282 Amendments of Chloé RIDEL
Amendment 8 #
2024/2718(RSP)
Draft motion for a resolution
Citation 21 a (new)
Citation 21 a (new)
– having regard to the UNFCCC Second report on the determination of needs of developing country Parties related to implementing the Convention and the Paris Agreement of January 2024,
Amendment 20 #
2024/2718(RSP)
Draft motion for a resolution
Citation 63 a (new)
Citation 63 a (new)
– having regard to the UN Convention on the Rights of the Child (1989), as well as the General Comment No. 26 (2023) on Children’s Rights and the Environment with a Special Focus on Climate Change’ from the United Nations Committee on the Rights of the Child, as well as the EU Strategy on the Rights of the Child (2022),
Amendment 40 #
2024/2718(RSP)
Draft motion for a resolution
Recital D
Recital D
D. whereas the 2023 UNFCCC synthesis report on NDCs states that the total global greenhouse gas (GHG) emissions level in 2030 is projected to be 2 % below the 2019 level; whereas the first global stocktake (GST) completed in 2023 at COP28 highlights the critical need to limit global warming to 1,5ºC to significantly reduce the risks and impacts of climate change; whereas the IPCC concludes that in scenarios limiting warming to 1.5 °C, GHG emissions need to be 43 % below their 2019 level by 2030;
Amendment 55 #
2024/2718(RSP)
Draft motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas water is a fundamental resource for human life, agriculture, and ecosystems, and its availability is being severely impacted by climate change, leading to increased droughts, floods, and water scarcity across the globe; whereas the degradation of water-related ecosystems, including rivers, wetlands, and lakes, exacerbates the impacts of climate change on biodiversity and human livelihoods;
Amendment 60 #
2024/2718(RSP)
Draft motion for a resolution
Recital G
Recital G
G. whereas the ocean plays a vital role in regulating the climate by absorbing around 25% of human-caused CO2 emissions and over 90% of the excess heat generated by these emissions; whereas marine ecosystems such as coral reefs, mangroves, and seagrass beds act as crucial carbon sinks that support global climate regulation; whereas the degradation of these ecosystems weakens the ocean’s ability to sequester carbon and adapt to climate change, exacerbating climate impacts; whereas marine biodiversity is seriously endangered, despite the ocean playing athis unique and vital role as a climate regulator;
Amendment 70 #
2024/2718(RSP)
Draft motion for a resolution
Recital H
Recital H
H. whereas methane has been responsible for around 30 % of the rise in global temperatures since the industrial revolution; whereas rapid and sustained reductions in methane emissions are crucial to limiting near-term global warming, as methane is around 80 times more powerful than CO2 over a 20-year period;
Amendment 80 #
2024/2718(RSP)
Draft motion for a resolution
Recital I
Recital I
I. whereas the OECD’s seventh assessment of progress towards the UNFCCC climate finance goal finds that in 2022 developed countries provided a total of USD 115.9 billion in climate finance for developing countries, a figure still well below the actual needs; whereas developing countries face the double challenge of simultaneously investing in development and in climate mitigation and adaptation, while addressing the costs of loss and damage;
Amendment 84 #
2024/2718(RSP)
Draft motion for a resolution
Recital J
Recital J
J. whereas the UNEP’s 2023 adaptation gap report highlights that the current adaptation finance gap is estimated at USD 194 billion to USD 366 billion per year, a gap that will be increasing as climate impacts intensify;
Amendment 86 #
2024/2718(RSP)
Draft motion for a resolution
Recital K
Recital K
K. whereas the European Scientific Advisory Board on Climate Change highlights the need to urgently and fully phase out harmful fossil fuel subsidies across the EU; whereas the elimination of these subsidies is critical to accelerating the transition to renewable energy, ensuring a fair allocation of resources, and meeting the EU’s climate targets under the Paris Agreement;
Amendment 97 #
2024/2718(RSP)
Draft motion for a resolution
Recital K a (new)
Recital K a (new)
Ka. whereas cities, which cover only 2% of the world's surface, are responsible for around 70% of global CO2 emissions, primarily due to industrial activities and transportation systems reliant on fossil fuels1a; _________________ 1a Intergovernmental Panel on Climate Change (IPCC). (2022). Climate Change 2022: Mitigation of Climate Change. Contribution of Working Group III to the Sixth Assessment Report of the Intergovernmental Panel on Climate. https://www.ipcc.ch/report/ar6/wg3/
Amendment 102 #
2024/2718(RSP)
Draft motion for a resolution
Recital K b (new)
Recital K b (new)
Kb. whereas people in the richest 1% of the global population are set to generate per capita consumption emissions in 2030 that are still 30 times higher than the global per capita level, while the footprints of the poorest half of the world population are set to remain several times below that level1a; _________________ 1a Institute for European Environmental Policy (IEEP) and Oxfam. (2021). Carbon Inequality in 2030. https://www.oxfam.org/en/research/carbo n-inequality-2030
Amendment 104 #
2024/2718(RSP)
Draft motion for a resolution
Recital K c (new)
Recital K c (new)
Kc. whereas the most vulnerable populations, including infants, children, pregnant women, the elderly, indigenous communities, and people with disabilities, are disproportionately impacted by the effects of climate change, facing greater risks of food and water insecurity, health threats, displacement, and loss of livelihoods;
Amendment 107 #
2024/2718(RSP)
Draft motion for a resolution
Recital K d (new)
Recital K d (new)
Kd. whereas climate change is increasingly becoming a major driver of migration and displacement, with millions of people forced to flee their homes due to rising sea levels, extreme weather events, droughts, and resource scarcity; whereas by 2050, as many as 216 million people could be internal climate migrants across the regions of Africa, Latin America, Asia and the Pacific and Eastern Europe1a; _________________ 1a World Bank. (2021). Groundswell Part 2: Acting on Internal Climate Migration. Washington, DC: World Bank. https://openknowledge.worldbank.org/enti ties/publication/2c9150df-52c3-58ed- 9075-d78ea56c3267
Amendment 114 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 1
Paragraph 1
1. Takes note ofWelcomes the outcome of the first GST at COP28, which recognises that limiting global warming to 1.5 °C with no or limited overshoot requires deep, rapid and sustained reductions in global GHG emissions of 43 % by 2030 and 60 % by 2035 relative to the 2019 level, reaching net zero GHG emissions by 2050;
Amendment 119 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 2
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; calls on the EU and Member States to lead by example by enhancing investment in renewable energy infrastructure, promoting innovation in energy storage technologies, and implementing strong regulatory frameworks to ensure rapid deployment and equitable access to renewable energy; emphasises the importance of providing financial and technical assistance to developing countries to facilitate their contribution to this global effort, in line with the principles of climate justice and equitable transition;
Amendment 131 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 3
Paragraph 3
3. Supports the COP28 call on the Parties to accelerate efforts towards the phase-down of unabated coal power, and to transition away from fossil fuels in energy systems in a just, orderly and equitable manner, with a view toensuring that the transition prioritises social justice and leave no one behind; highlights the urgency of accelerating action within this critical decade, so as to achieve net zero by 2050, in keeping with the science; reiterates its call on all Parties to work on developing a fossil fuel non-proliferation treaty; at the latest, as scientific evidence continues to show that delays in reducing fossil fuel reliance will lead to increasingly severe climate impacts1a; reiterates its call on all Parties to work on developing a fossil fuel non-proliferation treaty; _________________ 1a International Energy Agency (IEA). (2023). Net Zero by 2050 Roadmap. https://www.iea.org/reports/net-zero- roadmap-a-global-pathway-to-keep-the- 15-0c-goal-in-reach
Amendment 142 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 4
Paragraph 4
4. Expresses concern at the findings of the UNEP’s 2023 emissions gap report that fully implementing current unconditional NDCs would put the world on track for 2.9 °C global warming while the additional implementation and continuation of conditional NDCs would lead to 2.5 °C global warming by the end of the century; draws attention to the fact that this trajectory is far from the 1.5°C target of the Paris Agreement, putting the world on a dangerous path toward irreversible climate changes and the crossing of critical tipping points;
Amendment 147 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on all Parties to scale up their climate targets and accompanying policies and raise the ambition of their NDCs to pursue efforts to limit the temperature increase to 1.5 °C; stresses that these revised NDCs must be aligned with the latest climate science to close the emissions gap, and should include transparent mechanisms for monitoring and accountability to ensure progress is tracked effectively;
Amendment 159 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 6
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; stresses that these mechanisms must prevent loopholes that could undermine climate ambition, while promoting real and verifiable emission reductions and supporting the transition to renewable energy, particularly in developing countries;
Amendment 171 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 7
Paragraph 7
7. Notes that the EU and its Member States are the largest providers of public climate finance, with all EU climate finance reaching an all-time high in 2022 of EUR 28.5 billion; expresses concern that a large part of this contribution was extended through non-grant instruments, particularly loans, which risks exacerbating the already critical debt crises in many developing countries;
Amendment 180 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that developed countries provided and mobilised a total of USD 115.9 billion in climate finance for developing countries in 2022, of which a significant share (over two thirds) was extended as loans, exceeding the UNFCC annual USD 100 billion climate finance goal for the first time, two years after the target year of 2020; points out that this delay resulted in a cumulative shortfall of approximately USD 32 billion between 2020 and 2021;
Amendment 189 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on all Parties to agree on a post-2025 nNew cCollective qQuantified gGoal (NCQG) on climate finance at COP29 with safeguards to reach the agreed quantum and timeframe; stresses that this new goal must exceed the outdated USD 100 billion target and should be set in a science- based manner, in line with developing countries’ climate finance needs; recognises that post-2025 climate finance needs will rise substantially; highlights that the NCQG must be ambitious enough to mobilize the necessary funds, while ensuring robust accountability and transparency mechanisms in the allocation and tracking of resources;
Amendment 204 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 10
Paragraph 10
10. Notes that many developing countries, particularly climate-vulnerable countries, are in debt distress or at significant risk of debt distressfacing a dual crisis of unsustainable debt levels and escalating climate impacts, with many already in or at significant risk of debt distress; stresses that this situation exacerbates their vulnerability to economic instability and severely undermines their capacity to invest in climate action; calls for a shift in international climate finance towards prioritizing public, grant-based and non- debt inducing instruments and measures to ensure that these countries can implement necessary mitigation and adaptation measures without increasing their debt burden;
Amendment 213 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 11
Paragraph 11
11. Considers it essential to advance the Bridgetown Agenda without delay; believes that the NCQG represents a pivotal opportunity to not only scale up climate finance but also to promote reforms in the international financial system by incorporating the principles of the Bridgetown Agenda; calls on all the major international financial institutions and multilateral development banks to align their portfolios and lending policies with the Paris Agreement;
Amendment 220 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 12
Paragraph 12
12. Recalls that fossil fuels are responsible for over 75 % of all GHGs and are therefore the largest contributor to climate change; notes that despite this, fossil fuels still meet over 80% of the world's energy needs; stresses that the phase-out of fossil fuels is both necessary and technologically feasible, and that renewable energy technologies, such as solar and wind, have seen costs drop by nearly 90% over the last decade, making them a viable alternative for a sustainable energy transition;
Amendment 237 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 14
Paragraph 14
14. Is concerned that governments worldwide spent USD 620 billion in 2023 on subsidising the use of fossil fuels, which is over five times more than the 115,9 billion reported as international climate finance to developing countries, and significantly more than the USD 70 billion that was spent in 2023 on support for consumer-facing clean energy investments; encourages all Parties to end all direct and indirect fossil fuel subsidies as soon as possible, reallocating these harmful subsidies toward climate action, including toward international climate finance for the most vulnerable developing countries;
Amendment 245 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Recognises that developed countries, including the EU, should lead by introducing innovative taxes in line with the polluter pays principle, such as wealth taxes and levies on high-emitting sectors like fossil fuels;
Amendment 248 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 15
Paragraph 15
15. Underlines the need to significantly step up adaptation action within the EU and globally to minimise the negative effects of climate change and biodiversity loss; points out that while mitigation finance and implementation have progressed, adaptation efforts continue to lag behind, with a widening gap in both funding and concrete action; recognises that without immediate action, the costs of adaptation will continue to rise, with Europe already experiencing economic losses of EUR 650 billion between 1980 and 2021 due to weather and climate- related extremes1a; _________________ 1a European Environment Agency (EEA). (2023). Economic losses from climate- related extremes in Europe. https://www.eea.europa.eu/en/analysis/ind icators/economic-losses-from-climate- related
Amendment 261 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes the agreement on the framework for the global goal on adaptation (GGA) at COP28, namely the UAE Framework for Global Climate Resilience; highlights the need to translate the GGA into measurable outcomes and to track progress towards achieving the goal; stresses that the GGA must be translated into clear, measurable outcomes with robust tracking systems in place to monitor progress, particularly in the areas of climate finance, nature-based solutions, and resilience-building;
Amendment 265 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Welcomes the European Commission’s Communication on "Managing Climate Risks: Protecting People and Prosperity", which highlights the need for resilience in the face of escalating climate risks; regrets that the communication lacks concrete and actionable measures, relying instead on general recommendations that fail to fully address the urgency of the crisis; calls on the Commission to propose legislation that mandates concrete actions, particularly regarding infrastructure resilience, water management, and nature-based solutions, while prioritizing the protection of vulnerable communities;
Amendment 269 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 17
Paragraph 17
17. Stresses that early warning systems are critical to effective adaptation and, as they can save lives and significantly reduce the socioeconomic impacts of climate change; calls for the rapid implementation of both the Climate Risk and Early Warning Systems (CREWS) initiative, which focuses on vulnerable countries such as Least Developed Countries (LDCs) and Small Island Developing States (SIDS), and the "Early Warnings for All" initiative, which seeks to ensure global access to early warning systems by 2027; emphasises that these systems must be robust, people-centered, and multi- hazard, ensuring the protection of lives, livelihoods, and critical infrastructure from increasing climate risks;
Amendment 274 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the EU Member States and the Commission to ensure the EU is contributing its part to achieving the COP26 commitment of doubling public adaptation finance provision from developed countries to developing countries by 2025, compared to 2019 levels, which implies reaching an aggregate level of at least around USD 40 billion1a; _________________ 1a United Nations Framework Convention on Climate Change (UNFCCC) Standing Committee on Finance. (2023). Report on the Doubling of Adaptation Finance. https://unfccc.int/sites/default/files/resour ce/231120%20BLS23393%20UCC%20Ad aptation%20Finance%20v04.pdf
Amendment 288 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Appreciates the progress in operationalising the Fund since COP28 including through the acceptance of the offer of the Government of the Philippines to host the Fund;
Amendment 301 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 21
Paragraph 21
21. Stresses that climate goals cannot be achieved without the support and involvement of the public, involvement and Free Prior and Informed Consent (FPIC) of the public, including indigenous peoples, local communities, migrants, children and youth, persons with disabilities, and people in vulnerable situations; calls on all Parties to raise awareness of climate change and related issues, combat misinformation and work with public representatives to gain public support for mitigation and adaptation measures; encourages Parties to include children and young people in their national delegations to ensure that future generations have an active role in shaping decisions concerning their future;
Amendment 315 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Recognises the leadership of local and regional governments in accelerating and broadening climate action; stresses the need for enhanced cooperation with local and regional governments in the process of preparing, financing, and implementing NDCs ahead of COP30, as well as other key national climate and environmental strategies, ensuring cohesive and comprehensive planning across all levels of governance;
Amendment 349 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 25
Paragraph 25
25. Takes note of the EU’s updated NDC; highlights that the EU’s current climate legislation will reduce the EU’s net GHG emissions by around 57 % compared to 1990; stresses that, according to the ESABCC, additional efforts to increase the Union’s ambition beyond reaching a 55 % reduction in net GHG emissions by 2030 would considerably decrease the Union’s cumulative emissions until 2050 and thereby increase the fairness of the Union’s contribution to global mitigation;
Amendment 360 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Highlights the importance that the EU moves forward to adopt an ambitious climate target for 2040 of at least 90 % and up to 95 % reduction in net GHG emissions compared to 1990 levels, in line with the recommendation of the European Scientific Advisory Board on Climate Change;
Amendment 365 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 25 b (new)
Paragraph 25 b (new)
25b. Recalls that the Paris Agreement requires the revision of NDCs every five years, with the next revision due in 2025; underlines that this new NDC must reflect the findings of the first global stocktake and align with the EU’s fair share in limiting global warming to 1.5°C, as agreed at COP28;
Amendment 414 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29a. Recognises that achieving the Paris Agreement targets will require substantial decarbonisation of urban areas; emphasises the importance of ensuring that financial support reaches the local level to continue advancing climate action while protecting local economies; welcomes the efforts of EU cities and regions in the Mission on 100 Climate-Neutral Cities, Mission on Adaptation to Climate Change, the Covenant of Mayors, and other initiatives; calls on the Commission to continue supporting and expanding these initiatives;
Amendment 417 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 29 b (new)
Paragraph 29 b (new)
29b. Reiterates that COP28 noted the importance of transitioning to sustainable lifestyles and sustainable patterns of consumption and production in efforts to address climate change, including through circular economy approaches, and encourages further efforts in the EU in this regard as a critical contribution towards achieving climate targets;
Amendment 423 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 30
Paragraph 30
30. Underscores that the climate and biodiversity crises are interlinked; emphasises the importance of protecting, conserving and restoring biodiversity and ecosystems and of managing natural resources sustainably in order to enhance nature-based climate change mitigation and adaptation;
Amendment 454 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 33
Paragraph 33
33. Stresses the need toat all climate actions must protect, respect, promotect the rights and interests of indigenous peoples and local communities; stresses the need to support and protect environmental defender and fulfil human rights, including the right to a clean, healthy and sustainable environment, and the rights of indigenous peoples, local communities, migrants, children and youth, persons with disabilities, and people in vulnerable situations; emphasises the importance of gender equality, the empowerment of women and girls, and intergenerational fairness in addressing the climate crisis; stresses the need to support and protect environmental defenders; calls on all Parties to uphold these values and ensure meaningful public participation, access to information, and Free Prior and Informed Consent (FPIC) for affected communities;
Amendment 466 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 34
Paragraph 34
34. Stresses the importance of implementing the Kunming-Montreal Global Biodiversity Framework; recalls the failure in achieving the Aichi targets; welcomes the submission of EU targets under this Framework to the Convention on Biological Diversity based on the Nature Restoration Law;
Amendment 472 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 35 a (new)
Paragraph 35 a (new)
35a. Stresses the critical link between air pollution and climate change, noting that air pollution is responsible for around 7 million premature deaths annually, with fossil fuel combustion accounting for a significant share of these deaths; welcomes international efforts to address both climate change and air quality through initiatives like the UNECE Convention on Long-Range Transboundary Air Pollution and the Climate and Clean Air Coalition (CCAC); calls on all Parties to enhance cooperation on this matter and align air quality policies with climate action to protect public health and the environment globally;
Amendment 477 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 36
Paragraph 36
36. Emphasises the importance of protecting, conserving and restoring water and water-related ecosystems as vital components of climate resilience and biodiversity conservation; highlights the devastating environmental, social and economic impacts of desertification, droughts, floods and water pollution; calls for enhanced international cooperation to address the growing water crisis, promote sustainable water management, and implement nature-based solutions that can mitigate the impacts of extreme weather events and support long-term water security;
Amendment 518 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 42
Paragraph 42
42. Highlights the fact that the transport sector is the only sector in which emissions have risen at the EU level since 1990 and that this is not compatible with the EU’s climate goals, which is not compatible with the EU’s climate goals; stresses that achieving the EU’s climate objectives will require greater and faster emission reductions from all sectors of society, including the aviation and maritime sectors; welcomes the inclusion of maritime and aviation emissions in the EU ETS as a crucial step toward decarbonisation, which should inspire greater ambition at the international level, including within the International Maritime Organization (IMO) and the International Civil Aviation Organization (ICAO); calls for the EU to advocate for the adoption of stricter global targets and timelines within these organisations; is concerned by the slow progress achieved in the IMO and ICAO in addressing emissions from international shipping and aviation;
Amendment 526 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 43
Paragraph 43
43. Calls on the International Maritime Organization to adopt measures to reduce maritime emissions; calls on the Commission and the Member States to restart UNFCCC negotiations on attributing international shipping emissions to national inventories in line with the Paris Agreement’s 1.5ºC target, requiring a 37 % reduction by 2030, 96 % by 2040, and full decarbonisation by 2050; recognises that if the IMO negotiations fail to achieve action in line with the Paris Agreement, the EU should revise its shipping legislation to enlarge its scope and to align it with the Science Based Targets; notes that recently approved EU shipping legislation is a step in the right direction, but acknowledges that further efforts are needed to achieve zero emissions from shipping; calls on the Commission and the Member States to restart UNFCCC negotiations on attributing international shipping emissions to national inventories on a 50-50 % basis, mirroring the scope of the ETS and FuelEU Maritime; notes with concern the rise in black carbon emissions from Arctic shipping and the insufficient IMO ban on heavy fuel oil; calls for immediate action to address these emissions by requiring ships operating in or near the Arctic to switch to cleaner fuels and install particulate filters to protect the region from further harm; calls for the EU to engage in bilateral and multilateral diplomacy to support other countries in setting up their own national and regional legislation to decarbonise the shipping sector;
Amendment 530 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 43 a (new)
Paragraph 43 a (new)
43a. Stresses the urgent need for the aviation sector to align with global climate goals, particularly the 1.5°C target of the Paris Agreement, as aviation accounts for 2.5 % of global CO₂ emissions but has a total climate impact of around 4 % due to non-CO₂ effects; calls on the International Civil Aviation Organization (ICAO) to adopt more ambitious measures under CORSIA to reduce these emissions; highlights the disproportionate climate impact of private jets, which are up to 14 times more polluting than commercial flights, and urges leaders to choose the least polluting transport options, including for COP29;
Amendment 535 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 44
Paragraph 44
44. Acknowledges the significant potential for GHG emissions reduction in the agricultural sector;, which globally accounts for 10-12 % of anthropogenic emissions and 11 % of total EU emissions in 20201a; notes that EU agricultural emissions have stagnated since 2005, with only a 1.5 % reduction projected by 2040 under current policies; stresses that a transition towards more sustainable agricultural practices, shorter supply chains, and shifts towards healthier foods, diets, and lifestyles would significantly reduce agricultural emissions, enhance mitigation and adaptation, release pressure on land, and help restore soil quality and ecosystems; reiterates that the overconsumption of meat and ultra- processed products needs to be addressed; emphasises the importance of developing more sustainable agriculture by providing farmers with alternatives to reduce the use of synthetic fertilisers and pesticides; highlights that reducing the production and use of synthetic fertilisers and increasing natural carbon sequestration in soils and soil organic matter can offer multiple benefits by increasing soil fertility, restoring biodiversity, and providing substantial mitigation potential; _________________ 1a European Environment Agency (EEA). (2023). Progress and prospects for decarbonisation in the agriculture sector and beyond. https://www.eea.europa.eu/publications/P rogress-and-prospects-for- decarbonisation/progress-and-prospects- for-decarbonisation.
Amendment 565 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 45
Paragraph 45
45. Stresses that all sectors must contribute to the reduction of emissions; calls for a UNFCCC COP29 outcome of a strengthened Mitigation Work Programme that accelerates action pre- 2030 and complements the Global Stocktake, with a focus on sector-specific partnerships to implement outcomes and promote the rapid, equitable shift to renewable energy;
Amendment 582 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 47
Paragraph 47
47. Stresses the urgent need to address the significant climate and environmental impact of the textile sector;, which is responsible for around 8-10 % of global GHG emissions and substantial resource consumption, particularly water and energy1a; calls for the adoption of circular economy principles, including sustainable production, waste reduction, and increased recycling, while tackling challenges such as microplastic shedding, overproduction, and water usage; urges the EU and international bodies to set ambitious targets for reducing emissions, phasing out harmful chemicals, and promoting eco-friendly materials, and to establish global standards for verifiable sustainability claims to prevent greenwashing and help consumers make informed choices; _________________ 1a International Finance Corporation (IFC). (2023). Strengthening Sustainability in the Textile Industry. https://www.ifc.org/en/insights- reports/2023/strengthening-sustainability- in-the-textile-industry
Amendment 598 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 49 a (new)
Paragraph 49 a (new)
49a. Highlights the fact that the Mediterranean is one of the regions most affected by climate change, warming 20 % faster than the global average, with projections of 250 million people facing water scarcity within 20 years1a; notes that the Mediterranean Sea is becoming the fastest warming sea globally, with severe consequences for marine ecosystems, economic sectors, and biodiversity; calls on the Commission and Member States to act urgently, cooperating with Mediterranean partners to implement ambitious adaptation measures and lead mitigation action, focusing on water management, ecosystem restoration, and sustainable economic transitions; _________________ 1a Mediterranean experts on climate and environmental change, ‘Risks associated to climate and environmental changes in the Mediterranean region’, 2019. https://ufmsecretariat.org/wp- content/uploads/2019/10/MedECC- Booklet_EN_WEB.pdf
Amendment 605 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 49 b (new)
Paragraph 49 b (new)
49b. Recognises the disproportionate impact of climate change on women and girls, particularly in developing countries where they are more reliant on natural resources for their livelihoods; notes that climate-induced disasters exacerbate gender inequalities, as women often face greater obstacles in accessing resources, land rights, and decision-making processes; believes that gender balance and the empowerment of women and girls are key to an inclusive and just transition; stresses the need for gender-responsive climate policies that ensure women’s participation in climate action and leadership roles at all levels;
Amendment 610 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 50
Paragraph 50
50. EUnderscores the importance of inclusive approaches in the UNFCCC Process, including the Just Transition Work Programme; calls on all Parties, including the EU and its Member States, to increase efforts to integrate gender equality in their revised NDCs, as well as in climate and environmental policies, in particular those related to mitigation, adaptation and loss and damage, and to increase the meaningful involvement of women’s groups in their design and implementation; emphasises the need for more concrete actions by all Parties to deliver on the commitments of the renewed Gender Action Plan agreed at COP25; urges the Member States and the Commission to increase efforts to achieve the goals set out in the EU Gender Action Plan III;
Amendment 611 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 50 a (new)
Paragraph 50 a (new)
50a. Highlights the importance of aligning climate finance with gender equality, noting that women receive disproportionately less access to financial resources for climate adaptation and mitigation projects; considers that increasing women’s access to inclusive climate finance is critical for a just transition, and emphasises the need for a gender-transformative approach in climate finance; urges the EU and Member States to report on the gender responsiveness of their climate finance contributions and to enhance coherence between gender and climate support through external action instruments and the European Investment Bank (EIB), including through enhancing the participation of women in governance, decision-making, and programmes that support women’s role in climate governance;
Amendment 616 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 50 b (new)
Paragraph 50 b (new)
50b. Highlights the importance of increasing women’s participation in decision-making in the climate diplomacy context, including in COP delegations and leadership at all levels of climate action; regrets that women made up less than 34 % of country negotiating teams at COP28, with only 2 % of delegations achieving gender parity, and notes that some Party delegations still consist of up to 90 % men; calls on all Parties to aim for gender parity in their delegations and at all levels of climate change decision- making and negotiations; urges all Parties to nominate a national gender and climate change focal point and increase their resources, training, and support, including within the EU;
Amendment 4 #
2024/2081(INI)
Motion for a resolution
Citation 6 a (new)
Citation 6 a (new)
– having regard to the International Covenant on Economic, Social and Cultural Rights,
Amendment 8 #
2024/2081(INI)
Motion for a resolution
Citation 7 a (new)
Citation 7 a (new)
– having regard to the United Nations Convention against Torture and other Cruel, Inhuman or Degrading Treatment or Punishment (UNCAT) of 10 December 1984,
Amendment 13 #
2024/2081(INI)
Motion for a resolution
Citation 8 a (new)
Citation 8 a (new)
– having regard to the United Nations Convention on the Rights of Persons with Disabilities (CRPD),
Amendment 17 #
2024/2081(INI)
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
– having regard to the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) of 13 September 2007,
Amendment 18 #
2024/2081(INI)
Motion for a resolution
Citation 11 b (new)
Citation 11 b (new)
– having regard to the United Nations Declaration on the Rights of Peasants and Other People Working in Rural Areas (UNDROP) of 17 December 2018,
Amendment 31 #
2024/2081(INI)
Motion for a resolution
Citation 18
Citation 18
– having regard to Protocols No. 6 and 13 to the Council of Europe Convention of 28 April 1983 for the Protection of Human Rights and Fundamental Freedoms concerning the Abolition of the Death Penalty,
Amendment 54 #
2024/2081(INI)
Motion for a resolution
Citation 40
Citation 40
– having regard to its Sakharov Prize for Freedom of Thought, which in 20234 was awarded to Jina Mahsa Amini and the Woman, Life, Freedom movement in IranMaría Corina Machado and Edmundo González Urrutia, the leader of Venezuela’s democratic forces and the opposition candidate in the July presidential elections,
Amendment 60 #
2024/2081(INI)
Motion for a resolution
Recital A
Recital A
A. whereas the EU is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, as set out in Article 2 TEU; whereas the EU’s action worldwide is guided by the universality and indivisibility of human rights and by the fact that the effective protection and defence of human rights and democracy is at the core of the EU’s external action, including trade, development, security and defence, and enlargement, among others;
Amendment 89 #
2024/2081(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas in November 2024, the Convention of the Rights on the Child celebrates its 35th anniversary;
Amendment 101 #
2024/2081(INI)
Motion for a resolution
Recital G
Recital G
G. whereas the legitimacy of the international rules-based order is dependent on compliance with the orders of international bodies, such as the United Nations Security Council resolutions and orders and decisions of the International Court of Justice and the International Criminal Court; whereas there are increasing global threats to compliance with such orders and decisions, as well as, generally, with provisions of international law, human rights law and international humanitarian law in emerging and ongoing conflict situations;
Amendment 111 #
2024/2081(INI)
Motion for a resolution
Recital I
Recital I
I. whereas human rights defenders (HRDs) and civil society organisations (CSOs) are crucial partners in the EU’s efforts to safeguard and advance human rights, democracy and the rule of law, as well as to prevent conflicts globally; whereas governments around the world are increasingly censoring, silencing and harassing HRDs and CSOs in their work, leading to an increasingly shrinking civil space; whereas this behaviour includes measures encompassing strategic lawsuits against public participation (SLAPPs), restrictive government policies, defamation campaigns, discrimination, intimidation and violence, including extrajudicial killings, abductions, and arbitrary arrests and detention; whereas attacks on HRDs are increasingly extending to their families and communities;
Amendment 119 #
2024/2081(INI)
Motion for a resolution
Recital I a (new)
Recital I a (new)
Ia. whereas gender equality is a core value of the EU; and the human rights of women and girls, including their sexual and reproductive rights, continue to be violated across the world; whereas women human rights defenders and civil society organisations working on gender equality, women’s rights and sexual and reproductive health and rights continue to experience shrinking space for their critical work, as well as threats of violence, harassment and intimidation;
Amendment 136 #
2024/2081(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Reasserts the universality and indivisibility of human rights and the inherent dignity of every human being; reaffirms the duty of the EU and its Member States to promote and protect democracy and the universality of human rights around the world; calls for the EU and its Member States to lead by example and strictly uphold human rights and ensure an enabling civil society environment;
Amendment 165 #
2024/2081(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Condemns the increasing trend of violations and abuses of human rights and democratic principles and values across the world, such as executions, extrajudicial killings, arbitrary arrests and detentions, torture, gender-based violence, clampdowns on civil society and, political opponents, excessive use of violence by public authorities, censorship and threats to independent mediamarginalised and vulnerable groups as well as ethnic and religious minorities, slavery and forced labour, excessive use of violence by public authorities, systematic and structural discrimination and inequality, censorship and threats to independent media, including threats in the digital sphere such as online surveillance and internet shutdowns, political attacks against international institutions, and increasing use of unlawful methods of war in grave breach of international humanitarian law and human rights law, among others; deplores the weakening of the protection of democratic institutions and processes, and the shrinking space for civil societies around the world;
Amendment 196 #
2024/2081(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Denounces the tailor-made narratives of authoritarian and illiberal regimes attacking the universality of human rights and the rule of law, which are being spread by these regimes in international forums such as the United Nations Human Rights Council;
Amendment 213 #
2024/2081(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Observes that the EU and its Member States have made substantial progress in implementing the EU action plan on human rights and democracy, although they have not reached all of its goals, in particular also due to the unprecedented challenges the world has experienced since its adoption; welcomes, in this sense, the extension of the action plan until 2027, with a view to maximising the synergies and complementarity between human rights and democracy at local, national and global levels;
Amendment 219 #
2024/2081(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Fully supports the work of the EUSR for Human Rights in contributing to the visibility and coherence of the EU’s human rights actions in its external relations; upholds the EUSR’s central role in the EU’s promotion and protection of human rights by engaging with non-EU countries and like-minded partners; underlines the need for close cooperation between the EUSR for Human Rights and other EUSRs and Special Envoys in order to further improve this coherence, and calls for greater visibility for the role of the EUSR for Human Rights; calls for the EUSR to be supported in his work with increased resources; insists on the need for the EUSR to report back to Parliament regularly;
Amendment 238 #
2024/2081(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Reiterates its call to include robust clauses on human rights in agreements between the EU and non-EU countries, supported by a clear set of benchmarks and procedures to be followed in the event of violations; calls on the Commission and the EEAS to actively reflect on how to ensure that the human rights clauses in current international agreements are actively monitored and effectively enforced; reiterates that in the face of persistent breaches of human rights clauses by its partner countries, the EU shouldmust react swiftly and decisively, including by suspending the agreements in question if other options prove ineffective; calls on the Commission to ensure the creation of accessible, citizen-friendly and transparent complaint mechanism, to which also non-EU actors are able to submit complaints regarding failures of the parties to the agreement to comply with human rights clauses;
Amendment 255 #
2024/2081(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses the important role of human rights dialogues within the EU’s human rights toolbox and as a key vehicle for the implementation of the EU action plan on human rights and democracy; highlights that these dialogues should address the overall situation of human rights and democracy with the relevant countries and ensure the meaningful participation of civil society; notes that human rights dialogues should be seen as a key element of sustained EU engagement and not as a free-standing instrument; recalls that these dialogues need to be used in conjunction and synergy with other instruments; reiterates the need to raise individual cases, in particular Sakharov Prize laureates and those highlighted by Parliament in its resolutions, and ensure adequate follow-up; calls to increase the visibility of these dialogues and their outcomes, including through the publication of a joint press statement;
Amendment 267 #
2024/2081(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Welcomes the increasing use of the EU GHRSR as a key political tool in the EU’s defence of human rights and democracy across the world; notes, however, the challenges that the requirement of unanimity poses in the adoption of sanctions and reiterates its call for the introduction of qualified majority voting for decisions on the GHRSR; fully supports the possibility of imposingrecalls, in this regard, the formal request submitted by the European Parliament to the Council, in 2023, on whether to open the EU reform convention, with the aim of evolving to more decisions by qualified majority, among others; reiterates its calls for the adoption of targeted anti-corruption sanctions within the EU framework in this regard, which has been a long-standing priority of Parliament, whether through its inclusion in the GHRSR or under a different regime; highlights the need for the complete enforcement of sanctions and calls for circumventions to be tackled;
Amendment 297 #
2024/2081(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Welcomes the update of the EU Visa Code Handbook in relation to human rights defenders and calls for its full and consistent use by the Member States; reiterates its call for the Commission to take a proactive role in the establishment of an EU-wide multi-entry visa scheme for HRDs at risk;
Amendment 303 #
2024/2081(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Expresses concern with the rise of transnational repression as a tool used by autocratic regimes to target human rights defenders beyond their borders; calls for the formulation of an EU strategy harmonising national responses to transnational repression;
Amendment 321 #
2024/2081(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Reaffirms that promoting the respect, protection and fulfilment of human rights around the world requires strong international cooperation at a multilateral level; underlines the particularly important role of the UN and its bodies as the main forum which must be able to effectively advance efforts for peace and security, sustainable development and respect for human rights and international law; calls for the EU and its Member States to continue supporting the work of the UN, both politically and financially; reiterates the need for the EU and its Member States to speak with one voice at the UN and in other multilateral forums and calls for progress in ensuring an EU seat in international organizations, including in the UN Security Council; calls for EU delegations to play a stronger role in multilateral forums, for which they should have appropriate resources available;
Amendment 368 #
2024/2081(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Reiterates the strong support of the EU for the International Court of Justice and the ICC amid a particularly challenging time for the international justice; notes with deep concern the worrying and rising trend to undermine the decisions of international institutions and their employees by state officials; regrets the failure of some ICC Member States to execute ICC arrest warrants, thereby undermining the Courts work;
Amendment 371 #
2024/2081(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Urges the EU to put in place preventive measures to effectively shield the ICC against the potential adoption of the pending legislation at the US House of Representatives which aims to impose targeted sanctions on judges, staff and legal experts of the ICC, mitigating its harmful consequences on the Courts work;
Amendment 387 #
2024/2081(INI)
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Condemns in the strongest terms the use of sexual violence against women and girls as a weapon of war and calls for more concerted efforts to end impunity for the perpetrators;
Amendment 390 #
2024/2081(INI)
Motion for a resolution
Paragraph 21 b (new)
Paragraph 21 b (new)
21b. Reiterates its call on the Member States to help contain armed conflicts and serious violations of human rights or international humanitarian law by strictly abiding by the provisions of Article 7 of the UN Arms Trade Treaty on Export and Export Assessment and Council Common Position 2008/944/CFSP on Arms Exports;
Amendment 427 #
2024/2081(INI)
Motion for a resolution
Paragraph 24
Paragraph 24
24. Recalls that the right to food, including having physical and economic access to adequate food or the means to its procurement, is a human right; is extremely concerned about the challenges to the right to food worldwide, especially in situations of war and conflicts; notes with concern the increasing reports of the weaponisation of food in situations of armed conflict; calls for the EU and its Member States to promote mandatory guidelines on the right to food without discrimination within the UN system; recalls the importance of the United Nations Declaration on the Rights of Peasants and Other People Working in Rural Areas in view of attaining food security;
Amendment 432 #
2024/2081(INI)
Motion for a resolution
Subheading 18
Subheading 18
Climate change and the right to a clean, healthy, and sustainable environment
Amendment 440 #
2024/2081(INI)
Motion for a resolution
Paragraph 25
Paragraph 25
25. Highlights that climate change and its impact on the environment has direct effects on the effective enjoyment of all human rights; recognises the important work of CSOs, indigenous people, traditional local communities, land and environmental HRDs and indigenous activists for the protection of a clean, healthy and sustainable environment, including access to land and water sources; deplores the risks that environmental HRDs and indigenous and local communities activists face and calls for their effective protection to be guaranteed; notes with deep concern the increasing threats to a clean, healthy and sustainable environment posed by the deployment of weapons of mass destruction and other forms of warfare that adversely and disproportionately affect the environment;
Amendment 443 #
2024/2081(INI)
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Stresses the need to effectively address the displacement of people caused by environmental destruction and climate change, which increases the risk of human rights violations and vulnerabilities to different forms of exploitation;
Amendment 464 #
2024/2081(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Stresses that women’s rights and gender equality are indispensable and indivisible human rights, as well as a basis for the rule of law and inclusive resilient democracies; deplores the fact that millions of women and girls continue to experience discrimination and violence, especially in the context of conflicts, and are denied their dignity, autonomy and even life; calls for the EU, its Member States and like- minded partners to step up their efforts to ensure the full enjoyment and protection of women’s and girls’ human rights; condemns in the strongest terms the increasing attacks on sexual and reproductive health and rights around the world, as well as gender-based violence; welcomes the accession of the EU to the Istanbul Convention; calls for the EU and its international partners to strengthen their efforts to ensure that women fully enjoy human rights and are treated equally to men; underlines the need to keep opposing and condemning in the stronger terms the cruel and misogynistic anti- abortion laws that punish women and girls with decades-long jail sentences, even in cases of rape, incest or when the life of the pregnant person is at risk; stresses the need to pursue efforts to fully eradicate the practice of female genital mutilation;
Amendment 512 #
2024/2081(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Denounces the erosion of the human rights and the safety of refugees, asylum seekers and forcibly displaced persons; reaffirms their inalienable human rights and fundamental right to seek asylum; recalls the obligation of states to protect them in accordance with international law; calls for the EU and its Member States to effectively uphold their rights in the EU’s asylum and migration policy and in the EU’s cooperation with partner countries in this regard; stresses that the EU should step up its efforts to acknowledge and develop ways to address the root causes of irregular migration and forced displacement, building the resilience of migrants’ communities of origin and helping them offer their members the possibility to enjoy a decent life in their home country; calls for the EU and its Member States to continue and, where possible, step up their support for countries hosting the most refugees, as well as for transit countries; reiterates that close cooperation and engagement with non-EU countries, in full respect of fundamental rights, remain key to preventing migrant smuggling; stresses, in this regard, that the dissemination of information and awareness-raising campaigns on the risks of smuggling are crucial; calls for EU- funded humanitarian operations to take into consideration the specific needs and vulnerabilities of children and to ensure their protection while they are displaced; underlines the importance of developing an effective framework of safe and legal pathways to the EU and welcomes, in this regard, the Commission communication on attracting skills and talent to the EU10 , including the development of talent partnerships with partner countries; _________________ 10 Commission communication of 27 April 2022 on attracting skills and talent to the EU (COM(2022)0657).
Amendment 518 #
2024/2081(INI)
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28a. Is deeply concerned about the practice of concluding informal arrangements with third countries in relation to migration cooperation, over which the European Parliament has no oversight; calls on the Member States to ensure transparency and allow for parliamentary scrutiny and democratic oversight, notably regarding cooperation with parties known to have committed violations of human rights; calls on the Commission and the Member States to integrate pre-assessment as well as monitoring mechanisms to evaluate the human rights impact of cooperation on migration with third countries, and to share the results with Parliament; insists on including human rights clauses in migration agreements and calls for their suspension if human rights violations occur;
Amendment 556 #
2024/2081(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Reiterates its call for the EU and its Member States to develop new avenues to strengthen the rights of elderly people, taking into account the multiple challenges they face, such as age-based discrimination, poverty, violence and a lack of social protection, healthcare and other essential services, as well as barriers to employment; underlines the work of the UN Open-ended Working Group on Ageing on a legally binding instrument to strengthen the protection of the human rights of older people and calls for the EU and its Member States to consider actively supporting that work; stresses the need for a crosscutting intergenerational approach in EU policies, in order to build and encourage solidarity between the young and the elderly;
Amendment 590 #
2024/2081(INI)
Motion for a resolution
Paragraph 34
Paragraph 34
34. Reiterates its concern regarding violations of the right to freedom of thought, conscience, religion and belief; deplores the instrumentalisation of religious or belief identities for political purposes and the exclusion of persons belonging to religious and belief minorities and religious communities in certain non- EU countries; recommendconsiders that the Special Envoy for the promotion and protection of freedom of religion or belief outside the EU be must be integranted more resources so that he can comfortably carry out his mandateinto the EEAS in a similar way to the other special envoys and EU special representatives; highlights the necessity for the Special Envoy to continue to work closely and in a complementary manner with the EUSR for Human Rights and the Council Working Party on Human Rights; calls for the EU and its Member States to step up their efforts to protect the right to freedom of thought, conscience, religion or belief, to raise these issues at UN human rights forums and to continue working with the relevant UN mechanisms and committees;
Amendment 629 #
2024/2081(INI)
Motion for a resolution
Paragraph 35
Paragraph 35
35. Emphasises the critical significance of freedom of expression and access to trustworthy information for sustaining democracy and a thriving civic space; is seriously concerned about the increasing restrictions on freedom of expression in numerous countries worldwide, particularly for journalists, through censorship, enforced self-censorship, and the misuse of counter-terrorism or anti- corruption laws to suppress journalists and civil society groups; raises concerns, additionally, about the physical security of journalists and media workers and their being targeted and often killed in conflict zones;
Amendment 636 #
2024/2081(INI)
Motion for a resolution
Paragraph 36
Paragraph 36
36. Calls urgently for the EU to back trustworthy media and information outlets that promote the accountability of authorities and support democratic transitions; voices concern about the extensive use of SLAPPs to silence journalists, activists, trade unionists and HRDs globally; welcomes, in this context, the directive designed to shield journalists and HRDs from abusive legal actions and SLAPPs; encourages lawmakers in non-EU countries to develop legislation with the same goal, as part of broader efforts to promote and protect media freedom and pluralism; asks the EU to take into consideration the attacks on media freedom, as well as the persistent and systematic erosion of the right to information, in the monitoring of the compliance of association and trade agreements with democracy and humans rights;
Amendment 640 #
2024/2081(INI)
Motion for a resolution
Paragraph 37
Paragraph 37
37. Welcomes the Commission’s plan to finance initiatives that support journalists on legal and practical matters, including beyond the EU, through the European Democracy Action Plan; calls for the EU to strengthen its efforts to aid targeted journalists globally; acknowledges the contribution to achieving this goal of programmes such as the now defunct Media4Democracy and other EU-funded activities, including those of the European Endowment for Democracy; urges the EU to help make reliable news sources available to more people living in countries that restrict press freedom;
Amendment 646 #
2024/2081(INI)
Motion for a resolution
Paragraph 38 a (new)
Paragraph 38 a (new)
38a. Notes with concern that more than half of the world's population lives within environments of completely or severely restricted levels of academic freedom, which has severe consequences for the right to education, the enjoyment of the benefits of scientific progress and the freedom of opinion and expression; urges the EU and its Member States to step up their efforts to halt censorship, threats or attacks on academic freedom, and especially the imprisonment of scholars worldwide;
Amendment 647 #
Amendment 648 #
2024/2081(INI)
Motion for a resolution
Subheading 29 b (new)
Subheading 29 b (new)
Notes with regret that indigenous peoples continue to face widespread and systematic discrimination and persecution worldwide, including forced displacements; condemns arbitrary arrests and the killing of human rights and land defenders who stand up for the rights of indigenous peoples; stresses that the promotion of the rights of indigenous peoples and their traditional practices are key to achieving sustainable development, combating climate change and conserving biodiversity; urges governments to pursue development and environmental policies that respect economic, social and cultural rights, and that are inclusive of indigenous peoples and local populations, in line with the UN Sustainable Development Goals; reiterates its call for the EU, its Member States and their partners in the international community to adopt all necessary measures for the recognition, protection and promotion of the rights of indigenous peoples, including as regards their languages, lands, territories and resources, as set out in the UN Declaration on the Rights of Indigenous Peoples; calls on all states, including EU Member States, to ensure that indigenous peoples and local communities are included in the deliberations and decision-making processes of international climate diplomacy; encourages the Commission to continue to promote dialogue and collaboration between indigenous peoples and the EU;
Amendment 662 #
2024/2081(INI)
Motion for a resolution
Paragraph 40
Paragraph 40
40. Stresses the role of trade as a major instrument to promote and improve the human rights situation in the EU’s partner countries; notes, however, that there has been little to no improvement in some of the countries concerned; deplores the detrimental effects of some excessive and exploitative business activities on human rights and democracy; welcomes the harmonisation resulting from the adoption of the Directive on corporate sustainability due diligence with binding EU rules on responsible corporate behaviour with regard to human, labour and environmental rights; further welcomes the Regulation on prohibiting products made with forced labour on the Union market11 and calls for its swift implementation at Member State level; _________________ 11 Proposal for a regulation of the European Parliament and of the Council on prohibiting products made with forced labour on the Union market (COM(2022)0453).recalls the responsibility of businesses in ensuring that their operations and supply chains are not implicated in human rights abuses, including against environmental, indigenous and labour rights defenders; emphasises the need to tackle corporate human rights abuses and ensure justice and reparation for victims;
Amendment 665 #
2024/2081(INI)
Motion for a resolution
Paragraph 40 a (new)
Paragraph 40 a (new)
40a. Welcomes the harmonisation resulting from the adoption of the Directive on corporate sustainability due diligence with binding EU rules on responsible corporate behaviour with regard to human, labour and environmental rights; further welcomes the Regulation on prohibiting products made with forced labour on the Union market 11a and calls for its swift implementation at Member State level; _________________ 11a Proposal for a regulation of the European Parliament and of the Council on prohibiting products made with forced labour on the Union market (COM(2022)0453).
Amendment 666 #
2024/2081(INI)
Motion for a resolution
Paragraph 40 b (new)
Paragraph 40 b (new)
40b. Reiterates its call for the Council to adopt a negotiating mandate for the UN binding instrument on business and human rights;
Amendment 680 #
2024/2081(INI)
Motion for a resolution
Paragraph 42
Paragraph 42
42. Is concerned by the threat that artificial intelligence (AI) can pose to democracy and human rights, especially if it is not duly regulated; welcomes the Council conclusions on Digital Diplomacy of 26 June 2023 to strengthen the EU’s role and leadership in global digital governance, in particular its position as a shaper of thea global digital rulebook based on democratic principles; welcomes, in this regard, the adoption of the EU Artificial Intelligence Act which aims to harmonise the rules on AI for protecting human rights, and the advantages that AI can bring to human wellbeing; notes with concern the adverse effects of the ‘fake content industry’ on the right to information and press freedom, including the rapid development of AI and the subsequent empowerment of the disinformation industry12 ; _________________ 12 Reporters Without Borders, ‘2023 World Press Freedom Index – journalism threatened by fake content industry’ https://rsf.org/en/2023-world-press- freedom-index-journalism-threatened-fake- content-industry.
Amendment 683 #
2024/2081(INI)
Motion for a resolution
Paragraph 43
Paragraph 43
43. Stresses that the internet should be a place where freedom of expression prevails; considers, nevertheless, that the rights of individuals need to be respected; is of the opinion that, where applicable, what is considered to be illegal offline, should be considered illegal online; expresses concern for the growing number of internet shutdowns; highlights that internet shutdowns are often used by authoritarian regimes, among others, to silence political dissidence and curb political freedom; calls urgently for the EU to combat this alarming phenomenon; urges the EU to take a firm stance against any attempts by tech giants to circumvent or undermine national legal systems and independent court decisions;
Amendment 686 #
2024/2081(INI)
Motion for a resolution
Paragraph 43 a (new)
Paragraph 43 a (new)
43a. Takes the firm position that the export of spyware from the Union to third countries where such tools are used against human rights activists, journalists and government critics, is a severe violation of the fundamental rights enshrined in the Charter and a gross violation of Union export rules;
Amendment 32 #
2024/2019(DEC)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Considers that civil society and NGOs play an instrumental role in shaping policies that benefit society and our environment; recalls the commitment of the Commission in its political guidelines to step up its engagement with civil society organisations that have expertise and an important role to play in defending specific societal issues and upholding human rights; urges the Commission to revise its guidelines1a from May 2024 in order to ensure the continuation of the funding of NGO activities, including advocacy, under the LIFE programme; considers that discontinuation of this funding for all NGO activities would seriously undermine the voice of civil society in the public debate and would cause a severe reputational risk for the Commission; _________________ 1a Guidance on funding for activities related to the development, implementation, monitoring and enforcement of Union legislation and policy
Amendment 4 #
2023/0455(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) To improve further the cooperation among Union agencies in the area of chemicals, and to increase coherence and efficiency of assessments related to chemicals across Union legislation, it is necessary to lay the foundation for a common approach to hazard assessment of chemicals across Union legislation. This Regulation should establish a forum for Agencies to improve sharing and re-use of chemicals data, exchange best practices, and foster cooperation in the hazard assessment of chemicals.
Amendment 9 #
2023/0455(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Correspondingly, this Regulation aims to address the eventual divergence between scientific opinions of the European Food Safety Authority and those of other Union agencies. Regulation (EC) No 178/2002 of the European Parliament and Council already contains provisions establishing a procedure to solve divergent scientific opinions. Those resolution procedures should be reinforced, in that the European Food Safety Authority and the other dissenting agency should be bound to make their best effort to resolve the divergence on general scientific issues, and only when they are not able to resolve the divergence, should they refer to risk managers. Differences in assessment methodologies resulting in divergent opinions, particularly with regards to the protection of vulnerable groups, should be duly clarified. In such instances, priority should be given to the most protective opinion to safeguard the most vulnerable populations.
Amendment 12 #
2023/0455(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) In the more specific case of scientific divergence pertaining to the hazard identification of chemical substances, a new procedure enabling the resolution of the divergence should be established. This procedure should enable the Commission to request the European Chemicals Agency, as the Union agency most equipped with expertise and capacity in hazard assessment, as well as long- standing experience with the harmonised classification and labelling process, to develop a proposal for harmonised classification and labelling, in accordance withe Regulation (EC) No 1272/2008 of the European Parliament and Council, moving closer to the ‘one substance, one assessment’ vision as regards uniformity of hazard assessments of chemicals across the Union. This possibility should be reflected in the relevant provision providing for the resolution of diverging scientific opinions laid down in Regulation (EC) No 178/2002.
Amendment 17 #
2023/0455(COD)
Proposal for a regulation
Article -1 (new)
Article -1 (new)
Article -1 Forum on Hazard Assessment 1. The Commission shall, by means of an implementing decision, establish and manage a Forum on Hazard Assessment ('the Forum') which shall include representatives from each of the Agencies, the Commission, Member states and the European Parliament. 2. The Forum shall establish a work programme to (a) foster cooperation in the area of hazard assessment of chemicals; (b) improve the sharing and re-use of data between agencies; (c) establish a strategy toward the common hazard assessment of chemicals across Union legislation in the area of chemicals. 2. The forum shall meet and update its work programme regularly. 3. The Forum shall draw up an annual report, compiling and analysing the advancement and conclusions of its work programme referred to in paragraph 2. The first report shall be prepared by [OP: please insert date: 1 year after the end of the first calendar year after entry into force of this Regulation]. The Forum shall present this report to the Commission, relevant Union agencies and Member State competent authorities, the European Parliament and the Council for consideration of the need for regulatory or policy action related to the conclusion of this report
Amendment 19 #
2023/0455(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 178/2002
Article 30 – paragraph 2 – subparagraph 3
Article 30 – paragraph 2 – subparagraph 3
Where the Authority identifies a potential source of divergence, it shall contact the body concerned in order to ensure that all relevant scientific or technical information is shared and in order to identify the potentially contentious scientific or technical issues. Difference in assessment methodologies resulting in divergent opinions shall be duly justified, especially regarding the protection of vulnerable groups.
Amendment 22 #
2023/0455(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 178/2002
Article 30 – paragraph 2 – subparagraph 2
Article 30 – paragraph 2 – subparagraph 2
The Authority and the body concerned shall cooperate to resolve the divergence. Priority shall be given to the opinion that affords the highest level of protection in order to safeguard the most vulnerable groups. If the Authority and the body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues and identify the relevant uncertainties in the data and be made publicly available.
Amendment 26 #
2023/0455(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)
Article 1 – paragraph 1 – point 2 a (new)
Regulation (EC) No 178/2002
Article 30 – paragraph 3 a (new)
Article 30 – paragraph 3 a (new)
In article 30, the following paragraph is added 3a. In cases where a divergence is identified, and the Authority requests additional information from the other Union or Member State authority, the period by when the relevant authorities are required to adopt their respective output, or the joint output referred to in paragraph 2, may be extended. After consulting the body concerned, the Authority shall lay down a period within which this information shall be provided and shall inform the Commission of the additional period needed. The Commission shall inform the concerned business operator(s) and the Member States of the extension.
Amendment 30 #
2023/0455(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
Regulation (EU) 2017/745
Annex I – Section 10.4.1 – point b
Annex I – Section 10.4.1 – point b
(b) substances which are identclassified as endocrine disruptors for human health, of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council12 andor substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council or substances having endocrine disrupting properties relevant to human health identified in accordance with Regulation (EU) No 528/2012. _________________ 12 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006( OJ L 353 31.12.2008, p. 1 ).
Amendment 33 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EU) 2019/1021
Article 8 – paragraph 1a – point a
Article 8 – paragraph 1a – point a
(a) as appropriate, information on human health and environmental impacts of waste consisting of, containing or contaminated with POPs, including impacts on waste management;
Amendment 34 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EU) 2019/1021
Article 8 – paragraph 1a – subparagraph 2
Article 8 – paragraph 1a – subparagraph 2
The Agency shall, as soon as it receives the request referred to in the first subparagraphArticle 8(1), point (i), publish on its website a notice that a report on a possible amendment of Annex IV or V will be prepared inviting all interested parties, including waste operators and users of recycled materials, to submit comments within 8 weeks. The Agency shall publish those comments on its website.
Amendment 35 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EU) 2019/1021
Article 8 – paragraph 1a – subparagraph 3
Article 8 – paragraph 1a – subparagraph 3
At the latest 9 months following the submission of that report referred to in Article 8(1), point (i), the Committee for Socio-economic Analysis of the Agency, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 shall adopt an opinion on the report and on the concentration limit values proposed therein. For the purpose of adopting an opinion on the report, Article 87 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis.
Amendment 36 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 4
Article 4 – paragraph 1 – point 4
Regulation (EU) 2019/1021
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The Commission is empowered to adopt delegated acts in accordance with Article 18, to amend Annexes IV and V to adapt them to the changes to the list of substances set out in the Annexes I, II or III to Regulation(EU) 2019/1021, or the Annexes to the Convention or the Protocol or to adapt them to scientific and technical progress.
Amendment 38 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Article 18 – paragraph 6
Article 18 – paragraph 6
6. A delegated act adopted pursuant to Articles 4(3), 10(2) and 15 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period may be extended by two months at the initiative of the European Parliament or of the Council’.
Amendment 39 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 5 Present text
Annex IV – Table 1 – Row 5 Present text
Amendment 40 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 12 Present text
Annex IV – Table 1 – Row 12 Present text
Amendment 41 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 30
Annex IV – Table 1 – Row 30
Amendment 42 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 27 Present text
Annex IV – Table 1 – Row 27 Present text
Amendment 43 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 31 Present text
Annex IV – Table 1 – Row 31 Present text
Amendment 8 #
2023/0454(COD)
Proposal for a directive
Recital 6 a (new)
Recital 6 a (new)
(6 a) The list of restricted substances Directive 2011/65/EU should be periodically reviewed to ensure a high level of protection of human health, the environment and consumer safety. It is considered appropriate to set the review period by taking into account market developments and technical and scientific progress and in view of the fact that restriction dossiers can be submitted by Member States at any time and horizontal restriction measures can be initiated and adopted by Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021 or other Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 8 #
2023/0454(COD)
Proposal for a directive
Recital 6 a (new)
Recital 6 a (new)
(6a) The list of restricted substances Directive 2011/65/EU should be periodically reviewed to ensure a high level of protection of human health, the environment and consumer safety. It is considered appropriate to set the review period by taking into account market developments and technical and scientific progress and in view of the fact that restriction dossiers can be submitted by Member States at any time and horizontal restriction measures can be initiated and adopted by Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021 or other Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 10 #
2023/0454(COD)
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8 a) In order to ensure that this Directive is coherent with any future amendment of Regulation (EC) No 1907/2006, or of other future Union law concerning sustainability criteria for hazardous substances and chemicals, the Commission should assess whether an amendment of Articles 5 and 6 of this Directive is required. Where appropriate, the Commission should propose amendments to this Directive in a future regulation amending Regulation (EC) No 1907/2006 or in other future Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 10 #
2023/0454(COD)
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8a) In order to ensure that this Directive is coherent with any future amendment of Regulation (EC) No 1907/2006, or of other future Union law concerning sustainability criteria for hazardous substances and chemicals, the Commission should assess whether an amendment of Articles 5 and 6 of this Directive is required. Where appropriate, the Commission should propose amendments to this Directive in a future regulation amending Regulation (EC) No 1907/2006 or in other future Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 14 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 2 – point a a (new)
Article 5 – paragraph 4a – subparagraph 2 – point a a (new)
(a a) shall publish the draft opinions referred to in point (a) on its website without delay and invite interested parties to provide their comments on the draft opinion for a period no shorter than 60 days after its publication;
Amendment 14 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 2 – point a a (new)
Article 5 – paragraph 4a – subparagraph 2 – point a a (new)
(aa) shall publish the draft opinions referred to in point (a) on its website without delay and invite interested parties to provide their comments on the draft opinion for a period no shorter than 60 days after its publication;
Amendment 16 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 3
Article 5 – paragraph 4a – subparagraph 3
Each Committee shall take into account any information submitted by interested parties in accordance with the second subparagraph, point (aa), and submitted by third parties in accordance with the second subparagraph, point (c).
Amendment 16 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 3
Article 5 – paragraph 4a – subparagraph 3
Each Committee shall take into account any information submitted by interested parties in accordance with the second subparagraph, point (aa), and submitted by third parties in accordance with the second subparagraph, point (c).
Amendment 18 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 5
Article 5 – paragraph 4a – subparagraph 5
The Agency shall identify which parts of its opinions and of any attachments thereto should be made publicly available on its website and shall make those parts publicly available on its website, together with any requests made in accordance with the second subparagraph, point (c).
Amendment 18 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 5
Article 5 – paragraph 4a – subparagraph 5
The Agency shall identify which parts of its opinions and of any attachments thereto should be made publicly available on its website and shall make those parts publicly available on its website, together with any requests made in accordance with the second subparagraph, point (c).
Amendment 22 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b a (new)
Article 1 – paragraph 1 – point 1 – point b a (new)
Directive 2011/65/EU
Article 5 – paragraph 5
Article 5 – paragraph 5
Amendment 22 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b a (new)
Article 1 – paragraph 1 – point 1 – point b a (new)
Directive 2011/65/EU
Article 5 – paragraph 5
Article 5 – paragraph 5
Amendment 23 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Directive 2011/65/EU
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 30 months on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.;
Amendment 23 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Directive 2011/65/EU
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 30 months on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.;
Amendment 25 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
The review and amendment of the list of restricted substances, or group of substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
Amendment 25 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
The review and amendment of the list of restricted substances, or group of substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
Amendment 27 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
The Agency or a Member State shall take into account any available information and any relevant risk assessment submitted for the purposes of other Union legislation covering any part of the life cycle of the substance used in EEE, in particular the waste phase. To this end, other bodies established under Union law and carrying out a similar task shall, on request, provide information to the Agency or Member State concerned.
Amendment 27 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
The Agency or a Member State shall take into account any available information and any relevant risk assessment submitted for the purposes of other Union legislation covering any part of the life cycle of the substance used in EEE, in particular the waste phase. To this end, other bodies established under Union law and carrying out a similar task shall, on request, provide information to the Agency or Member State concerned.
Amendment 29 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a (new)
Article 6 – paragraph 2 – point –a (new)
(-a) The identity of the substance;
Amendment 29 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a (new)
Article 6 – paragraph 2 – point –a (new)
(-a) The identity of the substance;
Amendment 30 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a a (new)
Article 6 – paragraph 2 – point –a a (new)
(-a a) a precise and clear wording of the entry of the proposed restriction in Annex II;
Amendment 30 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a a (new)
Article 6 – paragraph 2 – point –a a (new)
(-aa) a precise and clear wording of the entry of the proposed restriction in Annex II;
Amendment 31 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a b (new)
Article 6 – paragraph 2 – point –a b (new)
(-a b) references and scientific evidence for the restriction;
Amendment 31 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a b (new)
Article 6 – paragraph 2 – point –a b (new)
(-ab) references and scientific evidence for the restriction;
Amendment 32 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b a (new)
Article 6 – paragraph 2 – point b a (new)
(b a) information on possible alternatives, their availability and suitability;
Amendment 32 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b a (new)
Article 6 – paragraph 2 – point b a (new)
(ba) information on possible alternatives, their availability and suitability;
Amendment 34 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b b (new)
Article 6 – paragraph 2 – point b b (new)
(b b) justification for considering a Union-wide restriction as the most appropriate measure.
Amendment 34 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b b (new)
Article 6 – paragraph 2 – point b b (new)
(bb) justification for considering a Union-wide restriction as the most appropriate measure.
Amendment 35 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b c (new)
Article 6 – paragraph 2 – point b c (new)
(b c) socioeconomic assessment.
Amendment 35 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b c (new)
Article 6 – paragraph 2 – point b c (new)
(bc) socioeconomic assessment.
Amendment 38 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Directive 2011/65/EU
Article 20 – paragraph 1
Article 20 – paragraph 1
Amendment 38 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Directive 2011/65/EU
Article 20 – paragraph 1
Article 20 – paragraph 1
Amendment 39 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 b (new)
Article 1 – paragraph 1 – point 4 b (new)
Directive 2011/65/EU
Article 20 – paragraph 1 b (new)
Article 20 – paragraph 1 b (new)
(4 b) In Article 20, the following paragraph 1a is inserted: “1a. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.”
Amendment 39 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 b (new)
Article 1 – paragraph 1 – point 4 b (new)
Directive 2011/65/EU
Article 20 – paragraph 1 b (new)
Article 20 – paragraph 1 b (new)
(4b) In Article 20, the following paragraph 1a is inserted: “1a. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.”
Amendment 94 #
2023/0453(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The European Green Deal1 sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability2 is a crucial delivery of this zero-pollution ambition and introduces the ‘one substance, one assessment’ approach, which aims to improve the efficiency, effectiveness, coherence, and transparency of safety assessments of chemicals across Union legislation. According to that Strategy, ‘safe and sustainable by design’ criteria should be developed to enable the production and use of chemicals that are safe and sustainable throughout their entire lifecycle. The Strategy also sets out that the interaction between scientific developments and policy-making should be strengthened by means of an early warning system for chemicals and groups of chemicals to ensure that Union policies address emerging chemical risks as soon as these are identified by monitoring and research, and that a framework of indicators should be developed to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation. This Regulation aims to implement these objectives. _________________ 1 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. 2 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,
Amendment 100 #
2023/0453(COD)
Proposal for a regulation
Recital 2
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 chemicals. 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 transparency, 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, enable scrutiny by interested parties of data generated and used for regulatory purposes, as well as to strengthen public trust in the robustness of scientific decision-making.
Amendment 101 #
2023/0453(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2 a) People and other living organisms are exposed daily to a wide mix of chemicals originating and environmental stressors from various sources. However, the safety of chemicals in the EU is usually assessed through the evaluation of single chemicals without considering the combined exposure to multiple chemicals from different sources and over time. If some pieces of legislation require to assess the cumulative exposure to the same chemical from different sources, explicit requirements to take into account the impact of unintentional mixtures is generally lacking. The human exposome is a concept that provides a holistic view of human health and disease. It includes exposures from our diets, our lifestyles, and environmental factors, such as chemicals. This regulation should help gathering data on the impacts of the exposure to multiple chemicals and environmental factors to foster research on the human exposome and help to understand the causal pathways leading to common diseases such as cardiovascular disease, respiratory diseases, immunological disorders, mental health, and non-communicable diseases.
Amendment 102 #
2023/0453(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) In its communication of 19 February 2020 on a European strategy for data4 , the Commission described its vision of a common European data space and highlighted the need for the development of sectoral data spaces in strategic areas, since not all sectors of the economy and society are moving at the same speed. This Regulation aims therefore to build a data space for chemicals by establishing a common data platform on chemicals (‘common data platform’), which is also part of the Green Deal data space, as referred to in the European strategy for data. Furthermore, in that strategy, the Commission highlighted several issues concerning the availability of data for the public good, including data availability, data infrastructures and governance, interoperability, as well as the lack of adequate sharing of data between public authorities. This Regulation aims to increase data availability on chemicals by requiring the relevant Union agencies and Member States' authorities to make data available for integration in the common data platform on chemicals, to promote interoperability of that data by providing for the establishment of standard formats and controlled vocabularies, as well as to facilitate data exchange and use by public authorities to enable them to effectively carry out their regulatory and policy developing tasks. _________________ 4 Communication from the Commission to the European Parliament, The Council, The European Economic and Social Committee and the Committee of the Regions, A European strategy for data, COM/2020/66 final.
Amendment 112 #
2023/0453(COD)
Proposal for a regulation
Recital 7
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, exposure and fate 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.
Amendment 113 #
2023/0453(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The common data platform should contain all 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.
Amendment 117 #
2023/0453(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Due to the different nature of the risk and hazard assessments performed under Union acts on medicinal products, when compared to those performed under the main Union acts on chemicals, for medicinal products, only chemicals data related to environmental risk assessments for human and veterinary medicines, non- clinical studies for human medicines and maximum residue limit values 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 applications regulated by other Union legislation identified in this Regulation, as well as other active substances with particular persistent, bio-accumulative and toxic properties or with a known high level of residues in the environment.
Amendment 125 #
2023/0453(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) These data should also be limited to 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, and no later than 4 years after the entry into force of this Regulation, 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 Regulation.
Amendment 129 #
2023/0453(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Other chemicals data submitted or generated under Union legislation on medicinal products may also be of interest to chemicals regulatory areas, such as data related to other active substances contained in medicinal products, clinical data, data related to other substances contained in medicinal products besides active substances and data that is submitted to the EMA in the context of the relevant procedures that are finalised before the entry into force of this Regulation. Moreover, a relevant part of the medicinal data is held by the National Competent Authorities. At a later stage and no later than 5 years after the entry into force of this Regulation, the Commission should therefore assess, in close cooperation with Member States and the Agencies, whether such additional data should be included in the common data platform. This assessment should take also into account the relevancy, the anticipated added value as well as the cost-benefit balance of incorporating the additional data.
Amendment 145 #
2023/0453(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) While the ECHA should identify and develop the technical functionalities of the common data platform in stages, certain dedicated services should be defined by this Regulation. As such, the common data platform should, in addition to providing access to chemicals-related data made available by the Agencies and the Commission, provide access to the chemicals data and information made available through its dedicated services. These dedicated services should be integrated into the common data platform and consist of the existing Information Platform for Chemical Monitoring (‘IPCHEM’), a repository of reference values, a database of study notifications, a database with information on regulatory processes, a database with information on applicable legal obligations, a repository of standard formats and controlled vocabularies, a database on environmental sustainability related data, a database on chemicals in products and their alternatives, as well as a dashboard of indicators on chemicals.
Amendment 146 #
2023/0453(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The Commission should adopt an implementation plan identifying initial datasets of chemicals data to be made accessible via the platform and the timeline for their integration, informed by the preparatory work of the Commission and the Agencies10 . The Commission should set up a governance scheme to support and steer the common data platform’s operation and evolution covering the organisation of work structures and coordination between ECHA and data providers, and required rules, formats and vocabularies for data integration, and maintain a rolling implementation plan to ensure the progress in identification and integration of new datasets of chemicals data and services for inclusion. The governance scheme should be adopted and updated as necessary by the Commission, after consultation with a newly established platform steering committee composed of representatives from Union agencies and the Commission. In order to ensure uniform conditions for the implementation of the obligations to establish an implementation plan and a governance scheme, implementing powers should be conferred on the Commission. _________________ 10 European Union Common Data Platform on Chemicals Project Initiation Document, v1.1 endorsed by the One Substance One Assessment Interservice Group 27 February 2023.
Amendment 148 #
2023/0453(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The common data platform should serve the widest possible community, with the ability to address new use cases, incorporate new relevant datasets, develop new functionalities, and respond to developing tools and applications. Other parties, such as Member States, scientific bodies of Member States or national authorities, academia, and civil society should be able to submit chemicals data to the Agencies or the Commission for hosting and maintenance.
Amendment 154 #
2023/0453(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) To ensure that an adequate knowledge base on chemicals is available through the common data platform, the Commission should be able to request the Agencies to host, maintain and make available, via the common data platform, chemicals data generated as part of Union, national or international legislation, programmes or research activities beyond the data already flowing to the Agencies as part of the obligations under the Union acts listed in Annex I or other obligations subject to this Regulation. The Commission should make such requests to the Agencies in accordance with their mandates and allocated tasks.
Amendment 155 #
2023/0453(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) To improve the uptake of academic data and to expand the knowledge base for chemicals safety assessments and environmental sustainability impacts of chemicals, researchers or research consortia funded by Union framework programmes should make available, in line with the ‘as open as possible, as closed as necessary’ principle, any human biomonitoring data they collect or generate resulting from research and development programmes to the EEA and any environmental sustainability data on chemicals or materials they collect or generate to the ECHA. Member States should require researchers or research consortia funded by national framework programmes to make their data that is relevant for regulatory purposes available to the EEA or to ECHA.
Amendment 159 #
2023/0453(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23 a) Independent research studies are often given comparatively low weight as evidence in hazard and risk assessment of chemicals creating a gap between independent research and chemicals regulation and policy. It is necessary to provide structure and transparency in the evaluation of research data in order to increase their use in regulatory assessment of chemicals. The Commission should publish a guidance setting minimum quality and reporting requirements to improve the uptake of research data.
Amendment 161 #
2023/0453(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) The EEA, as the agency responsible for monitoring data and information on chemicals in the environment, should also be responsible for collecting, hosting, and maintaining human biomonitoring data. To the extent that human biomonitoring data constitutes a special category of personal data, namely, health data, the EEA should process that data only where the processing is necessary for reasons of substantial public interest, as required by Article 10(2)(g) of the Regulation (EU) No 2018/1725 of the European Parliament and of the Council11 . This Regulation lays down the cases where there is such substantial public interest in processing human biomonitoring data: namely, where the EEA processes that data to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure, to develop health risk and impact indicators, to monitor the impact of regulatory intervention, and to support regulatory risk assessments. _________________ 11 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
Amendment 163 #
2023/0453(COD)
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24 a) The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission should be able to process human biomonitoring data constituting personal data. Since human biomonitoring personal data constitutes a special category of personal data, namely, health data, the EEA, the Commission, the ECHA, the EFSA, the EU-OSHA and the EMA should process that data only where the processing is necessary for reasons of substantial public interest, as laid out in Article 10(2)(g) and for scientific research as laid out in Article 10(2)(j) of the Regulation (EU) No 2018/1725. The present Regulation lays down the cases where there is such substantial public interest in processing human biomonitoring data constituting personal data.
Amendment 166 #
2023/0453(COD)
Proposal for a regulation
Recital 24 b (new)
Recital 24 b (new)
(24 b) The EEA should be allowed to process human biomonitoring data to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure, to develop health risk and impact indicators, to monitor the impact of regulatory intervention, and to support regulatory risk assessments, risk management and policy making. The Commission should be allowed to process human biomonitoring data constituting personal data, notably for scientific research, to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure of populations to chemicals, to develop indicators on health risks associated to such exposure, as well as to measure the efficiency and effectiveness of regulatory measures in preventing exposure by analysing, for example, co-exposure to multiple chemicals for which data on co- occurrence of various chemicals per individual is necessary to observe common patterns and draw conclusions for populations, and supporting further risk assessments and risk management. The ECHA should also be allowed to act as a data processor for human biomonitoring data constituting personal data for the performance of assessments on chemicals, such as risk and safety assessments. Individual measurements of chemicals in human matrices may assist regulatory exposure and risk assessment, such as in the formulation of an opinion of the ECHA’s Risk Assessment Committee, and lead to recommendations of risk management measures. The EFSA and the EMA should also be allowed to act as a data processor for human biomonitoring data constituting personal data, notably to support the prioritisation of regulatory actions. The EU-OSHA should be allowed to process human biomonitoring data constituting personal data, notably for scientific research, to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure of populations to chemicals, as well as to measure the efficiency and effectiveness of regulatory measures in preventing exposure. Such data is also useful for the EFSA when conducting assessments of chemicals in food and for understanding the effectiveness of existing measures in preventing human contamination through the food and feed chains. When processing human biomonitoring data constituting personal data, the EEA, the ECHA, the EFSA, the EMA , the EU- OSHA, and the Commission should pay particular attention to compliance with Article 13 of Regulation (EU) No 2018/1725.
Amendment 168 #
2023/0453(COD)
Proposal for a regulation
Recital 24 c (new)
Recital 24 c (new)
(24 c) Human biomonitoring data collected prior to the coming into force of this Regulation is necessary to ensure the completeness, quality, and relevance of the human biomonitoring datasets for the purposes of guaranteeing the substantial public interests, and scientific research purposes as listed in this Regulation. Therefore, any such data gathered prior to the coming into force of this Regulation should be able to be processed by the EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission when this Regulation comes into force.
Amendment 170 #
2023/0453(COD)
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26 a) There are data gaps on the occurrence of hazardous and other harmful chemicals in products on the EU market. In order to enhance visibility on the availability of data, and to promote research and development activities as regards safer alternatives, as well as the uptake of such alternatives, ECHA should establish and maintain a repository of information on chemicals in products and their available alternatives generated under Union acts listed in Annex I. In addition, ECHA should integrate into the common data platform all chemicals data related to chemicals present in products or used in production processes and which is accessible through the web portal under Article 14 of Regulation (EU) 2024/178.
Amendment 171 #
2023/0453(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) In order to promote the use and harmonisation of reference values among risk assessors and risk managers across different Union acts and to facilitate compliance with, and enforcement of, regulatory reference values, the ECHA should establish and maintain a repository of reference values established or adopted under the Union acts listed in Annexes I and II The Agencies should provide the ECHA with reference values they hold or establish as part of their activities. In addition, the ECHA should regularly screen Union acts for reference values adopted under them. To facilitate automatic access of the general public to up-to-date reference values, the ECHA should integrate the repository of reference values in the common data platform as a dedicated service, include in that repository all reference values together with the relevant context data it has received or retrieved and ensure that those values and that context data are machine readable. For a reference value for the carcinogenic effect of a chemical for which no maximum exposure level can be specified below which no harmful effects on human health are to be expected, the statistical cancer risk associated with that reference value should also be specified, if available.
Amendment 187 #
2023/0453(COD)
Proposal for a regulation
Recital 31
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 with 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.
Amendment 202 #
2023/0453(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to ensure chemicals data are easily findable within the database and to avoid duplicates, each chemical contained in the common data platform shall be identified by a unique chemical identifier and a chemical notation specifying its molecular structure. 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.
Amendment 206 #
2023/0453(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The International Uniform Chemical Information Database (‘IUCLID’) is a software application designed to record, store, maintain and exchange data on chemicals. The ECHA develops and maintains the IUCLID software and the underlying format in collaboration with the Organisation for Economic Cooperation and Development (‘OECD’). The IUCLID implements all OECD-harmonised templates, which are harmonised formats agreed at the OECD level to facilitate structured and consistent documentation of test outputs and similar chemicals data. Since chemicals data is being submitted to the ECHA in IUCLID under Union acts such as Regulations (EC) No 1907/2006, (EC) No 1107/200913 and (EU) No 528/201214 of the European Parliament and of the Council, the ECHA is closely involved in the continued development of IUCLID, and IUCLID implements the standard formats agreed at the OECD level, it is appropriate and necessary to require the Commission and the AgencAuthorities to use IUCLID for the relevant parts of dossiers under specified Union acts listed in Annex I when they make the data contained in those dossiers available to the ECHA . _________________ 13 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309 24.11.2009, p. 1). 14 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167 27.6.2012, p. 1).
Amendment 207 #
2023/0453(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) To increase the availability and facilitate the use of information on the environmental performance of chemicals throughout their lifecycle, and to enable a comprehensive assessment of the impacts of chemicals on the environment and health, the Commission should identify relevant data and information related to the environmental sustainability and health impacts of chemicals, including, where available, information on their impact on climate change, for integration into the common data platform. Once the Commission has identified the relevant existing datasets of chemicals data on environmental sustainability and health related data and has designed the relevant related database functionalities, the ECHA should establish a database on environmental sustainability- and health- related data, collect the data as made available by the Commission, the Agencies and, where relevant, by the researchers and research consortia funded by Union framework programmes, and integrate the content of that database into the common data platform as a dedicated service. In order to ensure uniform conditions for the implementation of the obligation to identify relevant environmental sustainability and health datasets of chemicals datasets, implementing powers should be conferred on the Commission.
Amendment 210 #
2023/0453(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) To monitor the impacts on humans and the environment, including the climate, of exposure to chemicals and to establish a knowledge base to measure the effectiveness of chemicals legislation in protecting human health and the environment, the EEA and the ECHAAgencies should jointly develop and regularly, at least every two years, update a set of indicators and present it in the form of a dashboard. The EFSA, the EMA, the EU- OSHAIn order to monitor the aggregated risk for territories associated to the impacts on humans and the environment, including the climate, of exposure to chemicals and pollutants, the Agencies should jointly develop and regularly, at least every two years, update an aggregated indicator at different territorial level, in collaboration with the Joint Research Centre and drawing inspiration from its European wide vulnerability framework1a. The EEA should cross-reference the results of this indicator with other health and environment datasets, such as epidemiological data on occupational health, life-style factors, and socio- economic factors, in order to assess the impacts and risks of cumulated risk factors on population at the territorial level. The Agencies and the Commission shall regularly provide the EEA with any available data falling within their mandate and relevant for the establishment of the indicators. The EEA and the ECHAAgencies should integrate this dashboard of indicators into the common data platform. _________________ 1a Eklund, L.G., Sibilia, A., Salvi, A., Antofie, T., Rodomonti, D., Salari, S., Poljansek, K., Marzi, S., Gyenes, Z. and Corban, C., Towards a European wide vulnerability framework, Publications Office of the European Union, Luxembourg, 2023, doi:10.2760/353889, JRC118850.
Amendment 212 #
2023/0453(COD)
Proposal for a regulation
Recital 43 a (new)
Recital 43 a (new)
(43 a) In order to ensure the widest possible access to chemicals data and to improve trust in the implementation of this Regulation and Union policies on chemicals, and further acknowledging existing experience with citizen science approaches, natural or legal person should be able to submit substantiated concerns regarding impacts of chemicals on humans and the environment, such as peer-reviewed research results, or biomonitoring data. The authorities should assess submitted evidence and take action when they identify a concern. In line with commitments of the Union in relation to the Aarhus Convention, individuals submitting evidence should be equipped with procedural rights to ensure their concerns are appropriately taken into account.
Amendment 213 #
2023/0453(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) This Regulation should establish an early warning and action system as regards existing and emerging chemical risks. To enable the identification and evaluation of emerging chemical risks, the EEA should develop and compile information on early warning signals and draw up an annual summary report to inform regulatory follow-up actions by authorities. In its work, the EEA should include its own sources, targeted literature searches and make use of information from national early warning systems. It should also include relevant information made available by the related work of the ECHA, the EFSA, the EU-OSHA, the EMA and their networks, such as the EFSA’s task of identifying and collecting information on emerging risks under Regulation 178/2002. The EEA should make the summary report and the underlying data available through the common data platform, ensuring public access and its use for further action on existing and emerging risks of chemicals, groups of chemicals, and cumulative exposure to chemicals. In order to allow the EEA sufficient time to organise the collection of early warning signals and to compile and analyse the initial information the EEA should only deliver the first report six months after the end of the first calendar year after entry into force of this Regulation. this Regulation sets a deadline for the first report and associated data. For any risk and warning signal identified by the report, the Authorities should consider undertaking regulatory, policy or enforcement actions and provide justification when they decide not to proceed with any action. Emerging chemicals risks identified in the early warning and action system should also be taken into account when setting priorities for the strategic planning of Horizon Europe.
Amendment 216 #
2023/0453(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) The ECHA should continue operating the EUON and transform it into an observatory for specific chemicals, or groups of chemicals with potential contribution to emerging chemical risks (‘the observatory’), which should cover also other chemicals and innovative (rationally designed complex ‘advanced’) materials selected by the Commission, using, as appropriate, signals from the early warning and action system. One of the criteria for selecting chemicals for the observatory should be their novelty and disruptive potential that may contribute to an emerging chemical risk. Another criterion for that selection should be the higher degree of uncertainty surrounding them and, due to less regulatory experience regarding those chemicals, the resulting need for additional scrutiny and transparency. The observatory should facilitate regulatory implementation and responsible use of these chemicals by collecting, generating, and disseminating reliable information on selected chemicals’ properties, uses and market presence to the general public.
Amendment 220 #
2023/0453(COD)
Proposal for a regulation
Recital 48
Recital 48
(48) Under Regulation (EC) No 178/2002, the EFSA is able to commission, in an open and transparent manner, the scientific studies it needs to accomplish its mission, while seeking to avoid duplication with Member States or Union research programmes. The ECHA should also be able to commission studies to obtain adequate data and information on chemicals, groups of chemicals, and the risk of their cumulative exposure thereof, within its mission, while maintaining the principle that the burden to prove compliance with Union chemicals legislation remains on the duty holder. Furthermore, the ECHA should commission such studies out of its own initiative or at the request of the Commission, with the objective of supporting the effective and efficient implementation and evaluation of Union acts on chemicals within its mandate and contributing the development of a Union chemicals policy.
Amendment 221 #
2023/0453(COD)
Proposal for a regulation
Recital 48 a (new)
Recital 48 a (new)
(48 a) In order to contribute to the overall objective of this Regulation 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, this Regulation should require the Commission to draw up a report analysing the adequacy between the resources of the agencies and their current tasks, their new tasks under this Regulation, and a prospective view of the ressources needed to address key areas of regulatory challenge in the future. The Commission should also draw up a report on the impacts of cumulative exposure to chemicals on health and the environment, and analysing the efficacy of the current risk assessment of chemicals across Union legislation to adequately address the combination effect of chemical mixtures and to ensure a high level of protection of health and the environment.
Amendment 225 #
2023/0453(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation aims to ensure the efficient delivery of coherent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, to achieve a high level of protection of human health and the environment, to enable the development and use of safe and sustainable chemicals, to ensure the proper functioning of the single market for chemicals, to enable scrutiny by interested parties of data generated and used for regulatory purposes, and to improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals.
Amendment 244 #
2023/0453(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10
Article 2 – paragraph 1 – point 10
10. ‘chemicals data’ means any representation of facts or information relating to chemicals and any compilation of such facts or information, including information on physico-chemical properties, hazard properties, use, exposure, risk, occurrence, emissions, fate, 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, information on availability and suitability of alternatives, standard formats, controlled vocabularies, or any information on applicable legal obligations related to chemicals and the enforcement thereof;
Amendment 250 #
2023/0453(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 11 a (new)
Article 2 – paragraph 1 – point 11 a (new)
11 a. 'research data' means any hazard, occurrence, exposure, and fate data derived from scientific studies published in peer-reviewed literature that are not carried out specifically to inform regulatory assessments;
Amendment 256 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point a
Article 3 – paragraph 2 – point a
(a) generated or submitted as part of the implementation of the Union acts listed in Annex I to this Regulation and held by the Agencies or, the Commission or Member States autorities ('the Authorities');
Amendment 259 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
(b) generated as part of Union, national or international programmes or research activities in the sphere of chemicals and held by the ECHA, the EEA, the EFSA, the EU-OSHA or the CommissionAuthorities;
Amendment 263 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point c a (new)
Article 3 – paragraph 2 – point c a (new)
(c a) generated under Regulation (EU) 2024/1781 and accessible through the web portal under Article 14 of that regulation.
Amendment 268 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
Amendment 270 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 4 a (new)
Article 3 – paragraph 4 a (new)
4 a. Each chemical or material hosted on the common data platform shall be identified by a unique chemical identifier and a chemical notation specifying its molecular structure.
Amendment 272 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 5 – point d a (new)
Article 3 – paragraph 5 – point d a (new)
(d a) information on chemicals in products and their alternatives referred to in Article 10a;
Amendment 274 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 5 – point g
Article 3 – paragraph 5 – point g
(g) the database on environmental sustainability and health-related data referred to in Article 13.
Amendment 278 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. The Authorities and the general public shall have access free of charge to the data contained in the common data platform in accordance with Article 16.
Amendment 281 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 11
Article 3 – paragraph 11
11. The common data platform and its dedicated services shall be established by [OP: please insert date: threone years after the date of entry into force of this Regulation], unless specified otherwise. The relevant datasets of chemicals data, including those generated or submitted before the entry into force of this Regulation, unless specified otherwise shall be integrated progressively into the common data platform by [OP please insert date: tensix 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.
Amendment 286 #
2023/0453(COD)
Proposal for a regulation
Article 4 – paragraph 1
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 datasets of chemicals data for inclusion in the common data platform together with a timeline for their inclusion by means of an implementing decisionacts. Subsequent rolling implementation plans shall be adopted in line with the governance scheme referred to in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 288 #
2023/0453(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The Commission shall, by means of an implementing decisionacts, establish and manage a platform steering committee, which shall include one representative from the ECHA, one representative from the EEA, one representative from the EFSA, one representative from the EMA, one representative from the EU-OSHA and five representatives from the Commission. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 290 #
2023/0453(COD)
Proposal for a regulation
Article 4 – paragraph 4
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 decisionimplementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 297 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. At the Commission’s request, the Agencies shall host and maintain chemicals data generated as part of Union, national or international legislation, programmes or research activities, corresponding to their mandate and the type of data they already hold. The Agencies may host and maintain chemicals data corresponding to their mandate and submitted to them by Member States or other parties.
Amendment 307 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Where the Commission or the AgencAuthorities 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 AgencAuthorities shall indicate whether that data or information is made available to the publicconfidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 310 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. Researchers or research consortia funded by Union framework programmes shall make available to the EEA any human biomonitoring data they collect or generate from [OP please insert: date of the entry into force of this Regulation]. For human biomonitoring data constituting personal data, the EEA shall specify which type of data shall be made available to it.
Amendment 313 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
5 a. Member States shall require researchers or research consortia funded by national programmes to make available to the EEA any human biomonitoring data they collect or generate from [OP please insert: date of the entry into force of this Regulation]. For human biomonitoring data constituting personal data, the EEA shall specify which type of data shall be made available to it.
Amendment 314 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 6
Article 5 – paragraph 6
6. Researchers or research consortia funded by Union framework programmes shall make available to the ECHA any chemicals data other than biomonitoring data, including environmental sustainability and health-related data on chemicals or materials they collect or generate from [OP please insert: date of the entry into force of this Regulation].
Amendment 316 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 6 a (new)
Article 5 – paragraph 6 a (new)
6 a. Member States shall require researchers or research consortia funded by national programmes, to make available to the ECHA any chemicals data relevant for regulatory purposes other than biomonitoring data, including environmental sustainability and health related data on chemicals or materials they collect or generate from [OP please insert: 6 months after the entry into force of this Regulation].
Amendment 318 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 7
Article 5 – paragraph 7
7. The Commission and the AgencAuthorities shall provide the necessary technical cooperation to the ECHA to enable the integration of the chemicals data provided in accordance with paragraph 2 in the common data platform as well as its publication through that platform.
Amendment 320 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 8
Article 5 – paragraph 8
8. For the purpose of paragraph 2, the Commission and the AgencAuthorities shall make chemicals data 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.
Amendment 321 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 9
Article 5 – paragraph 9
9. The Commission and the AgencAuthorities shall ensure that data made available to the ECHA shall be downloadable, machine readable and interoperable. They shall appropriately curate and validate the data before providing them to the ECHA.
Amendment 323 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 – introductory part
Article 6 – paragraph 4 – introductory part
4. HThe EEA may process human biomonitoring data constituting personal data may be processed by the EEA for the following purposes only:
Amendment 326 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 – point e a (new)
Article 6 – paragraph 4 – point e a (new)
(e a) supporting regulatory risk management;
Amendment 327 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 – point e b (new)
Article 6 – paragraph 4 – point e b (new)
(e b) supporting policy making and legislative processes at Union level;
Amendment 328 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 – point e c (new)
Article 6 – paragraph 4 – point e c (new)
(e c) facilitating the processing by the Commission, the ECHA, the EFSA, the EMA, and the EU-OSHA in accordance with paragraphs 4a, 4b, 4c, 4d and 4e of this article.
Amendment 329 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4 a. The Commission may process human biomonitoring data constituting personal data for the following purposes only: (a) scientific research aimed at policy making; (b) assessing the impact of chemicals on human health and the environment; (c) monitoring time and spatial trends in exposure; (d) developing health risk and impact indicators; (e) monitoring the impact of regulatory intervention; (f) assessing the need for further regulatory action and prioritising such actions; (g) supporting regulatory risk assessment and risk management.
Amendment 330 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 b (new)
Article 6 – paragraph 4 b (new)
4 b. The ECHA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory actions; (b) performing assessments of chemicals; (c) supporting regulatory risk management; (d) as part of the commissioning of studies under the data generation mechanism referred to in Article 21.
Amendment 331 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 c (new)
Article 6 – paragraph 4 c (new)
4 c. The EFSA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory action; (b) performing assessments of chemicals; (c) supporting regulatory risk management.
Amendment 332 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 d (new)
Article 6 – paragraph 4 d (new)
4 d. The EMA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory action; (b) performing assessments of chemicals; (c) supporting regulatory risk management.
Amendment 333 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 e (new)
Article 6 – paragraph 4 e (new)
4 e. The EU-OSHA may process human biomonitoring data constituting personal data for the following purposes only: (a) scientific research aimed at policy making; (b) assessing the impact of chemicals on human health and the environment; (c) monitoring time and spatial trends in exposure; (d) monitoring the impact of regulatory intervention; (e) assessing the need for further regulatory action and prioritising such actions; (f) supporting regulatory risk management.
Amendment 334 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 f (new)
Article 6 – paragraph 4 f (new)
4 f. Any processing of human biomonitoring data constituting personal data by the EEA, the ECHA, the EFSA, the EMA, the EU-OSHA, or the Commission for the purposes referred to in paragraph 4, 4a, 4b, 4c, 4d, and 4e shall not entail the sharing of such data with third parties.
Amendment 335 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission shall act as data controller for the human biomonitoring data constituting personal data ithey holds or hosts and or processes for the purposes referred to in paragraph 24, 4a, 4b, 4c, 4d and 4e.
Amendment 336 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 6 a (new)
Article 6 – paragraph 6 a (new)
6 a. The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission shall define the storage period and any review thereof for the human biomonitoring data constituting personal data they hold as well as the criteria used to define the storage period.
Amendment 337 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 6 b (new)
Article 6 – paragraph 6 b (new)
6 b. The human biomonitoring data referred to in this Article includes personal data lawfully collected before the entry into force of this Regulation.
Amendment 346 #
2023/0453(COD)
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4 a. The ECHA shall include in the repository of reference values without undue delay any reference value generated as part of Union, national or international programmes or research activities and made available to it in the standard formats provided for in Article 14, where developed.
Amendment 350 #
2023/0453(COD)
Proposal for a regulation
Article 9 – paragraph 3 a (new)
Article 9 – paragraph 3 a (new)
3 a. Authorities and national enforcement authorities shall have access to the data contained in the Database of Study Notifications before that data is integrated in the common data platform.
Amendment 355 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on regulatory processes on individual substancechemicals or groups of substancechemicals that are planned, ongoing or have been completed since the entry into force of this Regulation by the Member States or the Union institutions, agencies or committees referred to in the Union acts listed in Annex III.
Amendment 357 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex III hold the information referred to in paragraph 1, they shall make that information available to the Union agency responsible under the respective Union act listed in Annex III without undue delay. For each regulatory process or activity, at least the following information shall be included:
Amendment 359 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point a (new)
Article 10 – paragraph 2 – point a (new)
(a) chemical identity;
Amendment 361 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point b (new)
Article 10 – paragraph 2 – point b (new)
(b) the Union act and the regulatory process under which the activity takes place;
Amendment 363 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point c (new)
Article 10 – paragraph 2 – point c (new)
(c) submitter or actor responsible for the regulatory process or activity;
Amendment 365 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point d (new)
Article 10 – paragraph 2 – point d (new)
(d) status of the regulatory process or activity;
Amendment 367 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point e (new)
Article 10 – paragraph 2 – point e (new)
(e) outcome of the regulatory process or activity, including, where applicable, reports or opinions adopted;
Amendment 369 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point f (new)
Article 10 – paragraph 2 – point f (new)
(f) where applicable, date of intention to start the regulatory process or activity, completion and latest update.
Amendment 370 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 3 – point a
Article 10 – paragraph 3 – point a
(a) substancechemical identity;
Amendment 376 #
2023/0453(COD)
Proposal for a regulation
Article 10 a (new)
Article 10 a (new)
Article 10a Information on chemicals in products and their alternatives 1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on chemicals in products and their alternatives generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. This database shall integrate the information subject to paragraph 2 of Article 3, point (ca). 2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex I hold the information referred to in paragraph 1, they shall make that information available to the Union agency responsible under the respective Union act listed in Annex I without undue delay. 3. Where the ECHA, the EEA, the EFSA, the EU-OSHA or the Commission hold the information referred to in paragraph 1, they shall make that information available to the ECHA for integration in the common data platform in the standard formats provided for in Article 14 without undue delay and, where relevant, once the responsible agency or the Commission has performed the validity assessment. For each chemical in a product, where available, at least the following information shall be included: (a) chemical identity; (b) product uses identified; (c) uses for which available alternatives have been identified; (d) alternatives identified for each use; (e) available information on the suitability of alternatives; (f) available information on substitution plans and efforts for each use; 4. The ECHA shall encourage providers of alternatives referred to in paragraph 3 points (c) and (d) to identify themselves.
Amendment 382 #
2023/0453(COD)
Proposal for a regulation
Article 13 – title
Article 13 – title
Database on environmental sustainability and health related data
Amendment 385 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. At the latest within threOne 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 and health related data.
Amendment 388 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Where the Commission or the AgencAuthorities host or hold environmental sustainability or health related data in addition to the chemicals data already available in the common data platform, they shall make that data available to the ECHA without undue delay once the Commission or the AgencAuthority hosting or holding that data has completed, where relevant, validity and confidentiality assessments. The Commission and the AgencAuthorities shall provide the necessary technical cooperation to the ECHA to enable the integration of environmental sustainability related and health data in the database on environmental sustainability and health related data.
Amendment 393 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 3 a (new)
Article 13 – paragraph 3 a (new)
3 a. The ECHA shall integrate the environmental sustainability or health related data on chemicals or materials, made available in accordance with Article 5(6a), in the database on environmental sustainability and health related data.
Amendment 396 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. By [OP please insert date: threone years after the date of entry into force of this Regulation], the Commission shall adopt an implementing decision 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.
Amendment 398 #
2023/0453(COD)
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. The Commission and the AgencAuthorities shall exchange data contained in the common data platform in the relevant standard format.
Amendment 400 #
2023/0453(COD)
Proposal for a regulation
Article 14 – paragraph 5 – introductory part
Article 14 – paragraph 5 – introductory part
5. The Commission and the AgencAuthorities 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:
Amendment 402 #
2023/0453(COD)
Proposal for a regulation
Article 14 – paragraph 5 – point i a (new)
Article 14 – paragraph 5 – point i a (new)
(i a) Regulation (EC) No 1107/2009 of the European Parliament and of the Council1a. _________________ 1a Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
Amendment 403 #
2023/0453(COD)
Proposal for a regulation
Article 14 – paragraph 5 – point i b (new)
Article 14 – paragraph 5 – point i b (new)
(i b) Regulation (EC) No 396/2005 of the European Parliament and of the Council1b; _________________ 1b Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC
Amendment 413 #
2023/0453(COD)
Proposal for a regulation
Article 15 a (new)
Article 15 a (new)
Article 15a Uptake of research data 1. Researchers shall be able to submit publicly available research data on chemicals related to an entry in the common data platform. Research data shall be submitted in a format prescribed by the ECHA. 2. By [OP: insert 18 months after the entry into force of this Regulation], the ECHA shall establish and maintain an online platform for the submission process referred to in paragraph 1. 3. The ECHA shall assess the compliance of research data submitted through the portal referred to in paragraph 2 with the requirements set in the guidance referred to in paragraph 4. Where research data submitted are deemed to fulfil these requirements, the data shall be hosted on the common data platform together with the corresponding entry. 4. By [OP: insert 12 months after the entry into force of this Regulation], the Commission shall publish a guidance setting minimum quality and reporting requirements to improve the uptake of research data. 5. In order to ensure a uniform format of the research data submitted, the Commission shall, by means of implementing acts, adopt a standard format for the submission of research data. Those implementing acts shall be adopted by [OP: please insert the date = 12 months after the entry into force of this Regulation], in accordance with the examination procedure referred to in Article 24a(2).
Amendment 424 #
2023/0453(COD)
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
3. The general public shall have access to all the chemicals data contained in the common data platform and considered as available to the publ, except data which in accordance with the Union act under which the data was generated or submitteds deemed to be confidential under Article 5(2), second sentence.
Amendment 427 #
2023/0453(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The Authorities may use the chemicals data contained in the common data platform in the performance of any of their activities, where those activities support the development or, implementation, or enforcement of chemicals legislation and policy.
Amendment 429 #
2023/0453(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. Without prejudice to existing provisions enabling the sharing and use of chemicals data under the Union acts listed in Annexes I and II, and to the possibility of identifying data gaps in the applications received from business operators, Authorities shall not use chemicals data contained in the common data platform to fulfil any legal obligations of duty holders.
Amendment 434 #
2023/0453(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. The EEA, in collaboration with the ECHA, the EFSA, the EMA, the EU- OSHA and the Commission, shall establish, operate, and maintain, and update as appropriate a framework of indicators to monitor chemical pollution along the chemical’s lifecycle, including emissions, occurrence, and fate, to monitor the drivers and impacts of exposure to chemicals, and to measure the effectiveness of chemicals legislation and measure the transition towards the production of safe and sustainable chemicals.
Amendment 437 #
2023/0453(COD)
Proposal for a regulation
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1 a. The EEA, on the basis of the framework of indicators referred to in paragraph 1, as well as data from the database on environmental sustainability and health related data referred to in Article 13, the Union early warning system for emerging chemical risks referred to in Article 19, and human biomonitoring data shall establish, operate, maintain, and update as appropriate an aggregated territory-based risk indicator at different administrative levels (Country, NUTS2 and NUTS3) based on the Nomenclature of territorial units for statistics (NUTS) as defined in Regulation (EC) No 1059/200, to monitor time and spatial trends in exposure of populations to individual and multiple chemicals and health risks associated to such exposure and co-exposure. Where possible, the EEA shall cross- reference the results of the aggregated risk indicator with other health and environment datasets, including epidemiological data, to identify potential emerging risks for the purpose of Article 19.
Amendment 438 #
2023/0453(COD)
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The framework of indicators referred to in paragraph 1, and the aggregated indicator referred to in paragraph 1a, shall be accessible in the form of an indicator dashboard, which the EEA shall establish and which the ECHA shall make available through the common data platform.
Amendment 440 #
2023/0453(COD)
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Article 18a Substantiated concerns 1. Any natural or legal person, individually or in association, shall be entitled to submit to an Agency a substantiated concern regarding impacts of chemicals on humans and the environment, relating in particular to the properties, use, exposure, risk, occurrence and emissions of chemicals or groups of chemicals, and which is based on objective and verifiable information such as peer-reviewed studies, human biomonitoring data, or environmental monitoring data. 2. Where the concern does not correspond to the mandate of the Agency to which it is submitted, this Agency shall make it available to the authority or authorities with a corresponding mandate. 3. The authority or authorities with a mandate corresponding to the submitted concern shall diligently and impartially assess it and, where appropriate, take one or more of the following actions: (a) regulatory measures under Union legislation, including by imposing obligations on duty holders, such as to corroborate the evidence or mitigate any detrimental effects; (b) initiate or develop new policies addressing the concern submitted; (c) transfer the concern indicating a non- compliance to enforcement agencies. 4. The authority or authorities shall, within 6 months, inform the natural or legal persons referred to in paragraph 1 of any decision taken under paragraph 3, providing the reasons for such decision. 5. The ECHA shall publish an annual report compiling all substantiated concerns submitted under paragraph 1 and the information subject to paragraph 3. The report shall be integrated in the common data platform without undue delay.
Amendment 443 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1 – point c
Article 19 – paragraph 2 – subparagraph 1 – point c
(c) data that the EEA holds, including data from the framework of indicators, and the aggregated indicator as referred to in Article 18;
Amendment 445 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1 – point e a (new)
Article 19 – paragraph 2 – subparagraph 1 – point e a (new)
(e a) substantiated concerns submitted in accordance with Article 18a and made available by an Agency.
Amendment 449 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The ECHA, the EFSA, the EU- OSHA and the EMA shall identify and gather relevant available data on early warning signals obtained in accordance with this Regulation or from the field falling within their mandate and provide this data to the EEA to host it.
Amendment 450 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. The EEA shall draw up an annual report, compiling and analysing the data on early warning signals gathered in accordance with paragraphs 2 and 3. [The first report shall be prepared by [OP: please insert date: 6 months after the end of the first calendar year after entry into force of this Regulation]. The EEA shall present this report to the Commission, relevant Union agencies and Member State competent authorities for consideration of the need for regulatory or policy action related to the early warning signals. Within six months of the presentation of the report, the Authorities shall consider undertaking regulatory, policy or enforcement actions accordingly or and justify if they decide not to proceed with any action related to any of the early warning signals identified by the report.
Amendment 454 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. The EEA shall make all relevant data on early warning signals that it holds or hosts as well as the report referred to in paragraph 4 available to the ECHA for integration in the common data platform.
Amendment 457 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 5 a (new)
Article 19 – paragraph 5 a (new)
5 a. Where the data analysis indicates there is a risk that warrants urgent action, the EEA shall inform the authorities without undue delay.
Amendment 458 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 5 b (new)
Article 19 – paragraph 5 b (new)
5 b. The Commission shall take into account the emerging chemicals risks identified in accordance with this Article in the strategic planning of R&I activities of Regulation (EU) 2021/6951a, where relevant. _________________ 1a Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013
Amendment 459 #
2023/0453(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. The ECHA shall establish, operate and maintain an observatory for specific chemicals or group of chemicals that the Commission considers as requiring additional scrutiny. The observatory shall include reliable information on the chemicals’ properties, safety aspects, uses and market presence.
Amendment 461 #
2023/0453(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish a list of the selected chemicals by means of an implementing decisionacts. The Commission shall review the list of selected chemicals regularly adopt any revision thereof by the same means. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 464 #
2023/0453(COD)
Proposal for a regulation
Article 20 – paragraph 4 – point c
Article 20 – paragraph 4 – point c
(c) make compiled data publicly available through the common data platform or other communication and outreach tools as appropriate, to facilitate the identification of potential further research needs or risk management measures, to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update that information.
Amendment 467 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Using the best independent resources available, the ECHA may commission scientific studies to support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy.:
Amendment 468 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 1 – point a (new)
Article 21 – paragraph 1 – point a (new)
(a) support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy;
Amendment 469 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 1 – point b (new)
Article 21 – paragraph 1 – point b (new)
(b) investigate further emerging chemical risks identified in the report referred to in Article 19(4) of this Regulation;
Amendment 470 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 1 – point c (new)
Article 21 – paragraph 1 – point c (new)
(c) conduct Union-wide data sampling survey of human biomonitoring in collaboration with Member states.
Amendment 475 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. The ECHA shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. It shall not commission studies with a predominant research objective.
Amendment 485 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 6 a (new)
Article 21 – paragraph 6 a (new)
6 a. Without prejudice to the obligation on applicants to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances of serious controversies or conflicting results, may request the ECHA to commission scientific studies with the objective of verifying evidence used in its hazard and risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification.
Amendment 491 #
2023/0453(COD)
Proposal for a regulation
Article 21 a (new)
Article 21 a (new)
Article 21a Centralised data generation mechanism 1. The Commission, the Agencies, and Member states competent authorities may submit request for studies to the Commission in accordance with the governance scheme referred to in Article 21b(4). A request for studies shall include, at the minimum, the following: (a) a rational for the request, summarizing the current knowledge and latest relevant findings; (b) a proposal for testing, including technical feasibility, the involvement of national or EU reference laboratories where necessary, and possibilities for appropriate sample acquisition; (c) a preliminary cost estimate; (d) an estimated timeline. 2. Using the best independent resources available, the Commission may commission scientific studies on the basis of request submitted in accordance with paragraph 1 to: (a) support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy; (b) investigate further emerging chemical risks identified in the report referred to in Article 19(4) of this Regulation; (c) conduct Union-wide data sampling survey of human biomonitoring in collaboration with Member states. 2. The Commission may mandate the Agencies to commission the scientific studies referred to in paragraph 1, in accordance with the governance scheme referred to in Article 21b(4). 3. The Commission shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. 4. The Commission shall seek to avoid duplication with Member State or Union research or implementation programmes. 5. The Commission shall commission these scientific studies in an open and transparent manner. 6. The Agencies shall closely cooperate with each other on the submission of requests for and planning of scientific studies undertaken in accordance with paragraph 1. 7. Without prejudice to the obligation on applicants to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances of serious controversies or conflicting results, may request the Agencies to commission scientific studies with the objective of verifying evidence used in its hazard and risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification. 8. The Commission shall make the results of the scientific studies performed under this Article available through the common data platform.
Amendment 493 #
2023/0453(COD)
Proposal for a regulation
Article 21 b (new)
Article 21 b (new)
Article21b Governance of the centralised data generation mechanism 1. The Commission shall establish and manage a centralised data generation mechanism. 2. The Commission shall prepare and adopt a governance scheme for the data generation mechanism, in collaboration with the Agencies. 3. The Commission shall publish the governance scheme referred to in paragraph 2 and any revision thereof by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2). 4. That governance scheme shall describe: (a) the organisation of the main work structures supporting the development and implementation of the data generation mechanism; (b) the centralised system for the submission of testing proposals, the eligibility check, and the assessment and submissions; (c) the decision-making process for approval and prioritisation of the requests; (d) the procedural steps and assignment of responsibilities at the execution stage of data generation. 5. The Commission may establish an expert working group for the purpose of point (c) of paragraph 4. The expert working group shall be composed of representatives from the Commission, Union agencies, and Member States.
Amendment 511 #
2023/0453(COD)
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
2. For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 the identity of the chemical(s) concerned, 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.
Amendment 516 #
2023/0453(COD)
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. Laboratories and testing facilities shall also, without undue delay, notify any study commissioned by business operators to support an application, notification, or 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.
Amendment 517 #
2023/0453(COD)
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
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 identity of the chemical(s) concerned, 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.
Amendment 518 #
2023/0453(COD)
Proposal for a regulation
Article 22 – paragraph 5 a (new)
Article 22 – paragraph 5 a (new)
5 a. By ... [OP please insert date: 5 years after the date of entry into force of this Regulation], business operators shall notify to the Database of Study Notifications referred to in Article 9 any studies commissioned 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, for chemicals placed on the market before the entry into force of this Regulation, under the Union acts listed in Annex I. Subparagraph 1 shall only apply to chemicals placed on the market before the entry into force of this Regulation, under the Union acts listed in Annex I, and which are still authorised on the Union market by ... [OP please insert date: 5 years after the date of entry into force of this Regulation]. Studies notified in accordance with this paragraph shall only be included in the database for information and scientific purposes, and shall not, under any circumstances, have retroactive legal application.
Amendment 519 #
2023/0453(COD)
Proposal for a regulation
Article 22 – paragraph 6
Article 22 – paragraph 6
6. The obligations set under this article shall apply from [OP please insert date: 124 months after the date of entry into force of this Regulation].
Amendment 528 #
2023/0453(COD)
Proposal for a regulation
Chapter VII a (new)
Chapter VII a (new)
VII a Chapter VIIa ACCESS TO JUSTICE Article 22a Access to Justice 1. Any natural or legal person which has submitted substantiated concerns in accordance with Article 18a shall have access to an administrative or judicial procedure to review the procedural and substantive legality of the decisions, acts or omissions of the relevant authority under paragraph 3 of Article 18a. 2. Member States shall ensure access to administrative or judicial procedures to review their decisions, acts and omissions, in accordance with national law or practice. Decisions and omissions by the Commission shall be subject to review in accordance with Regulation EU (No) 1367/2006. 3. The procedures referred to in paragraph 2 shall be fair, equitable, timely and not prohibitively expensive while providing adequate and effective remedies, including injunctive relief where necessary. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.
Amendment 529 #
Amendment 531 #
2023/0453(COD)
Proposal for a regulation
Article 24 a (new)
Article 24 a (new)
Article24a Committee procedure 1. The Commission shall be assisted by the Committee established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/20111a. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. _________________ 1a Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 533 #
2023/0453(COD)
Proposal for a regulation
Article 26 a (new)
Article 26 a (new)
Article26a Reports 1. By [OP: please insert date: 2 years after the end of the first calendar year after entry into force of this Regulation], the Commission shall draw up a report, analysing the adequacy between the resources of the agencies and their current tasks, their new tasks under this Regulation, and a prospective view of the resources needed to address key areas of regulatory challenge. The Commission shall present this report to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. 2. By [OP: please insert date: 2 years after the end of the first calendar year after entry into force of this Regulation], the Commission shall draw up a report, compiling and analysing data on the impacts of cumulative exposure to chemicals on health and the environment, and analysing the efficacy of the current risk assessment of chemicals to adequately address the combination effect of chemical mixtures to ensure a high level of protection of health and the environment. The Commission shall present this report to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.
Amendment 535 #
2023/0453(COD)
Proposal for a regulation
Article 26 b (new)
Article 26 b (new)
Article 26b Review 1. No later than ... [OP: please insert the date = 5 years after the date of application of this Regulation], the Commission shall carry out a review of this Regulation. This review shall assess in particular (a) the efficacy of the early warning and action mechanism (b) whether it is appropriate to include additional data into the common data platform. 2. No later than ... [OP: please insert the date = 2 years after the date of application of this Regulation], the Commission shall assess the feasibility, in collaboration with scientific and academic publishers, of harmonised reporting and of enabling the integration of relevant contents from scientific journals and publications into the common data platform, in order to increase further the uptake of research data into the hazard and risk assessment of chemicals. 3. The Commission shall present a report on the main findings of the evaluation under paragraph 1, to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. The report shall assess whether this Regulation has contributed sufficiently to achieve its objectives, in particular to allow a better reuse of data across the Union acts referred to in Annex I. 4. Based on the findings of the assessment referred to in paragraph 2 and the report referred to in paragraph 3, the Commission may, as appropriate, submit legislative proposals to the European Parliament and to the Council in this regard.