Activities of Christophe CLERGEAU
Plenary speeches (7)
Outcome of the Strategic Dialogue on the Future of EU Agriculture (debate)
The devastating floods in Central and Eastern Europe, the loss of lives and the EU’s preparedness to act on such disasters exacerbated by climate change (debate)
One-minute speeches (Rule 179)
Question Time with Commissioners – Situation of animal health in Europe: how to prevent and prepare for future sanitary crises in agriculture
Protecting our oceans: persistent threats to marine protected areas in the EU and benefits for coastal communities (debate)
Signature of acts adopted in accordance with the ordinary legislative procedure (Rule 81)
Enhancing Europe’s civilian and defence preparedness and readiness (debate)
Institutional motions (2)
MOTION FOR A RESOLUTION on the draft Commission regulation amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for cyproconazole and spirodiclofen in or on certain products
MOTION FOR A RESOLUTION on the draft Commission regulation amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benomyl, carbendazim and thiophanate‐methyl in or on certain products
Written explanations (9)
EU/USA Agreement on launch of Galileo satellites from U.S. territory
Afin d'assurer les lancements de satellites Galileo nécessaires à la continuité des services du système européen de positionnement par satellite, le Conseil a autorisé l'ouverture de négociations entre l'UE et les États-Unis en vue d'un accord établissant des procédures de sécurité pour le lancement de satellites Galileo à partir du territoire américain.L'accord a été signé le 25 mars 2024 et nécessite l'approbation du Parlement européen. C’est un vote purement formel, les satellites ayant déjà été envoyés par SpaceX en avril et juillet dernier. J’ai voté en faveur, car il était, pour cette fois, nécessaire d’avoir recours à des lanceurs non européens, ici américains, afin d’assurer la continuité des services fournis par Galileo. Cette situation s'explique en grande partie par le retard pris par le programme européen Ariane 6 et la fin de la coopération entre l'Agence spatiale européenne et la Russie et donc, l'impossibilité de recourir au lanceur russe Soyouz suite à la guerre d'agression de la Russie contre l'Ukraine. Notre priorité reste de développer une industrie spatiale européenne solide, capable d'assurer sur ce secteur comme dans d'autres, la souveraineté européenne pour laquelle nous nous battons.
Objection pursuant to Rule 115(2) and (3): Genetically modified maize MON 89034 × 1507 × NK603
Ce vote est une victoire pour la protection de notre santé, de la biodiversité et des écosystèmes. Cela montre aussi que les préoccupations exprimées par de nombreux citoyens à travers l’Europe ont été entendues.Nous avons voté pour rejeter la mise sur le marché de huit variétés d’OGM de maïs et de coton, modifiées pour résister aux herbicides et produire des toxines insecticides Bt. Ce vote reflète les préoccupations liées au manque d’études suffisantes sur la sécurité de ces plantes pour l’environnement et la santé humaine, ainsi que les risques élevés qu’elles pourraient engendrer :Pour la santé humaine : avec des inquiétudes concernant leur potentiel allergène et leurs effets sur le système immunitaire.Pour la biodiversité des sols et des écosystèmes : les transferts de toxines et de matériel génétique peuvent déséquilibrer les chaînes alimentaires.Pour l'environnement global : en raison des propriétés insecticides affectant des espèces non ciblées et fragilisant la biodiversité.Nous venons d’envoyer un signal clair en faveur de l’agriculture durable et des engagements internationaux, notamment ceux liés aux Accords de Paris. Renforcer la sécurité alimentaire tout en protégeant les écosystèmes doit rester une priorité pour l'Europe et le monde.
Objection pursuant to Rule 115(2) and (3): Genetically modified cotton COT102
Nous avons voté pour rejeter la mise sur le marché de huit variétés d’OGM de maïs et de coton, modifiées pour résister aux herbicides et produire des toxines insecticides Bt. Ce vote reflète les préoccupations liées au manque d’études suffisantes sur la sécurité de ces plantes pour l’environnement et la santé humaine, ainsi que les risques élevés qu’elles pourraient engendrer :Pour la santé humaine : avec des inquiétudes concernant leur potentiel allergène et leurs effets sur le système immunitaire.Pour la biodiversité des sols et des écosystèmes : les transferts de toxines et de matériel génétique peuvent déséquilibrer les chaînes alimentaires.Pour l'environnement global : en raison des propriétés insecticides affectant des espèces non ciblées et fragilisant la biodiversité.
Objection pursuant to Rule 115(2) and (3): Genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and eight of its sub-combinations
Nous avons voté pour rejeter la mise sur le marché de huit variétés d’OGM de maïs et de coton, modifiées pour résister aux herbicides et produire des toxines insecticides Bt. Ce vote reflète les préoccupations liées au manque d’études suffisantes sur la sécurité de ces plantes pour l’environnement et la santé humaine, ainsi que les risques élevés qu’elles pourraient engendrer :Pour la santé humaine : avec des inquiétudes concernant leur potentiel allergène et leurs effets sur le système immunitaire.Pour la biodiversité des sols et des écosystèmes : les transferts de toxines et de matériel génétique peuvent déséquilibrer les chaînes alimentaires.Pour l'environnement global : en raison des propriétés insecticides affectant des espèces non ciblées et fragilisant la biodiversité.
Objection pursuant to Rule 115(2) and (3): Genetically modified maize MON 810
Nous avons voté pour rejeter la mise sur le marché de huit variétés d’OGM de maïs et de coton, modifiées pour résister aux herbicides et produire des toxines insecticides Bt. Ce vote reflète les préoccupations liées au manque d’études suffisantes sur la sécurité de ces plantes pour l’environnement et la santé humaine, ainsi que les risques élevés qu’elles pourraient engendrer :Pour la santé humaine : avec des inquiétudes concernant leur potentiel allergène et leurs effets sur le système immunitaire.Pour la biodiversité des sols et des écosystèmes : les transferts de toxines et de matériel génétique peuvent déséquilibrer les chaînes alimentaires.Pour l'environnement global : en raison des propriétés insecticides affectant des espèces non ciblées et fragilisant la biodiversité.
Objection pursuant to Rule 115(2) and (3): Genetically modified maize DP23211
Nous avons voté pour rejeter la mise sur le marché de huit variétés d’OGM de maïs et de coton, modifiées pour résister aux herbicides et produire des toxines insecticides Bt. Ce vote reflète les préoccupations liées au manque d’études suffisantes sur la sécurité de ces plantes pour l’environnement et la santé humaine, ainsi que les risques élevés qu’elles pourraient engendrer :Pour la santé humaine : avec des inquiétudes concernant leur potentiel allergène et leurs effets sur le système immunitaire.Pour la biodiversité des sols et des écosystèmes : les transferts de toxines et de matériel génétique peuvent déséquilibrer les chaînes alimentaires.Pour l'environnement global : en raison des propriétés insecticides affectant des espèces non ciblées et fragilisant la biodiversité.
Objection pursuant to Rule 115(2) and (3): Genetically modified maize DP202216
Nous avons voté pour rejeter la mise sur le marché de huit variétés d’OGM de maïs et de coton, modifiées pour résister aux herbicides et produire des toxines insecticides Bt. Ce vote reflète les préoccupations liées au manque d’études suffisantes sur la sécurité de ces plantes pour l’environnement et la santé humaine, ainsi que les risques élevés qu’elles pourraient engendrer :Pour la santé humaine : avec des inquiétudes concernant leur potentiel allergène et leurs effets sur le système immunitaire.Pour la biodiversité des sols et des écosystèmes : les transferts de toxines et de matériel génétique peuvent déséquilibrer les chaînes alimentaires.Pour l'environnement global : en raison des propriétés insecticides affectant des espèces non ciblées et fragilisant la biodiversité.
Objection pursuant to Rule 115(2) and (3): Genetically modified maize MON 94804
Nous avons voté pour rejeter la mise sur le marché de huit variétés d’OGM de maïs et de coton, modifiées pour résister aux herbicides et produire des toxines insecticides Bt. Ce vote reflète les préoccupations liées au manque d’études suffisantes sur la sécurité de ces plantes pour l’environnement et la santé humaine, ainsi que les risques élevés qu’elles pourraient engendrer :Pour la santé humaine : avec des inquiétudes concernant leur potentiel allergène et leurs effets sur le système immunitaire.Pour la biodiversité des sols et des écosystèmes : les transferts de toxines et de matériel génétique peuvent déséquilibrer les chaînes alimentaires.Pour l'environnement global : en raison des propriétés insecticides affectant des espèces non ciblées et fragilisant la biodiversité.
Recommendation on smoke- and aerosol-free environments
Cette résolution se basait sur les preuves croissantes collectées par l’OMS des risques respiratoires et cardiovasculaires posés par les cigarettes, e-cigarettes et dérivés. Alors que ce texte prévoyait notamment de protéger les enfants et les personnes les plus fragiles du tabagisme et du vapotage passif, les conservateurs du PPE ont choisi, en dernière minute, de s’allier à l’extrême droite en soutenant les amendements qui édulcoraient ce texte et défendaient les intérêts de l’industrie du tabac. Entre la santé publique et les intérêts de l’industrie du tabac, la droite et l’extrême-droite ont fait leur choix. Comme l’ensemble des Députés socialistes & démocrates européens, nous avons rejeté leur texte.
Written questions (4)
Protection mechanisms and competitiveness in the wind energy sector
Maximum residue limits of pesticides in feed imports
Presence of hexane residues in food products
Continued availability of operating grants under the 2025 EU4Health work programme
Amendments (606)
Amendment 8 #
2024/2718(RSP)
Draft motion for a resolution
Citation 21 a (new)
Citation 21 a (new)
– having regard to the UNFCCC Second report on the determination of needs of developing country Parties related to implementing the Convention and the Paris Agreement of January 2024,
Amendment 20 #
2024/2718(RSP)
Draft motion for a resolution
Citation 63 a (new)
Citation 63 a (new)
– having regard to the UN Convention on the Rights of the Child (1989), as well as the General Comment No. 26 (2023) on Children’s Rights and the Environment with a Special Focus on Climate Change’ from the United Nations Committee on the Rights of the Child, as well as the EU Strategy on the Rights of the Child (2022),
Amendment 40 #
2024/2718(RSP)
Draft motion for a resolution
Recital D
Recital D
D. whereas the 2023 UNFCCC synthesis report on NDCs states that the total global greenhouse gas (GHG) emissions level in 2030 is projected to be 2 % below the 2019 level; whereas the first global stocktake (GST) completed in 2023 at COP28 highlights the critical need to limit global warming to 1,5ºC to significantly reduce the risks and impacts of climate change; whereas the IPCC concludes that in scenarios limiting warming to 1.5 °C, GHG emissions need to be 43 % below their 2019 level by 2030;
Amendment 55 #
2024/2718(RSP)
Draft motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas water is a fundamental resource for human life, agriculture, and ecosystems, and its availability is being severely impacted by climate change, leading to increased droughts, floods, and water scarcity across the globe; whereas the degradation of water-related ecosystems, including rivers, wetlands, and lakes, exacerbates the impacts of climate change on biodiversity and human livelihoods;
Amendment 60 #
2024/2718(RSP)
Draft motion for a resolution
Recital G
Recital G
G. whereas the ocean plays a vital role in regulating the climate by absorbing around 25% of human-caused CO2 emissions and over 90% of the excess heat generated by these emissions; whereas marine ecosystems such as coral reefs, mangroves, and seagrass beds act as crucial carbon sinks that support global climate regulation; whereas the degradation of these ecosystems weakens the ocean’s ability to sequester carbon and adapt to climate change, exacerbating climate impacts; whereas marine biodiversity is seriously endangered, despite the ocean playing athis unique and vital role as a climate regulator;
Amendment 70 #
2024/2718(RSP)
Draft motion for a resolution
Recital H
Recital H
H. whereas methane has been responsible for around 30 % of the rise in global temperatures since the industrial revolution; whereas rapid and sustained reductions in methane emissions are crucial to limiting near-term global warming, as methane is around 80 times more powerful than CO2 over a 20-year period;
Amendment 80 #
2024/2718(RSP)
Draft motion for a resolution
Recital I
Recital I
I. whereas the OECD’s seventh assessment of progress towards the UNFCCC climate finance goal finds that in 2022 developed countries provided a total of USD 115.9 billion in climate finance for developing countries, a figure still well below the actual needs; whereas developing countries face the double challenge of simultaneously investing in development and in climate mitigation and adaptation, while addressing the costs of loss and damage;
Amendment 84 #
2024/2718(RSP)
Draft motion for a resolution
Recital J
Recital J
J. whereas the UNEP’s 2023 adaptation gap report highlights that the current adaptation finance gap is estimated at USD 194 billion to USD 366 billion per year, a gap that will be increasing as climate impacts intensify;
Amendment 86 #
2024/2718(RSP)
Draft motion for a resolution
Recital K
Recital K
K. whereas the European Scientific Advisory Board on Climate Change highlights the need to urgently and fully phase out harmful fossil fuel subsidies across the EU; whereas the elimination of these subsidies is critical to accelerating the transition to renewable energy, ensuring a fair allocation of resources, and meeting the EU’s climate targets under the Paris Agreement;
Amendment 97 #
2024/2718(RSP)
Draft motion for a resolution
Recital K a (new)
Recital K a (new)
Ka. whereas cities, which cover only 2% of the world's surface, are responsible for around 70% of global CO2 emissions, primarily due to industrial activities and transportation systems reliant on fossil fuels1a; _________________ 1a Intergovernmental Panel on Climate Change (IPCC). (2022). Climate Change 2022: Mitigation of Climate Change. Contribution of Working Group III to the Sixth Assessment Report of the Intergovernmental Panel on Climate. https://www.ipcc.ch/report/ar6/wg3/
Amendment 102 #
2024/2718(RSP)
Draft motion for a resolution
Recital K b (new)
Recital K b (new)
Kb. whereas people in the richest 1% of the global population are set to generate per capita consumption emissions in 2030 that are still 30 times higher than the global per capita level, while the footprints of the poorest half of the world population are set to remain several times below that level1a; _________________ 1a Institute for European Environmental Policy (IEEP) and Oxfam. (2021). Carbon Inequality in 2030. https://www.oxfam.org/en/research/carbo n-inequality-2030
Amendment 104 #
2024/2718(RSP)
Draft motion for a resolution
Recital K c (new)
Recital K c (new)
Kc. whereas the most vulnerable populations, including infants, children, pregnant women, the elderly, indigenous communities, and people with disabilities, are disproportionately impacted by the effects of climate change, facing greater risks of food and water insecurity, health threats, displacement, and loss of livelihoods;
Amendment 107 #
2024/2718(RSP)
Draft motion for a resolution
Recital K d (new)
Recital K d (new)
Kd. whereas climate change is increasingly becoming a major driver of migration and displacement, with millions of people forced to flee their homes due to rising sea levels, extreme weather events, droughts, and resource scarcity; whereas by 2050, as many as 216 million people could be internal climate migrants across the regions of Africa, Latin America, Asia and the Pacific and Eastern Europe1a; _________________ 1a World Bank. (2021). Groundswell Part 2: Acting on Internal Climate Migration. Washington, DC: World Bank. https://openknowledge.worldbank.org/enti ties/publication/2c9150df-52c3-58ed- 9075-d78ea56c3267
Amendment 114 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 1
Paragraph 1
1. Takes note ofWelcomes the outcome of the first GST at COP28, which recognises that limiting global warming to 1.5 °C with no or limited overshoot requires deep, rapid and sustained reductions in global GHG emissions of 43 % by 2030 and 60 % by 2035 relative to the 2019 level, reaching net zero GHG emissions by 2050;
Amendment 119 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 2
Paragraph 2
2. Supports the COP28 call on the Parties to the UNFCCC to contribute to the global effort of tripling renewable energy capacity globally and doubling the global average annual rate of energy efficiency improvements by 2030; calls on the EU and Member States to lead by example by enhancing investment in renewable energy infrastructure, promoting innovation in energy storage technologies, and implementing strong regulatory frameworks to ensure rapid deployment and equitable access to renewable energy; emphasises the importance of providing financial and technical assistance to developing countries to facilitate their contribution to this global effort, in line with the principles of climate justice and equitable transition;
Amendment 131 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 3
Paragraph 3
3. Supports the COP28 call on the Parties to accelerate efforts towards the phase-down of unabated coal power, and to transition away from fossil fuels in energy systems in a just, orderly and equitable manner, with a view toensuring that the transition prioritises social justice and leave no one behind; highlights the urgency of accelerating action within this critical decade, so as to achieve net zero by 2050, in keeping with the science; reiterates its call on all Parties to work on developing a fossil fuel non-proliferation treaty; at the latest, as scientific evidence continues to show that delays in reducing fossil fuel reliance will lead to increasingly severe climate impacts1a; reiterates its call on all Parties to work on developing a fossil fuel non-proliferation treaty; _________________ 1a International Energy Agency (IEA). (2023). Net Zero by 2050 Roadmap. https://www.iea.org/reports/net-zero- roadmap-a-global-pathway-to-keep-the- 15-0c-goal-in-reach
Amendment 142 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 4
Paragraph 4
4. Expresses concern at the findings of the UNEP’s 2023 emissions gap report that fully implementing current unconditional NDCs would put the world on track for 2.9 °C global warming while the additional implementation and continuation of conditional NDCs would lead to 2.5 °C global warming by the end of the century; draws attention to the fact that this trajectory is far from the 1.5°C target of the Paris Agreement, putting the world on a dangerous path toward irreversible climate changes and the crossing of critical tipping points;
Amendment 147 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on all Parties to scale up their climate targets and accompanying policies and raise the ambition of their NDCs to pursue efforts to limit the temperature increase to 1.5 °C; stresses that these revised NDCs must be aligned with the latest climate science to close the emissions gap, and should include transparent mechanisms for monitoring and accountability to ensure progress is tracked effectively;
Amendment 159 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 6
Paragraph 6
6. Urges all Parties to ensure an outcome at COP29 with robust rules for cooperative mechanisms under Article 6 of the Paris Agreement and calls on the EU and its Member States to strictly defend a high level of climate integrity, based on the best available science, in the negotiations; stresses that these mechanisms must prevent loopholes that could undermine climate ambition, while promoting real and verifiable emission reductions and supporting the transition to renewable energy, particularly in developing countries;
Amendment 171 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 7
Paragraph 7
7. Notes that the EU and its Member States are the largest providers of public climate finance, with all EU climate finance reaching an all-time high in 2022 of EUR 28.5 billion; expresses concern that a large part of this contribution was extended through non-grant instruments, particularly loans, which risks exacerbating the already critical debt crises in many developing countries;
Amendment 180 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 8
Paragraph 8
8. Notes that developed countries provided and mobilised a total of USD 115.9 billion in climate finance for developing countries in 2022, of which a significant share (over two thirds) was extended as loans, exceeding the UNFCC annual USD 100 billion climate finance goal for the first time, two years after the target year of 2020; points out that this delay resulted in a cumulative shortfall of approximately USD 32 billion between 2020 and 2021;
Amendment 189 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on all Parties to agree on a post-2025 nNew cCollective qQuantified gGoal (NCQG) on climate finance at COP29 with safeguards to reach the agreed quantum and timeframe; stresses that this new goal must exceed the outdated USD 100 billion target and should be set in a science- based manner, in line with developing countries’ climate finance needs; recognises that post-2025 climate finance needs will rise substantially; highlights that the NCQG must be ambitious enough to mobilize the necessary funds, while ensuring robust accountability and transparency mechanisms in the allocation and tracking of resources;
Amendment 204 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 10
Paragraph 10
10. Notes that many developing countries, particularly climate-vulnerable countries, are in debt distress or at significant risk of debt distressfacing a dual crisis of unsustainable debt levels and escalating climate impacts, with many already in or at significant risk of debt distress; stresses that this situation exacerbates their vulnerability to economic instability and severely undermines their capacity to invest in climate action; calls for a shift in international climate finance towards prioritizing public, grant-based and non- debt inducing instruments and measures to ensure that these countries can implement necessary mitigation and adaptation measures without increasing their debt burden;
Amendment 213 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 11
Paragraph 11
11. Considers it essential to advance the Bridgetown Agenda without delay; believes that the NCQG represents a pivotal opportunity to not only scale up climate finance but also to promote reforms in the international financial system by incorporating the principles of the Bridgetown Agenda; calls on all the major international financial institutions and multilateral development banks to align their portfolios and lending policies with the Paris Agreement;
Amendment 220 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 12
Paragraph 12
12. Recalls that fossil fuels are responsible for over 75 % of all GHGs and are therefore the largest contributor to climate change; notes that despite this, fossil fuels still meet over 80% of the world's energy needs; stresses that the phase-out of fossil fuels is both necessary and technologically feasible, and that renewable energy technologies, such as solar and wind, have seen costs drop by nearly 90% over the last decade, making them a viable alternative for a sustainable energy transition;
Amendment 237 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 14
Paragraph 14
14. Is concerned that governments worldwide spent USD 620 billion in 2023 on subsidising the use of fossil fuels, which is over five times more than the 115,9 billion reported as international climate finance to developing countries, and significantly more than the USD 70 billion that was spent in 2023 on support for consumer-facing clean energy investments; encourages all Parties to end all direct and indirect fossil fuel subsidies as soon as possible, reallocating these harmful subsidies toward climate action, including toward international climate finance for the most vulnerable developing countries;
Amendment 245 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Recognises that developed countries, including the EU, should lead by introducing innovative taxes in line with the polluter pays principle, such as wealth taxes and levies on high-emitting sectors like fossil fuels;
Amendment 248 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 15
Paragraph 15
15. Underlines the need to significantly step up adaptation action within the EU and globally to minimise the negative effects of climate change and biodiversity loss; points out that while mitigation finance and implementation have progressed, adaptation efforts continue to lag behind, with a widening gap in both funding and concrete action; recognises that without immediate action, the costs of adaptation will continue to rise, with Europe already experiencing economic losses of EUR 650 billion between 1980 and 2021 due to weather and climate- related extremes1a; _________________ 1a European Environment Agency (EEA). (2023). Economic losses from climate- related extremes in Europe. https://www.eea.europa.eu/en/analysis/ind icators/economic-losses-from-climate- related
Amendment 261 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes the agreement on the framework for the global goal on adaptation (GGA) at COP28, namely the UAE Framework for Global Climate Resilience; highlights the need to translate the GGA into measurable outcomes and to track progress towards achieving the goal; stresses that the GGA must be translated into clear, measurable outcomes with robust tracking systems in place to monitor progress, particularly in the areas of climate finance, nature-based solutions, and resilience-building;
Amendment 265 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Welcomes the European Commission’s Communication on "Managing Climate Risks: Protecting People and Prosperity", which highlights the need for resilience in the face of escalating climate risks; regrets that the communication lacks concrete and actionable measures, relying instead on general recommendations that fail to fully address the urgency of the crisis; calls on the Commission to propose legislation that mandates concrete actions, particularly regarding infrastructure resilience, water management, and nature-based solutions, while prioritizing the protection of vulnerable communities;
Amendment 269 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 17
Paragraph 17
17. Stresses that early warning systems are critical to effective adaptation and, as they can save lives and significantly reduce the socioeconomic impacts of climate change; calls for the rapid implementation of both the Climate Risk and Early Warning Systems (CREWS) initiative, which focuses on vulnerable countries such as Least Developed Countries (LDCs) and Small Island Developing States (SIDS), and the "Early Warnings for All" initiative, which seeks to ensure global access to early warning systems by 2027; emphasises that these systems must be robust, people-centered, and multi- hazard, ensuring the protection of lives, livelihoods, and critical infrastructure from increasing climate risks;
Amendment 274 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17a. Calls on the EU Member States and the Commission to ensure the EU is contributing its part to achieving the COP26 commitment of doubling public adaptation finance provision from developed countries to developing countries by 2025, compared to 2019 levels, which implies reaching an aggregate level of at least around USD 40 billion1a; _________________ 1a United Nations Framework Convention on Climate Change (UNFCCC) Standing Committee on Finance. (2023). Report on the Doubling of Adaptation Finance. https://unfccc.int/sites/default/files/resour ce/231120%20BLS23393%20UCC%20Ad aptation%20Finance%20v04.pdf
Amendment 288 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18a. Appreciates the progress in operationalising the Fund since COP28 including through the acceptance of the offer of the Government of the Philippines to host the Fund;
Amendment 301 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 21
Paragraph 21
21. Stresses that climate goals cannot be achieved without the support and involvement of the public, involvement and Free Prior and Informed Consent (FPIC) of the public, including indigenous peoples, local communities, migrants, children and youth, persons with disabilities, and people in vulnerable situations; calls on all Parties to raise awareness of climate change and related issues, combat misinformation and work with public representatives to gain public support for mitigation and adaptation measures; encourages Parties to include children and young people in their national delegations to ensure that future generations have an active role in shaping decisions concerning their future;
Amendment 315 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Recognises the leadership of local and regional governments in accelerating and broadening climate action; stresses the need for enhanced cooperation with local and regional governments in the process of preparing, financing, and implementing NDCs ahead of COP30, as well as other key national climate and environmental strategies, ensuring cohesive and comprehensive planning across all levels of governance;
Amendment 349 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 25
Paragraph 25
25. Takes note of the EU’s updated NDC; highlights that the EU’s current climate legislation will reduce the EU’s net GHG emissions by around 57 % compared to 1990; stresses that, according to the ESABCC, additional efforts to increase the Union’s ambition beyond reaching a 55 % reduction in net GHG emissions by 2030 would considerably decrease the Union’s cumulative emissions until 2050 and thereby increase the fairness of the Union’s contribution to global mitigation;
Amendment 360 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25a. Highlights the importance that the EU moves forward to adopt an ambitious climate target for 2040 of at least 90 % and up to 95 % reduction in net GHG emissions compared to 1990 levels, in line with the recommendation of the European Scientific Advisory Board on Climate Change;
Amendment 365 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 25 b (new)
Paragraph 25 b (new)
25b. Recalls that the Paris Agreement requires the revision of NDCs every five years, with the next revision due in 2025; underlines that this new NDC must reflect the findings of the first global stocktake and align with the EU’s fair share in limiting global warming to 1.5°C, as agreed at COP28;
Amendment 414 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 29 a (new)
Paragraph 29 a (new)
29a. Recognises that achieving the Paris Agreement targets will require substantial decarbonisation of urban areas; emphasises the importance of ensuring that financial support reaches the local level to continue advancing climate action while protecting local economies; welcomes the efforts of EU cities and regions in the Mission on 100 Climate-Neutral Cities, Mission on Adaptation to Climate Change, the Covenant of Mayors, and other initiatives; calls on the Commission to continue supporting and expanding these initiatives;
Amendment 417 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 29 b (new)
Paragraph 29 b (new)
29b. Reiterates that COP28 noted the importance of transitioning to sustainable lifestyles and sustainable patterns of consumption and production in efforts to address climate change, including through circular economy approaches, and encourages further efforts in the EU in this regard as a critical contribution towards achieving climate targets;
Amendment 423 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 30
Paragraph 30
30. Underscores that the climate and biodiversity crises are interlinked; emphasises the importance of protecting, conserving and restoring biodiversity and ecosystems and of managing natural resources sustainably in order to enhance nature-based climate change mitigation and adaptation;
Amendment 454 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 33
Paragraph 33
33. Stresses the need toat all climate actions must protect, respect, promotect the rights and interests of indigenous peoples and local communities; stresses the need to support and protect environmental defender and fulfil human rights, including the right to a clean, healthy and sustainable environment, and the rights of indigenous peoples, local communities, migrants, children and youth, persons with disabilities, and people in vulnerable situations; emphasises the importance of gender equality, the empowerment of women and girls, and intergenerational fairness in addressing the climate crisis; stresses the need to support and protect environmental defenders; calls on all Parties to uphold these values and ensure meaningful public participation, access to information, and Free Prior and Informed Consent (FPIC) for affected communities;
Amendment 466 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 34
Paragraph 34
34. Stresses the importance of implementing the Kunming-Montreal Global Biodiversity Framework; recalls the failure in achieving the Aichi targets; welcomes the submission of EU targets under this Framework to the Convention on Biological Diversity based on the Nature Restoration Law;
Amendment 472 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 35 a (new)
Paragraph 35 a (new)
35a. Stresses the critical link between air pollution and climate change, noting that air pollution is responsible for around 7 million premature deaths annually, with fossil fuel combustion accounting for a significant share of these deaths; welcomes international efforts to address both climate change and air quality through initiatives like the UNECE Convention on Long-Range Transboundary Air Pollution and the Climate and Clean Air Coalition (CCAC); calls on all Parties to enhance cooperation on this matter and align air quality policies with climate action to protect public health and the environment globally;
Amendment 477 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 36
Paragraph 36
36. Emphasises the importance of protecting, conserving and restoring water and water-related ecosystems as vital components of climate resilience and biodiversity conservation; highlights the devastating environmental, social and economic impacts of desertification, droughts, floods and water pollution; calls for enhanced international cooperation to address the growing water crisis, promote sustainable water management, and implement nature-based solutions that can mitigate the impacts of extreme weather events and support long-term water security;
Amendment 518 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 42
Paragraph 42
42. Highlights the fact that the transport sector is the only sector in which emissions have risen at the EU level since 1990 and that this is not compatible with the EU’s climate goals, which is not compatible with the EU’s climate goals; stresses that achieving the EU’s climate objectives will require greater and faster emission reductions from all sectors of society, including the aviation and maritime sectors; welcomes the inclusion of maritime and aviation emissions in the EU ETS as a crucial step toward decarbonisation, which should inspire greater ambition at the international level, including within the International Maritime Organization (IMO) and the International Civil Aviation Organization (ICAO); calls for the EU to advocate for the adoption of stricter global targets and timelines within these organisations; is concerned by the slow progress achieved in the IMO and ICAO in addressing emissions from international shipping and aviation;
Amendment 526 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 43
Paragraph 43
43. Calls on the International Maritime Organization to adopt measures to reduce maritime emissions; calls on the Commission and the Member States to restart UNFCCC negotiations on attributing international shipping emissions to national inventories in line with the Paris Agreement’s 1.5ºC target, requiring a 37 % reduction by 2030, 96 % by 2040, and full decarbonisation by 2050; recognises that if the IMO negotiations fail to achieve action in line with the Paris Agreement, the EU should revise its shipping legislation to enlarge its scope and to align it with the Science Based Targets; notes that recently approved EU shipping legislation is a step in the right direction, but acknowledges that further efforts are needed to achieve zero emissions from shipping; calls on the Commission and the Member States to restart UNFCCC negotiations on attributing international shipping emissions to national inventories on a 50-50 % basis, mirroring the scope of the ETS and FuelEU Maritime; notes with concern the rise in black carbon emissions from Arctic shipping and the insufficient IMO ban on heavy fuel oil; calls for immediate action to address these emissions by requiring ships operating in or near the Arctic to switch to cleaner fuels and install particulate filters to protect the region from further harm; calls for the EU to engage in bilateral and multilateral diplomacy to support other countries in setting up their own national and regional legislation to decarbonise the shipping sector;
Amendment 530 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 43 a (new)
Paragraph 43 a (new)
43a. Stresses the urgent need for the aviation sector to align with global climate goals, particularly the 1.5°C target of the Paris Agreement, as aviation accounts for 2.5 % of global CO₂ emissions but has a total climate impact of around 4 % due to non-CO₂ effects; calls on the International Civil Aviation Organization (ICAO) to adopt more ambitious measures under CORSIA to reduce these emissions; highlights the disproportionate climate impact of private jets, which are up to 14 times more polluting than commercial flights, and urges leaders to choose the least polluting transport options, including for COP29;
Amendment 535 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 44
Paragraph 44
44. Acknowledges the significant potential for GHG emissions reduction in the agricultural sector;, which globally accounts for 10-12 % of anthropogenic emissions and 11 % of total EU emissions in 20201a; notes that EU agricultural emissions have stagnated since 2005, with only a 1.5 % reduction projected by 2040 under current policies; stresses that a transition towards more sustainable agricultural practices, shorter supply chains, and shifts towards healthier foods, diets, and lifestyles would significantly reduce agricultural emissions, enhance mitigation and adaptation, release pressure on land, and help restore soil quality and ecosystems; reiterates that the overconsumption of meat and ultra- processed products needs to be addressed; emphasises the importance of developing more sustainable agriculture by providing farmers with alternatives to reduce the use of synthetic fertilisers and pesticides; highlights that reducing the production and use of synthetic fertilisers and increasing natural carbon sequestration in soils and soil organic matter can offer multiple benefits by increasing soil fertility, restoring biodiversity, and providing substantial mitigation potential; _________________ 1a European Environment Agency (EEA). (2023). Progress and prospects for decarbonisation in the agriculture sector and beyond. https://www.eea.europa.eu/publications/P rogress-and-prospects-for- decarbonisation/progress-and-prospects- for-decarbonisation.
Amendment 565 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 45
Paragraph 45
45. Stresses that all sectors must contribute to the reduction of emissions; calls for a UNFCCC COP29 outcome of a strengthened Mitigation Work Programme that accelerates action pre- 2030 and complements the Global Stocktake, with a focus on sector-specific partnerships to implement outcomes and promote the rapid, equitable shift to renewable energy;
Amendment 582 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 47
Paragraph 47
47. Stresses the urgent need to address the significant climate and environmental impact of the textile sector;, which is responsible for around 8-10 % of global GHG emissions and substantial resource consumption, particularly water and energy1a; calls for the adoption of circular economy principles, including sustainable production, waste reduction, and increased recycling, while tackling challenges such as microplastic shedding, overproduction, and water usage; urges the EU and international bodies to set ambitious targets for reducing emissions, phasing out harmful chemicals, and promoting eco-friendly materials, and to establish global standards for verifiable sustainability claims to prevent greenwashing and help consumers make informed choices; _________________ 1a International Finance Corporation (IFC). (2023). Strengthening Sustainability in the Textile Industry. https://www.ifc.org/en/insights- reports/2023/strengthening-sustainability- in-the-textile-industry
Amendment 598 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 49 a (new)
Paragraph 49 a (new)
49a. Highlights the fact that the Mediterranean is one of the regions most affected by climate change, warming 20 % faster than the global average, with projections of 250 million people facing water scarcity within 20 years1a; notes that the Mediterranean Sea is becoming the fastest warming sea globally, with severe consequences for marine ecosystems, economic sectors, and biodiversity; calls on the Commission and Member States to act urgently, cooperating with Mediterranean partners to implement ambitious adaptation measures and lead mitigation action, focusing on water management, ecosystem restoration, and sustainable economic transitions; _________________ 1a Mediterranean experts on climate and environmental change, ‘Risks associated to climate and environmental changes in the Mediterranean region’, 2019. https://ufmsecretariat.org/wp- content/uploads/2019/10/MedECC- Booklet_EN_WEB.pdf
Amendment 605 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 49 b (new)
Paragraph 49 b (new)
49b. Recognises the disproportionate impact of climate change on women and girls, particularly in developing countries where they are more reliant on natural resources for their livelihoods; notes that climate-induced disasters exacerbate gender inequalities, as women often face greater obstacles in accessing resources, land rights, and decision-making processes; believes that gender balance and the empowerment of women and girls are key to an inclusive and just transition; stresses the need for gender-responsive climate policies that ensure women’s participation in climate action and leadership roles at all levels;
Amendment 610 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 50
Paragraph 50
50. EUnderscores the importance of inclusive approaches in the UNFCCC Process, including the Just Transition Work Programme; calls on all Parties, including the EU and its Member States, to increase efforts to integrate gender equality in their revised NDCs, as well as in climate and environmental policies, in particular those related to mitigation, adaptation and loss and damage, and to increase the meaningful involvement of women’s groups in their design and implementation; emphasises the need for more concrete actions by all Parties to deliver on the commitments of the renewed Gender Action Plan agreed at COP25; urges the Member States and the Commission to increase efforts to achieve the goals set out in the EU Gender Action Plan III;
Amendment 611 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 50 a (new)
Paragraph 50 a (new)
50a. Highlights the importance of aligning climate finance with gender equality, noting that women receive disproportionately less access to financial resources for climate adaptation and mitigation projects; considers that increasing women’s access to inclusive climate finance is critical for a just transition, and emphasises the need for a gender-transformative approach in climate finance; urges the EU and Member States to report on the gender responsiveness of their climate finance contributions and to enhance coherence between gender and climate support through external action instruments and the European Investment Bank (EIB), including through enhancing the participation of women in governance, decision-making, and programmes that support women’s role in climate governance;
Amendment 616 #
2024/2718(RSP)
Draft motion for a resolution
Paragraph 50 b (new)
Paragraph 50 b (new)
50b. Highlights the importance of increasing women’s participation in decision-making in the climate diplomacy context, including in COP delegations and leadership at all levels of climate action; regrets that women made up less than 34 % of country negotiating teams at COP28, with only 2 % of delegations achieving gender parity, and notes that some Party delegations still consist of up to 90 % men; calls on all Parties to aim for gender parity in their delegations and at all levels of climate change decision- making and negotiations; urges all Parties to nominate a national gender and climate change focal point and increase their resources, training, and support, including within the EU;
Amendment 13 #
2024/2109(INI)
Motion for a resolution
Recital B
Recital B
B. whereas investments in R&D are essential for EU societal progress, innovation and competitiveness; whereas the report on the Future of European Competitiveness (the Draghi report) and the report by the Commission Expert Group on the Interim Evaluation of Horizon Europe (the Heitor report) recommended a budget for the 10th framework programme for research and innovation (FP10) of EUR 200 billion and EUR 220 billion respectively;
Amendment 15 #
2024/2109(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas the Letta report proposes the establishment of a “Fifth Freedom” to encompass research, innovation and education as a new dimension of the Single Market as the four original freedoms are fundamentally based on 20th-century theoretical principals.
Amendment 25 #
2024/2109(INI)
Motion for a resolution
Paragraph -1 (new)
Paragraph -1 (new)
-1. Recalls that we are at a crucial moment for R&I, and President Ursula Von der Leyen stated that Europe needs to put “research and innovation at the heart of our economy” during the presentation of her program in the European Parliament in July 2024 for her second term as president of the European Commission.
Amendment 26 #
2024/2109(INI)
Motion for a resolution
Paragraph -1 a (new)
Paragraph -1 a (new)
-1a. Notes that the Draghi, Letta and Heitor reports put R&I in a central place to achieve European competitiveness and stress the urgency to act not to fall behind. Thus, a strong commitment is needed to achieve a future Framework Programme that constitutes a crucial contribution to the competitiveness of Europe and the well-being of the entire European project.
Amendment 27 #
2024/2109(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Recalls that the Draghi and the Heitor reports are a wake-up call for Europe to face global competition and the significant rise of Chinese science in recent years; welcomes the higher success rate of HEU compared to Horizon 2020 (H2020); appreciates HEU’s responsiveness in crises, such as COVID-19 and geopolitical challenges, but regrets not only the lack of additional funding but also the continuous funding cuts , which compromises original priorities; notes that national spending for research should not be cut with reference to EU research funding; highlights that a joint effort of European and national funding for research and innovation is needed;
Amendment 46 #
2024/2109(INI)
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Recalls the need for better articulation between smart specialization strategies and Horizon Europe in order to better mobilize local and regional ecosystems of R&I and contribute to tackle innovation divide; salutes the efforts to connect ecosystems created within the framework of the EIE/European Innovation Ecosystems component and welcomes the establishment of the Regional Innovation Valleys (RIV);
Amendment 53 #
2024/2109(INI)
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Alerts on the persisting innovation divide through Europe, between Member States but also between regions from the same Member State; acknowledges the excessive concentration of funding on a few key actors and research ecosystems; considers that these disparities are undermining the European research area, the trust in European research policies, and their efficiency;
Amendment 56 #
2024/2109(INI)
Motion for a resolution
Paragraph 3 c (new)
Paragraph 3 c (new)
3c. Insists on the absolute necessity that Member States adopt concrete commitments to reach a target of 3% of GDP spending by 2035, including through significative increases of public direct funding;
Amendment 70 #
2024/2109(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Is deeply convinced that EU spending on science, research and innovation is the best investment in our common European future and for increasing societal progress and competitiveness; agrees with Mr Draghi that all public R&D spending in the EU should be better coordinated at EU level and that a reformed and strengthened FP is crucial in achieving this;
Amendment 84 #
2024/2109(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Recalls that, while acknowledging concerns about the perceived complexity and bureaucracy of some Horizon Europe requirements, gender equality measures are a critical mechanism for fostering inclusivity, which in turn delivers higher excellence research results.
Amendment 87 #
2024/2109(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Notes that a large number of beneficiaries do not consider the introduction of lump-sum funding to be a simplificationthe introduction of lump- sum funding received different assessment from different beneficiaries; also notes that simplification efforts at EU level should be implemented with coherence at national level;
Amendment 125 #
2024/2109(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Concludes that Pillar 2 remains too complex; believes that the implementation of this pillar should be improved, simplified and streamlined; notes that the number of instruments involved, the unsuccessful implementation of missions, and the many budgetary shifts have resulted in unnecessary complexity which discourages applicants, and especially newcomers, from participating;
Amendment 126 #
2024/2109(INI)
Motion for a resolution
Paragraph 8
Paragraph 8
8. Concludes that Pillar 2 remains too complex; believes that the implementation of this pillar should be improved, simplified and streamlined; notes that the number of instruments involved, the unsuccessful implementation of missions, and the many budgetary shifts have resulted in unnecessary complexity which discourages applicants, and especially newcomers, from participating;
Amendment 132 #
2024/2109(INI)
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Suggests to use a modern concept of innovation and that comprehensively consider the various facets of innovation, for example, social innovation.
Amendment 136 #
2024/2109(INI)
Motion for a resolution
Subheading 6 a (new)
Subheading 6 a (new)
8c. Notes that EIT contributes to strengthening links between Higher Education and Business closing the ‘skills gap’ and that synergies should be explored with the academies introduced in recent EU legislation (e.g. Net Zero Industry Act, Critical Raw Materials Act, Cybersecurity Package).
Amendment 138 #
2024/2109(INI)
Motion for a resolution
Subheading 6 b (new)
Subheading 6 b (new)
8d. Moreover, highlights that the EIT Regional Innovation Scheme (RIS) activities contribute to reducing the European innovation capacity divide. Recalls that more synergies to bridge the innovation divide should be created between the EIT and other actions such as the EU Preparatory Action 'Innovation for place-based transformation'1a _________________ 1a https://place-based- innovation.ec.europa.eu/projects- 0/preparatory-action-2024-2026_en
Amendment 140 #
2024/2109(INI)
Motion for a resolution
Subheading 6 c (new)
Subheading 6 c (new)
8b. Recognises the vital role of universities as drivers of place-based innovation.
Amendment 147 #
2024/2109(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Welcomes the fact that there has been an increase in the number of participants, from widening countries, in HEU; Acknowledges that the innovation divide persists despite a slight decrease in the disparities in innovation performance across Europe. Notes that Widening should be taken into account by region, not by member state.
Amendment 150 #
2024/2109(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Notes that a thriving European innovation ecosystem requires strong and well-connected place-based innovation ecosystems. Better connected European innovation ecosystem will be essential for enhancing the competitiveness of Europe, its resilience and strategic autonomy. Collaboration among territorial ecosystems enables European regions to leverage their combined strengths to develop innovative solutions more efficiently. This collaboration also accelerates the commercialisation and scaling of technologies, bolstering the EU’s competitiveness also globally.
Amendment 153 #
2024/2109(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Recalls that the Commission communication entitled ‘EU Missions two years on: assessment of progress and way forward’1a did not positively evaluate missions and concluded that missions had failed on core objectives such as crowding in external funding; nevertheless considers that EU Missions are a new and innovative tool and that their achievement, in light of their implementation timeline, are positive and justify going forward with developing their activities and research programs; _________________ 1a https://eur-lex.europa.eu/legal- content/EN/TXT/HTML/?uri=CELEX%3 A52023DC0457
Amendment 157 #
2024/2109(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Recalls that the Commission communication entitled ‘EU Missions two years on: assessment of progress and way forward’ did not positively evaluate missions and concluded that missions had failed on core objectives such as crowding in external funding;concluded that missions need to improve their governance, impact and crowding in external funding to live up to the potential of the concept to tackle ambitious societal challenges.
Amendment 165 #
2024/2109(INI)
Motion for a resolution
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Supports the Heitor Report call for the need to “elevate” the “political ownership” of the current (and future) Missions and Partnerships, in order to facilitate the coordination among different DG’s and national administrations, as well as to attract funding beyond the framework programme.
Amendment 167 #
2024/2109(INI)
Motion for a resolution
Paragraph 10 c (new)
Paragraph 10 c (new)
10c. Highlights the need to strengthen the science communication role of the missions. This will bring research results closer to society and help address the challenge of mistrust in R&I, while simultaneously helping gain societal approval for public investments in R&I.
Amendment 168 #
2024/2109(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
Amendment 189 #
2024/2109(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Although some efforts have already been made, regrets that synergies between the European Innovation Council (EIC), the European Institute of Innovation & Technology (EIT) and the European Research Council are not enough developed.
Amendment 191 #
2024/2109(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Calls on the Commission to restore without delay EIC autonomy and agility in order to get rid of existing complex processes leading to lower implementation;
Amendment 192 #
2024/2109(INI)
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13b. Notes that inclusive gender equality in R&I is a crucial driver of a sustainable research environment that lays the foundation for high standards of the research profession in the European Research Area (ERA) with improved career prospects and working conditions. Without effective measures to promote inclusive gender equality in Europe, research quality and competitiveness suffer, hindering potential scientific advancement and resulting in the loss of valuable talent.
Amendment 194 #
2024/2109(INI)
Motion for a resolution
Paragraph 13 c (new)
Paragraph 13 c (new)
13c. Significant advances have been made in the framework of Horizon Europe with Gender Equality Plans (GEPs) as an eligibility criterion, the gender dimension in the content of R&I as an award criterion by default across the programme, and gender balance as a ranking criterion for ex aequo proposals. Recent analyses confirm that the GEP eligibility criterion has had a catalytic effect. Therefore, the Gender Equality Plans as eligibility criteria for funding should be kept in FP10 as a permanent and integral element of EU research funding requirements.
Amendment 196 #
2024/2109(INI)
Motion for a resolution
Paragraph 13 d (new)
Paragraph 13 d (new)
13d. Recognising that inclusive science is foundational to excellent science, calls on the Commission to safeguard the requirements for sex and gender consideration in FP10 and further strengthen intersectional considerations; build upon existing policies to enhance participation of women and other population groups in science; and to fund research aimed at closing the gender health gap and delivering innovations in women’s health.
Amendment 197 #
2024/2109(INI)
Motion for a resolution
Paragraph 13 e (new)
Paragraph 13 e (new)
13e. Considers that gender as a research topic from an intersectional perspective is essential for understanding the development of our gendered societies, addressing current societal challenges such as anti-gender discourse in Europe, and identifying effective solutions.
Amendment 198 #
2024/2109(INI)
Motion for a resolution
Paragraph 13 f (new)
Paragraph 13 f (new)
13f. Prioritising inclusive gender equality provisions in Framework Programme 10 will enhance the competitiveness and sustainability of the ERA. By embedding inclusive gender equality in R&I policies, we maximise the potential of diverse talents, ensuring that Europe remains at the forefront of scientific excellence. Promoting inclusive gender equality serves as a catalyst for innovation, driving creative solutions and enhancing the relevance of R&I outputs. The higher productivity and innovative outcomes produced by diverse teams can translate into potential economic benefits for the EU and an additional competitive edge in the global research environment. Primarily, however, promoting gender equality makes the fundamental values of the EU a reality. Therefore, a steadfast commitment to inclusive gender equality is both a matter of social justice and a strategic investment in the future of research and economic prosperity in Europe
Amendment 199 #
2024/2109(INI)
Motion for a resolution
Paragraph 13 g (new)
Paragraph 13 g (new)
13g. Calls on the Commission to report on the Horizon Europe Key Impact Pathways, including the scientific, societal and economic/technological impacts, which analyse the overall societal impact of research and innovation projects in order to assess the Program's progress towards the achievement of its objectives.
Amendment 201 #
2024/2109(INI)
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13a. Insists on the need for strong political commitment to ensure adequate financial resources and a specified budget for FP10.
Amendment 213 #
2024/2109(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls for FP10 to be a stand-alone EU programme dedicated to EU research excellence, with a substantially higher budget that is sufficient for achieving the 3 % GDP spending target and for funding at least 75 % of the excellent proposals submitted; recommends that FP10 focus on three core objectives: (i) advancing the European Research Area (ERA) with specific measures that address regional disparities and support under-represented Member States in their innovation capacities, (ii) creating a European competition of ideas, and (iii) supporting strategic, large-scale collaborative research initiatives; recommends that FP10 be structured in three parts, each addressing one of the three core objectives; further calls for full recognition of the place- based approach to research and innovation excellence;
Amendment 219 #
2024/2109(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Considers that sustained investments in R&I at both EU and national levels are important to ensure adequate national investments in R&I. Moreover, firmly believes the need to mobilise more private investments in R&I all over the Union.
Amendment 225 #
2024/2109(INI)
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14b. Considers crucial to keep funding basic research and applied research.
Amendment 227 #
2024/2109(INI)
Motion for a resolution
Paragraph 14 c (new)
Paragraph 14 c (new)
14c. Recommends the improvement of synergies with cohesion funds. Also highlights to strengthen and coordinate synergies between innovation programmes managed by different administrations.
Amendment 228 #
2024/2109(INI)
Motion for a resolution
Paragraph 14 d (new)
Paragraph 14 d (new)
14d. Urges the Commission to launch from 2025 a task force to guarantee a better efficacy of the European Semester, in line with the Union’s share towards the 3% target, as clearly described in the Draghi and Heitor reports;
Amendment 229 #
2024/2109(INI)
Motion for a resolution
Paragraph 14 e (new)
Paragraph 14 e (new)
14e. Notes that Horizon Europe has seen an increase in bureaucracy compared to Horizon 2020 and efforts for simplification should be taken for FP10 for the benefit of beneficiaries and the contribution of excellent research. However, simplification cannot erode the progress made in previous framework programs such as the advances achieved thanks to green and gender conditionalities.
Amendment 242 #
2024/2109(INI)
Motion for a resolution
Paragraph 15 – point a – point ii
Paragraph 15 – point a – point ii
Amendment 249 #
2024/2109(INI)
Motion for a resolution
Paragraph 15 – point a – point ii
Paragraph 15 – point a – point ii
ii. be less dominated by policy objectives;Recalls the need to keep policy objectives as guiding principles
Amendment 255 #
2024/2109(INI)
Motion for a resolution
Paragraph 15 – point a – point iii
Paragraph 15 – point a – point iii
iii. contribute to EU priorities, butilding on the terms of science and innovation rather than on the terms of policymakers;
Amendment 264 #
2024/2109(INI)
Motion for a resolution
Paragraph 15 – point a – point iv a (new)
Paragraph 15 – point a – point iv a (new)
iva. include every two years a report to policy makers from the Council, the European Parliament and the European Commission;
Amendment 284 #
2024/2109(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Recommends that the objective of the part of FP10 on advancing the ERA be to build an excellent, unified ERA; underlines that this requires attracting talent, integrating newcomers, providing access to leading research and technology infrastructures, defending academic freedom and promoting gender mainstreaming, supporting joint early research programmes with national funders, and developing European universities alliances into European scientific institutes;and regional funders, achieving identification and direct support to local and regional ecosystems of R&I and their initiatives, and developing European universities alliances into European scientific institutes; this new pillar should mobilize no less than 25% of the FP and aim to improve coordination between ERA and the European Education Area
Amendment 288 #
2024/2109(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Calls for a strong ecosystem of research and technology infrastructures (RIs) throughout the Union as a fundamental prerequisite for excellent R&I to be performed in Europe.
Amendment 292 #
2024/2109(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Believes that an expanded European Research Council (ERC) and European Innovation Council (EIC) should be at the heart of the part of FP10 dealing with a European competition of ideas and that this part should receive half of the FP10 budget; recommends that these programmes be designed so that they create a European, bottom-up funnel for innovation to develop quickly from fundamental science to innovation scale- up; considers that the EIC can only succeed if it can both offer blended finance as a single project and act with the same speed and agility as private actors on the venture capitalist market through a tailor-made legal entity for implementation; underlines that the strengthened autonomy and self- governance of both the ERC and the EIC are crucial to achieving this; holds the opinion that basic research should go beyond ERC and EIC and that funding basic research must also be considered when tackling the EU’s strategic objectives; is therefore convinced that the ultimate source of innovation is the creation of new information through basic research, which must coexist (with other forms of research) with an emphasis on high-risk breakthrough research and innovation;
Amendment 298 #
2024/2109(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Believes that an expanded European Research Council (ERC) and European Innovation Council (EIC) should be at the heart of the part of FP10 dealing with a European competition of ideas and that this part should receive half of the FP10 budget; recommends that these programmes be designed so that they create a European, bottom-up funnel for innovation to develop quickly from fundamental science to innovation scale- up; considers that the EIC can only succeed if it can both offer blended finance as a single project and act with the same speed and agility as private actors on the venture capitalist market through a tailor-made legal entity for implementation; underlines that the strengthened autonomy and self- governance of both the ERC and the EIC are crucial to achieving this;
Amendment 302 #
2024/2109(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Believes that an expanded European Research Council (ERC), the Marie Skłodowska-Curie Actions (MSCA) and European Innovation Council (EIC) should be at the heart of the part of FP10 dealing with a European competition of ideas and that this part should receive half of the FP10 budget; recommends that these programmes be designed so that they create a European, bottom-up funnel for innovation to develop quickly from fundamental science to innovation scale- up; considers that the EIC can only succeed if it can both offer blended finance as a single project and act with the same speed and agility as private actors on the venture capitalist market through a tailor-made legal entity for implementation; underlines that the strengthened autonomy and self- governance of both the ERC and the EIC are crucial to achieving this;
Amendment 315 #
2024/2109(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Urges the Commission to design the part of FP10 on strategic deployment such that it focuses on a limited number of pan-European research initiatives with 2040 set as the time horizon and which require cross-border collaboration due to the scale and complexity of the issue in question; believes that this part should consider that these initiatives could take the form of societal missions which address socio-economic and/or ecological challenges, technology missions to accelerese initiatives should be closely linked to main European challenges such as climate neutrality, the green and digital transitions, industrial sovereignty and competitiveness, health and well-being, European security and preparedness, combining technological and socio-economic challenges; believes thate the development of strategic technologies in Europe, or joint undertakings to securese initiatives could be set through direct programming, missions or joint investments by industry, Member Stsectoral privates and the EU to support research-based competitiveness and the resilience of key sectors inpublic actors, Member States and the European economyUnion; believes that all of these initiatives should receive a budget of between EUR 2.5 and 5 billion;
Amendment 322 #
2024/2109(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Notes that the allocation of at least 35% of the programme Horizon Europe expenditures to climate objectives served the general EU objective of mainstreaming climate actions into its sectoral policies and funds. Calls to ensure that FP10 pursues the effort to fund adequately science research and innovation that support the EU climate objectives
Amendment 324 #
2024/2109(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Considers that collaboration is key for excellent research and innovation and highlights that international collaboration should continue in the next FP10, as open as possible and as closed as necessary to tackle global challenges jointly.
Amendment 325 #
2024/2109(INI)
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Reiterates the need for sufficient funding for research projects that address societal challenges and that fall within the area of social sciences;
Amendment 332 #
2024/2109(INI)
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19b. Recalls the important participation of SMEs in Horizon Europe and their central role in the European R&I ecosystem and highlights the need to maintain measures reinforce their presence in the next Framework Programme.
Amendment 338 #
2024/2109(INI)
Motion for a resolution
Paragraph 19 c (new)
Paragraph 19 c (new)
19c. Calls for additional measures to reduce the geographic divide, making the programme more accessible for entities located in low-income countries and promoting interest and capacity for applying to the EIC for companies in less advanced regions.
Amendment 339 #
2024/2109(INI)
Motion for a resolution
Paragraph 19 c (new)
Paragraph 19 c (new)
19c. The programme should recognise the role of interdisciplinary research in addressing societal challenges, also including a better integration of Social Sciences, Humanities and the Arts (SSHA).
Amendment 343 #
2024/2109(INI)
Motion for a resolution
Paragraph 19 d (new)
Paragraph 19 d (new)
19d. Leverage the programme’s capacity to strengthen society’s trust in science. FP10 should provide more opportunities for the engagement of citizens and society as a whole, raising awareness of the role they can play in contributing to research activities.
Amendment 344 #
2024/2109(INI)
Motion for a resolution
Paragraph 19 d (new)
Paragraph 19 d (new)
19d. Urges the European Commission to increase efforts to boost women's involvement in high-risk innovation by expanding targeted initiatives such as Women TechEU and the Women Leadership Programme.
Amendment 359 #
2024/2109(INI)
Motion for a resolution
Paragraph 20 a (new)
Paragraph 20 a (new)
20a. Notes that FP10 should take into account the use of AI as a way to foster European research development while identifying specific risks of an abusive use of AI in the scientific environment and the corresponding mitigation measures.
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 28 #
2023/2720(RSP)
Recital D a (new)
Da. whereas market withdrawals over four decades of the active substances most harmful to biodiversity used as pesticides have not led to a decline in agricultural production thanks to the competence of farmers using alternatives such as bio- control;
Amendment 54 #
2023/2720(RSP)
Paragraph 5
5. Emphasises the need to close the gaps in key EU sectoral policies, in particular the common agricultural policy, tackling pollinator decline, and to streamline measures for the protection of pollinators into relevant EU policies; calls for consideration to be given to the budgetary means needed to support the agro-ecological transition of European agriculture while maintaining a high level of self-sufficiency in the key agricultural products;
Amendment 55 #
2023/2720(RSP)
Paragraph 5 a (new)
5a. Regrets that in 2022 the Commission proposed derogations from GAEC 7 and 8 in relation to the environmental conditionality of the new CAP, given that multicropping and ecological focus areas are positive for insect populations and biodiversity in general; calls on the Commission to propose a genuine forward-looking food security strategy so as not to have to propose such derogations, which are ineffective in terms of increasing production but are harmful to biodiversity protection;
Amendment 65 #
2023/2720(RSP)
Paragraph 7
7. Underlines the continued need to better protect pollinators from risks resulting from pesticides and biocides by reducing the use of pesticides by 50% by 2030 as set out in the farm to fork strategy, and regrets the delay in taking action to protect pollinators through the authorisation procedures laid down in Regulation (EC) 1107/20097 and Regulation (EU) 528/20128; _________________ 7 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). 8 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).
Amendment 70 #
2023/2720(RSP)
Paragraph 7 a (new)
7a. Is surprised that, in its proposal for a regulation on new GMOs, the Commission is promoting varieties made resistant to systemic herbicides by proposing their deregulation, given that pollen from weed flora is an important food resource for all pollinators;
Amendment 75 #
2023/2720(RSP)
Paragraph 9
9. Calls for an end to the importation of agricultural products produced using pesticides that are banned in the EU and tolerances for residues of pesticides that are banned in the EU for reasons of human health and biodiversity protection, in order to prevent the import of products that can cause unacceptable harm to pollinators;
Amendment 80 #
2023/2720(RSP)
Paragraph 9 a (new)
Amendment 86 #
2023/2720(RSP)
Paragraph 10 a (new)
10a. Recalls that a major obstacle to improving pesticide risk assessment for pollinators is the lack of internationally validated testing methods; welcomes the Commission’s commitment to draw up a work plan to this end; insists that adequate financial support be provided to this end, for example through the EU Framework Programme for Research and Innovation – Horizon Europe;
Amendment 87 #
2023/2720(RSP)
Paragraph 10 a (new)
10a. Notes the Commission’s commitment to update the guidance document for pesticide risk assessment for non-target arthropods (including wild pollinators other than bees); stresses the urgency of this update and calls for a clear deadline to be set for it;
Amendment 137 #
2023/2720(RSP)
Paragraph 19
19. Highlights the essential role of farmers in maintaining habitats for pollinators and fostering sustainable agricultural practices that prioritise the well-being of these crucial species and contribute to the preservation of biodiversity; stresses the importance of an independent network of advisors trained in pollinator conservation in agricultural areas in order to ensure the dissemination and effective implementation of pollinator-friendly measures;
Amendment 158 #
2023/2720(RSP)
Paragraph 23 a (new)
23a. Recalls that one of the obstacles to the effective implementation of citizen science programmes is the lack of taxonomic expertise for data processing and the lack of taxonomic tools; calls on the Commission and the Member States to address these shortcomings;
Amendment 329 #
2023/2074(INI)
Motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
Amendment 457 #
2023/2074(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Invites the Commission and the Member States to invest in further research on mental health, and to include often overlooked sectors, such as agriculture (farmers, rural areas, etc.) within key target groups to benefit from such research;
Amendment 1 #
2023/2073(INI)
Motion for a resolution
Citation 1
Citation 1
– having regard to the UN 2030 Agenda for Sustainable Development and the Sustainable Development Goals (SDGs), in particular SDG 1 on poverty eradication, SDG 7 on ensuring access to affordable, reliable, sustainable and modern energy for all, SDG 9 on industry and infrastructure, and SDG 13 on climate action, and SDG 5 on achieving gender equality and empowering all women and girls,
Amendment 4 #
2023/2073(INI)
Motion for a resolution
Citation 14
Citation 14
– having regard to the 1992 United Nations Framework Convention on Climate Change (UNFCCC) and the Kyoto Protocol thereto, to the 21st Conference of the Parties (COP21) to the UNFCCC in Paris, in December 2015, and to the adoption of the Paris Agreement, the first- ever universal, legally binding global climate deal, and to the IPCC Fifth Assessment Report on Climate Change,
Amendment 19 #
2023/2073(INI)
Motion for a resolution
Recital A
Recital A
A. whereas SDG 7 stipulates the aim to achieve sustainable access to affordable and clean energy by 203012, notably by calling for greater international cooperation to facilitate access to clean energy research and technology, including renewable energy, energy efficiency and advanced and cleaner fossil-fuel technology, and promote investment in energy infrastructure and clean energy technology; _________________ 12 UN Department of Economic and Social Affairs, ‘The Sustainable Development Goals Report 2023: Special Edition – July 2023’, New York, USA, 2023.
Amendment 53 #
2023/2073(INI)
Motion for a resolution
Recital E
Recital E
E. whereas developing countries have an abundance of renewable energy sources, but often lack an enabling policy and regulatory framework forand industrial and technological ecosystems conducive to the sustainable energy development and use, production and use of such energy sources;
Amendment 60 #
2023/2073(INI)
Motion for a resolution
Recital F
Recital F
F. whereas the EU together with its Member States provided the vast majority of Official Development Assistance financing for SDG 7 projects in Africa amounting to EUR 13.8 billion between 2014 and 2020; whereas an estimated 53 % of the disbursements were in the form of loans and therefore debt for beneficiaries, thus reducing their ability to invest in the SDGs, including SDG 7, in future;
Amendment 62 #
2023/2073(INI)
Motion for a resolution
Recital F a (new)
Recital F a (new)
Fa. whereas in terms of geographical targeting, Morocco (EUR 2.5 billion) and South Africa (EUR 1.2 billion) were the first to be granted funding, and only three least developed countries were among the top 10 first beneficiaries of funding; whereas, priority has thus not been given to directing resources towards access and the fight against energy poverty;
Amendment 74 #
2023/2073(INI)
Motion for a resolution
Recital I
Recital I
I. whereas the Africa-EU Energy Partnership was renewed in February 2022 with explicit objectives to promote renewable energy generation and distribution;
Amendment 92 #
2023/2073(INI)
Motion for a resolution
Recital L
Recital L
L. whereas the expansion of renewables based on solar and wind power also raises challenges as they require large areas of land, thus interfering with existing land use and local needs, in particular regarding access to water; whereas land and sea areas that could be used for renewable energy production need to be identified, taking into account connection conditions and with respect for biodiversity, the local economy and the consent of indigenous populations;
Amendment 158 #
2023/2073(INI)
11a. Stresses the significant potential in developing countries for offshore renewable energy production facilities to be installed; emphasises the need for holistic management of maritime areas, involving all stakeholders and respecting the consent of local communities;
Amendment 173 #
2023/2073(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Notes, with concern, that Africa hosts an increasing number of fossil fuel projects, which risks preventing it from making a timely leap to renewable energy; also notes, however, that although Africa is home to 18 % of the world’s population, it only accounts for 6 % of global energy consumption; recalls that a major portion of current oil, gas and coal production in Africa is destined for export, while the continent continues to be plagued by energy poverty;
Amendment 179 #
2023/2073(INI)
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Recommends that a joint energy transition planning exercise be carried out within the framework of the EU-AU partnership, drawing on the ACP-EU Joint Parliamentary Assembly and African civil societies, while respecting the sovereignty of African nations; calls for the objectives of decarbonising cities, mobility and industry, ensuring universal access to energy for local populations, generating renewable energy for export, developing energy transport, distribution and storage infrastructures, and improving the resilience of electricity networks to be combined; recommends that guidelines on the fair sharing of investments, revenues, technologies and skills be drawn up;
Amendment 184 #
2023/2073(INI)
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Stresses the importance of scientific cooperation in sharing the knowledge and skills needed to successfully carry out the energy transition; calls on the European Union to step up cooperation with developing countries on access to research and renewable energy technologies;
Amendment 231 #
2023/2073(INI)
Motion for a resolution
Paragraph 26 – point c
Paragraph 26 – point c
(c) implement and strictly apply the rights-based approach providing effective complaint and redress mechanisms, notably in projects under the Global Gateway initiative, and requiring full impact studies for each project, particularly on climate change, inequalities and the displacement of local populations;
Amendment 233 #
2023/2073(INI)
Motion for a resolution
Paragraph 26 – point d a (new)
Paragraph 26 – point d a (new)
da. support local and regional electricity interconnection projects;
Amendment 3 #
2023/2029(INI)
Motion for a resolution
Citation 4
Citation 4
Amendment 16 #
2023/2029(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the Instrument’s external investment framework brings together blended finance and guarantees under the European Fund for Sustainable Development Plus (EFSD+) External Action Guarantee (EAG), which is to be implemented by eligible partners in an open and collaborative approach, with a specific role for the European Investment Bank (EIB); whereas the EFSD+ considerably expands the financial envelope of its predecessor, the EFSD, and will be able to guarantee operations up to EUR 53.4 billion through EAG; whereas the ‘policy first’ principle must result in a cooperation driven by policy objectives and ensure that the European financial architecture for development is aligned in this regard; proposes for example to refine the broad and vague MSMEs window into sub-windows that should be dedicated to individual entrepreneurs and cooperatives;
Amendment 22 #
2023/2029(INI)
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas inequalities are amongst the root causes of instability, insecurity and violence;
Amendment 23 #
2023/2029(INI)
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas the promotion of human rights is a cornerstone of the EU’s external action;
Amendment 24 #
2023/2029(INI)
Motion for a resolution
Recital B c (new)
Recital B c (new)
Bc. whereas human development remains a key area for the EU’s external and development policies; whereas investments in health care, education, nutrition and social protection are paramount to ensure universal access to these services which constitute basic human rights;
Amendment 28 #
2023/2029(INI)
Motion for a resolution
Recital C
Recital C
C. whereas due to limited resources, the external financing instruments have often been stretched to their limits; whereas, since the adoption of the Regulation establishing the Instrument, events such as the Russian war of aggression against Ukraine (which triggered a food, energy and cost of living crisis) and the impact ofand the COVID-19 pandemic have exacerbated the situationfood, energy and debt crises in particular to such a degree that an early mid-term evaluation (MTE) of the Instrument and a mid-term revision (MTR) of the multiannual financial framework (MFF) are necessary, and that crisis anticipation and resilience need to be built into these;
Amendment 55 #
2023/2029(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Welcomes the consolidation of most of the EU’s external action in a single Instrument, gradually streamlining and harmonising the numerous previous instruments; is of the opinion, however, that although this simplification has enhanced flexibility and efficiency, it has not been accompanied by sufficient levels of effective accountability; underlines in this regard that measures can only be considered effective when this can be proven by clear and comparable monitoring and evaluation mechanisms; reminds of the findings of the 2023 ECA special report on programming of the Instrument, which points out that baseline and target indicators as well as data sources in MIPs where fragmented or missing; calls on the Commission to make the use of ‘Global Europe Results Framework’ (GERF) indicators compulsory for all measures throughout the entire programming cycle of MIPs, that is planning, implementation and reporting of results and for considerably increasing EU delegations capacities; emphasises that the Instrument should provide an efficient, effective, coherent and inclusive implementation, underpinned by the ‘policy first’ principle and in line with the strategic interests and values of the EU; reiterates its call on the Commission to publish, at least biannually, an aid effectiveness progress report, that consistently includes standardized, comprehensible and comparable indicators, covering joint planning, joint implementation and joint results frameworks; calls on the Commission to present this progress report to Parliament;
Amendment 94 #
2023/2029(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses the importance of meeting all the Instrument’s spending targets and calls for detailed information on the progress made in this regard; regrets, in particular, the substantial deficit in reaching the Instrument’s climate target and the biodiversity target; recalls that biodiversity is a crucial factor in combatting climate change; calls for a detailed plan outlining how the Commission intends to meet the climatespending targets by the end of the MFF;
Amendment 98 #
2023/2029(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Reaffirms the commitment set out in the Instrument to eradicating poverty, fighting inequalities and discrimination and promoting human development; recalls that actions under the Instrument are expected to contribute at least 20 % of the ODA funded under the Instrument to social inclusion and human development; underlines that the EFSD+ should aim to support investments as a means of contributing to the achievement of the SDGs by fostering sustainable and inclusive economic, environmental and social development; calls in this regard for the full implementation of the EU Gender Action Plan III, as well as the operationalisation of the EU Global Health Strategy and the Youth Action Plan in EU external action; underlines the need to enhance the Union’s efforts to promote and protect human rights in its external action, in view of the mid-term review of the implementation of the EU Action Plan on Human Rights and Democracy;
Amendment 100 #
2023/2029(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Reaffirms the commitment set out in the Instrument to eradicating poverty, fighting inequalities and discrimination and promoting human development; recalls the commitment made by the EU and the Member States to increase their official development assistance (ODA) to 0.7 % of gross domestic product by 2030, including 20 % of the EU’s ODA for social inclusion and human development, and 0.2 % of the EU’s gross national income for ODA to the least-developed countries;
Amendment 103 #
2023/2029(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Reaffirms the commitment set out in the Instrument to eradicating poverty, fighting inequalities and discrimination and promoting human development; emphasises the importance of following a holistic approach to human security as a new guiding paradigm;
Amendment 109 #
2023/2029(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Underlines the importance of guaranteeing an effective needs-based and people-centred approach in the EU’s external action; highlights the essential role that local partners and civil society should have in the design, implementation, monitoring and evaluation of the programmes;
Amendment 132 #
2023/2029(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses that under no circumstances should the 2024 MTR of the MFF result in the Instrument’s funds being cut or reallocated between programmes; underlines the key role of the Instrument, the EFSD+ and the EAG in providing a strategic framework for blended finance, de-risking investments and guarantees and in mobilising resources from the private sector with the support of the EU budget, particularly in the light of increasing geopolitical and economic competition; calls for the impact of these investments on achieving the Sustainable Development Goals (SDGs) to be systematically assessed, in particular in terms of combating poverty and inequality, especially on the basis of gender; calls for the EFSD+ not to finance investments that have a negative impact on the SDGs, particularly as regards combating climate change and protecting aquatic fauna and flora,
Amendment 142 #
2023/2029(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Notes the specific role played by the EIB in the European financial architecture for development, as set out in Article 209 of the TFEU and in Article 36 of the Regulation establishing the Instrument, and acknowledges the EIB’s potential to mobilise additional funding that contributes to the Instrument’s objectives; welcomes the creation of EIB Global, which has been operational since 1 January 2022 and sets out to increase the bank’s presence and expertise in developing countries; notes that, since the setting up of the new development branch, the EIB Global has made record use of the dedicated investment window provided by the Instrument, delivering over EUR 10 billion in 2022, notably in support of Ukraine and the Global Gateway; recalls the importance of the EU budget as the sole guarantor for the EIB’s to provide loans outside the EU in support of EU policies; calls for an increase in the guarantees granted to the EIB by the EU budget in order to allow the EU bank to continue to deliver vital public and private sector operations in Ukraine and to expand its activities in the Global South; calls on the EIB to use its position to mobilise investments for sustainable development in line with the purpose and criteria established by the EFSD+; highlights the important role of the EIB in partnering with the Commission to deliver EUR 100 billion of the 300 billion commitment under the Global Gateway strategy; calls on the EIB to continue to strengthen its presence in the field by building on the current approach of co- location within EU delegations, while further exploiting possible synergies with the EBRD and other European DFIs; underlines that EU investment projects should be subject to evaluation, monitoring and reporting, in order to avoid unintended negative impacts; in this regard, calls on the Commission, together with EIB, EBRD and other European DFIs to develop standardised procedures, including ex ante and ex post evaluations and by applying the Commission’s Result Management Framework (ReMF); urges the Commission to publish this Framework and to make sure that DFIs using their own indicators to clearly define them and explain their application and comparability with the ReMF; calls for the introduction of standardised complaint mechanisms for all DFIs that are sufficiently staffed and resourced and easily accessible; calls on the Commission to follow-up environmental, social and governance (ESG) standards of all investment projects; encourages the EIB to continue to actively engage in developing planning, monitoring and evaluation at country level, hand in hand with the EU delegations and through co- financing with development finance institutions; calls for stronger coordination between the Commission and the EEAS and EU delegations to facilitate discussions and cooperation with relevant actors on the ground in order to identify projects which best meet development effectiveness objectives;
Amendment 146 #
2023/2029(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Notes the specific role played by the EIB in the European financial architecture for development, as set out in Article 209 of the TFEU and in Article 36 of the Regulation establishing the Instrument, and; acknowledges the EIB’s potential to mobilise additional funding that contributes to the Instrument’s objectives; welcomes the creation of EIB Global, which has been operational since 1 January 2022 and sets out to increase the bank’s presence and expertise in developing countries; recommends that these financial instruments not be implemented in investment-recipient countries that lack suitable institutional and legal frameworks for EU-backed public-private partnership projects
Amendment 155 #
2023/2029(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Wwelcomes the ‘open architecture’ of the EFSD+, which was established to support private-sector investments, and; calls on the Commission, the EIB, the Member States and development finance institutions (DFIs) to fully utilise the options provided by the EAG and the relevant investment windows to promote sustainable private- sector investments; recalls Parliament's power of scrutiny and the need for transparency in the implementation of the EFSD+, including by the EIB,
Amendment 164 #
2023/2029(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes the Team Europe approach and its aim of increasing the coherence, impact and visibility of EU development projects, and calls for more joint actions with the Member States, in particular Team Europe Initiatives (TEIs); recalls however that individual Member States’ contributions have to be indicated in MIPs in order to ensure certainty over the Member States’ financial support; calls on the Commission to review the effectiveness of the approach including Member States’ compliance, and to inform Parliament of its findings;
Amendment 167 #
2023/2029(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes the Team Europe approach and its aim of increasing the coherence, impact and visibility of EU development projects, and calls for more joint actions with the Member States, in particular Team Europe Initiatives (TEIs); calls on the Commission to review the effectiveness of the approach and to inform Parliament of its findings; calls on the Commission to clarify the roles surrounding the Team Europe approach and to propose a mechanism that increases the transparency and democratic scrutiny of the initiative;
Amendment 168 #
2023/2029(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Wwelcomes the Team Europe approach and its aim of increasing the coherence, impact and visibility of EU development projects, and; calls for more joint actions with the Member States, in particular Team Europe Initiatives (TEIs) and in cooperation with the countries receiving the funds, in particular Team Europe Initiatives (TEIs), while respecting the consent of local and, in particular, indigenous populations, especially for infrastructure projects; calls on the Commission to review the effectiveness of the approach and to inform Parliament of its findings;
Amendment 188 #
2023/2029(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Recalls Parliament’s functions of political control and consultation and stresses the role of the high-level geopolitical dialogue in providing general orientations for the implementation of the Instrument; powers of political and budgetary control and consultation; underlines that the Parliament needs full and timely access to documents and has to be able to monitor the impact and progress of projects, which is, why it needs full access to standardised baseline and target indicators as well as data sources; regrets that decision- making processes in particular in the framework of the Global Gateway are still undefined and not fully transparent; points out that the overlap of financial instruments, for example in the context of guarantees, makes scrutiny difficult; calls on the Commission to provide after consultations with the Parliament a comprehensible, clear and complete overview in a single document about the financial instruments their relations with each other and the different actors as well as a complete and precise overview about grants and guarantees and how they are covered; furthermore, calls on the Commission to provide regular information about the Global Gateway steering group and to make the Result Management Framework (ReMF) fully available; calls for an oversight of the complaint mechanisms and for regular information about complaints; calls on the Parliament to establish a sufficiently staffed and resourced parliamentary oversight body for the Instrument including EFSD+ and Global Gateway projects and calls on the Commission to provide a consistent inter-institutional information flow with the European Parliament being kept informed about investment projects including Global Gateway projects; is of the opinion that the format of the high-level geopolitical dialogue alone cannot fully provide general orientations for the implementation of the Instrument; reiterates that Parliament’s positions need to be fully taken into consideration; also reiterates that European Parliament resolutions constitute part of the overall policy framework for the implementation of the Instrument;
Amendment 215 #
2023/2029(INI)
Motion for a resolution
Paragraph 26
Paragraph 26
26. Stresses that the MTE should be accompanied by the necessary legislative changes to the Instrument and the IPA III so that the relevant regulations reflect Ukraine and Moldova’s new status as EU candidate countries, and by a new delegated act setting out the specific objectives and priority areas of cooperation for each region; underlines the importance of providing funding via development finance institutions and the EIB that targets, in particular, access to essential primary materials, to renewable energies and to the economy, as part of shared planning for the development of renewable energies between Europe and its partners, in particular in Latin America, Africa and the Maghreb countries, as part of a shared strategic vision responding to the needs of local populations and not solely those of European countries;
Amendment 220 #
2023/2029(INI)
Motion for a resolution
Paragraph 27
Paragraph 27
27. Considers that the geopolitical challenges that emerged with the Russian war of aggression against Ukraine require the Instrument’s budget to be increased considerably so that support for Ukraine can be provided alongside the support for people in developing countries, with priority currently being given to our African and Southern Mediterranean partners; highlights that the challenges are spread all over the world, meaning the EU must increase its geopolitical influence and prioritise the implementation of the post- Cotonou agreements; stresses that it will only be possible to respond to these challenges in a balanced way if the proportion of allocations for each area of the Instrument is kept the same;
Amendment 230 #
2023/2029(INI)
Motion for a resolution
Paragraph 28
Paragraph 28
28. Iinsists that Parliament is part of Team Europe and should be treated as such, and therefore expects more frequent, detailed and meaningful information about the implementation of the Instrument, including the list of the EIB's investments involving the Instrument's funds;
Amendment 233 #
2023/2029(INI)
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
Amendment 2 #
2023/2000(INI)
Motion for a resolution
Citation 9 a (new)
Citation 9 a (new)
– having regard the Humanitarian Partnership 2021-2027 and its goal to improving the effectiveness and efficiency of humanitarian aid;
Amendment 9 #
2023/2000(INI)
Motion for a resolution
Citation 14 a (new)
Citation 14 a (new)
– having regard to the UN Security Council Resolution 2664 (2022) on a Humanitarian Exemption to asset freeze measures imposed by United Nations Sanctions Regimes;
Amendment 10 #
2023/2000(INI)
Motion for a resolution
Citation 15
Citation 15
– having regard to the Grand Bargain agreement signed on 23 May 2016, to the annual independent reports thereon, in particular the 2021 report, and to the Grand Bargain 2.0 framework and the annexes thereto presented at the Grand Bargain annual meeting of 15-17 June 2021, as well as the renewed commitments at the Grand Bargain annual meeting of 19-20 June 2023;
Amendment 12 #
2023/2000(INI)
Motion for a resolution
Citation 17 a (new)
Citation 17 a (new)
– having regard to the Climate and Environment Charter for humanitarian organizations and the Donors’ Declaration on climate and the environment of March 2022;
Amendment 18 #
2023/2000(INI)
Motion for a resolution
Recital B
Recital B
B. whereas humanitarian crises are becoming more protracted and complex, and are causing global spillover effects; whereas increasing numbers of conflicts, climate change hazards and their impacts and the COVID-19 pandemic have created more economic vulnerability and displacement, resulting in even greater needs; whereas these crises have significantly risen inequalities;
Amendment 26 #
2023/2000(INI)
Motion for a resolution
Recital D
Recital D
D. whereas innovative structural solutions are needed to address global humanitarian challenges and ensuring the humanitarian system is more agile, prepared for and responsive to humanitarian crisis, more gender- inclusive, locally-led and accountable; whereas these solutions should focus on ensuring sufficient and quality funding, implementing effectively the humanitarian- development-peace nexus (triple nexus) approach and creating an enabling humanitarian environment for humanitarian workers and organisations; whereas efforts to address current and future humanitarian challenges must be guided by a people-centred approach, especially with regard to women, children and persons with disabilities; whereas the role and participation of local actors and first responders in humanitarian responses must be recognised and supported; whereas it is estimated that over 40% of the half a million humanitarian workers who provide frontline care during emergencies, wars and disasters, are women;
Amendment 40 #
2023/2000(INI)
Motion for a resolution
Paragraph 1
Paragraph 1
1. Calls urgently on the Commission and the Member States to substantially increase their humanitarian aid budgets to respond to humanitarian needs, which are at a record high, without compromising on the development budget; reiterates its call on the Member States to allocate a fixed share of their gross national incomes to humanitarian aid; supports, in this regard, the Council conclusions of 22 May 2023 encouraging the Member States to devote 10 % of their official development assistance to humanitarian action and calls for their swift implementation; calls on the Commission and Member States to set ambitious targets and to create roadmaps for gradually increasing official development assistance to meet the final target;
Amendment 44 #
2023/2000(INI)
Motion for a resolution
Paragraph 2
Paragraph 2
2. Notes that closing the funding gap is a global responsibility; reiterates, therefore, the need to expand the humanitarian resource base by promoting the greater involvement of non-traditional donor countries with major economic potential and by mobilising private funding, accompanied by follow-up mechanisms, in full respect of humanitarian principles; of humanity, neutrality, impartiality and independence;
Amendment 56 #
2023/2000(INI)
Motion for a resolution
Paragraph 4
Paragraph 4
4. Is concerned about the imbalances in funding between crises and within sectors and warns of the consequences of chronic underfunding on the most vulnerable; notes that in 2022, only 27.7 % of the humanitarian appeal for El Salvador was funded compared to 94.5 % of the humanitarian appeal for the Central African Republic, reflecting that funding imbalances can result in some appeals receiving as much as three times more funding than others; notes the critical and continuous underfunding of the protection and gender based violence sectors, which highly impacts on access to services of people in need; calls for more equitable, needs-based distribution of funding to ensure that no one is left behind; calls on the Commission to develop a more harmonised approach to forgotten crises and to report on its commitment to allocate 15 % of its initial annual humanitarian budget to forgotten crises and prevent the transfer of resources from already underfunded crises; calls on the Council to better coordinate the Member States’ attention and support for these crises;
Amendment 60 #
2023/2000(INI)
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission and the Member States to support and implement the G7 foreign ministers statement on anticipatory action and invest an increased part of the humanitarian funding for early warning and anticipatory action ; invites the Commission and the Member States to strengthen existing and currently developed early warning systems (IPC, FEWSNET and local ones) to enhance and disseminate the evidence base for a political warning and triggering of an adequate government, donor and partner response to prevent IPC 2 levels deteriorating into IPC 3, 4 or 5;
Amendment 64 #
2023/2000(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Calls on the Commission and the Member States to provide more quality funding through flexible, unearmarked, softly earmarked and multiannual funding that is tailored to local contexts, prioritising protracted crises where predictability is critical, needs-based and people-centred; highlights the need to harmonise and simplify donors’ contracting procedures; applications, contracting, grants management and reporting procedures; calls on the Commission and Member States to allocate increased direct funding to NGOs who are able to more efficiently and cost-effectively utilise funding; calls for greater transparency regarding the recipients and amounts of funding on the ECHO website;
Amendment 73 #
2023/2000(INI)
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Welcomes the Commission commitment to allocate 25% of humanitarian funding to local and national actors and responders; calls on the EC and Member States to monitor and report on the implementation of this commitment;
Amendment 80 #
2023/2000(INI)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Notes that the triple nexus is key to addressing context-specific needs in complex and protracted crises, and in building resilience to future crises, in order to improve coherence and complementary of responses in line with humanitarian principles; insists on more visibilitynexus-specific funding, visibility, coordination, and knowledge-sharing among stakeholders when applying the triple nexus approach, including through better involvement of local actors;
Amendment 85 #
2023/2000(INI)
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Commission to ensure the effective implementation of the triple nexus across its policies and structures and to regularly report on its implementation; calls for the promotion of more joint assessments, analysis and planning across different funding instruments, especially at country level; notes the potential of the Neighbourhood, Development and International Cooperation – Global Europe instrument (NDICI-GE) to put the triple nexus approach into practice; calls for better coordination between the Commission’s Directorate-General for International Partnerships and, the Directorate- General for European Civil Protection and Humanitarian Aid Operations and the European External Action Service in implementing the rapid response pillar of NDICI-GE, in order to ensure that their responses complement one another;
Amendment 88 #
2023/2000(INI)
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Commission to respond to and implement the recommendations from the INTPA- commissioned study on the nexus entitled “HDP nexus: challenges and opportunities for its implementation,” particularly on the recommendation to monitor the implementation of the nexus across the relevant services;
Amendment 101 #
2023/2000(INI)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls for climate funding to be scaled up in order to prevent, mitigate and respond to the alarming impact of climate change on humanitarian crises; is concerned that NDICI-GE expenditure with a climate objective falls far short of the commitment that such expenditure should represent 30 % of NDICI-GE’s overall financial envelope; calls on the Commission to scale this up without delay, focusing in particular on locally-led adaptation in least developed countries;
Amendment 107 #
2023/2000(INI)
Motion for a resolution
Paragraph 10
Paragraph 10
10. Stresses the need to localise disaster risk reduction, climate preparedness, adaptation and response, build, recognise and utilise the capacities of local actors and communities and ensure the climate resilience of the most vulnerable groups;
Amendment 109 #
2023/2000(INI)
Motion for a resolution
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Calls for donors and Member States to adopt and implement the Humanitarian Aid Donors’ Declaration on Climate and the Environment by increasing their funding for disaster prevention, preparedness, anticipatory action, and response; calls for humanitarian actors to sign onto and implement the Climate Charter for humanitarian organisations, to maximise the environmental sustainability of their work;
Amendment 114 #
2023/2000(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Stresses the importance of building human resilience by enhancing protection and minimizing the risks people face in a crisis and ensuring full respect of their rights while supporting access to education and health services and pre-crisis capacity building; emphasises the need to involve the affected people and local communities inand local/national humanitarian actors in coordination structures, implementing early warning systems, conducting needs assessments and determining and monitoring the humanitarian response;
Amendment 118 #
2023/2000(INI)
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Highlights the role and importance of local formal and informal civil society organisations in the humanitarian response; calls on the Commission and Member States to guarantee their inclusion and participation in all processes in line with the Guidelines on Promoting Equitable Partnerships with Local Responders in Humanitarian Settings published by the Commission;
Amendment 123 #
2023/2000(INI)
Motion for a resolution
Paragraph 13
Paragraph 13
13. Asks the Commission to better address the needs of vulnerable groups in humanitarian responses, including minorities, children, women, the elderly, and particularly persons with disabilities and intersectional vulnerabilities; encourages the use of the Organisation for Economic Co-operation and Development’s disability marker to track the progress made in humanitarian action; calls on the Commission to support the External Action Service in order to update the EU guidelines on children and armed conflict and ensure their implementation;
Amendment 129 #
2023/2000(INI)
Motion for a resolution
Paragraph 14
Paragraph 14
14. Notes that the number of forcibly displaced persons worldwide is at a record high; calls for the EU and the global community to support refugees, internally displaced people and their host communities, including those forced to flee due the impacts of climate change, and to work for durable solutions, in particular in forgotten crises; calls on the Commission and Member States to report on and reiterate the commitments made under the Global Compact for Refugees to ensure that the global responsibility to host refugees is shared more fairly;
Amendment 132 #
2023/2000(INI)
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14a. Underlines that existing structural gender inequalities are exacerbated during crises and that therefore, women and girls, as well as the most marginalised groups that suffer different and intersecting forms of discrimination are disproportionately affected by conflicts, natural disasters or climate change hazards; deplores the increase in gender- based violence in humanitarian settings and stresses the need to prevent it; underlines that the specific needs and rights of these groups should be addressed in all humanitarian responses;
Amendment 137 #
2023/2000(INI)
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls for the EU and the Member States to take positive action on gender mainstreaming in humanitarian action, given that women and girls are the most likely victims of conflicts and natural disasters but also agents of change; underlines the need to accelerate the implementation of the EU Gender Action Plan; deplores the increase in gender-based violence in humanitarian settings and stresses the need to prevent it;
Amendment 145 #
2023/2000(INI)
Motion for a resolution
Paragraph 16
Paragraph 16
16. Insists on the need to reinforce the centrality and protection of international humanitarian law, international human rights law and humanitarian principles in the EU’s external action; invites the Commission to develop a humanitarian diplomacy strategy together with the Member States, ensuring that this strategy advocates the protection of civilians, compliance with international humanitarian law and respect for humanitarian principles;
Amendment 147 #
2023/2000(INI)
Motion for a resolution
Paragraph 16 a (new)
Paragraph 16 a (new)
16a. Calls on the European Union and the Member States to use all of their political influence to promote and uphold IHL, protect civilians and support humanitarian access to allow disaster affected people to access humanitarian aid as civilians must be better protected and not become intentional, accidental, or collateral victims of conflicts;
Amendment 152 #
2023/2000(INI)
Motion for a resolution
Paragraph 17
Paragraph 17
17. Strongly condemns war crimes and serious violations of international humanitarian law; calls for all perpetrators to be held accountable and for victims to receive reparations; deplores the rise in attacks on civilians, humanitarian personneland medical personnel and critical infrastructure, inlcuding hospitals and schools, worldwide and insists on the need to increase protection measures for civilians, humanitarian and medical workers, critical infrastructures and preventing sexual exploitation and abuse within the humanitarian workers; condemns discriminatory policies, such as the ban on female humanitarian workers in Afghanistan;
Amendment 162 #
2023/2000(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Welcomes the adoption of UN Security Council Resolution 2664 (201622) introducing a humanitarian exemption in UN sanction regimes; calls for the EU to further align with the global standard set by UN Security Council Resolution 2664 (2016) and to22); calls the Commission to carry out analysis of the impact of sanctions on the delivery of humanitarian aid and subsequently adopt standing humanitarian exemptions in its autonomous sanction regimes in order to facilitate humanitarian activities in contexts affected by armed conflict, as required by international humanitarian law; furthermore insists on the need to include a standing humanitarian exemption in the future Directive on the definition of criminal offences and penalties for the violation of Union restrictive measures in order to ensure that humanitarian activities are not criminalized under EU sanction regimes and that humanitarian workers are protected in the contexts where EU sanctions apply; calls on the European Commission to work closely with financial institutions and humanitarian actors to ensure that administrative barriers including de-risking over- compliance are addressed to enable the delivery of humanitarian aid;
Amendment 174 #
2023/2000(INI)
Motion for a resolution
Paragraph 19
Paragraph 19
19. Underlines the importance of supporting local actors in line with the Grand Bargain commitment to making principled humanitarian action as local as possible; invitpraises the Commission and the Member States to furole that local and national organisations and first responders play in humanitarian responses and the support they provide to people in the most acute needs; welcomes the EC guidance note on equitable parthner developships and ECHO’s commitment to advance their localisation strategies in close collaboration with humanitarian partners, and to ensure an adequate sharing of riskagenda in the Grand Bargain discussions; calls on the European Commission and Member States for the full and meaningful implementation of the commitments enshrined in guidance note, ensuring accountability for the commitments made, a proper support to its partners as well as a fair sharing of risks with intermediate and local partner organisations;
Amendment 4 #
2023/0455(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) To improve further the cooperation among Union agencies in the area of chemicals, and to increase coherence and efficiency of assessments related to chemicals across Union legislation, it is necessary to lay the foundation for a common approach to hazard assessment of chemicals across Union legislation. This Regulation should establish a forum for Agencies to improve sharing and re-use of chemicals data, exchange best practices, and foster cooperation in the hazard assessment of chemicals.
Amendment 9 #
2023/0455(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Correspondingly, this Regulation aims to address the eventual divergence between scientific opinions of the European Food Safety Authority and those of other Union agencies. Regulation (EC) No 178/2002 of the European Parliament and Council already contains provisions establishing a procedure to solve divergent scientific opinions. Those resolution procedures should be reinforced, in that the European Food Safety Authority and the other dissenting agency should be bound to make their best effort to resolve the divergence on general scientific issues, and only when they are not able to resolve the divergence, should they refer to risk managers. Differences in assessment methodologies resulting in divergent opinions, particularly with regards to the protection of vulnerable groups, should be duly clarified. In such instances, priority should be given to the most protective opinion to safeguard the most vulnerable populations.
Amendment 12 #
2023/0455(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) In the more specific case of scientific divergence pertaining to the hazard identification of chemical substances, a new procedure enabling the resolution of the divergence should be established. This procedure should enable the Commission to request the European Chemicals Agency, as the Union agency most equipped with expertise and capacity in hazard assessment, as well as long- standing experience with the harmonised classification and labelling process, to develop a proposal for harmonised classification and labelling, in accordance withe Regulation (EC) No 1272/2008 of the European Parliament and Council, moving closer to the ‘one substance, one assessment’ vision as regards uniformity of hazard assessments of chemicals across the Union. This possibility should be reflected in the relevant provision providing for the resolution of diverging scientific opinions laid down in Regulation (EC) No 178/2002.
Amendment 17 #
2023/0455(COD)
Proposal for a regulation
Article -1 (new)
Article -1 (new)
Article -1 Forum on Hazard Assessment 1. The Commission shall, by means of an implementing decision, establish and manage a Forum on Hazard Assessment ('the Forum') which shall include representatives from each of the Agencies, the Commission, Member states and the European Parliament. 2. The Forum shall establish a work programme to (a) foster cooperation in the area of hazard assessment of chemicals; (b) improve the sharing and re-use of data between agencies; (c) establish a strategy toward the common hazard assessment of chemicals across Union legislation in the area of chemicals. 2. The forum shall meet and update its work programme regularly. 3. The Forum shall draw up an annual report, compiling and analysing the advancement and conclusions of its work programme referred to in paragraph 2. The first report shall be prepared by [OP: please insert date: 1 year after the end of the first calendar year after entry into force of this Regulation]. The Forum shall present this report to the Commission, relevant Union agencies and Member State competent authorities, the European Parliament and the Council for consideration of the need for regulatory or policy action related to the conclusion of this report
Amendment 19 #
2023/0455(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 178/2002
Article 30 – paragraph 2 – subparagraph 3
Article 30 – paragraph 2 – subparagraph 3
Where the Authority identifies a potential source of divergence, it shall contact the body concerned in order to ensure that all relevant scientific or technical information is shared and in order to identify the potentially contentious scientific or technical issues. Difference in assessment methodologies resulting in divergent opinions shall be duly justified, especially regarding the protection of vulnerable groups.
Amendment 22 #
2023/0455(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 178/2002
Article 30 – paragraph 2 – subparagraph 2
Article 30 – paragraph 2 – subparagraph 2
The Authority and the body concerned shall cooperate to resolve the divergence. Priority shall be given to the opinion that affords the highest level of protection in order to safeguard the most vulnerable groups. If the Authority and the body concerned are not able to resolve the divergence, they shall draw up a joint report. The report shall clearly outline the contentious scientific issues and identify the relevant uncertainties in the data and be made publicly available.
Amendment 26 #
2023/0455(COD)
Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)
Article 1 – paragraph 1 – point 2 a (new)
Regulation (EC) No 178/2002
Article 30 – paragraph 3 a (new)
Article 30 – paragraph 3 a (new)
In article 30, the following paragraph is added 3a. In cases where a divergence is identified, and the Authority requests additional information from the other Union or Member State authority, the period by when the relevant authorities are required to adopt their respective output, or the joint output referred to in paragraph 2, may be extended. After consulting the body concerned, the Authority shall lay down a period within which this information shall be provided and shall inform the Commission of the additional period needed. The Commission shall inform the concerned business operator(s) and the Member States of the extension.
Amendment 30 #
2023/0455(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
Regulation (EU) 2017/745
Annex I – Section 10.4.1 – point b
Annex I – Section 10.4.1 – point b
(b) substances which are identclassified as endocrine disruptors for human health, of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council12 andor substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council or substances having endocrine disrupting properties relevant to human health identified in accordance with Regulation (EU) No 528/2012. _________________ 12 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006( OJ L 353 31.12.2008, p. 1 ).
Amendment 33 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EU) 2019/1021
Article 8 – paragraph 1a – point a
Article 8 – paragraph 1a – point a
(a) as appropriate, information on human health and environmental impacts of waste consisting of, containing or contaminated with POPs, including impacts on waste management;
Amendment 34 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EU) 2019/1021
Article 8 – paragraph 1a – subparagraph 2
Article 8 – paragraph 1a – subparagraph 2
The Agency shall, as soon as it receives the request referred to in the first subparagraphArticle 8(1), point (i), publish on its website a notice that a report on a possible amendment of Annex IV or V will be prepared inviting all interested parties, including waste operators and users of recycled materials, to submit comments within 8 weeks. The Agency shall publish those comments on its website.
Amendment 35 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
Regulation (EU) 2019/1021
Article 8 – paragraph 1a – subparagraph 3
Article 8 – paragraph 1a – subparagraph 3
At the latest 9 months following the submission of that report referred to in Article 8(1), point (i), the Committee for Socio-economic Analysis of the Agency, set up pursuant to Article 76(1), point (d), of Regulation (EC) No 1907/2006 shall adopt an opinion on the report and on the concentration limit values proposed therein. For the purpose of adopting an opinion on the report, Article 87 of Regulation (EC) No 1907/2006 shall apply mutatis mutandis.
Amendment 36 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 4
Article 4 – paragraph 1 – point 4
Regulation (EU) 2019/1021
Article 15 – paragraph 2
Article 15 – paragraph 2
2. The Commission is empowered to adopt delegated acts in accordance with Article 18, to amend Annexes IV and V to adapt them to the changes to the list of substances set out in the Annexes I, II or III to Regulation(EU) 2019/1021, or the Annexes to the Convention or the Protocol or to adapt them to scientific and technical progress.
Amendment 38 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Article 18 – paragraph 6
Article 18 – paragraph 6
6. A delegated act adopted pursuant to Articles 4(3), 10(2) and 15 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period may be extended by two months at the initiative of the European Parliament or of the Council’.
Amendment 39 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 5 Present text
Annex IV – Table 1 – Row 5 Present text
Amendment 40 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 12 Present text
Annex IV – Table 1 – Row 12 Present text
Amendment 41 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 30
Annex IV – Table 1 – Row 30
Amendment 42 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 27 Present text
Annex IV – Table 1 – Row 27 Present text
Amendment 43 #
2023/0455(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 5 – point c
Article 4 – paragraph 1 – point 5 – point c
Regulation (EU) 2019/1021
Annex IV – Table 1 – Row 31 Present text
Annex IV – Table 1 – Row 31 Present text
Amendment 8 #
2023/0454(COD)
Proposal for a directive
Recital 6 a (new)
Recital 6 a (new)
(6 a) The list of restricted substances Directive 2011/65/EU should be periodically reviewed to ensure a high level of protection of human health, the environment and consumer safety. It is considered appropriate to set the review period by taking into account market developments and technical and scientific progress and in view of the fact that restriction dossiers can be submitted by Member States at any time and horizontal restriction measures can be initiated and adopted by Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021 or other Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 8 #
2023/0454(COD)
Proposal for a directive
Recital 6 a (new)
Recital 6 a (new)
(6a) The list of restricted substances Directive 2011/65/EU should be periodically reviewed to ensure a high level of protection of human health, the environment and consumer safety. It is considered appropriate to set the review period by taking into account market developments and technical and scientific progress and in view of the fact that restriction dossiers can be submitted by Member States at any time and horizontal restriction measures can be initiated and adopted by Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021 or other Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 10 #
2023/0454(COD)
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8 a) In order to ensure that this Directive is coherent with any future amendment of Regulation (EC) No 1907/2006, or of other future Union law concerning sustainability criteria for hazardous substances and chemicals, the Commission should assess whether an amendment of Articles 5 and 6 of this Directive is required. Where appropriate, the Commission should propose amendments to this Directive in a future regulation amending Regulation (EC) No 1907/2006 or in other future Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 10 #
2023/0454(COD)
Proposal for a directive
Recital 8 a (new)
Recital 8 a (new)
(8a) In order to ensure that this Directive is coherent with any future amendment of Regulation (EC) No 1907/2006, or of other future Union law concerning sustainability criteria for hazardous substances and chemicals, the Commission should assess whether an amendment of Articles 5 and 6 of this Directive is required. Where appropriate, the Commission should propose amendments to this Directive in a future regulation amending Regulation (EC) No 1907/2006 or in other future Union law concerning sustainably criteria for hazardous substances and chemicals.
Amendment 14 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 2 – point a a (new)
Article 5 – paragraph 4a – subparagraph 2 – point a a (new)
(a a) shall publish the draft opinions referred to in point (a) on its website without delay and invite interested parties to provide their comments on the draft opinion for a period no shorter than 60 days after its publication;
Amendment 14 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 2 – point a a (new)
Article 5 – paragraph 4a – subparagraph 2 – point a a (new)
(aa) shall publish the draft opinions referred to in point (a) on its website without delay and invite interested parties to provide their comments on the draft opinion for a period no shorter than 60 days after its publication;
Amendment 16 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 3
Article 5 – paragraph 4a – subparagraph 3
Each Committee shall take into account any information submitted by interested parties in accordance with the second subparagraph, point (aa), and submitted by third parties in accordance with the second subparagraph, point (c).
Amendment 16 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 3
Article 5 – paragraph 4a – subparagraph 3
Each Committee shall take into account any information submitted by interested parties in accordance with the second subparagraph, point (aa), and submitted by third parties in accordance with the second subparagraph, point (c).
Amendment 18 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 5
Article 5 – paragraph 4a – subparagraph 5
The Agency shall identify which parts of its opinions and of any attachments thereto should be made publicly available on its website and shall make those parts publicly available on its website, together with any requests made in accordance with the second subparagraph, point (c).
Amendment 18 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b
Article 1 – paragraph 1 – point 1 – point b
Directive 2011/65/EU
Article 5 – paragraph 4a – subparagraph 5
Article 5 – paragraph 4a – subparagraph 5
The Agency shall identify which parts of its opinions and of any attachments thereto should be made publicly available on its website and shall make those parts publicly available on its website, together with any requests made in accordance with the second subparagraph, point (c).
Amendment 22 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b a (new)
Article 1 – paragraph 1 – point 1 – point b a (new)
Directive 2011/65/EU
Article 5 – paragraph 5
Article 5 – paragraph 5
Amendment 22 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 1 – point b a (new)
Article 1 – paragraph 1 – point 1 – point b a (new)
Directive 2011/65/EU
Article 5 – paragraph 5
Article 5 – paragraph 5
Amendment 23 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Directive 2011/65/EU
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 30 months on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.;
Amendment 23 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Directive 2011/65/EU
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
With a view to achieving the objectives set out in Article 1 and taking account of the precautionary principle, a review, based on a thorough assessment, and an amendment of the list of restricted substances in Annex II shall be considered by the Commission periodically and at least every 30 months on its own initiative or following the submission of a restriction dossier prepared by a Member State containing the information referred to in paragraph 2.;
Amendment 25 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
The review and amendment of the list of restricted substances, or group of substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
Amendment 25 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – subparagraph 1
Article 6 – paragraph 2 – subparagraph 1
The review and amendment of the list of restricted substances, or group of substances, in Annex II shall be based on restriction dossiers prepared by the Agency at the request of the Commission or prepared by a Member State.
Amendment 27 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
The Agency or a Member State shall take into account any available information and any relevant risk assessment submitted for the purposes of other Union legislation covering any part of the life cycle of the substance used in EEE, in particular the waste phase. To this end, other bodies established under Union law and carrying out a similar task shall, on request, provide information to the Agency or Member State concerned.
Amendment 27 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – subparagraph 2
Article 6 – paragraph 2 – subparagraph 2
The Agency or a Member State shall take into account any available information and any relevant risk assessment submitted for the purposes of other Union legislation covering any part of the life cycle of the substance used in EEE, in particular the waste phase. To this end, other bodies established under Union law and carrying out a similar task shall, on request, provide information to the Agency or Member State concerned.
Amendment 29 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a (new)
Article 6 – paragraph 2 – point –a (new)
(-a) The identity of the substance;
Amendment 29 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a (new)
Article 6 – paragraph 2 – point –a (new)
(-a) The identity of the substance;
Amendment 30 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a a (new)
Article 6 – paragraph 2 – point –a a (new)
(-a a) a precise and clear wording of the entry of the proposed restriction in Annex II;
Amendment 30 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a a (new)
Article 6 – paragraph 2 – point –a a (new)
(-aa) a precise and clear wording of the entry of the proposed restriction in Annex II;
Amendment 31 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a b (new)
Article 6 – paragraph 2 – point –a b (new)
(-a b) references and scientific evidence for the restriction;
Amendment 31 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point –a b (new)
Article 6 – paragraph 2 – point –a b (new)
(-ab) references and scientific evidence for the restriction;
Amendment 32 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b a (new)
Article 6 – paragraph 2 – point b a (new)
(b a) information on possible alternatives, their availability and suitability;
Amendment 32 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b a (new)
Article 6 – paragraph 2 – point b a (new)
(ba) information on possible alternatives, their availability and suitability;
Amendment 34 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b b (new)
Article 6 – paragraph 2 – point b b (new)
(b b) justification for considering a Union-wide restriction as the most appropriate measure.
Amendment 34 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b b (new)
Article 6 – paragraph 2 – point b b (new)
(bb) justification for considering a Union-wide restriction as the most appropriate measure.
Amendment 35 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b c (new)
Article 6 – paragraph 2 – point b c (new)
(b c) socioeconomic assessment.
Amendment 35 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 3 – point c
Article 1 – paragraph 1 – point 3 – point c
Directive 2011/65/EU
Article 6 – paragraph 2 – point b c (new)
Article 6 – paragraph 2 – point b c (new)
(bc) socioeconomic assessment.
Amendment 38 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Directive 2011/65/EU
Article 20 – paragraph 1
Article 20 – paragraph 1
Amendment 38 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 a (new)
Article 1 – paragraph 1 – point 4 a (new)
Directive 2011/65/EU
Article 20 – paragraph 1
Article 20 – paragraph 1
Amendment 39 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 b (new)
Article 1 – paragraph 1 – point 4 b (new)
Directive 2011/65/EU
Article 20 – paragraph 1 b (new)
Article 20 – paragraph 1 b (new)
(4 b) In Article 20, the following paragraph 1a is inserted: “1a. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.”
Amendment 39 #
2023/0454(COD)
Proposal for a directive
Article 1 – paragraph 1 – point 4 b (new)
Article 1 – paragraph 1 – point 4 b (new)
Directive 2011/65/EU
Article 20 – paragraph 1 b (new)
Article 20 – paragraph 1 b (new)
(4b) In Article 20, the following paragraph 1a is inserted: “1a. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.”
Amendment 94 #
2023/0453(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) The European Green Deal1 sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability2 is a crucial delivery of this zero-pollution ambition and introduces the ‘one substance, one assessment’ approach, which aims to improve the efficiency, effectiveness, coherence, and transparency of safety assessments of chemicals across Union legislation. According to that Strategy, ‘safe and sustainable by design’ criteria should be developed to enable the production and use of chemicals that are safe and sustainable throughout their entire lifecycle. The Strategy also sets out that the interaction between scientific developments and policy-making should be strengthened by means of an early warning system for chemicals and groups of chemicals to ensure that Union policies address emerging chemical risks as soon as these are identified by monitoring and research, and that a framework of indicators should be developed to monitor the drivers and impacts of chemical pollution and to measure the effectiveness of chemicals legislation. This Regulation aims to implement these objectives. _________________ 1 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM (2019) 640 final. 2 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Chemicals Strategy for Sustainability Towards a Toxic-Free Environment, COM (2020) 667 final,
Amendment 100 #
2023/0453(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The main objective of this Regulation is to increase the level of protection of the environment and human health from the risks arising from hazardous chemicals, as well as to facilitate the functioning of the internal market for chemicals. For that purpose, this Regulation should establish a common data platform data on chemicals (‘the common data platform’), to be managed by the European Chemicals Agency (‘ECHA’). The common data platform is a digital infrastructure that brings together chemicals data and information generated under the Union chemicals acquis. This Regulation should also establish dedicated services within the common data platform and lay down rules on the transparency, accessibility, and usability of the data contained in that platform. This Regulation aims to create a common knowledge base on chemicals available to authorities to enable better, complete, coherent and robust scientific assessments of chemicals and their impacts and to ensure the best use of existing information for the purpose of the implementation and the development of Union legislation on chemicals. Moreover, the Regulation aims to provide a one-stop- shop on chemicals data and information in the Union accessible to the general public and, thus, to increase the predictability and the transparency of regulatory processes on chemicals, enable scrutiny by interested parties of data generated and used for regulatory purposes, as well as to strengthen public trust in the robustness of scientific decision-making.
Amendment 101 #
2023/0453(COD)
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2 a) People and other living organisms are exposed daily to a wide mix of chemicals originating and environmental stressors from various sources. However, the safety of chemicals in the EU is usually assessed through the evaluation of single chemicals without considering the combined exposure to multiple chemicals from different sources and over time. If some pieces of legislation require to assess the cumulative exposure to the same chemical from different sources, explicit requirements to take into account the impact of unintentional mixtures is generally lacking. The human exposome is a concept that provides a holistic view of human health and disease. It includes exposures from our diets, our lifestyles, and environmental factors, such as chemicals. This regulation should help gathering data on the impacts of the exposure to multiple chemicals and environmental factors to foster research on the human exposome and help to understand the causal pathways leading to common diseases such as cardiovascular disease, respiratory diseases, immunological disorders, mental health, and non-communicable diseases.
Amendment 102 #
2023/0453(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) In its communication of 19 February 2020 on a European strategy for data4 , the Commission described its vision of a common European data space and highlighted the need for the development of sectoral data spaces in strategic areas, since not all sectors of the economy and society are moving at the same speed. This Regulation aims therefore to build a data space for chemicals by establishing a common data platform on chemicals (‘common data platform’), which is also part of the Green Deal data space, as referred to in the European strategy for data. Furthermore, in that strategy, the Commission highlighted several issues concerning the availability of data for the public good, including data availability, data infrastructures and governance, interoperability, as well as the lack of adequate sharing of data between public authorities. This Regulation aims to increase data availability on chemicals by requiring the relevant Union agencies and Member States' authorities to make data available for integration in the common data platform on chemicals, to promote interoperability of that data by providing for the establishment of standard formats and controlled vocabularies, as well as to facilitate data exchange and use by public authorities to enable them to effectively carry out their regulatory and policy developing tasks. _________________ 4 Communication from the Commission to the European Parliament, The Council, The European Economic and Social Committee and the Committee of the Regions, A European strategy for data, COM/2020/66 final.
Amendment 112 #
2023/0453(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The common data platform should contain chemicals-related data and information held by relevant Union agencies or the Commission generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. This includes, for instance, all regulatory dossiers or applications submitted to the relevant Union agencies, but also chemicals data on occurrence, exposure and fate of chemicals submitted by Member States to Union agencies or the Commission in compliance with their reporting obligations. The common data platform should also include chemicals data and information generated as part of Union, national or international programmes or research activities related to chemicals, where this data and information is held by the Commission or one of the relevant agencies.
Amendment 113 #
2023/0453(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The common data platform should contain all chemicals-related data and information held by relevant Union agencies or the Commission generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. This includes, for instance, all regulatory dossiers or applications submitted to the relevant Union agencies, but also chemicals data on occurrence of chemicals submitted by Member States to Union agencies or the Commission in compliance with their reporting obligations. The common data platform should also include chemicals data and information generated as part of Union, national or international programmes or research activities related to chemicals, where this data and information is held by the Commission or one of the relevant agencies.
Amendment 117 #
2023/0453(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) Due to the different nature of the risk and hazard assessments performed under Union acts on medicinal products, when compared to those performed under the main Union acts on chemicals, for medicinal products, only chemicals data related to environmental risk assessments for human and veterinary medicines, non- clinical studies for human medicines and maximum residue limit values the European Medicines Agency (‘EMA’) holds, as well as specific reference values, should be included in the common data platform. For medicinal active substances, only data on relevant substances should be included. These concern active substances covered by the medicines legislation and also used for other applications regulated by other Union legislation identified in this Regulation, as well as other active substances with particular persistent, bio-accumulative and toxic properties or with a known high level of residues in the environment.
Amendment 125 #
2023/0453(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) These data should also be limited to data submitted to the EMA in the context of the relevant procedures that are finalised or submitted after the entry into force of this Regulation. At a later stage, and no later than 4 years after the entry into force of this Regulation, it should also be possible to include in the common data platform, where relevant, data the EMA holds on procedures concluded before the entry into force of this Regulation.
Amendment 129 #
2023/0453(COD)
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Other chemicals data submitted or generated under Union legislation on medicinal products may also be of interest to chemicals regulatory areas, such as data related to other active substances contained in medicinal products, clinical data, data related to other substances contained in medicinal products besides active substances and data that is submitted to the EMA in the context of the relevant procedures that are finalised before the entry into force of this Regulation. Moreover, a relevant part of the medicinal data is held by the National Competent Authorities. At a later stage and no later than 5 years after the entry into force of this Regulation, the Commission should therefore assess, in close cooperation with Member States and the Agencies, whether such additional data should be included in the common data platform. This assessment should take also into account the relevancy, the anticipated added value as well as the cost-benefit balance of incorporating the additional data.
Amendment 145 #
2023/0453(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) While the ECHA should identify and develop the technical functionalities of the common data platform in stages, certain dedicated services should be defined by this Regulation. As such, the common data platform should, in addition to providing access to chemicals-related data made available by the Agencies and the Commission, provide access to the chemicals data and information made available through its dedicated services. These dedicated services should be integrated into the common data platform and consist of the existing Information Platform for Chemical Monitoring (‘IPCHEM’), a repository of reference values, a database of study notifications, a database with information on regulatory processes, a database with information on applicable legal obligations, a repository of standard formats and controlled vocabularies, a database on environmental sustainability related data, a database on chemicals in products and their alternatives, as well as a dashboard of indicators on chemicals.
Amendment 146 #
2023/0453(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) The Commission should adopt an implementation plan identifying initial datasets of chemicals data to be made accessible via the platform and the timeline for their integration, informed by the preparatory work of the Commission and the Agencies10 . The Commission should set up a governance scheme to support and steer the common data platform’s operation and evolution covering the organisation of work structures and coordination between ECHA and data providers, and required rules, formats and vocabularies for data integration, and maintain a rolling implementation plan to ensure the progress in identification and integration of new datasets of chemicals data and services for inclusion. The governance scheme should be adopted and updated as necessary by the Commission, after consultation with a newly established platform steering committee composed of representatives from Union agencies and the Commission. In order to ensure uniform conditions for the implementation of the obligations to establish an implementation plan and a governance scheme, implementing powers should be conferred on the Commission. _________________ 10 European Union Common Data Platform on Chemicals Project Initiation Document, v1.1 endorsed by the One Substance One Assessment Interservice Group 27 February 2023.
Amendment 148 #
2023/0453(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The common data platform should serve the widest possible community, with the ability to address new use cases, incorporate new relevant datasets, develop new functionalities, and respond to developing tools and applications. Other parties, such as Member States, scientific bodies of Member States or national authorities, academia, and civil society should be able to submit chemicals data to the Agencies or the Commission for hosting and maintenance.
Amendment 154 #
2023/0453(COD)
Proposal for a regulation
Recital 21
Recital 21
(21) To ensure that an adequate knowledge base on chemicals is available through the common data platform, the Commission should be able to request the Agencies to host, maintain and make available, via the common data platform, chemicals data generated as part of Union, national or international legislation, programmes or research activities beyond the data already flowing to the Agencies as part of the obligations under the Union acts listed in Annex I or other obligations subject to this Regulation. The Commission should make such requests to the Agencies in accordance with their mandates and allocated tasks.
Amendment 155 #
2023/0453(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) To improve the uptake of academic data and to expand the knowledge base for chemicals safety assessments and environmental sustainability impacts of chemicals, researchers or research consortia funded by Union framework programmes should make available, in line with the ‘as open as possible, as closed as necessary’ principle, any human biomonitoring data they collect or generate resulting from research and development programmes to the EEA and any environmental sustainability data on chemicals or materials they collect or generate to the ECHA. Member States should require researchers or research consortia funded by national framework programmes to make their data that is relevant for regulatory purposes available to the EEA or to ECHA.
Amendment 159 #
2023/0453(COD)
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23 a) Independent research studies are often given comparatively low weight as evidence in hazard and risk assessment of chemicals creating a gap between independent research and chemicals regulation and policy. It is necessary to provide structure and transparency in the evaluation of research data in order to increase their use in regulatory assessment of chemicals. The Commission should publish a guidance setting minimum quality and reporting requirements to improve the uptake of research data.
Amendment 161 #
2023/0453(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) The EEA, as the agency responsible for monitoring data and information on chemicals in the environment, should also be responsible for collecting, hosting, and maintaining human biomonitoring data. To the extent that human biomonitoring data constitutes a special category of personal data, namely, health data, the EEA should process that data only where the processing is necessary for reasons of substantial public interest, as required by Article 10(2)(g) of the Regulation (EU) No 2018/1725 of the European Parliament and of the Council11 . This Regulation lays down the cases where there is such substantial public interest in processing human biomonitoring data: namely, where the EEA processes that data to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure, to develop health risk and impact indicators, to monitor the impact of regulatory intervention, and to support regulatory risk assessments. _________________ 11 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
Amendment 163 #
2023/0453(COD)
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24 a) The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission should be able to process human biomonitoring data constituting personal data. Since human biomonitoring personal data constitutes a special category of personal data, namely, health data, the EEA, the Commission, the ECHA, the EFSA, the EU-OSHA and the EMA should process that data only where the processing is necessary for reasons of substantial public interest, as laid out in Article 10(2)(g) and for scientific research as laid out in Article 10(2)(j) of the Regulation (EU) No 2018/1725. The present Regulation lays down the cases where there is such substantial public interest in processing human biomonitoring data constituting personal data.
Amendment 166 #
2023/0453(COD)
Proposal for a regulation
Recital 24 b (new)
Recital 24 b (new)
(24 b) The EEA should be allowed to process human biomonitoring data to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure, to develop health risk and impact indicators, to monitor the impact of regulatory intervention, and to support regulatory risk assessments, risk management and policy making. The Commission should be allowed to process human biomonitoring data constituting personal data, notably for scientific research, to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure of populations to chemicals, to develop indicators on health risks associated to such exposure, as well as to measure the efficiency and effectiveness of regulatory measures in preventing exposure by analysing, for example, co-exposure to multiple chemicals for which data on co- occurrence of various chemicals per individual is necessary to observe common patterns and draw conclusions for populations, and supporting further risk assessments and risk management. The ECHA should also be allowed to act as a data processor for human biomonitoring data constituting personal data for the performance of assessments on chemicals, such as risk and safety assessments. Individual measurements of chemicals in human matrices may assist regulatory exposure and risk assessment, such as in the formulation of an opinion of the ECHA’s Risk Assessment Committee, and lead to recommendations of risk management measures. The EFSA and the EMA should also be allowed to act as a data processor for human biomonitoring data constituting personal data, notably to support the prioritisation of regulatory actions. The EU-OSHA should be allowed to process human biomonitoring data constituting personal data, notably for scientific research, to assess the impact of chemicals on human health and the environment, to monitor time and spatial trends in exposure of populations to chemicals, as well as to measure the efficiency and effectiveness of regulatory measures in preventing exposure. Such data is also useful for the EFSA when conducting assessments of chemicals in food and for understanding the effectiveness of existing measures in preventing human contamination through the food and feed chains. When processing human biomonitoring data constituting personal data, the EEA, the ECHA, the EFSA, the EMA , the EU- OSHA, and the Commission should pay particular attention to compliance with Article 13 of Regulation (EU) No 2018/1725.
Amendment 168 #
2023/0453(COD)
Proposal for a regulation
Recital 24 c (new)
Recital 24 c (new)
(24 c) Human biomonitoring data collected prior to the coming into force of this Regulation is necessary to ensure the completeness, quality, and relevance of the human biomonitoring datasets for the purposes of guaranteeing the substantial public interests, and scientific research purposes as listed in this Regulation. Therefore, any such data gathered prior to the coming into force of this Regulation should be able to be processed by the EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission when this Regulation comes into force.
Amendment 170 #
2023/0453(COD)
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26 a) There are data gaps on the occurrence of hazardous and other harmful chemicals in products on the EU market. In order to enhance visibility on the availability of data, and to promote research and development activities as regards safer alternatives, as well as the uptake of such alternatives, ECHA should establish and maintain a repository of information on chemicals in products and their available alternatives generated under Union acts listed in Annex I. In addition, ECHA should integrate into the common data platform all chemicals data related to chemicals present in products or used in production processes and which is accessible through the web portal under Article 14 of Regulation (EU) 2024/178.
Amendment 171 #
2023/0453(COD)
Proposal for a regulation
Recital 27
Recital 27
(27) In order to promote the use and harmonisation of reference values among risk assessors and risk managers across different Union acts and to facilitate compliance with, and enforcement of, regulatory reference values, the ECHA should establish and maintain a repository of reference values established or adopted under the Union acts listed in Annexes I and II The Agencies should provide the ECHA with reference values they hold or establish as part of their activities. In addition, the ECHA should regularly screen Union acts for reference values adopted under them. To facilitate automatic access of the general public to up-to-date reference values, the ECHA should integrate the repository of reference values in the common data platform as a dedicated service, include in that repository all reference values together with the relevant context data it has received or retrieved and ensure that those values and that context data are machine readable. For a reference value for the carcinogenic effect of a chemical for which no maximum exposure level can be specified below which no harmful effects on human health are to be expected, the statistical cancer risk associated with that reference value should also be specified, if available.
Amendment 187 #
2023/0453(COD)
Proposal for a regulation
Recital 31
Recital 31
(31) While the study notification obligation established in this Regulation should apply in the context of all the Union acts on chemicals listed in Annex I, the various relevant data collection and safety assessment processes under those acts may vary widely procedurally. The overarching aim of the database of study notifications established under this Regulation should be to bring together information on studies on chemicals being commissioned by business operators, such as to enable a centralised and complete overview of the studies being performed to support regulatory compliance under Union acts on chemicals as listed in Annex I. On the basis of this objective and considering the fact that assessment procedures under Union acts on chemicals in Annex I may vary widely, it would be beyond the scope and aim of this Regulation to amend existing assessment processes set under those Union acts listed in Annex I by imposing additional conditions leading to potential market access consequences not foreseen in those Union acts. Consequently, it is not appropriate to introduce in this Regulation the consequences associated with non- compliance with the study notification obligation as laid out in Article 32b of Regulation (EC) No 178/2002 of the European Parliament and of the Council.
Amendment 202 #
2023/0453(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) In order to ensure chemicals data are easily findable within the database and to avoid duplicates, each chemical contained in the common data platform shall be identified by a unique chemical identifier and a chemical notation specifying its molecular structure. In order to ensure the interoperability and comparability of chemicals data and to facilitate their automatic and electronic exchange, the Agencies and the Commission should store chemicals data in adequate and mutually coherent and interoperable formats and use mutually coherent and interoperable controlled vocabularies. Some Union acts listed in Annex I or II set procedures to establish or make available data formats, in particular for the submission of chemicals data by business operators or Member States. Where such procedures do not exist in the Union acts listed in Annex I or II, the Agencies and the Commission should, where relevant, specify appropriate formats for chemicals data they receive and store, avoiding the use of proprietary standards while, as appropriate, using OECD or other internationally agreed formats, making use of existing formats and ensuring interoperability with existing data submission approaches.
Amendment 206 #
2023/0453(COD)
Proposal for a regulation
Recital 41
Recital 41
(41) The International Uniform Chemical Information Database (‘IUCLID’) is a software application designed to record, store, maintain and exchange data on chemicals. The ECHA develops and maintains the IUCLID software and the underlying format in collaboration with the Organisation for Economic Cooperation and Development (‘OECD’). The IUCLID implements all OECD-harmonised templates, which are harmonised formats agreed at the OECD level to facilitate structured and consistent documentation of test outputs and similar chemicals data. Since chemicals data is being submitted to the ECHA in IUCLID under Union acts such as Regulations (EC) No 1907/2006, (EC) No 1107/200913 and (EU) No 528/201214 of the European Parliament and of the Council, the ECHA is closely involved in the continued development of IUCLID, and IUCLID implements the standard formats agreed at the OECD level, it is appropriate and necessary to require the Commission and the AgencAuthorities to use IUCLID for the relevant parts of dossiers under specified Union acts listed in Annex I when they make the data contained in those dossiers available to the ECHA . _________________ 13 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309 24.11.2009, p. 1). 14 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167 27.6.2012, p. 1).
Amendment 207 #
2023/0453(COD)
Proposal for a regulation
Recital 42
Recital 42
(42) To increase the availability and facilitate the use of information on the environmental performance of chemicals throughout their lifecycle, and to enable a comprehensive assessment of the impacts of chemicals on the environment and health, the Commission should identify relevant data and information related to the environmental sustainability and health impacts of chemicals, including, where available, information on their impact on climate change, for integration into the common data platform. Once the Commission has identified the relevant existing datasets of chemicals data on environmental sustainability and health related data and has designed the relevant related database functionalities, the ECHA should establish a database on environmental sustainability- and health- related data, collect the data as made available by the Commission, the Agencies and, where relevant, by the researchers and research consortia funded by Union framework programmes, and integrate the content of that database into the common data platform as a dedicated service. In order to ensure uniform conditions for the implementation of the obligation to identify relevant environmental sustainability and health datasets of chemicals datasets, implementing powers should be conferred on the Commission.
Amendment 210 #
2023/0453(COD)
Proposal for a regulation
Recital 43
Recital 43
(43) To monitor the impacts on humans and the environment, including the climate, of exposure to chemicals and to establish a knowledge base to measure the effectiveness of chemicals legislation in protecting human health and the environment, the EEA and the ECHAAgencies should jointly develop and regularly, at least every two years, update a set of indicators and present it in the form of a dashboard. The EFSA, the EMA, the EU- OSHAIn order to monitor the aggregated risk for territories associated to the impacts on humans and the environment, including the climate, of exposure to chemicals and pollutants, the Agencies should jointly develop and regularly, at least every two years, update an aggregated indicator at different territorial level, in collaboration with the Joint Research Centre and drawing inspiration from its European wide vulnerability framework1a. The EEA should cross-reference the results of this indicator with other health and environment datasets, such as epidemiological data on occupational health, life-style factors, and socio- economic factors, in order to assess the impacts and risks of cumulated risk factors on population at the territorial level. The Agencies and the Commission shall regularly provide the EEA with any available data falling within their mandate and relevant for the establishment of the indicators. The EEA and the ECHAAgencies should integrate this dashboard of indicators into the common data platform. _________________ 1a Eklund, L.G., Sibilia, A., Salvi, A., Antofie, T., Rodomonti, D., Salari, S., Poljansek, K., Marzi, S., Gyenes, Z. and Corban, C., Towards a European wide vulnerability framework, Publications Office of the European Union, Luxembourg, 2023, doi:10.2760/353889, JRC118850.
Amendment 212 #
2023/0453(COD)
Proposal for a regulation
Recital 43 a (new)
Recital 43 a (new)
(43 a) In order to ensure the widest possible access to chemicals data and to improve trust in the implementation of this Regulation and Union policies on chemicals, and further acknowledging existing experience with citizen science approaches, natural or legal person should be able to submit substantiated concerns regarding impacts of chemicals on humans and the environment, such as peer-reviewed research results, or biomonitoring data. The authorities should assess submitted evidence and take action when they identify a concern. In line with commitments of the Union in relation to the Aarhus Convention, individuals submitting evidence should be equipped with procedural rights to ensure their concerns are appropriately taken into account.
Amendment 213 #
2023/0453(COD)
Proposal for a regulation
Recital 44
Recital 44
(44) This Regulation should establish an early warning and action system as regards existing and emerging chemical risks. To enable the identification and evaluation of emerging chemical risks, the EEA should develop and compile information on early warning signals and draw up an annual summary report to inform regulatory follow-up actions by authorities. In its work, the EEA should include its own sources, targeted literature searches and make use of information from national early warning systems. It should also include relevant information made available by the related work of the ECHA, the EFSA, the EU-OSHA, the EMA and their networks, such as the EFSA’s task of identifying and collecting information on emerging risks under Regulation 178/2002. The EEA should make the summary report and the underlying data available through the common data platform, ensuring public access and its use for further action on existing and emerging risks of chemicals, groups of chemicals, and cumulative exposure to chemicals. In order to allow the EEA sufficient time to organise the collection of early warning signals and to compile and analyse the initial information the EEA should only deliver the first report six months after the end of the first calendar year after entry into force of this Regulation. this Regulation sets a deadline for the first report and associated data. For any risk and warning signal identified by the report, the Authorities should consider undertaking regulatory, policy or enforcement actions and provide justification when they decide not to proceed with any action. Emerging chemicals risks identified in the early warning and action system should also be taken into account when setting priorities for the strategic planning of Horizon Europe.
Amendment 216 #
2023/0453(COD)
Proposal for a regulation
Recital 46
Recital 46
(46) The ECHA should continue operating the EUON and transform it into an observatory for specific chemicals, or groups of chemicals with potential contribution to emerging chemical risks (‘the observatory’), which should cover also other chemicals and innovative (rationally designed complex ‘advanced’) materials selected by the Commission, using, as appropriate, signals from the early warning and action system. One of the criteria for selecting chemicals for the observatory should be their novelty and disruptive potential that may contribute to an emerging chemical risk. Another criterion for that selection should be the higher degree of uncertainty surrounding them and, due to less regulatory experience regarding those chemicals, the resulting need for additional scrutiny and transparency. The observatory should facilitate regulatory implementation and responsible use of these chemicals by collecting, generating, and disseminating reliable information on selected chemicals’ properties, uses and market presence to the general public.
Amendment 220 #
2023/0453(COD)
Proposal for a regulation
Recital 48
Recital 48
(48) Under Regulation (EC) No 178/2002, the EFSA is able to commission, in an open and transparent manner, the scientific studies it needs to accomplish its mission, while seeking to avoid duplication with Member States or Union research programmes. The ECHA should also be able to commission studies to obtain adequate data and information on chemicals, groups of chemicals, and the risk of their cumulative exposure thereof, within its mission, while maintaining the principle that the burden to prove compliance with Union chemicals legislation remains on the duty holder. Furthermore, the ECHA should commission such studies out of its own initiative or at the request of the Commission, with the objective of supporting the effective and efficient implementation and evaluation of Union acts on chemicals within its mandate and contributing the development of a Union chemicals policy.
Amendment 221 #
2023/0453(COD)
Proposal for a regulation
Recital 48 a (new)
Recital 48 a (new)
(48 a) In order to contribute to the overall objective of this Regulation to enable better, complete, coherent and robust scientific assessments of chemicals and their impacts and to ensure the best use of existing information for the purpose of the implementation and the development of Union legislation on chemicals, this Regulation should require the Commission to draw up a report analysing the adequacy between the resources of the agencies and their current tasks, their new tasks under this Regulation, and a prospective view of the ressources needed to address key areas of regulatory challenge in the future. The Commission should also draw up a report on the impacts of cumulative exposure to chemicals on health and the environment, and analysing the efficacy of the current risk assessment of chemicals across Union legislation to adequately address the combination effect of chemical mixtures and to ensure a high level of protection of health and the environment.
Amendment 225 #
2023/0453(COD)
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation aims to ensure the efficient delivery of coherent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, to achieve a high level of protection of human health and the environment, to enable the development and use of safe and sustainable chemicals, to ensure the proper functioning of the single market for chemicals, to enable scrutiny by interested parties of data generated and used for regulatory purposes, and to improve the Union’s citizens’ trust in the scientific base for the decisions taken under Union legal acts on chemicals.
Amendment 244 #
2023/0453(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 10
Article 2 – paragraph 1 – point 10
10. ‘chemicals data’ means any representation of facts or information relating to chemicals and any compilation of such facts or information, including information on physico-chemical properties, hazard properties, use, exposure, risk, occurrence, emissions, fate, and manufacturing process of the chemicals, as well as environmental sustainability related information, including climate change related information, on those chemicals, regulatory process-related information on chemicals, information on availability and suitability of alternatives, standard formats, controlled vocabularies, or any information on applicable legal obligations related to chemicals and the enforcement thereof;
Amendment 250 #
2023/0453(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point 11 a (new)
Article 2 – paragraph 1 – point 11 a (new)
11 a. 'research data' means any hazard, occurrence, exposure, and fate data derived from scientific studies published in peer-reviewed literature that are not carried out specifically to inform regulatory assessments;
Amendment 256 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point a
Article 3 – paragraph 2 – point a
(a) generated or submitted as part of the implementation of the Union acts listed in Annex I to this Regulation and held by the Agencies or, the Commission or Member States autorities ('the Authorities');
Amendment 259 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
(b) generated as part of Union, national or international programmes or research activities in the sphere of chemicals and held by the ECHA, the EEA, the EFSA, the EU-OSHA or the CommissionAuthorities;
Amendment 263 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 2 – point c a (new)
Article 3 – paragraph 2 – point c a (new)
(c a) generated under Regulation (EU) 2024/1781 and accessible through the web portal under Article 14 of that regulation.
Amendment 268 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
Amendment 270 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 4 a (new)
Article 3 – paragraph 4 a (new)
4 a. Each chemical or material hosted on the common data platform shall be identified by a unique chemical identifier and a chemical notation specifying its molecular structure.
Amendment 272 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 5 – point d a (new)
Article 3 – paragraph 5 – point d a (new)
(d a) information on chemicals in products and their alternatives referred to in Article 10a;
Amendment 274 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 5 – point g
Article 3 – paragraph 5 – point g
(g) the database on environmental sustainability and health-related data referred to in Article 13.
Amendment 278 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. The Authorities and the general public shall have access free of charge to the data contained in the common data platform in accordance with Article 16.
Amendment 281 #
2023/0453(COD)
Proposal for a regulation
Article 3 – paragraph 11
Article 3 – paragraph 11
11. The common data platform and its dedicated services shall be established by [OP: please insert date: threone years after the date of entry into force of this Regulation], unless specified otherwise. The relevant datasets of chemicals data, including those generated or submitted before the entry into force of this Regulation, unless specified otherwise shall be integrated progressively into the common data platform by [OP please insert date: tensix years from the date of entry into force of this Regulation] according to the implementation plan referred to in Article 4 (1), first sentence. Upon integration of those datasets in the common data platform, when the ECHA receives chemicals data in accordance with Article 5, it shall make that data available through the common data platform without undue delay.
Amendment 286 #
2023/0453(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish an implementation plan identifying datasets of chemicals data for inclusion in the common data platform together with a timeline for their inclusion by means of an implementing decisionacts. Subsequent rolling implementation plans shall be adopted in line with the governance scheme referred to in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 288 #
2023/0453(COD)
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. The Commission shall, by means of an implementing decisionacts, establish and manage a platform steering committee, which shall include one representative from the ECHA, one representative from the EEA, one representative from the EFSA, one representative from the EMA, one representative from the EU-OSHA and five representatives from the Commission. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 290 #
2023/0453(COD)
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. The Commission shall adopt and publish the governance scheme referred to in paragraph 3 and any revision thereof by means of an implementing decisionimplementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 297 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. At the Commission’s request, the Agencies shall host and maintain chemicals data generated as part of Union, national or international legislation, programmes or research activities, corresponding to their mandate and the type of data they already hold. The Agencies may host and maintain chemicals data corresponding to their mandate and submitted to them by Member States or other parties.
Amendment 307 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. Where the Commission or the AgencAuthorities hold data or information referred to in Article 3(2), they shall make that data available to the ECHA, in a standard format, where available, together with the relevant context data as referred to in Article 4(4), point (c). The Commission and the AgencAuthorities shall indicate whether that data or information is made available to the publicconfidential in accordance with the provisions on confidentiality under the originating Union act.
Amendment 310 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. Researchers or research consortia funded by Union framework programmes shall make available to the EEA any human biomonitoring data they collect or generate from [OP please insert: date of the entry into force of this Regulation]. For human biomonitoring data constituting personal data, the EEA shall specify which type of data shall be made available to it.
Amendment 313 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
5 a. Member States shall require researchers or research consortia funded by national programmes to make available to the EEA any human biomonitoring data they collect or generate from [OP please insert: date of the entry into force of this Regulation]. For human biomonitoring data constituting personal data, the EEA shall specify which type of data shall be made available to it.
Amendment 314 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 6
Article 5 – paragraph 6
6. Researchers or research consortia funded by Union framework programmes shall make available to the ECHA any chemicals data other than biomonitoring data, including environmental sustainability and health-related data on chemicals or materials they collect or generate from [OP please insert: date of the entry into force of this Regulation].
Amendment 316 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 6 a (new)
Article 5 – paragraph 6 a (new)
6 a. Member States shall require researchers or research consortia funded by national programmes, to make available to the ECHA any chemicals data relevant for regulatory purposes other than biomonitoring data, including environmental sustainability and health related data on chemicals or materials they collect or generate from [OP please insert: 6 months after the entry into force of this Regulation].
Amendment 318 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 7
Article 5 – paragraph 7
7. The Commission and the AgencAuthorities shall provide the necessary technical cooperation to the ECHA to enable the integration of the chemicals data provided in accordance with paragraph 2 in the common data platform as well as its publication through that platform.
Amendment 320 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 8
Article 5 – paragraph 8
8. For the purpose of paragraph 2, the Commission and the AgencAuthorities shall make chemicals data available to the ECHA without undue delay after collection or receipt of the data, after performance of validity and confidentiality assessments in accordance with applicable rules and once the corresponding dataset has been integrated in the common data platform.
Amendment 321 #
2023/0453(COD)
Proposal for a regulation
Article 5 – paragraph 9
Article 5 – paragraph 9
9. The Commission and the AgencAuthorities shall ensure that data made available to the ECHA shall be downloadable, machine readable and interoperable. They shall appropriately curate and validate the data before providing them to the ECHA.
Amendment 323 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 – introductory part
Article 6 – paragraph 4 – introductory part
4. HThe EEA may process human biomonitoring data constituting personal data may be processed by the EEA for the following purposes only:
Amendment 326 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 – point e a (new)
Article 6 – paragraph 4 – point e a (new)
(e a) supporting regulatory risk management;
Amendment 327 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 – point e b (new)
Article 6 – paragraph 4 – point e b (new)
(e b) supporting policy making and legislative processes at Union level;
Amendment 328 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 – point e c (new)
Article 6 – paragraph 4 – point e c (new)
(e c) facilitating the processing by the Commission, the ECHA, the EFSA, the EMA, and the EU-OSHA in accordance with paragraphs 4a, 4b, 4c, 4d and 4e of this article.
Amendment 329 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 a (new)
Article 6 – paragraph 4 a (new)
4 a. The Commission may process human biomonitoring data constituting personal data for the following purposes only: (a) scientific research aimed at policy making; (b) assessing the impact of chemicals on human health and the environment; (c) monitoring time and spatial trends in exposure; (d) developing health risk and impact indicators; (e) monitoring the impact of regulatory intervention; (f) assessing the need for further regulatory action and prioritising such actions; (g) supporting regulatory risk assessment and risk management.
Amendment 330 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 b (new)
Article 6 – paragraph 4 b (new)
4 b. The ECHA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory actions; (b) performing assessments of chemicals; (c) supporting regulatory risk management; (d) as part of the commissioning of studies under the data generation mechanism referred to in Article 21.
Amendment 331 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 c (new)
Article 6 – paragraph 4 c (new)
4 c. The EFSA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory action; (b) performing assessments of chemicals; (c) supporting regulatory risk management.
Amendment 332 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 d (new)
Article 6 – paragraph 4 d (new)
4 d. The EMA may process human biomonitoring data constituting personal data for the following purposes only: (a) evaluating and prioritising required regulatory action; (b) performing assessments of chemicals; (c) supporting regulatory risk management.
Amendment 333 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 e (new)
Article 6 – paragraph 4 e (new)
4 e. The EU-OSHA may process human biomonitoring data constituting personal data for the following purposes only: (a) scientific research aimed at policy making; (b) assessing the impact of chemicals on human health and the environment; (c) monitoring time and spatial trends in exposure; (d) monitoring the impact of regulatory intervention; (e) assessing the need for further regulatory action and prioritising such actions; (f) supporting regulatory risk management.
Amendment 334 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 4 f (new)
Article 6 – paragraph 4 f (new)
4 f. Any processing of human biomonitoring data constituting personal data by the EEA, the ECHA, the EFSA, the EMA, the EU-OSHA, or the Commission for the purposes referred to in paragraph 4, 4a, 4b, 4c, 4d, and 4e shall not entail the sharing of such data with third parties.
Amendment 335 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission shall act as data controller for the human biomonitoring data constituting personal data ithey holds or hosts and or processes for the purposes referred to in paragraph 24, 4a, 4b, 4c, 4d and 4e.
Amendment 336 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 6 a (new)
Article 6 – paragraph 6 a (new)
6 a. The EEA, the ECHA, the EFSA, the EMA, the EU-OSHA and the Commission shall define the storage period and any review thereof for the human biomonitoring data constituting personal data they hold as well as the criteria used to define the storage period.
Amendment 337 #
2023/0453(COD)
Proposal for a regulation
Article 6 – paragraph 6 b (new)
Article 6 – paragraph 6 b (new)
6 b. The human biomonitoring data referred to in this Article includes personal data lawfully collected before the entry into force of this Regulation.
Amendment 346 #
2023/0453(COD)
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4 a. The ECHA shall include in the repository of reference values without undue delay any reference value generated as part of Union, national or international programmes or research activities and made available to it in the standard formats provided for in Article 14, where developed.
Amendment 350 #
2023/0453(COD)
Proposal for a regulation
Article 9 – paragraph 3 a (new)
Article 9 – paragraph 3 a (new)
3 a. Authorities and national enforcement authorities shall have access to the data contained in the Database of Study Notifications before that data is integrated in the common data platform.
Amendment 355 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on regulatory processes on individual substancechemicals or groups of substancechemicals that are planned, ongoing or have been completed since the entry into force of this Regulation by the Member States or the Union institutions, agencies or committees referred to in the Union acts listed in Annex III.
Amendment 357 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2
Article 10 – paragraph 2
2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex III hold the information referred to in paragraph 1, they shall make that information available to the Union agency responsible under the respective Union act listed in Annex III without undue delay. For each regulatory process or activity, at least the following information shall be included:
Amendment 359 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point a (new)
Article 10 – paragraph 2 – point a (new)
(a) chemical identity;
Amendment 361 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point b (new)
Article 10 – paragraph 2 – point b (new)
(b) the Union act and the regulatory process under which the activity takes place;
Amendment 363 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point c (new)
Article 10 – paragraph 2 – point c (new)
(c) submitter or actor responsible for the regulatory process or activity;
Amendment 365 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point d (new)
Article 10 – paragraph 2 – point d (new)
(d) status of the regulatory process or activity;
Amendment 367 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point e (new)
Article 10 – paragraph 2 – point e (new)
(e) outcome of the regulatory process or activity, including, where applicable, reports or opinions adopted;
Amendment 369 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 2 – point f (new)
Article 10 – paragraph 2 – point f (new)
(f) where applicable, date of intention to start the regulatory process or activity, completion and latest update.
Amendment 370 #
2023/0453(COD)
Proposal for a regulation
Article 10 – paragraph 3 – point a
Article 10 – paragraph 3 – point a
(a) substancechemical identity;
Amendment 376 #
2023/0453(COD)
Proposal for a regulation
Article 10 a (new)
Article 10 a (new)
Article 10a Information on chemicals in products and their alternatives 1. The ECHA shall establish and manage, as part of the common data platform, a new database containing information on chemicals in products and their alternatives generated or submitted as part of the implementation of Union chemicals legislation listed in Annex I. This database shall integrate the information subject to paragraph 2 of Article 3, point (ca). 2. Where Member State competent authorities as referred to in any of the Union acts listed in Annex I hold the information referred to in paragraph 1, they shall make that information available to the Union agency responsible under the respective Union act listed in Annex I without undue delay. 3. Where the ECHA, the EEA, the EFSA, the EU-OSHA or the Commission hold the information referred to in paragraph 1, they shall make that information available to the ECHA for integration in the common data platform in the standard formats provided for in Article 14 without undue delay and, where relevant, once the responsible agency or the Commission has performed the validity assessment. For each chemical in a product, where available, at least the following information shall be included: (a) chemical identity; (b) product uses identified; (c) uses for which available alternatives have been identified; (d) alternatives identified for each use; (e) available information on the suitability of alternatives; (f) available information on substitution plans and efforts for each use; 4. The ECHA shall encourage providers of alternatives referred to in paragraph 3 points (c) and (d) to identify themselves.
Amendment 382 #
2023/0453(COD)
Proposal for a regulation
Article 13 – title
Article 13 – title
Database on environmental sustainability and health related data
Amendment 385 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. At the latest within threOne years after the publication of the decision referred to in paragraph 4, the ECHA shall establish and manage, as part of the common data platform, a database containing environmental sustainability and health related data.
Amendment 388 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Where the Commission or the AgencAuthorities host or hold environmental sustainability or health related data in addition to the chemicals data already available in the common data platform, they shall make that data available to the ECHA without undue delay once the Commission or the AgencAuthority hosting or holding that data has completed, where relevant, validity and confidentiality assessments. The Commission and the AgencAuthorities shall provide the necessary technical cooperation to the ECHA to enable the integration of environmental sustainability related and health data in the database on environmental sustainability and health related data.
Amendment 393 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 3 a (new)
Article 13 – paragraph 3 a (new)
3 a. The ECHA shall integrate the environmental sustainability or health related data on chemicals or materials, made available in accordance with Article 5(6a), in the database on environmental sustainability and health related data.
Amendment 396 #
2023/0453(COD)
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. By [OP please insert date: threone years after the date of entry into force of this Regulation], the Commission shall adopt an implementing decision identifying existing datasets on environmental sustainability related data, other than those referred to in paragraph 2, for inclusion in the common data platform and shall design relevant related database functionalities.
Amendment 398 #
2023/0453(COD)
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. The Commission and the AgencAuthorities shall exchange data contained in the common data platform in the relevant standard format.
Amendment 400 #
2023/0453(COD)
Proposal for a regulation
Article 14 – paragraph 5 – introductory part
Article 14 – paragraph 5 – introductory part
5. The Commission and the AgencAuthorities shall use the International Uniform Chemical Information Database format (IUCLID) for making available to the ECHA for integration in the common data platform the relevant parts of dossiers under the following Union acts:
Amendment 402 #
2023/0453(COD)
Proposal for a regulation
Article 14 – paragraph 5 – point i a (new)
Article 14 – paragraph 5 – point i a (new)
(i a) Regulation (EC) No 1107/2009 of the European Parliament and of the Council1a. _________________ 1a Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
Amendment 403 #
2023/0453(COD)
Proposal for a regulation
Article 14 – paragraph 5 – point i b (new)
Article 14 – paragraph 5 – point i b (new)
(i b) Regulation (EC) No 396/2005 of the European Parliament and of the Council1b; _________________ 1b Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC
Amendment 413 #
2023/0453(COD)
Proposal for a regulation
Article 15 a (new)
Article 15 a (new)
Article 15a Uptake of research data 1. Researchers shall be able to submit publicly available research data on chemicals related to an entry in the common data platform. Research data shall be submitted in a format prescribed by the ECHA. 2. By [OP: insert 18 months after the entry into force of this Regulation], the ECHA shall establish and maintain an online platform for the submission process referred to in paragraph 1. 3. The ECHA shall assess the compliance of research data submitted through the portal referred to in paragraph 2 with the requirements set in the guidance referred to in paragraph 4. Where research data submitted are deemed to fulfil these requirements, the data shall be hosted on the common data platform together with the corresponding entry. 4. By [OP: insert 12 months after the entry into force of this Regulation], the Commission shall publish a guidance setting minimum quality and reporting requirements to improve the uptake of research data. 5. In order to ensure a uniform format of the research data submitted, the Commission shall, by means of implementing acts, adopt a standard format for the submission of research data. Those implementing acts shall be adopted by [OP: please insert the date = 12 months after the entry into force of this Regulation], in accordance with the examination procedure referred to in Article 24a(2).
Amendment 424 #
2023/0453(COD)
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
3. The general public shall have access to all the chemicals data contained in the common data platform and considered as available to the publ, except data which in accordance with the Union act under which the data was generated or submitteds deemed to be confidential under Article 5(2), second sentence.
Amendment 427 #
2023/0453(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The Authorities may use the chemicals data contained in the common data platform in the performance of any of their activities, where those activities support the development or, implementation, or enforcement of chemicals legislation and policy.
Amendment 429 #
2023/0453(COD)
Proposal for a regulation
Article 17 – paragraph 2
Article 17 – paragraph 2
2. Without prejudice to existing provisions enabling the sharing and use of chemicals data under the Union acts listed in Annexes I and II, and to the possibility of identifying data gaps in the applications received from business operators, Authorities shall not use chemicals data contained in the common data platform to fulfil any legal obligations of duty holders.
Amendment 434 #
2023/0453(COD)
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. The EEA, in collaboration with the ECHA, the EFSA, the EMA, the EU- OSHA and the Commission, shall establish, operate, and maintain, and update as appropriate a framework of indicators to monitor chemical pollution along the chemical’s lifecycle, including emissions, occurrence, and fate, to monitor the drivers and impacts of exposure to chemicals, and to measure the effectiveness of chemicals legislation and measure the transition towards the production of safe and sustainable chemicals.
Amendment 437 #
2023/0453(COD)
Proposal for a regulation
Article 18 – paragraph 1 a (new)
Article 18 – paragraph 1 a (new)
1 a. The EEA, on the basis of the framework of indicators referred to in paragraph 1, as well as data from the database on environmental sustainability and health related data referred to in Article 13, the Union early warning system for emerging chemical risks referred to in Article 19, and human biomonitoring data shall establish, operate, maintain, and update as appropriate an aggregated territory-based risk indicator at different administrative levels (Country, NUTS2 and NUTS3) based on the Nomenclature of territorial units for statistics (NUTS) as defined in Regulation (EC) No 1059/200, to monitor time and spatial trends in exposure of populations to individual and multiple chemicals and health risks associated to such exposure and co-exposure. Where possible, the EEA shall cross- reference the results of the aggregated risk indicator with other health and environment datasets, including epidemiological data, to identify potential emerging risks for the purpose of Article 19.
Amendment 438 #
2023/0453(COD)
Proposal for a regulation
Article 18 – paragraph 2
Article 18 – paragraph 2
2. The framework of indicators referred to in paragraph 1, and the aggregated indicator referred to in paragraph 1a, shall be accessible in the form of an indicator dashboard, which the EEA shall establish and which the ECHA shall make available through the common data platform.
Amendment 440 #
2023/0453(COD)
Proposal for a regulation
Article 18 a (new)
Article 18 a (new)
Article 18a Substantiated concerns 1. Any natural or legal person, individually or in association, shall be entitled to submit to an Agency a substantiated concern regarding impacts of chemicals on humans and the environment, relating in particular to the properties, use, exposure, risk, occurrence and emissions of chemicals or groups of chemicals, and which is based on objective and verifiable information such as peer-reviewed studies, human biomonitoring data, or environmental monitoring data. 2. Where the concern does not correspond to the mandate of the Agency to which it is submitted, this Agency shall make it available to the authority or authorities with a corresponding mandate. 3. The authority or authorities with a mandate corresponding to the submitted concern shall diligently and impartially assess it and, where appropriate, take one or more of the following actions: (a) regulatory measures under Union legislation, including by imposing obligations on duty holders, such as to corroborate the evidence or mitigate any detrimental effects; (b) initiate or develop new policies addressing the concern submitted; (c) transfer the concern indicating a non- compliance to enforcement agencies. 4. The authority or authorities shall, within 6 months, inform the natural or legal persons referred to in paragraph 1 of any decision taken under paragraph 3, providing the reasons for such decision. 5. The ECHA shall publish an annual report compiling all substantiated concerns submitted under paragraph 1 and the information subject to paragraph 3. The report shall be integrated in the common data platform without undue delay.
Amendment 443 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1 – point c
Article 19 – paragraph 2 – subparagraph 1 – point c
(c) data that the EEA holds, including data from the framework of indicators, and the aggregated indicator as referred to in Article 18;
Amendment 445 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 1 – point e a (new)
Article 19 – paragraph 2 – subparagraph 1 – point e a (new)
(e a) substantiated concerns submitted in accordance with Article 18a and made available by an Agency.
Amendment 449 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. The ECHA, the EFSA, the EU- OSHA and the EMA shall identify and gather relevant available data on early warning signals obtained in accordance with this Regulation or from the field falling within their mandate and provide this data to the EEA to host it.
Amendment 450 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 4
Article 19 – paragraph 4
4. The EEA shall draw up an annual report, compiling and analysing the data on early warning signals gathered in accordance with paragraphs 2 and 3. [The first report shall be prepared by [OP: please insert date: 6 months after the end of the first calendar year after entry into force of this Regulation]. The EEA shall present this report to the Commission, relevant Union agencies and Member State competent authorities for consideration of the need for regulatory or policy action related to the early warning signals. Within six months of the presentation of the report, the Authorities shall consider undertaking regulatory, policy or enforcement actions accordingly or and justify if they decide not to proceed with any action related to any of the early warning signals identified by the report.
Amendment 454 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. The EEA shall make all relevant data on early warning signals that it holds or hosts as well as the report referred to in paragraph 4 available to the ECHA for integration in the common data platform.
Amendment 457 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 5 a (new)
Article 19 – paragraph 5 a (new)
5 a. Where the data analysis indicates there is a risk that warrants urgent action, the EEA shall inform the authorities without undue delay.
Amendment 458 #
2023/0453(COD)
Proposal for a regulation
Article 19 – paragraph 5 b (new)
Article 19 – paragraph 5 b (new)
5 b. The Commission shall take into account the emerging chemicals risks identified in accordance with this Article in the strategic planning of R&I activities of Regulation (EU) 2021/6951a, where relevant. _________________ 1a Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013
Amendment 459 #
2023/0453(COD)
Proposal for a regulation
Article 20 – paragraph 1
Article 20 – paragraph 1
1. The ECHA shall establish, operate and maintain an observatory for specific chemicals or group of chemicals that the Commission considers as requiring additional scrutiny. The observatory shall include reliable information on the chemicals’ properties, safety aspects, uses and market presence.
Amendment 461 #
2023/0453(COD)
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. By [OP please insert date: 6 months after the date of entry into force of this Regulation] the Commission shall adopt and publish a list of the selected chemicals by means of an implementing decisionacts. The Commission shall review the list of selected chemicals regularly adopt any revision thereof by the same means. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2).
Amendment 464 #
2023/0453(COD)
Proposal for a regulation
Article 20 – paragraph 4 – point c
Article 20 – paragraph 4 – point c
(c) make compiled data publicly available through the common data platform or other communication and outreach tools as appropriate, to facilitate the identification of potential further research needs or risk management measures, to facilitate informed societal discussion and increase public awareness on the properties, use and safety aspects of specific chemicals, and regularly update that information.
Amendment 467 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Using the best independent resources available, the ECHA may commission scientific studies to support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy.:
Amendment 468 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 1 – point a (new)
Article 21 – paragraph 1 – point a (new)
(a) support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy;
Amendment 469 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 1 – point b (new)
Article 21 – paragraph 1 – point b (new)
(b) investigate further emerging chemical risks identified in the report referred to in Article 19(4) of this Regulation;
Amendment 470 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 1 – point c (new)
Article 21 – paragraph 1 – point c (new)
(c) conduct Union-wide data sampling survey of human biomonitoring in collaboration with Member states.
Amendment 475 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. The ECHA shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. It shall not commission studies with a predominant research objective.
Amendment 485 #
2023/0453(COD)
Proposal for a regulation
Article 21 – paragraph 6 a (new)
Article 21 – paragraph 6 a (new)
6 a. Without prejudice to the obligation on applicants to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances of serious controversies or conflicting results, may request the ECHA to commission scientific studies with the objective of verifying evidence used in its hazard and risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification.
Amendment 491 #
2023/0453(COD)
Proposal for a regulation
Article 21 a (new)
Article 21 a (new)
Article 21a Centralised data generation mechanism 1. The Commission, the Agencies, and Member states competent authorities may submit request for studies to the Commission in accordance with the governance scheme referred to in Article 21b(4). A request for studies shall include, at the minimum, the following: (a) a rational for the request, summarizing the current knowledge and latest relevant findings; (b) a proposal for testing, including technical feasibility, the involvement of national or EU reference laboratories where necessary, and possibilities for appropriate sample acquisition; (c) a preliminary cost estimate; (d) an estimated timeline. 2. Using the best independent resources available, the Commission may commission scientific studies on the basis of request submitted in accordance with paragraph 1 to: (a) support the implementation of Union acts on chemicals listed in Annex I within its mandate and to contribute to the support, evaluation or development of a Union chemicals policy; (b) investigate further emerging chemical risks identified in the report referred to in Article 19(4) of this Regulation; (c) conduct Union-wide data sampling survey of human biomonitoring in collaboration with Member states. 2. The Commission may mandate the Agencies to commission the scientific studies referred to in paragraph 1, in accordance with the governance scheme referred to in Article 21b(4). 3. The Commission shall only commission scientific studies when results cannot be obtained through existing legal provisions or processes under Union legislation listed in Annex I. 4. The Commission shall seek to avoid duplication with Member State or Union research or implementation programmes. 5. The Commission shall commission these scientific studies in an open and transparent manner. 6. The Agencies shall closely cooperate with each other on the submission of requests for and planning of scientific studies undertaken in accordance with paragraph 1. 7. Without prejudice to the obligation on applicants to demonstrate the safety of a subject matter submitted to a system of authorisation, the Commission, in exceptional circumstances of serious controversies or conflicting results, may request the Agencies to commission scientific studies with the objective of verifying evidence used in its hazard and risk assessment process. The studies commissioned may have a wider scope than the evidence subject to verification. 8. The Commission shall make the results of the scientific studies performed under this Article available through the common data platform.
Amendment 493 #
2023/0453(COD)
Proposal for a regulation
Article 21 b (new)
Article 21 b (new)
Article21b Governance of the centralised data generation mechanism 1. The Commission shall establish and manage a centralised data generation mechanism. 2. The Commission shall prepare and adopt a governance scheme for the data generation mechanism, in collaboration with the Agencies. 3. The Commission shall publish the governance scheme referred to in paragraph 2 and any revision thereof by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 24a(2). 4. That governance scheme shall describe: (a) the organisation of the main work structures supporting the development and implementation of the data generation mechanism; (b) the centralised system for the submission of testing proposals, the eligibility check, and the assessment and submissions; (c) the decision-making process for approval and prioritisation of the requests; (d) the procedural steps and assignment of responsibilities at the execution stage of data generation. 5. The Commission may establish an expert working group for the purpose of point (c) of paragraph 4. The expert working group shall be composed of representatives from the Commission, Union agencies, and Member States.
Amendment 511 #
2023/0453(COD)
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
2. For the purposes of paragraph 1, business operators shall notify to the Database of Study Notifications referred to in Article 9 the identity of the chemical(s) concerned, title, scope, laboratory, or testing facility carrying out the study, the intended starting and planned completion dates and, where relevant, whether the study is commissioned to comply with a decision of the ECHA pursuant to Articles 40, 41 or 46 of Regulation (EC) No 1907/2006.
Amendment 516 #
2023/0453(COD)
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
3. Laboratories and testing facilities shall also, without undue delay, notify any study commissioned by business operators to support an application, notification, or regulatory dossier on which an Agency is required to provide a scientific output, including a scientific opinion, under the Union acts listed in Annex I. However, laboratories and testing facilities shall not notify to the Database of Study Notifications referred to in Article 9 studies that are to be notified under Article 32b of Regulation (EC) No 178/2002.
Amendment 517 #
2023/0453(COD)
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
4. For the purposes of paragraph 3, laboratories and testing facilities shall notify to the Database of Study Notifications referred to in Article 9 the identity of the chemical(s) concerned, title, scope, intended starting and planned completion dates of any test they carry out, as well as the name of the business operator who commissioned the test.
Amendment 518 #
2023/0453(COD)
Proposal for a regulation
Article 22 – paragraph 5 a (new)
Article 22 – paragraph 5 a (new)
5 a. By ... [OP please insert date: 5 years after the date of entry into force of this Regulation], business operators shall notify to the Database of Study Notifications referred to in Article 9 any studies commissioned to support an application, notification or regulatory dossier notified or submitted to an Authority, as well as any studies on chemicals on their own or in products they commission as part of a risk or safety assessment, for chemicals placed on the market before the entry into force of this Regulation, under the Union acts listed in Annex I. Subparagraph 1 shall only apply to chemicals placed on the market before the entry into force of this Regulation, under the Union acts listed in Annex I, and which are still authorised on the Union market by ... [OP please insert date: 5 years after the date of entry into force of this Regulation]. Studies notified in accordance with this paragraph shall only be included in the database for information and scientific purposes, and shall not, under any circumstances, have retroactive legal application.
Amendment 519 #
2023/0453(COD)
Proposal for a regulation
Article 22 – paragraph 6
Article 22 – paragraph 6
6. The obligations set under this article shall apply from [OP please insert date: 124 months after the date of entry into force of this Regulation].
Amendment 528 #
2023/0453(COD)
Proposal for a regulation
Chapter VII a (new)
Chapter VII a (new)
VII a Chapter VIIa ACCESS TO JUSTICE Article 22a Access to Justice 1. Any natural or legal person which has submitted substantiated concerns in accordance with Article 18a shall have access to an administrative or judicial procedure to review the procedural and substantive legality of the decisions, acts or omissions of the relevant authority under paragraph 3 of Article 18a. 2. Member States shall ensure access to administrative or judicial procedures to review their decisions, acts and omissions, in accordance with national law or practice. Decisions and omissions by the Commission shall be subject to review in accordance with Regulation EU (No) 1367/2006. 3. The procedures referred to in paragraph 2 shall be fair, equitable, timely and not prohibitively expensive while providing adequate and effective remedies, including injunctive relief where necessary. Member States shall ensure that practical information is made available to the public on access to administrative and judicial review procedures.
Amendment 529 #
Amendment 531 #
2023/0453(COD)
Proposal for a regulation
Article 24 a (new)
Article 24 a (new)
Article24a Committee procedure 1. The Commission shall be assisted by the Committee established by Article 133 of Regulation (EC) No 1907/2006. That committee shall be a committee within the meaning of Regulation (EU) No 182/20111a. 2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply. _________________ 1a Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 533 #
2023/0453(COD)
Proposal for a regulation
Article 26 a (new)
Article 26 a (new)
Article26a Reports 1. By [OP: please insert date: 2 years after the end of the first calendar year after entry into force of this Regulation], the Commission shall draw up a report, analysing the adequacy between the resources of the agencies and their current tasks, their new tasks under this Regulation, and a prospective view of the resources needed to address key areas of regulatory challenge. The Commission shall present this report to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. 2. By [OP: please insert date: 2 years after the end of the first calendar year after entry into force of this Regulation], the Commission shall draw up a report, compiling and analysing data on the impacts of cumulative exposure to chemicals on health and the environment, and analysing the efficacy of the current risk assessment of chemicals to adequately address the combination effect of chemical mixtures to ensure a high level of protection of health and the environment. The Commission shall present this report to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.
Amendment 535 #
2023/0453(COD)
Proposal for a regulation
Article 26 b (new)
Article 26 b (new)
Article 26b Review 1. No later than ... [OP: please insert the date = 5 years after the date of application of this Regulation], the Commission shall carry out a review of this Regulation. This review shall assess in particular (a) the efficacy of the early warning and action mechanism (b) whether it is appropriate to include additional data into the common data platform. 2. No later than ... [OP: please insert the date = 2 years after the date of application of this Regulation], the Commission shall assess the feasibility, in collaboration with scientific and academic publishers, of harmonised reporting and of enabling the integration of relevant contents from scientific journals and publications into the common data platform, in order to increase further the uptake of research data into the hazard and risk assessment of chemicals. 3. The Commission shall present a report on the main findings of the evaluation under paragraph 1, to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. The report shall assess whether this Regulation has contributed sufficiently to achieve its objectives, in particular to allow a better reuse of data across the Union acts referred to in Annex I. 4. Based on the findings of the assessment referred to in paragraph 2 and the report referred to in paragraph 3, the Commission may, as appropriate, submit legislative proposals to the European Parliament and to the Council in this regard.
Amendment 104 #
2023/0228(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 47 a (new)
Article 3 – paragraph 1 – point 47 a (new)
(47 a) ‘One Health Approach’ means an integrated, unifying approach that aims to sustainably balance and optimise the health of people, animals, plants and ecosystems. It recognises that the health of humans, domestic and wild animals, plants, and the wider environment including ecosystems are closely interlinked and inter-dependent.
Amendment 106 #
2023/0228(COD)
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 6
Article 4 – paragraph 2 – subparagraph 6
The basic material for all categories shall be assessed for its sustainability characteristics in line with the One Health approach as set out in Annexes II to V, to take into account the climatic and ecological conditions.
Amendment 92 #
2023/0227(COD)
Proposal for a regulation
Recital 49
Recital 49
(49) In order to contribute to the sustainability of agricultural production and food systems while recognising that sustainability cannot be reduced to a single trait or variety but can only apply to a cultivated system as a whole, and in order to serve economic, environmental and broader societal needs, new varieties of all genera or species should show an improvement compared to the other varieties of the same genera or species registered in the same national variety register, concerning certain aspects. Among those aspects are their yield, including yield stability and yield under low input conditions; tolerance/resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses, insects and other pests; tolerance/resistance to abiotic stresses, including adaptation to climate change conditions; more efficient use of natural resources, such as water and nutrients; reduced need for external inputs, such as plant protection products and fertilisers; characteristics that enhance the sustainability of storage, processing and distribution; and quality or nutritional characteristics (‘value for sustainable cultivation and use’). For the purpose of deciding on the variety registration and in order to provide sufficient flexibility to register varieties with the most desirable characteristics, those aspects should be considered for a given variety as a whole.
Amendment 95 #
2023/0227(COD)
Proposal for a regulation
Recital 64
Recital 64
Amendment 101 #
2023/0227(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point e
Article 2 – paragraph 2 – point e
(e) to contribute to sustainable agricultural production, adapted to a diversity of climatic and soil conditions, currently and in the perspective of future projected climatic conditions;
Amendment 106 #
2023/0227(COD)
Proposal for a regulation
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
(f) to contribute to food security and food sovereignty
Amendment 116 #
2023/0227(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 2 – point c
Article 3 – paragraph 1 – point 2 – point c
(c) maintenance or multiplication of varieties;
Amendment 137 #
2023/0227(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 35 a (new)
Article 3 – paragraph 1 – point 35 a (new)
(35a) ‘conservation and sustainable use of plant genetic resources and agro- biodiversity’ means the preservation of the genetic diversity within and between cultivated plant species, and includes both the in situ dynamic conservation, whether on farm or in garden, the ex situ conservation outside of their natural habitat, and the sustainable use of plant genetic resources and agro-biodiversity in a way and at a rate that does not lead to the long-term decline of biological diversity, thereby maintaining its potential to meet the needs and aspirations of present and future generations.
Amendment 139 #
2023/0227(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 35 b (new)
Article 3 – paragraph 1 – point 35 b (new)
(35b) 'One Health Approach’ means an integrated, unifying approach that aims to sustainably balance and optimise the health of people, animals, plants and ecosystems. It recognises that the health of humans, domestic and wild animals, plants, and the wider environment including ecosystems are closely interlinked and inter-dependent ;
Amendment 152 #
2023/0227(COD)
Proposal for a regulation
Article 8 – paragraph 4 – introductory part
Article 8 – paragraph 4 – introductory part
4. The Commission is empowered to adopt delegated acts, in accordance with Article 75, in order to amend Annex III, to adapt the requirements referred to in paragraphs 1 and 2 to the scientific and technical developments and to the applicable international standards in line with the One Health approach. Those amendments shall concern the following:
Amendment 181 #
2023/0227(COD)
Proposal for a regulation
Article 22 – paragraph 1 – subparagraph 1 – point c a (new)
Article 22 – paragraph 1 – subparagraph 1 – point c a (new)
(ca) it is not covered by an intellectual property right limiting its use for conservation purposes
Amendment 182 #
2023/0227(COD)
Proposal for a regulation
Article 22 – paragraph 1 – subparagraph 1 – point c b (new)
Article 22 – paragraph 1 – subparagraph 1 – point c b (new)
(cb) it does not consist of a GMO or a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) or of a category 1 or 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation ...).
Amendment 183 #
2023/0227(COD)
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. By way of derogation from Article 20, PRM of all genera or species listed in Annex I belonging to a conservation variety registered in a national variety register referred to in Article 44(1), point (b), may be produced and marketed in the Union as standard seed or material, if it complies with all the requirements concerning standard seed and material for the respective species, as referred to in Article 8.
Amendment 184 #
2023/0227(COD)
Proposal for a regulation
Article 26 – paragraph 2 a (new)
Article 26 – paragraph 2 a (new)
2a. A variety of conservation, its parts and/or its genetic components may not be covered by an intellectual property right limiting its use for conservation, research, breeding and/or training, including on- farm participatory research and breeding.
Amendment 185 #
2023/0227(COD)
Proposal for a regulation
Article 26 – paragraph 2 b (new)
Article 26 – paragraph 2 b (new)
2b. A variety of conservation does not consist of a GMO or a category 1 NGT plant as defined in Article 3(7) of Regulation (EU) or of a category 1 or 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… .
Amendment 186 #
2023/0227(COD)
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 2
Article 27 – paragraph 3 – subparagraph 2
Those amendments shall be adopteddeveloped in consultation with respective multi actor stakeholders involved in heterogeneous material in order to adapt to the development of the respective technical and scientific evidence, and the international standards, and to follow up on the experience gained by the application of this Article concerning all or certain genera or species only.
Amendment 187 #
2023/0227(COD)
Proposal for a regulation
Article 27 – paragraph 4
Article 27 – paragraph 4
4. Any professional operator producing and/or intending to market PRM of heterogeneous material shall submit a notification to the competent authority prior to marketing. If no further information is requested by the national competent authority within a time determined by the competent authority3 months, the PRM of heterogeneous material may be marketed.
Amendment 205 #
2023/0227(COD)
Proposal for a regulation
Article 38 – paragraph 1 – subparagraph 1
Article 38 – paragraph 1 – subparagraph 1
Amendment 206 #
2023/0227(COD)
Proposal for a regulation
Article 38 – paragraph 1 – subparagraph 2
Article 38 – paragraph 1 – subparagraph 2
Those experiments may take the form of technical or scientific trials examining the feasibility and appropriateness of new requirements compared to the ones set out in Articles 2, 5, 6, 7, 8 and 20 of this Regulation. Multi actor stakeholders shall be involved in the framing of these temporary experiments financed by the Commission.
Amendment 207 #
2023/0227(COD)
Proposal for a regulation
Article 38 – paragraph 2 – subparagraph 1 – introductory part
Article 38 – paragraph 2 – subparagraph 1 – introductory part
The implementing acexperiments referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 76(2) and shall specify one or more of the following elements:
Amendment 208 #
2023/0227(COD)
Proposal for a regulation
Article 38 – paragraph 2 – subparagraph 2
Article 38 – paragraph 2 – subparagraph 2
Those acexperiments shall adapt to the evolution of techniques for production of the PRM concerned, as shall be based on any comparative trials carried out by the Member States.
Amendment 212 #
2023/0227(COD)
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
2. PRM belonging to a variety registered in at least one national variety register may be produced and marketed in the Union, in accordance with this Regulation unless it consists on a plant covered by an opt-out possibility given to Member States as defined in the GMO Directive 2001/18/EC of the European Parliament and of the Council and in the NGT plant Regulation (EU) .../... of the European Parliament and of the Council.
Amendment 213 #
2023/0227(COD)
Proposal for a regulation
Article 46 – paragraph 2
Article 46 – paragraph 2
2. The Commission is empowered to adopt a delegated act in accordance with Article 75, in order to amend Annex VII only to further add elements that need to be included in the variety registers, taking into account the technical and scientific developments, and on the basis of gained experience indicating the need of competent authorities or professional operators to obtain more precise information about the registered varieties.
Amendment 219 #
2023/0227(COD)
Proposal for a regulation
Article 47 – paragraph 1 – subparagraph 1 – point f
Article 47 – paragraph 1 – subparagraph 1 – point f
(f) where the varieties are tolerant to herbicides, they are subject to cultivation conditions for the production of PRM and for any other purpose, adopted pursuant to paragraph 3 or, in the case they have not been adopted, as adopted by the competent authorities responsible for registration, to avoid the development of herbicide resistance in weeds due to their use. These conditions will be subject to a public consultation process by the competent authority before they are adopted;
Amendment 220 #
2023/0227(COD)
Proposal for a regulation
Article 47 – paragraph 1 – subparagraph 1 – point g
Article 47 – paragraph 1 – subparagraph 1 – point g
(g) where the varieties have particular characteristics other than the ones referred to in point (f) that may lead to undesirable agronomic effects, they are subject to cultivation conditions for the production of PRM and any other purpose, adopted pursuant to paragraph 3 or, in the case they have not been adopted, as adopted by the competent authorities responsible for their registration, to avoid those particular undesirable agronomic effects, such as the development of resistance of pests to the respective varieties or undesirable effects on pollinators. These conditions will be subject to a public consultation process by the competent authority before they are adopted;
Amendment 240 #
2023/0227(COD)
Proposal for a regulation
Article 53 – paragraph 1 – point b
Article 53 – paragraph 1 – point b
(b) it has an indication of its initial region of origin or the local conditions to which has been bred for ;
Amendment 245 #
2023/0227(COD)
Proposal for a regulation
Article 56 – paragraph 1 – point l a (new)
Article 56 – paragraph 1 – point l a (new)
(la) the existence of intellectual property rights other than granted plant variety right on the variety as a whole or its components;
Amendment 247 #
2023/0227(COD)
Proposal for a regulation
Article 56 – paragraph 1 – point m
Article 56 – paragraph 1 – point m
(m) in case the variety contains or consists of a category 1 NGT as defined in Article 3(7) of Regulation (EU) …/… of the European Parliament and of the Council50 (Office of Publications, please insert referrence to NGT Regulation), evidence that the plant has obtained a declaration of category 1 NGT plant status pursuant to Article 6 or 7 of that Regulation or is progeny of such plant(s); as well as information allowing their detection ; _________________ 50 Regulation (EU) …./…. of the European Parliament and of the Council of … (….., p….).
Amendment 249 #
2023/0227(COD)
Proposal for a regulation
Article 56 – paragraph 1 – point n
Article 56 – paragraph 1 – point n
(n) in case the variety contains or consists of a category 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… (Office of Publications, please insert reference to NGT Regulation), indication of that fact as well as information allowing their detection ;
Amendment 252 #
2023/0227(COD)
Proposal for a regulation
Article 61 – paragraph 1 a (new)
Article 61 – paragraph 1 a (new)
1a. Paragraph 1 does not apply in the cases where the variety: (a) contains or consists of a genetically modified organism, in accordance with Directive 2001/18/EC or Regulation (EC) No 1829/2003; (b) contains or consists of a category 1 NGT as defined in Article 3(7) of Regulation (EU) …/… of the European Parliament and of the Council ; (c) contains or consists of a category 2 NGT plant as defined in Article 3(8) of Regulation (EU) …/… ; (d) is tolerant to herbicides pursuant to Article 47(1)(f) or has particular characteristics that may lead to undesirable agronomic effects pursuant to Article(1)(g).
Amendment 253 #
2023/0227(COD)
Proposal for a regulation
Article 66 – paragraph 1
Article 66 – paragraph 1
After the formal examination of the application provided for in Article 57, and prior to the registration of a variety in a national variety register pursuant to Article 67, the competent authority shall consult the CPVO onrelevant stakeholders at national level, as well as the Committee mentioned in Article 76(1) on the suitability of the variety denomination proposed by the applicant in light of the requirements of Article 54.
Amendment 254 #
2023/0227(COD)
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – paragraph 2
Thet CPVO competent authority may also consult the CPVO, which shall submit to the competent authority a recommendation on the suitability of the variety denomination proposed by the applicant, in accordance with Article 54. The competent authority shall inform the applicant on that recommendation.
Amendment 261 #
2023/0227(COD)
Proposal for a regulation
Annex VI – Part B – point 2 – point c a (new)
Annex VI – Part B – point 2 – point c a (new)
(ca) Heterogeneous material must not be derived from genetic engineering nor from parental material derived from genetic engineering. This excludes GMO as defined in Directive 2001/18/EC art. 2 (2) detailed in Annex 1A part I and NGT I and NGT II as defined in the regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques
Amendment 262 #
2023/0227(COD)
Proposal for a regulation
Annex VI – Part B – point 2 – point c b (new)
Annex VI – Part B – point 2 – point c b (new)
(cb) Heterogeneous material must not be derived from parental material covered by patents nor be protected by patents.
Amendment 266 #
2023/0227(COD)
Proposal for a regulation
Annex VII – paragraph 1 – point t a (new)
Annex VII – paragraph 1 – point t a (new)
(ta) disclose which breeding techniques have been applied for the development of the plant (e.g., cell fusion, genetic engineering, chemical or irradiation mutation breeding, microspore culture, etc.)
Amendment 268 #
2023/0227(COD)
Proposal for a regulation
Annex VII – paragraph 1 – point t b (new)
Annex VII – paragraph 1 – point t b (new)
(tb) disclose if the respective variety is covered by existing patents
Amendment 42 #
2023/0226(COD)
Proposal for a regulation
Recital 1
Recital 1
(1) Since 2001, when Directive 2001/18/EC of the European Parliament and of the Council (32), on the deliberate release of genetically modified organisms (GMOs) into the environment was adopted, significant progress in biotechnology has led to the development of new genomic techniques (NGTs), most prominently genome editing techniques that enable changes to be made to the genome at precise locations. Major advances in genetic engineering have already contributed to the widespread use of marker-assisted selection, which makes it possible to identify and mobilise interesting genes that are present in biodiversity. _________________ 32 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
Amendment 53 #
2023/0226(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) NGTs constitute a diverse group of genomic techniques, and each of them can be used in various ways to achieve different results and products. They can result in organisms with modifications equivalent to what can be obtained by conventional breeding methods or by means of genetic modification techniques referred to in Annex IB to Directive 2001/18/EC, but also in organisms with more complex modifications. Among NGTs, targeted mutagenesis and cisgenesis (including intragenesis) introduceshould bring about genetic modifications without inserting genetic material from non- crossable species (transgenesis). They rely only on the breeders’ gene pool, i.e. the total genetic information that is available for conventional breeding including from distantly related plant species that can be crossed by advanced breeding techniques, provided that the latter do not lead to the introduction of genetic material from non-crossable species. Targeted mutagenesis techniques result in modification(s) of the DNA sequence at precise locations in the genome of an organism. Cisgenesis techniques result in the insertion, in the genome of an organism, of genetic material already present in the breeders’ gene pool. Intragenesis is a subset of cisgenesis resulting in the insertion in the genome of a rearranged copy of genetic material composed of two or more DNA sequences already present in the breeders’ gene pool. Modifications made at precise locations may result in the interruption of endogenous genes and may also be accompanied by unintentional genetic modifications at the targeted location or elsewhere in the genome.
Amendment 68 #
2023/0226(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) There is ongoing public and private research using NGTs or other techniques such as marker-assisted selection on a wider variety of crops and traits compared to those obtained through transgenic techniques authorised in the Union or globally(33). This includes plants with improved tolerance or resistance to plant diseases and pests, plants with improved tolerance or resistance to climate change effects and environmental stresses, improved nutrient and water-use efficiency, plants with higher yields and resilience and improved quality characteristics. TIn spite of the difficulty in generating complex multifactorial traits, these types of new plants, coupled with the fairly easy and speedy applicability of those new techniques, could deliver benefits to farmers, consumers and to the environment which are at least equal to those that marker-assisted selection already offers. Thus, NGTs have the potential to contribute to the innovation and sustainability goals of the European Green Deal (34) and of the ‘Farm to Fork’ (35), Biodiversity (36) and Adaptation to Climate Change(37) Strategies, to global food security (38), and the Bioeconomy Strategy (39), and to the Union’s strategic autonomy (40)lthough it is more the socio- economic conditions of production and consumption that determine sustainability transition pathways. _________________ 33 Insights and solutions stemming from EU-funded research and innovation projects on plant breeding strategies may contribute to address detection challenges, ensure traceability and authenticity, and promote innovation in the area of new genomic techniques. More than 1,000 projects were funded under the Seventh Framework Programme and successor Horizon 2020 programme with an investment of over 3 billion Euros. Horizon Europe support to new collaborative research projects on plant breeding strategies is also ongoing, SWD(2021) 92. 34 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, COM/2019/640 final. 35 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Farm to Fork Strategy for a fair, healthy and environmentally friendly food system, COM/2020/381 final. 36 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, EU Biodiversity Strategy for 2030: Bringing nature back into our lives, COM/2020/380 final. 37 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions forging a Climate-Resilient Europe - The New EU Strategy on Adaptation to Climate Change, COM(2021) 82 final 38 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, Safeguarding food security and reinforcing the resilience of food systems, COM (2022) 133 final; Food and Agriculture Organisation of the United Nations (FAO), 2022, Gene editing and agrifood systems, Rome, ISBN 978-92-5- 137417-7. 39 European Commission, Directorate- General for Research and Innovation, A sustainable bioeconomy for Europe – Strengthening the connection between economy, society and the environment: updated bioeconomy strategy, Publications Office, 2018, https://data.europa.eu/doi/10.2777/792130. 40 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Trade Policy Review - An Open, Sustainable and Assertive Trade Policy, COM(2021)66 final.
Amendment 73 #
2023/0226(COD)
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) The development of NGTs will lead to increased control over plant reproductive material by a few multinationals which will exercise the patents they have been granted on genetic processes and extending them to the plants obtained. This development is not without risk for the sustainability of the plant breeding system operating in the European Union, which has allowed joint management of plant genetic resources that ensures that innovation is spread among a number of breeders of different sizes. The Commission has acknowledged the importance of this issue, into which there will need to be an additional investigation in order to assess the impact of patents on NGTs in terms of strategic autonomy for the European Union, concentration on the seed sector and preservation of cultivated biodiversity, but also the cost of food for consumers. In so far as all plant reproductive material that has been genetically modified may be the subject of one or more patents, traceability and labelling measures should be made compulsory for category 1 and 2 NGT plants and products in order, on the one hand, to enforce the rights of patent holders and, on the other, to ensure that other breeders, farmers and other economic agents are fully informed, since they might otherwise be led to make use of patented plants or products without their knowledge and risk being required by patent holders to pay royalties.
Amendment 83 #
2023/0226(COD)
Proposal for a regulation
Recital 6
Recital 6
(6) TRather than applying the Court of Justice judgment, by making NGT varieties subject to Directive 2001/18, the Council, in Decision (EU) 2019/190444, requested the Commission to submit, by 30 April 2021, a study in light of that judgment regarding the status of novel genomic techniques under Union law, and a proposal (accompanied by an impact assessment), if appropriate, depending on the conclusions of the study. _________________ 44 Council Decision (EU) 2019/1904 of 8 November 2019 requesting the Commission to submit a study in light of the Court of Justice’s judgment in Case C- 528/16 regarding the status of novel genomic techniques under Union law, and a proposal, if appropriate in view of the outcomes of the study (OJ L 293, 14.11.2019, p. 103).
Amendment 88 #
2023/0226(COD)
Proposal for a regulation
Recital 7
Recital 7
(7) The Commission’s study on new genomic techniques (45) concluded that the Union GMO legislation is not fit for the purpose of regulating the deliberate release of plants obtained by certain NGTs and the placing on the market of related products including food and feed. In particular, the study concluded that the authorisation procedure and risk assessment requirements for GMOs under the Union GMO legislation are not adapted to the variety of potential organisms and products that can be obtained with some NGTs, namely targeted mutagenesis and cisgenesis (including intragenesis), and these requirements can be disproportionate or inadequate. The study showed that this is particularly the case for plants obtained by these techniques, given the amount of scientific evidence that is already available, in particular on their safety. Furthermore, the Union GMO legislation is difficult to implement and enforce for plants obtained by targeted mutagenesis and cisgenesis and related products in the absence of sufficient investment to upgrade the European Network of GMO Laboratories (ENGL). In certain cases, genetic modifications introduced by these techniques are incurrently regarded as not being easily distinguishable with analytical methods normally used from natural mutations or from genetic modifications introduced by conventional breeding techniques or by genetic modification techniques referred to in Annex IB to Directive 2001/18/EC, whereas the distinction is generally possible for genetic modifications introduced by transgenesis. The Union GMO legislation is also not conducive to developing innovative and bENGL network considers that the provision by notifiers of information (as provided for in Regulation (EC) No 1829/2003) and of reference material would make it possible to detect and trace NGT products. The matrix approach devised and used by ENGL also makes it possible to determine the natural or artificial origin of genefticial products that could contribute to sust or epigenetic modifications. More effective detection methods are being developed thanks to growing research efforts that were begun recently (late 2022). At all events, the avainlability, food security and resilience of the agri-food chain of detection methods cannot be regarded as a prerequisite for the establishment of appropriate traceability arrangements, which, moreover, may involve documentary traceability, as is the case for many products of high quality and with different designations. _________________ 45 Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C- 528/16, SWD(2021) 92 final.
Amendment 91 #
2023/0226(COD)
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) In a statement in October 2022, the EFSA proposed six criteria for conducting a risk assessment for plants produced by targeted mutagenesis, cisgenesis and intragenesis. The first four criteria relate to the molecular characterisation of the genetic modification to the NGT plant: presence or absence of an exogenous DNA sequence (criterion 1), whether or not the DNA sequence derives from the breeders’ gene pool (criterion 2), type of integration (criterion 3), and whether or not any endogenous gene is interrupted (criterion 4). According to those criteria, the plant may be regarded as a plant with no exogenous DNA sequence or a cisgenic or intragenetic plant as a result of targeted insertion with or without interruption of endogenous genes. In the case of endogenous-gene interruption, two additional criteria round off the assessment: history of safe use (criterion 5) and the structure and function of the new allele (criterion 6). Where the history of safe use is not sufficiently established, the function and structure of the allele introduced should be carefully assessed. Ultimately, risk assessment cannot be based on the number of genetic modifications intentionally carried out; rather, it should be based on the impact of genetic modifications on the expression of the plant's genes, whether endogenous or exogenous.
Amendment 96 #
2023/0226(COD)
Proposal for a regulation
Recital 8
Recital 8
(8) It is therefore necessary to adopt a specific legal framework for GMOs obtained by targeted mutagenesis and cisgenesis and related products when deliberately released into the environment or placed on the market, while maintaining the central principles of GMO legislation that has been in place for over 20 years: sound information and freedom of choice for consumers and farmers, risk assessment and monitoring by health authorities, precautionary principle and reversibility, and coexistence of sectors.
Amendment 103 #
2023/0226(COD)
Proposal for a regulation
Recital 9
Recital 9
(9) Based on the current scientific and technical knowledge in particular on safety aspects, this Regulation shouldmust be limited to GMOs that are plants, i.e. organisms in the taxonomic groups Archaeplastida or Phaeophyceae, excluding microorganisms, fungi and animals for which the available knowledge is even more limited. For the same reason, this Regulation shouldmust only cover plants obtained by certain NGTs: targeted mutagenesis and cisgenesis (including intragenesis) (hereinafter ‘NGT plants’), but not by other new genomic techniques. Such NGT plants domust not carry genetic material from non-crossable species. GMOs produced by other new genomic techniques that introduce into an organism genetic material from non- crossable species (transgenesis) should and any contaminating technique such as passaging through bridge species allowing foreign sequences into the genome of the target species) must remain subject only to the Union GMO legislation, given that the resulting plants might bear specific risks associated to the transgeneforeign sequences and their unintended effects. Moreover, there is no indication that current requirements in the Union GMO legislation for GMOs obtained by transgenesis need adaptation at the present time.
Amendment 116 #
2023/0226(COD)
Proposal for a regulation
Recital 10
Recital 10
(10) The legal framework for NGT plants shouldmust share the objectives of the Union GMO legislation to ensure a high level of protection of human and animal health and of the environment and the good functioning of the internal market for the concerned plants and products, while addressing the specificity of NGT plants. This legal framework shouldmust enable the development and, health and environmental assessment and orderly placing on the market of labelled plants, food and feed containing, consisting of or produced from NGT plants and other products labelled as containing or consisting of NGT plants (‘NGT products’) s. So as to contribute to the innovation and sustainability objectives of the European Green Deal and the Farm to Fork, Biodiversity and Climate Adaptation strategies and to enhance the competitiveness of the Union agri-food sector at Union and world level, the legal framework applicable to NGT plants must differentiate NGT plants having positive sustainability characteristics from those that induce increased consumption of herbicides because they have been made resistant to them and those that produce their own insecticides or pesticides.
Amendment 127 #
2023/0226(COD)
Proposal for a regulation
Recital 11
Recital 11
(11) This Regulation constitutes lex specialis with regard to the Union GMO legislation. It introduces specific provisderogations for NGT plants and NGT products. However, where there are no specific rules in this Regulation, NGT plants and products (including food and feed) obtained from them shouldmust remain subject to the requirements of the Union GMO legislation and the rules on GMOs in sectoral legislation, such as Regulation (EU) 2017/625 on official controls or the legislation on certain products like plant and forest reproductive material.
Amendment 130 #
2023/0226(COD)
Proposal for a regulation
Recital 12
Recital 12
(12) The potential risks of NGT plants vary, ranging from risk profiles potentially similar to conventionally-bred plants or plants obtained by the genetic modification techniques referred to in Annex 1B of Directive 2001/18/EC to various types and degrees of hazards and risks that might be similar to those of plants obtained by transgenesis. This Regulation shouldmust therefore lay down special rules to adjust the risk assessment and risk management requirements according to the potentialactually assessed risks or lack thereof posed by NGT plants and NGT products.
Amendment 137 #
2023/0226(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) This Regulation shouldmust distinguish between two categories of NGT plants.
Amendment 149 #
2023/0226(COD)
Proposal for a regulation
Recital 14
Recital 14
(14) NGT plants that could also occur naturally or be produced by conventional breeding techniques and their progeny obtained by conventional breeding techniquesor through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC and their progeny when it respects the same criteria (‘category 1 NGT plants’) shouldmust be treated as plants that have occurred naturally or have been produced by conventional breeding techniques, given that they are equival or through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC, when they have a similar unmodified parent and thatwhen their risks are comparable, thereby derogating in fullpart from the Union GMO legislation and GMO related requirements in sectoral legislation. In order to ensure legal certainty, tThis Regulation should sets out the criteria to ascertain if a NGT plant is equivalent to naturally occurring or conventionally bred plants or those obtained through the genetic modifications listed in Annex 1B to Directive 2001/18/EC, and lays down a procedure for competent authorities to verify and take a decision on the fulfillment of those criteria, prior to the release or placing on the market of NGT plants or NGT productson a case-by-case basis and on the basis of the unique characteristics of each NGT plant and not on ex ante criteria, in accordance with the principles of the Cartagena Protocol. Those criteria should be transparent, objective and based on science. They should cover the type and extent of genetic modifications that can be observed in nature or in organisms obtained with conventional breeding techniques and should include thresholds for both size and number of genetic modifications to the genome of NGT plants. Since scientific and technical knowledge evolves rapidly in this area, the Commission should be empowermust be based on the OMICS approach in order to verify equivalence with conventional plants using standard biochemistry techniques in particular. They must also be based ion accordance with Article 290 of the Treaty on the Functioning of the European Union to update these criteria in light of scientific and technical progress as regards the type and extent of genetic modifications that can occur in nature or through conventional breedingthe six criteria set out by EFSA, in particular the presence of exogenous DNA sequences and the disruption of endogenous genes.
Amendment 168 #
2023/0226(COD)
Proposal for a regulation
Recital 16
Recital 16
(16) Category 1 NGT plants and products should not be subject to all the rules and requirements of the Union GMO legislation and to all provisions in other Union legislation that apply to GMOs. For legal certainty for operators and transparency for the competent authorities responsible for the assessment of the associated risks, the environmental assessment and monitoring, and in order to allow freedom of choice for both producers and consumers, a declaration of the category 1 NGT plant status shouldmust be obtained prior to deliberate release, including the placing on the market.
Amendment 174 #
2023/0226(COD)
Proposal for a regulation
Recital 17
Recital 17
(17) This declaration shouldmust be obtained prior to any deliberate release of any category 1 NGT plants for any other purpose than placing on the market, such as for field trials that are to take place in the territory of the Union, since the criteria are based on data that is available before the field trials and on tests in closed environments and does not depend on these field trials. When no field trials are to take place in the territory of the Union, operators shouldmust obtain that declaration before placing the category 1 NGT product on the market.
Amendment 181 #
2023/0226(COD)
Proposal for a regulation
Recital 18
Recital 18
(18) Since the criteria for considering that a NGT plant is equivalent to naturally occurring or conventionally bred plants are unrelated to the type of activity that requires the deliberate release of the NGT plant, a declaration of the category 1 NGT plant status made prior to its deliberate release for any other purpose than placing on the market in the territory of the Union should also be valid for the placing on the market of related NGT products. In view of the high uncertainty existing at the field trial stage about the product reaching the market and the likely involvement of smaller operators in such releases, the verification procedure of category 1 NGT plant status prior to field trials should be conducted by national competent authorities in close cooperation with the European Food Safety Authority (‘the Authority’) as this would be less administratively burdensome for operators, and a decision should be taken at Union level only in case there are comments to the verification report by other national competent authorities. Where the verification request is submitted prior to the placing on the market of NGT products, the procedure should be conducted at Union level in order to ensure effectiveness of the verification procedure and consistency of the category 1 NGT plant status declarations.
Amendment 194 #
2023/0226(COD)
Proposal for a regulation
Recital 19
Recital 19
(19) The competent authorities of the Member States, the Commission and the European Food Safety Authority (‘the Authority’) should be subject to strict appropriate deadlines to ensure that category 1 NGT plant status declarations are made within a reasonable time.
Amendment 203 #
2023/0226(COD)
(20) The verification of category 1 NGT plant status is of technical nature and does not involve any risk assessment or risk management considerations and the decision on the status is only declaratory. Therefore, when the procedure is conducted at Union level, such implementing decisions should be adopted by the advisory procedure, supported by scientific and technical assistance by the Authority.
Amendment 213 #
2023/0226(COD)
Proposal for a regulation
Recital 22
Recital 22
(22) Category 1 NGT plants should remain subject to any regulatory framework that applies to conventionally bred plants or to plants obtained through the techniques of genetic modification listed in Annex 1B to Directive 2001/18/EC. As is the case for conventional plants and products, those NGT plants and their products will be subject to the applicable sectoral legislation on seed and other plant reproductive material, food, feed and other products, and horizontal frameworks, such as the nature conservation legislation and environmental liability. In this regard, category 1 NGT food featuring a significantly changed composition or structure that affects the nutritional value, metabolism or level of undesirable substances of the food will be considered as novel food and thus fall into the scope of Regulation (EU) 2015/2283 of the European Parliament and of the Council (46) and will be risk assessed in that context. NGT plants or products presented as having properties for treating or preventing disease in human beings or as being suitable to be used or administered to human beings with a view to restoring, correcting or modifying physiological functions through pharmacological, immunological or metabolic action within the meaning of Article 1(2)(a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use should not benefit from the derogation for Category 1 NGTs. _________________ 46 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).
Amendment 226 #
2023/0226(COD)
Proposal for a regulation
Recital 23
Recital 23
(23) Regulation (EU) 2018/848 of the European Parliament and the Council on organic production and labelling of organic products and repealing Council Regulation (EC) 834/2007(47) prohibits the use of GMOs and products from and by GMOs in organic production. It defines GMOs for the purposes of that Regulation by reference to Directive 2001/18/EC, excluding from the prohibition GMOs which have been obtained through the techniques of genetic modification listed in Annex 1.B of Directive 2001/18/EC. As a result, category 2 NGT plants will be banned in organic production. However, it is necess based on the record of safe use and the limited knowledge available at the time with regaryd to clarify the status of category 1 NGT plants for the purposes ofidentification. As a result, NGT plants are banned in organic production. The use of new genomic techniques is currently incompatible with the conceptprinciples of organic production in the Regulation (EC) 2018/848 and with consumers’ perception of organic products. The use of category 1 NGT plants should therefore be also prohibited in organic production. _________________ 47 Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).
Amendment 236 #
2023/0226(COD)
Proposal for a regulation
Recital 24
Recital 24
(24) Provision should be made to ensure transparencceability as regards the use of category 1 NGT plant varieties, to ensure that production chains that wish to remain free from NGTs can do so and thereby safeguard consumer trust. NGT plants that have obtained a category 1 NGT plant status declaration should be listed in a publicly available database. TIn order to ensure traceability, transparency and choice ofor operators, during research and plant breeding, when selling seed to farmers or making plant reproductive material available to third parties in any other way, plant reproductive material of category 1 NGT plants should be labelled as category 1 NGT at all stages between production and consumption of the final products, including processing, category 1 NGT plants and products must be labelled and traced. Traceability measures should make it easier to both withdraw products in the event of unforeseen effects on human health, animal health or the environment, and monitor the environmental effects. Traceability must also facilitate the implementation of crisis management measures in line with the precautionary principle.
Amendment 250 #
2023/0226(COD)
Proposal for a regulation
Recital 25
Recital 25
(25) Category 2 NGT plants shouldmust remain subject to the requirements of the Union GMO legislation given that on the basis of current scientific and technical knowledge, their risks need to be assessed. Special rules should be provided in order to adapt the procedures and certain other rules laid down in Directive 2001/18/EC and Regulation (EC) No 1829/2003 to the specific nature of category 2 NGT plants and the differing levels of risk that they may pose.
Amendment 258 #
2023/0226(COD)
(27) Requirements on the content of notifications for consent for the placing on the market of products containing or consisting of GMOs other than food or feed and on the content of applications for authorisation for the placing on the market of genetically modified food and feed are laid down in different pieces of legislation. To ensure consistency between the notifications for consent and applications for authorisation for category 2 NGT products, the content of such notifications and applications should be the same, except those concerning the assessment of food and feed safety assessment as these are only relevant to category 2 NGT food and feed.
Amendment 267 #
2023/0226(COD)
Proposal for a regulation
Recital 28
Recital 28
(28) The European Union Reference Laboratory for GM Food and Feed (EURL), in collaboration with the European Network of GM Laboratories (ENGL), concluded that analytical testing is not considered feasible for all products obtained by targeted mutagenesis and cisgenesis51. When the introduced modifications of the genetic material are not specific to the NGT plant in question, they do not allow the systematic differentiation of the NGT plant from conventional plants. In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the notifier or the applicant, the modalities to comply with analytical method requirements should be adapted. This should be done in the implementing acts adopted pursuant to this Regulation. Provision should also be made for the EURL, assisted by the ENGL, to adopt guidance for applicants on the minimum performance requirements for analytical methods. Modalities for performing method validation may also be adapted. _________________ 51 European Network of GMO Laboratories (ENGL), Detection of food and feed plant products obtained by new mutagenesis techniques, 26 March 2019 (JRC116289); 13 June 2023 (JRC133689; EUR 31521 EN)
Amendment 277 #
2023/0226(COD)
Proposal for a regulation
Recital 29
Recital 29
(29) Directive 2001/18/EC requires a monitoring plan for environmental effects of GMOs after their deliberate release or placing on the market but provides for flexibility as to the design of the plan taking into account the environmental risk assessment, the characteristics of the GMO, of its expected use and of the receiving environment. Genetic modifications in category 2 NGT plants may range from changes only needing a limited risk assessment to complex alterations requiring a more thorough analysis of potential risks. Therefore, post- market monitoring requirements for environmental effects of category 2 NGT plants should be adapted in the light of the environmental risk assessment and the experience in field trials, the characteristics of the NGT plant concerned, the characteristics and scale of its expected use, in particular any history of safe use of the plant and the characteristics of the receiving environment. Therefore, athe monitoring plan for environmental effects should not be required ifalthough it may be adapted depending on whether or not the category 2 NGT plant is unlikely to pose risks that need monitoring, such as indirect, delayed or unforeseen effects on human health or on the environment.
Amendment 293 #
2023/0226(COD)
Proposal for a regulation
Recital 33
Recital 33
Amendment 298 #
2023/0226(COD)
Proposal for a regulation
Recital 34
Recital 34
Amendment 303 #
2023/0226(COD)
Proposal for a regulation
Recital 35
Recital 35
Amendment 309 #
2023/0226(COD)
Proposal for a regulation
Recital 36
Recital 36
(36) Herbicide tolerant plants are bred to be intentionally tolerant to herbicides, in order to be cultivated in combination with the use of those herbicides. If such cultivation is not done under appropriate conditions, it may lead to development of weeds resistant to those herbicides or to the need to increase of quantities of herbicides applied, regardless of the breeding technique. For this reason, NGT plants featuring herbicide-tolerant traits should not be eligible for incentives under this framework. However, this Regulation should not take other specific measures on herbicide tolerant NGT plants, because such measures are taken horizontally in [the Commission’s Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union]fall under category 1. The same applies to NGT plants whose genetic modification has enabled them to produce insecticides or other pesticides.
Amendment 310 #
2023/0226(COD)
Proposal for a regulation
Recital 37
Recital 37
Amendment 322 #
2023/0226(COD)
Proposal for a regulation
Recital 38
Recital 38
(38) The special rules laid down in this Regulation concerning the authorisation procedure for category 2 NGT plants are expected to result in more cultivation in the Union of category 2 NGT plants compared to the situation so far under the current Union GMO legislation. That renders necessary for Member States’ public authorities to define coexistence measures to balance the interests of producers of conventional, organic and GM plants and thereby allow producers a choice between different types of production, in line with the Farm to Fork Strategy’s target of 25 % of agricultural land under organic farming by 2030. In order to ensure that the coexistence measures are consistent, the Commission should draw up an implementing act to cover, in particular, the size of buffer strips between conventional plants and NGT plants, for each type of crop.
Amendment 352 #
2023/0226(COD)
Proposal for a regulation
Recital 45
Recital 45
(45) In order to ensure uniform conditions for the implementation of this Regulation, implementingdelegated powers should be conferred on the Commission as regards the information required to demonstrate that a NGT plant is a category 1 NGT plant, as regards the preparation and the presentation of the notification for that determination, and as regards the methodology and information requirements for the environmental risk assessments of category 2 NGT plants and of NGT food and NGT feed, in accordance with the principles and criteria laid down in this Regulation. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council55. _________________ 55 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
Amendment 398 #
2023/0226(COD)
(3a) 'conventional plants' means plants obtained by conventional breeding techniques excluding genetic modifications and techniques of genetic modification listed in Annex IB to Directive 2001/18/EC like mutagenesis and cell fusion;
Amendment 409 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene pool’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crossesnaturally be cross-pollinated;
Amendment 412 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘breeders’ gene pool’ means the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, and induced polyploidy and bridge crosses;
Amendment 423 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point a
Article 3 – paragraph 1 – point 7 – point a
(a) fulfils the criteria of equivalence to conventional plants, set out in Annex I and Annex IV, and has at least one of the intended characteristic(s) conveyed by the genetic modification that is contained in Part 1 of Annex III and does not have any one of those listed in Part 2 of Annex III, or
Amendment 428 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b
Article 3 – paragraph 1 – point 7 – point b
(b) is progeny of the NGT plant(s) referred to in point (a), including progeny derived by crossing of such plants, on the condition that there are no further modifications tha criteria of equivalence set would make it subject to Directive 2001/18/EC or Regulation 1829/2003t in Annex 1 and Annex 4 are still satisfied;
Amendment 432 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 7 – point b a (new)
Article 3 – paragraph 1 – point 7 – point b a (new)
(ba) is not presented as having properties for treating or preventing diseases in human beings and may not be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2.(a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Amendment 456 #
2023/0226(COD)
Proposal for a regulation
Article 3 – paragraph 1 – point 15 a (new)
Article 3 – paragraph 1 – point 15 a (new)
(15a) 'variety' means a variety as defined in Article 5(2) of Regulation (EC) 2100/94.
Amendment 471 #
2023/0226(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 1 – point b
Article 4 – paragraph 1 – point 1 – point b
(b) is progeny of plant(s) referred to in point (a) on the condition that the criteria of equivalence set out in Annex 1 and Annex 4 are still satisfied ; or
Amendment 477 #
2023/0226(COD)
Proposal for a regulation
Article 4 – paragraph 1 – point 2 a (new)
Article 4 – paragraph 1 – point 2 a (new)
(2a) an extended producer responsibility (EPR) scheme has been settled at European or national level to ensure the financing of risks and possible future damages of human health, animal health or the environment or cross- contamination of organic food and non GMO-food are financed in line with the polluter pays principle.
Amendment 498 #
2023/0226(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
Amendment 518 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. To obtain the declaration of category 1 NGT plant status referred to in Article 4(1), point (a), before undertaking a deliberate release of a NGT plant for any other purpose than placing on the market, the person intending to undertake the deliberate release shall submit a request to verify whether the criteria set out in Annex I are met (‘verification request’) to the competent authority designated in accordance with Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the release is to take place in accordance with paragraphs 2 and 3 and the implementingdelegated act adopted in accordance with Article 27, point (b)6.
Amendment 523 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 2
Article 6 – paragraph 2
2. Where a person intends to undertake such a deliberate release simultaneously in more than one Member State, that person shall submit the verification request to the competent authority of one of thoseeach Member States.
Amendment 525 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point b a (new)
Article 6 – paragraph 3 – point b a (new)
(ba) the denomination of the variety;
Amendment 526 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point c
Article 6 – paragraph 3 – point c
(c) a description of the trait(s) and characteristics which have been introduced or modified, including disclosure of the sequence of the genetic modification;
Amendment 529 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point c a (new)
Article 6 – paragraph 3 – point c a (new)
(ca) a declaration on possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2. (a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use;
Amendment 530 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point c b (new)
Article 6 – paragraph 3 – point c b (new)
(cb) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;
Amendment 532 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point d – point i
Article 6 – paragraph 3 – point d – point i
(i) the plant is a NGT plant, including that it does not contain any genetic material originating from outside the breeders’ gene pool where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements specified in the implementingdelegated act adopted in accordance with Article 27, point (a)6;
Amendment 541 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point d – point ii a (new)
Article 6 – paragraph 3 – point d – point ii a (new)
(iia) the results of the in-door safety assessment set out in Annex IV.
Amendment 547 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point e
Article 6 – paragraph 3 – point e
Amendment 549 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point e a (new)
Article 6 – paragraph 3 – point e a (new)
(ea) an environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);
Amendment 550 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point e b (new)
Article 6 – paragraph 3 – point e b (new)
(eb) a monitoring plan for environmental effects as mentioned in Parts 1 and 2 of Annex II;
Amendment 551 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point e c (new)
Article 6 – paragraph 3 – point e c (new)
(ec) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant. The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2) or assess whether the information provided by the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph;
Amendment 552 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point e d (new)
Article 6 – paragraph 3 – point e d (new)
(ed) samples of the category 1 NGT plant and their control samples, and information as to the place where the reference material can be accessed;
Amendment 555 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point f a (new)
Article 6 – paragraph 3 – point f a (new)
Amendment 556 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 3 – point f b (new)
Article 6 – paragraph 3 – point f b (new)
(fb) any other relevant information relating to the file, including possible refusal, withdrawal or acceptance of previous requests or national or European decisions;
Amendment 558 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 5
Article 6 – paragraph 5
5. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the competent authority within 30 working day2 months within the date of receipt of a verification request. The competent authority shall inform the requester, the other Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.
Amendment 559 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 6
Article 6 – paragraph 6
6. If the verification request is not deemed inadmissible in accordance with paragraph 5, the competent authority shall verify whether the NGT plant fulfils the criteria set out in Annex I and prepare a verification report within 30 working dayAnnex IV. For that purpose, the competent authority shall forward the request to the European Food Safety Authority (“The Authority”) without undue delay. Within 6 months, the Authority shall make a statement on whether the plant is a NGT plant fulfilling the criteria set out in Annex I, including whether it contains any genetic material originating from outside the breeders’ gene pool. The statement shall be forwarded to all Member States, to the Commission, and shall be made public. After receiving this statement, the competent authority shall prepare a verification report within 3 months from the date of receipt of athe verification request. The competent authority shall make available the verification report to the other Member States and to the Commission without undue delay.
Amendment 570 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 7
Article 6 – paragraph 7
7. The other Member States and the Commission may make comments to the verification report within 20 day3 months from the date of receipt of that report.
Amendment 583 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 8
Article 6 – paragraph 8
8. In the absence of any comments from a Member State or the Commission, within 10 working daysone month from the expiry of the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall adopt a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, the other Member States and to the Commission.
Amendment 591 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 9
Article 6 – paragraph 9
9. In cases where a comment is made by another Member State or by the Commission by the deadline referred to in paragraph 7, the competent authority that prepared the verification report shall forward the comment(s) to the Commission and to the other Member States, without undue delay.
Amendment 600 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 10
Article 6 – paragraph 10
10. The Commission, after having consulted the European Food Safety Authority (‘the Authority’), shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 45 working day3 months from the date of receipt of the comment(s), taking the latter into account. The decision shall be adopted in accordance with the procedure referred to in Article 28(2).
Amendment 604 #
2023/0226(COD)
Proposal for a regulation
Article 6 – paragraph 11
Article 6 – paragraph 11
11. The Commission shall publish a summary of the decisions referred to in paragraphs 8 and 10 in the Official Journal of the European UnionWithin 15 days following their submission or issuance, the competent authority of the Member State where the verification request was submitted to and, where relevant, the Commission shall make public the verification request, the verification report referred to in paragraph 6, the comments referred to in paragraph 7 and the decisions referred to in paragraphs 8 and 10.
Amendment 614 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where a declaration of category 1 NGT plant status referred to in Article 4(1), point (a), has not already been made in accordance with Article 6, to obtain such a declaration bBefore placing on the market a NGT product, the person intending to place the product on the market shall submit a verification request to the Authority in accordance with paragraph 2 and the implementing act adopted in accordance with Article 27, point (b).
Amendment 616 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point b a (new)
Article 7 – paragraph 2 – point b a (new)
(ba) the denomination of the variety;
Amendment 618 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point c
Article 7 – paragraph 2 – point c
(c) a description of the trait(s) and characteristics which have been introduced or modified, including disclosure of the sequence of genetic modification ;
Amendment 620 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point c a (new)
Article 7 – paragraph 2 – point c a (new)
(ca) a declaration on possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, within the meaning of Article 1-2. (a) and (b) of Directive 2001/83/EC on the Community code relating to medicinal products for human use;
Amendment 621 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point c b (new)
Article 7 – paragraph 2 – point c b (new)
(cb) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;
Amendment 629 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point d – point ii a (new)
Article 7 – paragraph 2 – point d – point ii a (new)
(iia) the results of the in-door safety assessment set out in Annex IV
Amendment 631 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point d a (new)
Article 7 – paragraph 2 – point d a (new)
(da) an environmental risk assessment carried out in accordance with the principles and criteria set out in Parts 1 and 2 of Annex II and with the implementing act adopted in accordance with Article 27, point (c);
Amendment 633 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point d b (new)
Article 7 – paragraph 2 – point d b (new)
(db) a monitoring plan for environmental effects as mentioned in Parts 1 and 2 of Annex II;
Amendment 634 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point d c (new)
Article 7 – paragraph 2 – point d c (new)
(dc) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant. The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2) or assess whether the information provided by the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph;
Amendment 637 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point d d (new)
Article 7 – paragraph 2 – point d d (new)
(dd) samples of the category 1 NGT plant and their control samples, and information as to the place where the reference material can be accessed;
Amendment 641 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point e a (new)
Article 7 – paragraph 2 – point e a (new)
(ea) a declaration on the non- applicability of Regulation (EU) 2015/2283 of 25 November 2015 on novel foods, or on the correct application of possible obligations arising from this Regulation;
Amendment 642 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 2 – point e b (new)
Article 7 – paragraph 2 – point e b (new)
(eb) any other relevant information relating to the file, including possible refusal, withdrawal or acceptance of previous requests or national or European decisions.
Amendment 645 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 4
Article 7 – paragraph 4
4. If the verification request does not contain all the necessary information, it shall be declared inadmissible by the Authority within 360 working days within the date of receipt of a verification request. The Authority shall inform the requester, the Member States and the Commission without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.
Amendment 646 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 5
Article 7 – paragraph 5
5. If the verification request is not deemed inadmissible in accordance with paragraph 4, the Authority shall deliver its statement on whether the NGT plant fulfils the criteria set out in Annex I within 30 working day6 months from the date of receipt of a verification request. The Authority shall make available the statement to the Commission and the Member States without undue delay. Member States may make comments on the statement within 2 months from the date of receipt of that statement. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement, and where relevant, comments made by Member States, public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.
Amendment 651 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 6
Article 7 – paragraph 6
6. The Commission shall prepare a draft decision declaring whether the NGT plant is a category 1 NGT plant within 30 working day months from the date of receipt of the statement of the Authority, taking the latter into account. The decision shall be adoptedMember States may make comments on the draft decision within 2 months from the date of receipt of that draft decision. The decision shall be adopted within the 3 following months, in accordance with the procedure referred to in Article 28(2).
Amendment 654 #
2023/0226(COD)
Proposal for a regulation
Article 7 – paragraph 7
Article 7 – paragraph 7
7. The Commission shall publish a summary of themake public its draft decision in, the Official Journal of the European Uncomments referred to in paragraph 6, and its decision.
Amendment 668 #
2023/0226(COD)
Proposal for a regulation
Article 9 – title
Article 9 – title
Amendment 670 #
2023/0226(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 1
Article 9 – paragraph 1 – subparagraph 1
The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(8) and (10) and Article 7(6)register for the purpose of recording the information related to all products consisting of, made of, or containing Cat.1 NGT plant.
Amendment 671 #
2023/0226(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – introductory part
Article 9 – paragraph 1 – subparagraph 2 – introductory part
The databaseregister shall contain the following information:
Amendment 672 #
2023/0226(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point b
Article 9 – paragraph 1 – subparagraph 2 – point b
(b) the designation and specification of the category 1 NGT plant;
Amendment 673 #
2023/0226(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point b a (new)
Article 9 – paragraph 1 – subparagraph 2 – point b a (new)
(ba) the denomination of the variety ;
Amendment 674 #
2023/0226(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d
Article 9 – paragraph 1 – subparagraph 2 – point d
(d) a description of the trait(s) and characteristics which have been introduced or modified, including possible properties for treating or preventing disease in human beings or possible use or administration to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action;
Amendment 676 #
2023/0226(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d a (new)
Article 9 – paragraph 1 – subparagraph 2 – point d a (new)
(da) a copy of the studies, which have been carried out and any other available material to demonstrate that: (i) the plant is a NGT plant; (ii) the NGT plant meets the criteria set out in Annex I; (iii) the results of the in-door safety assessment set out in Annex IV;
Amendment 680 #
2023/0226(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d b (new)
Article 9 – paragraph 1 – subparagraph 2 – point d b (new)
(db) the sequence of the genetic modification;
Amendment 682 #
2023/0226(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d c (new)
Article 9 – paragraph 1 – subparagraph 2 – point d c (new)
(dc) any granted patent or pending application for patent covering the whole Cat.1 NGT plant or part of it;
Amendment 683 #
2023/0226(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point d d (new)
Article 9 – paragraph 1 – subparagraph 2 – point d d (new)
(dd) methods for sampling (including references to existing official or standardised sampling methods, e.g. genetic markers or PCR primers), detection, identification and quantification of the NGT plant;
Amendment 685 #
2023/0226(COD)
Proposal for a regulation
Article 9 – paragraph 1 – subparagraph 2 – point e a (new)
Article 9 – paragraph 1 – subparagraph 2 – point e a (new)
(ea) the opinion or statement of EFSA, as referred to in Article 6 (10) and Article 7(5), and
Amendment 697 #
2023/0226(COD)
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The databaseregister shall be publicly available.
Amendment 704 #
2023/0226(COD)
Proposal for a regulation
Article 10 – title
Article 10 – title
Amendment 711 #
2023/0226(COD)
Proposal for a regulation
Article 10 – paragraph 1
Article 10 – paragraph 1
Amendment 731 #
2023/0226(COD)
Proposal for a regulation
Article 11 – paragraph 3 – point b
Article 11 – paragraph 3 – point b
(b) DNA sequence information, except for sequences used for the purpose of detection, identification and quantification of the genetic modification ; and
Amendment 735 #
2023/0226(COD)
Proposal for a regulation
Article 11 – paragraph 6 a (new)
Article 11 – paragraph 6 a (new)
6 a. Notwithstanding paragraphs 3, 5 and 6 of this Article: (a) where urgent action is essential to protect human health, animal health or the environment, such as in emergency situations, the competent authority may disclose the information referred to in paragraph 3; and (b) information which forms part of the opinions or statements of the Authority or the conclusions of the assessment reports and which relate to foreseeable effects on human health, animal health or the environment shall nevertheless be made public. In that case, Article 39c of Regulation (EC) No 178/2002 shall apply.
Amendment 736 #
2023/0226(COD)
Proposal for a regulation
Article 11 – paragraph 7 a (new)
Article 11 – paragraph 7 a (new)
7 a. Third parties may submit request to the National competent authority, to the Commission or to the Authority to access confidential information with substantiated argumentation, such as significant concerns about the environment, animal or human health.
Amendment 737 #
2023/0226(COD)
Proposal for a regulation
Article 11 a (new)
Article 11 a (new)
Article11a Measures to avoid the unintended presence of category 1 NGT plants 1. Member States shall take appropriate measures to avoid the unintended presence of category 1 NGT plants in other products on the basis of a delegated act proposed by Commission in accordance with Article 26 to define notably the size of the buffer strip for each sort of crops and the obligation of NGT growers to inform organic and certified non-GMO growers with field plots next to those where NGT plants are grown. Member States shall develop the definition of crop specific and adapted measures as a matter of subsidiarity, based on the latest scientific and experimental knowledge, to avoid the unintended presence of category 1 NGT plants. 2. Member States shall instate a strict liability system and a compensation fund to compensate operators in the event of contamination in accordance with the principal of the extended producer responsibility. 3. The Commission shall gather and coordinate information based on the studies at EU and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of NGT, conventional and organic crops.
Amendment 739 #
2023/0226(COD)
Proposal for a regulation
Article 11 b (new)
Article 11 b (new)
Article 11b Duration of the validity of the declaration If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter.
Amendment 770 #
2023/0226(COD)
Proposal for a regulation
Article 13 – paragraph 1 – point d a (new)
Article 13 – paragraph 1 – point d a (new)
(da) a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC;
Amendment 786 #
2023/0226(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point h
Article 14 – paragraph 1 – point h
(h) where appropriate, a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the time-period of the monitoring plan; this time-period may be different from the proposed period for the consent. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the notifiercompetent authority considers thatif the NGT plant does not need a monitoring plan, the notifier may propose not to submit ashould require a lighter monitoring plan;
Amendment 807 #
2023/0226(COD)
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
The written consent referred to in Article 19 of Directive 2001/18/EC shall either specify monitoring requirements, as described in Article 19(3) point (f) or state that monitoring is not requiredcould be lighter. The written consent shall provide the adequate grounds that justifies that a monitoring plan is lighter. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not required by the consent.
Amendment 820 #
2023/0226(COD)
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The consent granted under Part C of Directive 2001/18/EC shall, after the firsteach renewal in accordance with Article 17 of Directive 2001/18/EC, be valid for an unlimited period, unles10 years, unless after three renewal rounds the decision referred to in Article 17(6) or (8) provides that the renewal is for a n unlimited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent.
Amendment 824 #
2023/0226(COD)
Proposal for a regulation
Article 17 – paragraph 2 a (new)
Article 17 – paragraph 2 a (new)
2a. If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis, the competent authority may withdraw its decision. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter.
Amendment 846 #
2023/0226(COD)
Proposal for a regulation
Article 19 – paragraph 2 – subparagraph 2
Article 19 – paragraph 2 – subparagraph 2
In cases where it is not feasible to provide an analytical method that detects, identifies and quantifies, if duly justified by the applicant orand concluded by the European Union Reference Laboratory referred to in Article 32 of Regulation (EC) No 1829/2003 during the procedure referred to in Article 20(4), the modalities to comply with analytical method requirements shall be adapted as specified in the implementing act adopted in accordance with Article 27, point (e) and the guidance referred to in Article 29(2);
Amendment 854 #
2023/0226(COD)
Proposal for a regulation
Article 19 – paragraph 3 – point b
Article 19 – paragraph 3 – point b
(b) where appropriate, a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan. This duration may be different from the duration of the authorisation. If, based on the results of any release notified in accordance with Section 1, the findings of the environmental risk assessmeIn case the application is a request for renewal and if based on the results of the monitoring report or regarding the findings of the environmental risk assessment of any released Cat 2 NGT plant or food or feed containing or consisting of Cat 2 NGT plant, the characteristics of the NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, point (d), the applicant considers that the NGT plant does need a monitoring plan, the applicant may propose not to submit acompetent authority may propose not require the continuation of the monitoring plan.
Amendment 860 #
2023/0226(COD)
Proposal for a regulation
Article 20 – paragraph 1 – subparagraph 1
Article 20 – paragraph 1 – subparagraph 1
By way of derogation from Article 6(1) and (2) and Article 18(1) and (2) of Regulation (EC) No 1829/2003, the Authority shall deliver an opinion onassent the application for authorisation referred to in Article 19 of this Regulation within six months as from the receipt of a valid application.
Amendment 864 #
2023/0226(COD)
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. The Union reference laboratory shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 19(2) or assess whether the information provided by. If the applicant justifies the application of adapted modalities to comply with detection method requirements referred to in that paragraph, the Union reference laboratory shall proceed to his own research and analyses to confirm the claimed unfeasibility. In that case, the decision of the Union reference laboratory shall be motivated and be made public.
Amendment 869 #
2023/0226(COD)
Amendment 875 #
2023/0226(COD)
Proposal for a regulation
Article 21 – paragraph 1 a (new)
Article 21 – paragraph 1 a (new)
1. The authorisation shall be valid for a limited period of 10 years, unless the Commission decides after three renewal rounds by way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) N° 1829/2003 to renew the authorisation for an unlimited period, on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.
Amendment 876 #
2023/0226(COD)
Proposal for a regulation
Article 21 – paragraph 1 b (new)
Article 21 – paragraph 1 b (new)
If the monitoring results show that there is a risk to health or the environment, or if new scientific data supports this hypothesis or if the , the competent authority may withdraw its decision. The withdrawal decision must be sent by registered mail to the beneficiary of the decision, who has 15 days in which to make observations. In that case, the marketing of the NGT plant or product is prohibited from the day following the date of receipt of the registered letter.
Amendment 884 #
2023/0226(COD)
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – paragraph 1
Amendment 889 #
2023/0226(COD)
Proposal for a regulation
Article 22 – paragraph 2
Article 22 – paragraph 2
Amendment 893 #
2023/0226(COD)
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
Amendment 896 #
2023/0226(COD)
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
Amendment 900 #
2023/0226(COD)
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
Amendment 904 #
2023/0226(COD)
Proposal for a regulation
Article 22 – paragraph 6
Article 22 – paragraph 6
Amendment 905 #
2023/0226(COD)
Proposal for a regulation
Article 22 – paragraph 7
Article 22 – paragraph 7
Amendment 908 #
2023/0226(COD)
Proposal for a regulation
Article 22 – paragraph 8
Article 22 – paragraph 8
Amendment 926 #
2023/0226(COD)
1. Member States shall take appropriate measures to avoid the unintended presence of category 2 NGT plants in products not subject to Directive 2001/18 or Regulation 1829/2003on the basis of a delegated act proposed by Commission in accordance with Article 26 to define notably the size of the buffer strip for each sort of crops and the obligation of NGT growers to inform organic and certified non-GMO growers with field plots next to those where NGT plants are grown. Member States shall develop the definition of crop specific and adapted measures as a matter of subsidiarity, based on the latest scientific and experimental knowledge, to avoid the unintended presence of category 2 NGT plants. 2. Member States shall instate a strict liability system and a compensation fund to compensate operators in the event of contamination in accordance with the principal of the extended producer responsibility. 3. The Commission shall gather and coordinate information based on the studies at EU and national level, observe the developments regarding coexistence in the Member States and, on the basis of the information and observations, develop guidelines on the coexistence of NGT, conventional and organic crops.
Amendment 947 #
2023/0226(COD)
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
Article 26b of Directive 2001/18/EC shall not apply to category 2 NGT plantNGT plants. Article 23 of Directive 2001/18/EC shall apply for all NGT mutatis mutandis.
Amendment 958 #
2023/0226(COD)
Proposal for a regulation
Article 26 – paragraph 2
Article 26 – paragraph 2
2. The power to adopt the delegated acts referred to in Article 5(3)6(1), Article 6(3), Article 11a and Article 22(8)4 shall be conferred on the Commission for a period of 5 years from [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than 9 months before the end of the 5-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than 3 months before the end of each period.
Amendment 963 #
2023/0226(COD)
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
3. The delegations of power referred to in Article 5(3)6(1), Article 6(3), Article 11a and Article 22(8)4 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 968 #
2023/0226(COD)
Proposal for a regulation
Article 26 – paragraph 6
Article 26 – paragraph 6
6. A delegated act adopted pursuant to Articles 6(1), Article 56(3), Article 11a and Article 22(8)4 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.
Amendment 972 #
2023/0226(COD)
Proposal for a regulation
Article 27 – paragraph 1 – point a
Article 27 – paragraph 1 – point a
Amendment 975 #
2023/0226(COD)
Proposal for a regulation
Article 27 – paragraph 1 – point b
Article 27 – paragraph 1 – point b
Amendment 989 #
2023/0226(COD)
Proposal for a regulation
Article 27 – paragraph 2
Article 27 – paragraph 2
Before adopting the implementing acts referred to in points (a) to (d), the Commission shall consult the Authority. The implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).
Amendment 993 #
Amendment 994 #
2023/0226(COD)
Proposal for a regulation
Article 29 – paragraph 2 a (new)
Article 29 – paragraph 2 a (new)
Amendment 1030 #
2023/0226(COD)
Proposal for a regulation
Article 32 a (new)
Article 32 a (new)
Amendment 1035 #
2023/0226(COD)
Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 1
Article 34 – paragraph 2 – subparagraph 1
It shall apply from [24when delegated acts referred to in Article 6(1), Article 6(3), Article 11a, Article 24 and all implementing acts required according to article 27 are adopted but no sooner than [36 months from the date of entry into force of this Regulation].
Amendment 1044 #
2023/0226(COD)
Proposal for a regulation
Annex I – title
Annex I – title
Criteria of equivalence of NGT plants to conventional plants 1. 1. A NGT plant is considered equivalent to conventional plants when it differs from the unedited parent plant by no more than 20 genetic modifications of the types referred to in points 1 to 2 within the whole genome of the host plant. (1) substitution or insertion of no more than 20 nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ; (2) deletion of target inversion of any number of nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ; 2. Alongside these process-based criteria, equivalence shall be verified on the basis of the results the genetic modifications produce on the plant. When compared to the unedited parent of the same species grown in the same conditions, result- based criteria shall be set out as follows : (1) the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and (2) the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; and (3) biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired.
Amendment 1045 #
2023/0226(COD)
Proposal for a regulation
Annex I – title
Annex I – title
Criteria of equivalence of NGT plants to conventional plants A NGT plant is considered equivalent to conventional plants if, when compared to the unedited parent of the same species grown in the same conditions : - the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and - the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; provided any alteration of biochemical pathways, examined through gene ontology analysis, does not give rise to any adverse compositional consequences, and - biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired; provided any novel biochemicals or proteins produced by the plant does not present adverse effects on the plant itself, on any other forms of life it is known to interact with or bound to consume it.
Amendment 1046 #
2023/0226(COD)
Proposal for a regulation
Annex I – title
Annex I – title
Criteria of equivalence of NGT plants to conventional plants A NGT plant is considered equivalent to conventional plants if, when compared to the unedited parent of the same species grown in the same conditions : - the whole genome sequencing and profiling shows the desired genetic modifications have not modified the function of one or more genes other that the one or those specifically targeted; and - the whole transcriptome sequencing realized on the relevant part of the plant shows the desired genetic modifications have not modified other biochemical pathways than those specifically targeted; and - biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the desired genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of novel biochemicals or proteins other than those specifically desired.
Amendment 1058 #
2023/0226(COD)
Proposal for a regulation
Annex I – paragraph 1
Annex I – paragraph 1
A NGT plant is considered equivalent to conventional plants when it differs from the recipient/unedited parental plant by no more than 20 genetic modifications of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools2 within the whole genome of the host plant.
Amendment 1060 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 1
Annex I – point 1
(1) substitution or insertion of no more than 20 nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded;
Amendment 1070 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 2
Annex I – point 2
(2) deletion of target inversion of any number of nucleotides for the purpose of disrupting or abolishing gene function ; any novel (intended or unintended) gene function shall be excluded ;
Amendment 1072 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 3
Annex I – point 3
Amendment 1094 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 4
Annex I – point 4
Amendment 1099 #
2023/0226(COD)
Proposal for a regulation
Annex I – point 5
Annex I – point 5
Amendment 1145 #
2023/0226(COD)
Proposal for a regulation
Annex II – Part 1 – paragraph 5
Annex II – Part 1 – paragraph 5
Amendment 1190 #
2023/0226(COD)
Proposal for a regulation
Annex III – Part 2 – paragraph 1
Annex III – Part 2 – paragraph 1
Traits excluding the application of the incentives referred to in Article 22: - tolerance to herbicides. - plants producing insecticides and pesticides
Amendment 1193 #
2023/0226(COD)
Proposal for a regulation
Annex III a (new)
Annex III a (new)
ANNEX IIIa In-door safety assessment A Cat.1 NGT plant is considered safe, without having to go through field trials, if the following confined experiments have been undertaken and provide evidence that: (1) the whole genome sequencing and profiling shows the intended and unintended genetic modifications have not adversely modified the function of one or more genes; and (2) the whole transcriptome sequencing realized on the relevant part of the plant shows the intended and unintended genetic modifications have not adversely modified biochemical pathways, leading in particular to adverse compositional consequences, verified e.g. through gene ontology analysis; and (3) biochemical metabolite (metabolomics) and protein (proteomics) profiling realized on the relevant part of the plant shows the intended and unintended genetic modifications have not induced an increase in the levels of known toxins or allergens or the production by the plant of toxic or allergenic novel biochemicals or proteins for the plant itself, any other forms of life it is known to interact with or bound to consume it.
Amendment 86 #
2023/0199(COD)
Proposal for a regulation
Recital 2
Recital 2
(2) The EU industry has proven its inbuilt resilience but is being challenged. High inflation, labour shortages, post- COVID supply chains disruptions, rising interest rates, and spikes in energy costs and input prices are weighing on the competitiveness of the EU industry. This is paired with strong, but not always ese difficulties are accompanied by strong, sometimes unfair, competition oin thea fragmented global market and difficulties structuring local value chains around networks of industrial stakeholders capable of carrying out projects. The EU has already put forward several initiatives to support its industry, such as the Green Deal Industrial Plan40, the Critical Raw Materials Act41, the Net Zero Industry Act42, the new Temporary Crisis and Transition Framework for State aid43, and REPowerEU44. While these solutions provide fast and targeted support, the EU needs a more structural answer to the investment needs of its industries, safeguarding cohesion and the level playing field in the Single Market and to reduce the EU’s strategic dependencies. _________________ 40 Communication on A Green Deal Industrial Plan for the Net-Zero Age, COM(2023) 62 final. 41 COM(2023) 160 final. 42 COM(2023) 161 final. 43 Communication on a Temporary Crisis and Transition Framework for State Aid measures (OJ C 101, 17.3.2023, p. 3). 44 Regulation (EU) 2023/435 as regards REPowerEU (OJ L 63, 28.2.2023, p. 1).
Amendment 93 #
2023/0199(COD)
Proposal for a regulation
Recital 3
Recital 3
(3) The uptake and scaling up in the Union of deep and digital technologies, clean technologies, and biotechnologies will be essential to seize the opportunities and meet the objectives of the green and digital transitions, thus promoting the competitiveness of the European industry, its structure and its sustainability. Therefore, immediate action is required to support the development or manufacturing in the Union of such technologies, safeguarding and strengthening their value chains thereby reducing the Union’s strategic dependencies, and addressing existing labour and skills shortages in those sectors through trainings and apprenticeships and the creation of attractive, quality jobs accessible to all.
Amendment 103 #
2023/0199(COD)
Proposal for a regulation
Recital 4
Recital 4
(4) There is a need to support critical technologies in the following fields: deep and digital technologies, clean technologies, and biotechnologies (including the respective critical raw materials value chains), in particular projects, companies and sectors with a critical role for EU’s competitiveness and resilience and its value chains. By way of example, deep technologies and digital technologies should include microelectronics, high-performance computing, quantum technologies (i.e., computing, communication and sensing technologies), cloud computing, edge computing, and artificial intelligence, cybersecurity technologies, robotics, 5G and advanced connectivity and virtual realities, including actions related to deep and digital technologies for the development of defence and aerospace applications. Clean technologies should include, among others, renewable energy; electricity and heat storage; heat pumps; electricity grid; renewable fuels of non- biological origin; sustainable alternative fuels; electrolysers and fuel cells; carbon capture, utilisation and storage; energy efficiency; hydrogen and its related infrastructure; smart energy solutions; technologies vital to sustainability such as water purification and desalination; advanced materials such as nanomaterials, composites and future clean construction materials, and technologies for the sustainable extraction and processing of critical raw materials. Biotechnology should be considered to include technologies such as biomolecules and its applications, pharmaceuticals and medical technologies vital for health security, crop biotechnology, and industrial biotechnology, such as for waste disposal, and biomanufacturing. The Commission may, at the latest one month after the entry into force of this regulation, issue guidance to further specify the scope of the technologies in these three fields considered to be critical in accordance with this Regulation, in order to promote a common interpretation of the projects, companies and sectors to be supported under the respective programmes in light of the common strategic objective. Moreover, technologies in any of these three fields which are subjects of an Important Project of Common European Interest (IPCEI) approved by the Commission pursuant to Article 107(3), point (b) TFEU should be deemed to be critical, and individual projects within the scope of such an IPCEI should be eligible for funding, in accordance with the respective programme rules, to the extent that the identified funding gap and the eligible costs have not yet been completely covered.
Amendment 114 #
2023/0199(COD)
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) In order to strengthen the EU industry’s manufacturing capacities, regional and local industrial actors must have resilient ecosystems. The development of value chains comprising a large number of VSEs/SMEs is key for the reindustrialisation of Europe but a suitable approach is needed. This ecosystem of VSEs/SMEs finds it difficult to mobilise European funding instruments and access public contracts. It is therefore necessary to strengthen these local value chains and their structures, and set up local and regional platforms to support their projects and facilitate access to finance.
Amendment 158 #
2023/0199(COD)
Proposal for a regulation
Recital 13
Recital 13
(13) In order to extend support possibilities for investments aimed at strengthening industrial development and reinforcement of value chains in strategic sectors, the scope of support from the ERDF should be extended by providing for new specific objectives under the ERDF, without prejudice to the rules on eligibility of expenditure and climate spending as set out in Regulation (EU) 2021/106055 and Regulation (EU) 2021/105856. In strategic sectors, it should also be possible to support productive investments in enterprises other than SMEs, which can make a significant contribution to the development of less developed and transition regions, as well as in more developed regions of Member States with a GDP per capita below the EU average. Managing authorities are encouraged to promote collective structures of VSEs/SMEs and the collaboration between large enterprises and local SMEs, supply chains, innovation and technology ecosystems. This would allow reinforcing Europe’s overall capacity to strengthen its position in those sectors through providing access to all Member States for such investments, thus counteracting the risk of increasing disparities. _________________ 55 Regulation (EU) 2021/1060 laying down common provisions (OJ L 231, 30.6.2021, p. 159). 56 Regulation (EU) 2021/1058 on the European Regional Development Fund and on the Cohesion Fund (OJ L 224, 24.6.2021, p. 31).
Amendment 191 #
2023/0199(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point a – introductory part
Article 2 – paragraph 1 – point a – introductory part
(a) supporting the development or manufacturing throughout the Union, or safeguarding and, strengthening and structuring the respective value chains at local, regional and national level, of critical technologies in the following fields:
Amendment 207 #
2023/0199(COD)
Proposal for a regulation
Article 2 – paragraph 1 – point b a (new)
Article 2 – paragraph 1 – point b a (new)
(ba) strengthening Europe's economic, social and territorial cohesion and reducing disparities between the level of development of the various regions.
Amendment 243 #
2023/0199(COD)
Proposal for a regulation
Article 3 – paragraph 2 a (new)
Article 3 – paragraph 2 a (new)
2a. Non-associated third-country entities are not eligible for support under this regulation, i.e. legal entity that is established in a non-associated third country or, where it is established in the Union or in an associated country that has its executive management structures in a non-associated third country.
Amendment 244 #
2023/0199(COD)
Proposal for a regulation
Article 3 – paragraph 2 b (new)
Article 3 – paragraph 2 b (new)
2b. By way of derogation from the preceding paragraph, a legal entity established in the Union or in an associated country and controlled by a non-associated third country or a non- associated third-country entity shall be eligible to be a recipient or subcontractor involved in an action only if guarantees approved by the Member State or the associated country in which it is established in accordance with its national procedures are made available to the Commission. Those guarantees may refer to the legal entity’s executive management structure established in the Union or in an associated country. If considered to be appropriate by the Member State or associated country in which the legal entity is established, those guarantees may also refer to specific governmental rights in the control over the legal entity. The guarantees provide assurances that participation in an action of such a legal entity is not contrary to the objectives set out in Article 2 of this Regulation.
Amendment 246 #
2023/0199(COD)
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Commission shall award a Sovereignty Seal to any action contributing to any of the Platform objectives, provided the action has been assessed and complies with the minimum quality requirements, in particular eligibility, exclusion and award criteria, provided by a call for proposals under Regulation (EU) 2021/695, Regulation (EU) 2021/694, Regulation (EU) 2021/697, Regulation (EU) 2021/522, or Commission Delegated Regulation (EU) 2019/856. In particular, the Commission shall take into account the action’s ability to strengthen and provide a structure for local networks of industrial actors, and preserve and generate employment.
Amendment 274 #
2023/0199(COD)
Proposal for a regulation
Article 5 – paragraph 3
Article 5 – paragraph 3
3. The Commission shall report on the expenditure financed by the Platform. It shall, as appropriate, report on the achievements related to each of the specific Platform objectives and in particular on objective 2(1)(c) (new) to ensure that the implementation of the Platform does not harm cohesion.
Amendment 281 #
2023/0199(COD)
Proposal for a regulation
Article 6 – paragraph 1 – point d a (new)
Article 6 – paragraph 1 – point d a (new)
(da) organisations and actors responsible for networks of industrial actors at local level that help to achieve the Platform’s objectives.
Amendment 287 #
2023/0199(COD)
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. The annual report shall include consolidated information on the progress made in implementing the Platform objectives under each of the programmes and funds. It shall include qualitative and quantitative information on how Europe's social, economic and territorial cohesion is being reinforced.
Amendment 291 #
2023/0199(COD)
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. The evaluation report shall, provide an overview of the regions for which the programmes have been amended (including information on relevant aspects of the partnership principle), and in particular, shall assess to which extent the objectives have been achieved, the efficiency of the use of the resources and the European added value. It shall also consider the continued relevance of all objectives and actions, in view of their potential upscaling. It shall be accompanied by a thorough assessment of differentiated territorial impacts and effects on cohesion in the implementation of the Platform.
Amendment 310 #
2023/0199(COD)
Proposal for a regulation
Article 10 – paragraph 1 – point 3
Article 10 – paragraph 1 – point 3
Regulation (EU) 2021/1058
Article 3 – paragraph 1a
Article 3 – paragraph 1a
The Commission shall pay 30 % of the ERDF allocation to that priority as set out in the decision approving the programme amendment as exceptional one-off pre- financing in addition to the yearly pre- financing for the programme provided for in Article 90(1) and (2) of Regulation (EU) 2021/1060 or in Article 51(2), (3) and (4) of Regulation (EU) 2021/1059. The exceptional pre-financing shall be paid by 31 December 2024, providedafter the Ccommission has adopted the decision approving the programme amendment by 31 October 2024pletion of the mid-term review of the programs, as provided for in Article 18 of Regulation (EU) 2021/1060.
Amendment 320 #
2023/0199(COD)
Proposal for a regulation
Article 11 – paragraph 1 – point 2
Article 11 – paragraph 1 – point 2
Regulation (EU) 2021/1056
Article 8 – paragraph 2 – new subparagraph
Article 8 – paragraph 2 – new subparagraph
The JTF may also support productive investments in enterprises other than SMEs contributing to the STEP objectives referred to in Article 2 of Regulation .../...65 [STEPRegulation]. That support may be provided irrespective of whether the gap analysis was carried out in accordance with Article 11(2)(h) and irrespective of its outcome. Such investments shall only be eligible where they do not lead to relocation as defined in point (27) of Article 2 of Regulation (EU) 2021/1060. The provision of such support shall not require a revision of the territorial just transition plan where that revision would be exclusively linked to the gap analysis. _________________ 65 Regulation …/… of the European Parliament and of the Council … [insert full title and OJ reference].
Amendment 331 #
2023/0199(COD)
Proposal for a regulation
Article 14 – paragraph 1 – point 2 a (new)
Article 14 – paragraph 1 – point 2 a (new)
Regulation (EU) 1303/2013
Article 24 – paragraph 1 a (new)
Article 24 – paragraph 1 a (new)
(2a) In Article 24 the following paragraph is inserted: "1a. By way of derogation from Article 60(1) and the first and fourth subparagraphs of Article 120(3), a co-financing rate of 100 % may be applied to expenditure declared in the final accounting year for one or more priority axes in a programme supported by the ERDF, the ESF or the Cohesion Fund. By way of derogation from Article 30(1) and (2) and Article 96(10), the application of the co-financing rate of 100 % shall not require a Commission decision approving a programme amendment. The Member State shall notify the revised financial tables to the Commission following approval by the monitoring committee. The co-financing rate of 100 % shall apply only if the financial tables are notified to the Commission before the submission of the final application for an interim payment for the final accounting year in accordance with Article 135(2)."
Amendment 332 #
2023/0199(COD)
Proposal for a regulation
Article 14 – paragraph 1 a (new)
Article 14 – paragraph 1 a (new)
Regulation (EU) 1303/2013
Article 2 – paragraph 29 a (new)
Article 2 – paragraph 29 a (new)
In Article 2 the following paragraph is inserted: "29a. The last accounting year of the period should be extended until June 30, 2025. "
Amendment 63 #
2023/0105(COD)
Proposal for a directive
Recital 12 a (new)
Recital 12 a (new)
(12a) In accordance with Annex I to Directive 2001/112/EC, fruit juices are the fermentable but unfermented products obtained from fruit which is sound and ripe. Other than products derived from the fermentation of grapes, products derived from the fermentation of fruit juices had no legal definition in EU legislation. The purpose of this Directive is to better inform consumers about the absence of added sugar in fruit juices and to promote techniques to reduce the sugar content naturally present in fruit juices. In view of the importance of cider and perry in market outlets for apple juice and pear juice respectively and the objective of promoting a healthier and more sustainable food system in the EU, Annex III to Directive 2001/112/EC should be amended to define the denominations ‘cider’ and ‘perry’ and to restrict them to products derived from the fermentation of, respectively, apple juice and pear juice without the addition of either sugar or alcohol, in order to ensure that consumers are properly informed.
Amendment 111 #
2023/0105(COD)
Proposal for a directive
Recital 12 a (new)
Recital 12 a (new)
Amendment 200 #
2023/0105(COD)
Proposal for a directive
Annex I – paragraph 1 – point 2
Annex I – paragraph 1 – point 2
Directive 2001/112/EC
Annex 3 – point a a (new)
Annex 3 – point a a (new)
(aa) ‘cider’: for the product of the fermentation of apple juice or concentrated apple juice or a mixture of the two products, possibly with the addition of water, without the addition of sugar or alcohol.
Amendment 201 #
2023/0105(COD)
Proposal for a directive
Annex I – paragraph 1 – point 2
Annex I – paragraph 1 – point 2
Directive 2001/112/EC
Annex 3 – point a b (new)
Annex 3 – point a b (new)
(ab) ‘perry’: for the product of the fermentation of pear juice or concentrated pear juice or a mixture of the two products, possibly with the addition of water, without the addition of sugar or alcohol.
Amendment 291 #
2023/0105(COD)
Proposal for a directive
Annex I – paragraph 1 – point 2
Annex I – paragraph 1 – point 2
Directive 2001/112/EC
Annex III – point 1 – point a a (new)
Annex III – point 1 – point a a (new)
aa. ‘cider’: for the product of the fermentation of apple juice or concentrated apple juice or a mixture of the two products, possibly with the addition of water, without the addition of sugar or alcohol.
Amendment 292 #
2023/0105(COD)
Proposal for a directive
Annex I – paragraph 1 – point 2
Annex I – paragraph 1 – point 2
Directive 2001/112/EC
Annex III – point 1 – point a b (new)
Annex III – point 1 – point a b (new)
Amendment 6 #
2023/0038M(NLE)
Draft opinion
Recital B a (new)
Recital B a (new)
Ba. whereas the EU has chosen to develop its open strategic autonomy so that it is less exposed to crises and disruptions in supply;
Amendment 10 #
2023/0038M(NLE)
Draft opinion
Recital B b (new)
Recital B b (new)
Bb. whereas, with the Green Deal, the EU is embarking on a new development project that is based on raising environmental standards in Europe and around the world;
Amendment 14 #
2023/0038M(NLE)
Draft opinion
Paragraph 1
Paragraph 1
1. Welcomes the elimination of tariffs on EU agri-food exports, including key products such as pigmeat (current tariff: 5%) and wine and sparkling wine (current tariff: 5%), thereby opening up new, albeit modest, business opportunities;
Amendment 22 #
2023/0038M(NLE)
Draft opinion
Paragraph 2
Paragraph 2
2. Welcomes the protection of geographical indications for EU wines and spirits as well as other food products, as required by the TRIPS Agreement since 1995; notes the efforts being made in relation to EU sensitive agricultural sensitivitieproducts by imposing limited and controlled access to highly sensitive products with the aim of protecting EU farmers through tariff rate quotas (TRQs); notescalls on the Commission to report within the next two years on the progress being made in including sustainability and animal welfare provisions;
Amendment 29 #
2023/0038M(NLE)
Draft opinion
Paragraph 3
Paragraph 3
3. Insists, nevertheless, that the Commission carefully manage and monitor the TRQs, and considers that TRQs should be accompanied by minimum entry prices to prevent dumping;
Amendment 35 #
2023/0038M(NLE)
Draft opinion
Paragraph 4
Paragraph 4
4. Calls on the EU to implement safeguards, such as seasonality, on the additional TRQs for agricultural products, as permitted by the WTO rules which the Commission very seldom uses to protect European market integrity;
Amendment 43 #
2023/0038M(NLE)
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Notes that the New Zealand milk sector benefits from an undertaking with a virtual monopoly over its exports;
Amendment 45 #
2023/0038M(NLE)
Draft opinion
Paragraph 5
Paragraph 5
5. Recognises that the EU dairy, beef and sheep sectors are under pressure owing to the market access being given to non-EU countries and the level of international prices, which are never balanced prices, but either dumping prices when surpluses are being dumped, or speculative prices when security of supply is at stake; calls on the Commission to consider the cumulative impacts of past and future trade deals on EU farmers and the need for investment into protect local EU production; when international prices are too low, in order to ensure food security for Europeans;
Amendment 56 #
2023/0038M(NLE)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Commission to refrain from proposing tariff concessions that threaten livestock breeding in Europe;
Amendment 60 #
2023/0038M(NLE)
Draft opinion
Paragraph 6
Paragraph 6
6. Underlines that it would welcome exchanges between the EU and New Zealand on good practices, in particular regarding regulations on new breeding techniques and attracting young peopleexchanging good regulatory and scientific practices, in particular regarding existing regulations on GMOs and the regulations on new GMOs that are currently being negotiated, in order to take advantage of New Zealand’s long experience in controlling invasive species; considers that this Free Trade Agreement will not help to attract young Europeans into the farming profession;
Amendment 71 #
2023/0038M(NLE)
Draft opinion
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Commission to move towards new and real partnership agreements with States and regional entities that want to cooperate in order to achieve human development goals and the ecological transition, and to organise fair trade; considers that real partnership agreements should be developed by involving civil society in democratic processes and should be implemented with the consent of the local populations affected;
Amendment 76 #
2023/0038M(NLE)
Draft opinion
Paragraph 7 b (new)
Paragraph 7 b (new)
7b. Calls on the Commission to draw inspiration from the history of commodity agreements in order to secure the supply of raw materials through multiannual government-to-government agreements with restricted prices and thereby break the stranglehold of the large international traders;
Amendment 2 #
2021/2213(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the multiplication of crises such as the global consequences of the COVID-19 pandemic and the Russian war of aggression against Ukraine call for the forging of stronger alliances and more effective partnerships which deliver tangible results in order to better address emerging needs and global challenges by supporting early warning systems for a swift range of information and early actions in live-saving assistance;
Amendment 2 #
2021/2213(INI)
Motion for a resolution
Recital B
Recital B
B. whereas the multiplication of crises such as the global consequences of the COVID-19 pandemic and the Russian war of aggression against Ukraine call for the forging of stronger alliances and more effective partnerships which deliver tangible results in order to better address emerging needs and global challenges by supporting early warning systems for a swift range of information and early actions in live-saving assistance;
Amendment 6 #
2021/2213(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the long-standing partnership between the EU and the ACP countries is of great importance given the number of countries it unites and the greater role it could play in the multilateral system, which is currently under strain; whereas this partnership agreement brings together more than half of the UN member states;
Amendment 6 #
2021/2213(INI)
Motion for a resolution
Recital C
Recital C
C. whereas the long-standing partnership between the EU and the ACP countries is of great importance given the number of countries it unites and the greater role it could play in the multilateral system, which is currently under strain; whereas this partnership agreement brings together more than half of the UN member states;
Amendment 7 #
2021/2213(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the EU and ACP countries must pursue a strengthened partnership between equals in order to generate mutually beneficial outcomes on common and intersecting interests and in a spirit of shared responsibility, solidarity, reciprocity, mutual respect and accountability;
Amendment 7 #
2021/2213(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the EU and ACP countries must pursue a strengthened partnership between equals in order to generate mutually beneficial outcomes on common and intersecting interests and in a spirit of shared responsibility, solidarity, reciprocity, mutual respect and accountability;
Amendment 8 #
2021/2213(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the EU and ACP countries must pursue a strengthened partnership in order to generate mutually beneficial outcomes on common and intersecting interests and in a spirit of shared responsibility, co-creation, solidarity, reciprocity, mutual respect and accountability;
Amendment 8 #
2021/2213(INI)
Motion for a resolution
Recital D
Recital D
D. whereas the EU and ACP countries must pursue a strengthened partnership in order to generate mutually beneficial outcomes on common and intersecting interests and in a spirit of shared responsibility, co-creation, solidarity, reciprocity, mutual respect and accountability;
Amendment 19 #
2021/2213(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Reiterates the importance of the parliamentary dimension and the political dialogue as an integral part of the partnership;
Amendment 19 #
2021/2213(INI)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Reiterates the importance of the parliamentary dimension and the political dialogue as an integral part of the partnership;
Amendment 34 #
2021/2213(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Insists on the need to give greater prominence to the human and social development aspects of the agreement and the need to improve resources for humanitarian aid and to guarantee effective channels of access to its implementation;
Amendment 34 #
2021/2213(INI)
Motion for a resolution
Paragraph 11
Paragraph 11
11. Insists on the need to give greater prominence to the human and social development aspects of the agreement and the need to improve resources for humanitarian aid and to guarantee effective channels of access to its implementation;
Amendment 96 #
2021/2213(INI)
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28 a. Stresses the importance of the parliamentary dimension in this agreement, as representatives of the civil society of four continents and aggregators of the diversity in a parliamentary assembly;
Amendment 96 #
2021/2213(INI)
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28 a. Stresses the importance of the parliamentary dimension in this agreement, as representatives of the civil society of four continents and aggregators of the diversity in a parliamentary assembly;
Amendment 98 #
2021/2213(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Welcomes the commitment to promote a multi-stakeholder approach, enabling the active engagement of a wide variety of actors, including parliaments, local authorities, civil society, especially women and young people, and the private sector; calls for this commitment to be rapidly translated into practice, which will necessitate the creation of an open and transparent mechanism for structured consultation in order to ensure the effective participation of stakeholders;
Amendment 98 #
2021/2213(INI)
Motion for a resolution
Paragraph 29
Paragraph 29
29. Welcomes the commitment to promote a multi-stakeholder approach, enabling the active engagement of a wide variety of actors, including parliaments, local authorities, civil society, especially women and young people, and the private sector; calls for this commitment to be rapidly translated into practice, which will necessitate the creation of an open and transparent mechanism for structured consultation in order to ensure the effective participation of stakeholders;
Amendment 102 #
2021/2213(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Welcomes the provisions on global alliances and international cooperation included in the new agreement, with commitments to the rules-based international order and to promoting international dialogue and seeking multilateral solutions to drive global action forward, promoting peace and development;
Amendment 102 #
2021/2213(INI)
Motion for a resolution
Paragraph 31
Paragraph 31
31. Welcomes the provisions on global alliances and international cooperation included in the new agreement, with commitments to the rules-based international order and to promoting international dialogue and seeking multilateral solutions to drive global action forward, promoting peace and development;