EUROPEAN COMMISSION

Brussels, 7.12.2023

COM(2023) 783 final

2023/0455(COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals

(Text with EEA relevance)

{SWD(2023) 850 final}

EXPLANATORY MEMORANDUM

1.    CONTEXT OF THE PROPOSAL

•    Reasons for and objectives of the proposal

The European Union has developed a comprehensive regulatory framework for chemicals to ensure a high level of protection of human health and the environment from the harmful effects of chemicals and to support the efficient functioning of the internal market for chemicals while also promoting the competitiveness and innovation of EU industry. The framework consists of over 40 pieces of legislation addressing: (i) the production and placing on the market of chemicals and products containing chemicals; (ii) emissions of chemicals and safety of (iii) workers; (iv) consumer products; (v) food and feed stuff; (vi) and the environment.

The fitness check of the most relevant EU chemicals legislation 1 concluded that, overall, this framework of Union acts delivers the intended results and is fit for purpose. However, there are shortcomings in the consistency of safety assessments, the efficiency of the underlying technical and scientific work, and the consistency of transparency rules. The implementation of the individual legislative instruments is supported by a large volume of technical and scientific work. Depending on the legislation in question, the work is initiated by different bodies at different points in time, using different data and carried out by different EU agencies (the European Chemicals Agency (‘ECHA’), the European Food Safety Authority (‘EFSA’), the European Environment Agency (‘EEA’) and the European Medicines Agency (‘EMA’)), scientific committees, expert groups, Commission departments and contractors.

This sometimes leads to inconsistent outcomes of assessments for the same chemicals across different legislation. This situation also implies an inefficient use of resources and carries unnecessary costs – from operating multiple committees conducting similar assessments, assessing the same chemical by several committees or bodies, to duplicating supporting technical and scientific work with potentially diverging hazard or risk assessment outcomes. In addition, the assessments that are not carried out by the EU agencies are sometimes perceived by stakeholders as not being transparent and inclusive enough or as not being of sufficient scientific quality and robustness.

Building on the findings of the fitness check, the Commission committed in the European Green Deal 2 to present a Chemicals Strategy for Sustainability 3 (‘the Strategy’). As part of this work, it committed to start using the ‘one substance – one assessment’ approach to improve the efficiency, effectiveness, coherence and transparency of issuing safety assessments of chemicals across different pieces of EU legislation.

Overall, the one substance, one assessment approach focuses on the main factors influencing the efficiency, effectiveness, coherence and transparency of safety assessments. It covers:

·Initiation of chemicals safety assessments. This means synchronising and coordinating the initiation or triggering of assessments and assessing groups of substances instead of assessing substances individually, to the extent possible.

·Attribution of tasks. This involves a clear allocation of responsibilities to bodies performing assessments, making good use of available expertise and resources, as well as ensuring the good cooperation between the parties involved.

·Information. Ensuring that information is easily findable, accessible, interoperable, secure, of high quality and shared and reused to ensure that assessors have access to all available data without technical or administrative burden.

·Methodologies. The methods used for the assessments are coherent and, to the extent possible, harmonised.

·Transparency. Ensuring a high level of transparency in performing assessments, as well as in the underlying scientific data and information on chemicals.

Two key actions set out in the Strategy to improve the overall efficiency, effectiveness, coherence and transparency are to:

·‘rationalise the use of expertise and resources by proposing the reattribution of technical and scientific work on chemicals performed under the relevant pieces of legislation to European agencies, including work of the Scientific Committee on Health, Environmental and Emerging Risks and Scientific Committee on Consumer Safety’;

·ensure ‘a clear attribution of responsibilities and good cooperation among the European agencies’.

The Council 4 welcomed the ‘one substance, one assessment’ initiative and the European Parliament 5 welcomed the ‘one substance, one hazard assessment’ approach.

The EU Action Plan ‘Towards Zero Pollution for Air, Water and Soil’ 6 further contributed to this effort through commitments to consolidate the roles of the European Environment Agency and the Commission’s Joint Research Centre in close collaboration with the European Chemicals Agency, the European Food Safety Agency, the European Maritime Safety Agency and other relevant agencies as the EU’s Knowledge Centres of Excellence for Zero Pollution Monitoring and Outlook Framework.

Re-attributing existing tasks and attributing new tasks to EU agencies require targeted amendments of the existing pieces of chemicals legislation. The preferred technique is to attribute tasks by making amendments when the individual Union acts are revised for other purposes, such as meeting other objectives of the Strategy. Therefore, where possible, relevant changes have already been proposed or will be proposed as part of the revisions of individual pieces of legislation or as part of new legislation as detailed in the section below.

This proposal focuses on amending those pieces of legislation that are not currently being revised. It proposes targeted amendments to attribute tasks in Regulation (EU) 2019/1021 on persistent organic pollutants 7 , and Regulation (EU) 2017/745 on medical devices 8 . The proposal also amends Regulation (EC) No 401/2009 establishing the European Environmental Agency 9 and Regulation (EC) No 178/2002 laying down the general principles and requirements of food law and establishing the European Food Safety Authority 10 . These amendments will ensure good cooperation among EU agencies on all aspects involving the consistency and efficiency of chemical assessments. These include the development of methodologies, data exchanges and reconciling divergence in scientific output.

·the allocation of responsibilities for performing the assessments and the underlying technical and scientific work on chemicals is clear, exploits and maximises synergies and makes best use of available expertise and resources in EU agencies;

·the deliverables are of high scientific quality and the procedures are transparent and inclusive;

·there is good cooperation and coordination among players on all aspects underling the assessment of chemicals, including methodology development and data exchange.

•    Consistency with existing policy provisions in the policy area

The proposal complements and is consistent with the re-attribution of tasks on chemicals to EU agencies already proposed, that are under development as part of the revisions of individual pieces of legislation, or that are envisaged as part of new legislation.

Attribution or re-attribution of tasks to EU agencies has been already proposed as part of:

·Directive (EU) 2020/2184 of the European Parliament and of the Council on the quality of water intended for human consumption 11 ;

·Regulation (EU) 2022/2371 of the European Parliament and of the Council on serious cross-border threats to health 12 ;

·Proposal for a Regulation of the European Parliament and of the Council concerning batteries and waste batteries 13 ;

·Proposal for a Regulation of the European Parliament and of the Council on reporting of environmental data from industrial installations and establishing an Industrial Emissions Portal 14 ;

·Proposal for a Directive of the European Parliament and of the Council amending Directive 2010/75/EU on industrial emissions (industrial pollution prevention and control) 15 ;

·Proposal for a Directive of the European Parliament and of the Council amending Directive 2000/60/EC establishing a framework for Community action in the field of water policy, Directive 2006/118/EC on the protection of groundwater against pollution and deterioration and Directive 2008/105/EC on environmental quality standards in the field of water policy 16 ;

·Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures 17 ;

·Proposal for a Regulation of the European Parliament and of the Council on packaging and packaging waste 18 ;

·Proposal for a Directive of the European Parliament and of the Council amending Directive 2000/53/EC on end-of-life vehicles 19 ;

·Proposal for a Regulation of the European Parliament and of the Council on the safety of toys 20 ;

·Commission Implementing Decision (EU) 2022/1979 on establishing the form and databases for communicating the information referred to in Articles 18(1) and 21(3) of Directive 2012/18/EU on the control of major-accident hazards involving dangerous substances 21 .

Attributing or re-attributing tasks to EU agencies are being considered as part of the following proposals in preparation:

·Proposal for a Regulation of the European Parliament and the Council on the European Chemicals Agency 22 ;

·Proposal for a Regulation of the European Parliament and the Council amending Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals 23 ;

·Proposal for a Regulation of the European Parliament and the Council amending Regulation (EC) No 1223/2009 on cosmetic products 24 .

The proposed provisions on the development of methodologies and cooperation among EU agencies complements the proposal for a Regulation of the European Parliament and the Council 25 amending Regulation (EC) No 726/2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency, which contains similar provisions.

This proposal relates to the proposal being prepared for a Regulation of the European Parliament and the Council on the ECHA, which may contain similar provisions on methodologies and cooperation among EU agencies applicable to ECHA. In addition, the ECHA proposal will consider restructuring the agency’s scientific committees to better manage the increased workload arising from the tasks re-attributed by means of this proposal and of those listed above.

This proposal is closely linked to, and part of the same ‘one substance, one assessment’ legislative package, as the proposal for a Directive of the European Parliament and the Council amending Directive 2011/65/EU 26  as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency, specifically amending Articles 5 and 6 of that Directive. Those amendments refer to the attribution of a role and specific tasks to ECHA and its scientific committees in the processes for substance restrictions and assessing exemption requests corresponding to the restrictions, in line with existing procedures laid out in Regulation (EC) No 1907/2006 27 (‘the REACH Regulation’).

This proposal also relates to other ‘one substance, one assessment’ actions announced in the chemicals strategy for sustainability – in particular to the proposal for a Regulation of the European Parliament and the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals 28 . That proposal aims, among others, to encourage the sharing and re-using of chemicals data and information among EU agencies and Member State competent authorities. This will further contribute to improving the consistency, efficiency and transparency of chemical assessments across legislation. It will also attribute several new tasks to EU agencies in the sharing and generation of data, as well as in data and information management.

•    Consistency with other EU policies

Attributing and re-attributing scientific and technical tasks in the assessment of chemicals to EU agencies is consistent with the objectives of the Better Regulation agenda. EU agencies benefit from robust scientific expertise and transparent and inclusive processes, which effectively support policymaking. Consolidating the work in the EU agencies and thus lowering the number of bodies involved contributes to simplifying and standardising procedures and reducing administrative burdens.

The proposal also contributes to the objectives of the EU’s data and digital policies by promoting the interoperability and machine-readability of chemical data held by EU agencies.

2.    LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY

•    Legal basis

The legal basis for this proposal is Articles 43, 114, 207, 168(4)(c) and 192(1) of the Treaty on the Functioning of the European Union. The proposal is an ‘omnibus’ regulation that amends four regulations, each having their own legal bases. Regulation (EC) No 178/2002 is based on Article 43, 114, 207 and 168(4)(c), Regulation (EU) 2019/1021 is based on 192(1) TFEU, Regulation (EU) 2017/745 is based on Article 114 and Article 168(4)(c) TFEU, while Regulation 401/2009 is based on Article 192(1) TFEU.

It is therefore appropriate to base this Regulation on all legal bases of the individual acts being amended.

•    Subsidiarity (for non-exclusive competence)

The initiative will revise and amend existing EU legal instruments in a targeted manner. The revisions target the attribution of tasks for conducting scientific and technical work at EU level, which is necessary for the operation of those instruments. Given that the Member States are not in a position to ensure the re-attribution of tasks to the EU Agencies, which are EU bodies regulated at the EU level, the objective can only be achieved at EU level, respecting thus the subsidiarity principle.

•    Proportionality

The initiative does not go beyond what is necessary to achieve the desired objectives.

The accompanying staff working document 29 assesses the administrative impact of the proposed revisions taking into account the re-attribution of other tasks to EU agencies in other legislative proposals.

The scientific and technical tasks attributed to ECHA in this proposal are existing tasks that are similar to tasks that the agency already carries out under other pieces of legislation. The slight increase in administrative costs is proportionate to the added value of the re-attribution of tasks. The added value stems from the improved quality and scientific robustness of the assessments, the strengthened transparency and inclusiveness of the procedures, and improved consistency with assessments conducted under other pieces of legislation.

In the long term, the improved consistency of EU scientific assessments will lead to better, more informed and more efficient policy choices for the benefit of the public, industry and the environment. The envisaged amendments will also reduce administrative burden at EU and national levels due to more streamlined scientific work and the avoidance of duplication.

•    Choice of the instrument

The desired changes require targeted amendments of specific provisions related to roles and tasks of Agencies in scientific assessments. This requires amendment by means of a directly applicable Omnibus regulation of four regulations.

3.    RESULTS OF EX POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS

•    Ex post evaluations/fitness checks of existing legislation

The fitness check of the most relevant chemicals legislation (assessing over 40 pieces of legislation) was carried out in 2019 30 . It concluded that overall, the legislation delivers the intended results and is fit for purpose. However, several significant weaknesses prevent the legislation from reaching its full potential. Across the framework, it identified shortcomings in the consistency of safety assessments, the efficiency of the underlying technical and scientific work, and the consistency of transparency rules. These shortcomings can lead to inconsistent safety assessments, slow procedures, inefficient use of resources, unnecessary burdens, a (perceived) lack of transparency, and an impact on the quality of scientific advice.

The fitness check also showed that there are significant opportunities for streamlining the technical and scientific work through EU agencies. This would improve the efficiency of chemicals legislation (e.g. avoiding duplication of efforts and making the best use of available expertise in EU agencies) and make it more consistent (e.g. reducing the risk of different outcomes of hazard or risk assessments at EU level). It would also simplify the current set-up, improve the quality of assessments, and ensure predictability for stakeholders and the public.

This proposal directly addresses the problems and opportunities identified in the fitness check.

•    Stakeholder consultations

A call for evidence for the initiative on making the best use of EU agencies to streamline scientific assessments was published on the Commission  Have your say website on 15 March 2022. The public and stakeholders were invited to provide feedback up until 12 April 2022. In total, 65 submissions were received. Most submissions were received from business associations and companies (around 70% of submissions), followed by submissions from EU citizens (11%), non-governmental organisations (6%), public authorities (6%), others (5%) and academic/research institutions (1.5%). 

Generally, there was a large support of the initiative among the respondents for the ‘one substance, one assessment’ approach, as well as for the specific initiative on the reattribution of tasks. 67% of respondents expressed their explicit support, 23% did not express explicitly their opinion but provided relevant advices on how to develop the one substance, one assessment approach. About 10% expressed doubts about usefulness of the initiative or opposition to the initiative.

Stakeholders were also informed and consulted on the re-attribution of tasks to EU agencies during the Information Session on One Substance, One Assessment with Stakeholders held on 1 June 2022. Around 800 participants followed this event online.

An extensive discussion on re-attribution of tasks to EU agencies was held with representatives of Member States and EU agencies at the meetings of the Expert Group on One Substance, One Assessment 31 on 2-3 June 2022 and on 30 March 2023. Representatives of Member States and EU Agencies participating in the expert group meetings were supportive to the initiative as well, providing concrete suggestions on the reattributions.

Main input received from the consultations

The feedback regarding the re-attribution of tasks to the EU agencies received from the call for evidence and from Member States and EU agencies during meetings of the Expert Group on One Substance, One Assessment can be grouped in 6 areas:

Level of centralisation

Stakeholders and Member States suggested that re-attribution of work should not result in one agency being responsible for the risk evaluations of all chemicals. The regulations must clearly set out the responsibilities of each agency.

This suggestion is reflected in the proposal. The proposal does not reallocate tasks between EU agencies. The proposal aims to only re-attribute those tasks carried out by bodies other than EU agencies.

Expertise 

Stakeholders suggested that re-attributing tasks should be done based on the existing expertise in the agencies to ensure that the agency receiving the task benefits from the necessary expertise. It should be ensured that valuable expertise acquired by existing bodies is preserved. Expertise in risk assessments under the different regulations should stay with those agencies currently responsible for them. Each agency is best positioned to lead and carry out specific assessments because of their extensive experience in product-specific matters, e.g. EFSA for food use, EMA for medicines use.

These suggestions are reflected in the proposal. The criteria used to decide which EU agency should carry out a certain task includes similarity with existing expertise and how the task fits with an agency’s core focus and mandate. The initiative and the proposal do not change the conditions for using data in the regulatory processes and maintains the ‘specialisation’ of the agencies.

Resources 

Member States insisted that the new tasks for the agencies must be accompanied by the required resources. Re-attributing work should not lead to an agency or committee being unable to manage the workload and jeopardising the quality of the work.

This suggestion is reflected in the proposal. The proposal is accompanied by a detailed assessment of the EU agencies’ resource and capacity needs. The proposals for re-attributing tasks (made as part of the revisions of individual pieces of legislation or as part of this omnibus proposal) are accompanied with proposals of financial and human resources to ensure that adequate resources are available taking into account synergies and economies of scale.

Organisation of scientific committees 

Member States indicated that the agencies’ committees, especially those of ECHA, might need reorganising such as to deal with the increased workload, especially insofar as the committee for risk assessment (RAC) of ECHA has already now a high workload. Instead of creating new scientific panels or committees, the agencies should preferably reinforce and reuse the existing panels, committees, and expert/working groups. In any event, safety assessments should be performed by an independent panel, independent committee or expert group that is independent.

This suggestion is partly reflected in the proposal. The resources provided for this proposal will also be beneficial for the involved scientific committees. The structure of ECHA committees will be addressed as part of the Proposal for Regulation of the European Parliament and the Council on the European Chemicals Agency 32 , which is under preparation. All agencies’ scientific committees are independent and this is not changed.

Tasks to re-attribute

Some stakeholders and Member States suggested that the ECHA should be involved in hazard assessments as part of the assessment of food contact materials, and EFSA should be involved in risk assessments. The agencies should be included in evaluating cosmetic ingredients, deriving environmental quality standards under the Water Framework Directive and in opinions on chemical substances in products (i.e., in toys).

This comment is reflected in the proposal. All the suggested legislation and tasks were considered for re-attribution, and the proposals have been either made or are in preparation.

Assessment of potential impacts on business operators

A few respondents from stakeholders suggested to carry out an impact assessment on the one substance, one assessment initiative to ensure that possible impacts on businesses are considered sufficiently and that businesses are involved in developing the initiative.

This suggestion is reflected in the proposal. Although no formal impact assessment was carried out, the impacts were assessed where relevant and possible in the accompanying staff working document 33 , with particular focus on the impacts on EU agencies’ resources. The proposed measures will not imply costs to businesses or have significant economic impact at EU scale.

•    Collection and use of expertise

The Commission considered input provided by the EU agencies concerned when it assessed which tasks are worth re-attributing to EU agencies, how they should be attributed, as well as potential effects on those agencies.

•    Impact assessment

The fitness check of all chemical legislation (excluding REACH) assessed most of the challenges and risks addressed through this initiative and concluded that there are significant opportunities for streamlining the technical and scientific work through EU agencies. Moreover, there is little discretion of the policy choice as to achieve objectives of the initiative. The consolidation of the technical and scientific work on chemicals at the EU level is possible only in the EU Agencies. Therefore, no formal impact assessment was carried out. The impacts were nevertheless assessed where relevant and possible in the accompanying staff working document 34 .

Overall, this proposal is expected to improve the efficiency, effectiveness, coherence and transparency of EU processes for chemical assessments for the benefit of all stakeholders. Citizens and the environment will benefit from better protection from dangerous chemicals as a result of more efficient and effective assessment processes. Companies will benefit from more harmonised and transparent processes across legislation, from a reduced number of bodies involved in safety and risk assessments, as well as from strengthened certainty regarding the validity of assessments. Finally, the national and EU authorities will benefit from improved efficiency of delivery of assessments and improved public trust and acceptance of regulatory decisions.

·Improved scientific consistency and coherence of assessments – The reduced number of actors involved in the scientific and technical work, as well as an increased cooperation and obligation to solve divergent opinions among agencies leads to improved coherence and scientific consistency - both across the various Union acts, and across the assessment processes laid out therein. The consolidation of work allows to better align priority setting, timelines, processes, and methodologies used for the assessments. It facilitates re-use of assessment insights developed under one Union act on chemicals in the assessment process of another.

·Improved robustness of assessment, trust and acceptance of regulatory decisions – The involvement of the EU agencies and their committees in the scientific and technical work on chemicals adds more scientific expertise, ensures high quality of scientific advice and leads to improved robustness of assessments and thus their acceptance.

·Strengthen independence of the scientific advice – Moving scientific and technical work on chemicals from the Commission, ad hoc committees or consultants to EU agencies and their committees reinforces the independence of the scientific advice and the separation between science and policy or between risk assessment and management. Agencies are independent and their committees work under stricter conflict of interest avoidance rules, improving guarantees of independent scientific advice to the Commission.

·Improved transparency – The involvement of the EU agencies in scientific and technical work will ensure transparency to the process in terms of overall process transparency. 

·Improved efficiency of delivery of assessments – Centralising assessment work in the EU agencies will allow the re-use of capabilities, the re-use of knowledge and experience, and the re-use of IT tools and support services.

While the proposed measures will not imply costs to businesses or have significant economic impact at EU scale, the initiative will have a major impact on the EU agencies’ resource and capacity needs. This impact was assessed in detail quantitatively in cooperation with the agencies concerned. The re-attribution of tasks made as part of the individual pieces of legislation were assessed as part of their respective impact assessments. For the re-attribution of tasks made as part of this proposal for an omnibus regulation amending four pieces of legislation, as well as the accompanying proposal for a Directive amending the RoHS directive, the assessment is presented in the staff working document 35 accompanying this proposal. That document summarises the impact of all re-attributed tasks and assesses their cumulative impact on the EU agencies.

 •    Regulatory fitness and simplification

The proposed re-attribution of tasks to EU agencies and the provisions requiring cooperation among EU agencies will improve the coherence, efficiency, effectiveness and transparency of the legal framework on chemicals as a whole, and especially of the chemical assessments.

Re-attributing tasks to EU agencies will enable efficient use of resources as a result of:

·Re-using existing capabilities on hazard, risk, exposure and socio-economic assessments, development of committee opinions, stakeholder consultation;

·Re-using existing hazard and risk data;

·the economies of scale from reusing scientific support services and IT tools.

The proposed re-attribution of tasks and obligations on agencies to cooperate on the development of methodologies will generate added value in terms of improving scientific consistency across the chemicals legislation and the scientific quality and robustness of assessments. In addition, re-attributing tasks will significantly improve the transparency and inclusiveness of the processes. It will also guarantee the independence of the processes and ensure a separation between risk assessment and risk management.

The proposed provisions requiring cooperation among agencies on exchanging data and setting formats and controlled vocabularies will promote interoperability of data and facilitate digitalisation. This is also important in achieving the objective of removing technical barriers to sharing data strived for in the proposal for a Regulation establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals.

The proposal has an overall positive impact on companies, including on small and medium-sized companies and micro-enterprises. Centralising the scientific and technical work in the EU agencies will reduce the number of committees, expert groups or assessors the companies need to interact with in case of a regulatory action on a chemical. Furthermore, assessment and consultation procedures as well as IT tools used for the submission of data and information across legislation will be more standardised across legislation, thus easier to manage and follow. Strengthening the coherence of assessments across legislation and reducing the potential for divergent scientific outcomes across legislation will reduce the uncertainty for companies stemming from potential divergent scientific outcomes across legislation.

•    Fundamental rights

The proposal has no implications for the protection of fundamental rights.

4.    BUDGETARY IMPLICATIONS

The annexed financial statement relates to the one substance, one assessment package, which includes:

·the current proposal,

·the proposal for a Directive of the European Parliament and of the Council amending Directive 2011/65/EU as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency, and

·the proposal for a Regulation of the European Parliament and of the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals.

The financial statement also covers the financial implications for the European Chemicals Agency and the European Environment Agency of the proposals already adopted by the Commission which have not been reflected in the accompanying legislative financial statements, namely:

·Proposal for a Regulation of the European Parliament and of the Council on packaging and packaging waste 36 ,

·Proposal for a Directive of the European Parliament and of the Council amending directive 2008/98/EC on waste 37 , and

·Proposal for a Regulation on Circularity requirements for vehicle design and on management of end-of-life vehicles 38 . 

The financial statement shows the budgetary implications and the human resources required in the Commission, ECHA, EEA, EFSA and EMA. These impacts reflect both changes in the allocation of responsibilities across the agencies and the allocation of new tasks that the agencies will carry out. The main impacts are:

·For ECHA, an increase of the EU contribution by EUR 24,2 million for the period 2025-2027, and additional 17 TAs and 13 CAs;

·For EEA, an increase of the EU contribution by EUR 4,5 million for the period 2025-2027 and additional 4 TAs and 2 CAs;

·For EFSA, additional 2 CAs without an increase of the EU contribution;

·Contribution/service level agreements with EFSA an EMA for an estimated amount of EUR 4,4 million for the period 2025-2027 to cover 3 CAs per year for EFSA, 3 CAs per year for EMA and operational budget.

The detailed explanation of the financial needs of the proposals is provided in the financial statement and in the respective proposals.

5.    OTHER ELEMENTS

•    Implementation plans and monitoring, evaluation and reporting arrangements

The efficiency in performing the attributed tasks in the EU agencies will be monitored as part of the regular evaluation of the agencies’ performance. In addition, implementation will be evaluated and reported on as part of the review or reporting obligations of each piece of legislation.

•    Detailed explanation of the specific provisions of the proposal

Article 1 amends Regulation (EC) No 178/2002 (General Food Law Regulation) 39 . It includes provisions enabling EFSA to better cooperate and coordinate with ECHA, EMA and EEA. This cooperation would lead to more consistent scientific assessments of chemicals and encourage the agencies to develop consistent scientific opinions and methodologies, taking into account specific sectoral characteristics. The provisions on data and information exchange would bring the EU a step closer to the one substance, one assessment goals. These provisions make greater interoperability possible and scientific processes more robust.

Article 2 amends Regulation (EC) No 401/2009 (the EEA Founding Regulation) 40 . It includes streamlining obligations on the EEA to promote and coordinate the development of assessment methodologies and places the cooperation obligation laid out under Article 1 for EFSA, also on the EEA.

Article 3 amends Annex I of Regulation (EU) 2017/745 (the Medical Devices Regulation) 41 to task ECHA with updating existing guidelines on conducting the risk-benefit assessment of the presence of phthalates in medical devices. The agency will also develop guidelines for other substances, which are classified as either carcinogenic, mutagenic or toxic to reproduction, of category 1A or 1B or have endocrine disrupting properties for human health of Category 1, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 (the CLP Regulation) 42 .

Article 4 amends Regulation (EU) No 2019/1021 by giving the Commission the possibility to request ECHA to develop a report analysing the human health, environmental, social, and economic impact of introducing or modifying concentration limit values specified in Annexes IV and V to Regulation (EU) No 2019/1021 (POPs Regulation) 43 . Together with the newly introduced requirement for an opinion of the agency’s Committee for Socio-Economic Analysis on the report and on the proposed concentration limit values therein, this report will provide the necessary expert support for the Commission to develop the required proposal to introduce or amend the concentration limits in those Annexes.

Considering the highly technical nature of the amendments, this provision also introduces the adoption of amendments to Annexes IV and V by means of a delegated act. To promote the development of a comprehensive chemical exposure and toxicity knowledge base, as well as streamline data flows in line with the one substance, one assessment policy target, the provision also diverts data flows on the presence of persistent organic pollutant substances in the environment to EEA, which is the agency responsible for collecting occurrence data on chemicals in the environment.

2023/0455 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 43, 114, 168(4)(c), 192(1) and 207 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee,

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure,    

Whereas:

(1)The European Green Deal 44 sets a high ambition for enabling the transition towards a toxic-free environment and zero pollution. The Chemicals Strategy for Sustainability 45 (‘the Strategy’) is a crucial delivery of the 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.  

(2)In order to achieve this objective, a part of the scientific and technical work on chemicals performed at Union level in support of Union legislation needs to be consolidated in the relevant Union agencies, while obligations on Union agencies to cooperate for the development of assessment methodologies and exchange of data and information should be introduced. This would simplify the current set-up, improve quality and coherence of safety assessments across Union legislation and ensure more efficient use of existing resources.

(3)The reattribution of certain existing scientific and technical tasks to the European Chemicals Agency, as well as the attribution of new tasks, were proposed as part of ongoing revisions of Union acts. This horizontal proposal aims to provide for further attribution of tasks in respect of those Union acts which are not in the process of being revised and is necessary in order to ensure that the European Chemicals Agency is involved in tasks pertaining to its expertise and developed capacities on chemicals. This is in line with the ‘one substance, one assessment’ aim to ensure that technical and scientific work is performed by the appropriate Union agency, benefiting from demonstrated experience and established tools in its field. The proposal for a Regulation is accompanied by a proposal for a Directive for the amendment of Directive 2011/65/EU of the European Parliament and of the Council 46 , aiming to achieve the same objectives.

(4)As part of the coordinated consolidation and attribution of tasks under the ‘one substance, one assessment’ approach, provisions to allocate a mandate to the European Medicines Agency to develop and cooperate on the development of assessment methodologies, standard formats and controlled vocabularies and exchange of data and information on chemicals have been introduced in Article 138(1), subparagraphs (zd) and (ze), as well as new procedures for ensuring the coherence between scientific opinions in Article 139 of the proposal for a Regulation amending Union pharmaceutical legislation. 47  

(5)To ensure the coherence of methodologies for assessments related to chemicals at Union level, all relevant Union agencies should have an equal mandate to develop such methodologies in the areas falling within their respective missions and should be subject to the same obligations to cooperate amongst each other to develop such methodologies. 

(6)To ensure the coherence and efficiency of assessments related to chemicals across Union legislation, it is also important to enable data interoperability and easy exchange of data between the relevant Union agencies, as well as to encourage cooperation on the development of standard formats and controlled vocabularies. Thus, to facilitate data exchange between agencies, any new data formats defined by the European Food Safety Authority or by the European Environmental Agency should be set in cooperation with other relevant Union agencies working on chemicals. To this end, relevant provisions should be introduced in Regulation (EC) No 401/2009 of the European Parliament and of the Council and, in Regulation (EC) No 178/2002 of the European Parliament and of the Council, existing provisions should be strengthened and, where relevant, new ones be introduced. Similar provisions should also be considered to be proposed for a strengthened mandate of the European Chemicals Agency in its founding regulation.

(7)To promote the coherence and efficiency of assessments related to chemicals across Union legislation, steps should be taken by the relevant Union agencies to avoid divergent scientific opinions. Existing cases of divergent opinions have lead to increased uncertainty for operators, as well as to declined public trust in the scientific robustness and coherence of scientific decision making. Proposals to address and strengthen procedures for resolving divergence of scientific opinions concerning the European Medicines Agency with other scientific bodies is proposed as part of the revision of Union pharmaceutical legislation. Similar provisions should also be considered to be proposed for a strengthened mandate of the European Chemicals Agency in its founding regulation, whilst such provisions are not relevant and applicable to the European Environmental Agency, since this agency does not issue scientific opinions on individual chemicals such as to be part in divergent outcomes. 

(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.

(9)In the more specific case of scientific divergence pertaining to the hazard identification of chemical substances, a new procedure enabling the resolution of the divergence should be established. This procedure should enable the Commission to request the European Chemicals Agency, as the Union agency most equipped with expertise and capacity in hazard assessment, as well as long-standing experience with the harmonised classification and labelling process, to develop a proposal for harmonised classification and labelling, in accordance the Regulation (EC) No 1272/2008 of the European Parliament and Council, moving closer to the ‘one substance, one assessment’ vision as regards uniformity of hazard assessments of chemicals across the Union. 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.

(10)To comply with the obligation laid down in Section 10.4.3 of Annex I to Regulation (EU) 2017/745 of the European Parliament and of the Council 48 , the Commission has provided the Scientific Committee on Health, Environmental and Emerging Risks (‘SCHEER’) with a mandate to prepare guidelines on the benefit-risk assessment of the presence of phthalates which are classified as either carcinogenic, mutagenic or toxic to reproduction category 1A or 1B, or which have endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health 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 49 . The SCHEER issued those guidelines in 2019 and the Commission has issued a mandate to the SCHEER to perform a first update of those guidelines.

(11)To comply with the obligation laid out in Section 10.4.4. of Annex I to Regulation (EU) 2017/745, the Commission should mandate the relevant scientific committee to prepare guidelines for substances other than phthalates and which are classified as either carcinogenic, mutagenic or toxic to reproduction category 1A or 1B, or which have endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health 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.

(12)The European Chemicals Agency already provides scientific advice on chemical substances, including on phthalates, endocrine disruptors and carcinogens, mutagens and reproductive toxicants under Regulation (EC) No 1907/2006. Several key capacities of the agency can be reused, including hazard, risk, exposure and socio-economic assessment capacities, the Committee opinion development and IT capabilities for stakeholder consultation and dissemination. To enable timely future updates on the presence of phthalates and to ensure that the appropriate Union agency develops new guidelines on other substances on the basis of the latest scientific evidence, these tasks should be attributed to the European Chemicals Agency.

(13)Taking account of the new hazard classes and criteria for classification, labelling and packaging of substances introduced by Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 50 , reference to endocrine disruptors for human health, of Category 1, should be specified in 10.4.1., point (b) of Annex I of Regulation (EU) 2017/745 in light of the relevance of that hazard class to the type of substances in medical devices.

(14)To make best use of the European Chemicals Agency’s knowledge and expertise gained through its involvement in the nomination and assessment processes under the Stockholm Convention on Persistent Organic Pollutants, the European Chemicals Agency should, upon request, assist the Commission in complying with its obligation to amend Annexes IV and V to Regulation (EU) 2019/1021 51 . Where the opinion of the Committee for Socio-Economic analysis is required, and in order to allow for the necessary capacity and resources for the effective functioning of that committee, Member States should be given the opportunity to cover for the specific expertise required for the effective performance of the task by nominating experts. In order to ensure that the Committee for Socio-Economic analysis benefits from sufficient resources, when the committee appoints one of their members as a rapporteur, that person, or his employer should be remunerated.

(15)In order to amend certain non-essential elements of Regulation (EU) 2019/1021 of the European Parliament and of the Council, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending Annexes IV and V in order to adapt them to the changes to the list of substances set out in the Annexes to the Stockholm Convention or the Protocol or adapt them to scientific and technical progress. 

(16)As part of their reporting obligations under the Regulation (EU) 2019/1021 of the European Parliament and of the Council, Member States must report to the European Chemicals Agency information on the presence of substances listed in Part A of Annex III in the environment. The use of the Information Platform for Chemical Monitoring (‘IPCHEM’) is encouraged as a means for Member States to comply with their obligations to report that chemical occurrence data and to simplify and reduce their reporting obligations. Where Member States make data available through IPCHEM, they no longer need to report it to the European Chemicals Agency, as the agency may retrieve it from the platform.

(17)The revision of the Directive (EU) 2020/2184 of the European Parliament and of the Council 52  requires Member States to share with European Environmental Agency all chemical occurrence or monitoring data in water. Additionally, the monitoring data on the presence of POPs in air are already being reported by Member States to the EEA as part of the Union air quality legislation. The proposal for a Regulation of the European Parliament and the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable, and reusable and establishing a monitoring and outlook framework for chemicals 53 will require all chemical occurrence data to be held by the EEA. As a result, chemical occurrence data provided to and held in IPCHEM by the Commission will thus be collected and held by the EEA, instead of by the Commission. Therefore, it is necessary to simplify the reporting obligations for Member States to ensure that, where Member States have already submitted that information to the EEA as part of fulfilling obligations required by the provisions of other pieces of Union environmental legislation, Member States should be considered to have fulfilled their reporting obligations under Regulation (EU) 2019/1021. 

(18)Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EC) No 178/2002

Regulation (EC) No 178/2002 is amended as follows:

(1) in Article 23, the following point (m) is added:

‘(m) to cooperate with the competent bodies in the Member States that carry out similar tasks to those of the Authority and to cooperate with other scientific bodies established under Union law, notably the European Chemicals Agency, the European Medicines Agency, and the European Environment Agency on the provision of relevant scientific opinions, on the exchange of data and information, including the possible establishment of related data formats and controlled vocabularies to facilitate such an exchange, and on the development of scientific methodologies for the assessment of chemicals.’;

(2)Article 30 is replaced by the following:

‘Article 30

Diverging scientific opinions

1.The Authority shall take the necessary and appropriate measures to monitor and identify at an early stage any potential source of divergence between its scientific opinions and the scientific opinions issued by other bodies carrying out similar tasks. 

2.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.  

The Authority and the body concerned shall cooperate to resolve the divergence. 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.

Where the body concerned is a Union agency or a scientific committee, the Authority shall present the joint report to the Commission.

3.Where relevant, and where the divergence concerns conflicting scientific opinions of the Authority and another Union body or agency on whether a substance fulfils the criteria laid out in Annex I of Regulation (EC) No 1272/2008 of the European Parliament and of the Council 54 , the Commission may request the European Chemicals Agency to prepare a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof following the procedure laid out in Article 37 of Regulation (EC) No 1272/2008. The Authority and the Union body or agency concerned shall co-operate with the European Chemicals Agency in developing that proposal.’.

Article 2

Amendments to Regulation (EC) No 401/2009

Regulation (EC) No 401/2009 is amended as follows:

(1)in Article 2, the following point (p) is added:

‘(p) to develop assessment methodologies related to chemicals in the fields falling within its mission.’; 

(2)in Article 15, the following paragraph 5 is added:

‘5. The Agency shall cooperate with other scientific bodies established under Union law, notably the European Chemicals Agency, the European Food Safety Authority, and the European Medicines Agency, on the exchange of data and information on chemicals, including the possible establishment of related data formats and controlled vocabularies to facilitate such an exchange, and on the development of scientific methodologies for the assessment of chemicals.’.

Article 3

Amendments to Regulation (EU) 2017/745

Annex I to Regulation (EU) 2017/745 is amended as follows:

(1)in Section 10.4.1, point (b) is replaced by the following:

‘(b) substances which are identified 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 Council 55 and 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.’ 

(2)in Section 10.4.2, point (d) is replaced by the following:

‘(d) where applicable and available, the latest relevant guidelines in accordance with Sections 10.4.3. and 10.4.4.’;

(3)Section 10.4.3 is replaced by the following:

‘10.4.3.   Guidelines on phthalates

When deemed appropriate based on the latest scientific evidence, but at least every 5 years, the Commission shall request the European Chemicals Agency (ECHA) to update guidelines on the benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in Section 10.4.1., points (a) and (b). The benefit-risk assessment shall consider the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments

When appropriate or when requested by the Commission, ECHA shall consult the Committee for Risk Assessment and the Committee for Socio-economic Analysis.’;

(4)Section 10.4.4 is replaced by the following:

‘10.4.4.   Guidelines on other CMR and endocrine-disrupting substances

The Commission shall request ECHA to prepare guidelines as referred to in Section 10.4.3. and following the process described therein also for other substances referred to in Section 10.4.1., points (a) and (b), where appropriate.’.

Article 4

Amendments to Regulation (EU) 2019/1021

Regulation (EU) 2019/1021 is amended as follows:

(1)Article 8(1) is amended as follows:

(a)the following point (i) is added:

‘(i) upon request from the Commission, and within 12 months from that request, draw up and provide a report on the human health, environmental and socio-economic impacts of introducing or modifying concentration limit values specified in Annex IV or V.’

(2)Article 8(1a) is added:

‘1a. The report referred to in Article 8(1), point (i), shall contain the following information:

(a)as appropriate, information on human health and environmental impacts of waste consisting of, containing or contaminated with POPs, including impacts on waste management;

(b)information on concentrations and mass flows of POPs in relevant waste streams and on waste treatment and treatment capacities;

(c)an analysis of the impacts of the different concentration limit values considered;

(d)a duly motivated proposal for concentration limit values to be introduced in Annex IV and, as appropriate, in Annex V.

The Agency shall, as soon as it receives the request referred to in the first subparagraph, 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.

At the latest 9 months following the submission of that report, 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.

The Agency shall submit the report and the opinion of the Committee for the Socio-economic Analysis on the concentration limit values to the Commission without delay.’;

(3)in Article 13, paragraph 2 is replaced by the following:

‘2.   Where a Member State shares the information referred to in paragraph 1, point (e), with the European Environmental Agency, that Member State shall indicate that in the report and the Member State shall be considered to have fulfilled its reporting obligations under that point.

Where the information referred to in paragraph 1, point (e), is contained in the report of a Member State provided to the Agency, the Agency shall transmit the information to the European Environmental Agency for compiling, storing and sharing that information’;

(4)in Article 15, paragraph 2 is replaced by the following:

‘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 to the Convention or the Protocol or to adapt them to scientific and technical progress.’

(5)Article 18 is amended as follows:

(a) The first sentence of paragraph 2 is replaced by the following:

‘2. The power to adopt delegated acts referred to in Articles 4(3), 10(2) and 15 shall be conferred on the Commission for a period of five years from 15 July 2019.’.

(b)The first sentence of paragraph 3 is replaced by the following:

‘3. The delegation of power referred to in Articles 4(3), 10(2) and 15 may be revoked at any time by the European Parliament or by the Council.’.

(c)Paragraph 6 is replaced by the following:

‘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.’.

Article 6

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Done at Brussels,

LEGISLATIVE FINANCIAL STATEMENT

1.FRAMEWORK OF THE PROPOSAL/INITIATIVE 

1.1.Title of the proposal/initiative

1.2.Policy area(s) concerned 

1.3.The proposal/initiative relates to: 

 a new action 

 a new action following a pilot project/preparatory action 56  

 the extension of an existing action 

 a merger or redirection of one or more actions towards another/a new action 

1.4.Objective(s)

1.4.1.General objective(s) 

1.4.2.Specific objective(s)

1.4.3.Expected result(s) and impact

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted.

1.4.4.Indicators of performance

Specify the indicators for monitoring progress and achievements.

1.5.Grounds for the proposal/initiative 

1.5.1.Requirement(s) to be met in the short or long term including a detailed timeline for roll-out of the implementation of the initiative

1.5.2.Added value of Union involvement (it may result from different factors, e.g. coordination gains, legal certainty, greater effectiveness or complementarities). For the purposes of this point 'added value of Union involvement' is the value resulting from Union intervention, which is additional to the value that would have been otherwise created by Member States alone.

1.5.3.Lessons learned from similar experiences in the past

1.5.4.Compatibility with the Multiannual Financial Framework and possible synergies with other appropriate instruments

1.5.5.Assessment of the different available financing options, including scope for redeployment

1.6.Duration and financial impact of the proposal/initiative

 limited duration

–    in effect from [DD/MM]YYYY to [DD/MM]YYYY

–    Financial impact from YYYY to YYYY for commitment appropriations and from YYYY to YYYY for payment appropriations.

 unlimited duration

–Implementation with a start-up period from 2025 to 2028,

–followed by full-scale operation.

1.7.Method(s) of budget implementation planned 61  

 Direct management by the Commission

– by its departments, including by its staff in the Union delegations;

–    by the executive agencies

 Shared management with the Member States

 Indirect management by entrusting budget implementation tasks to:

– third countries or the bodies they have designated;

– international organisations and their agencies (to be specified);

– the EIB and the European Investment Fund;

– bodies referred to in Articles 70 and 71 of the Financial Regulation;

– public law bodies;

– bodies governed by private law with a public service mission to the extent that they are provided with adequate financial guarantees;

– bodies governed by the private law of a Member State that are entrusted with the implementation of a public-private partnership and that are provided with adequate financial guarantees;

– bodies or persons entrusted with the implementation of specific actions in the CFSP pursuant to Title V of the TEU, and identified in the relevant basic act.

–If more than one management mode is indicated, please provide details in the ‘Comments’ section.

2.MANAGEMENT MEASURES 

2.1.Monitoring and reporting rules 

Specify frequency and conditions.

2.2.Management and control system(s) 

2.2.1.Justification of the management mode(s), the funding implementation mechanism(s), the payment modalities and the control strategy proposed

2.2.2.Information concerning the risks identified and the internal control system(s) set up to mitigate them

2.2.3.Estimation and justification of the cost-effectiveness of the controls (ratio of "control costs ÷ value of the related funds managed"), and assessment of the expected levels of risk of error (at payment & at closure) 

2.3.Measures to prevent fraud and irregularities 

Specify existing or envisaged prevention and protection measures, e.g. from the Anti-Fraud Strategy.

3.ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE 

3.1.Heading(s) of the multiannual financial framework and expenditure budget line(s) affected 

·Existing budget lines

In order of multiannual financial framework headings and budget lines.

·New budget lines requested

In order of multiannual financial framework headings and budget lines.

3.2.Estimated financial impact of the proposal on appropriations 

3.2.1.Summary of estimated impact on operational appropriations 

–    The proposal/initiative does not require the use of operational appropriations

–    The proposal/initiative requires the use of operational appropriations, as explained below:

EUR million (to three decimal places)

The details of the tasks to be performed by ECHA are specified in the staff working document 65 accompanying this legal proposal, in particular in the Annexes III and IV. The above increase of the contribution to ECHA will be offset from the LIFE Programme (budget line: 09.02.02).

The details of the tasks to be performed by EEA are specified in the staff working document 66 accompanying this legal proposal, in particular in the Annexes III and IV. The above increase of the contribution to the EEA will be offset from the LIFE Programme (budget line: 09.02.02).

The need for additional resources for EFSA is estimated at 3 contract agents and EUR 2 million of operational expenditure. The need for additional resources for EMA is estimated at 3 contract agents and EUR 0,3 million of operational expenditure. For 2025-2027, these costs will be covered through a contribution/service level agreement between the agencies and DG ENV. Without prejudice to the future MFF agreement, the costs from 2028 on should be covered by the EU subsidies to these agencies.

In addition, the need for additional resources for JRC is estimated at EUR 0,540 million of operational expenditure, to be channelled through an administrative agreement.

This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative Financial Statement (Annex 5 to the Commission decision on the internal rules for the implementation of the Commission section of the general budget of the European Union), which is uploaded to DECIDE for interservice consultation purposes.

EUR million (to three decimal places)

EUR million (to three decimal places)

3.2.2.Estimated output funded with operational appropriations 

Commitment appropriations in EUR million (to three decimal places)

3.2.3.Estimated impact on ECHA, EEA, EFSA and EMA human resources and administrative appropriations

3.2.3.1.Estimated requirements on ECHA’s human resources

–    The proposal/initiative does not require the use of human resources.

–    The proposal/initiative requires the use of human resources, as explained below:

EUR million (to three decimal places) 

Where applicable, amounts reflect the sum of the Union contribution to the agency and other revenue of the agency (fees and charges). 

Staff requirements (FTE): 

3.2.3.2.Estimated requirements on EEA’s human resources

–    The proposal/initiative does not require the use of human resources.

–    The proposal/initiative requires the use of human resources, as explained below:

EUR million (to three decimal places) 

Where applicable, amounts reflect the sum of the Union contribution to the agency and other revenue of the agency (fees and charges). 

Staff requirements (FTE): 

3.2.3.3.Estimated requirements on EMA’s human resources

–    The proposal/initiative does not require the use of human resources.

–    The proposal/initiative requires the use of human resources, as explained below:

Staff requirements (FTE): 

3.2.3.4.Estimated requirements on EFSA’s human resources

–    The proposal/initiative does not require the use of human resources.

–    The proposal/initiative requires the use of human resources, as explained below:

Staff requirements (FTE): 

3.2.4.Compatibility with the current multiannual financial framework 

The proposal/initiative:

–    can be fully financed through redeployment within the relevant heading of the Multiannual Financial Framework (MFF).

–    requires use of the unallocated margin under the relevant heading of the MFF and/or use of the special instruments as defined in the MFF Regulation.

–    requires a revision of the MFF.

3.2.5.Third-party contributions 

The proposal/initiative:

–    does not provide for co-financing by third parties

–    provides for the co-financing by third parties estimated below:

Appropriations in EUR million (to three decimal places)

3.3.Estimated impact on revenue 

–    The proposal/initiative has no financial impact on revenue.

–    The proposal/initiative has the following financial impact:

–    on own resources

–    on other revenue

–please indicate, if the revenue is assigned to expenditure lines     

EUR million (to three decimal places)

For assigned revenue, specify the budget expenditure line(s) affected.

Other remarks (e.g. method/formula used for calculating the impact on revenue or any other information).

(1)

   Commission Staff Working Document Fitness Check of the most relevant chemicals legislation (excluding REACH), as well as related aspects of legislation applied to downstream industries accompanying the document: Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Findings of the Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses ( SWD(2019) 199 ).

(2)    The European Green Deal. COM (2019) 640 final.

(3)    The Chemicals Strategy for Sustainability COM (2020) 667 final .

(4)     Council Conclusions on Sustainable Chemicals Strategy of the Union, 2021 .

(5)    European Parliament resolution of 10 July 2020 on the Chemicals Strategy for Sustainability (2020/2531(RSP)) ( OJ C 371, 15.9.2021, p.75 ).

(6)    Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions ‘Pathway to a Healthy Planet for All - EU Action Plan: 'Towards Zero Pollution for Air, Water and Soil' ( COM(2021) 400 final ).

(7)    Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants ( OJ L 169 25.6.2019, p. 45 ).

(8)    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ( OJ L 117 5.5.2017, p. 1 ).

(9)    Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the European Environment Agency and the European Environment Information and Observation Network ( OJ L 126 21.5.2009, p. 13).

(10)    Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( OJ L 031 1.2.2002, p. 1 ).

(11)     OJ L 435 23.12.2020, p. 1 .

(12)     OJ L 314 6.12.2022, p. 26 .

(13)     COM(2020) 798 final .

(14)     COM(2022) 157 final .

(15)     COM(2022) 156 final/3

(16)     COM(2022) 540 final .

(17)     COM(2022) 748 final .

(18)     COM(2022) 677 final .

(19)     COM/2023/451 final .

(20)     COM(2023) 462 final .

(21)     OJ L 272 20.10.2022, p. 14 .

(22)     European Chemicals Agency – proposal for a basic regulation (europa.eu)  

(23)     Chemicals legislation – revision of REACH Regulation to help achieve a toxic-free environment (europa.eu)

(24)     EU chemicals strategy for sustainability – Cosmetic Products Regulation (revision) (europa.eu)  

(25)

    COM/2023/193 final .

(26)

   Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction
of the use of certain hazardous substances in electrical and electronic equipment (OJ L 174, 1.7.2011,
p. 88).

(27)    Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ( OJ L 396, 30.12.2006 , p.1 ).

(28)    Proposal for a Regulation of the European Parliament and the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals (COM(2023) 779)

(29)    Commission staff working document accompanying the documents Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EC) No 178/2002,  (EC) No 401/2009,  (EU) 2017/745 and  (EU) 2019/1021 of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals and Proposal for a Directive of the European Parliament and the Council amending Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency (SWD (2023) 850)

(30)

   Report from the Commission to the European Parliament, the Council, the European Economic And Social Committee and the Committee of the Regions: Findings of the Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses ( COM/2019/264 final ).

(31)     Register of Commission expert groups and other similar entities (europa.eu) .

(32)     European Chemicals Agency – proposal for a basic regulation (europa.eu)

(33)    SWD (2023) 850

(34)    SWD (2023) 850

(35)    SWD (2023) 850

(36)     COM (2022) 677 final .

(37)     COM (2023) 420 final .

(38)     COM (2023) 451 final .

(39)    Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ( OJ L 31, 1.2.2002, p. 1 ).

(40)    Regulation (EC) No 401/2009 of the European Parliament and of the Council of 23 April 2009 on the European Environment Agency and the European Environment Information and Observation Network ( OJ L 126, 21.5.2009, p. 13 ).

(41)    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ( OJ L 117, 5.5.2017, p. 1 ).

(42)    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 ).

(43)    Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants ( OJ L 169, 25.6.2019, p. 45 ).

(44)    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 .

(45)    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

(46)    Directive 2011/65/EU of the European Parliament and of the Council as regards the re-attribution of scientific and technical tasks to the European Chemicals Agency.

(47)    Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006, COM(2023) 193 final . [OJ:Please insert correct reference once the Regulation is adopted].

(48)    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC ( OJ L 117, 5.5.2017, p. 1 ) .

(49)    Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC ( OJ L 396, 30.12.2006, p. 1–849 ).

(50)    Commission Delegated Regulation (EU) 2023/707 of 19 December 2022 amending Regulation (EC) No 1272/2008 as regards hazard classes and criteria for the classification, labelling and packaging of substances and mixtures ( OJ L 93, 31.3.2023, p. 7–39 ).

(51)    Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants ( OJ L 169, 25.6.2019, p. 45 ) .

(52)    Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast), ( OJ L 435, 23.12.2020, p. 1–62 ).

(53)    [OJ Please insert reference once proposal is adopted]

(54)    Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. OJ L 353 31.12.2008, p. 1 – 1355 .

(55)    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 ) .

(56)    As referred to in Article 58(2)(a) or (b) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (Financial Regulation). OJ L 193 30.7.2018, p. 1 – 222 .

(57)    Commission staff working document accompanying the document Proposal for a Regulation of the European Parliament and of the Council establishing a common data platform on chemicals, laying down rules to ensure that the data contained in it are findable, accessible, interoperable and reusable and establishing a monitoring and outlook framework for chemicals (COM (2023) 855).

(58)    8th Environmental Action Plan (EAP) monitoring framework. COM (2022) 357 final.

(59)

   Report from the Commission to the European Parliament, the Council, the European Economic And Social Committee and the Committee of the Regions: Findings of the Fitness Check of the most relevant chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses.  COM/2019/264 final .

(60)     EEA: Late lessons from early warnings: the precautionary principle 1896–2000, Luxembourg: Office for Official Publications of the European Communities, 2001

(61)    Details of budget implementation methods and references to the Financial Regulation may be found on the BUDGpedia site: https://myintracomm.ec.europa.eu/corp/budget/financial-rules/budget-implementation/Pages/implementation-methods.aspx

(62)    Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations.

(63)    EFTA: European Free Trade Association.

(64)    Candidate countries and, where applicable, potential candidates from the Western Balkans.

(65)    SWD (2023) 850

(66)    SWD (2023) 850

(67)    Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).

(68)    As described in point 1.4.2. ‘Specific objective(s)…’

(69)    Year N is the year in which implementation of the proposal/initiative starts. Please replace "N" by the expected first year of implementation (for instance: 2021). The same for the following years.

(70)    As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 20 % for collection costs.