Activities of Estelle CEULEMANS
Plenary speeches (14)
The future of European competitiveness (debate)
The crisis facing the EU’s automotive industry, potential plant closures and the need to enhance competitiveness and maintain jobs in Europe (debate)
World Mental Health Day - need for a comprehensive EU strategy on mental health (debate)
World Mental Health Day - need for a comprehensive EU strategy on mental health (debate)
Empowering the Single Market to deliver a sustainable future and prosperity for all EU citizens (debate)
Guidelines for the employment policies of the Member States (debate)
Tackling the steel crisis: boosting competitive and sustainable European steel and maintaining quality jobs (debate)
Closing the EU skills gap: supporting people in the digital and green transitions to ensure inclusive growth and competitiveness in line with the Draghi report (debate)
Urgent need to tackle the gender pay gap (debate)
Rise of energy prices and fighting energy poverty (debate)
Strengthening children’s rights in the EU - 35th anniversary of the adoption of the United Nations Convention on the Rights of the Child (debate)
Regional Emergency Support: RESTORE (debate)
Promoting social dialogue and collective bargaining and the right to strike in the EU (debate)
Tackling abusive subcontracting and labour market intermediaries (debate)
Written explanations (3)
Objection pursuant to Rule 115(2) and (3), and (4)(c): Maximum residue levels for carbendazim and thiophanate‐methyl
La proposition de la Commission européenne d'autoriser les résidus de trois pesticides interdits au sein de l’UE pour l'importation de certains aliments en provenance de pays tiers est dangereuse et incohérente.Avec cette proposition, la Commission met la santé des Européens en danger! Ces pesticides sont considérés comme mutagènes, potentiellement cancérigènes, toxiques pour la reproduction et perturbateurs endocriniens.Une telle décision exacerberait également la concurrence déloyale à laquelle les agriculteurs européens sont confrontés. Plus que jamais, je plaide pour l'intégration de clauses miroirs dans les accords commerciaux.Enfin, il est inacceptable d'approuver implicitement la poursuite de l'utilisation de pesticides interdits en Europe à l'étranger sans tenir compte de leur impact sur la santé des travailleurs agricoles et des communautés locales.
Mobilisation of the European Globalisation Adjustment Fund: application EGF/2024/001 BE/Match-Smatch
J’ai voté en faveur de l’activation du Fonds européen d’ajustement à la mondialisation (FEM) pour soutenir les 513 travailleurs licenciés des supermarchés Match-Smatch en Belgique. Cette aide de 2,66 millions d’euros, qui couvre 85 % des coûts des mesures proposées, est essentielle pour aider ces travailleurs à se réinsérer sur le marché du travail, notamment à travers des programmes de formation, de requalification et d’accompagnement à la création d’entreprises.La situation des travailleurs de Match-Smatch est particulièrement préoccupante. En 2023, le secteur de la vente au détail alimentaire en Belgique a été frappé de plein fouet par la crise énergétique et inflationniste, ainsi que par l’augmentation des achats transfrontaliers et du commerce en ligne.Il s’agit d’un soutien crucial pour ces travailleurs en difficulté. Je reste déterminée à poursuivre mon engagement pour une Europe sociale, solidaire et capable de proposer des emplois de qualité à tous. Cette décision s’inscrit dans une vision plus large de la défense de politiques industrielles ambitieuses, permettant de protéger nos emplois et de soutenir ceux qui en ont le plus besoin.
Deforestation Regulation: provisions relating to the date of application
Le vote de la proposition de la Commission européenne visant à retarder d’une année l’entrée en vigueur du règlement sur la déforestation marque un point de bascule au sein du Parlement européen.Ce vote est une attaque en règle du Parti populaire européen contre un élément important du Pacte vert. Ce règlement étant crucial pour garantir que les produits importés au sein de l'Union européenne ne soient pas issus de la déforestation et pour préserver la biodiversité en pleine urgence climatique encore symbolisée récemment par les dramatiques inondations à Valence.C’est un vote funeste pour la crédibilité de l’UE dans la lutte contre le changement climatique et pour la démocratie européenne.
Written questions (8)
Restructuring at Audi in Brussels
Human rights violations by EU-funded forces in Tunisia
The CJEU judgment and the ‘return of vehicles’ provision in the Mobility Package
Launch of European humanitarian corridors from Lebanon to the EU
Continued availability of operating grants under the 2025 EU4Health work programme
Blatant disregard of International Criminal Court decisions by the Hungarian Prime Minister
The role of TikTok in the Romanian presidential election
The spread of disinformation by recommender systems and other automated mechanisms as a systemic risk under the Digital Services Act
Amendments (274)
Amendment 2 #
2024/2829(RSP)
Draft motion for a resolution
Citation 2 a (new)
Citation 2 a (new)
– having regard to the revised European Social Charter,
Amendment 53 #
2024/2829(RSP)
Draft motion for a resolution
Recital D
Recital D
D. whereas companies often prioritise short-term profits over economic sustainability and long-term employment stability, underscoring the need for trade union involvement and corporate social responsibility in restructuring plans;
Amendment 66 #
2024/2829(RSP)
Draft motion for a resolution
Recital E
Recital E
E. whereas according to European Restructuring Monitor (ERM) the automotive industry is a vital economic pillar in Europe that currently supports around 13 million jobs;
Amendment 69 #
2024/2829(RSP)
Draft motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas Eurofound data shows that employment in vehicle manufacturing, the supplier industry and in sales has increased somewhat in the last decade, the last three years have seen signs of decline, with European Restructuring Monitor recording evidence of large scale lay-offs in a several countries and among different manufacturers. The overall number of jobs in the automotive sector (NACE C29, G45) is on a continuous decline since mid-2023;
Amendment 79 #
2024/2829(RSP)
Draft motion for a resolution
Recital F
Recital F
F. whereas the transition from internal combustion engines to electric vehicles is imperative, but it must be achieved in a way that avoids job losses in traditional automotive manufacturingbuilds on jobs and workers of traditional manufacturing and capitalises on the employment potential of EV manufacturing including the jobs in its supply chains and in the charging infrastructure;
Amendment 106 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 1
Paragraph 1
1. Highlights that employment security, fair wages and decent working conditions are fundamental rights that must be upheld in all restructuring processes to protect workers from corporate profit- seeking strategies; stresses the urgent need for an ambitious European industrial policy with significant investment that will support common goods and innovation and deliver quality jobs in every region and sector and social progress; underlines that this policy should be based on strong public services, social protection, housing, transport and childcare; supports a robust European industrial policy based on resilient and well-resourced public services and public administration, covering not just manufacturing, but all sectors and all transitions;
Amendment 118 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 2
Paragraph 2
2. Reiterates its call for a permanent investment tool at EU level to ensure that the necessary resources are available in all sectors for developing an industrial policy and for policies that support the protection and creation of quality jobs and help reach the social and green targets, based on the positive experiences of NextGenerationEU and the strong labour focus of the support to mitigate unemployment risks in an emergency instrument (SURE); remains that the Eurofound assessment shows the job retention schemes, in part supported through SURE, saved an estimated 26.9 million jobs in the EU during the pandemic;
Amendment 129 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 3
Paragraph 3
3. Highlights that the delivery of a European industrial policy for quality jobs requires the full involvement of social partners and needs to be implemented through social dialogue and collective bargaining; calls on the Commission to ensure targeted consultation of social partners in the definition of the Clean Industrial Deal; calls on the Commission to include the overall objective of raising workensuring quality jobs at the EU level;
Amendment 158 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 5
Paragraph 5
5. Urges the Commission to revise the European Public Procurement Directive6 in order to establish preferential treatment for companies complying with collective bargainingwhose workers are covered by collective agreements; calls on the Commission to strengthen the social clause and exclude from tenders companies that have engaged in criminal activities or union busting, have not respected workers’ and trade union rights or that have refused to participate in collective bargaining; highlights the importance of ensuring that public money is used to invest in those engaged in just transitions with the aim of promoting collective agreements and increasing trade union densities; considers, furthermore, that all EU financial support to undertakings should be made conditional on their compliance with the applicable working and employment conditions and/or employer obligations resulting from the relevant collective agreements; believes that this support should also be conditional on their commitment to investing in European industries and maintaining jobs in the EU; __________________ 6 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC, OJ L 94, 28.3.2014, p. 65, ELI: http://data.europa.eu/eli/dir/2014/24/oj.
Amendment 161 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Highlights that according to Eurofound research of working conditions, not all jobs created as a result of the de-carbonisation of the economy will be good quality jobs and that monitoring of job quality remains essential; calls for the quality jobs roadmap to include a proposal on social conditionalities in the access to European funds related to decarbonisation;
Amendment 170 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 6
Paragraph 6
6. Reiterates its call for EU funding and support to companies, including State aid, to be conditional on public policy objectives, especially in strategic sectors, and on social requirements, in order to offerensure high-quality jobs, promote collective bargaining, respect EU labour rights and standards, and ensure improved working conditions;
Amendment 181 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 7
Paragraph 7
7. Supports investments in sectors such as electric vehicle battery production, charging infrastructure, renewable energy and digital technologies; insists that these investments must prioritise quality jobs, workers’ rights and community development;
Amendment 190 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 8
Paragraph 8
8. Invites the Commission to monitor the trends in restructuring and their impact on employment, using data from tools, such as the European Restructuring Monitor and the forthcoming EU Fair Transition Observatory, to track the number of jobs created or abolished and the companies concerned;
Amendment 200 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 9
Paragraph 9
9. Stresses that restructuring processes are essential intransformation processes will need to take place in the process of achieving the green transition objectives and are an imperative for a net-zero economy that sustains its social and environmental standards; warns that transformation processes and restructuring processes must never come at the cost of workers’ rights or working conditions and must safeguard and create quality jobs; calls on the Commission to take action to reinforce and promote collective bargaining, ensuring an increase in collective bargaining coverage to at least 80 % in all Member States, a target, according to Eurofound currently reached in only 8 of them, and guaranteeing full respect of the right to collective bargaining;
Amendment 205 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Notes the need for strengthening social dialogue and for better articulation of collective agreements insofar as according to Eurofound most of the recently identified agreements have been concluded at company level, some have been identified at the cross-sectoral level, with few agreements available at sectoral level;
Amendment 213 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 10
Paragraph 10
10. Emphasises that when no other option is available restructuring processes should start as early as possible to prevent insolvency and mitigateavoid job losses; calls on the Commission and the Member States to support companies working closely with trade unions and workers’ representatives to identify warning signs early and develop comprehensive plans to address employment needs;
Amendment 222 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 11
Paragraph 11
11. Warns that restructuring must not be used as a pretext to violate workers’ and trade union rights7 ; deplores the frequent violations of the fundamental rights of collective bargaining and information and consultation before a decision is made; emphasises that trade unions must be empowered to challenge any company’s decision to restructure with the right to call on the support of an independent expert, paid by the employer, to evaluate any restructuring case; calls on the Commission to put in place further safeguards to prevent the misuse of restructuring as a means to exploit workers or avoid obligations, particularly in cases of tactical insolvency; sanctions should be imposed on abuses; __________________ 7 Study – ‘Study on monitoring the application of the EU Quality Framework for anticipation of change and restructuring’, European Commission, Directorate-General for Employment, Social Affairs and Inclusion, Publications Office of the European Union, 2018, https://op.europa.eu/en/publication-detail/- /publication/1c22896d-4e10-11ea-aece- 01aa75ed71a1/language-en.
Amendment 228 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Is alarmed that European company law provisions are being used to circumvent national systems of workers’ information, consultation and participation; reiterates its call to introduce a new framework directive on workers’ information, consultation and participation for European companies, in order to establish minimum standards for information, consultation and participation for those company forms , in particular at company level ; stresses that the Directive for a Just Transition in the world of work must strengthen democracy at work with regards to measures concerning climate change, digital transformation and restructuring;
Amendment 237 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 12
Paragraph 12
12. Calls on the Commission to present a proposal for a directive on just transition in the world of work, through anticipation and management of change, based on the principles of trade union involvement and collective bargaining; urges the Commission to ensure the right for all to training without cost to the worker and during working hours; believes that this proposal should include a right to job-to- job transition and a right to quality upskilling or reskilling training, employee training and career development support; points out that when job changes are necessary, the priority should always be upskilling workers to keep them in the same company; notes that, when job-to-job transition is necessary, keeping workers in the same sector and region while allowing them sufficient time for reconversion without personal financial losses is essential; stresses that the principle of a fair and social just transition willmust apply to restructuringany transformation or restructuring processes for any transitions (including the green and the digital ones), especially in transforming industries in strategic sectors such as automotive and energy, and will put the workersorkers must be put first;
Amendment 258 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 14
Paragraph 14
14. Calls on the Commission to develop a comprehensive plan, similar to the United States’ Inflation Reduction Act, focused on boosting investment in green technologies, renewable energy and sustainable industries and ensuring quality jobs, with the objective of accelerating the EU’s transition to a climate-neutral economy and managing all transitions while strengthening the European social model and social justice;
Amendment 266 #
2024/2829(RSP)
Draft motion for a resolution
Paragraph 15
Paragraph 15
15. Calls for the establishment of a comprehensive directive to address the challenges and complexities associated with subcontracting and labour intermediaries in Europe to ensure fair working conditions, adequate rights and protections for subcontracted workers; calls for the directive to include measures regulating the role of labour intermediaries and introducing an EU general legal framework limiting subcontracting and ensuring joint and several liability through the subcontracting chain, as well as provisions for collective bargaining rights to ensure equal treatment and enable subcontracted workers to negotiate their terms of employment effectively;
Amendment 31 #
2024/2077(INI)
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the number of women in poverty is higher than the number of men in poverty and women continue to be more affected by poverty and the risk of social exclusion than men, in particular women who experience intersectional forms of discrimination; whereas almost half of the single mothers live in poverty or at risk of poverty or social exclusion;
Amendment 36 #
2024/2077(INI)
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas the youth unemployment rate in the European Union is nearly 15%; whereas being unemployed in particular in the time of youth can lead to financial problems, as well as less happiness, social isolation and mental health issues;
Amendment 37 #
2024/2077(INI)
Motion for a resolution
Recital C c (new)
Recital C c (new)
Cc. whereas the digital and green transitions are much needed and at the same time bring challenges along, such as the need to reskill the workforce, investment in new technologies, the digital skills gap and the digital gender divide; whereas these transitions can only be successful if we do not leave the people and the workers necessary for these transitions out of sight by ensuring a just transition;
Amendment 39 #
2024/2077(INI)
Motion for a resolution
Recital C d (new)
Recital C d (new)
Cd. whereas the social and economic integration of labour migrants should be improved in order to ensure that they are included in our societies; whereas special attention should be given to labour migrants coming from third countries and undocumented migrants;
Amendment 41 #
2024/2077(INI)
Motion for a resolution
Recital C e (new)
Recital C e (new)
Ce. whereas the European Care Strategy aims to ensure quality, affordable and accessible care services with better working conditions and work- life balance for carers across the European Union;
Amendment 71 #
2024/2077(INI)
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Stresses that the ESF+ must address, contribute and adapt to tackling challenges such as consequences of climate change, digitalization, supply chain weaknesses, while addressing the social challenges, such as the cost of living and stagnating wages, promoting social resilience, reducing inequalities, and protecting the most vulnerable; insists that ESF+ should drive long-term investment, focusing on economic, social, and territorial cohesion, while supporting structural transformation across the EU and enhancing convergence between countries;
Amendment 73 #
2024/2077(INI)
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Insists that ESF+ must continue to enhance upward social mobility, especially for the most deprived, invest in human capital, employment, skills development, and social inclusion, addressing the digital and green transitions, demographic challenges, and regions impacted by crises like the war in Ukraine;
Amendment 74 #
2024/2077(INI)
Motion for a resolution
Paragraph 1 c (new)
Paragraph 1 c (new)
1c. Insists that ESF+ must continue to enhance employment opportunities, facilitate decent labour mobility, foster creation of quality jobs, ensure fair working conditions, and improve employment participation to enhance social and economic resilience, and thus help to adapt to industrial changes through training and upskilling;
Amendment 114 #
2024/2077(INI)
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Highlights that the availability and equal access to free and quality public services such as early childhood education and care, education, health, as well as access to adequate, affordable and decent housing and essential services such as affordable energy, sanitation, water and healthy nutrition are necessary conditions for ensuring equal opportunities and improving employment levels, for the improvement of living and working conditions and to fight poverty and social exclusion;
Amendment 150 #
2024/2077(INI)
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Stresses the importance of the social inclusion of people with disabilities and insists therefore that the ESF+ supports the employment of people with disabilities through work and training placements, especially in facilitating transitions from sheltered workshops to the open labour market; underlines that the ESF+ should support community- based services and independent living and facilitate home support and personal assistance schemes;
Amendment 151 #
2024/2077(INI)
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11b. Stresses that the ESF+ should invest in projects targeting the employment and social and economic inclusion of women, with special attention to female headed households; insists that the ESF+ supports women who are as a consequence of gender based violence having difficulties to (re)integrate in society and need extra support to be socially included; repeats its call to have an intersectional approach in this matter;
Amendment 152 #
2024/2077(INI)
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11c. Reminds that the ESF+ should also aim to provide a healthy and well- adapted working environment in order to respond to health risks related to changing forms of work, and the needs of the ageing workforce; stresses that the pandemic has accelerated new realities, new forms of work brought by digitalisation, including artificial intelligence (AI), that have affected workers’ occupational safety and health; in this light calls to support and fund sufficiently the Directive on the right to disconnect and teleworking rules, a Directive on AI at workplace and the Directive on psychosocial risks and well- being at work, as well as an increased funding for an effective work on the protection of workers against dangerous and harmful substances;
Amendment 159 #
2024/2077(INI)
Motion for a resolution
Paragraph 12
Paragraph 12
12. Calls on the Commission, in the light of current challenges, to include in the specific objectives of the ESF+ the promotion of the just transition, the socio- economic integration of migrants, including labour migrants, the social inclusion of women who are victims of gender-based violence, including economic violence, and the integration of older people;
Amendment 221 #
2024/2077(INI)
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls for a strengthening of efforts to support the implementation of the Youth Guarantee with an increased earmarking for all Member States that dedicate at least 15 % of their ESF+ resources to support the targeted actions and structural reforms to support quality youth employment, vocational education and training, in particular traineeships and apprenticeships, and the transition from school to work, pathways to reintegrate into education or training and second chance education ; repeats in this context its call on the Member States to ban unpaid traineeships;
Amendment 246 #
2024/2077(INI)
Motion for a resolution
Paragraph 20
Paragraph 20
20. Stresses that the Employment and Social Innovation strand of the ESF+ provides support regardsupports initiatives addressing the precarious situation of mobile workers beyond sporadic projects and secures funding for trade union-related counselling; calls on the Commission and the Member States to ensure permanent funding for a European network of national and transnational trade union counselling services for such workers in order to enhance fair labour mobility;
Amendment 6 #
2024/2030(DEC)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Appreciates the high quality work performed by the agencies working in the area of employment, social affairs and inclusion (Eurofound, EU-OSHA, CEDEFOP, ETF and ELA); recalls the particular mandates of these agencies and the specific composition of their management bodies based on the tripartite principle and thus including representatives of the national authorities and social partners; recognises that trough their members the management bodies ensure the necessary alignment between the agencies’ work and stakeholders’ needs and priorities;
Amendment 7 #
2024/2030(DEC)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Stresses the importance, autonomy and added value of the five agencies in their field of expertise; reiterates the need to equip the agencies at a level commensurate to the assigned tasks, with a sufficient number of staff, employed in a stable manner and having sufficient material resources;
Amendment 8 #
2024/2030(DEC)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1 c. Appreciates the five agencies’ key contribution in promoting the European Year of Skills 2023; congratulates in this regard for successfully hosting the event ‘Skills, skills, skills! Skills for people, skills for competitiveness, skills for sustainability’ with the participation of the five agencies at the European Parliament in September 2023;
Amendment 9 #
2024/2030(DEC)
Draft opinion
Paragraph 1 d (new)
Paragraph 1 d (new)
1 d. Recalls the importance of developing a long term HR policy on work-life balance, ensuring teleworking, right to disconnect and career development, enhancing the geographical balance to have an appropriate representation from all Member States, and recruiting and integrating people with disabilities as well as promoting their equal treatment and their opportunities;
Amendment 11 #
2024/2030(DEC)
Draft opinion
Paragraph 2
Paragraph 2
2. Welcomes the five agencies’ continued and growing cooperation and sharing of resources among them and with other institutions, including other EU agencies from different policy areas, the Commission and the Parliament;
Amendment 13 #
2024/2030(DEC)
Draft opinion
Paragraph 3
Paragraph 3
3. Calls on the Commission to ensure better use of the Agencies’ expertise in relevant policy areas regarding for example, elaboration of reports and studies, conducting research and surveys, which can allow for more efficient utilisation of Union budget resources compared to alternative solutions; stresses, in this regard, the unused potential in providing for specific, relevant information and the same quality products as external consultants, when their mandates allow it;
Amendment 17 #
2024/2030(DEC)
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3 a. Appreciates the five agencies’ efforts to further develop their digital and online communication in order to increase their visibility and raise awareness of their high-impact work;
Amendment 31 #
2024/2030(DEC)
Draft opinion
Paragraph 5
Paragraph 5
5. Appreciates the Foundation’s high quality work on enhancing and disseminating knowledge, and providing evidence-based expertise to support the development of better informed social, employment and work-related policies in Europe, to analyse policy options to improve working conditions, industrial relations, employment and living, and to produce expertise on right to disconnect, telework, hybrid work and related impacts on work– life balance and quality of working conditions; highly values the Foundation’s work in providing insights on pressing issues, such as poverty, the inaccessibility of affordable housing, labour shortages, and just transition;
Amendment 35 #
2024/2030(DEC)
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5 a. Observes some of the Foundation’s most important publications in 2023 on topics as job quality (including of essential workers), hybrid work, right to disconnect, involvement of the social partners in setting and implementing the national resilience and recovery plans, and minimum wages in Europe;
Amendment 37 #
2024/2030(DEC)
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5 b. Appreciates the Foundation’s report on right to disconnect published in 2023 which fills an information gap by providing evidence on how the right to disconnect is implemented at company level and what the impact is;
Amendment 40 #
2024/2030(DEC)
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6 a. Notes from the Foundation’s report with regard to the follow-up measures taken in light of the discharge in respect of the implementation of the budget of the Foundation for the financial year 2022 that corrective actions have been taken in connection to its procurement templates and traineeship scheme;
Amendment 46 #
2024/2030(DEC)
Draft opinion
Paragraph 9
Paragraph 9
9. Appreciates the Agency’s activities to develop, gather and provide reliable and relevant information, analysis and tools on national and EU priorities in the field of occupational safety and healthto advance knowledge, raise awareness, and exchange information and good practise on national and EU priorities in the field of occupational safety and health, which contribute to the Union policy aiming to promote healthy and safe work places across the Union;
Amendment 47 #
2024/2030(DEC)
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9 a. Notes the prominent role of the Agency in delivering on the priorities and principles identified in the European Pillar of Social Rights and the EU OSH Strategic Framework; appreciates in this regard the Agency’s continued significant contribution, through several actions carried out alone or in collaboration with EU institutions, other agencies and bodies;
Amendment 54 #
2024/2030(DEC)
Draft opinion
Paragraph 15
Paragraph 15
15. Appreciates the Cedefop’s activities tohigh quality work on provideing research, analyses and technical advice and expertise in vocational education and training (VET), qualifications and skills policies, to compile and disseminate research on skills mismatches with the aim of promoting high-quality training tailored to the needs of individuals and of the labour market, and to ensure digital skills are integrated into VET across the Union, as well as, the Cedefop involvement in the 2023 European Year of Skills;
Amendment 62 #
2024/2030(DEC)
Draft opinion
Paragraph 17 a (new)
Paragraph 17 a (new)
17 a. Notes with appreciation the Centre’s commitment to become carbon neutral by 2030; welcomes the adoption of a climate neutrality strategy and roadmap in 2023 and the efforts to become EMAS certified by 2025;
Amendment 70 #
2024/2030(DEC)
Draft opinion
Paragraph 23
Paragraph 23
23. Appreciates the Authority’s work to assist Member States and the Commission in ensuring a fair and effective enforcement of Union rules on labour mobility and coordination of social security systems, in facilitating effective labour mobility in Europe through European Employment Services (EURES) activities, making it easier for citizens and businesses to benefit from the internal market, and to raising awareness, through training and information campaigns, about the rights and obligations of workers and employers;
Amendment 74 #
2024/2030(DEC)
Draft opinion
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Notes that the year 2023 was a final year of the Authority’s setup and growth phase, resulting in reaching full operational capacity, as regards both operational activities and resources;
Amendment 75 #
2024/2030(DEC)
Draft opinion
Paragraph 23 b (new)
Paragraph 23 b (new)
23 b. Welcomes the adoption of the Authority’s business continuity plan in September 2023;
Amendment 4 #
2024/2019(DEC)
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1 a. Recalls the importance to monitor the use of EU funds to ensure the protection of the EU’s financial interests; calls on the Commission to make full use of the tools available to address the clear risk of a serious breach of the EU’s values and the rule of law;
Amendment 5 #
2024/2019(DEC)
Draft opinion
Paragraph 1 b (new)
Paragraph 1 b (new)
1 b. Recalls that spending under the subheading 2a “Economic, social and territorial cohesion” (Subheading 2a) focuses on reducing disparities between Member States and regions of the EU; stresses the importance of EU cohesion policy in supporting the implementation of the European Pillar of Social Rights and the EPSR Action Plan and its headline targets, provide an important contribution to the EU’s employment, social, education and skills policies, including structural reforms in these areas; stresses in this regard especially the importance of ESF+ and expresses the need to provide it with the continued financial and political support of the EU, national and regional institutions in the delivery of its objectives and targets in the years to come;
Amendment 6 #
2024/2019(DEC)
Draft opinion
Paragraph 1 c (new)
Paragraph 1 c (new)
1 c. Welcomes the launch of the European Year of Skills on 9 May 2023 with the aim to boost the competitiveness of Union undertakings, in particular small and medium-sized enterprises (SMEs), and to contribute to the creation of quality jobs, with a view to realising the full potential of the green and digital transitions in a socially fair, inclusive and just manner, thereby promoting equal access to skills development and reducing inequalities and segregation in education and training and contributing to continuous learning and career progression, empowering people to access quality jobs and to fully participate in the economy and society;
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 2 #
2024/0599(NLE)
Recital 1
(1) Member States and the Union are to work towards developing a coordinated strategy for employment and in particular for the promotion of quality employment and improving working conditions, a skilled, trained and adaptable workforce, as well as labour markets that are inclusive, future-oriented and responsive to economic and demographic change, with a view to achieving the objectives of full employment and social progress, balanced growth, a high level of protection and improvement of the quality of the environment laid down in Article 3 of the Treaty on European Union (TEU). Member States are to regard promoting employment as a matter of common concern and are to coordinate their action in that respect within the Council, taking into account national practices related to the responsibilities of management and labour.
Amendment 6 #
2024/0599(NLE)
Recital 4
(4) In order to enhance economic and social progress and upward convergence, support the green and digital transitions, strengthen the Union industrial base and achieve inclusive, competitive and resilient labour markets in the Union, Member States should while avoiding any negative social consequences, Member States should promote good wages, decent working conditions, foster democracy at work, social dialogue and collective bargaining, protect workers´ rights, address labour and skills shortages and promote quality and inclusive education and training, with a particular focus on improving basic skills, especially among disadvantaged students, and on STEM (science, technology, enginerering and mathematiscs) in school and higher education, future-oriented vocational education and training, and lifelong upskilling and reskilling, as well as effective active labour market policies and improved working conditions and career opportunities. This is of particular relevance for the less developed, remote and outermost regions of the EU, where the needs are the greatest. Shortages can be further addressed by improving fair intra- EU mobility for workers and learners and attracting talent from outside the EU. In addition, the links between the education and training systems and the labour market should be strengthened and skills, knowledge and competences acquired through non-formal and informal learning recognised.
Amendment 14 #
2024/0599(NLE)
Recital 6
(6) The European Semester combines different instruments in an overarching framework for integrated multilateral coordination and surveillance of economic and employ, employment, social and environmental policies within the Union. While pursuing environmental sustainability, productivity, fairness and macroeconomic stability, the European Semester integratesAs part of its integrated analysis of employment and social developments in the context of the European Semester, the Commission assesses risks to upward social convergence in Member States and monitors progress on the implementation of the principles of the European Pillar of Social Rights and its monitoring tool,on the basis of the Social Scoreboard, also allowing an analysis of risks and challenges to upward social convergence in the Union, andnd of the principles of the Social Convergence Framework. While pursuing environmental sustainability, productivity, fairness and macroeconomic stability, the European Semester provides for strong engagement with social partners, civil society and other stakeholders. It also supports the delivery of the Sustainable Development Goals. The economic and employment policies of the Union and the Member States should go hand in hand with the Union’s fair transition to a climate-neutral, socially inclusive, environmentally sustainable and digital economy, improve competitiveness, ensure adequategood wages and decent working conditions, foster innovation, democracy at work, social dialogue and collective bargaining, promote social justice, equal opportunities and upward socio-economic convergence, and tackle inequalities and regional disparities and reduce poverty.
Amendment 20 #
2024/0599(NLE)
Recital 7 – paragraph 1
Climate change and other environment- related challenges, the need to ensure a fair green transition, energy independence, enhanced competitiveness of net-zero industries and the need to secure Europe’s open strategic autonomy, as well as the development of digitalisation, artificial intelligence and the platform economy, an increase in teleworking and demographic change are deeply transforming Union economies and societies. The Union and its Member States are to work together to effectively and proactively address such structural developments and adapt existing systems as needed, recognising the close interdependence of the Member States’ economies and labour markets, and related policies. This requires coordinated, ambitious and effective policy action at both Union and national levels while recognising the role of social partners and involving them, in accordance with the TFEU and with the Union’s provisions on economic governance, taking into account the European Pillar of Social Rights. Such policy action should encompass a boost in sustainable investment across all EU regions, a renewed commitment to appropriately sequenced reforms and investments that enhance sustainable and inclusive economic growth, the creation of quality jobs, productivity, adequatecent working conditions, social and territorial cohesion, upward socio-economic convergence, social justice, equal opportunities, resilience and the exercise of fiscal and social responsibility.
Amendment 23 #
2024/0599(NLE)
Recital 8
(8) The European Pillar of Social Rights, proclaimed by the European Parliament, the Council and the Commission in November 2017 (35 ), sets out twenty principles and rights to support well-functioning and fair labour markets and welfare systems, structured around three categories: equal opportunities and access to the labour market, fair working conditions, and social protection and inclusion. Those principles and rights give strategic direction to the Union, ensuring that the transitions to climate-neutrality, environmental sustainability, digitalisation and the impact of demographic change are socially fair and just and preserve territorial cohesion. The European Pillar of Social Rights, with its accompanying Social Scoreboard and the Social Convergence Framework, constitutes a reference framework to monitor the employment and social performance of Member States and upward social convergence in the Union, to drive reforms and investments at national, regional and local levels and to reconcile the ‘social’ and the ‘market’ in today’s modern economy, including by promoting the social economy. On 4 March 2021, the Commission put forward an Action Plan for the implementation of the European Pillar of Social Rights (the ‘Action Plan’), including ambitious yet realistic Union headline targets on employment, skills and poverty reduction and complementary sub- targets for 2030, as well as the revised Social Scoreboard. __________________ 35 Interinstitutional Proclamation on the European Pillar of Social Rights (OJ C 428, 13.12.2017, p. 10).
Amendment 26 #
2024/0599(NLE)
Recital 10
(10) The Union headline targets for 2030 on employment (that at least 78 % of the population aged 20-64 should be in employment), skills (that at least 60 % of all adults should participate in training every year) and poverty reduction (that at least 15 million fewer people should be at risk of poverty or social exclusion, including five million children), welcomed by the Heads of State or Government at the Porto Social Summit on 8 May 2021 and by the June 2021 European Council, will help, together with the Social Scoreboard and the Social Convergence Framework, in monitoring progress towards the implementation of the principles of the European Pillar of Social Rights as part of the policy coordination framework in the European Semester. In addition, the Porto Social Summit called on Member States to set ambitious national targets which, taking due account of the starting position of each country, should constitute an adequate contribution to the achievement of the Union headline targets for 2030. Between September 2021 and June 2022, at the invitation of the Commission, Member States submitted their national targets. At the June 2022 Employment, Social Policy, Health and Consumer Affairs Council (EPSCO), Ministers stressed the importance of closely following the progress achieved towards the implementation of the European Pillar of Social Rights and the EU headline targets for 2030. Against that background, progress on those national targets is monitored in the Joint Employment Report 2024, and is integrated in the monitoring tools for the European Semester. In addition, the Joint Employment Report 2024 integrated the Social Convergence Framework which contained a ‘first-stage country analysis’ on potential risks to upward social convergence, identifying seven countries as experiencing potential risks, which resulted in a deeper ‘second- stage analysis’ for these seven Member States (36 ). __________________ 36 Resulting in a Commission Staff Working Document (https://ec.europa.eu/transparency/docume nts- register/detail?ref=SWD(2024)132&lang= en), drawing on the Key Messages of the EPSCO advisory bodies on a possible framework to strengthen the assessment and monitoring of risks to upward social convergence in the Union, which informed the debate regarding the Semester at the June 2023 EPSCO.
Amendment 29 #
2024/0599(NLE)
Recital 12 – paragraph 1
Reforms to the labour market, including national wage-setting mechanisms, should respect and strenghten national practices of social dialogue, collective bargaining and the autonomy of the social partners, with a view to providing fair wages that enable a decent standard of living, sustainable growth and upward socio- economic convergence. Such reforms should allow for a broad consideration of socio-economic factors, including improvements in sustainability, competitiveness, innovation, the creation of quality jobs, decent working conditions, democracy at work, gender equality, in- work poverty, education, training and skills, public health, social protection and inclusion, as well as real incomes. Member States should implement the Directive on adequate minimum wages without delay and prepare action plans to increase the collective bargaining coverage in line with the directive, where applicable. The importance of social dialogue in tackling challenges in the world of work, including labour and skills shortages, was reaffirmed at the 2024 Val Duchesse Summit.
Amendment 33 #
2024/0599(NLE)
Recital 12 – paragraph 2
The Recovery and Resilience Facility and other Union funds are supporting Member States in implementing reforms and investments that are in line with the Union’s priorities, making Union economies and societies more sustainable and resilient and better prepared for the green and digital transitions in the changing context following the COVID-19 pandemic. Russia’s war of aggression against Ukraine has further aggravated pre- existing socio-economic challenges, as higher energy prices particularly affected low-income households. Member States and the Union should continue to ensure that the social, employment and economic impacts are mitigated and that transitions are socially fair and just, also in light of the fact that increased open strategic autonomy and an accelerated green transition will help reduce the dependence on imports of energy and other strategic products and technologies, in particular from Russia. Strengthening resilience and pursuing an inclusive and resilient society in which people are protected and empowered to anticipate and manage change, and in which they can actively participate in society and the economy, are essential. This is why democracy at work has to be strengthened at the union and at national level.
Amendment 40 #
2024/0599(NLE)
Recital 13 – paragraph 1
Discrimination in all its forms should be tackleliminated, gender equality ensured and employment of young people supporpromoted. Equal access and opportunities for all should be ensured and poverty and social exclusion, in particular that of children, persons with disabilities and the Roma peoplewith a special emphasis on vulnerable groups, namely children, young and older persons, persons with disabilities, single parents, ethnic minorities, such as the Roma people, LGBTIQA+ people and people living in remote areas, should be reduceradicated, in particular by ensuring an effective functioning of labour markets and adequate and inclusive social protection systems, as set out in the Council Recommendation of 8 November 2019 and the Council Recommendation of 30 January 2023 (39 ). In addition, barriers to inclusive and future- oriented education, training, retraining, lifelong learning and labour- market participation should be removed and Member States should invest in early childhood education and care, in line with the European Child Guarantee and the Council Recommendation on early childhood education and care (the ‘Barcelona targets for 2030’), in making vocational education and training more attractive and inclusive in line with the Council Recommendation on vocational education and training, and in digital and green skills, in line with the Digital Education Action Plan and the Council Recommendation on learning for the green transition and sustainable development and the Council Recommendation on Pathways for School Success. Access to decent and affordable housing, including through social housing, is a necessary condition for ensuring equal opportunities, which is why the European Union and the Member States should take the necessary actions to provide affordable housing for all. Homelessness is one of the most extreme forms of social exclusion, which negatively affects people´s physical and mental health, wellbeing, and quality of life, as well as their access to employment and other economic and social services. Timely and equal access to affordable high-quality long-term care, in line with the Council Recommendation on access to affordable high-quality long-term care, and healthcare services, including prevention and healthcare promotion, are particularly relevant, in light of potential future health risks and in a context of ageing societies. __________________ 39 Council Recommendation of 30 January 2023 on adequate minimum income ensuring active inclusion (OJ C 41, 3.2.2023, p.1).
Amendment 47 #
2024/0599(NLE)
Recital 14 – paragraph 2
In addition, for the 2021-2027 programming period, Member States should make full use of the European Social Fund Plus, the European Regional Development Fund, the Recovery and Resilience Facility and other Union funds, including the Just Transition Fund as well as InvestEU established by Regulation (EU) 2021/523 of the European Parliament and of the Council (46 ), as well as the Technical Support Instrument (TSI), to foster quality employment and social investments, to fighteradicate poverty and social exclusion, to combeliminate discrimination, to ensure accessibility and inclusion, and to promote upskilling and reskilling opportunities of the workforce, lifelong learning and high-quality education and training for all, including digital literacy and skills in order to empower citizens with the knowledge and qualifications required for a digital and green economy. Member States are also to make full use of the European Globalisation Adjustment Fund for Displaced Workers established by Regulation (EU) 2021/691 of the European Parliament and of the Council (47 ) to support workers made redundant as a result of major restructuring events, such as socioeconomic transformations that are the result of global trends and technological and environmental changes. While the Integrated Guidelines are addressed to Member States and the Union, they should be implemented, monitored and evaluated in partnership with all national, regional and local authorities, closactively involving parliaments, as well as the social partners and representatives of civil society. __________________ 46 Regulation (EU) 2021/523 of the European Parliament and of the Council of 24 March 2021 establishing the InvestEU Programme and amending Regulation (EU) 2015/1017 (OJ L 107, 26.3.2021, p. 30). 47 Regulation (EU) 2021/691 of the European Parliament and of the Council of 28 April 2021 on the European Globalisation Adjustment Fund for Displaced Workers (EGF) and repealing Regulation (EU) No 1309/2013 (OJ L 153, 3.5.2021, p. 48).
Amendment 49 #
2024/0599(NLE)
Recital 16 a (new)
(16 a) Welcomes the Commission’s proposal for updated employment guidelines for the Member States, in particular its strong focus on education and training as well as new technologies, artificial intelligence and algorithmic management as well as recent policy initiatives such as platform work, affordable housing and tackling labour and skills shortages; with a view to strengthening democratic decision- making, reiterates its call to be involved in setting the Integrated Guidelines at Union level on an equal footing with Council, in line with its legislative resolutions of 8 July 2015, 19 April 2018, 10 July 2020 and 18 October 2022 on the proposal for a Council decision on guidelines for the employment policies of the Member States;
Amendment 56 #
2024/0599(NLE)
Annex I – paragraph 2
To strengthen resilience in the face of possible economic and/or labour market shocks, well-designed short-time work schemes, like the ones developed in the context of the European instrument for temporary Support to mitigate Unemployment Risks in an Emergency (SURE), and similar arrangements play an important role. They can also support structural transformations by facilitating and supporting restructuring processes and the reallocation of labour from declining sectors towards emerging ones, thereby increasing productivity, preserving employment and helping to modernise the economy, including via associated skills development. Well-designed hiring and transition incentives and upskilling and reskilling measures, developed in close cooperation with social partners, should be considered in order to support quality job creation and transitions throughout the working life, and to address labour and skill shortages, also in light of the digital and green transformations, demographic change, as well as of the impact of Russia’s war of aggression against Ukraine.
Amendment 61 #
2024/0599(NLE)
Annex I – paragraph 3
Taxation should be shifted away from labour to other sources more supportive of employment and inclusive growthprogressive, supportive of job creation, and in line with climate and environmental objectives, taking account of the redistributive effect of the tax system, while protecting revenue for adequate social protection and growth- enhancing expenditure.
Amendment 64 #
2024/0599(NLE)
Annex I – paragraph 4
Member States, including those with statutory minimum wages, should promote collective bargaining on wage setting and ensure an effective involvement of social partners in a transparent and predictable manner, allowing for adequate responsiveness of wages to productivity developments, inflation and the cost of living, and fostering fair wages that enable a decent standard of living, paying particular attention to lower and middle income groups with a view to strengthening upward socio-economic convergence. Wage-setting mechanisms should also take into account socio- economic conditions, including employment growth, competitiveness, purchasing power and regional and sectoral developments. Respecting national practices and the autonomy of the social partners, Member States and social partners should ensure that all workers have adequate wages by benefitting, directly or indirectly, from collective agreements or adequate statutory minimum wages, taking into account their impact on competitiveness, quality job creation, purchasing power and in-work poverty.
Amendment 67 #
2024/0599(NLE)
Annex I – paragraph 5
In the context of the digital and green transitions, demographic change and Russia’s war of aggression against Ukraine, Member States should promote sustainability, productivity, competitiveness, employability and human capitalthe development, fostering and acquisition of skills and competences throughout people’s lives and responding to current and future labour market needs, also in light of the Union and national headline targets for 2030 on skills. Member States should also modernise and invest in their education and training systems to provide high quality and inclusive education and training including vocational education and training, improve educational outcomes and the provision of skills and competences needed for the green and digital transitions, and ensure access to digital learning, language training (e.g. in the case of refugees including from Ukraine or in facilitating labour market access in cross-border regions) and the acquisition of entrepreneurial skills. Member States should work together with the social partners, education and training providers, enterprises and other stakeholders, also in the context of the action plan to tackle labour and skills shortages put forward by the Commission in March 2024, to address structural weaknesses in education and training systems and improve their quality and labour-market relevance, including through targeted financial and technical support. This would also contribute to enabling the green and digital transitions, addressing skills mismatches and labour shortages, including for activities related to net-zero and digital industries, including those relevant for the EU’s economic security, and those related to the green transition, such as renewable energy deployment or buildings’ renovation. Decent working conditions, comprising amongst others good wages, standard employment contracts, access to social protection, lifelong learning opportunities, occupational health and safety, a good work-life balance, reasonable working time, worker’s representation, democracy at work and collective agreements, play a crucial role in attracting and retaining skilled workers.
Amendment 73 #
2024/0599(NLE)
Annex I – paragraph 6
Particular attention should be paid to addressing theany decline in the educational performance of young people, especially in the area of basic skills. Action is needed to address the challenges faced by the teaching profession, including its attractiveness, tackling teacher shortages, and the need to invest in teachers’ and trainers’ digital skills competences. Moreover, education and training systems should equip all learners with key competences, including basic and digital skills as well as transversal competences, and critical thinking in light of the threat of disinformation, to lay the foundations for adaptability and resilience throughout life, while ensuring that teachers are prepared to foster those competencies in learners. Member States should support working age adults in accessing training and increase individuals’ incentives and motivation to seek training, including, where appropriate, through individual learning accounts and occupation related training provided during working hours and financed by the employer, and ensuring their transferability during professional transitions, as well as through a reliable system of training quality assessment. Member States should explore the use of micro-credentials to support lifelong learning and employability. They should enable everyone to anticipate and better adapt to labour-market needs, in particular through continuous upskilling and reskilling and the provision of integrated guidance and counselling, with a view to supporting fair and just transitions for all, strengthening employment and social outcomes and productivity, addressing labour-market shortages and skills mismatches, improving the overall resilience of the economy to shocks and making potential adjustments easier.
Amendment 75 #
2024/0599(NLE)
Annex I – paragraph 7
Member States should foster equal opportunities for all by addressing inequalities in education and training systems, including in terms of regional coverage. In particular, children should be provided with access to affordable and high-quality early childhood education and care, in line with the new “Barcelona targets” and the European Child Guarantee Member States should raise overall qualification levels, reduce the number of early leavers from education and training, support equal access to education of children from disadvantaged groups and remote areas, increase the attractiveness of vocational education and training (VET), support access to and completion of tertiary education, and increase the number of science, technology, engineering and mathematics (STEM) graduates both in VET and in tertiary education, especially women. Top performance and excellence in educational outcomes should also be supported, given their role in fostering the future innovation potential of the EU. Mermber States should facilitate the transition from education to employment for young people through paid quality traineeships and apprenticeships, as well as increase adult participation in continuing learning, particularly among learners from disadvantaged backgrounds and the least qualified. Taking into account the new requirements of digital, green and ageing societies, Member States should upgrade and increase the supply and uptake of flexible initial and continuing VET, strengthen work-based learning in their VET systems, including through accessible, quality and effective apprenticeships, and support low-skilled adults maintain their employability. Furthermore, Member States should enhance, where appropriate, the labour- market relevance of tertiary education and, where appropriate, research; improve skills monitoring and forecasting; make skills and qualifications more visible and comparable, including those acquired abroad, and ensure a more consistent use of EU-wide classifications (i.e. ESCO); and increase opportunities for recognising and validating skills and competences acquired outside formal education and training, including for refugees and persons under a temporary protection status. Beyond using the untapped potential of the EU domestic workforce, attracting talent and skills from outside the EU viaopening legal channels for managed migration and preventing exploitative working conditions by offering migrant workers the same working and employment conditions as local workers can also contribute to addressing skills and labour shortages, including those linked to the green and digital transitions such as in STEM sectors ands well as in healthcare and long-term care, education, transport and construction. Member States should likewise ensure that labour migration does not result in a deterioration of existing working conditions for domestic workers.
Amendment 80 #
2024/0599(NLE)
Annex I – paragraph 7 a (new)
In order to avoid the offshoring of companies that have received European aid, it is essential to review existing state aid rules and funding programmes and establish strategic solutions aimed at maintaining the industrial base within Europe. This includes strengthening European strategic autonomy and promoting a robust European industrial policy. Furthermore, the transition must be accompanied by social and employment measures to ensure a just transition for all, ensuring that no workers or communities are left behind during this process.
Amendment 81 #
2024/0599(NLE)
Annex I – paragraph 8
Member States should provide unemployed and inactive people with effective, timely, coordinated and tailor-made assistance based on support for job searches, training, up- and reskilling and access to other enabling services, paying particular attention to vulnerable groups and people affected by the green and digital transitions or labour market shocks. Comprehensive strategies that include in-depth individual assessments of unemployed people should be pursued as soon as possible, at the latest after 18 months of unemployment, with a view to significantly reducing and preventing long-term and structural unemployment. Youth unemployment and the issue of young people not in employment, education or training (NEETs) should continue to be addressed through prevention of early leaving from education and training and structural improvement of the school-to-work transition, including through the full implementation of the reinforced Youth Guarantee, which should also support quality youth employment opportunities. In addition, Member States should boost efforts notably at highlighting how the green and digital transitions offer a renewed perspective for the future and opportunities for young people in the labour market.
Amendment 86 #
2024/0599(NLE)
Annex I – paragraph 9
Member States should aim to remove barriers and disincentives to, and provide incentives for, participation in the labour market, in particular for low-income earners, second earners (often women) and those furthest from the labour market, including people with a migrant background and marginalised Roma people. In view of high labour shortages in certain occupations and sectors (notably in STEM sectors, healthcare and long-term care, education, transport and construction), Member States should contribute to fostering labour supply, notably through promoting adequate wages and decent working conditions, ensuring that the design of tax and benefit systems encourages labour market participation, and that active labour market policies are effective and accessible, respecting the role of social partners. Member States should also support a work environment adapted for persons with disabilities, including through targeted financial and technical support, information and awareness raising, and services that enable them to participate in the labour market and in society. The various guidelines developed within the framework of the employment package of the European Strategy for the Rights of Persons with Disabilities 2023- 2030 should be fully implemented in the workplace. Particular attention should be paid to the right to reasonable accommodation, the deployment of retention strategies, and the fight against discriminatory practices. The gender employment and pay gaps as well as gender stereotypes should be tackled. Member States should ensure gender equality and increased labour market participation of women, including through ensuring equal opportunities and career progression and eliminating barriers to leadership access at all levels of decision making, as well as by tackling violence and harassment at work which is a problem that mainly affects women. Equal pay for equal work, or work of equal value, and pay transparency should be ensured. The reconciliation of work, family and private life for both women and men should be promoted, in particular through access to affordable, quality long-term care and early childhood education and care services, as well as through adequate policies catering to the changes brought to the world of work by digitalisation. The right of workers to disconnect is essential in this context. Member States should ensure that parents and other people with caring responsibilities have access to suitable family-related leave and flexible working arrangements in order to balance work, family and private life, and promote a balanced use of those entitlements between parents.
Amendment 90 #
2024/0599(NLE)
Annex I – paragraph 10
In order to benefit from a dynamic and productive workforce and new work patterns and business models, Member States should work together with the social partners on fair, transparent and predictable working conditions, balancing rights and obligations. They should reduce and prevent segmentation within labour markets, fight undeclared work and bogus self-employment, and foster the transition towards open-ended forms of employment. Employment protection rules, labour law and institutions should all provide both a suitable environment for recruitment and the necessary flexibility for employers to adapt swiftly to changes in the economic context, while protecting labour rights and ensuring social protection, an appropriate level of security, and healthy, safe and well-adapted working environments for all workers. Promoting the use of flexible working arrangements such as teleworking can contribute to higher employment levels and more inclusive labour markets. Furthermore, Member States should support workers, businesses, and other actors in the digital transformation, including via promoting the uptake of ethical and trustworthly Artificial Intelligence (AI) tools. This can range from policies, developed in cooperation with social partners, to upskill and reskill workers for new occupations and incentives for companies to develop and deploy technologies that have the potential to increase productivity, complement human labour, and alleviate labour shortages in critical sectors. In general, and in the digital context in particular, it is important to ensure that the workers’ rights in terms of working time, democracy at work, working conditions, mental health at work and work-life balance are respected and equally applied for all workers, regardless of the size of the company or the underlying employment contract. Employment relationships that lead to precarious working conditions, shoulduch as bogus self-employment or bogus traineeships, must be prevented, including cases involving platform workers, by ens. It is therefore essential that Member States implement the Directive on improving the working conditions in platform work, ensure people working through digital labour platforms can fully enjoy their rights and social benefits, strengthen labour ingspections and introduce dissuasive sanctions. Member States should ensure fairness, transparency and human accountability in the use of algorithms, and by fighting the abuse of atypical contracts. Access to effective, impartial dispute resolution and a right to redress, including adequate compensation, where applicable, should be ensured in cases of unfair dismissal.
Amendment 96 #
2024/0599(NLE)
Annex I – paragraph 11
Policies should aim to improve and support labour-market participation, matching and transitions, also in light of demographic change, and including in disadvantaged regions. Member States should effectively activate and enable those who can participate in the labour market, especially under-represented groups, such as women and youndg people, as well as people in vulnerable situations, such as lower-skilled people and the long-term unemployed, persons with disabilities, people with a migrant background, including persons under a temporary protection status, people from marginalised Roma communities and older workers. Member States should strengthen the scope and effectiveness of active labour-market policies by increasing their targeting, outreach and coverage and by better linking them with social services, training and income support for the unemployed, while they are seeking work and based on their rights and responsibilities. Member States should make the best use of EU funding and technical support as well as national resources to enhance the capacity of public employment services to provide timely and tailor-made assistance to jobseekers, respond to current and future labour- market needs, and implement performance- based management, supporting their capacity to use data and digital technology. Private employment services also play a role in this respect.
Amendment 97 #
2024/0599(NLE)
Annex I – paragraph 12
Member States should provide the unemployed with adequate unemployment benefits of reasonable duration, in line with their contributions and national eligibility rules and based on the principle of non- discrimination. Unemployment benefits should not disincentivise a prompt return to employment and should be accompanied by active labour market policies, including up- and reskilling measures, also in light of labour and skills shortages.
Amendment 104 #
2024/0599(NLE)
Annex I – paragraph 14
The mobility of workers in critical occupations and of cross-border, seasonal and posted workers should be supported in the case of temporary border closures triggered by public health considerations. Member States should further engage in talent partnerships to enhance legal migration pathways by launching new mobility schemes and provide for an effective integration policy for workers and their families, encompassing education and training, including language training, employment, health and housing.
Amendment 108 #
2024/0599(NLE)
Annex I – paragraph 15
Member States should also strive to create the appropriate conditions for new forms of work, and working methods, delivering on their job-creation potential while ensuring they are compliant with existing social rights as well as Union and national labour law. They should provide advice and guidance on the rights and obligations which apply in the context of atypical contracts and new forms of work, such as work through digital labour platforms and permanent or semi-permanent teleworking arrangements. In this regard, social partners can play an instrumental role and Member States should support them in reaching out and representing people in atypical and new forms of work. Member States should also consider providing support for enforcement – such as strengthening labour inspectorates and issuing guidelines or dedicated trainings for labour inspectorates – concerning the challenges stemming from new forms of organising work, including the use of digital technologies and of AI, such as algorithmic management, workers’ surveillance and telework.
Amendment 109 #
2024/0599(NLE)
Annex I – paragraph 16
Member States should foster democracy at work and ensure an enabling environment for bipartite and tripartite social dialogue at all levels, including collective bargaining, in the public and private sectors in accordance with national law and/or practice, after consultation and in close cooperation with social partners, while respecting their autonomy. Member States should involve social partners in a systematic, meaningful and timely manner in the design and implementation of employment, social and, where relevant, economic and other public policies including in the setting and updating of statutory minimum wages. Member States should promote a higher level of covergage of collective bargaining, including by promoting the building and strengthening of capacity of the social partners, enable effective collective bargaining at all appropriate levels and encourage coordination between and across those levels. The social partners should be encouraged to negotiate and conclude collective agreements in matters relevant to them, fully respecting their autonomy and the right to collective action. Member States should implement the Directive on adequate minimum wages without delay and prepare action plans to increase the collective bargaining coverage in line with the directive, where applicable.
Amendment 111 #
2024/0599(NLE)
Annex I – paragraph 17
Where relevaithout prejudice to the competences and autonomy of social partners as well as their right to negotiate and conclude collective agreements, and building on existing national practices, Member States should also take into account the relevant experience of civil society organisations’ in employment and social issues, where relevant.
Amendment 119 #
2024/0599(NLE)
Annex I – paragraph 20
Member States should develop and integrate the three strands of active inclusion: adequate income support, inclusive labour markets and access to quality enabling services, to meet individual needs. Social protection systems should ensure adequate minimum income benefits for everyone lacking sufficient resources and promote social inclusion by supporting and encouraging people in working age to actively participate in the labour market and society, including through targeted provision of social services. The availability of affordable, accessible and quality services such as early childhood education and care, out-of- school care, education, training, housing, and health and long-term care is a necessary condition for ensuring equal opportunities. Particular attention should be given to fighting poverty and social exclusion, including in- work poverty, in line with the Union headline and national targets for 2030 on poverty reduction. Child poverty and social exclusion should be especially addressed by comprehensive and integrated measures, including through the full implementation of the European Child Guarantee. Member States should ensure that everyone, including children, has access to essential services of good quality. For those in need or in a vulnerable situation, they should also ensure access to adequate affordable and social housing or housing assistance. They should ensure a clean and fair energy transition and address energy poverty as an increasingly significant form of poverty, including, where appropriate, via targeted support measures aimed at households in vulnerable situations. Member States should make effective use of EU funding and technical support to invest in social housing, housing renovation and accompanying services and address the urgent need for affordable and decent housing. The specific needs of persons with disabilities, including accessibility, should be taken into account in relation to those services. Homelessness should be tackled specifically by promoting access to permanent housing (housing first approach) and the provision of enabling support services.
Amendment 124 #
2024/0599(NLE)
Annex I – paragraph 21
Member States should ensure timely access to affordable preventive and curative healthcare and long-term care of good quality, while safeguarding sustainability in the long term. In the context of an increasing demand for long-term care, also linked to demographic changes, gaps in adequacy, as well as workforcelabour shortages and poor working conditionss, should be addressed.
Amendment 2 #
2024/0226(BUD)
Motion for a resolution
Recital B
Recital B
B. whereas Belgium submitted application EGF/2024/001 BE/Match- Smatch for a financial contribution from the European Globalisation Adjustment Fund (EGF), following a total number of 513 displacements5 in the economic sector classified under the NACE Revision 2 division 47 (Retail trade, except of motor vehicles and motorcycles) in the provinces of Hainaut (BE32), Liège (BE33), and Namur (BE35) with 444 displacements within a reference period for the application from 11 December 2023 to 11 April 2024, and 69 displacements before or after the reference period; whereas workers in this region have experienced increased hardship due to lack of sufficient alternatives; whereas employees in the Belgian commerce sector in general find themselves in a precarious situation, brought upon by the broader structural transformations taking place within the industry; _________________ 5 Within the meaning of Article 3 of the EGF Regulation.
Amendment 3 #
2024/0226(BUD)
Motion for a resolution
Recital C
Recital C
C. whereas the application relates to 444 displacements within the reference period for the application whose activity has ceased in Match-Smatch; whereas many of these workers have been long- term employees, creating an additional barrier to re-entry into the labour market, with trade unions highlighting that many of these layoffs occurred without sufficient negotiation and without exploring alternative options to retain workers or transition them into new roles;
Amendment 4 #
2024/0226(BUD)
Motion for a resolution
Recital D
Recital D
D. whereas the application relates to 69 displacements whose activity ceased before or after the reference period of four months, where a clear causal link can be established with the event that triggered the cessations of activity of the displaced workers during the reference period as required by Article 6(2) of the EGF Regulation; whereas trade unions have expressed concerns that these workers were prematurely laid off as part of a larger restructuring that did not adequately consider their welfare, and that little effort was made to mitigate the impact on these vulnerable employees;
Amendment 5 #
2024/0226(BUD)
Motion for a resolution
Recital E
Recital E
E. whereas the application is based on the intervention criteria of Article 4(2), point (a), of EGF Regulation, which requires the cessation of activity of at least 200 displaced workers over a reference period of four months in an enterprise in a Member State, including workers displaced in suppliers and downstream producers and/or self-employed persons whose activity has ceased; whereas trade unions point to this as an example of mass layoffs and hyperflexibility becoming more common in the retail sector;
Amendment 6 #
2024/0226(BUD)
Motion for a resolution
Recital F
Recital F
F. whereas the Belgian food retail sector recorded a significant decline in volumes sold in 2023, due to the energy and inflationary crisis, and increased cross- border shopping and e-commerce; whereas trade unions highlight that despite these external challenges, the sector has failed to adequately protect its workers through effective collective agreements and adequate social dialogue;
Amendment 8 #
2024/0226(BUD)
Motion for a resolution
Recital H
Recital H
H. whereas to prevent a further accumulation of losses, Match-Smatch accepted the Colruyt Group’s offer to acquire 57 of the 84 stores in September 2023, also taking over the stores' staff (1 069 people); whereas eight additional stores went to Carrefour, Delhaize, Intermarche and Delfood; whereas workers, particularly those in non- acquired stores, have been left uncertain about their future, with trade unions raising alarms about the lack of clear communication and safeguards for workers in the event of store closures and restructuring;
Amendment 11 #
2024/0226(BUD)
Motion for a resolution
Recital M
Recital M
M. whereas the multiannual financial framework (MFF) revision reduces the maximum annual amount of the EGF from EUR 186 million to EUR 30 million (in 2018 prices), as laid down in Article 8 of Regulation (EU, Euratom) 2020/2093 as amended by Regulation (EU, Euratom) 2024/765; whereas all institutions needthe Commission should closely monitor the implementation of the EGF and all institutions should take any and all necessary measures to ensure that, despite these cuts, workers made redundant can count on EU solidarity via support of the EGF;
Amendment 13 #
2024/0226(BUD)
Motion for a resolution
Paragraph 5
Paragraph 5
5. Notes that half of the Match- Smatch redundant workers (46 %) are aged fifty or older, an age group that faces more barriers to employment and that in the last quarter of 2023, there was a difference of 18,3 percentage points between the employment rate for the 20-54 age group (76,8 %) and the employment rate for the 55+ age group (58,5 %) at national level7 ; stresses that reskilling and upskilling the workers in line with labour-market demand for qualified jobs will thus pose a challenge, all the more considering the large number of people dismissed at the same time; _________________ 7 Statbel. Emploi et chômage (13.6.2024). Chiffres.
Amendment 14 #
2024/0226(BUD)
Motion for a resolution
Paragraph 6
Paragraph 6
6. Welcomes the fact that the co- ordinated package of personalised services has been drawn up by Belgium in consultation with targeted beneficiaries, their representatives and the social partners to make the affected areas, and the overall labour market, more sustainable and resilient in the future;
Amendment 17 #
2024/0226(BUD)
Motion for a resolution
Paragraph 9
Paragraph 9
9. Notes that the digital and green transformationConsiders it a social responsibility of the Union to provide these workers made redundant with the necessary qualifications for the digital and green transformation of the Union industry and economy, which will also have an effect on the labour market; calls, therefore, for special attention to be paid to qualified and relevant education, including vocational training;
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.