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 - Main contents

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This page contains a limited version of this dossier in the EU Monitor.

dossier	COM(2023)783 - Amendment of Regulations (EC) No 178/2002, (EC) No 401/2009, (EU) 2017/745 and (EU) 2019/1021 of the European Parliament and ...
source	COM(2023)783
date	07-12-2023

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:
Two key actions set out in the Strategy to improve the overall efficiency, effectiveness, coherence and transparency are to:
The objectives of the proposal are to ensure that:
Attribution or re-attribution of tasks to EU agencies has been already proposed as part of:
Attributing or re-attributing tasks to EU agencies are being considered as part of the following proposals in preparation:
Re-attributing tasks to EU agencies will enable efficient use of resources as a result of:

1. 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.

2. 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.

3. The objectives of the proposal are to ensure that:

- 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.

4. 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.

5. 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 Assessment³¹ 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.

6. 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.

Please note

Contents

1.

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

2.

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

3.

The objectives of the proposal are to ensure that:

4.

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

5.

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

6.

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