BETA

Activities of Kristoffer STORM

Plenary speeches (3)

Ensuring sustainable, decent and affordable housing in Europe - encouraging investment, private property and public housing programmes (debate)
2024/10/09
State sponsored terrorism by the Islamic Republic of Iran in light of the recent attacks in Europe (debate)
2024/10/22
EU-US relations in light of the outcome of the US presidential elections (debate)
2024/11/13

Major interpellations (1)

EU funding of physical border protection structures such as walls, fences or other barriers at the external border
2024/09/20
Documents: PDF(65 KB) DOC(11 KB)

Written questions (6)

EU funding of physical border protection structures such as walls, fences or other barriers
2024/08/19
Documents: PDF(66 KB) DOC(12 KB)
The EU is increasing aid payments despite promoting Palestinian terror
2024/09/04
Documents: PDF(59 KB) DOC(12 KB)
European Court of Auditors – unclear green spending under RRF funds
2024/09/26
Documents: PDF(55 KB) DOC(11 KB)
Denmark’s interpretation of the Energy Taxation Directive
2024/10/04
Documents: PDF(50 KB) DOC(10 KB)
Directive on work-life balance for parents and carers, and its application to self-employed persons and small business owners
2024/11/14
Documents: PDF(50 KB) DOC(10 KB)
Consequences of imposing greenhouse gas emissions tax on Danish farmers
2024/12/02
Documents: PDF(52 KB) DOC(10 KB)

Individual motions (1)

MOTION FOR A RESOLUTION on enabling Member States to opt-out of EU migration policy
2024/10/10
Documents: PDF(136 KB) DOC(44 KB)

Amendments (42)

Amendment 1 #

2024/2030(DEC)

Draft opinion
Paragraph 1
1. Welcomes the constructive cooperation between the European Parliament and the European Centre for Disease Prevention and Control (ECDC), the European Chemicals Agency (ECHA), the European Environment Agency (EEA), the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) (the Agencies), illustrated, inter alia, by the annual exchanges of views that took place in 2023 in the Committee on the Environment, Public Health and Food Safety (ENVI); calls for the consolidation of overlapping functions among the Agencies to reduce redundancies, streamline operations, and ensure that resources are directed towards core functions that provide tangible value to EU citizens in the area of environmental, public health, and food safety objectives;
2024/12/11
Committee: ENVI
Amendment 5 #

2024/2030(DEC)

Draft opinion
Paragraph 3
3. Expresses its satisfaction that the European Court of Auditors (ECA) has declared the transactions of the Agencies underlying the annual accounts for the financial year 2023 to be legal and regular in all material respects, and that their financial position, at 31 December 2023, is fairly represented in all material respects; requires the Agencies to adopt zero-based budgeting practices, ensuring that every expense is justified from the ground up, and calls for a significant reduction in administrative costs to focus funding on essential activities such as environmental, public health, and food safety objectives;
2024/12/11
Committee: ENVI
Amendment 7 #

2024/2030(DEC)

Draft opinion
Paragraph 4
4. Welcomes the measures taken by the aAgencies in light of the European Parliament recommendations in its discharge for the financial year 2022; stresses the importance of increasing the Agencies’ efforts in terms of cooperation with other agencies and international organisations, digitalisation, and gender and geographical balance in senior management positions; proposes a comprehensive audit of the Agencies to identify and eliminate non-essential activities, ensuring that resources are concentrated on critical areas of public health, safety, and environmental protection; recommends that appointments to senior management positions in the Agencies be based on merit and expertise, ensuring optimal performance, while remaining unbiased with regard to gender;
2024/12/11
Committee: ENVI
Amendment 9 #

2024/2030(DEC)

Draft opinion
Paragraph 5
5. Welcomes the fact that the Agencies took effective corrective actions following most of the 2022 observations from the ECA; takes note of 2023 observations for the Agencies, in particular observations related to ex-ante checks, and calls on them to ensure an effective follow- up.; demands that Agencies failing to implement corrective actions within stipulated timelines face reductions in their administrative budgets, with the aim of improving the efficiency of funding for essential activities such as environmental protection, public health, and food safety objectives in the long run;
2024/12/11
Committee: ENVI
Amendment 13 #

2024/2030(DEC)

Draft opinion
Paragraph 1
1. Acknowledges the key role of the ECDC in identifying and assessing current and emerging threats to human health from communicable diseases and related special health issues, in order to enhance the capacity of the Union and the Member States to protect human health through the prevention and control of communicable diseases in humans and related special health issue, emphasizing the need to prioritize cost-effective measures and avoid duplicating Member State efforts;
2024/12/11
Committee: ENVI
Amendment 26 #

2024/2030(DEC)

Draft opinion
Paragraph 1
1. Acknowledges that the ECHA is key’s crucial role in implementing a growing number of Union legislation that regulatcore Union legislation on chemicals and emphasizes cthemicals for the benefit of need to focus strictly on essential regulatory functions that directly protect public health and the environment, as well as forwhile also fostering innovation and competitiveness; recognises that the ECHA collects, evaluates and disseminates a vast amount of information on chemicals, helps companies comply with legislation and promotes the safe use of chemicals, and avoiding unnecessary expansion of its mandate;
2024/12/11
Committee: ENVI
Amendment 33 #

2024/2030(DEC)

Draft opinion
Paragraph 3
3. Recalls the necessity of ensuring adequate staffing reflecting the needs of the European Green Deal and the Union Chemical Strategy for Sustainability, Circular Economy Action Plan and, in particular, the zero pollution target, and the associated increase in tasksimportance of prioritizing efficient resource allocation over increasing staffing levels and stresses the need to allocate staff primarily to scientific roles critical to achieving ENVI objectives, while avoiding unnecessary expansion of the Agency’s workforce;
2024/12/11
Committee: ENVI
Amendment 35 #

2024/2030(DEC)

Draft opinion
Paragraph 3 a (new)
3 a. Cautions against overburdening the ECHA with additional regulatory tasks introduced by new directives and regulations, and emphasizes the importance of maintaining focus on its primary responsibilities under REACH and CLP;
2024/12/11
Committee: ENVI
Amendment 45 #

2024/2030(DEC)

Draft opinion
Paragraph 8
8. Welcomes the ECHA Strategy Statement for 2024 - 2028 adopted in December 2023, which sets out the priorities for the ECHA in implementing its evolving mandate. and calls for its implementation to prioritize efficiency, financial sustainability, and a reduction in regulatory burdens on businesses and Member States, in order to improve effectiveness in delivering ENVI-related objectives;
2024/12/11
Committee: ENVI
Amendment 50 #

2024/2030(DEC)

Draft opinion
Paragraph 2
2. Acknowledges the adaptability of the EEA, which, in addition to its planned publications for 2023, released additional works on topics ranging from extreme weather to human health, such as The importance on restoring nature in Europe, demonstrating its capacity to inform and fuel current policy debates arising from evolving circumstanStresses the need for the EEA to prioritize the production of essential reports directly tied to measurable policy outcomes; calls on the EEA to exercise caution in expanding its scope beyond planned publications, focusing instead on delivering core outputs efficiently without overextending its resources;
2024/12/11
Committee: ENVI
Amendment 53 #

2024/2030(DEC)

Draft opinion
Paragraph 3
3. Notes that the EEA is tasked with tracking progress towards the 8th Environment Action programme (‘8th EAP’), which builds on the European Green Deal and sets the framework for Union environmental policy until 2030, with a long-term priority objective for 2050 of living well within planetary boundaries; welcomes the release of its first annual monitoring report in December 2023, on the basis of a set of 28 headline indicators and corresponding targets such as climate change mitigation and adaptation, circular economy and biodiversityRaises concerns about the practicality, financial sustainability, and scientific reliability of tracking progress towards long-term objectives, such as the 2050 planetary boundaries goal, and stresses the importance of prioritizing achievable, cost-effective short- and medium-term targets that align with current technological capabilities and deliver measurable benefits to Member States and citizens;
2024/12/11
Committee: ENVI
Amendment 60 #

2024/2030(DEC)

Draft opinion
Paragraph 6
6. Takes note with concern that despite the multi-year nature of the EEA’s tasks, an imbalance exists concerning the numbers of permanent versus contractual posts, as well as operational staff versus support staff, leading to a constant need for reskilling as well as an overload of administrative work for scientists; considers that taking into account the substantial increase of workload,opposes however substantial increases in staff numbers, calling instead for and in orderternal review of staff allocation and responsibilities to improperly perform the tasks on the Union’s goals for, inter alia, climate neutrality, circular economy and nature restoration, the EEA’s staff number should continue to substantially grow in the years to come.ve effectiveness in delivering ENVI-related objectives; recommends the adoption of automation and digital solutions to alleviate administrative burdens on scientific staff, enabling them to focus on core research activities without requiring substantial increases in staff numbers;
2024/12/11
Committee: ENVI
Amendment 63 #

2024/2030(DEC)

Draft opinion
Paragraph 6 a (new)
6 a. Cautions against overburdening the EEA with additional tasks arising from new directives and regulations, emphasizing the need to focus on its primary responsibilities; stresses the importance of ensuring that resources are not diluted by attempting to address an overly broad range of objectives, which could compromise the quality and impact of its outputs;
2024/12/11
Committee: ENVI
Amendment 65 #

2024/2030(DEC)

Draft opinion
Paragraph 1
1. WelcomAcknowledges the EFSA's' contribution to essential role in ensuring the safety of the Union food and feed chain, and its considerable efforts in providing risk managers with comprehensive,providing independent and, up-to- date scientific advice on questions linked to the food chain, communicating clearly to the public on its outputs and the information on which they are based, and cooperating with interested parties and institutional partners to promote coherence and trust in the food safety system; stresses the need for the EFSA to focus on its core responsibilities, avoiding unnecessary expansion into non-essential initiatives that may dilute its effectiveness;
2024/12/11
Committee: ENVI
Amendment 68 #

2024/2030(DEC)

Draft opinion
Paragraph 2 a (new)
2 a. Cautions against overburdening the EFSA with additional tasks linked to broader initiatives such as the Farm to Fork and Union Chemical strategies, emphasizing that its primary focus should remain on food safety and core chemical risk assessments;
2024/12/11
Committee: ENVI
Amendment 83 #

2024/2030(DEC)

Draft opinion
Paragraph 6
6. Welcomes the fact that the EFSA continued implementing its new organisational structure that was put in place in 2022 to reflect the Transparency Regulation; h, but emphasizes the importance of ensuring that it leads to measurable efficiency gains, avoids increased administrative complexity or costs, and enhances effectiveness in achieving ENVI-related objectives. Highlights the need to improve efficiency and transparency in the EFSA’s process architecture.;
2024/12/11
Committee: ENVI
Amendment 90 #

2024/2030(DEC)

Draft opinion
Paragraph 1
1. Reiterates the key role of the EMA in protecting human and animal health by assessing and supervising medicines for human or veterinary use and protecting public health by raising awareness on key issues including antimicrobial resistance and prevention of communicable diseases through vaccination; emphasizes the importance of focusing resources on its core responsibilities and avoiding unnecessary expansion into broader public health awareness campaigns;
2024/12/11
Committee: ENVI
Amendment 93 #

2024/2030(DEC)

Draft opinion
Paragraph 3
3. Notes the EMA decision to lift its COVID-19 business continuity measures, in alignment with the World Health Organisation declaration of the end of COVID-19 as a public health emergency of international concern; welcomes the fact that it enabled the EMA to shift its focus to address other challenges, including the finalisation of the EMA’s extended mandate obligations, of the medical devices and in vitro medical devices regulations (MDR/IVDR), and the first reflections on the EC proposal for the revision of the general Union pharmaceutical legislation for human medicines; cautions against overburdening the EMA with growing obligations and instead highlights the need to focus on existing tasks in order to directly enhance human and animal health outcomes;
2024/12/11
Committee: ENVI
Amendment 3 #

2024/2019(DEC)

Draft opinion
Paragraph 2
2. Is satisfied withAcknowledges the work carried out by the five decentralised agencies which are under its remit, which carry out technical, scientific or managerial tasks that help the Union institutions elaborate and implement policies in the area of environmentbut stresses the need to streamline their operations, celiminate action, public health and food safety, as well as with the way in which those agencies' budgets are implemented; stresses that, given the scale and importance of their current tasks and the increase of responsibilities some of them are facing, adequate funding and staffing must be guaranteed for the agencies and the Commission Directorates-General working in the areas of environment, climate action, public health and food safredundancies, and focus resources on achieving measurable outcomes; calls for a comprehensive review of their mandates to ensure alignment with core objectives and cost- efficiency, avoiding unnecessary expansion of staff and budgetys;
2024/12/11
Committee: ENVI
Amendment 6 #

2024/2019(DEC)

Draft opinion
Paragraph 3
3. RecognisNotes that in 2023 about EUR 160 billion, approximately 38% of the Union budget, based on commitment appropriations, was dedicated to climate mainstreaming objectives, in line with the Interinstitutional Agreement of 13 April 2016 on Better Law-Making1 plans for at least 30 % of 2021-27 Multiannual Financial Framework (MFF) to be used for this purpose; notes that the largest contributions to those spendings come from the Recovery and Resilience Facility (RRF), the Common Agricultural Policy (CAP) and from cohesion policy programmes; notes that the Innovation Fund provided an additional EUR 6,5 billion in grants for projects advancing innovative low-carbon technologies; questions the allocation of EUR 160 billion to climate mainstreaming objectives and stresses the need for clear, measurable outcomes to justify such expenditures; calls for an evaluation of both the cost-effectiveness and real impact of climate-related spending under the Recovery and Resilience Facility (RRF), the Common Agricultural Policy (CAP), and cohesion policy programs; _________________ 1 OJ L 123, 12.5.2016, p. 1, ELI: http://data.europa.eu/eli/agree_interinstit/2 016/512/oj.
2024/12/11
Committee: ENVI
Amendment 8 #

2024/2019(DEC)

Draft opinion
Paragraph 4
4. Notes that the largest contribution to the climate-relevant spending in 2023 came from the RRF; in this context, is concerned about the Court of Auditors’(the ‘Court’) annual report for 2023 which, similar to previous years findings, states weaknesses in the design of measures and cases of vaguely defined milestones and targets, weaknesses in the Member States’ reporting and control systems and problems with the reliability of information that Member States included in their management declaration; also notes with concern the Court’s Special Report No 14/2024 that finds multiple shortcomings of the RRF framework and the national recovery and resilience plans as well as inconsistencies in the implementation of measures which call into question the achievement of its climate and environmental objectives, and that concludes that the contribution of the RRF to the green transition is not clear; expresses concern over the shortcomings in RRF implementation, including weak monitoring, vague milestones, and unreliable data; calls for the Commission to introduce stricter oversight mechanisms to ensure that RRF spending delivers tangible environmental and climate outcomes;
2024/12/11
Committee: ENVI
Amendment 20 #

2024/2019(DEC)

Draft opinion
Paragraph 6
6. Underlines the importance of properStresses the need for rigorous scrutiny of climate-related expenditure in the Union budget, and to ensure maximum cost-efficiency and measurable results; holds the Commission fully accountable for the implementation of a robusing a transparent and relverifiable methodology, in line withstrict adherence to the commitments undertaken inof the MFF agreement and paragraph 16d of the Interinstitutional Agreement of 16 December 2020 between the European Parliament, the Council of the European Union and the European Commission on budgetary discipline, on cooperation in budgetary matters and on sound financial management, as well as on new own resources, including a roadmap towards the introduction of new own resources2 ; calls on the Commission to follow the Court’s recommendations in the relevant reports to better estimat; calls on the Commission to adopt the Court’s recommendations to improve climate spending estimates under future funding instruments, to ensure adequate design of future funding instruments that are to support the climate and environmental objectives and targets, to enhance the performancefunding directly supports concrete climate and environmental objectives, enhance the effectiveness of green transition measures, and to ensure comprehensive, consistent, reliable and transparentguarantee full transparency and accountability in reporting on climate- related spending under the RRF; _________________ 2 OJ L 433I, 22.12.2020, p. 28, ELI: http://data.europa.eu/eli/agree_interinstit/ 2020/1222/oj
2024/12/11
Committee: ENVI
Amendment 40 #

2024/2019(DEC)

Draft opinion
Paragraph 10
10. Notes that HERA, established in 2021, has continued in 2023 to grow the number of its staff and to expand its operations; welcomes the progress of HERA’s efforts in ensuring the Union’s preparedness and crisis response readiness for health emergencies as well as its involvement in collaborations with international partners to increase global preparedness, prevention and detection of health emergence progress of HERA and the EU4Health program but cautions against continuous expansion without measurable proof of effectiveness. Calls for a cost-benefit analysis of HERA’s activities and staffing increases to ensure that resources are allocated efficiently to deliver on core public health priorities;
2024/12/11
Committee: ENVI
Amendment 2 #

2024/0185(BUD)

Motion for a resolution
Citation 7
– having regard to Council Decision (EU, Euratom) 2020/2053 EU of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom5 , _________________ 5 OJ L 424, 15.12.2020, p. 1, ELI: http://data.europa.eu/eli/dec/2020/2053/oj.deleted
2024/09/30
Committee: BUDG
Amendment 8 #

2024/0185(BUD)

Motion for a resolution
Paragraph 3
3. Underlines that, with Draft amending budget No 4/2024, GNI lump- sum reductions for the five beneficiary Member States amount to just under EUR 5,4 billion net; stresses that these rebates are inflation-linked and have therefore increased at a higher rate than the MFF ceilings, which are adjusted annually on the basis of the 2 % deflator; underlines that this anomaly increases the burden on the other Member States; recalls once again that the rebates serve foremost as a corrective mechanism, aiming to compensate for high per capita contributions of the net-paying Member States into the EU budget and must absolutely be maintained;
2024/09/30
Committee: BUDG
Amendment 11 #

2024/0185(BUD)

Motion for a resolution
Paragraph 4
4. Urges the Council to adopt swiftly the Commission proposals on own resources in order to increase the own resources available to the Union budget; recalls its long-standing position that fines and fees should be used as supplementary revenue for the Union budget;deleted
2024/09/30
Committee: BUDG
Amendment 21 #

2024/0185(BUD)

Motion for a resolution
Paragraph 6
6. RegreAccepts that, in the current multiannual financial framework (MFF), a total of EUR 1,5 billion has so far been, or is proposed to be, redeployed from programmes to decentralised agencies; underlines that the magnitude of thelimited redeployments isare symptomatic of the stretched resources available to the Union budgetambitions of the EU federalist agenda;
2024/09/30
Committee: BUDG
Amendment 23 #

2024/0185(BUD)

Motion for a resolution
Paragraph 7
7. Notes that Draft amending budget No 4/2024 entails an increase of EUR 2 million for Eurojust owing to inflationary pressure; considers that, with inflation running above the annual 2% deflator by which the MFF ceilings increase and staff and operating costs for decentralised agencies under substantial pressure as a result, the current treatment ofnumber of EU decentralised agencies’ budgets as separate from administ must be drastive spending under Heading 7 requires further reflection as part of the Commission’s preparations for the post-2027 MFFcally reduced given the economic hardships of the bloc;
2024/09/30
Committee: BUDG
Amendment 25 #

2024/0159M(NLE)

Motion for a resolution
Paragraph 1
1. Notes the importance of the EU- Guinea-Bissau SFPA, both for Guinea- Bissau and for EU fleets operating in the Guinea-Bissau fishing zone; emphasises that there could be more effective fisheries cooperation between the EU and Guinea- Bissau and reiterates its call on the Commission to take every step required to make the new Protocol on implementing the agreement more ambitious and clearer than its predecessors so as to ensure that this SFPA leads to a satisfactory level of development of the local fisheries sector in overall terms and is consistent with the objectives referred to in UN Sustainable Development Goal (SDG) 14 to conserve and sustainably use the oceans, seas and marine resources for sustainable development;
2024/12/13
Committee: DEVE
Amendment 28 #

2024/0159M(NLE)

Motion for a resolution
Paragraph 2
2. Considers that the objectives of the EU-Guinea-Bissau SFPA have been realised to varying degrees: while the agreement has offered and still provides considerable fishing opportunities for EU vessels in the Guinea-Bissau fishing zone, in view of the considerable use made of those opportunities by European vessel ownersfrom Spain, Portugal, Italy, Greece and France in the Guinea-Bissau fishing zone, the same cannot be said of the local fisheries sector, whose development remains insufficient or unsatisfactory overall;
2024/12/13
Committee: DEVE
Amendment 32 #

2024/0159M(NLE)

Motion for a resolution
Paragraph 4
4. Stresses that, in Article 3, the Protocol contains a non-discrimination clause whereby Guinea-Bissau undertakes not to grant more favourable technical conditions to other foreign fleets operating in Guinea-Bissau's fishing zone that have the same characteristics and target the same species; calls on the Commission to closely follow and constantly monitor EU fisheries agreements with third countries in Guinea-Bissau's fishing zone; supports the Commission’s precautionary approach in setting TACs at 0 GRT for small-pelagic trawlers, but questions the ability of stakeholders to enforce an equivalent obligation for third- party-flagged fleets;
2024/12/13
Committee: DEVE
Amendment 43 #

2024/0159M(NLE)

Motion for a resolution
Paragraph 7
7. Supports the need for significant progress in the development of the Guinea- Bissau fisheries sector, including as regards related industries and activities, and calls on the Commission to take all necessary measures, including a possible revision and strengthening of the sectoral support component of the agreement, along with measures to without increaseing the financial contribution take-up ratebut just upgrading the already existent measures, in order to achieve that objective;
2024/12/13
Committee: DEVE
Amendment 44 #

2024/0159M(NLE)

Motion for a resolution
Paragraph 8 – introductory part
8. Takes the view that the EU-Guinea- Bissau SFPA will not achieve its objectives unless it contributes to establishing a long- term sustainable management system for the exploitation of its fisheries resources plus responsible socio-economic arrangements; regards it as extremely important that the sectoral support provisions set out in the Protocol be complied with, with the utmost transparency, in order to help fully implement the national strategy for sustainable fisheries; points out in this regard that the EU should mobilise its technical and financial assistance in order, as a matter of priority, to:
2024/12/13
Committee: DEVE
Amendment 8 #

2024/0089(BUD)

Motion for a resolution
Paragraph 5
5. Takes note of the calculation of the adjusted annual GNI lump-sum reductions for the five beneficiary Member States, which amount to around EUR 5,4 billion net; highlights the fact that these rebates are inflation-linked and have therefore increased at a higher rate than the MFF ceilings, which are adjusted annually on the basis of the 2 % deflator; stresses that this anomaly increases the burden on the other Member States; recalls that the rebates serve foremost as a corrective mechanism, aiming to compensate for high per capita contributions of the net- paying Member States into the EU budget and must absolutely be maintained;
2024/09/19
Committee: BUDG
Amendment 105 #

2023/0453(COD)

Proposal for a regulation
Recital 6
(6) Business operators and Members States’ competent authorities are required by various Union acts to submit data and information to a multitude of Union agencies, as well as to the Commission in specific cases. This generates a fragmentation of data and information on chemicals, which are held under various data sharing and use conditions and in different formats. Such fragmentation prevents public authorities, as well as the general public, from having a clear overview of what information is available on individual chemicals or groups of chemicals, of where and how information can be accessed and whether it can be used. This increases the likelihood of inconsistency between various assessments of the same chemical required by various Union acts on chemicals and of damaging the general public’s trust in the scientific grounds for Union decisions on chemicals. In order to ensure that data on chemicals is easily findable, accessible, interoperable and usable, the ECHA should establish a common data platform on chemicals. The common data platform on chemicals should serve as a single point of reference and as a broadened and shared evidence base to enable the efficient delivery of coherent hazard and risk assessments of chemicals across various Union acts on chemicals, as well as to enable the timely identification of emerging chemical risks and the drivers and impact of chemical pollution. Authorities should take the necessary measures to protect the confidentiality of data, including, where relevant, by means of physical and cybersecurity measures.
2024/12/05
Committee: ENVI
Amendment 121 #

2023/0453(COD)

Proposal for a regulation
Recital 8 a (new)
(8 a) Chemicals contained in medicinal products are covered by Annex II to this Regulation, as well as Annex I since chemicals in medicinal products are also subject to regulatory procedures under the majority of other Union legislation listed under Annex I. In order to protect the confidentiality of certain data and to prevent any conflicts between legislative acts, the provisions from Directive 2001/83/EC of the European Parliament and the Council and Regulation (EC) 726/2004 of the European Parliament and the Council should always take precedence over this Regulation. This covers future implementation through delegating and/or implementing acts.
2024/12/05
Committee: ENVI
Amendment 303 #

2023/0453(COD)

Proposal for a regulation
Article 5 – paragraph 2
2. Where the Commission or the Agencies hold data or information referred to in Article 3(2), they shall make that data available to the ECHA, in a standard format, where available, together with the relevant context data as referred to in Article 4(4), point (c). The Commission and the Agencies shall indicate whether that data or information is made available to the public or they are deemed confidential in accordance with the provisions on confidentiality under the originating Union act.
2024/12/05
Committee: ENVI
Amendment 419 #

2023/0453(COD)

Proposal for a regulation
Article 16 – paragraph 2
2. The Authorities shall take the necessary measures, including security measures, to ensure that information contained in the common data platform marked as confidential in accordance with Article 5(2), is not made publicavailable to the public in accordance with the provisions on confidentiality under the originating Union act.
2024/12/05
Committee: ENVI
Amendment 490 #

2023/0453(COD)

Proposal for a regulation
Article 21 – paragraph 7 a (new)
7 a. In alignment with the REACH regulation and the CLP regulation, the obligations put forward in article 22 shall not apply to substances manufactured, imported or used in Scientific Research and Development (SR&D) and Product and Process Orientated Research and Development (PPORD).
2024/12/05
Committee: ENVI
Amendment 508 #

2023/0453(COD)

Proposal for a regulation
Article 22 – paragraph 2
2. For the purposes of paragraph 1, information to be notified by business operators shall notify to the Database of Study Notifications referred to in Article 9 shall be limited to the title, scope, laboratory, or testing facility carrying out the study, the intended starting and planned completion dates and, where relevant, whether the study is commissioned to comply with a decision of the ECHA pursuant to Articles 40, 41 or 46 of Regulation (EC) No 1907/2006. For medicinal products, notification is only required after the market authorisation application has been submitted.
2024/12/05
Committee: ENVI
Amendment 512 #

2023/0453(COD)

Proposal for a regulation
Article 22 – paragraph 2 a (new)
2 a. For the purpose of paragraphs 1 and 2, business operators may claim part of the information in paragraph 2 is confidential in accordance with the provisions on confidentiality under the originating Union act.
2024/12/05
Committee: ENVI
Amendment 514 #

2023/0453(COD)

Proposal for a regulation
Article 22 – paragraph 3
3. Laboratories and testing facilities shall also, without undue delay, notify any study commissioned by business operators to support a regulatory dossier on which an Agency is required to provide a scientific output, including a scientific opinion, under the Union acts listed in Annex I. However, laboratories and testing facilities shall not notify to the Database of Study Notifications referred to in Article 9 studies that are to be notified under Article 32b of Regulation (EC) No 178/2002. The confidentiality of information on laboratories and testing facilities shall be respected.
2024/12/05
Committee: ENVI