BETA

Activities of Beatrice TIMGREN

Plenary speeches (9)

One-minute speeches on matters of political importance
2024/09/16
State of the Energy union (debate)
2024/09/17
Iraq, notably the situation of women’s rights and the recent proposal to amend the Personal Status Law
2024/10/09
Closing the EU skills gap: supporting people in the digital and green transitions to ensure inclusive growth and competitiveness in line with the Draghi report (debate)
2024/10/24
UN Climate Change Conference 2024 in Baku, Azerbaijan (COP29) (debate)
2024/11/13
Dossiers: 2024/2718(RSP)
One-minute speeches on matters of political importance
2024/11/13
The increasing and systematic repression of women in Iran
2024/11/27
Urgent need for EU action to preserve nature and protect biodiversity to avoid the extinction of species (debate)
2024/12/18
Commission’s plans to include the revision of the outstanding proposals on animal welfare in its work plan for 2025 (debate)
2024/12/19

Institutional motions (5)

MOTION FOR A RESOLUTION Iraq, notably the situation of women’s rights and recent proposal to amend the Personal Status Law
2024/10/07
Dossiers: 2024/2858(RSP)
Documents: PDF(148 KB) DOC(45 KB)
JOINT MOTION FOR A RESOLUTION on the cases of unjustly imprisoned Uyghurs in China, notably Ilham Tohti and Gulshan Abbas
2024/10/09
Documents: PDF(147 KB) DOC(46 KB)
JOINT MOTION FOR A RESOLUTION on Hong Kong, notably the cases of Jimmy Lai and the 45 activists recently convicted under the national security law
2024/11/27
Documents: PDF(146 KB) DOC(47 KB)
JOINT MOTION FOR A RESOLUTION on the increasing and systematic repression of women in Iran
2024/11/27
Documents: PDF(147 KB) DOC(46 KB)
JOINT MOTION FOR A RESOLUTION on the continued repression of civil society and independent media in Azerbaijan and the cases of Dr Gubad Ibadoghlu, Anar Mammadli, Kamran Mammadli, Rufat Safarov and Meydan TV
2024/12/18
Documents: PDF(147 KB) DOC(46 KB)

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 (15)

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)
Mismatch between ambitious targets and demand and investment needs for hydrogen
2024/09/17
Documents: PDF(56 KB) DOC(11 KB)
Political pressure on content moderation and limiting freedom of speech in social media
2024/09/18
Documents: PDF(66 KB) DOC(11 KB)
Regarding the digital platform for due diligence statements on deforestation
2024/09/26
Documents: PDF(65 KB) DOC(11 KB)
European Court of Auditors – unclear green spending under RRF funds
2024/09/26
Documents: PDF(55 KB) DOC(11 KB)
Facilitating the financing of nuclear power in the EU
2024/09/26
Documents: PDF(50 KB) DOC(10 KB)
Areas for deregulation within the EU
2024/10/15
Documents: PDF(56 KB) DOC(11 KB)
Concerns regarding satellite data accuracy in the EU forest monitoring proposal
2024/10/21
Documents: PDF(52 KB) DOC(11 KB)
Reform of Medical Devices Regulation required to foster innovation and competitiveness
2024/10/21
Documents: PDF(54 KB) DOC(11 KB)
Introduction of a bureaucracy cost index at EU level
2024/10/22
Documents: PDF(55 KB) DOC(11 KB)
Commission’s response in addressing social dumping following CJEU ruling on Mobility Package
2024/10/31
Documents: PDF(72 KB) DOC(11 KB)
Impact of new cybersecurity regulations on SMEs in digital services
2024/11/07
Documents: PDF(56 KB) DOC(11 KB)
Transparency, priorities and financial risks of the ‘Scaling up renewables in Africa’ campaign
2024/11/21
Documents: PDF(66 KB) DOC(11 KB)
Financial risks to EU taxpayers following Northvolt’s bankruptcy filing
2024/11/26
Documents: PDF(69 KB) DOC(11 KB)

Individual motions (2)

MOTION FOR A RESOLUTION on the audit of green investments in light of Northvolt developments
2024/10/02
Documents: PDF(123 KB) DOC(42 KB)
MOTION FOR A RESOLUTION on introducing competitiveness mainstreaming for EU legislation
2024/11/04
Documents: PDF(129 KB) DOC(45 KB)

Amendments (154)

Amendment 120 #

2024/2718(RSP)

Draft motion for a resolution
Paragraph 2
2. Supports the COP28 call on the Parties to the UNFCCC to contribute to the global effort of tripling renewable energy capacity globally and doubling the global average annual rate of energy efficiency improvements by 2030; demands however that such a renewables clause is only included in the agreement of the climate conference, if the tripling of nuclear power is also formulated as a goal on an equal footing;
2024/09/11
Committee: ENVI
Amendment 126 #

2024/2718(RSP)

Draft motion for a resolution
Paragraph 2 a (new)
2a. Emphasises that the target of net- zero greenhouse gas emissions by 2050, cannot be achieved without nuclear power; welcomes that 22 countries, including 13 European countries, joined forces at COP 28 in Dubai, with the aim of tripling nuclear power by 2050; calls on all parties to support their nuclear pledge;
2024/09/11
Committee: ENVI
Amendment 157 #

2024/2718(RSP)

Draft motion for a resolution
Paragraph 6
6. Urges all Parties to ensure an outcome at COP29 with robust rules for cooperative mechanisms under Article 6 of the Paris Agreement and calls on the EU and its Member States to strictly defend a high level of climate integrity, based on the best available science, in the negotiations; calls upon the EU and its member states to support the strengthening of the Clean Development Mechanism (CDM) in accordance with Article 6 of the Paris Agreement, not only during upcoming negotiations, but also by meeting its own climate targets through the use of these certificates, in order to make a greater contribution to global climate protection than would be possible through unilateral measures alone; emphasizes the importance of developing models for such framework agreements to ensure that partner countries cannot have the reductions credited additionally;
2024/09/11
Committee: ENVI
Amendment 284 #

2024/2718(RSP)

Draft motion for a resolution
Paragraph 18
18. WelcomNotes the decision at COP28 to use the loss and damage (L&D) fund to address and respond to the economic and non- economic impacts of climate change for particularly vulnerable developing countries;
2024/09/11
Committee: ENVI
Amendment 290 #

2024/2718(RSP)

Draft motion for a resolution
Paragraph 19
19. Reiterates its call for L&D to be a standing agenda item at COPs, in order to monitor and make progress on this issue, and for the full use of the Santiago Network in order to effectively catalyse technical assistance for adequately addressing L&D;deleted
2024/09/11
Committee: ENVI
Amendment 306 #

2024/2718(RSP)

Draft motion for a resolution
Paragraph 21
21. Stresses that climate goals cannot be achieved without the support and involvement of the public; calls on all Parties to raise awareness of climate change and related issues, combat misinformationto encourage a transparent and open debate and work with public representatives to gain public support for mitigation and adaptation measures;
2024/09/11
Committee: ENVI
Amendment 331 #

2024/2718(RSP)

Draft motion for a resolution
Paragraph 24
24. Expresses concern that more than 2 400 fossil fuel lobbyists were accredited attendees at COP28; calls for the UNFCCC and the Parties to strengthen the principle of technological neutrality, in order to reduce all forms of lobbying and ensure that the decision- making process is protected from interests that run counter to the goal of the Paris Agreement;
2024/09/11
Committee: ENVI
Amendment 385 #

2024/2718(RSP)

Draft motion for a resolution
Paragraph 27
27. Calls on the Member States and the Commission to ensure that the national energy and climate plans and long-term strategies of the Member States include sufficient action and financial means to achieve the EU’s 2030 targets; highlights in this context the importance of strengthening the Clean Development Mechanism (CDM) in accordance with Article 6 of the Paris Agreement to facilitate the achievement of these climate targets through the use of these certificates;
2024/09/11
Committee: ENVI
Amendment 399 #

2024/2718(RSP)

Draft motion for a resolution
Paragraph 28
28. Stresses that the current geopolitical situation highlights the urgency of cutting the EU’s dependence on fossil fuels and the need to boost the deployment of renewables and nuclear energy;
2024/09/11
Committee: ENVI
Amendment 575 #

2024/2718(RSP)

Draft motion for a resolution
Paragraph 46
46. Highlights the factNotes that the EU’s carbon border adjustment mechanism will provide an effective mechanism to price emissions from products imported to the EU and to address carbon leakage while supporting the adoption of carbon pricing worldwide;
2024/09/11
Committee: ENVI
Amendment 603 #

2024/2718(RSP)

Draft motion for a resolution
Subheading 10
Climate change and genderdeleted
2024/09/11
Committee: ENVI
Amendment 607 #

2024/2718(RSP)

Draft motion for a resolution
Paragraph 50
50. Emphasises the need for more concrete actions by all Parties to deliver on the commitments of the renewed Gender Action Plan agreed at COP25;deleted
2024/09/11
Committee: ENVI
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 23 #

2024/0176(BUD)

Motion for a resolution
Paragraph 1
1. Emphasises that Russia’s war of aggression against Ukraine and its economic and societal consequences continue to put a severe strain on the everyday lives of people across Europe and frontline countries; acknowledges that a confluence of political, security, socio- economic, climate and environmental challenges demand a resolute response from the Union, including by exploiting to the fullest possible extent the crisis response capacity of the EU budget; considers it crucial for the Union to be able to act swiftly and adequately in emergency situations caused by major natural disasters, humanitarian emergencies or public health crises in Member States and accession countries and to support third countries suffering from conflicts, refugee crises or natural disasters;
2024/09/30
Committee: BUDG
Amendment 29 #

2024/0176(BUD)

Motion for a resolution
Paragraph 2
2. Notes with concern that while inflation has begun to subside compared to previous years’ peaks, its longer term impact on the cost of living, energy and food prices continues to be a burden on households’ purchasing power and companies’ competitiveness and productivity; stresses that, against this background, a combination of policy responses comprising regulatory, fiscal and budgetary measures will have to be deployed to adequatel this situation has been partially caused by baddress the broad range of challenges; reminds that the Union budget, in complementarity with the national budgets of the Member States and private finance should play a central role in this regard; recalls that the EU budget is an investment budget in line with Union’s political priorities and programmes which g economic and monetary policy of the European Cenetrates a return on investment and growth possibilitiesl Bank; emphasises that the 2024 European Parliament elections have sent a clear message for more solidarity between Member Statesuch stricter migration policy, transitioning climate policy from utopianism to realism and more investments in policies and programmes on national level which improve people’s lives; highlights that this call must not be answered by ever more budgetary cuts and by a reduction in badly needmanaged resources to help people go through these difficult times;
2024/09/30
Committee: BUDG
Amendment 41 #

2024/0176(BUD)

Motion for a resolution
Paragraph 4
4. Underscores that the revision of the Multiannual Financial Framework has been partly successful and partly unsatisfactory; acknowledges that the revision has resulted in providing additional resources for Ukraine, the Western Balkan and several other budget lines of strategic importance as well as replenished flexibility mechanism; welcomes that the Commission has proceeded with translating the outcome of the MFF revision into the Financial Programming as well as amending budgets 2024 and the draft general budget for 2025 (the “DB”); underlines once again that the higher than foreseen repayment costs of the European Union Recovery Instrument (EURI) should have been placed fully in a EURI special instrument over and above the MFF ceilings with a view to restoring some margin within Heading 2b and protecting budgetary space in the Flexibility and Single Margin Instrumentsare the result of overoptimistic, imprudent borrowing policy of the Union; recalls the Interinstitutional Agreement adopted as part of the 2020 MFF agreement, according to which expenditure to cover NGEU financing costs “shall aim at not reducing programmes and funds”;
2024/09/30
Committee: BUDG
Amendment 44 #

2024/0176(BUD)

Motion for a resolution
Paragraph 5
5. Stresses that the 2025 Budget will be the first full annual budgetary procedure under the revised MFF ceilings and rules; insists that the spirit and letter of the MFF revision be respected and the additional appropriations resulting from the revision be fully authorised and committed; reminds that a certain level of redeployments, in particular under headings 1 and 6 was part of the MFF revision package; wishes to not see such reductions repeated or made worse in the annual procedure;
2024/09/30
Committee: BUDG
Amendment 54 #

2024/0176(BUD)

Motion for a resolution
Paragraph 8
8. Takes note that the Council, in its position which it calls “prudent”, proposes to cut commitment appropriations by EUR 1.52 billion across the MFF headings, leaving a total of EUR 191,527 billion, and reduces payment appropriations by EUR 876 million across the MFF headings; strongly believes that the European Parliament shall fully adhere to this approach; stresses that, by cutting across headings on programme lines to generate additional unallocated margins, the Council’s position may convey an ambiguousencouraging message of creating additional availabilities for 2025; underlines that this approach, however, is not is in accordance with the reality of current budgetary needs, as these margins are not intended for use in the annual budget 2025 of national treasuries of the Member States;
2024/09/30
Committee: BUDG
Amendment 58 #

2024/0176(BUD)

Motion for a resolution
Paragraph 9
9. Is adamant that, in times of geopolitical and institutional change, financial pressure, climate change and societal challenges, a reliable, robust, flexible, investment oriented EU budget remain instrumental for the implementation of the Union’s policies and central in responding to people’s increasing needs, leaving no-one behind through the green and digital transitions, in delivering prosperity and security for people and in boosting the competitiveness of the Union economy; to defend the social dimension of Union spending in all policy areas, in other words, we will work to reinforce budgetary lines that have a direct impact on improving peoples’ livthe annual budget of the EU shall be fully concentrated on internal investments of the block and Ukraine as external recipient of military aid and other support measures;
2024/09/30
Committee: BUDG
Amendment 81 #

2024/0176(BUD)

Motion for a resolution
Paragraph 13
13. RegretWelcomes the Council’s approach to opt for what it calls “prudent” budgeting, creating artificialdequate margins under the MFF ceilings; notes that the Council, in its position on the 2025 budget, and similar to 2024, reduces appropriations dedicated for EURI borrowing costs; points out that the Council’s position to cover only around 35% of the overrun costs by the EURI Special Instrument runs counter to the 50:50 benchmark that the Council itself insisted on during the MFF negotiations; alerts; is aware that in order to finance the difference and create additional unallocated margin (mostly in H2b but also in other headings, presumably in view of using it in future years through the SMI), sizeable reductions to a number of flagship programme envelopes shavell been proposed that have repercussions in 2025 as well as in 2026 and 2027; recalls that the most affected programmes, Horizon Europe, CEF digital and Erasmus, are well-established priorities for the European Parliament and flagship programmes of the Union; highlighconsents that the Council targets for reductions are across several headings and even touch some programmes that were already subject to the MFF redeployments, such as Horizon, reduced by 400 million; or lines that were topped up in previous years, such as Erasmus+, reduced by 295 million, EU4Health or LIFE;
2024/09/30
Committee: BUDG
Amendment 85 #

2024/0176(BUD)

Motion for a resolution
Paragraph 14
14. Recalls the Interinstitutional Agreement adopted as part of the 2020 MFF agreement, whereby expenditure to cover NGEU financing costs “shall aim at not reducing programmes and funds”; questions whether the Council’s approach is in line with the MFF agreement on the cascade;deleted
2024/09/30
Committee: BUDG
Amendment 88 #

2024/0176(BUD)

Motion for a resolution
Paragraph 15
15. Intends, therefore, to restore the cuts proposed by Council; to ensure that programmes are properly resourced and that the budget’s flexibility and response capacity are maintained throughout the annual budgetary procedure; insists on the need for the Commission to provide reliable, timely and accurate information on NGEU borrowing costs and on expected Recovery and Resilience Facility disbursements throughout the budgetary procedure; recalls that Parliament is deeply concerned about the impact of the inherent uncertainty for the EURI interest line and questions the forecast from the Commission on NGEU borrowing costs and expected Recovery and Resilience Facility disbursements throughout the budgetary procedure;deleted
2024/09/30
Committee: BUDG
Amendment 97 #

2024/0176(BUD)

Motion for a resolution
Paragraph 16
16. Underlines, once again, that repayment of the EURI borrowing costs is a legal obligation for the Union and a non- discretionary expenditure item in the EU budget; is adamant, therefore to cater fully and timely for the NGEU repayment costs that will fall due in 2025; agrees to apply, in this regard, the newly established EURI cascade mechanism, in the letter and the spirit of the recently revised MFF Regulation; proposes to finance 65% of the overrun costs by the de-commitment compartment of the EURI Special Instrument; deems the margin of EUR 46.2 million, which was programmed before the DB was submitted, to be available for reinforcing programmes under the ceiling of Heading 2b; intends to revisit the amendments linked to the cascade mechanism once the Amending Letter provides updated estimations of the actual needs for the EURI line in 2025;
2024/09/30
Committee: BUDG
Amendment 107 #

2024/0176(BUD)

Motion for a resolution
Paragraph 18
18. Highlights the vital role that Horizon Europe plays in this context; recalls that the programme remains heavily over-subscribed and is therefore unable to support a large number of research projects evaluated as ‘excellent’; proposes, therefore, to increase allocations for the programme by a total of EUR 242 million compared to the DB, with reinforcements for the European Research Council, Marie Skłodowska-Curie Actions and Clusters ‘Health’, ‘Culture’ ‘Climate, Energy and Mobility’, ‘Food’, EIC and ‘Widening participation’;
2024/09/30
Committee: BUDG
Amendment 115 #

2024/0176(BUD)

Motion for a resolution
Paragraph 20
20. Recalls that the Connecting Europe Facility (CEF) is key to boosting investment in high-performance, and sustainable trans-European networks and to decarbonising the Union economy, thereby accelerating the green transition and, thereby promoting interconnectivity; proposes, to increase appropriations for CEF Transport by EUR 40 million above the DB in 2025; further proposes to top-up CEF Energy with an additional EUR 30 million;
2024/09/30
Committee: BUDG
Amendment 125 #

2024/0176(BUD)

Motion for a resolution
Paragraph 24
24. Reiterates the important role played by the decentralised agencies active under this heading; proposes to increase appropriations for the European Union Agency for Railways and for the BEREC Office; in line with their identified needs and expanding mandates;deleted
2024/09/30
Committee: BUDG
Amendment 139 #

2024/0176(BUD)

Motion for a resolution
Paragraph 28
28. Reinforces Heading 2a by EUR 755 965 in commitment appropriations, i.e. by the remaining margin undConsiders crucial to reform the Cohesion policy, where the sub-ceiling, above the DB (excluding pilot projects and preparatory actions) and by EUR 889 718 compared to the Councilbest results would be achieved by not conveying the funds via Brussels' readingstributive machine;
2024/09/30
Committee: BUDG
Amendment 144 #

2024/0176(BUD)

Motion for a resolution
Paragraph 29
29. Underlines that the expenditure programmes under Heading 2b have to share the tight resources and margins under Heading 2b with the EURI budget line which covers the NGEU debt management and interest costs and, eventually, debt repayments; is intent on covering these borrowing costs in a reliable and transparent manner without having toby reduceing programme allocations for this purpose; is convinced that, for 2025, the cascade mechanism and the newly created EURI Special Instrument make it possible that this objective can be achieved; emphasises that this is a crucial message to the beneficiaries of EU fundingtaxpayers of the EU and the public at large;
2024/09/30
Committee: BUDG
Amendment 186 #

2024/0176(BUD)

Motion for a resolution
Paragraph 37
37. Reiterates the indispensable role of the Citizens, Equality, Rights and Values programme in promoting European values and citizens’ rights, in fostering active civic engagement, in building resilient societies, in combatting gender-based violence and in supporting the key principles of democracy, the rule of law, solidarity, inclusiveness, justice, non- discrimination and equality; proposes, therefore, to increase appropriations for the programme by EUR 9 million above the DB, with reinforcements for the equality and rights, ‘citizens’ engagement and participation’, Daphne and ‘Union values’ strands; to this end, reminds that the European Commission shall absolutely restrain from promoting islamic veil in its public campaigns as a legitimising sign of islamisation;
2024/09/30
Committee: BUDG
Amendment 192 #

2024/0176(BUD)

Motion for a resolution
Paragraph 38
38. Deems it necessary to allocate adequate resources for the effective implementation of EU rules on social security coordination in order to facilitate labour mobility and easier transfer of social security benefits, by financing the relevant line by EUR 2 million;deleted
2024/09/30
Committee: BUDG
Amendment 200 #

2024/0176(BUD)

Motion for a resolution
Paragraph 40
40. Recalls the important role played by the decentralised agencies under Heading 2b; reinforcing funding and staffing levels for the Fundamental Rights Agency, for the European Institute for Gender Equality, the European Labour Authority and the European Union Agency for Criminal Justice Cooperation in line with the agencies’ identified needs; proposes, furthermore, to reinforce the European Public Prosecutor’s Office in terms of financing and staff to allow the body to fulfil its duties and protect the Union’s financial interests;
2024/09/30
Committee: BUDG
Amendment 223 #

2024/0176(BUD)

Motion for a resolution
Paragraph 45 a (new)
45 a. Calls on the European Court of Auditors to audit without delay all EU funded green investments, without limiting the scope of investigation;
2024/09/30
Committee: BUDG
Amendment 232 #

2024/0176(BUD)

Motion for a resolution
Paragraph 49
49. Underlines that instability in neighbouring regions, as well as poverty and underlying trends in economic development, demographic changes, globalisation in transport and communications continue to create migration flows towards the Union, placing significant pressure on programmes and agencies under Heading 4 fall under the full responsibility of the neighbouring states and have zero connection with the European taxpayers;
2024/09/30
Committee: BUDG
Amendment 237 #

2024/0176(BUD)

Motion for a resolution
Paragraph 50
50. Notes that additional financing is needed underIs convinced that the Asylum, Migration and Integration Fund (AMIF) in order to ensure appropriate and speedy implementation ofmust be rebranded as the Asylum and, Migration Pact; decides, therefore, to reinforce the AMIF by EUR 25 million above DB in 2025 given AMIF’s positive contribution in providing immediate support to refugeesand Repatriation Fund (AMRF) and be fully focused on deportation of illegal migrants from the EU;
2024/09/30
Committee: BUDG
Amendment 243 #

2024/0176(BUD)

Motion for a resolution
Paragraph 51
51. Underlines the important role that the Border Management and Visa Instrument (BMVI) plays in managing the Union’s external borders and in particular in supporting Member States with reinforced border protection capabilities including physical infrastructure, buildings, equipment, systems and services required at border crossing points; underlines that the instrument should also support the acceleration of Romania’s and Bulgaria’s accession to the Schengen area; proposes therefore to increase appropricalls on the European Commission to provide particular attention and resources to the construction of the walls at the Finnish- Russian, Polish-Belorussian and Greco- Turkish borders; calls for a swift approval of the Finnish government applications for the BMVI by EUR 35 million above DB;50mln EUR in BVMI funding to help secure the EU external border1a; _________________ 1a https://intermin.fi/-/suomi-hakee-50- miljoonan-euron-rahoitusta-komissiolta- itarajan-valvonnan-vahvistamiseen-
2024/09/30
Committee: BUDG
Amendment 254 #

2024/0176(BUD)

Motion for a resolution
Paragraph 53
53. Proposes to reinforce the European Union Agency for the Operational Management of Large-Scale IT Systems in the Area of Freedom, Security and Justice (eu-LISA) by EUR 2 million and to reinforce staff at the European Union Agency for Asylum (EUAA), which shall start immediately the negotiations aiming at creating asylum reception centers in third countries outside the Union;
2024/09/30
Committee: BUDG
Amendment 266 #

2024/0176(BUD)

Motion for a resolution
Paragraph 60
60. Emphasises that, and once more as a consequence of Russia’s war of aggression against Ukraine, the international context has deteriorated rapidly as a result of the food, energy and economic crises, which have dramatically increased pressure on Heading 6; welcomes the fact that the introduction of the Ukraine Facility and the Western Balkan Facility over the MFF ceilings provides a stable basis for support for Ukraine and the Western Balkan countries and releases some pressure on the availabilities within Heading 6 and more particularly on the cushion and buffers in the NDICI envelope; reminds that the commensurate redeployments leave behind gaps on some other budget lines which are difficult to manage;
2024/09/30
Committee: BUDG
Amendment 270 #

2024/0176(BUD)

Motion for a resolution
Paragraph 61
61. Stresses the importance of the Southern Neighbourhood line in supporting political, economic and social reforms in the region; taking into consideration the increasing humanitarian needs in the region as well as other purposes of regional cooperation in providing assistance to refugees, in particular Syrian and Palestinian refugees, and in enabling support along the southern migration routes; proposes to increase appropriations for the line by EUR 60 million above the DB, including to reinforce funding for UNRWA based on EU regulations and valuesconsiders vital to condition EU aid with repatriation agreements to increase returns; is equally convinced that EU partnerships with third countries must be built on strict requirement of non- cooperation with the Russian regime;
2024/09/30
Committee: BUDG
Amendment 289 #

2024/0176(BUD)

Motion for a resolution
Paragraph 65 a (new)
65 a. Is profoundly sceptical as regards the rule of law in the Western Balkan countries and expresses concern over how this affects the reliability of the EU funds being spent under the Western Balkan Facility;
2024/09/30
Committee: BUDG
Amendment 290 #

2024/0176(BUD)

Motion for a resolution
Paragraph 67
67. Overall, reinforces Heading 6 by EUR 256 200 000 in commitment appropriations above the DB and by EUR 234 461 645 compared to the Cocalls to redeploy all external action funds under Heading 6 towards Ukraine unctil rpeadingce in Europe is restored;
2024/09/30
Committee: BUDG
Amendment 292 #

2024/0176(BUD)

Motion for a resolution
Paragraph 71
71. Maintains unchanged the overall level of its budget for 2025 set at EUR 2 499 233 329, in line with its estimates of revenue and expenditure for the financial year 2025; incorporates budgetary-neutral adjustments to reflect updated information which was not available earlier this year; calls for an establishment of the Single Seat of the European Parliament;
2024/09/30
Committee: BUDG
Amendment 297 #

2024/0176(BUD)

Motion for a resolution
Paragraph 73 – point b a (new)
(b a) Highlights once again the necessity of savings and unaffordability of 19 Europa Experiences and of 33 European Parliament Liaison Offices in times of economic hardships and squeezed Heading 7ceilings;
2024/09/30
Committee: BUDG
Amendment 310 #

2024/0176(BUD)

Motion for a resolution
Paragraph 80 – point b
(b) restore the level of appropriations partially in line with the estimates of the European Court of Auditors, the European Economic and Social Committee, the European Committee of the Regions, the European Data Protection Supervisor and the European External Action Service by increasing the appropriations above the DB for budgetary lines that cover cyber- security and operational needs;
2024/09/30
Committee: BUDG
Amendment 3 #

2023/0455(COD)

Proposal for a regulation
Recital 2
(2) In order to achieve this objective, a part of the scientific and technical work on chemicals performed at Union level in support of Union legislation needs to be consolidated in the relevant Union agencies, while obligations on Union agencies to cooperate for the development of assessment methodologies and exchange of data and information should be introduced. This would simplify the current set-up, improve quality and coherence of safety assessments across Union legislation, and ensure more efficient use of existing resources as well as reduce duplication of efforts across multiple Union agencies. This approach supports the competitiveness of Union industries by reducing compliance costs and administrative burdens on businesses.
2024/12/05
Committee: ENVI
Amendment 7 #

2023/0455(COD)

Proposal for a regulation
Recital 7 a (new)
(7a) The measures introduced under this Regulation seek to align regulatory requirements and processes across relevant sectors without creating unnecessary administrative burdens or overregulation. By prioritizing proportionality and efficiency, the Regulation ensures that new tasks are effectively integrated into existing systems while maintaining high standards of environmental and public health protection.
2024/12/05
Committee: ENVI
Amendment 10 #

2023/0455(COD)

Proposal for a regulation
Recital 8 a (new)
(8a) A consistent and predictable regulatory framework is essential for fostering innovation and encouraging investment in sustainable chemical technologies. By simplifying assessment methodologies under the ‘one substance, one assessment’ approach, this Regulation promotes regulatory efficiency and supports the Union’s objective of creating a more competitive internal market.
2024/12/05
Committee: ENVI
Amendment 13 #

2023/0455(COD)

Proposal for a regulation
Recital 10 a (new)
(10a) Leveraging existing digital tools and data-sharing platforms, this Regulation aims to minimize duplicative reporting obligations, reduce costs for Member States and economic operators, and provide better access to data for stakeholders. This approach strengthens the role of digital solutions in achieving regulatory efficiency and cost savings.
2024/12/05
Committee: ENVI
Amendment 3 #

2023/0454(COD)

Proposal for a directive
Recital 1
(1) The Commission has, in its Communication ‘European Green Deal’2 , set an objective that chemical safety assessments should move towards a process of ‘one-substance, one- assessment’, calling for more transparent and simpler risk assessment processes in order to reduce the burden on all stakeholders, accelerate decision-making, as well as to increase consistency and predictability of scientific decisions and opinions. The Commission, in its Communication on Chemicals Strategy for Sustainability3 concludes that, in order to achieve that objective, part of the scientific and technical work on chemicals performed at Union level in support of Union legislation needs to be reattributed to the most suitable Union agencies. This would simplify the current set-up, improve quality and coherence of safety assessments across Union legislation, and ensure more efficient use of existing resources. This approach is also expected to promote cost-effectiveness and competitiveness by simplifying regulatory procedures and reducing administrative burdens, ensuring that businesses can adapt efficiently to evolving regulatory frameworks. _________________ 2 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, The European Green Deal (COM (2019) 640 final of 11 December 2019). 3 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Chemicals Strategy for Sustainability Towards a Toxic-Free Environment (COM (2020) 667 final of 14 October 2020).
2024/12/09
Committee: ENVI
Amendment 3 #

2023/0454(COD)

Proposal for a directive
Recital 1
(1) The Commission has, in its Communication ‘European Green Deal’2 , set an objective that chemical safety assessments should move towards a process of ‘one-substance, one- assessment’, calling for more transparent and simpler risk assessment processes in order to reduce the burden on all stakeholders, accelerate decision-making, as well as to increase consistency and predictability of scientific decisions and opinions. The Commission, in its Communication on Chemicals Strategy for Sustainability3 concludes that, in order to achieve that objective, part of the scientific and technical work on chemicals performed at Union level in support of Union legislation needs to be reattributed to the most suitable Union agencies. This would simplify the current set-up, improve quality and coherence of safety assessments across Union legislation, and ensure more efficient use of existing resources. This approach is also expected to promote cost-effectiveness and competitiveness by simplifying regulatory procedures and reducing administrative burdens, ensuring that businesses can adapt efficiently to evolving regulatory frameworks. _________________ 2 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, The European Green Deal (COM (2019) 640 final of 11 December 2019). 3 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Chemicals Strategy for Sustainability Towards a Toxic-Free Environment (COM (2020) 667 final of 14 October 2020).
2024/12/11
Committee: ENVI
Amendment 4 #

2023/0454(COD)

Proposal for a directive
Recital 2
(2) The reattribution of certain scientific and technical tasks to the European Chemicals Agency is necessary in order to align processes and levels of scientific scrutiny and digitalisation with current standards and processes of the European Chemicals Agency. This is also necessary in order to ensure a consistent standard of scientific quality, transparency, data searchability and interoperability, in line with the ‘one-substance, one- assessment’ ambition. Moreover, digitalization and streamlined processes will reduce duplicative efforts and administrative delays, providing significant cost savings and efficiency gains for both Member States and economic operators.
2024/12/09
Committee: ENVI
Amendment 4 #

2023/0454(COD)

Proposal for a directive
Recital 2
(2) The reattribution of certain scientific and technical tasks to the European Chemicals Agency is necessary in order to align processes and levels of scientific scrutiny and digitalisation with current standards and processes of the European Chemicals Agency. This is also necessary in order to ensure a consistent standard of scientific quality, transparency, data searchability and interoperability, in line with the ‘one-substance, one- assessment’ ambition. Moreover, digitalization and streamlined processes will reduce duplicative efforts and administrative delays, providing significant cost savings and efficiency gains for both Member States and economic operators.
2024/12/11
Committee: ENVI
Amendment 5 #

2023/0454(COD)

Proposal for a directive
Recital 4
(4) Data and information held by the European Chemicals Agency in the context of regulatory processes under Titles VII and VIII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council5 can be usefully deployed for the assessment of potential substance restrictions and for assessing applications for exemption under Directive 2011/65/EU. Established structures and procedures can help to build on the existing knowledge base, maximise synergies, and make the best use of available expertise and resources. Utilising these established structures not only enhances efficiency but also reduces compliance costs for businesses, ensuring that regulatory processes support innovation and competitiveness in Union industries. _________________ 5 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC - OJ L 396 30.12.2006, p. 1.
2024/12/09
Committee: ENVI
Amendment 5 #

2023/0454(COD)

Proposal for a directive
Recital 4
(4) Data and information held by the European Chemicals Agency in the context of regulatory processes under Titles VII and VIII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council5 can be usefully deployed for the assessment of potential substance restrictions and for assessing applications for exemption under Directive 2011/65/EU. Established structures and procedures can help to build on the existing knowledge base, maximise synergies, and make the best use of available expertise and resources. Utilising these established structures not only enhances efficiency but also reduces compliance costs for businesses, ensuring that regulatory processes support innovation and competitiveness in Union industries. _________________ 5 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC - OJ L 396 30.12.2006, p. 1.
2024/12/11
Committee: ENVI
Amendment 6 #

2023/0454(COD)

Proposal for a directive
Recital 5 a (new)
(5 a) The information submitted as part of the confidential version of an exemption application should be subject to an assessment by the European Chemicals Agency. Such assessment should comply with Union law concerning confidential data and protection of personal data, in particular regarding dissemination and confidentiality criteria established under Regulation (EC) No 1907/2006.
2024/12/09
Committee: ENVI
Amendment 6 #

2023/0454(COD)

Proposal for a directive
Recital 5 a (new)
(5a) The information submitted as part of the confidential version of an exemption application should be subject to an assessment by the European Chemicals Agency. Such assessment should comply with Union law concerning confidential data and protection of personal data, in particular regarding dissemination and confidentiality criteria established under Regulation (EC) No 1907/2006.
2024/12/11
Committee: ENVI
Amendment 7 #

2023/0454(COD)

Proposal for a directive
Recital 5 b (new)
(5 b) Most exemption requests are expected to require the expertise of the Committee for Socio-economic Analysis set up pursuant to Article 76(1), point (d) of Regulation (EC) No 1907/2006. The Members States’ representatives should be consulted by the Commission when adopting guidelines on the involvement of the Committee for Risk Assessment.
2024/12/09
Committee: ENVI
Amendment 7 #

2023/0454(COD)

Proposal for a directive
Recital 5 b (new)
(5b) Most exemption requests are expected to require the expertise of the Committee for Socio-economic Analysis set up pursuant to Article 76(1), point (d) of Regulation (EC) No 1907/2006. The Members States’ representatives should be consulted by the Commission when adopting guidelines on the involvement of the Committee for Risk Assessment.
2024/12/11
Committee: ENVI
Amendment 9 #

2023/0454(COD)

Proposal for a directive
Recital 8
(8) For amending procedural provisions under Directive 2011/65/EU, a transitional period of 124 months is necessary to allow for appropriate resource and task allocation for the European Chemicals Agency. That timeframe is considered sufficient to allow potential applicants or Member States to adjust to the modified procedural steps under that Directive.
2024/12/09
Committee: ENVI
Amendment 9 #

2023/0454(COD)

Proposal for a directive
Recital 8
(8) For amending procedural provisions under Directive 2011/65/EU, a transitional period of 124 months is necessary to allow for appropriate resource and task allocation for the European Chemicals Agency. That timeframe is considered sufficient to allow potential applicants or Member States to adjust to the modified procedural steps under that Directive.
2024/12/11
Committee: ENVI
Amendment 41 #

2023/0454(COD)

Proposal for a directive
Article 2 – paragraph 1
The provisions under this Directive shall be applicable from [OJ: 124 months after the publication of this Directive].
2024/12/09
Committee: ENVI
Amendment 41 #

2023/0454(COD)

Proposal for a directive
Article 2 – paragraph 1
The provisions under this Directive shall be applicable from [OJ: 124 months after the publication of this Directive].
2024/12/11
Committee: ENVI
Amendment 96 #

2023/0453(COD)

Proposal for a regulation
Recital 2
(2) The main objective of this Regulation is to increase the level of protection of the environment and human health from the risks arising from hazardous chemicals, as well as to facilitate the functioning of the internal market for chemical while ensuring proportionality and reducing unnecessary burdens on economic operators. By modernising the integration of information and establishing a cost- effective digital infrastructure, this Regulation seeks to facilitate the internal market for chemicals and improve the predictability and transparency of regulatory processes. For that purpose, this Regulation should establish a common data platform data on chemicals (‘the common data platform’), to be managed by the European Chemicals Agency (‘ECHA’). The common data platform is a digital infrastructure that brings together chemicals data and information generated under the Union chemicals acquis. This Regulation should also establish dedicated services within the common data platform and lay down rules on the accessibility and usability of the data contained in that platform. This Regulation aims to create a common knowledge base on chemicals available to authorities to enable better, complete, coherent and robust scientific assessments of chemicals and their impacts and to ensure the best use of existing information for the purpose of the implementation and the development of Union legislation on chemicals. Moreover, the Regulation aims to provide a one-stop- shop on chemicals data and information in the Union accessible to the general public and, thus, to increase the predictability and the transparency of regulatory processes on chemicals, as well as to strengthen public trust in the robustness of scientific decision-making.
2024/12/05
Committee: ENVI
Amendment 108 #

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 prioritise and protect the confidentiality of data and sensitive information while facilitating efficient data sharing.
2024/12/05
Committee: ENVI
Amendment 111 #

2023/0453(COD)

Proposal for a regulation
Recital 7
(7) The common data platform should contain chemicals-related data and information held by relevant Union agencies or the Commission generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. This includes, for instance, all regulatory dossiers or applications submitted to the relevant Union agencies, but also chemicals data on occurrence of chemicals submitted by Member States to Union agencies or the Commission in compliance with their reporting obligations. The common data platform should also include chemicals data and information generated as part of Union, national or international programmes or research activities related to chemicals, where this data and information is held by the Commission or one of the relevant agencies.focus on consolidating data directly related to regulatory purposes, excluding broader research or international program data unless explicitly required by Union legislation
2024/12/05
Committee: ENVI
Amendment 119 #

2023/0453(COD)

Proposal for a regulation
Recital 8
(8) Due to the differenstinct nature of the risk and hazard assessments performed under Union acts on medicinal products, wthen compared to those performed under the main Union acts on chemicals, for medicinal products, onlymon data platform should include only essential chemicals data related to environmental risk assessments for human and veterinary medicines, non- clinical studies for human medicines and and specific maximum residue limit values held by the European Medicines Agency (‘EMA’) holds, as well as specific reference values, should be included in the common data platform. For medicinal active substances, only data on relevant substances should be included. These concern active substances covered by the medicines legislation and also used for other applicationswith cross-sectoral relevance—those also regulated byunder other Union legislation identified in this Regulation, as well as other active substances with particular—should be included. Data on other active substances should be limited to those with confirmed persistent, bio- accumulative, and toxic properties or with a known high level of residues ia significant impact on the environment.
2024/12/05
Committee: ENVI
Amendment 124 #

2023/0453(COD)

Proposal for a regulation
Recital 9
(9) These data should also be limited to essential chemicals data submitted to the EMA in the context of the relevant procedures that are finalised or submitted after the entry into force of this Regulation. At a later stage, it should also be possible to include in the common data platform, where relevant, data the EMA holds on procedures concluded before the entry into force of this RegulationThe inclusion of data on earlier procedures finalised before the entry into force of this Regulation should be considered only for substances with persistent, bio-accumulative, and toxic properties or substances with significant environmental impact, where such inclusion is deemed necessary for coherence and interoperability within the common data platform.
2024/12/05
Committee: ENVI
Amendment 136 #

2023/0453(COD)

Proposal for a regulation
Recital 12
(12) In order to respond to the needs of the digital economy and to ensure a high level of protection of the environment and human health, it is necessary to lay down a harmonised framework specifying who is entitled to access and use the chemicals data contained in the common data platform, under which conditions, on what basis, and for which purposes. The Authorities that are entrusted with regulatory tasks related to chemicals should be allowed and encouraged to use the chemicals data and information contained in the common data platform to effectively fulfil their regulatory duties and tasks, in order to improve the effectiveness, efficiency, and coherence of chemicals-related assessments as well as the development of Union chemicals policuse the platform to fulfil their regulatory duties efficiently and cost-effectively. Provisions ensuring proportionality and minimised administrative burdens should guide the access and use framework, ensuring balance between robust regulatory oversight and economic competitiveness. Access to personal data should be limited to what is necessary in relation to the purposes for which this data is processed by the Authorities.
2024/12/05
Committee: ENVI
Amendment 139 #

2023/0453(COD)

Proposal for a regulation
Recital 13
(13) Chemicals data and information generated as a result of obligations set by Union acts on chemicals may be protected by confidentiality claims on confidential business information. The public dissemination of such data may affect the commercial interest of private parties. To protect the competitiveness of Union industries, ensure legal certainty for duty holders, and to protect their legitimate expectations, as well as to ensure industry’s competitiveness on the internal marketuphold legitimate commercial interests, the ECHA, as a manager of the common data platform, should grant differentiated access rights to the data and information contained in the common data platformensure that access rights are differentiated based on the sensitivity and confidentiality of the information. To this end, the Authorities should have full access to all chemicals data and information contained in the common data platform, including access to confidential information, while business operators and the general public should have restricted access to that data and information, which does not include access to confidential information.
2024/12/05
Committee: ENVI
Amendment 147 #

2023/0453(COD)

Proposal for a regulation
Recital 18 a (new)
(18 a) When exercising implementing powers, and in the cases in which Regulation (EU) No. 182/2011 does not apply, the Commission should, as part of its preparatory work, take into account views of Member States.
2024/12/05
Committee: ENVI
Amendment 149 #

2023/0453(COD)

Proposal for a regulation
Recital 19
(19) The common data platform should serve the widest possible community, with the ability to address new use cases, incorporate new relevant chemicals datasets, develop new functionalities, and respond to developing tools and applications.
2024/12/05
Committee: ENVI
Amendment 172 #

2023/0453(COD)

Proposal for a regulation
Recital 27 a (new)
(27 a) Given the wide scope of Union acts listed in Annex I, when laying down the practical arrangements for implementing the study notification provisions, consideration should be given to proportionality to avoid the overburdening of business operators, laboratories and the ECHA.
2024/12/05
Committee: ENVI
Amendment 173 #

2023/0453(COD)

Proposal for a regulation
Recital 28
(28) In order to increase transparency, as well as to enable Authorities to have complete prior knowledge of studies commissioned by business operators, irrespective of whether such studies are carried out by the business operator itself or are outsourced, business operators and laboratories should notify to a database of study notifications established and managed by the ECHA the studies on chemicals they commission for compliance with regulatory requirements under the Union acts listed in Annex I. For this purpose, the ECHA should establish and manage a database of study notifications, as a dedicated service of the common data platform, to store the information related to those studies. In order to allow business operators and laboratories sufficient time to prepare the notifications of studies, the obligation to notify studies should only start to apply two years after the date of entry into force of this Regulation.deleted
2024/12/05
Committee: ENVI
Amendment 180 #

2023/0453(COD)

Proposal for a regulation
Recital 29
(29) Under Regulation (EC) No 178/2002 of the European Parliament and of the Council, business operators and laboratories are obliged to notify to the database of study notifications established and managed by the EFSA the studies they commission to support an application or notification in relation to which Union law contains provisions for the EFSA to provide a scientific output. To avoid overburdening business operators and laboratories, they should therefore not be required to also notify those studies to the database of study notifications established and managed by the ECHA under this Regulation.deleted
2024/12/05
Committee: ENVI
Amendment 181 #

2023/0453(COD)

Proposal for a regulation
Recital 30
(30) To ensure the coherence between those two study notification mechanisms, as well as to ensure certainty for business operators submitting notifications, the rules on the public dissemination of study notifications should, where relevant, correspond in that the notifications should only be made available through the common data platform once a corresponding registration, application, notification or other relevant regulatory dossier was submitted to the relevant Union or national institution and a decision on the confidentiality of the data contained in that regulatory dossier was taken by that Union or national institution. In addition, in order to facilitate compliance with the requirement to notify a study, the ECHA and the EFSA should cooperate to ensure a common approach for the identification of notified information in order to facilitate the traceability of studies notified to their respective databases.deleted
2024/12/05
Committee: ENVI
Amendment 184 #

2023/0453(COD)

Proposal for a regulation
Recital 31
(31) While the study notification obligation established in this Regulation should apply in the context of all the Union acts on chemicals listed in Annex I, the various relevant data collection and safety assessment processes under those acts may vary widely procedurally. The overarching aim of the database of study notifications established under this Regulation should be to bring together information on studies on chemicals being commissioned by business operators, such as to enable a centralised and complete overview of the studies being performed to support regulatory compliance under Union acts on chemicals as listed in Annex I. On the basis of this objective and considering the fact that assessment procedures under Union acts on chemicals in Annex I may vary widely, it would be beyond the scope and aim of this Regulation to amend existing assessment processes set under those Union acts listed in Annex I by imposing additional conditions leading to potential market access consequences not foreseen in those Union acts. Consequently, it is not appropriate to introduce in this Regulation the consequences associated non-compliance with the study notification obligation as laid out in Article 32b of Regulation (EC) No 178/2002 of the European Parliament and of the Council.deleted
2024/12/05
Committee: ENVI
Amendment 189 #

2023/0453(COD)

Proposal for a regulation
Recital 32
(32) Nevertheless, to ensure compliance with the study notification obligation laid down in this Regulation, and to cater to the specificities of individual assessment processes, where existing, Member States should lay down rules on penalties applicable to the infringement of that obligation and take all necessary measures to ensure that those rules are complied with. Those penalties should be effective, proportionate, and dissuasive, since non- compliance with this Regulation could result in less robust chemicals risk assessments, creating potential risks and consequently adverse effects on human health and the environment.deleted
2024/12/05
Committee: ENVI
Amendment 191 #

2023/0453(COD)

Proposal for a regulation
Recital 33
(33) In order to facilitate enforcement by Member States, the Agencies responsible for assessing and providing scientific output, including scientific opinions, on regulatory dossiers containing studies subject to notification to ECHA should, where relevant, cooperate and exchange information with the Member State enforcement authorities on the compliance with the obligations laid out in Article 22.deleted
2024/12/05
Committee: ENVI
Amendment 197 #

2023/0453(COD)

Proposal for a regulation
Recital 34
(34) While Regulation (EC) No 178/2002 of the European Parliament and of the Council also requires the consultation of stakeholders and the public following the notification to the EFSA of studies commissioned for the purposes of the renewal of an authorisation or approval, a similar requirement under this Regulation would lay a disproportionate administrative burden on the ECHA, given the wide scope of the studies that is to be notified under this Regulation.deleted
2024/12/05
Committee: ENVI
Amendment 199 #

2023/0453(COD)

Proposal for a regulation
Recital 35
(35) A mechanism related to study notifications exists in Regulation (EC) No 1907/2006 of the European Parliament and of the Council. Where registrants are required to perform studies to generate data in accordance with requirements in Annexes IX and X to that Regulation, they must first submit a testing proposal to the ECHA in order to receive a decision requiring them to perform a study. Such decision may also be issued as an outcome of compliance check or substance evaluation under that Regulation. In order to facilitate the transparency, traceability, and effective monitoring of studies commissioned or carried out pursuant to a decision of the ECHA in accordance with Articles 40, 41 or 46 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council, business operators should specify in their notifications of studies under this Regulation that those studies are being commissioned or carried out in compliance with those decisions.deleted
2024/12/05
Committee: ENVI
Amendment 203 #

2023/0453(COD)

Proposal for a regulation
Recital 38
(38) In order to ensure the interoperability and comparability of chemicals data and to facilitate their automatic and electronic exchange, the Agencies and the Commission should store chemicals data in adequate and mutually coherent and interoperable formats and use mutually coherent and interoperable controlled vocabularies. Some Union acts listed in Annex I or II set procedures to establish or make available data formats, in particular for the submission of chemicals data by business operators or Member States. Where such procedures do not exist in the Union acts listed in Annex I or II, the Agencies and the Commission should, where relevant, specify appropriate formats for chemicals data they receive and store, avoiding the use of proprietary standards while, as appropriate, using OECD or other internationally agreed formats, making use of existing formats and ensuring interoperability with existing data submission approaches. When specifying such formats and controlled vocabularies, the Agencies and Commission should, where relevant, take into account input and contributions from Member States and stakeholders.
2024/12/05
Committee: ENVI
Amendment 229 #

2023/0453(COD)

Proposal for a regulation
Article 1 – paragraph 2 – introductory part
2. To achieve the objectives referred to in paragraph 1, this Regulation contains targeted measures to:
2024/12/05
Committee: ENVI
Amendment 232 #

2023/0453(COD)

Proposal for a regulation
Article 1 – paragraph 2 – point a
(a) bring togetherconsolidate existing essential data and information on chemicals and ensure that data and information are easily findable, accessible, interoperable and re- usable;
2024/12/05
Committee: ENVI
Amendment 235 #

2023/0453(COD)

Proposal for a regulation
Article 1 – paragraph 2 – point b
(b) keep records of studies commissioned or carried out by business operators in the context of fulfilling their obligations set under Union chemicals legislationas required under existing Union chemicals legislation, ensuring no additional obligations or market access conditions are imposed beyond those already set out in the relevant acts;
2024/12/05
Committee: ENVI
Amendment 239 #

2023/0453(COD)

Proposal for a regulation
Article 1 – paragraph 3
3. The provisions laid down in this Regulation apply only to chemicals data as laid out in Article 3(2)explicitly referenced under the Union acts listed in Annex I.
2024/12/05
Committee: ENVI
Amendment 240 #

2023/0453(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 2
2. ‘Authorities’ means the European Commission, the competent authorities of the Member States as referred to in any of the Union acts listed in Annexes I and III, and the Agencies, excluding their management boardsAnnex I, and the Agencies, only insofar as they perform tasks directly under the Union acts listed in Annex I;
2024/12/05
Committee: ENVI
Amendment 241 #

2023/0453(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 3
3. ‘dDuty holder’ means a natural or legal person directly responsible for meeting obligations under the Union acts listed in Annex I or IIfulfilling specific obligations under Annex I-listed Union acts;
2024/12/05
Committee: ENVI
Amendment 242 #

2023/0453(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 10
10. ‘chemicals data’ means any representation of facts factual or regulatory information relating to chemicals and any compilation of such facts or information, including information onsubmitted or generated under Union acts listed in Annex I, specifically concerning chemicals’ physico-chemical properties, hazard properties, use, exposure, risk, occurrence, emissions and manufacturing process of the chemicals, as well as environmental sustainability related information, including climate change related information, on those chemicals, regulatory process-related information on chemicals, standard formats, controlled vocabularies, or any information on applicable legal obligations related to chemicaland use, as well as regulatory process-related information. Environmental sustainability data is included only where explicitly required by Annex I-listed acts;
2024/12/05
Committee: ENVI
Amendment 245 #

2023/0453(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 11 – introductory part
11. ‘environmental sustainability related data’ means any data relevantdata explicitly generated or required under Annex I- listed Union acts for the environmental sustainability assessment of a chemical or material throughout its entire life cycle, including, limited to:
2024/12/05
Committee: ENVI
Amendment 247 #

2023/0453(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 11 – point a
(a) data on resources, including raw materials, water, energy, fossil fuels and l and emissions relevant to the assessment of the chemical under applicable Union legislation; and;
2024/12/05
Committee: ENVI
Amendment 248 #

2023/0453(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 11 – point b
(b) data on emissions, including greenhouse gases, eutrophication-relevant substances, dust and all other polluting substances; andby-products explicitly identified in regulatory submissions;
2024/12/05
Committee: ENVI
Amendment 249 #

2023/0453(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 11 – point c
(c) data on by-products originating during the chemical’s life cycle that can be used as resources for other production processes, including hydrogen and carbon monoxide.deleted
2024/12/05
Committee: ENVI
Amendment 252 #

2023/0453(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 15
15. ‘interoperability’ means the ability of two or more data spaces or communication networks, systems, products, applications or components to exchange and use data in order to perform their functions.;
2024/12/05
Committee: ENVI
Amendment 253 #

2023/0453(COD)

Proposal for a regulation
Article 2 – paragraph 1 – point 15 a (new)
15 a. ‘Study’ means research conducted or commissioned by business operators for the purpose of preparing an application, notification, or regulatory dossier to be submitted to an Authority in compliance with the regulatory requirements of the Union acts specified in Annex I.
2024/12/05
Committee: ENVI
Amendment 255 #

2023/0453(COD)

Proposal for a regulation
Article 3 – paragraph 2 – introductory part
2. The common data platform shall provide access to essentiall chemicals data:
2024/12/05
Committee: ENVI
Amendment 257 #

2023/0453(COD)

Proposal for a regulation
Article 3 – paragraph 2 – point a
(a) generated or submitted as part of the implementation of specific obligations under the Union acts listed in Annex I to this Regulation and held by the Agencies or the Commission;
2024/12/05
Committee: ENVI
Amendment 260 #

2023/0453(COD)

Proposal for a regulation
Article 3 – paragraph 2 – point c
(c) listed in Annex II and held by the EMA;deleted
2024/12/05
Committee: ENVI
Amendment 266 #

2023/0453(COD)

Proposal for a regulation
Article 3 – paragraph 3 – point b a (new)
(b a) data not explicitly required for hazard or risk assessment purposes;
2024/12/05
Committee: ENVI
Amendment 267 #

2023/0453(COD)

Proposal for a regulation
Article 3 – paragraph 3 – point b b (new)
(b b) information submitted to the Agencies or Commission prior to [a specific cutoff date].
2024/12/05
Committee: ENVI
Amendment 271 #

2023/0453(COD)

Proposal for a regulation
Article 3 – paragraph 5 – introductory part
5. The common data platform shall provide the dedicatedfollowing essential services, as identified in the governance scheme referred to in Article 4(3) including:
2024/12/05
Committee: ENVI
Amendment 273 #

2023/0453(COD)

Proposal for a regulation
Article 3 – paragraph 5 – point g
(g) the database on environmental sustainability-related data referred to in Article 13.deleted
2024/12/05
Committee: ENVI
Amendment 284 #

2023/0453(COD)

Proposal for a regulation
Article 3 – paragraph 11
11. The common data platform and its dedicated services shall be established by [OP: please insert date: threfive years after the date of entry into force of this Regulation], unless specified otherwise. The relevant datasets shall be integrated progressively into the common data platform by [OP please insert date: ten15 years from the date of entry into force of this Regulation] according to the implementation plan referred to in Article 4 (1), first sentence. Upon integration of those datasets in the common data platform, when the ECHA receives chemicals data in accordance with Article 5, it shall make that data available through the common data platform without undue delay.
2024/12/05
Committee: ENVI
Amendment 287 #

2023/0453(COD)

Proposal for a regulation
Article 4 – paragraph 1
1. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish an implementation plan identifying chemicals datasets for inclusion in the common data platform together with a timeline for their inclusion by means of an implementing decision. Subsequent rolling implementation plans shall be adopted in line with the governance scheme referred to in paragraph 3.
2024/12/05
Committee: ENVI
Amendment 291 #

2023/0453(COD)

Proposal for a regulation
Article 4 – paragraph 4
4. The Commission shall adopt and publish the governance scheme referred to in paragraph 3 and any revision thereof by means of an implementing decision. Stakeholders shall be consulted before decisions on implementation plans and governance are taken.
2024/12/05
Committee: ENVI
Amendment 302 #

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 iscan be 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 319 #

2023/0453(COD)

Proposal for a regulation
Article 5 – paragraph 8
8. For the purpose of paragraph 2, the Commission and the Agencies shall make chemicals data referred to in Annex I available to the ECHA without undue delay after collection or receipt of the data, after performance of validity and confidentiality assessments in accordance with applicable rules and once the corresponding dataset has been integrated in the common data platform.
2024/12/05
Committee: ENVI
Amendment 342 #

2023/0453(COD)

Proposal for a regulation
Article 8 – paragraph 1
1. TOnce notified by the Authority responsible, the ECHA shall establish and manage a repository of reference values as part of the common data platform.
2024/12/05
Committee: ENVI
Amendment 344 #

2023/0453(COD)

Proposal for a regulation
Article 8 – paragraph 2
2. The ECHA shall include any reference value adopted under Union acts listed in Annex I or Annex II, Part 1, in the repository of reference values without undue delay.
2024/12/05
Committee: ENVI
Amendment 348 #

2023/0453(COD)

Proposal for a regulation
Article 9 – paragraph 2
2. The ECHA shall store in the Database of Study Notifications the data notified to it in accordance with Article 22only chemical data submitted to it under Annex I-listed Union acts where such data are part of registrations, applications, or notifications required under Union law.
2024/12/05
Committee: ENVI
Amendment 353 #

2023/0453(COD)

Proposal for a regulation
Article 9 – paragraph 5
5. The ECHA and the EFSA shall cooperate to ensure a common approach for the identification of information notifisubmitted to them in accordance with Article 22 of this Regulation and Article 32b of Regulation (EC) No 178/2002, respectivelytheir respective mandates under Annex I-listed Union acts and facilitate the traceability of the studies notifiincluded toin their respective databases.
2024/12/05
Committee: ENVI
Amendment 380 #

2023/0453(COD)

Proposal for a regulation
Article 12 – paragraph 2
2. Where standard data formats are established under the Union acts listed in Annexes I and I I, the ECHA shall include them in the common data platform.
2024/12/05
Committee: ENVI
Amendment 383 #

2023/0453(COD)

Proposal for a regulation
Article 13 – paragraph 1
1. At the latest within threfive years after the publication of the decision referred to in paragraph 4, the ECHA shall establish and manage, as part of the common data platform, a database containing environmental sustainability related data.
2024/12/05
Committee: ENVI
Amendment 391 #

2023/0453(COD)

Proposal for a regulation
Article 13 – paragraph 3
3. Where researchers or research consortia funded by Union framework programmes make available to the ECHA, under Article 5(6), any environmental sustainability data on chemicals or materials they collect or generate, the ECHA shall integrate the relevant data in the database on environmental sustainability related data.
2024/12/05
Committee: ENVI
Amendment 394 #

2023/0453(COD)

Proposal for a regulation
Article 13 – paragraph 4
4. By [OP please insert date: three years after the date of entry into force of this Regulation], the Commission shall adopt an implementing decision, in consultation with Member States, identifying existing datasets on environmental sustainability related data, other than those referred to in paragraph 2, for inclusion in the common data platform and shall design relevant related database functionalities.
2024/12/05
Committee: ENVI
Amendment 399 #

2023/0453(COD)

Proposal for a regulation
Article 14 – paragraph 5 – introductory part
5. The Commission and the Agencies shall use the International Uniform Chemical Information Database format (IUCLID) for making available to the ECHA for integration in the common data platform the relevant parts of dossiers under the following Union acts listed in Annex I:
2024/12/05
Committee: ENVI
Amendment 407 #

2023/0453(COD)

Proposal for a regulation
Article 14 – paragraph 6
6. The Commission and the Agencies shall cooperate when setting standard formats to ensure coherence with other formats and the interoperability of the standard formats with the common data platform and with existing data submission approaches. They shall also consult stakeholders.
2024/12/05
Committee: ENVI
Amendment 412 #

2023/0453(COD)

Proposal for a regulation
Article 15 – paragraph 6
6. The Commission and the Agencies shall cooperate with each other in setting the controlled vocabularies and will consult stakeholders.
2024/12/05
Committee: ENVI
Amendment 420 #

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 mad, second sentence, is not made available to the public.
2024/12/05
Committee: ENVI
Amendment 423 #

2023/0453(COD)

Proposal for a regulation
Article 16 – paragraph 3
3. The general public shall only have access to all the chemicals data contained in the common data platform and considered as available to the public in accordance with the Union act under which the data was generated or submitted.
2024/12/05
Committee: ENVI
Amendment 436 #

2023/0453(COD)

Proposal for a regulation
Article 18 – paragraph 1
1. The EEA, in collaboration with the ECHA, the EFSA, the EMA, the EU- OSHA and the Commission, shall establish, in consultation with Member States, operate, and maintain a framework of indicators to monitor the drivers and impacts of exposure to chemicals, measure the effectiveness of chemicals legislation and measure the transition towards the production of safe and sustainable chemicals.
2024/12/05
Committee: ENVI
Amendment 479 #

2023/0453(COD)

Proposal for a regulation
Article 21 – paragraph 5
5. The ECHA shall commission these scientific studies in an open and transparent manner and after a consultation of stakeholders and the public on the intended studies.
2024/12/05
Committee: ENVI
Amendment 494 #

2023/0453(COD)

Proposal for a regulation
Article 22
Article 22 Notification of studies 1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, without undue delay, any studies on chemicals they commission to support an application, notification or regulatory dossier notified or submitted to an Authority, as well as any studies on chemicals on their own or in products they commission as part of a risk or safety assessment , prior to placing on the market, under the Union acts listed in Annex I. However, business operators 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. 2. For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 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. 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. 4. For the purposes of paragraph 3, laboratories and testing facilities shall notify to the Database of Study Notifications referred to in Article 9 the title, scope, intended starting and planned completion dates of any test they carry out, as well as the name of the business operator who commissioned the test. 5. Paragraphs 3 and 4 shall apply, mutatis mutandis, to laboratories and testing facilities located in third countries insofar as set out in relevant agreements with those third countries. 6. The obligations set under this article shall apply from [OP please insert date: 24 months after the date of entry into force of this Regulation]. 7. The ECHA shall lay down the practical arrangements for implementing the provisions of this Article.deleted
2024/12/05
Committee: ENVI
Amendment 532 #

2023/0453(COD)

Proposal for a regulation
Article 25 – title
EnforcementCooperation on compliance
2024/12/05
Committee: ENVI
Amendment 537 #

2023/0453(COD)

Proposal for a regulation
Annex I – point 9
9. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1)deleted
2024/12/05
Committee: ENVI
Amendment 538 #

2023/0453(COD)

Proposal for a regulation
Annex I – point 29
29. Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19)deleted
2024/12/05
Committee: ENVI
Amendment 539 #

2023/0453(COD)

Proposal for a regulation
Annex I – point 65
65. Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1).deleted
2024/12/05
Committee: ENVI
Amendment 543 #

2023/0453(COD)

Proposal for a regulation
Annex III – point 21
21. Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1)deleted
2024/12/05
Committee: ENVI
Amendment 544 #

2023/0453(COD)

Proposal for a regulation
Annex III – point 31
31. Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1).deleted
2024/12/05
Committee: ENVI