elements based on criticality crieria set out in this Regulation, as well as for specifying the minimum content of the EU declaration of conformity and supplementing the elements to be included in the technical documentation. Powers to adopt acts should also be delegated to the Commission to specify the format and elements of the software bill of materials, specify further the type of information, format and procedure of the notifications on actively exploited vulnerabilities and incidents submitted to ENISA by manufacturers. The Commission is also empowered to adopt delegated acts to establish common specifications in respect of the essential requirements set out in Annex I. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making33. 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. _________________ 33 OJ L 123, 12.5.2016, p. 1.
Amendment 191 #
2022/0272(COD)
Proposal for a regulation
Recital 63
Recital 63
(63) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to: specify the format and elements of the software bill of materials, specify further the type of information, format and procedure of the notifications on actively exploited vulnerabilities and incidents submitted to ENISA by the manufacturers, specify the European cybersecurity certification schemes adopted pursuant to Regulation (EU) 2019/881 that can be used to demonstrate conformity with the essential requirements or parts therefore as set out in Annex I of this Regulation, adopt common specifications in respect of the essential requirements set out in Annex I, lay down technical specifications for pictograms or any other marks related to the security of the products with digital elements, and mechanisms to promote their use, decide on corrective or restrictive measures at Union level in exceptional circumstances which justify an immediate intervention to preserve the good functioning of the internal market. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council34. _________________ 34 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p.13).
Amendment 195 #
2022/0272(COD)
Proposal for a regulation
Recital 65
Recital 65
(65) In order to ensure effective enforcement of the obligations laid down in this Regulation, each market surveillance authority should have the power to impose or request the imposition of administrative fines. Maximum levels for administrative fines to be provided for in national laws for non-compliance with the obligations laid down in this Regulation should therefore be established. When deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation should be taken into account, notably the economic operator's size, whether it is a micro, small or medium sized enterprise, and as a minimum thosee circumstances explicitly established in this Regulation, including whether administrative fines have been already applied by other market surveillance authorities to the same operator for similar infringements. Such circumstances can be either aggravating, in situations where the infringement by the same operator persists on the territory of other Member States than the one where an administrative fine has already been applied, or mitigating, in ensuring that any other administrative fine considered by another market surveillance authority for the same economic operator or the same type of breach should already take account, along with other relevant specific circumstances, of a penalty and the quantum thereof imposed in other Member States. In all such cases, the cumulative administrative fine that could be applied by market surveillance authorities of several Member States to the same economic operator for the same type of infringement should ensure the respect of the principle of proportionality.
Amendment 196 #
2022/0272(COD)
Proposal for a regulation
Recital 66 a (new)
Recital 66 a (new)
(66a) The revenues generated from the payments of penalties should be used to strengthen the level of cybersecurity within the Union, including by developing capacity and skills related to cybersecurity, improving economic operators' cyber resilience, in particular of micro, small and medium sized enterprises and more in general fostering public awareness of cyber security issues.
Amendment 198 #
2022/0272(COD)
Proposal for a regulation
Recital 69
Recital 69
(69) Economic operators should be provided with a sufficient time to adapt to the requirements of this Regulation. This Regulation should apply [2430 months] from its entry into force, with the exception of the reporting obligations concerning actively exploited vulnerabilities and incidents, which should apply [12 months] from the entry into force of this Regulation.
Amendment 205 #
2022/0272(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point d
Article 1 – paragraph 1 – point d
(d) rules on market monitoring, surveillance and enforcement of the above- mentioned rules and requirements.
Amendment 208 #
2022/0272(COD)
Proposal for a regulation
Article 2 – paragraph 1
Article 2 – paragraph 1
1. This Regulation applies to products with digital elements whose intended or reasonably foreseeable use includesthat have a direct or indirect logical or physical data connection to an external device or network.
Amendment 213 #
2022/0272(COD)
4a. This regulation does not apply to spare parts that are exclusively manufactured in order to repair products with digital elements that have been placed on the market before the application date of this regulation referred to in Article 57.
Amendment 233 #
2022/0272(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 21 a (new)
Article 3 – paragraph 1 – point 21 a (new)
(21a) 'consumer' means any natural person who, under the circumstances of this Regulation, is acting for purposes which are outside their trade, business, craft or profession.
Amendment 239 #
2022/0272(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 31
Article 3 – paragraph 1 – point 31
(31) ‘substantial modification’ means a change or a series of changes to the product with digital elements following its placing on the market, which affects the compliance of the product with digital elements with the essential requirements set out in Section 1 of Annex I or results in a modification to the intended use for which the product with digital elements has been assessed;
Amendment 256 #
2022/0272(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Products with digital elements that belong to a category which is listed in Annex III shall be considered critical products with digital elements. POnly products which have the core functionality of a category that is listed in Annex III to this Regulation shall be considered as falling into that category. Categories of critical products with digital elements shall be divided into class I and class II as set out in Annex III, reflecting the level of cybersecurity risk related to these products. The integration of a component of higher class of criticality does not change the level of criticality for the product the component is integrated into.
Amendment 261 #
2022/0272(COD)
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Commission is empowered to adopt a delegated act in accordance with Article 50 to supplement this Regulation by specifying the definitions of the product categories under class I and class II as set out in Annex III. The delegated act shall be adopted [by 129 months since the entry into force of this Regulation].
Amendment 266 #
2022/0272(COD)
Proposal for a regulation
Article 6 – paragraph 5 – introductory part
Article 6 – paragraph 5 – introductory part
5. The Commission is empowered to adopt delegated acts in accordance with Article 50 to supplement this Regulation by specifying categories of highly critical products with digital elements for which the manufacturers shall be required to obtain a European cybersecurity certificate under a European cybersecurity certification scheme at assurance level "high" pursuant to Regulation (EU) 2019/881 to demonstrate conformity with the essential requirements set out in Annex I, or parts thereof. When determining such categories of highly critical products with digital elements, the Commission shall take into account the level of cybersecurity risk related to the category of products with digital elements, in light of one or several of the criteria listed in paragraph 2, as well as in view of the assessment of whether that category of products is:
Amendment 267 #
2022/0272(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1 (new)
Article 9 – paragraph 1 – subparagraph 1 (new)
Internal networks of a machinery product with digital elements are not subject to this Regulation when they are secured via dedicated endpoints and isolated from external networks, and where the manufacturer assess and indicate the intended final use of the component for the sole internal operations and communication.
Amendment 273 #
2022/0272(COD)
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. For the purposes of complying with the obligation laid down in paragraph 1, manufacturers shall exercise due diligence when integrating components sourced from third parties in products with digital elements, including when they integrate components of open-source software that have not been supplied in the course of a commercial activity. They shall ensure that such components do not compromise the security of the product with digital elements.
Amendment 281 #
2022/0272(COD)
Proposal for a regulation
Article 10 – paragraph 6 – subparagraph 1
Article 10 – paragraph 6 – subparagraph 1
When placing a product with digital elements on the market, and for the expected product lifetime or for a period of five years from the placing of the product on the market, whichever is shorter, manufacturers shall ensure that vulnerabilities of that product are handled effectively and in accordance with the essential requirements set out in Section 2 of Annex I. Where applicable, the expected product lifetime shall be stated on the product or be included in contractual agreements.
Amendment 285 #
2022/0272(COD)
Proposal for a regulation
Article 10 – paragraph 8
Article 10 – paragraph 8
8. Manufacturers shall keep the technical documentation and the EU declaration of conformity, where relevant, at the disposal of the market surveillance authorities for ten years, or for the expected product lifetime, whichever is longer, after the product with digital elements has been placed on the market.
Amendment 289 #
2022/0272(COD)
Proposal for a regulation
Article 10 – paragraph 9
Article 10 – paragraph 9
9. Manufacturers shall ensure that procedures are in place for products with digital elements that are part of a series of production to remain in conformity. The manufacturer shall adequately take into account changes in the development and production process or in the design or characteristics of the product with digital elements and changes in the harmonised horizontal or domain specific standards, European cybersecurity certification schemes or the common specifications referred to in Article 19 by reference to which the conformity of the product with digital elements is declared or by application of which its conformity is verified.
Amendment 295 #
2022/0272(COD)
Proposal for a regulation
Article 10 – paragraph 12
Article 10 – paragraph 12
12. From the placing on the market and for the expected product lifetime or for a period of five years after the placing on the market of a product with digital elements, whichever is shorter, manufacturers who know or have reason to believe that the product with digital elements or the processes put in place by the manufacturer are not in conformity with the essential requirements set out in Annex I shall immediately take the corrective measures necessary to bring that product with digital elements or the manufacturer’s processes into conformity, to withdraw or to recall the product, as appropriate.
Amendment 303 #
2022/0272(COD)
Proposal for a regulation
Article 10 – paragraph 15
Article 10 – paragraph 15
15. The Commission may, by means of implementingdelegated acts, specify the format and elements of the software bill of materials set out in Section 2, point (1), of Annex I. Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 51(2)0.
Amendment 333 #
2022/0272(COD)
Proposal for a regulation
Article 11 – paragraph 5
Article 11 – paragraph 5
5. The Commission may, by means of implementing acts, specify furtheris empowered to adopt delegated acts, in accordance with Article 50, to further specify the type of information, format and procedure of the notifications submitted pursuant to paragraphs 1 and 2. Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 51(2)within 9 months of entry into force of this Regulation.
Amendment 360 #
2022/0272(COD)
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
A natural or legal person, other than the manufacturer, the importer or the distributor, that carries out a substantial modification of the product with digital elements, making it available on the market, shall be considered a manufacturer for the purposes of this Regulation.
Amendment 370 #
2022/0272(COD)
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
Where harmonised standards referred to in Article 18 do not exist or where the Commission considers that the relevant harmonised standards are insufficient to satisfy the requirements of this Regulation or to comply with the standardisation request of the Commission, or where there are undue delays in the standardisation procedure or where the request for harmonised standards by the Commission has not been accepted by the European standardisation organisations, the Commission is empowered, by means of implementdelegated acts, ing actscordance with Article 50, to adopt common specifications in respect of the essential requirements set out in Annex I. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 51(2) for products within the scope of this Regulation.
Amendment 371 #
2022/0272(COD)
Proposal for a regulation
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The technical documentation shall be drawn up before the product with digital elements is placed on the market and shall be continuously updated, where appropriate, during the expected product lifetime or during a period of five years after the placing on the market of a product with digital elements, whichever is shorter.
Amendment 374 #
2022/0272(COD)
Proposal for a regulation
Article 23 – paragraph 5
Article 23 – paragraph 5
5. The Commission is empowered to adopt delegated acts in accordance with Article 50 to supplement this Regulation by the elements to be included in the technical documentation set out in Annex V to take account of technological developments, of the dimension of economic operators with particular regard to micro, small and medium sized enterprises, as well as developments encountered in the implementation process of this Regulation.
Amendment 385 #
2022/0272(COD)
Proposal for a regulation
Article 24 – paragraph 5
Article 24 – paragraph 5
5. Notified bodies shall take into account the specific interests and needs of micro, small and medium sized enterprises (SMEs) when setting the fees for conformity assessment procedures and reduce those fees proportionately to their specific interests and needs.
Amendment 389 #
2022/0272(COD)
Proposal for a regulation
Article 29 – paragraph 7 a (new)
Article 29 – paragraph 7 a (new)
7a. Member States shall put in place appropriate measures to ensure sufficient availability of skilled professionals, in order to minimise bottlenecks in the assessment activities and facilitate the compliance of economic operators to this Regulation.
Amendment 390 #
2022/0272(COD)
Proposal for a regulation
Article 29 – paragraph 12
Article 29 – paragraph 12
12. Conformity assessment bodies shall operate in accordance with a set of consistent, fair and reasonable terms and conditions, in particular taking into account the interests of SMEmicro, small and medium sized enterprises in relation to fees.
Amendment 398 #
2022/0272(COD)
Proposal for a regulation
Article 41 – paragraph 6
Article 41 – paragraph 6
6. Member States shall ensure that the designated market surveillance authorities are provided with adequate financial and human resources, with appropriate cybersecurity skills, in order to fulfil their tasks under this Regulation.
Amendment 437 #
2022/0272(COD)
Proposal for a regulation
Article 50 – paragraph 2
Article 50 – paragraph 2
2. The power to adopt delegated acts referred to in Article 2(4), Article 6(2), Article 6(3), Article 6(5), Article 10 (15), Article 11(5), Article 19 (1), Article 20(5), and Article 23(5) shall be conferred on the Commission.
Amendment 438 #
2022/0272(COD)
Proposal for a regulation
Article 50 – paragraph 3
Article 50 – paragraph 3
3. The delegation of power referred to in Article 2(4), Article 6(2), Article 6(3), Article 6(5), Article 10(15), Article 11 (5), Article 19(1), Article 20(5), and Article 23(5) 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 448 #
2022/0272(COD)
Proposal for a regulation
Article 53 a (new)
Article 53 a (new)
Article53a Allocation of penalties Member States shall determine the use of revenues generated from the payments of penalties. At least 50% of the revenues generated from the payments of penalties referred to in Article 53 (1) should be earmarked for one or more of the following: (i) increasing the number of skilled professionals in the field of cybersecurity, notably of women; (ii) capacity-building for micro, small and medium sized enterprises in order to facilitate their compliance with this Regulation; (iii) improving public awareness of cyber threats, with particular regard to their prevention and management;
Amendment 457 #
2022/0272(COD)
Proposal for a regulation
Article 57 – paragraph 2
Article 57 – paragraph 2
It shall apply from [2430 months after the date of entry into force of this Regulation]. However Article 11 shall apply from [12 months after the date of entry into force of this Regulation].
Amendment 466 #
2022/0272(COD)
Proposal for a regulation
Annex I – Part 1 – point 3 – point a
Annex I – Part 1 – point 3 – point a
(a) be delivered with a secure by default configuration, including the possibility to reset the product to its original state, while safeguarding its security;
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.