181 Amendments of Jonas SJÖSTEDT
Amendment 26 #
2024/2718(RSP)
Draft motion for a resolution
Recital A
Recital A
A. whereas the European Parliament has declared a climate and environmental emergency and has committed to urgently fight and contain this threat before it is too late; whereas biodiversity loss and climate change are interlinked and exacerbate each other, representing equal threats to life on our planet, and as such should be tackled together as a matter of urgency;
Amendment 32 #
2024/2718(RSP)
Draft motion for a resolution
Recital B
Recital B
B. whereas the Paris Agreement entered into force on 4 November 2016; whereas to date, 193 states plus the EU have joined the agreement, representing over 98 % of global emissions;
Amendment 35 #
2024/2718(RSP)
Draft motion for a resolution
Recital C
Recital C
C. whereas, according to UNEP’s 2023 emissions gap report, fully implementing unconditional NDCs made under the Paris Agreement for 2030 would put the world on course to limit the temperature rise to 2.9 °C this century; whereas fully implementing conditional NDCs would lower the temperature rise to 2.5 °C; whereas the report underlines that the world is witnessing a disturbing acceleration in the number, speed and scale of broken climate records;
Amendment 41 #
2024/2718(RSP)
Draft motion for a resolution
Recital D
Recital D
D. whereas inadequate progress has been made towards achieving the long- term goals of the Paris Agreement since it was adopted in 2015; 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 IPCC concludes that in scenarios limiting warming to 1.5 °C, GHG emissions need to be 43 % below their 2019 level by 2030;
Amendment 47 #
2024/2718(RSP)
Draft motion for a resolution
Recital E
Recital E
E. whereas on 16 October 2023 the EU and its Member States submitted their update of the NDC committing to reduce their net GHG emissions by at least 55 % by 2030 compared to 1990;
Amendment 51 #
2024/2718(RSP)
Draft motion for a resolution
Recital F
Recital F
F. whereas the first global stocktake (GST) completed in 2023 at COP28 underlined the urgent need to address the interlinked global crises of climate change and biodiversity loss in the broader context of achieving the Sustainable Development Goals, as well as the vital importance, for sustainable climate action, of protecting, conserving, restoring and sustainably using nature and ecosystems; whereas the outcome of the stocktaking exercise should subsequently spur on the Parties to ratchet up their level of ambition and drive climate action;
Amendment 61 #
2024/2718(RSP)
Draft motion for a resolution
Recital G
Recital G
G. whereas marine biodiversity is seriously endangered, despite the ocean playing a unique and vital role as a climate regulator; whereas the ocean is the planet’s greatest carbon sink and absorbs excess heat and energy released from rising greenhouse gas emissions, having until now absorbed around 90 % of heat generated by rising GHGs trapped in the earth’s system, and taken in 30 % of carbon emissions; whereas a healthy ocean is key for both climate adaptation and mitigation;
Amendment 68 #
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; and rapid and sustained reductions in methane emissions are key to limiting near-term warming and improving air quality1a; whereas according to the IPCC’s 6th Assessment Report, keeping global warming under 1,5 °C requires major reductions in anthropogenic methane emissions by 20301b; whereas methane is a potent GHG which is 28 times more powerful than CO2 in terms of its climate impact over a 100- year time frame and 80 times more potent over a 20-year time frame; whereas according to the UNEP emissions gap report, methane and nitrous oxide emissions remained steady from 2019 to 2021, and fluorinated gases continued to surge; whereas stronger action to reduce methane emissions is one of the most cost- effective measures for cutting GHG emissions in the short term1c; whereas the agriculture and livestock sector emits 145 million tonnes of methane a year, making it the largest and most significant sector for methane emissions; whereas methane emissions in agriculture are primarily driven by increasing livestock numbers; whereas livestock emissions from manure and enteric fermentation account for roughly 32 % of all anthropogenic methane emissions; _________________ 1a https://www.iea.org/reports/global- methane-tracker-2022/methane-and- climate-change 1b https://www.ipcc.ch/report/ar6/syr/downlo ads/report/IPCC_AR6_SYR_LongerRepor t.pdf 1c UNEP report of 6 May 2021 entitled ‘Global Methane Assessment: Benefits and Costs of Mitigating Methane Emissions’
Amendment 71 #
2024/2718(RSP)
Draft motion for a resolution
Recital H a (new)
Recital H a (new)
Ha. whereas the IPCC’s AR6 conclusions warn that climate change impacts are already and increasingly affecting the productivity of all agricultural and fishery sectors, exacerbating water scarcity and threatening food security, nutrition and livelihoods; whereas global food systems account for 31 % of global emissions; whereas over 100 million tonnes of synthetic fertiliser are applied to crops worldwide every year1a; whereas most emissions from synthetic nitrogen fertilisers occur after they are applied to the soil and enter the atmosphere as nitrous oxide (N2O) – a persistent GHG with 265 times more global warming potential than CO2 over a 100 year period; whereas the synthetic nitrogen fertiliser supply chain was responsible for an estimated 2.1 % of global greenhouse gas emissions1b; _________________ 1a https://openknowledge.fao.org/server/api/ core/bitstreams/42d5a668-f44c-4976- 8540-8efdb0f4d17b/content 1b Menegat, S. et al., ‘Greenhouse gas emissions from global production and use of nitrogen synthetic fertilisers in agriculture’, Scientific Reports, 2022
Amendment 81 #
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; whereas mitigation finance continues to account for the majority of finance, representing 60 % of the total; whereas adaptation finance reached USD 32.4 billion in 2022;
Amendment 83 #
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; whereas the report finds that the adaptation finance needs of developing countries are 10-18 times as big as international public finance flows, which is over 50 % higher than the previous range estimate;
Amendment 93 #
2024/2718(RSP)
Draft motion for a resolution
Recital K a (new)
Recital K a (new)
Ka. whereas soils are the largest terrestrial carbon pool on the planet; whereas ensuring healthy soils strengthens resilience and reduces vulnerability to climate change; whereas, globally, 500 000 hectares of peatlands a year are lost, while already drained and degraded peatlands contribute around 4 % of annual global human-induced emissions1a; whereas despite only covering 3-4 % of the world’s land surface area, peatlands are responsible for storing nearly one third of the world’s soil carbon, which is more than double that of all the world’s forests combined; _________________ 1a https://www.unep.org/news-and- stories/press-release/global-assessment- reveals-huge-potential-peatlands-climate- solution
Amendment 100 #
2024/2718(RSP)
Draft motion for a resolution
Recital K b (new)
Recital K b (new)
Kb. whereas there are scientifically proven interlinkages between health and the environmental and climate crises; whereas the European Climate and Health Observatory identifies serious health effects from heat, wildfires, flooding, vector-borne diseases, water and food-borne diseases, pollution, air pollution, UV radiation, aeroallergens, ground-level ozone, mental health effects and occupational safety and health effects; whereas extreme weather events, biodiversity loss, land degradation and water scarcity are displacing people and having a dramatic impact on their health and their ability to fully enjoy their human rights;
Amendment 106 #
2024/2718(RSP)
Draft motion for a resolution
Recital K c (new)
Recital K c (new)
Kc. whereas water scarcity is becoming endemic as a result of the local impact of physical water stress coupled with the acceleration and spread of freshwater pollution;
Amendment 113 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 1
Paragraph 1
1. Takes note ofHighlights 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 141 #
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; underlines that current policies are insufficient to meet the goals of the Paris Agreement and emphasises that climate risks will be magnified by any further delay in implementing ambitious and effective measures to mitigate and adapt to climate change;
Amendment 173 #
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; reiterates its call for a dedicated EU public finance mechanism that provides additional and adequate support towards delivering the EU’s fair share of international climate finance goals;
Amendment 175 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Highlights that significant financial resources from a variety of sources are needed to implement the goals of the Paris Agreement in developing countries, also considering that many developing countries have conditional NDCs, the achievement of which depends on sufficient financial support; recalls that the Glasgow Climate Pact urges developed country Parties to significantly scale up their provision of climate finance as a matter of urgency;
Amendment 179 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Stresses that financing from the developed countries responsible for a large share of historical emissions will also be crucial to build trust for a more ambitious dialogue on climate mitigation targets; calls on historical emitters to help developing countries adapt to climate change, inter alia, through grants-based financing and technical support;
Amendment 183 #
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, exceeding the UNFCC annual USD 100 billion climate finance goal for the first time, two years after the target year of 2020; notes that there is still a significant imbalance between adaptation and mitigation finance and that the adaptation finance gap is growing;
Amendment 187 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on all Parties to agree on a post-2025 new collective quantified goal (NCQG) on climate finance at COP29 with safeguards to reach the agreed quantum and timeframe; calls also for dedicated sub-goals for mitigation, adaptation and Loss and Damage in the NCQG in order to bring greater resources to where they are most needed and to improve climate finance tracking; believes that the NCQG should be firmly anchored in both the qualitative and quantitative needs of developing countries, with a target and structure that respond to lessons learned from the annual USD 100 billion goal; believes that the Core Goal of the NCQG should be measured on a grant-equivalent basis and delivered by additional contributions from developed countries; considers that a fair and effort-sharing approach could be used among developed countries, using for example GNI;
Amendment 202 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 10
Paragraph 10
10. Notes that many climate-vulnerable countries are in debt distress or at significant risk of debt distress; calls on other countries and multilateral development banks, including the EIB, to adopt climate resilience debt clauses in future lending; looks forward to the conclusions of the global expert review on debt, nature and climate as proposed by France, Colombia and Kenya during the Paris Summit for a New Global Financing Pact; considers it necessary to have solutions that jointly tackle the climate and debt crises; reiterates the need to clearly prioritise grants-based climate finance to ensure that climate finance does not contribute to unsustainable debt levels in developing countries and calls on the Parties to engage in discussions and undertake the necessary measures to alleviate the debt burden of developing countries; stresses that many developing countries are in great fiscal need and require investments in order to transition their energy systems and undertake effective climate mitigation and adaptation efforts; highlights the importance of increasing grants-based finance, especially for adaptation, and that climate finance provided in the form of loans can exacerbate developing countries’ debt distress; notes that 50 % of the EU’s total climate finance in 2020 was provided in the form of grants and urges the EU and all Member States to increase grants-based finance, particularly for adaptation and especially for least developed countries and SIDs;
Amendment 210 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 11
Paragraph 11
11. Considers it essential to advance the Bridgetown Agenda without delay; calls on all the major international financial institutions and multilateral development banks to align their portfolios and lending policies with the Paris Agreement, integrate tackling climate change and preserving nature and biodiversity into their practices and priorities, phase out direct and indirect support to fossil fuels and gather and use high-quality climate risk, vulnerability and impact data to guide the direction of investments towards 1,5 °C aligned investments;
Amendment 282 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 18
Paragraph 18
18. Welcomes the decision at COP28 to use theestablish a loss and damage (L&D) fund to address and respond to the economic and non-economic impacts of climate change for particularly vulnerable developing countries;
Amendment 286 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Urges all Parties to deliver on making the loss and damage fund fully operational in order to ensure new, additional, adequate and predictable funding to avert, minimise and address loss and damage associated with the adverse impacts of climate change; strongly believes that loss and damage funding should prioritise grants and be additional to and distinct from humanitarian aid; urges the Commission and the Member States, together with other major emitters, to contribute their fair share to the loss and damage fund to ensure global climate justice;
Amendment 289 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18b. Highlights that climate change has been affecting cultural heritage at an unprecedented speed and scale; stresses the need to strengthen efforts to protect and safeguard the worlds cultural and natural heritage focusing on risk preparedness and on strengthening resilience to climate change; considers it important to incorporate the loss and damage of cultural heritage in the UN climate talks and negotiations, which has so far been neglected;
Amendment 291 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 19
Paragraph 19
19. Reiterates its call for L&D to be a standing agenda item at COPs, in order to monitor and make progress on this issue, and for the full useoperationalisation of the Santiago Network in order to effectively catalyse technical assistance for adequately addressing L&D;
Amendment 293 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Calls on the Loss and Damage Transitional Committee to ensure that the Loss and Damage Fund is gender- sensitive and transformative, is guided by the needs of those most impacted and responds to specific losses suffered by women; believes that women should be centrally engaged in the design, management and disbursement of the new fund;
Amendment 296 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 20
Paragraph 20
20. Recalls the importance of the full involvement of all Parties in the UNFCCC decision-making processes; calls on the COP29 presidency and future presidencies to better enable the participation of all delegates, with a special focus on developing countries and delegates from the least developed countries, and to allocate additional resources to this, in order to eliminate financial and other access barriers and to avoid inequalities in the COP process;
Amendment 313 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 22
Paragraph 22
22. Recalls its resolution of 25 April 2024 on Azerbaijan and calls on the UNFCCC, all Parties and the authorities of Azerbaijan to ensure equitable access to COP29 and full and unrestricted participation for all citizens and civil society organisations; reiterates its call on the UNFCCC Secretariat to develop human rights criteria that countries hosting future COPs must commit to as part of the host agreement; calls attention to Azerbaijan’s restrictions on free speech and strongly calls for freedom of expression to be respected;
Amendment 319 #
2024/2718(RSP)
Draft motion for a resolution
Subheading 6 a (new)
Subheading 6 a (new)
Points out that switching to a more plant- based diet has a positive impact on the climate; calls on the Presidency of COP29 to endorse the climate-friendly catering concept of ‘plant-based by default’, which promotes a more plant-based diet without restricting people’s freedom of choice, by offering plant-based food to participants unless they have requested meat or fish in advance; stresses that the current habit of serving meat by default should be reversed to reduce the climate footprint and set a climate-friendly example for society;
Amendment 320 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 23
Paragraph 23
23. Welcomes the preparation of the first biennial transparency reports under the Paris Agreement; stresses the importance of this granular and transparent reporting assessing progress on the NDCs; takes note of the launching of the Baku Global Platform for Climate Transparency;
Amendment 321 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23a. Calls attention once again to the appointment of a COP president with links to the state’s oil company, and stresses that this is again cause for concern; underlines that Azerbaijan plans to increase its gas production threefold over the next decade; urges the Commission and the Member States to take all necessary actions to ensure that this and upcoming COP presidencies are free of conflicts of interest; calls for clear conflict of interest, lobbying and anti- corruption rules for the UNFCCC process, including the selection of the COP president;
Amendment 330 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 24
Paragraph 24
24. Expresses concern that more than 2 400 fossil fuel lobbyists were accredited attendees at COP28; calls for the UNFCCC and the Parties to ensure that the decision- making process is protected from interests that run counter to the goal of the Paris Agreement and to ensure that fossil fuel companies do not exert any undue and improper influence over public officials and the UNFCCC public decision-making process that may compromise the goals of the Paris Agreement; urges the UNFCCC to take the lead in proposing an ambitious Accountability Framework that would protect the UNFCCC’s work from undue influence from corporate actors with proven vested interests, based on the model contained in the WHO Framework Convention on Tobacco Control with regard to the tobacco industry;
Amendment 338 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24a. Strongly insists that the Host Country Agreements (HCA) for future COPs must be made public as soon as possible and must contain guarantees that human rights will be respected, inside and outside the COP venue, including the right to freedom of expression and peaceful assembly; calls on the UNFCCC secretariat to publish all past and future HCAs;
Amendment 353 #
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 the need to adopt the post-2030 target in a timely manner in order to be able to submit it as an NDC;
Amendment 400 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 28
Paragraph 28
28. Stresses that the current geopolitical situation further highlights the urgency of cutting the EU’s dependence on fossil fuels and the need to boost the deployment of renewables;
Amendment 412 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 29
Paragraph 29
29. NotWelcomes the Council Decision of 4 March 2024 on the approval of the withdrawal of the European Atomic Energy Community from the Energy Charter Treaty;
Amendment 419 #
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 that the responses to both crises need to be aligned; recalls that, currently, 80 % of habitats in the EU are in a bad state1a; emphasises the importance of protecting, conserving and restoring biodiversity and ecosystems, in particular soils, forests, agricultural ecosystems, freshwater bodies, oceans and other carbon-rich ecosystems, and of managing natural resources sustainably in order to enhance nature-based climate change mitigation and build resilience, which are necessary for achieving the objectives of the Paris Agreement; firmly believes that the Paris Agreement goals cannot be met without restoring nature, including in the Union; calls for the swift implementation of the EU Nature Restoration Law; stresses that agriculture should contribute to protecting and restoring biodiversity; _________________ 1a https://www.eea.europa.eu/en/newsroom/ news/ecosystems-need- restoration#:~:text=According%20to%20t he%20EEA%27s%20latest,a%20poor%20 or%20bad%20state
Amendment 440 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 31
Paragraph 31
31. Recognises that healthy ecosystems and rich biodiversity underpin human survival and provide life-critical services such as food and clean water, and highlights the fact that climate change is one of the direct drivers of biodiversity loss; points to how climate change has already altered terrestrial, freshwater and marine ecosystems all around the world, causing species losses and declines in key ecosystem services; recognises that these climate-driven impacts on ecosystems have caused measurable economic and livelihood losses around the world; notes that the IPPC’s 6th Assessment Report concludes that climate change has reduced food security and affected water security due to warming, changing precipitation patterns, the reduction in and loss of cryospheric elements, and the greater frequency and intensity of climatic extremes; stresses that the world’s land and ocean sinks have absorbed 56 % of the human-induced GHG emissions of the past 60 years, and that according to the IPCC, maintaining the resilience of biodiversity and ecosystem services on a global scale depends on effective and equitable conservation of approximately 30 % to 50 % of the Earth’s land, freshwater and ocean areas1a; _________________ 1a https://www.ipcc.ch/assessment- report/ar6/
Amendment 447 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 32
Paragraph 32
32. Underlines that the conservation and restoration of high-carbon ecosystems such as peatlands, wetlands, rangelands, and blue carbon ecosystems (salt marshes, seagrasses, mangroves), and the species that enable these ecosystems to function, offer a wide range of mitigation and adaptation benefits; calls on the Commission to develop the mapping of these ecosystems and developin order to work further on the identification of robust, transparent and science-based methodologies for the proper accounting of carbon removals and emissions from those ecosystems in a manner that does not undermine other biodiversity objectives;
Amendment 453 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 33
Paragraph 33
33. Stresses the need to protect the rights and interests of indigenous peoples and local communities; stresses the need to support and protect environmental defenders by ensuring effective and robust regulatory protection of the environment, land rights and indigenous peoples’ rights, livelihoods and cultures, including the right to free, prior and informed consent; stresses the central role of indigenous communities in climate action, implementation, data collection, decision-making and knowledge-sharing; calls on the Parties to ensure that all commitments made at COP28 to implement the Paris Agreement align with existing international human rights obligations and standards applicable to business operations, and respect indigenous people’s rights; stresses the need to support and protect environmental defenders and calls for those responsible for murders, defamatory attacks, acts of persecution, criminalisation, imprisonment, harassment and intimidation against them to be held accountable;
Amendment 462 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 34
Paragraph 34
34. Stresses the importance of effectively, swiftly and fully implementing the Kunming-Montreal Global Biodiversity Framework; recalls the failure in achieving the Aichi targetsunderlines that its implementation can maximise the ability of nature to help mitigate and adapt to climate change and to minimise negative impacts of climate action on biodiversity; reminds that conserving highly biodiverse, intact ecosystems on land and in the ocean is the most cost-effective nature- based action to tackle climate change; recalls the failure in achieving the Aichi targets, owing largely to the lack of implementation; insists therefore on the need to translate the 4 goals and 23 targets of the GBF into nationally driven action;
Amendment 468 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 35
Paragraph 35
35. Welcomes all efforts by governments and non-governmental actors to maximise the potential of soils to mitigate climate change and to improve water availability; underlines the transboundary impacts of soil degradation that warrant joint international efforts to tackle all soil degradation threats; draws attention to the huge importance of peatlands for climate change mitigation; calls for efforts globally and within the EU to swiftly restore peatlands, so that they can be a sink rather than a source;
Amendment 475 #
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; highlights the devastating environmental, social and economic impacts of desertification, droughts, floods and water pollution; and the need for common approaches to properly prevent and adapt to this phenomenon and overcome it; underlines, therefore, the importance of water availability and sustainable water management for climate change mitigation and adaptation; highlights that water stress is becoming a major and growing concern in Europe and that droughts and water scarcity are no longer rare or extreme events, with about 20 % of the European territory and 30 % of Europeans affected by water stress during an average year according to the EEA1a; highlights the need to prevent excessive pressures from economic activities on river bodies in some regions of Europe affecting their ecological flow; calls for the efficient use, reuse and recycling of water and for the protection and restoration of ecosystems supporting groundwater resources; stresses the need for the speedy and full implementation of the EU Water Framework Directive in order to achieve its objectives and better manage Europe’s water resources; _________________ 1a EEA report entitled ‘Water resources across Europe – confronting water stress: an updated assessment’, October 2021
Amendment 484 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 37
Paragraph 37
37. Welcomes the adoption of the historic UN High Seas Treaty (Biodiversity Beyond National Jurisdiction Agreement); calls on the Parties to continue work on the UN Ocean and Climate Change Dialogue; stresses that climate mechanisms depend on the health of the ocean and marine ecosystems currently affected by global warming, pollution, overexploitation of marine biodiversity, acidification, deoxygenation and coastal erosion; stresses that the IPCC recalls that the ocean is part of the solution to mitigate and adapt to the effects of climate change; recalls the importance of ocean-based solutions also in restoring ecosystems, ensuring food security and providing resources;
Amendment 490 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 38
Paragraph 38
38. Stresses the need to combat plastic pollution; welcomes the ongoing work on the Global Plastics Treaty because of the climate impact of plastic throughout its life cycles; welcomes the ongoing work on the Global Plastics Treaty; and calls on the UN member states to reach an ambitious and effective agreement, consistent with the Paris Agreement, at the fifth session of the Intergovernmental negotiating committee in Busan this year; underlines the necessity to address plastic pollution by reducing waste at its source, cutting down on plastic use and consumption, and increasing circularity; calls for a systemic approach in order to appropriately address plastic pollution in the environment, including microplastics, and its impact on climate change;
Amendment 500 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 39
Paragraph 39
39. Welcomes the fact that 158 countries have become signatories to the Global Methane Pledge to date; calls for a quantified, science-based assessment of the progress made since its adoption at COP26; strongly urges, in particular, the large methane-emitting Parties that have not joined the pledge to do so as soon as possible; urges all signatories to ensure that they reduce methane emissions within their territories by at least 30 % from 2020 levels by 2030 and to adopt national measures to achieve this aim; calls for the signatories of the pledge to enhance governance on methane by drawing up an overarching framework to make progress towards the collective commitment; calls for more attention at the upcoming and future COPs to be given to mitigating non-CO2 GHGs;
Amendment 510 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 40
Paragraph 40
40. Calls on all Parties also to include specific methane reduction targets in their NDCs; notes that no Parties have set any quantified targets to address methane emissions from livestock; reiterates its call to ensure ambitious reductions of GHG emissions in the agriculture sector along with tackling competitive disadvantages among different global regimes beyond the EU;
Amendment 515 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 41
Paragraph 41
41. Recalls the EU regulation on methane emissions reduction in the energy sector which will apply, from 1 January 2027, also to EU importers of crude oil, natural gas and coal; reiterates its call on the Commission to propose, based on an impact assessment, a 2030 EU binding methane emissions reduction target covering all relevant emitting sectors and including methane among the regulated pollutants in the National Emission Reduction Commitments Directive1a; _________________ 1a Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1)
Amendment 519 #
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 EU level since 1990 and that this is not compatible with the EU’s climate goals, which require greater and faster reductions in emissions from all sectors; is concerned by the slow progress achieved in the IMO and the ICAO in addressing emissions from international shipping and aviation;
Amendment 536 #
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; emphasises the importance of developing a more sustainable agriculture, including by giving farmers alternatives in order to reduce the use of synthetic fertilisers and pesticides; emphasises that reducing the overall production and use of synthetic fertilisers and increasing the use of natural carbon sequestration in soils and soil organic matter can offer multiple benefits by increasing soil fertility and biodiversity restoration while providing substantial mitigation potential; points, moreover, to the need to tackle in parallel competitive disadvantages among different global regimes beyond the EU that undermine the GHG emissions reduction efforts;
Amendment 555 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 44 c (new)
Paragraph 44 c (new)
44c. Underlines the fact that the Strategic Dialogue on the future of EU Agriculture calls for urgent, ambitious, and feasible action at all levels to guarantee that the agricultural sector operates within planetary boundaries; and welcomes their acknowledgement that a shift towards balanced and more plant- based diets that are healthier and more sustainable is essential for a successful transition;
Amendment 556 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 44 d (new)
Paragraph 44 d (new)
44d. Emphasises that adapting our diets and drastically reducing the production and consumption of animals while developing alternative protein sources to substitute meat, dairy and other animal products is a cost-effective, quick, healthy and easy measure to fight climate change and will realise countless co-benefits for human, animal and ecosystem health and welfare;
Amendment 557 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 44 e (new)
Paragraph 44 e (new)
44e. Recalls the significant impact of the agricultural sector, particularly the intensive livestock industry on climate change and biodiversity loss; emphasises that intensive industrial agriculture and livestock farming should not receive funding, nor be incentivised or rewarded; stresses instead the importance of supporting the development of agro- ecological and plant-based agricultural practices, reducing animal density and the amount of farmed animals, stimulating local production and investing in the development of regional infrastructure for a more sustainable agricultural sector;
Amendment 558 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 44 f (new)
Paragraph 44 f (new)
44f. Stresses that the IPCC underlined that balanced diets, featuring plant-based foods, such as those based on coarse grains, legumes, fruits and vegetables, nuts and seeds, and animal-sourced food produced in resilient, sustainable and low-GHG emission systems, present major opportunities for adaptation and mitigation while generating significant co-benefits in terms of human health; underlines that the IPCC concluded that by 2050, dietary changes could free several million km2 of land and provide a technical mitigation potential of 0.7 to 8.0 GtCO2eq yr-1, relative to business-as- usual projections1a; _________________ 1a IPCC, 2019: Summary for Policymakers. In: Climate Change and Land: an IPCC special report on climate change, desertification, land degradation, sustainable land management, food security, and greenhouse gas fluxes in terrestrial ecosystems
Amendment 560 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 45
Paragraph 45
45. Stresses that all sectors must contribute to the reduction of emissions, including the defence sector, while maintaining operational effectiveness, and that the development of decarbonisation technologies and strategies in the defence sector should be accelerated; notes that the inclusion of disaggregated military emissions in UNFCCC submissions is voluntary and it is not currently possible to identify reported military GHG emissions from the submitted UNFCCC data; calls on the High Representative of the Union for Foreign Affairs and Security Policy, the Commission and the Council to formulate a proposal for the transparent accounting of military emissions to the UNFCCC which acknowledges the adoption of the Strategic Compass for Security and Defence, and in order to fully implement the Climate Change and Defence Roadmap;
Amendment 567 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 45 a (new)
Paragraph 45 a (new)
45a. Points to the disproportionate climate impact of the use of private jets; stresses that private jets are up to 14 times more polluting than commercial planes per passenger; notes again with concern that private jet use in Europe is estimated to have increased by 30 % compared to the pre-pandemic level; calls on all Parties, including the EU Member States, to take measures to discourage the use of private jets;
Amendment 581 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 47
Paragraph 47
47. Stresses the need to address the climate and environmental impact of the textile sector; recognises that the textile industry needs to play an important role in the transformation to a circular economy and tackle challenges related to, for example, waste prevention, waste management, microplastic shedding, water usage, overproduction and the overall durability and non-toxicity of the production process and recyclability of textile products, including by ensuring that textiles are designed to be long- lasting and recyclable; stresses that working towards establishing global standards for when brands can make green claims about a product is imperative; highlights, in this regard, that consistent and transparent mandatory criteria will help consumers make informed choices and prevent greenwashing and ensure that sustainability claims are backed by verifiable evidence;
Amendment 592 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 49
Paragraph 49
49. Stresses that climate change and environmental degradation lead to scarcity of natural resources, can increase conflicts and tensions, as well as food shortages and natural catastrophes, and are major drivers of human displacement and threat multipliers; highlights the fact that women are disproportionately affected by this and that 80 % of people displaced by climate change are women1a; expects COP29 to pay more attention to climate-induced displacement; calls on the Commission and the Member States to recognise the needs and vulnerability of people affected by climate displacement and step up efforts to find solutions; _________________ 1a https://www.undp.org/sites/g/files/zskgke3 26/files/publications/UNDP%20Linkages %20Gender%20and%20CC%20Policy%2 0Brief%201-WEB.pdf
Amendment 614 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 50 a (new)
Paragraph 50 a (new)
50a. Points to the fact that people are impacted by climate change in different ways, depending on factors such as gender, age, disability, ethnicity and poverty; notes that vulnerable populations, such as the poor, indigenous peoples, women and the elderly are the hardest hit by its consequences; believes that gender balance and the empowerment of women and girls are key to an inclusive and just transition; emphasises the need for more effective gender mainstreaming throughout all relevant targets and goals;
Amendment 617 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 50 b (new)
Paragraph 50 b (new)
50 b. Calls on all Parties, including the EU and its Member States, to increase efforts to integrate gender equality in the implementation of their NDCs, as well as in climate and environmental policies and to increase the meaningful involvement of women’s groups in the design and implementation; stresses the need for more concrete actions by all Parties, including the EU, to deliver on the commitments contained in 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 619 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 50 c (new)
Paragraph 50 c (new)
50c. Stresses the need to accelerate action for gender-responsive disaster risk reduction and therefore for a gender- responsive implementation of the Sendai Framework; calls for further efforts to be made to prioritise and account for gender in disaster preparedness, particularly using disaggregated disaster risk reduction data sets;
Amendment 620 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 50 d (new)
Paragraph 50 d (new)
50d. Considers that women’s access to inclusive climate finance must be increased and enabled; highlights the fact that gender-responsive climate financing is critical for a just transition; emphasises the importance of a gender- transformative approach in climate finance; urges the EU and its Member States to report on the gender responsiveness of its climate finance contributions and to increase the coherence between support for gender and climate through external action instruments and through the EIB, including through enhancing the participation of women and women’s organisations in governance, decision- making and programmes which support the role of women in climate governance;
Amendment 621 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 50 e (new)
Paragraph 50 e (new)
50e. 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, less than one in five Heads of Delegation (19 %) was a woman, only 2 % of delegations had equal numbers of men and women and that 79 % of delegations had more men than women; 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 in the EU;
Amendment 4 #
2024/2030(DEC)
Draft opinion
Paragraph 2
Paragraph 2
2. Considers that regular visits to and from the Agencies are a key aspect of the scrutiny exercised by the European Parliament over them; notes to this regard the success of the ENVI delegation to EMA in February 2023 and to ECHA in April 2023;
Amendment 8 #
2024/2030(DEC)
Draft opinion
Paragraph 4
Paragraph 4
4. Welcomes the measures taken by the aAgencies in light of the European Parliament recommendations in its discharge for the financial year 2022; stresses the importance of increasing the Agencies’ efforts in terms of cooperation with other agencies and international organisations, digitalisation, and gender and geographical balance in senior management positionsstresses the importance of intensifying efforts to achieve gender and geographical balance among institutional staff and in senior management positions, reminds the Agencies in this regard of the importance of protecting the work-life balance not least among parent staff and to continously develop strategies to protect workers' health and well-being;
Amendment 19 #
2024/2030(DEC)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4 a. Notes the discrepancy between ECDC and ECA on the 2022 qualified opinion provided by ECA demonstrating that the accounts were reliable but that the transactions underlying the accounts were partly not legal and regular; stresses the importance of such discrepancies to be harmonised, urges ECDC to adhere to the standards provided by ECA 1a; _________________ 1a https://www.ecdc.europa.eu/sites/default/fi les/documents/consolidated-annual- activity-report-2023_1.pdf , page 56
Amendment 25 #
2024/2030(DEC)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Encourages ECDC to further cooperate with Member States to ensure an approach based on the solidarity principle in vaccine distribution and preparedness, notes that in the case of Mpox Member States undermined the ECDC capacity to face transmittable diseases by withholding vaccines;
Amendment 31 #
2024/2030(DEC)
Draft opinion
Paragraph 3
Paragraph 3
3. Recalls the necessity of ensuring adequate staffing reflecting the needs of the European Green Deal and the Union Chemical Strategy for Sustainability, Circular Economy Action Plan and, in particular, the zero pollution target, and the associated increase in tasks; laments indicators from the 2023 internal staff survey showing that only 42% agree fully that their units operate in an efficient manner1b, reiterates the need for ECHA to continuously work with staff satisfaction, worker health and well-being, ensuring gender and geographical balance in the work place and facilitating the participation in the work life by parent staff; _________________ 1b https://echa.europa.eu/documents/10162/ 7362407/annual_Report_2023_en.pdf/ca1 6f5a4-a8ae-ac22-21f1- 57af476f0bb1?t=1713865234883 , page 57
Amendment 40 #
2024/2030(DEC)
Draft opinion
Paragraph 6
Paragraph 6
6. Welcomes the ECHA’s efforts to promote the use of alternatives to animal testing for the regulatory assessment of chemicals and to foster understanding of the opportunities and challenges in moving away from animal testing while ensuring a high level of protection of human health and the environment and encourages ECHA to promote the use of non-animal testing methods;
Amendment 41 #
2024/2030(DEC)
Draft opinion
Paragraph 7
Paragraph 7
7. Notes with concern the difficulty to recruit sufficient experts from Member States to the ECHA’s Scientific Committees, posing a risk to the ECHA’s ability to meet legal deadlines and targets in regulatory processes that are dependent on the Committees’ outputs, in particular in the light of increasing tasks being attributed to the ECHA, stresses the importance of the Commission working actively to ensure Agencies can recruit adequate competence to fulfil their missions, encourages in this regard an increased cooperation with universities and other relevant institutions;
Amendment 47 #
2024/2030(DEC)
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses that the EEA provides sound, independent information on the environment; commends the quality of its outputs released in 2023, such as Pathways towards circular plastics in Europe — good practice examples from countries, business and citizens, Assessing the costs and benefits of climate change adaptation and European forest ecosystems: key allies in sustainable development, acknowledges the outmost importance of the EEA to reach the Union’s climate goals;
Amendment 64 #
2024/2030(DEC)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Reiterates the need for the EEA to adequately hire staff able to carry out the immense task devoted to the Agency, encourages in this regard the Commission to intensify its measures to assist Agencies in ensuring the competence required, reminds the EEA of the importance of achieving gender and geographical balance among staff, ensuring a healthy work-life balance for everyone but not least for parent staff and to continuously work with improving workers' health and well-being;
Amendment 66 #
2024/2030(DEC)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the EFSA's' contribution to the safety of the Union food and feed chain, and its considerable efforts in providing risk managers with comprehensive, independent and up-to- date scientific advice on questions linked to the food chain, communicating clearly to the public on its outputhowever expresses deep concern over some of the aspects of the Agency's work relating to inadequate actualisation of regulation regarding pesticides and othe information on which they are based, and cooperating with interested parties and institutional partners to promote coherence and trustr toxins, deplores the close ties between the agency and agrochemical industry and reiterates the need for a thorough investigation into the food safety systemse ties;
Amendment 69 #
2024/2030(DEC)
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2 a. Believes that EFSA should continue to pay special attention to the public opinion, and commit itself to increased openness, transparency and scrutiny to and by the public and independent scientists;
Amendment 72 #
2024/2030(DEC)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Reiterates its regrets that the EFSA, in relation to the two-year cooling off period, still includes in its independence policy the obligation to screen experts' interests only in relation to the mandate of the scientific group to which the expert is applying, and reiterates its regrets that the research funding from companies in the Authority's remit is not considered relevant to the cooling off period as long as amounts at stake do not rise above 25 % of the total research budget managed by the expert and/or their research team, and that the threshold is applied to individual sources as opposed to all private sources combined; highlights that the Authority's refusal to address these two very serious issues in relation to the Authority's prevention and management of conflicts of interests is unacceptable and needs to be resolved immediately;
Amendment 75 #
2024/2030(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Highlights the need for the EFSA to develop strong cooperation with all its stakeholders, including the other Agencies for better connection and outputs dissemination; welcomes the fact that the EFSA developed cooperation with Member States, including with the increase support of focal points, mainly focusing on support in the area of data collection and communication; encourages EFSA to even further increase its efforts to protect animal welfare and promote the use of non-animal testing methods, also in its cooperation with other institutions;
Amendment 91 #
2024/2030(DEC)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Expresses deep concern over reports of conflict of interest and influence of the pharmaceutical industry over EMA 1d, reiterates that the agency serves the public interest of safe and affordable medicine, regrets inaction shown by the agency to tackle accusations of "revolving doors" in the case of scientific experts and their involvement with big pharmaceutical companies, regrets with profound concern the unwillingness of the Agency to challenge financial interests and to properly prioritise public health concerns; _________________ 1d https://www.investigate- europe.eu/posts/deadly-prices-big- pharma-influence-hangs-over-europes- medicines-regulator
Amendment 94 #
2024/2030(DEC)
Draft opinion
Paragraph 4
Paragraph 4
4. Welcomes the EMA’s efforts to contribute to Union priorities, including via inter alia the implementation of the Union Beating Cancer Plan, the Union Chemical Strategy for Sustainability and the European One Health Action Plan against Antimicrobial Resistance.; urges the EMA to further cooperate with relevant agencies and actors to combat new, rare and difficult-to-diagnose cancers; reiterates the need to pay special attention to often misdiagnosed conditions among women and girls and to be conscious of class bias in health related issues and pharmacological needs;
Amendment 95 #
2024/2030(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Recalls that the EMA is a fee- funded agency, with 88,21 % of its 2023 revenue stemming from fees for applications for marketing licenses for pharmaceutical products and for post- authorisation activities, 11,43 % stemming from the Union budget and 0,36 % from various other sources; highlights the need to ensure transparency of these revenues and welcomes the fact that in the future the EMA will have the obligation to publish in its activity report the annual revenue received per type of fee and charge according to Regulation (EU) 2024/5682 ; reiterates the importance of scientific integrity and patient safety; commits to supporting the EMA to guard these principles regardless of the levels of fee- based incomes to the agency; _________________ 2 Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95 (OJ L, 2024/568, 14.2.2024, ELI: http://data.europa.eu/eli/reg/2024/568/oj).
Amendment 100 #
2024/2030(DEC)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Acknowledges that accessibility to medicine at affordable rates is a national competence; commits however to assuring that the EMA contributes to these ends; encourages the agency to find methods and practices that manages development costs of new pharmacological products;
Amendment 105 #
2024/2030(DEC)
Draft opinion
Paragraph 1
Paragraph 1
1. Recommends, based on the facts available, that discharge should not be granted to the Executive Directors of the Agencies EFSA and EMA in respect of the implementation of the budget of the EU agencies for the financial year 2023, recommends that discharge be granted to all other Executive Directors of the Agencies .
Amendment 1 #
2024/2019(DEC)
Draft opinion
Paragraph 1
Paragraph 1
1. Is satisfied withNotes with concern the lack of increased climate ambition in the Commission's overall implementation of the budget in the areas of environment, climate action, public health and food safety in 2023;
Amendment 5 #
2024/2019(DEC)
Draft opinion
Paragraph 2
Paragraph 2
2. Is mostly satisfied with the work carried out by the five decentralised agencies which are under its remit, whichunder the conditions in which they operate, carrying out technical, scientific or managerial tasks that help the Union institutions elaborate and implement policies in the area of environment, climate action, public health and food safety, as well as with the way in which those agencies' budgets are implemented; stresses that, given the scale and importance of their current tasks and the increase of responsibilities some of them are facing, adequate funding and staffing must be guaranteed for the agencies and the Commission Directorates- General working in the areas of environment, climate action, public health and food safety;
Amendment 18 #
2024/2019(DEC)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Notes with grave concern how the mismanagement of the RRF negatively influences the EU's credibility in both fiscal and environmental matters; demands a thorough examination of the structure of the RRF, urges the commission to commit to a better controlled and more sustainable financial instrument in the future;
Amendment 25 #
2024/2019(DEC)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Notes with great concern the special report by the European court of Auditors titled Green transition - Unclear contribution from the Recovery and Resilience Facility, according to which the contribution by the RRF to the green transition appears to be heavily overestimated; notes further how the RRF has an unclear implementation structure in the field of green transition; notes how the RRF funds appears to have been grossly disconnected from actual costs and results in the green transitions; concludes that the RRF mismanagement and poor design has severely hindered an ambitious green transition and severed the reputation of green investment within the EU framework; regrets the missed opportunity to advance green investment through the RRF;
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 37 #
2024/2019(DEC)
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8 a. Insists on an ambitious and well- managed environmental policy with the highest regard for biodiversity, sustainability, social progress and animal welfare in the works of the decentralised agencies, building on successful methods and tools from the past year while continuously developing strategies to face current challenges;
Amendment 50 #
2024/2019(DEC)
Draft opinion
Paragraph 12
Paragraph 12
12. Is of the opinion, on the basis of the data and reports available, that discharge cannot be granted to the Commission in respect of expenditure in the areas of environment, climate action, public health and food safety for the financial year 2023.
Amendment 5 #
2023/0455(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) To ensure the coherence and efficiency of assessments related to chemicals across Union legislation, it is also important to enable data interoperability and easy exchange of data between the relevant Union agencies, as well as to encourage cooperation on the development of standard formats and controlled vocabularies. Thus, to facilitate data exchange between agencies, any new data formats defined by the European Food Safety Authority or by the European Environmental Agency should be set in cooperation with other relevant Union agencies working on chemicals. To this end, relevant provisions should be introduced in Regulation (EC) No 401/2009 of the European Parliament and of the Council and, in Regulation (EC) No 178/2002 of the European Parliament and of the Council, existing provisions should be strengthened and, where relevant, new ones be introduced. Similar provisions should also be considered to be proposed for a strengthened mandate of the European Chemicals Agency in its founding regulation, which should be proposed as soon as possible and no later than 31 December 2025.
Amendment 6 #
2023/0455(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) To promote the transition towards a toxic-free environment and zero pollution, and the robustness, coherence and efficiency of assessments related to chemicals across Union legislation, steps should be taken by the relevant Union agencies to avoid divergent scientific opinions. Existing cases of divergent opinions have lead to increased uncertainty for operators, as well as to declined public trust in the scientific robustness and coherence of scientific decision making. Proposals to address and strengthen procedures for resolving divergence of scientific opinions concerning the European Medicines Agency with other scientific bodies is proposed as part of the revision of Union pharmaceutical legislation. Similar provisions should also be considered to be proposed for a strengthened mandate of the European Chemicals Agency in its founding regulation, whilst such provisions are not relevant and applicable to the European Environmental Agency, since this agency does not issue scientific opinions on individual chemicals such as to be part in divergent outcomes.
Amendment 8 #
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 ooptimising the protection of health and the environment. Diverging scientific opinions and their causes, including in methodological differences, should be duly explained and clarified. Where diverging scientific opinions exist, the most protective opinion from the One Health perspective should be agreed on. Only when they are not able to resolve the divergence, should they refer to risk managers.
Amendment 11 #
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 the 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, optimising the protection of health and the environment. 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 14 #
2023/0455(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) To comply with the obligation laid out in Section 10.4.4. of Annex I to Regulation (EU) 2017/745, the Commission should mandate the relevant scientific committee to prepare guidelines for substances other than phthalates and which are classified as either carcinogenic, mutagenic or toxic to reproduction category 1A or 1B, or which have endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health or the environment 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.
Amendment 15 #
2023/0455(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Taking account of the new hazard classes and criteria for classification, labelling and packaging of substances introduced by Commission Delegated Regulation (EU) 2023/707 of 19 December 20227 , reference to endocrine disruptors for human health or the environment, of Category 1, should be specified in 10.4.1., point (b) of Annex I of Regulation (EU) 2017/745 in light of the relevance of that hazard class to the type of substances in medical devices. _________________ 7 Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures (OJ L 93, 31.3.2023, p. 7–39).
Amendment 21 #
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, with the aim of optimising the protection of health and the environment, prioritising the most protective opinion. 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 the possible causes for the diverging opinions, including on methodological differences and be made publicly available.
Amendment 25 #
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 3
Article 30 – paragraph 3
3. Where relevant, and where the divergence concerns conflicting scientific opinions of the Authority and another Union body or agency on whether a substance fulfils the criteria laid out in Annex I of Regulation (EC) No 1272/2008 of the European Parliament and of the Council11 , the Commission may request the European Chemicals Agency to prepare a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof following the procedure laid out in Article 37 of Regulation (EC) No 1272/2008, with the aim of optimising the protection of health and the environment. The Authority and the Union body or agency concerned shall co-operate with the European Chemicals Agency in developing that proposal.. _________________ 11 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 – 1355.
Amendment 27 #
2023/0455(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 1 a (new)
Article 2 – paragraph 1 – point 1 a (new)
Regulation (EC) No 401/2009
Article 15 – paragraph 4
Article 15 – paragraph 4
Amendment 28 #
2023/0455(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 2
Article 2 – paragraph 1 – point 2
Regulation (EC) No 401/2009
Article 15 – paragraph 5
Article 15 – paragraph 5
5. The Agency shall cooperate with other scientific bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, and the European Medicines Agency, on the exchange of data and information on chemicals, including the possible establishment of related data formats and controlled vocabularies to facilitate such an exchange, and on the development of scientific methodologies for the assessment of chemicals. This cooperation shall aim to support the development of innovative methods and tools, notably non animal approaches and aim to ensure that animal testing takes place only as last resort.
Amendment 29 #
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 identified as endocrine disruptors for human health or the environment, 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 or the environment 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 or the environment 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 31 #
2023/0455(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
Regulation (EU) 2017/745
Annex I – Section 10.4.3
Annex I – Section 10.4.3
When deemed appropriate based on the latest scientific evidence, but at least every 53 years, the Commission shall request the European Chemicals Agency (ECHA) to update guidelines on the benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in Section 10.4.1., points (a) and (b). The benefit-risk assessment shall consider the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments
Amendment 92 #
2023/0453(COD)
Proposal for a regulation
Citation 1
Citation 1
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114(1), 168 and 191 thereof.
Amendment 93 #
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. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes3a establishes measures for the protection of animals used for scientific or educational purposes, making full replacement of animal testing its ultimate goal. According to the Strategy, safety testing and chemical risk assessment need to innovate in order to reduce dependency on animal testing but also to improve the quality, efficiency and speed of chemical hazard and risk assessments. 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, 3a Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes, OJ L 276, 20.10.2010, p. 33–79
Amendment 99 #
2023/0453(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The main objectives of this Regulation isare to increase the level of protection of the environment and human health from the risks arising from hazardous chemicals, to contribute to phasing out animal testing 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 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 and to contribute to ensuring animal testing takes place only as a last resort. Moreover, the Regulation aims to provide a one-stop- shop on chemicals data and information in the Union accessible to the general public and, thus, to increase the predictability and the transparency of regulatory processes on chemicals, as well as to strengthen public trust in the robustness of scientific decision-making.
Amendment 103 #
2023/0453(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) Business operators and Members States’ competent authorities are required by various Union acts to submit data and information to a multitude of Union agencies, as well as to the Commission in specific cases. This generates a fragmentation of data and information on chemicals, which are held under various data sharing and use conditions and in different formats. Such fragmentation prevents public authorities, as well as the general public, from having a clear overview of what information is available on individual chemicals or groups of chemicals, of where and how information can be accessed and whether it can be used. This increases the likelihood of inconsistency between various assessments of the same chemical required by various Union acts on chemicals and of damaging the general public’s trust in the scientific grounds for Union decisions on chemicals. In order to ensure that data on chemicals is easily findable, accessible, interoperable and usable, the ECHA should establish a common data platform on chemicals. The common data platform on chemicals should serve as a single point of reference and as a broadened and shared evidence base to enable the efficient delivery of coherent hazard and risk assessments of chemicals across various Union acts on chemicals, as well as to enable the timely identification of emerging chemical risks and the drivers and impact of chemical pollution. Where multiple studies exist for the same chemical, potentially generated to meet requirements across different regulatory frameworks, data from each study should be published in a harmonised format which facilitates rapid comparison and review.
Amendment 109 #
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 and occurence of chemicals in articles. The common data platform should also include chemicals data and information generated as part of Union, national or international programmes, enforcement actions or research activities related to chemicals, where this data and information is held by the Commission or one of the relevant agencies. For studies initiated after entry into force of this Regulation, the standard formats shall ensure publication of the date of commencement of studies and the name of the relevant GLP or equivalent compliance monitoring authority responsible for ensuring test facility compliance.
Amendment 115 #
2023/0453(COD)
Proposal for a regulation
Recital 8
Recital 8
Amendment 122 #
2023/0453(COD)
Proposal for a regulation
Recital 9
Recital 9
Amendment 130 #
2023/0453(COD)
Proposal for a regulation
Recital 10
Recital 10
Amendment 132 #
2023/0453(COD)
Proposal for a regulation
Recital 11
Recital 11
Amendment 133 #
2023/0453(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) In order to respond to the needs of the digital economy and to ensure a high level of protection of the environment and human healthealth and a high level of transparency, it is necessary to lay down a harmonised framework, granting as a general principle, the widest possible access to chemicals data and, where appropriate and justified, specifying who is entitled to access and use the chemicals data contained in the common data platform, under which conditions, on what basis, and for which purposes. The Authorities that are entrusted with regulatory tasks related to chemicals should be allowed and encouraged to use all of the chemicals data and information contained in the common data platform to effectively fulfil their regulatory duties and tasks, in order to improve the effectiveness, efficiency, and coherence of chemicals- related assessments as well as the development of Union chemicals policies.
Amendment 138 #
2023/0453(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) Chemicals data and information generated as a result of obligations set by Union acts on chemicals may be protected by confidentiality claims on confidential business information. The public dissemination of such data may affect the commercial interest of private parties. To ensure legal certainty for duty holders and to protect their legitimate expectations, as well as to ensure industry’s competitiveness on the internal marketo ensure optimal transparency to the public as well as certainty for duty holders, the ECHA, as a manager of the common data platform, should grant differentiated access rights to the data and information contained in the common data platform, while prioritising transparency. To this end, the Authorities should have full access to all chemicals data and information contained in the common data platform, including access to confidential information, while business operators and the general public should have restricted access to that data and information, which does not include access to confidential informationle as much of the information as possible should be made public.
Amendment 141 #
2023/0453(COD)
Proposal for a regulation
Recital 15
Recital 15
(15) To ensure the protection of legitimate expectations of duty holders when generating or submitting data or information under the Union acts listed in Annex I, as well as to protect the confidentiality of that information when used by the Authorities, exceptional grounds for disclosing confidential information laid down in the Union acts listed in Annex I should apply only to the disclosure of the data and information submitted or generated in compliance with those actshealth and the environment, there may be exceptional grounds for disclosing confidential information laid down in the Union acts listed in Annex I. For example, under Article 39(4) of Regulation (EC) No 178/2002 of the European Parliament and of the Council8 , where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the European Food Safety Authority (‘EFSA’) may disclose information previously considered confidential under that Regulation and the EFSA is required to make public information, previously considered confidential, that forms part of conclusions of scientific outputs of the EFSA and relates to foreseeable effects on human health, animal health or the environment. Likewise, Article 118 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council9 provides for the possibility for the ECHA to disclose confidential information submitted to it under that Regulation if urgent action is essential to protect human health, safety or the environment, such as in emergency situations. These emergency provisions should apply to all information held in the common data platform. _________________ 8 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (General Food Law) (OJ L 031 1.2.2002, p. 1). 9 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396 30.12.2006, p. 1).
Amendment 142 #
2023/0453(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Taking into account that the Agencies would be required to store scientific data, which includes confidential and personal data, it is necessary to ensure that such storage is carried out in accordance with a high level of security of information systems and that confidentiality claims and access to confidential data isare auditable.
Amendment 143 #
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’) which should rapidly be elaborated to include all data on chemical substances in articles and on their alternatives, 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, as well as a dashboard of indicators on chemicals.
Amendment 151 #
2023/0453(COD)
Proposal for a regulation
Recital 20
Recital 20
(20) In order to bring together all relevant chemicals data and information in the common data platform, the Commission and Union agencies – notably the European Agency for Safety and Health at Work (‘EU-OSHA’), the ECHA, the European Environment Agency (‘EEA’), the EFSA, and the EMA (‘the Agencies’), should act as data providers and make available any such relevantchemical data they have or hold to the ECHA for integration in the common data platform. The Agencies, including the ECHA itself when making its own data available, should provide the necessary standard metadata, contextual information and relevant mapping to the platform’s structure, and respect rules on standard formats and controlled vocabularies where available.
Amendment 152 #
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, data generated as part of Union, national or international programmes, including monitoring and enforcement, or research activities beyond the data already flowing to the Agencies as part of the obligations under the Union acts listed in Annex I. The Commission should make such requests to the Agencies in accordance with their mandates and allocated tasks. Other parties, such as Member States, academic institutes, scientific bodies of Member States or national authorities, should be able to offer chemicals data to the Agencies or the Commission for hosting and maintenance. In such case, it should be for the Agencies or the Commission, as the case may be, to decide whether to respond positively to the offer, and give justification in case the offer is refused.
Amendment 157 #
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 andand their environmental sustainability impacts of chemicals, researchers or research consortia, notably those funded by Union framework programmes should be required to 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 other chemicals data, including environmental sustainability data on chemicals or materials they collect or generate to the ECHA.
Amendment 162 #
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 165 #
2023/0453(COD)
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24 a) The EEA, ECHA, EFSA, EMA 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 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 167 #
2023/0453(COD)
Proposal for a regulation
Recital 24 b (new)
Recital 24 b (new)
(24 b) The EEA should be allowed to process 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, 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. Such data is also useful for 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 and the Commission should pay particular attention to compliance with Article 13 of Regulation (EU) No 2018/1725.
Amendment 169 #
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 and the Commission when this Regulation comes into force.
Amendment 177 #
2023/0453(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) In order to increase transparency, as well as to enable Authorities to have complete prior knowledge of studies commissioned by business operators, irrespective of their purpose, results or of whether such studies are carried out by the business operator itself or are outsourced, business operators and laboratories should notify to a database of study notifications established and managed by the ECHA the studies on chemicals they commission for compliance with regulatory requirements under the Union acts listed in Annex I. For this purpose, the ECHA should establish and manage a database of study notifications, as a dedicated service of the common data platform, to store the information related to those studies. In order to allow business operators and laboratories sufficient time to prepare the notifications of studies, the obligation to notify studies should only start to apply twoone years after the date of entry into force of this Regulation.
Amendment 183 #
2023/0453(COD)
Proposal for a regulation
Recital 31
Recital 31
Amendment 190 #
2023/0453(COD)
Proposal for a regulation
Recital 32
Recital 32
(32) Nevertheless, tTo ensure compliance with the study notification obligation laid down in this Regulation, and to cater to the specificities of individual assessment processes, where existing, Member States should lay down rules on penalties applicable to the infringement of that obligation and take all necessary measures to ensure that those rules are complied with. Those penalties should be effective, proportionate, and dissuasive, since non- compliance with this Regulation could result in less robust chemicals risk assessments, creating potential risks and consequently adverse effects on human health and the environment.
Amendment 194 #
2023/0453(COD)
Proposal for a regulation
Recital 33
Recital 33
(33) In order to facilitate enforcement by Member States, the Agencies responsible for assessing and providing scientific output, including scientific opinions, on regulatory dossiers containing studies subject to notification to ECHA should, where relevant, cooperate and exchange information with the Member State enforcement authorities on the compliance with the obligations laid out in Article 22 and ensure information on enforcement is made public.
Amendment 200 #
2023/0453(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) To strengthen the coordination and cooperation between the different bodies performing chemicals assessments in the Union, and to promote an increased transparency of chemicals assessments and to promote the phasing out of animal tests, the ECHA should establish and manage a database with information on regulatory processes or activities that are planned, ongoing or completed by Member States, the Commission and Agencies referred to in the Union acts listed in Annex III to this Regulation and integrate it into the common data platform for access by the authorities. The information on such regulatory processes or activities should include at least the substance identity and the identification, status and eventually the outcome of the regulatory process or activity including any new requirement to conduct animal testing and the length of time each activity is expected to take. That information should also be made available without undue delay and kept updated through the assessment process. Once the process or activity has formally started, that information should be shared also publicly on the common data platform.
Amendment 204 #
2023/0453(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to ensure the interoperability and comparability of chemicals data and to facilitate their automatic and electronic exchange, the Agencies and the Commission should store chemicals data in adequate and mutually coherent and interoperable formats and use mutually coherent and interoperable controlled vocabularies. Some Union acts listed in Annex I or II set procedures to establish or make available data formats, in particular for the submission of chemicals data by business operators or Member States. Where such procedures do not exist in the Union acts listed in Annex I or II, the Agencies and the Commission should, where relevant, specify appropriate formats for chemicals data they receive and store, avoiding the use of proprietary standards while, as appropriate, using OECD or other internationally agreed formats, making use of existing formats and ensuring interoperability with existing data submission approaches. Such mutual coherence should be supported by the respective Agency’s efforts to ensure alignment across full study data, study reports and study summaries.
Amendment 208 #
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, the Commission should identify relevant data and information related to the environmental sustainability 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 on environmental sustainability related data and has designed the relevant related database functionalities, the ECHA should establish a database on environmental sustainability- related data, collect the data as made available by the Commission, the Agencies and Member States and, where relevant, by the researchers and research consortia funded by, in particular those funded by national and 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 datasets, implementing powers should be conferred on the Commission.
Amendment 211 #
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 and legislation on chemicals, and further acknowledging existing experience with citizen science approaches, individuals 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 be obliged to 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 214 #
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 and policy follow-up actions. 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 and groups of 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 justify if they decide not to proceed with any action.
Amendment 219 #
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 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. Where relevant and whenever possible, information generated through studies commissioned by the ECHA should be generated by means of non animal testing methods.
Amendment 227 #
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 sustainable and safe chemicals, to ensure the proper functioning of the single market for chemicals, to contribute to the goal of phasing out animal testing and to improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals.
Amendment 231 #
2023/0453(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) bring together data and information on chemicals and their alternative and ensure that data and information are easily findable, accessible, interoperable and re- usable;
Amendment 236 #
2023/0453(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
(b) keep records of all studies commissioned or carried out by business operators in the context of fulfilling their obligations set under Union chemicals legislation;
Amendment 238 #
2023/0453(COD)
Proposal for a regulation
Article 1 – paragraph 2 – point d a (new)
Article 1 – paragraph 2 – point d a (new)
(d a) foster innovations regarding advanced biologically-relevant tools, methods and models, and data analysis capacities.
Amendment 258 #
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 Commission;
Amendment 261 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point c
Article 3 – paragraph 2 – point c
(c) listed in Annex II and held by the EMA;
Amendment 262 #
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 265 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
Amendment 269 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
Amendment 276 #
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, as well as any related context data as referred to in paragraph 5 of Article 4, point (c), including, where relevant, an indication whether the data was generated by Authorities.
Amendment 283 #
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: threewo years after the date of entry into force of this Regulation], unless specified otherwise. The relevant datasets shall be integrated progressively into the common data platform by [OP please insert date: tenfive 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 294 #
2023/0453(COD)
Proposal for a regulation
Article 4 – paragraph 5 – point f
Article 4 – paragraph 5 – point f
(f) the operation, reporting requirements and transparency obligations of the steering committee itself.
Amendment 296 #
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. In addition, Agencies may host and maintain chemicals data according to their mandate and offered to them by Member States, research institutes or other parties.
Amendment 311 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. Researchers or research consortia, in particular those funded by Union or national 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].
Amendment 322 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. At the latest by [OP please insert date: 32 years after entry into force of this Regulation] the Commission shall transfer any human biomonitoring data it holds to the EEA.
Amendment 338 #
2023/0453(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. At the latest by [OP please insert date: 32 years after the date of entry into force of this Regulation], the Commission shall transfer the chemicals data contained in the Information Platform for Chemical Monitoring at that moment to the ECHA for integration in the common data platform.
Amendment 339 #
2023/0453(COD)
Proposal for a regulation
Article 7 – paragraph 3
Article 7 – paragraph 3
3. At the latest by [OP please insert date: 32 years after entry into force of this Regulation], the Commission shall transfer the chemicals data contained in the Information Platform for Chemical Monitoring to the ECHA, the EEA or the EFSA for hosting in accordance with the respective agencies’ mandate and in accordance with Article 5.
Amendment 347 #
2023/0453(COD)
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. The ECHA shall establish and operate a Database of Study Notifications by [OP please insert date: twoone years after the date of entry into force of this Regulation].
Amendment 352 #
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 372 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 3 – point f a (new)
Article 10 – paragraph 3 – point f a (new)
(f a) where applicable, whether animal testing is required and for which endpoint.
Amendment 374 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. The information referred to in paragraph 3, points (a) to (fa), on a specific regulatory process or activity shall be made available to the public once that process or activity has formally startedwithout delay.
Amendment 375 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 4 a (new)
Article 10 – paragraph 4 a (new)
4 a. Any planned new test, in particular tests on animals, shall be notified in advance and the ECHA shall record the intention in the database. Furthermore, the ECHA shall record where new animal testing has been requested by an Agency for regulatory purposes. These records shall be made public without undue delay.
Amendment 384 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. At the latest within threewo years after the publication of the decision referred to in paragraph 4, the ECHA shall establish and manage, as part of the common data platform, a database containing environmental sustainability related data.
Amendment 387 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Where the Commission or, the Agencies or the Member States host or hold environmental sustainability 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 Agency hosting or holding that data has completed, where relevant, validity and confidentiality assessments. The Commission and the Agencies and the Member States shall provide the necessary technical cooperation to the ECHA to enable the integration of environmental sustainability related data in the database on environmental sustainability related data.
Amendment 389 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Where researchers or research consortia, especially those funded by Union and national framework programmes make available to the ECHA, under Article 5(6), any environmental sustainability data on chemicals or materials they collect or generate, the ECHA shall integrate the relevant data in the database on environmental sustainability related data without undue delay.
Amendment 395 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. By [OP please insert date: threewo 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 and 3, for inclusion in the common data platform and shall design relevant related database functionalitiesrequest the ECHA to host and maintain them in accordance with Article 5(1).
Amendment 397 #
2023/0453(COD)
Proposal for a regulation
Article 14 – paragraph 2 – point e a (new)
Article 14 – paragraph 2 – point e a (new)
(e a) increase transparency
Amendment 401 #
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) (j) 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 (OJ L 309 24.11.2009, p. 1).
Amendment 404 #
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 Council1a _________________ 1a 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 (OJ L 70 16.3.2005, p. 1).
Amendment 408 #
2023/0453(COD)
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The Commission and the Agencies shall cooperate when setting standard formats to ensure transparency and coherence with other formats and the interoperability of the standard formats with the common data platform and with existing data submission approaches.
Amendment 414 #
2023/0453(COD)
Proposal for a regulation
Article 16 – paragraph -1 (new)
Article 16 – paragraph -1 (new)
-1. The public shall have access to all the chemicals data contained in the common data platform.
Amendment 426 #
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 431 #
2023/0453(COD)
Proposal for a regulation
Article 17 – paragraph 3
Article 17 – paragraph 3
3. When using chemicals data contained in the common data platform that is deemed confidential under Article 5(2), second sentenceas provided for in paragraph 1, the Authorities shall respect the confidentiality of informationthat data as marked by the originator and shall not disclose that data to the public without the consent of the originator.
Amendment 435 #
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 a framework of indicatorsnd update as appropriate a framework of indicators to monitor chemical pollution along the chemical’s lifecycle, including emissions and occurrence, to monitor the drivers and impacts of exposure to chemicals, measure the effectiveness of chemicals legislation and measure the transition towards the production of safe and sustainable chemicals.
Amendment 439 #
2023/0453(COD)
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Article18a 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 substances or groups of substances, 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. Any substantiated concern submitted under paragraph 1 and the information subject to paragraph 3 shall be made available to ECHA and compiled for publication in an annual report. The report shall be integrated in the common data platform without undue delay.
Amendment 444 #
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 as referred to in Article 18;
Amendment 446 #
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) relevant information resulting from national enforcement programmes
Amendment 447 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1 – point e b (new)
Article 19 – paragraph 2 – subparagraph 1 – point e b (new)
(e b) relevant data or information submitted by researchers.
Amendment 452 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 4 a (new)
Article 19 – paragraph 4 a (new)
4 a. Within two months after receipt of this report, the Commission, relevant Union agencies and Member State competent authorities shall publicly respond to the received early warning signals with the details and timeline of the undertaken or planned regulatory or policy action related to the early warning signals, or a justification of the lack of action.
Amendment 455 #
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 465 #
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 472 #
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 prioritise the use of non-animal methods, with animal tests only proposed as a last resort. Full justification for the need to perform any new test on animals shall be provided. It shall not commission studies with a predominant research objective.
Amendment 482 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 6
Article 21 – paragraph 6
6. The ECHA, the EMA and the EFSA shall closely cooperate with each other on the planning and commissioning of scientific studies undertaken by the ECHA in accordance with paragraph 1 and of studies undertaken by the EFSA in accordance with Article 32 of Regulation (EC) No 178/2002 and studies undertaken by EMA. The agencies shall aim to avoid duplication and to ensure animal testing takes place only as a last resort and is fully justified.
Amendment 488 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 7
Article 21 – paragraph 7
7. The ECHA shall make the results of the scientific studies performed under this Article available through the common data platform and shall, in advance, record the intention to perform new studies in accordance with Articles 9 and 10 of this Regulation.
Amendment 498 #
2023/0453(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
1. Business operators shall notify to the Database of Study Notifications referred to in Article 9, without undue delay, any studies onin one month from the date of the commissionning, any studies that generate data chemicals which they commission to support an application, notification or regulatory dossier notified or submitted to an Authority, as well as any studies on chemicals on their own or in products they commission as part of a hazard, risk or safety assessment , prior tor after the placing on the market, under the Union acts listed in Annex I. However, business operators shall not notify to the Database of Study Notifications referred to in Article 9 studies that are to be notified under Article 32b of Regulation (EC) No 178/2002.
Amendment 509 #
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, relevant GLP or equivalent compliance monitoring authority responsible for ensuring test facility compliance 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 520 #
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 534 #
2023/0453(COD)
Proposal for a regulation
Article 26 a (new)
Article 26 a (new)
Article26a 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 and omissions, in accordance with national law or practice. Decisions and omissions by the Commission shall be subject to review in accordance with Title IV of 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.