EUROPEAN COMMISSION

Brussels, 7.12.2023

SWD(2023) 850 final

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

{COM(2023) 783 final}
{COM(2023) 781 final}

Table of contents

1.Introduction: political and legal contex ………….…………………………………...……..

1.1Political context

1.2Legal context

1.3Scope of the document

2.Problem definition

3.Objectives: What is to be achieved?

4.Available options

5.Stakeholder views

6.Scientific and technical work on chemicals for (re-)attribution to the EU agencies and strengthening the cooperation among the Agencies

7.Assessment of impacts

8.Impacts of the legislative proposals on reattribution of tasks

9.Impact of the legislative proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals…

10.Overall impacts from all (re-)attributions

10.1Added value and synergies of the (re-)attributions

10.2Overall impact on resources

10.3Overall impacts on ECHA

10.4Overall impacts on EEA

10.5Overall impacts on EFSA

10.6Overall impacts on EMA

10.7Overall impacts on EU-OSHA

Annex I: Mission, core activities, competences and scientific bodies of the Agencies

1.European Food Safety Authority….

2.European Chemicals Agency

3.European Medicines Agency

4.European Environment Agency

5.European Agency for Safety and Health at Work

Annex II: Summary of the Feedback Received through the Public Consultation on the Call for Evidence for the Initiative on (Re-)Attribution of Scientific and Technical Work on Chemicals to the EU Agencies

1.Respondents

2.Type of responses

3.Support to the initiative on 1S1A

4.Scope and objectives of 1S1A

5.Reattribution of tasks to EU agencies

Annex III: Detailed impact analysis of the (re-)attribution of scientific and technical work related to chemicals to EU agencies

1.Drinking water directive (2020/2184)

2.Regulation on serious cross-border threats to health (2022/2371)

3.European Partnership for the Assessment of Risks from Chemicals (PARC)

4.Commission implementing decision 2022/1979 under SEVESO directive

5.Batteries Regulation (proposal)

6.E-PRTR Regulation (2006/166)

7.Industrial Emissions Directive (2010/75/EU)

8.Environmental Quality Standard Directive (2008/105/EC) + Water Framework Directive (2000/60/EC) + Groundwater Directive (2006/118/EC)

9.CLP Regulation (1272/2008)

10.Packaging and Packaging Waste Directive

11.Legislation on medicinal products for human use (726/2004)

12.End-of Life Vehicles (ELV) Directive

13.Toy Safety Directive

14.Restriction of Hazardous Substance (RoHS) Directive (2011/65/EU)

15.POPs Regulation (2019/1021)

16.Medical devices Regulation

17.EEA founding regulation (1210/90)

18.General Food Law (178/2002)

19.EU Common Data Platform on Chemicals

20.Information Platform for Chemical Monitoring (IPCHEM)

21.Information on regulatory processes on chemicals

22.Repository of reference values

23.Information on the obligations under Union acts on chemicals

24.Database on environmental sustainability related information

25.Mechanism for initiating testing and monitoring

26.Mechanism for notification of studies

27.EU Chemical Early Warning and Action System and Indicator Framework for Chemicals

28.Observatory for specific chemicals with potential contribution to emerging chemical risks

29.Cooperation of ECHA with other EU agencies

30.Scientific opinions on occupational exposure limits

31.REACH regulation (1907/2006)

32.Cosmetic Products Regulation

33.Scientific Committees and their secretariat (SCCS/SCHEER)

34.Ecodesign for Sustainable Products Regulation

35.Tobacco products directive

36.Regulation on fluorinated greenhouse gases and Regulation on ozone depleting substances

1.Introduction: political and legal context

1.1Political context 

Chemicals are everywhere in our daily lives and play a fundamental role in most of our activities, as they form part of virtually every device we use to ensure our well-being (be it for food, electronics, toys, clothes or industrial machines), protect our health and security, and meet new challenges through innovation. The EU is the second largest producer of chemicals in the world with EUR 541 billion turnover in 2018 (7.0% of EU manufacturing by turnover) and 14.4% of global sales in 2020 (CEFIC, 2022) 1 and chemical manufacturing is the fourth largest industry in the EU comprising 30 000 companies, 95% of which are SMEs, directly employing approximately 1.2 million people and 3.6 million indirectly.

At the same time, chemicals can cause harm to human health and the environment. Certain chemicals cause cancers, affect the immune, respiratory, endocrine, reproductive and cardiovascular systems and increase vulnerability to diseases. Exposure to these harmful chemicals is therefore a threat to human health. In addition, the pollution of environment with chemicals is one of the key drivers putting the Earth at risk 2 , impacting and amplifying planetary crises such as climate change, degradation of ecosystems and loss of biodiversity, examples being negative effects on pollinators, insects, aquatic ecosystems and bird population.

In order to ensure a high level of protection of human health and the environment from the adverse effects of chemicals and to support the efficient functioning of the internal market for chemicals while promoting the competitiveness and innovation of EU industry, the European Union has developed a comprehensive regulatory framework for chemicals.

The framework has been developed progressively, with the first legislation coming in place as early as in 1967. The framework consists currently of over 40 pieces of legislation, addressing: the production and placing on the market of chemicals and chemical products, such as (e.g. industrial chemicals, biocidal products, plant protection products, human and veterinary pharmaceuticals, cosmetic products, detergents), emissions of chemicals (e.g. from industrial installations, waste water treatment plants or use of fertilisers), protection of workers’ health (e.g. from carcinogens, mutagens and reprotoxic substances, from asbestos, or from chemical agents in general), chemicals in waste (e.g. in general, in packaging and packaging waste or in end-of-life vehicles), safety of consumer products (e.g. toys, food contact materials, batteries), safety of foodstuff and feedstuff (e.g. food improvements agents or maximum residue levels of food contaminants ) and protection of the environmental compartments (e.g. surface waters, ground waters, marine waters, drinking water, air and soil).

The fitness check of the most relevant chemicals legislation assessing over 40 pieces of legislation concluded that overall the EU chemicals legislation delivers results as intended and is fit-for-purpose, but a number of significant weaknesses prevent the EU chemicals legislation from living up to its full potential. There were identified shortcomings across legislative pieces as regards the coherence of safety assessments, efficiency of the underlying technical and scientific work and the coherence of transparency rules. These shortcomings can lead to inconsistency and incoherence in safety assessments, slow procedures, inefficient use of resources, unnecessary burden, (perceived) lack of transparency and sometimes low quality of scientific advice (see section 2).

Building on the findings of the fitness check, the European Green Deal announced the commitment ‘to review how to use better the EU’s agencies and scientific bodies to move towards a process of ‘one substance, one assessment’ and to provide greater transparency when prioritising action to deal with chemicals’. The Chemicals Strategy for Sustainability elaborated further on the concept of ‘one substance, one assessment’ and defined it as an approach to improve the overall efficiency, coherence and transparency of the delivery of safety assessments of chemicals across legislation. The strategy identified five key areas affecting the coherence and efficiency of delivery of safety assessments and for each of them defined number of specific objectives and actions (see sections 2 and 3). Two key actions identified 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 (SCHEER) and Scientific Committee on Consumer Safety (SCCS)’ and to ensure ‘a clear allocation of responsibilities and good cooperation among the European Agencies’.

The EU Action Plan ‘Towards Zero Pollution for Air, Water and Soil’ further contributed to the one substance, one assessment objectives 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.

The European Parliament resolution of 10 July 2020 welcomed the Strategy and the ‘one substance – one hazard assessment’ principle in order to better use the resources of the Union’s agencies and scientific bodies, avoid duplication of efforts, reduce the risk of diverging outcomes of assessments, speed up and bring consistency and transparency to chemicals regulation, and ensure enhanced health and environmental protection and a level playing field for industry. The resolution called to achieve coherence and synergies between legislation dealing with chemicals and chemical products, specific products regulation, general product legislation, legislation on environmental compartments, legislation on sources of pollution and legislation on waste. The resolution further called to pay special attention to reducing overlaps between legal frameworks, and between tasks allocated to the European Chemicals Agency, the European Food Safety Agency and the European Medicines Agency. The resolution also underlined the need to reinforce cooperation and coordination between the European evaluation agencies EFSA and ECHA together with national agencies, by developing common guidelines for risk assessment, namely for biocidal and phytopharmaceutical products, which take into account the most recent scientific results, so as to avoid inconsistencies. Finally, the European Parliament called on the Commission and Council to refrain from cutting ECHA’s resources in annual budget procedures and to provide ECHA with additional resources for any other tasks that may be required, such as conducting evaluations of substances.

The Council conclusions of 15 March 2021 also welcomed the Strategy and the ‘one substance, one assessment’ approach intending to simplify and improve the transparency of the regulatory framework for hazard and risk assessment of chemicals, to enhance coherence, to better coordinate the EU rules on chemicals, and to make decision-making faster. The conclusions called to continue ensuring policy coherence and exploit synergies among the chemicals and other policies. The conclusion further emphasised that the one substance, one assessment approach should not create delays in regulatory actions nor increase administrative burden, that the Member States are closely involved in the development of the approach and that the right of initiative of the Member States to initiate regulatory action is maintained. The conclusions also underlined the importance of allocating the necessary resources for the European agencies in the light of the envisaged re-attribution of technical and scientific work on chemicals, including an appropriate and long-term budgetary framework, and, in particular, for ECHA, taking into consideration their central role in the implementation of some key objectives of the Chemicals Strategy.

1.2Legal context 

The reattribution of existing tasks or attribution of new tasks to EU Agencies requires targeted amendments of the existing pieces of legislation on chemicals. The preferred way of doing it is by introducing changes in allocation of tasks when the individual pieces of legislation are being revised. Therefore, the relevant changes have been already proposed as part of the proposals for the regulation on serious cross-border threats to health 3  and for revisions of drinking water directive 4 , SEVESO III directive 5 , batteries regulation 6 , EPRTR regulation 7 , industrial emissions directive 8 , water framework directive, ground water directive, environmental quality standard directive 9 , CLP regulation 10 , packaging and packaging waste directive 11 , legislation on medicinal products for human use 12 , 13 , end-of-life vehicles directive 14 and directive on the safety of toys 15 . The relevant changes, including new or additional tasks, are also planned to be introduced in the upcoming proposals for a regulation on ECHA 16  and for the revisions of REACH 17 and cosmetics regulation 18 .

Where the chemical legislation is not to be opened within this mandate of the Commission, the necessary changes in allocation of tasks  is introduced through the horizontal proposals on reattribution of tasks to the EU Agencies consisting of a regulation and a directive, for reasons of legal consistency. The proposal for the regulation proposes targeted amendments to allocations of tasks in the POPs regulation 19 , medical devices regulation 20 , EEA founding regulation 21 and the general food law 22 , while the proposal for a directive proposes targeted amendments to allocations of tasks in the RoHS directive 23 .

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 is a standalone regulation aiming to implement one substance, one assessment actions related to data, information and transparency, namely:

·use a single ‘Public activities coordination tool’ to provide an up-to-date overview of all planned and ongoing initiatives on chemicals by authorities across legislation;

·develop a common open data platform on chemicals to facilitate the sharing, access and re-use of information on chemicals coming from all sources;

·promote reuse and harmonisation of human and environmental health-based limit values among EU risk assessors and managers through a centralised and curated EU repository;

·remove legislative obstacles for the re-use of data and better streamline the flow of chemical data between EU and national authorities;

·establish tools and practices to ensure that relevant academic data is easily and readily accessible for safety assessments and is suitable for regulatory purposes;

·enable EU authorities to commission testing and monitoring of substances as part of the regulatory framework when further information is considered necessary;

·extend the principle of open data and the relevant transparency principles from the EU food safety sector to other pieces of chemical legislation;

·develop an EU early warning and action system for chemicals to ensure that EU policies address emerging chemical risks as soon as identified by monitoring and research.

In order to implement these actions, the proposal also allocates some new tasks to EU agencies as regards the management, sharing and generation of data and information, operation of a monitoring and outlook framework for chemicals and formalises some existing tasks.

1.3Scope of the document

This document summarises all actions taken as of 2020 to (re-)attribute scientific and technical work on chemicals to EU agencies and to ensure good cooperation among the EU agencies in the area of chemicals. The document accompanies the horizontal legislative proposals on reattribution of tasks to EU agencies, and explains changes in (re-)attributions proposed in those proposals. It also explains, for the purpose of completeness of information changes which will be made to allocation of tasks via revisions of individual pieces of legislation or via a new legislation, including via the proposal for a Regulation on 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 (‘proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals’). The document explains how the changes in allocation of tasks to EU agencies contribute to achieving the one substance, one assessment objectives and provides an assessment of cumulative impacts of the changes in allocations of tasks on the functioning of the EU Agencies.

2.Problem definition 

The EU regulatory framework for hazard and risk assessment and management of chemicals is comprehensive. It consists of many pieces of legislation, addressing production and placing on the market of chemicals and chemical products, emissions of chemicals, chemicals in waste, protection of workers’ health and safety of consumer products, foodstuff and feedstuff, and the environment. A high volume of technical and scientific work supports the implementation of the individual legislative acts. Depending on the legislation, the work is performed using different data and methodologies and involving various EU Agencies (the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Environment Agency (EEA), the European Medicine Agency (EMA) and the European Agency for Safety and Health at Work (EU-OSHA)), scientific committees, (ad hoc) expert groups, Commission services or external contractors. This situation may lead to inconsistent and incoherent outcomes of assessments across legislation (in respect of the same chemicals), inefficient use of resources and unnecessary costs (from operating several committees performing similar assessments, from assessing the same chemical by several committees/bodies or from duplicating supporting technical and scientific work). In addition, the assessments that are not performed by the EU Agencies are often being criticised by the stakeholders as not sufficiently transparent and inclusive, having insufficient scientific quality and robustness or having insufficient separation between risk assessment and risk management.

The key problems arising from these drivers that the legislative proposals on (re-)attribution of tasks to EU Agencies aim to address are:

·multiple actors performing scientific and technical work;

·varying degree of scientific robustness and procedural rigour of the actors performing scientific and technical work;

·incoherent methodologies and guidance documents;

·insufficient cooperation and coordination among the actors performing scientific and technical work on chemicals.

The other problems arising from these drivers are being addressed as part of other ‘one substance, one assessment’ legislative as well as non-legislative actions. For example, the problems related to complicated accessibility and availability of data underlying the assessments are being addressed by the proposal for a Regulation on 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 problems have evolved as a consequence of the progressive development of the EU legislative framework for chemicals over the last 55 years and without this intervention, it will continue to persist.

3.Objectives: What is to be achieved? 

The general objective of one substance, one assessment approach and of this initiative is to ensure coherent, efficient and transparent delivery of safety assessments of chemicals across EU chemical legislation and thus contribute to a well-functioning single market for chemicals and a high level of protection of human health and the environment from chemicals.

The specific objectives of the legislative proposals on (re-)attribution of tasks to EU Agencies are one step to achieve the one substance, one assessment approach. They are to ensure that:

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

·there is a good cooperation among all players on all aspects underling the assessment of chemicals (such as methodology development and exchange of data);

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

4.Available options

Considering the problem drivers and the specific objectives to be achieved, there is very little discretion on the main policy choices. The preferred option is clearly to consolidate the technical and scientific work on chemicals performed under the relevant pieces of EU legislation in the EU Agencies and to strengthen the cooperation among the EU Agencies as regards technical and scientific work on chemicals. The EU agencies have been founded as independent bodies with adequate funding, they maintain the necessary expertise, provide robust and high quality scientific work and follow transparent and inclusive procedures. Any other possible option (e.g. consolidation of work at other actors than EU Agencies or bringing all the existing actors at the same level of scientific robustness and procedural transparency and ensuring cooperation among them) would be less efficient, more expensive and provide less benefits.

While the main policy option is clear and straightforward, there are sub-options as regards which tasks are suitable and useful to be reattributed to EU Agencies, which EU agency the (re-)attributed tasks should be assigned to and how and in which areas to strengthen the cooperation among the EU Agencies.

Guiding principles for (re-)attribution of scientific and technical work to EU Agencies

The following guiding principles were developed and followed to identify tasks for (re-)attribution to EU Agencies and to decide as to which EU Agency the task should be assigned:

1.The ‘technical and scientific work on chemicals’ is considered in a broad sense and includes:

·assessments of risk from, hazard of and exposure to chemicals;

·monitoring of occurrence and emissions of chemicals;

·determination of safe levels of chemicals for ecosystems and for humans;

·development of guidance documents;

·managing scientific committees, expert groups and network of experts;

·collecting, analysing and hosting data and information on chemicals and associated processes;

·hosting and operating (public) information platforms on chemicals;

·managing the data flows on chemicals and defining data formats; and

·assessments of socio-economic consequences/impacts of risk management measures on chemicals.

2.The existing technical and scientific work on chemicals performed at EU level under, or in support of, all relevant EU legislation is considered. No legislation is a priory excluded.

3.Consider attributing the scientific and technical work related to safety assessment of chemicals to one of the EU Agencies with a mandate related to chemicals, i.e. the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA), the European Medicine Agency (EMA), the European Environment Agency (EEA) or the European Agency for Safety and Health at Work (EU-OSHA);

4.Ensure fit with the core focus of the EU Agencies’ work on chemicals, in terms of use of substance in specific products, the route of exposure assessed, the type of sectors covered and mission of the agency.

5.Maximize synergies and coherence with ongoing activities, by attributing new activities on the basis of similarity with:

·Substances, data and data flows currently managed by the Agency;

·Existing expertise and competence;

·Output being provided by the Agency;

·Existing processes and procedures implemented by the Agency;

·Methodologies developed and applied by the Agency;

·Existing IT tools and planned developments;

·Networks of experts or committees governed or managed by the Agency.

6.Strive that the (re-)attribution of tasks brings synergies and benefits to the Union beyond a mere shift of responsibilities.

Solutions to strengthen the cooperation among the EU Agencies

The following solutions were identified for strengthening the cooperation among the EU Agencies:

1.All agencies have equal legal obligations to cooperate with other agencies. The areas to be covered are those identified under the one substance, one assessment as affecting the coherence and efficiency of the assessments of chemicals, such as

-development of methodologies,

-development of formats and controlled vocabularies,

-exchange of data and information related to chemicals and their assessment.

2.All agencies have a clear and equal mandate to develop methodologies for assessments related to chemicals in the fields falling within their mandate and to set formats and controlled vocabularies for data and information they hold.

3.All agencies performing the assessment of chemicals should have an obligation to cooperate to prevent the divergent opinions and if divergent opinions appear, they should cooperate to solve it. A procedure for solving the divergent opinions should be specified.

The best results in terms of strengthening the cooperation among the EU Agencies and enabling coherence of scientific and technical work provided by the EU Agencies is achieved by implementing all three solutions. Requiring cooperation among the agencies on certain areas without providing a clear mandate for those areas would not achieve the desired objective. Providing a mandate to an agency for certain areas and not obliging the cooperation among agencies might lead to even more divergence.

5.Stakeholder views 

A call for evidence for the initiative on making best use of EU agencies to streamline scientific assessments was published on the Commission website ‘ Have your say ’ on 15 March 2022. The public and stakeholders were invited to provide feedback on this initiative until 12 April 2022. In total, 65 submissions were received. Most were from business associations and companies (in total 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, whether of the ‘one substance, one assessment’ approach as a whole or of the specific initiative on the reattribution of tasks. 67% of respondents expressed their explicit support, 23% did not expressed 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.

As the call for evidence was the first public consultation on an initiative under the one substance, one assessment, a lot of feedback received was not specific about the consulted initiative on the (re-)attribution of task to the EU Agencies but about the general scope of the one substance, one assessment approach as well as other initiatives announced under the one substance, one assessment. Annex II provides a summary of all the feedback received.

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

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 Assessment7 held 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.

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 and summarised as follows:

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

·Expertise: Stakeholders suggested that reattributing tasks should be done based on the existing expertise available 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 assessment 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 and EMA for medicines use. 

·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 a committee being unable to manage the workload and jeopardise the quality of the work.  

·Organisation of scientific committees: Member State indicated that the agencies’ committees, especially of ECHA, might need to be reorganised to deal with increased workload, as the committee for risk assessment 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.  

·Tasks to re-attribute: Some stakeholders and Member States suggested that the ECHA should be involved in hazard assessment as part of the assessment of food contact materials, and EFSA should be involved in risk assessments. The agencies should be involved in evaluating cosmetic ingredients, deriving environmental quality standards under the Water Framework Directive, and in opinions on chemical substances in products (for example in toys).

·Impact assessment: 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. 

6.Scientific and technical work on chemicals for (re-)attribution to the EU agencies and strengthening the cooperation among the Agencies

Scientific and technical work on chemicals for (re-)attribution to the EU Agencies have been identified under 36 pieces of legislation or work packages (see Table 1 below). The tasks for (re-)attribution have been identified through the targeted inter-service consultation including the EU Agencies, targeted consultation with Member States and targeted consultation with stakeholders and by applying the guiding principles for the (re-)attribution of scientific and technical work on chemicals to the EU Agencies (see section 4). The way how the tasks are (re-)attributed to the EU Agencies was discussed at length between the concerned Commission Service and the receiving Agency, taking into account the policy objectives, desired scientific rigour, scrutiny and technical and organisational feasibility. A particular attention was paid to the assessment of the proximity of a task for (re-)attribution with the Agency’s mandate and to the identification of potential synergies and added value of the (re-)attribution.

There are various types of task (re-)attributions that have been proposed or are being considered (see ‘task type’ in Table 1). Reattribution of existing tasks from a non-agency body to the EU Agencies have been proposed or are being considered to be proposed under 12 pieces of legislation or work packages. Out of these 12 pieces of legislation or work packages, 3 contains reattributions that are accompanied with improvement or expansion of the reattributed tasks while 9 contains reattributions of tasks without their expansion. Attributions under 8 pieces of legislation or work packages are formalisation of the existing attributions of a task to an agency without a legal basis or are improvements of the specification of existing tasks. Attributions under 17 pieces of legislation or work packages contain tasks that are new. Either they are extension of the tasks that already exists at the agencies or they are completely new tasks.

The changes in the founding provisions of ECHA, EEA, EFSA and EMA to strengthen the cooperation among the agencies are listed here as a (re-)attribution, or improvement of the specification of existing tasks, under the respective founding regulations.

The (re-)attribution of tasks have been already adopted for 5 pieces of legislation / work packages, and it was proposed for another 8 pieces of legislation. The (re-)attributions are still to be proposed for 20 pieces of legislation/work packages and for 3 pieces of legislation the tasks are being defined and some of them might be suitable for attribution to the EU Agencies, but it is premature to conclude on this.

Following the guiding principles, the highest number of tasks is to be (re-)attributed to ECHA, followed by EEA, EFSA, EMA and EU-OSHA.

Legend: Colours are used to distinguish the legislative initiatives; N – attribution of a new task, EwE – existing task expanded; FE – formalisation of attribution of an existing task or better specification of an existing task, RE – reattribution of an existing task, REwE – reattribution of existing task and its expansion or improvement;

A brief description of the tasks and work for (re-)attribution per legislation or work package, including the strengthening the provisions for cooperation among the EU Agencies, is provided below (for detailed description see Annex III):

1.Drinking water directive 24

Revision of the drinking water directive in 2020 attributed new tasks to ECHA. ECHA is responsible for establishing and maintaining four EU positive lists for substances and compositions authorized to be used for the manufacturing of organic, cementitious, metallic and inorganic materials in contact with water intended for human consumption. ECHA first supports the Commission in compiling the first EU positive lists based on the national lists. Once established, ECHA will maintain the lists through the review of all the entries in the lists and then through the addition, removal and updating of the entries.

2.Regulation on serious cross-border threats to health 25  

The new regulation on serious cross-border threats to health reattributed an existing task performed by the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) to ECHA, EEA, EFSA, EMA and also to the European Centre for Disease Prevention and Control and the European Monitoring Centre for Drugs and Drug Addiction. The regulation requires the agencies, on the request of the Commission, to carry out a risk assessment of the potential severity of the threat to public health, including possible public health measures when there is an alert of a cross-border threat of chemical origin. The responsibility for rapid risk assessment for risks of a cross-border threat that is linked to medicinal products and medical devices is assigned to the EMA, for risks of a cross-border threat of chemical origin is shared between the ECHA and the EFSA based on their mandate and for risk of a cross border threat of threats of environmental origin, including those due to the climate, are shared among the ECHA, the EFSA and the EEA based on their mandate. The agencies will have to set up and maintain a continuous readiness to provide rapid risk assessments and on the request provide the requested risk assessment.

3.European Partnership for the Assessment of Risks from Chemicals (PARC) 26

PARC is a 7-year partnership funded by Horizon Europe that started in May 2022 and aims to advance research, share knowledge and improve skills in chemical risk assessment. ECHA, EEA and EFSA took a new task to provide input and support to the project in order to ensure maximum links with and benefits for the regulatory risk assessments of chemicals.

4.Commission implementing decision (EU) 2022/1979 under the SEVESO Directive 27  

The commission implementing decision reattributed an existing task performed by the Commission (DG JRC) to EEA. EEA is tasked to redevelop and maintain the databases and associated procedures for the reporting of information on industrial major accidents (eMARS) and for reporting of the location of Seveso establishments (eSPIRS) under the SEVESO III directive.

5.Batteries regulation 28

The new regulation on batteries revising an old battery directive attributed a new task to ECHA. ECHA is tasked to prepare, on the request of the Commission, restriction dossiers for substances in batteries, to get opinions on them from the Committee for Risk Assessment and from the Committee on Socio-Economic Analysis and to submit the opinions to the Commission for potential restrictions via a delegated act.

6.E-PRTR regulation 29  

The proposal for revision of the E-PRTR regulation proposes to expand the existing task of EEA to operate the European Pollutant Release and Transfer Register. EEA is tasked to operate an Industrial Emission Portal, which should replace the E-PRTR register and as compared to the E-PRTR should contain information on emissions for more substances and for more industrial activities and should contain also information on the use of water, energy and raw materials.

7.Industrial emissions directive 30  

The proposal for the revision of the Industrial Emissions Directive proposes to formalise existing task of ECHA performed at ad-hoc basis and extend it to cover holistic consideration of chemicals in the permits of the industrial emissions directive installations, from their presence in the (primary or secondary) raw materials to their presence in the emissions from the installations, as well as in the waste and by-products generated. ECHA is requested to support the Commission in the review of the Best Available Techniques Reference (BREF) documents as regards the chemicals and industrial chemicals processes.

8.Water framework directive, Environmental Quality Standard Directive and Ground Water Directive 31  

The proposal for the revision of the water framework directive, the environmental quality standard directive and the ground water directive proposes to reattribute existing tasks performed by the Commission and the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) to ECHA, attribute a new task to ECHA and expand the existing tasks performed by EEA. ECHA and its Committee for Risk Assessment are requested under the Environmental Quality Standard directive to take over performing assessments underpinning the amendment of priority list of substances, derivation of Environmental Quality Standards, amendment of the ‘watch list’ and coordination of the ‘watch list’ activities. ECHA and its Committee for Risk Assessment are requested under the Ground Water Directive to perform new assessments underpinning the review of Annexes I and II with limit values for chemicals in ground water, the amendment of ‘watch list’ and coordination of the ‘watch list’ activities. EEA is requested to expand its task on collection of monitoring data in surface waters and to harvest all chemical monitoring data in waters generated by Member States.

9.CLP Regulation 32

The proposal for revision of the CLP regulation proposes to attribute a new task to ECHA and EFSA and expand the existing tasks of ECHA. ECHA and EFSA are required to prepare, on the request of the Commission, dossiers for harmonised classification of substances. ECHA’s Committee for Risk Assessment is then expected to prepare opinions on the dossiers prepared by ECHA or EFSA, which will be submitted to the Commission for potential amendment of Annex VI of CLP.

10.Packaging and packaging waste directive 33  

The proposal for revision of the packaging and packaging waste proposes to extend the scope of task of ECHA to process or eventually also to prepare a proposal for restriction under REACH that covers or is focused on a presence of a substance in packaging. Such restriction will be under the scope of REACH, so this relies on the existing REACH task.

11.Legislation on medicinal products for human use 34 , 35  

The proposal for revision of the regulation and directive on medicinal products for human use proposes to introduce a new task and better specify existing tasks of EMA. EMA is required to actively cooperate with other EU Agencies as regards exchange of data, methodologies and scientific assessments. EMA is further required to engage more in preventing or solving a divergent opinion with other EU Agencies. The goal is to ensure coherence, consistency and interoperability in the specified areas. EMA is also expected to receive marketing authorisation applications, like any other applications submitted to EMA, in electronic form and follow the digital by default principle. In addition, EMA is requested to set up an active substance based monograph system from environmental risk assessments.

12.Directive on end-of-life vehicles 36  

The proposal for the revision of the directive on end-of-life vehicles proposes reattribution of an existing task to ECHA. ECHA’s Committee for Socio-Economic Assessment will be required to provide assessments underpinning review of exemption from existing restriction on lead, mercury, cadmium or hexavalent chromium. ECHA is also required as part of REACH process to provide assessments underpinning restriction of hazardous substances in end-of-life vehicles. Such restriction will be under the scope of REACH, so this relies on the existing REACH task.

13.Toy safety directive 37

The proposal for the revision of the toy safety directive proposes reattribution of existing tasks to ECHA and extending some of them. ECHA’s committees for risk assessment and socio-economic analysis is required to provide assessments underpinning the establishment or strengthening of chemical limit values in toys, the amendment of the limit values for heavy metals in toys, the amendments to the lists of allergenic fragrances that are prohibited in toys or that have to be labelled if present in toys and the granting of derogations for the use of carcinogenic, mutagenic and reprotoxic substances in toys.

14.Directive on restriction of hazardous substances (RoHS) in electrical and electronic equipment

The proposal for amendment of the RoHS directive adopted as part the one substance, one assessment package proposes to reattribute the existing tasks performed by the Commission to ECHA and improve how those tasks are executed. ECHA is required to prepare, on the request of the Commission, a restriction dossier for substances in electrical and electronic equipment. Such dossier can be also prepared by a Member State. ECHA’s Committees for Risk Assessment and for Socio-Economic Analysis are then requested to prepare an opinion on the restriction dossier (prepared by itself or by a Member State) and submit such opinions to the Commission. ECHA is also requested to receive applications for granting, renewing or revoking an exemption from the substance restrictions, verify its completeness, get an opinion of its Committee for Socio-Economic Analysis and if necessary from its Committee for Risk Assessment and submit the opinions to the Commission.

15.POPs regulation

The proposal for amendment of the POPs regulation via the omnibus regulation on (re-)attribution of tasks adopted as part of the one substance, one assessment package proposes to reattribute the existing tasks performed by the Commission to ECHA and EEA and improve how those tasks are executed. On the request of the Commission, ECHA is expected to provide assessments underpinning setting concentration limit values for substances subject to waste management provisions as part of the review of Annexes IV and V of the POPs regulation. As part of that assessment, ECHA is required to prepare a report on the assessment with the proposal for concentration limit values, get opinion of its Committee for Socio-Economic Assessment on the report and submit the opinion to the Commission as an input for amendment of Annexes IV and V via the delegated act. EEA is expected to host the chemical monitoring data in the environment of the POPs listed in Annex III, Part I.

16.Medical devices regulation

The proposal for amendment of the medical product regulation via the omnibus regulation on (re-)attribution of tasks adopted as part of the one substance, one assessment package proposes to reattribute the existing tasks performed by the Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) to ECHA. ECHA is required every 5 years to review the guidelines on how to perform the benefit-risk assessment of the presence of phthalates in medical devices. In addition, on the request of the Commission, ECHA is required to prepare and review the guidelines on how to perform the benefit-risk assessment of the presence of carcinogenic, mutagenic, reprotoxic or endocrine-disrupting substances in medical devices.

17.EEA founding regulation

The proposal for amendment of the EEA founding regulation via the omnibus regulation on (re-)attribution of tasks adopted as part of the one substance, one assessment package proposes to better specify existing tasks of EEA. EEA is given a mandate to develop assessment methodologies related to chemicals within the mission of the agency and EEA is required to actively cooperate with other EU Agencies as regards exchange of data and development of methodologies. The goal is to ensure coherence, consistency and interoperability in the specified areas.

18.General Food Law

The proposal for amendment of the General Food Law establishing EFSA via the omnibus regulation on (re-)attribution of tasks adopted as part of the one substance, one assessment package proposes to better specify existing tasks of EFSA. EFSA is required to actively cooperate with other EU Agencies as regards exchange of data and development of methodologies. EFSA is further required to engage more in preventing or solving a divergent opinion with other EU Agencies. The goal is to ensure coherence, consistency and interoperability in the specified areas.

19.Common Data Platform on Chemicals

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals adopted as part of the one substance, one assessment package assigns new tasks to ECHA, EEA, EFSA, EMA and EU-OSHA. ECHA is requested to set up and operate the common data platform on chemicals, including the database of standard formats and controlled vocabularies. All agencies are requested to make the data on chemicals they hold available to the platform in appropriate formats for sharing among the authorities, to set formats and controlled vocabularies in their area of competence so data can be easily shared and to cooperate with ECHA and among each other in developing and operating the common data platform.

20.Information platform for chemical monitoring (IPCHEM)

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals adopted as part of the one substance, one assessment package proposes to reattribute the existing task performed by the Commission to ECHA and EEA. ECHA is required to operate the IPCHEM as part of the common data platform on chemicals and host occupational monitoring data. EEA is requested to collect and host the human biomonitoring data and host environmental occurrence data and indoor air quality data. The proposal will also formalise the tasks of ECHA, EFSA, EEA, EMA and EU-OSHA to provide available chemical monitoring data to ECHA for integration into IPCHEM.

21.Information on regulatory processes on chemicals

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals adopted as part of the one substance, one assessment package proposes to extend the existing task currently managed by ECHA. ECHA is requested to continue operating the (public) activities coordination tool ((P)ACT) system and extend it to other pieces of legislation. EFSA, EEA and EU-OSHA are required to provide the relevant information to ECHA.

22.Repository of reference values

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals adopted as part of the one substance, one assessment package proposes a new task to ECHA, EFSA, EEA, EMA and EU-OSHA. ECHA is requested to set up, operate and populate with scientific and regulatory reference values a repository of reference values and to collate in it the regulatory reference values. EFSA, EEA, EMA and EU-OSHA are required to cooperate with ECHA in the operation of the repository and provide to ECHA the scientific reference values they derive.

23.Information on regulatory processes on chemicals

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals adopted as part of the one substance, one assessment package proposes to formalise and expand the existing task ECHA is already carrying out with the EU chemicals legislation finder (EUCLEF). ECHA is required to continue the operation of EUCLEF and extend it to cover all relevant legislative pieces on chemicals.

24.Database on environmental sustainability related data

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals adopted as part of the one substance, one assessment package proposes a new task to ECHA. ECHA is requested to set up and operate a database with environmental sustainability data on chemicals. ECHA, EEA, EFSA, EMA and EU-OSHA are required to make available to the ECHA any environmental sustainability related data they host or hold. The agencies also need to provide the necessary technical cooperation to ECHA to enable the integration of the data in the common data platform on chemicals.

25.Data generation mechanism

The proposal a regulation establishing a common data platform and a monitoring and outlook framework for chemicals adopted as part of the one substance, one assessment package proposes a new task to ECHA and EFSA. ECHA is required to commission studies in support of the implementation of chemicals legislation and to contribute to the support, evaluation or development of EU chemicals policy. ECHA is required to do it on its own initiative or on the request of the Commission. The procedure is complementary to the existing procedure operated by EFSA under Article 32 of the General Food Law and ECHA and EFSA should cooperate in designing and commissioning the studies under both procedures.

26.Mechanism for notification of studies and database for study notifications

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals adopted as part of the one substance, one assessment package proposes a new task to ECHA. ECHA is required to set up a database of study notifications for studies beyond the food sector (i.e. for studies not already subject to the notification obligation of Article 32b of the General Food Law and notified to EFSA). ECHA and EFSA are required to cooperate to ensure compatibility of the respective systems. ECHA is expected to control fulfilment of the obligations to notify the studies as part of the compliance check under REACH and as part of approval of biocidal active substances and products.

27.Early warning and action system for emerging chemical risks and framework of indicators

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals adopted as part of the one substance, one assessment package proposes a new task on an early warning and action system to EEA, ECHA, EFSA, EMA and EU-OSHA. It also proposes to formalise the existing task on an indicator framework performed by EEA and ECHA. For the early warning system, EEA is required to compile and collect annually the early warning signals into a report to be presented to the Member State authorities, relevant EU agencies and the Commission to consider whether any regulatory action is needed. ECHA, EFSA, EMA and EU-OSHA are required to cooperate with EEA and provide early warning signals from their areas of responsibility. For the framework of indicators, EEA and ECHA are required to operate and populate the indicator framework for chemicals policy.

28.Observatory for specific chemicals with potential contribution to emerging chemical risks

The proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals adopted as part of the one substance, one assessment package proposes to formalise the existing task performed by ECHA and expand its scope. ECHA is required to continue operating the existing observatory for nanomaterials and extend its scope to chemicals and materials of potential emerging risk.

29.Cooperation of ECHA with other EU agencies

The proposal for the regulation on ECHA will consider proposing a new task to ECHA and better specify the existing tasks. ECHA should be given a formal mandate to develop methodologies for assessment of chemicals in the areas falling within its mission. ECHA should be required to actively cooperate with other EU Agencies as regards exchange of data and development of methodologies. Finally, ECHA should be further required to engage more in preventing or solving a divergent opinion with other EU Agencies. The goal is to ensure coherence, consistency and interoperability in the specified areas.

30.Scientific opinions on occupational exposure limits

The proposal for the regulation on ECHA will consider to formalise the existing task of ECHA. ECHA and its Committee for Risk Assessment should be given a legal mandate to provide opinions on occupational exposure limits in support of the Directive on carcinogens, mutagen or reprotoxic substances at work, Chemical Agent Directive and Asbestos Directive. ECHA already does so, but without a formal mandate and via a service level agreement with the Commission.

31.REACH regulation 38

The proposal for a REACH revision will consider proposing changes in the existing tasks of ECHA. ECHA should be required to implement the changed tasks. This should include expanded registration obligations (to polymers), changes in the restriction (expansion of the generic approach to risk management) and authorisation procedures and changes in enforcement provisions.

32.Cosmetic products regulation 39  

The proposal for the targeted revision of the Cosmetic Products Regulation will consider proposing reattribution of existing tasks to ECHA. ECHA should be required to take over hosting of the Scientific Committee on Consumer Safety (SCCS) which assesses the safety of chemicals underpinning the process for the authorisation of colorants, preservatives and UV-filters, the process for prohibition or restriction of ingredients used in cosmetic products where concerns are raised due to potential risks to human health, the process for granting an exemption from the prohibition of chemicals that cause cancers, gene mutations, affect the reproductive or endocrine system and the process for examining the safety of substances used in cosmetic products that could affect the respiratory system and chemicals toxic to a specific organ. ECHA and its committee should be also required to produce a technical guidance document concerning different aspects of testing and safety evaluation of cosmetic substances including for nanomaterials used is cosmetics.

33.Non-chemical assessments performed by SCHEER

The Commission Decision on discontinuing the operation of scientific committees SCHEER and SCCS will result in reattribution of existing tasks to the Commission Scientific Advisory Mechanism (SAM). SAM will be required on the ad hoc basis to provide a scientific advice on non-chemical topics currently provided by SCHEER.

34.Ecodesign for sustainable products regulation 40  

The proposal for regulation on eco-design for sustainable products envisages some new tasks that could be potentially attributed to EU Agencies. These tasks are not defined in the proposal but rather to be specified in the envisaged implementing acts. Such envisaged tasks include involvement of ECHA in the development of a product passport that should hold also information on substances of concern.

35.Tobacco products directive 41

The tobacco directive is undergoing an evaluation and a revision of the directive is being envisaged. As part of the revision, a new scientific and technical work is being envisaged that could be potentially attributed to EU Agencies. This includes managing the laboratory network on tobacco control, checking compliance with product presentation provisions, running the procedure determining characterizing flavour, updating negative/positive lists of additives, hosting product database and making publicly available the product information, monitoring of data in product notifications and assessing information on leaflets. The tasks are not yet clear but those that are being considered do not naturally fit to the agencies considered in this initiative.

36.Regulation on fluorinated greenhouse gases 42 and the Regulation on ozone depleting substances 43  

The proposal for a regulation on fluorinated greenhouse gases establishes an obligation on the Commission to operate an electronic system for the management of the quota system, licensing of imports and exports and reporting and introduces invoicing fees for the quotas. Similarly for the Regulation on ozone depleting substance, the Commission has the obligation to operate a licencing and reporting system. It is not yet clear how the tasks can be implemented most effectively, but it is envisaged that an agency could take some of the tasks in case that would be deemed to be the best option at a later stage.

7.Assessment of impacts 

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.

Overall impact

Although no formal assessment of social, economic and environmental impacts was carried out, such impacts were qualitatively assessed by the Commission with the help of external consultants. The outcomes of the assessment is provided in the sub section ‘overall impact’ of the section 8 for the legislative proposals on reattribution of tasks and of the section 9 for the legislative proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals. The overall impacts from all reattributions are summarised in the section 10.1. ‘added value and synergies of the (re-)attributions’.

Assessment of impacts on resources and committees of EU agencies

As the (re-)attribution of tasks to EU agencies will have a major impacts on their resource and capacity needs, these impacts were assessed in great detail. Assessment of impacts of the (re-)attribution of each task to the EU Agencies included assessment of synergies and added value of the (re-)attribution, estimation of the impacts on Agencies’ committees, data model and IT infrastructure and key experts and estimation of the workload and associated resource needs for the Agencies. For the existing tasks to be reattributed, the assessment also included description of the current workload and estimation of the current use of resources. The detailed assessment of impacts for each task per legislation or work package is provided in Annex III.

The estimation of the current resource use included an estimation of the full time equivalents dedicated to the tasks. This consisted of the estimation of the full time equivalent of the Commission staff as well as estimation of the full-time equivalents of the contracted staff (external and intramurous consultant, interim staff). To convert the cost of consultants into full time equivalents, the cost of 1 full time equivalent of a consultant was estimated based on the contracts and average Belgium salary at ca. EUR 66 000 annually 44 . It should be noted that the estimation of full-time equivalents for the Commission staff does not include administrative or IT overhead of the Commission.

The estimation of the resource needs for the Agencies was done in close and frequent consultation with the Agencies concerned. The operation of each (re-)attributed task to Agencies has been assumed to be done through implementing similar processes and similar level of scientific scrutiny and digitalisation to what is already in place for Agencies’ current tasks. The benefit of this approach is to ensure a consistent standard of scientific quality, transparency and data interoperability as well as to maximise the reuse of existing processes and tools. In general, internal experts were assumed to be used for scientific and technical work underpinning assessments related to chemicals and the agencies’ committees to be used to validate the work through provisions of opinions. External contracting was envisaged for the IT development as well as for the collection of data or information.

ECHA is the agency to receive most of the assessment work on chemicals. The estimation of the resource needs for the new assessment task to be allocated to ECHA was built on the ECHA’s experience of the resource needs for their existing processes. The experience shows that resource requirement for the development of an opinion on harmonised classification varies between 0.35 – 0.65 FTEs per dossier (0.35 for low complexity dossier, 0.5 for average complexity and 0.65 FTE for complex dossier), for scientific opinion on the occupational exposure limit values is average of 0.7 FTE per dossier, for opinion on REACH authorisation is 0.15 FTE pre dossier of low complexity up to 0.35 FTE per dossier of high complexity, for opinion on REACH restriction is 1 FTE per dossier of low complexity up to 1.5 FTE per dossier of high complexity. An overhead of 15% was added to the resource estimate for the development and maintenance of common IT components and additional 15% for the contribution to the horizontal support (governance & enablers / administrative overhead).

8.Impacts of the legislative proposals on reattribution of tasks 

Overall impact

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.

Impact on resources of Agencies and the Commission

The proposal for a directive on reattribution of tasks will amend RoHS directive to reattribute the assessment work under this directive to ECHA. The proposal for a regulation on reattribution of tasks will amend 2 legislative pieces (POPs Regulation and Medical devices regulation) to reattribute the assessment work under these pieces of legislation to ECHA and it will amend the EEA founding regulation and the general food law (EFSA founding regulation) to ensure better cooperation among agencies on methodology development and on exchange of data. In summary for these two proposals on reattribution, in the first year, there will be a need of 4 FTEs (4 TAs) and operational costs of EUR 101 000 per year and as of the second year, there will be a need of 9 FTEs (6 TA + 3 CA) per year and operational budget of EUR 83 000 per year. All new resources are needed for ECHA, no additional resources are needed for EEA and EFSA. Considering the resources currently used for the tasks to be reattributed, there will be a total net increase in the resources from 2026 and beyond as compared to today of 4.5 FTEs per year and EUR 59 000 per year.

Changes to RoHS directive will reattribute the assessments underpinning restrictions of hazardous substances in electrical and electronic equipment and review of applications for exemptions from the restrictions to ECHA. For this work, ECHA will require in the first year 3 FTEs (3 TAs) and operational budget of EUR 66 000 and as of the second year 7 FTEs (4 TAs + 3 CAs) per year and operational budget of EUR 33 000 per year. The work is currently performed with the help of consultants and amounts to approximately 2.74 FTE per year (ca. EUR 145 000 annually for outsourcing the review of exemptions (ca. 2.2 FTEs/years) + ca. EUR 180 000 every 5 years for contracts to review restrictions (ca. 0.54 FTE/year)). DG ENV uses ca. 1.5 FTE of core staff for overall RoHS implementation, which will need to continue. The resources currently spent are however insufficient leading to the accumulation of requests for exemptions without processing them to the legal drafting (by December 2022, over 60 exemption requests were pending) and the revision of the restriction was delayed (the review not finalised although it has started in 2018). There are also complaints about the quality and robustness of the assessments, the transparency of the process and involvement of stakeholders. The reattribution to ECHA and using its processes will address these shortcomings and will ensure alignment with other chemicals legislation.

Changes to POPs regulation will reattribute the technical assistance in reviewing Annexes IV and V to ECHA and hosting the POPs monitoring data to EEA. For this work, ECHA will require in the first year 1 FTE (1 TA) and operational budget of EUR 35 000 and as of the second year 2 FTEs (2 TAs) per year and operational budget of EUR 50 000 per year. No resources are needed for EEA. The work on reviewing the Annexes IV and V is currently performed by the Commission with the help of consultants and amounts to approximately 1.5 FTEs per year (EUR 300 000 for consultants every 3 years (=1.5 FTE/year)). DG ENV uses ca. 0.5 FTE/year of core staff for implementing the review of Annexes IV and V, which will however need to continue. The involvement of ECHA and its Committee for Socio-Economic Analysis is envisaged to provide a significant increase in the scientific quality, the consistency, the robustness and the level of independence of the assessments upon which the Commission develops its proposals on this matter. The hosting of chemicals monitoring data under the POPs regulation is currently done by the Commission. Transfer of this work to EEA will require no additional resources, as POPs monitoring data in waters are to be reported to EEA under the water legislation and resources for that were proposed in the recent proposal, the POPs monitoring data in air are already being reported to EEA as part of the air quality legislation and covered by resources for that activity. In addition, hosting of any additional data sets in the environment is also covered in the resource for common data platform.

Changes to medical devices regulation will not require any additional resources for ECHA. The work is currently performed by the Commission supported by the SCHEER committee. The current resource use is estimated to be 0.3 FTE per year and EUR 24 000 per year (DG SANTE SCHEER secretariat 0.3 FTE (ca. 10% of SCHEER secretariat work), EUR 24 000 per year for indemnities, travel, e.g. costs for members of the committee). DG SANTE uses (policy unit) uses ca. 0.1 FTE of core staff per year for implementation of the related provisions, which will however need to continue. Considering that the envisaged frequency of the work is very low, the involvement of the Committees is only where necessary and the first work will likely materialise only in 2029, the work can be absorbed by ECHA without any additional resources.

Changes to the regulation on the European Environment Agency and to the regulation on the general principles and requirements of food law and establishing the European Food Safety Authority will have no resource implications. The provisions formalise the activities already performed, they prescribe the procedural steps to follow and they enable the implementation of 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. Any possible resource needs stemming from these provisions can be absorbed by the existing resources of the agencies.

Impact on committees of Agencies

There will be an impact on ECHA’s committees for risk assessment and for socio-economic analysis. It is estimated that the committee for risk assessment will have to process ca. 4 opinions per year: one opinion on new restriction of a substance (which is of equivalent of low complexity restriction under REACH) and 3 opinions per year on requests for new exemptions (which is expected to be lighter dossier than the low complexity restriction dossier under REACH) under RoHS. The committee for socio-economic analysis is expected to process ca. 33 opinions per year: 1 opinion on restriction of a substance and 30 opinions on the requests for exemption under RoHS, and 2 opinions on the revision of Annex IV and V and the proposed limit value under the POPs regulation.

9.Impact of the legislative proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals 

Overall impact

Overall, this proposal is expected to contribute to an improvement of the efficiency, coherence, quality and transparency of chemicals assessments under EU legislation as well as to the early identification of emerging chemicals risks. It will therefore improve the protection of human health and the environment from chemicals, for the benefit of Member State authorities, stakeholders and citizens. In addition, the initiative simplifies access to chemicals information for everyone (citizens, industry, national authorities, EU agencies, the Commission) thus increasing transparency. Moreover, it will improve predictability and thus the possibility for the industry, national authorities and EU agencies to plan – and where relevant coordinate – their activities:

·Bringing together chemicals data in one common data platform will increase findability and simplify access, which is beneficial for all users. The platform will operationalise the ambition of the one-substance one-assessment approach, supporting quality and mutual coherence of chemicals assessments. The use of standard formats and controlled vocabularies will enhance interoperability of information, thus increasing its findability. In addition, information across regulatory dossiers will be easier to compare. An increased findability and comparability will in turn reduce administrative burden for risk assessors, which include national administrations, and have a positive impact on the effectiveness, efficiency and coherence of chemical safety assessments.

·Through the extended utility of shared information in the common data platform, this proposal will help minimise potential duplication of efforts and optimise data generation strategies. With an increased volume and transparency of data on chemical properties and supported by adequate context data that enables the responsible use of that chemicals data, compliance with and enforcement of existing obligations should be facilitated.

·Building on integrated access and services the common data platform is expected to provide additional insight into effective risk management measures and to facilitate the search for safe and sustainable alternatives, leading to improvements in the protection of human health and the environment.

·Bringing together chemicals data and being allowed to use it will increase the knowledge base for scientific assessments and opinions, thus improving their robustness. This will in turn increase the acceptance by society of conclusions and regulatory decisions. Knowing through the notification of studies that all studies have been considered in an assessment further strengthens the trust of citizens in regulatory decisions.

·A dedicated service in the common data platform related to information on regulatory processes planned or ongoing by the Commission, EU agencies and Member States will improve the coordination of activities, which in turn will allow better planning for the authorities and agencies involved, thus increasing efficiency. That information will also allow better predictability and planning for industry, facilitating receipt of comprehensive but also consistent input to the activities, where required. It will be easier for industry but also other stakeholders to know when and how to contribute to regulatory processes.

·A dedicated service in the common data platform related to obligations under EU legal acts on chemicals will be very valuable for industry, and in particular for SMEs and microenterprises, to easily get an overview of their legal obligations, which will give them certainty on what exactly their duties are. Acting with such full knowledge in turn supports compliance and correspondingly reduces burden on national authorities.

·The establishment of a monitoring and outlook framework including an early warning and action system for emerging chemical risks will allow to shorten the reaction time between early signals of risks and regulatory measures to reduce those rusks, and as such will lead to an improved protection of human health and the environment.

·The establishment of a data generation mechanism allows the commissioning of studies when there are no legal provisions to obtain them. This will contribute to the creation of a complete knowledge base.

The establishment and operation of the platform will not impose any costs on industry. Economic operators will continue to have to fulfil their legal obligations as they are doing today under the relevant specific pieces of legislation. Economic operators and laboratories will experience some administrative burden linked to the requirement to submit a notification when a study is intended to be commissioned or carried out. Quantified costs associated with the notification obligation are set out in the staff working document accompanying this proposal 45 .

The establishment of the platform will be associated with significant costs for the EU agencies, but they should principally be seen as investment in technical progress within the data economy, enhancing the value of existing and future data. The task requires investment in entirely new data structures and IT systems/capabilities, principally on the ECHA’s side, but also on the side of other EU agencies as data source owners who are to prepare datasets for integration in the platform.

Impact on resources of Agencies and the Commission

The legislative proposal for a regulation establishing a common data platform and a monitoring and outlook framework for chemicals consists of 10 distinct activities that will have an impact on the resource needs of ECHA, EEA, EFSA, EMA and the Commission. The first three years there will be a need for up to 32 FTEs (12 TA + 20 CA) per year and an operational budget of up to EUR 8 657 000 per year. In the fourth year and beyond, there will be a need of 20 FTEs (12 TAs and 8 CA) per year and EUR 7 080 000 per year. Considering the resources currently used for the existing tasks to be reattributed (i.e. resources for IPCHEM), there will be a total net increase in the resources in the fourth year and beyond as compared to today of 15.5 FTEs per year and operational budget of EUR 7 080 000 per year.

The highest attribution of resources is necessary for ECHA, both in terms of FTEs and operational budget, followed by EEA, EFSA and EMA. After initial higher numbers for the first three years (2025-2027), as of the fourth year ECHA will need 13 FTEs (9 TA + 4 CA) and an operational budget of EUR 6 180 000 per year, EEA will need 3 FTEs (3 TAs) and EUR 400 000 per year, EFSA will need 2 FTEs (2 CA) and EUR 500 000 per year, EMA will need 2 FTEs (2 CAs) and EUR 0 per year and JRC 0 FTEs and EUR 0 per year. No additional resources are required for EU-OSHA.

Common Data Platform will be established and operated by ECHA with close involvement and contribution from EEA, EFSA, EMA, EU-OSHA and the Commission. The work will include development and operation of the infrastructure and the governance and provision of data into the platform. The principal aim of new IT infrastructure operating as part of the Green Deal Data Space is to support effective and coherent chemical safety assessments. It shall provide integrated, user-differentiated and highly functional access to chemicals-related datasets owned or managed by EU agencies and provide space for the dedicated services supporting EU chemicals policy and legislative implementation. The work will require resources for 4 agencies involved and the Commission (JRC). The resource requirement is higher for the first 3 years to set up the infrastructure and all the underlying processes to share the data and make them interoperable and in adequate formats. This will require for the first 3 years:

·for ECHA, 10 FTEs (4 TAs + 6 CAs) per year and operational budget of EUR 0 for the first year, EUR 2 226 000 for the second year and EUR 2 793 000 for the third year;

·for EEA, 3 FTEs (1 TA + 2 CAs) per year and operational budget of EUR 0 for the first year, EUR 266 000 for the second year and EUR 334 000 for the third year;

·for EFSA, 5 FTEs (5 CAs) per year and an operational budget of EUR 670 000 per year;

·for EMA, 3 FTEs (3 CAs) per year and an operational budget of EUR 100 000 per year;

·for EU-OSHA, 0 FTEs per year and operational budget of EUR 0 per year;

·for JRC, an operational budget of EUR 180 000 per year to cover integration of IPCHEM in the common data platform and handing over of IPCHEM operation to ECHA.

After the initial phase of 3 years, the resource requirement is reduced to maintain the infrastructure and the underlying processes. This phase will require

·for ECHA, 4 FTEs (4 TAs) per year and operational budget of EUR 600 000 per year;

·for EEA, 1 FTE (1 TA) per year and operational budget of EUR 200 000 per year;

·for EFSA, 2 FTEs (2 CAs) per year and operational budget of EUR 500 000 per year;

·for EU-OSHA, 0 FTEs per year and operational budget of EUR 0 per year;

·for EMA, 2 FTEs (2 CAs) per year and operational budget of EUR 0.

Information Platform for Chemical Monitoring (IPCHEM) will be formally established and its operation will be reattributed to the Agencies. For this work,

·ECHA will need as of the second year 2 FTEs (1 TA + 1 CA) per year and as of the third year operational budget of EUR 180 000 per year;

·EEA will need as of the first year 1 FTE (1 TA) per year and the operational budget in the first year EUR 0, in the second year EUR 200 000, in the third year EUR 200 000 and as of the fourth year EUR 50 000 per year.

The operation of IPCHEM is currently done by the Commission and the resource use accounts for total of 4.5 FTEs/year (DG JRC staff 2.5 FTEs/year + IT experts intramurous 2 FTEs/year (EUR 130 000/year)). The operation of IPCHEM will be entrusted to ECHA which will also integrate it into the Common Data Platform. As this work will be reattributed to ECHA, the resources at the Commission’s side will be saved. Hosting of data will be entrusted to the Agencies based on their mandates (ECHA will host occupational data) and EEA will host indoor air data and collect and host human biomonitoring data. EFSA already provides data to IPCHEM and contributes to its operation and will not require any additional resources to continue in this activity. EMA and EU-OSHA currently do not systematically collect or receive data relevant for IPCHEM and therefore will not require any additional resources.

Database containing information on regulatory processes on chemicals will be established on the basis of existing (public) activities coordination tool ((P)ACT) and enlarging its scope to cover all relevant legislation with safety assessment processes and initiatives to promote coordination of safety assessment activities across EU legislation and provide transparency on the ongoing assessments. This work will impact ECHA, EEA, EFSA and EU-OSHA but will not require additional resources for the agencies. ECHA already operates (P)ACT for REACH, CLP and POPs processes. EFSA already operates OpenEFSA which has similar level of information as PACT for food and feed legislation. Resources for the operation and continuous provision of information are to be absorbed by the Agencies as part of the existing processes. EEA and EU-OSHA are currently not involved in any processes relevant for the database, therefore no resources are required for them. The development and coordination of the system is covered by the resources provided for the common data platform.

Repository of reference values will be established to promote the reuse of existing reference values and thus improve coherence of assessments and reduce repetition of deriving reference values. The proposal will impact ECHA, EEA, EFSA, EMA, EU-OSHA and the Commission. To perform the required work, ECHA will need as of the first year 1 FTE (1 TA) per year and operational budget of EUR 0 in the first year, EUR 650 000 in the second year, EUR 650 000 in the third year and as of the fourth year EUR 200 000 per year. No additional resources will be needed for EEA, EFSA, EMA, EU-OSHA or the Commission. ECHA has developed and operates the EU Chemicals Legislation Finder (EUCLEF). EUCLEF lists some regulatory reference values derived and applicable under these legislative pieces. ECHA will have to collate the ‘old scientific reference values’ which can be done via contracting. The new scientific reference values will be provided to the repository progressively as part of ECHA’s assessment processes. ECHA will require additional resources for developing, operating and maintain the repository, being in contact with data providers. EFSA has developed and is maintaining the OpenFoodTox database that summarises the scientific reference values derived by EFSA as part of its assessment activities. EFSA will continue its activity and will provide the information to the new repository as part of its existing resources. Therefore, no additional resources are required. EMA will need to provide to the new repository on continuous basis all new predicted no effect concentrations (PNECs) derived for human and veterinary medicinal products after entry into force of this legislation. This can be done efficiently as part of EMA’s future assessment activities. In addition, this can be automatized for human medicines as digitalisation of environmental risk assessment is foreseen as part of the revision of human medicinal product legislation. Therefore, no additional resources are required. EEA and EU-OSHA currently do not hold any relevant data for the repository. Therefore, no additional resources are required.

The establishment and operation of a database with information on applicable laws and legal obligations applicable to chemicals under Union legislation to promote compliance will be formalised. This work will impact ECHA but will not require additional resources under this proposal. ECHA already operates EU chemical legislative finder (EUCLEF) as part of the contribution agreement with DG GROW. The contribution agreement amounts to ca. EUR 1.0 – 1.4 million annually. ECHA runs the service through the employment of 4 interim staff members (ca. EUR 270 000/year) and via contractors: communication activities and external helpdesk ca. EUR 60 000/year, IT costs EUR 200 000/year, data costs EUR 430 000/year. These existing resources will be used to continue operating, further developing and slightly expanding the system. The resources for major extension of the system, such as the repository of reference values, are provided under the work on repository of reference values. Although no resources are required under this proposal, the legislative proposal for a regulation on ECHA should address the fact that the operation of the EUCLEF became a structural task for ECHA and that the financing should become part of the annual contribution to ECHA.

Database on environmental sustainability related data on chemicals will be established. The work will impact ECHA. ECHA will be required to set up the database, operate it, establish and maintain the flows of adequate data into the database and provide interpretation of data. Other agencies (EEA, EFSA, EMA and EU-OSHA), if they host environmental sustainable data on chemicals, will provide that data to ECHA. To perform the work, ECHA will need as of the second year 1 FTE (1 TA) per year and operational budget of EUR 0 per year. Other agencies will not need additional resources as their task is small, currently do not hold any relevant data and the potential work can be absorbed by the agencies’ current resources.

Data generation mechanism will be established to allow ECHA and the Commission to commission studies supporting the implementation of Union chemicals legislation within ECHA’s mandate or contributing to the development of Union chemicals policy. The studies can be commissioned only when results cannot be obtained through existing legal provisions and they shall not have predominant research and development objective. The mechanism will allow ECHA and the Commission to generate data where needed and cannot be obtained otherwise. ECHA’s involvement is necessary as commissioning of such studies requires technical expertise. To perform the work, ECHA will require in the first year 1 FTE (1 TA) and operational budget of EUR 0, in the second year 2 FTEs (1 TA and 1 CA) and operational budget of EUR 1 000 000, in the third year 2 FTEs (1 TA and 1 CA) and operational budget of EUR 3 000 000 and as of the fourth year 2 FTEs (1 TA and 1 CA) per year and operational budget of EUR 5 000 000 per year. No current process exists, but there is a complementary process operated by EFSA for the food sector (4 FTEs/year, EUR 15 000 000/year). This will continue to be operated next to the new one and the two Agencies (ECHA and EFSA) are required to cooperate when commissioning such studies and develop a joint plan.

The obligation to notify studies before they start will be expanded from food sector to all chemical sector. The work will require additional resource for ECHA. ECHA will need as of the first year 3 FTEs (1 TA and 2 CAs) per year and operational budget in the first year of EUR 0, in the second year EUR 1 200 000, in the third year EUR 400 000 and as of the fourth year EUR 200 000 per year. ECHA will be required to develop the database, operate it, facilitate and check compliance with the provisions and provide feedback to the duty holders. EFSA already operates a database of notification of studies to serve the obligation under the food sector legislation. The resource use amounts to 2 FTEs/year and EUR 400 000/year. EFSA and ECHA will be required to ensure compatibility of the systems. No additional resources are needed for this for EFSA.

The operation of the indicators framework for chemicals will be formalised and an early warning and action system for chemicals will be established. The work will require additional resources for EEA. EEA will need as of the first year 1 FTE (1 TA) per year and operational budget for the first year of EUR 0, for the second year EUR 300 000 and as of the third year EUR 150 000 per year. EEA and ECHA already jointly develop the indicators framework for chemicals as part of the commitment under the 8th Environment Action Programme. As the resources for indicator framework (2 FTEs per year for ECHA, 1 FTE per year for EEA) were already attribution as part of the 8th EAP, no additional resources are needed for this work. The establishment of the early warning and action system is a new, non-existing task that aims to significantly shorten the regulatory response to identified risks. The EEA will be tasked to collect early warning signals from other agencies, Member State and by its own activity and compile annually a report for discussion and decision on the follow up with Member States authorities. Other contributing agencies (ECHA, EFSA, EMA and EU-OSHA) will absorb the costs as part of exiting activities. In case of ECHA, the resources attributed for the indicator framework will be partly used to support the EEA by generating relevant early warning signals.

Observatory for specific chemicals with potential contribution to emerging chemical risks will be established. This will de facto formalise the operation of existing EU Observatory for nanomaterials and extend its scope to specific chemicals considered to benefit from additional scrutiny and reliable information on their properties, safety aspects, uses and market presence. This work will impact ECHA but will not require additional resources under this proposal. ECHA operates the EU Observatory for nanomaterials as part of a contribution agreement with DG GROW. The resource use amounts to approximately EUR 700 000 per year including the 3 FTEs (3 CA). These existing resources will be used to continue operating, further developing and slightly expanding the system. The legislative proposal in preparation for a regulation on ECHA should address the fact that the operation of the EUCLEF became a structural task for ECHA and that the financing should become part of the annual contribution to ECHA.

Impact on committees of Agencies

There is no or a low impact of this proposal on committees of ECHA, EFSA and EMA and on the network of EEA. The rapporteurs of ECHA, EFSA and EMA committees that derive reference values will have to record the reference values and associated metadata into the repository of reference values or structure this information in the opinion to enable automatic extraction of that information to the repository. In addition, ECHA committees might be required to provide their suggestions for testing and monitoring of substances. The network of EEA will be required to assist in the collection of human biomonitoring data and early warning signals from member countries activities. There is no impact of this proposal on advisory groups of EU-OSHA.

10.Overall impacts from all (re-)attributions 

10.1Added value and synergies of the (re-)attributions 

Added value

The consolidation of scientific and technical work in the EU agencies provides for several benefits:

1.Scientific consistency and coherence - Less actors involved in the scientific and technical work, centralising the work in the Agencies and requiring the Agencies to cooperate and solve possible divergent opinions leads to improved coherence and scientific consistency among the legislative pieces and among the assessments. The consolidation of work allows to better align priority setting, timelines, processes and methodologies used for the assessments. It facilitates reuse of assessment insights developed under one piece of chemical legislation in the assessment under another piece of legislation. It also facilitates the reuse of data collected under one piece of chemical legislation in the assessment under another piece of legislation. It contributes to alignment of data formats, IT solutions, data storing practices and thus contribute to improved interoperability of data.

2.Robustness of assessment and acceptance - 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. Centralising data on chemicals in the EU Agencies will increase the knowledgebase and improve the robustness of the scientific advice provided. Re-use of (same) data will further facilitate acceptance of conclusions.

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

4.Transparency - Involvement of the EU agencies in scientific and technical work will ensure transparency to the process in terms of

-overall process transparency;

-publication of regulatory intentions of EU authorities and application submission intentions improves predictability for all stakeholders;

-public consultation/call for evidence;

-stakeholder involvement/observer status;

-dissemination of scientific data and outcomes.

The increased transparency will further increase the acceptance of the outcomes and trust in the regulatory system.

Synergies

The EU agencies already perform similar work to the work that is to be (re-)attributed to them. The consolidation of scientific and technical work in the EU agencies therefore provides for number of synergies:

1.Reuse of capabilities - The existing agencies’ capabilities, such as hazard, risk and exposure assessment, development of committee opinions, development of methodologies, IT capabilities for submission of information by industry and Member States, collection and processing of data, stakeholder consultations, dissemination, can be reused in performing the (re-)attributed tasks.

2.Reuse of data, information and knowledge - The information collected by the agencies on substances under one piece of legislation can be reused under other pieces of legislation. The knowledge on a substance developed under one piece of legislation can be reused under other legislation.

3.Workload balancing - More similar work consolidated at one place allows for better balancing the workload across the year and thus better using existing capacities at the Agencies.

4.IT tools: automation and economies of scale - Existing IT tools of the Agencies after some adaptation of the tools or the processes can be reused to support the tasks to be reattributed to the Agencies. This includes data submission and reporting tools, tools for case management, public consultation, interaction with Member States, regulatory intentions management and data dissemination

5.Support services: economies of scale - Existing scientific support services (such as committee secretariat, prioritisation and grouping of substances, substance identification, data management and dissemination) and administrative services of the agencies can be reused to support the tasks to be (re-)attributed to the agencies.

10.2Overall impact on resources 

Overall impact on resources per legislation and per agency

The (re-)attribution of scientific and technical work on chemicals to the EU Agencies with accompanying resources has been already proposed under 8 legislative proposals and one research cooperation action. The accompanying resources already attributed to the EU agencies following legislative initiatives already proposed by the Commission and some of which are already adopted by the co-legislator vary per year (see Table 8), with 54 FTEs (42 TA + 12 CA) and EUR 2 260 000 in 2024, 76 FTEs (63 TA + 13 CA) and EUR 1 873 000 in 2025, 92 FTEs (79 TA + 13 CA) and EUR 1 726 000 in 2026 and 98 FTEs (88 TA + 10 CA) and EUR 1 463 000 in 2027. The majority of resources were allocated to EMA (42 – 60 FTEs per year), followed by ECHA (24 – 29 FTEs and EUR 1 257 000 – EUR 1 364 000 per year) and EEA (9 – 11 FTEs and EUR 180 000 – EUR 919 000 per year). The majority of resources proposed for EMA are not related to the scope of the one substance, one assessment, but to improvement of processes for authorisation of medicinal products for human use.

The (re-)attribution of scientific and technical work has been already proposed by the Commission also under the revision of CLP regulation, packaging and packaging waste directive, end-of-life vehicle directive and toys safety directive but without the allocation of resources. As the resource allocation is still pending, these initiatives are mentioned in the table with pending resource needs below.

The re-attribution of tasks to the EU agencies is still to be proposed under 5 upcoming legislative proposals and under the reattribution of non-chemical assessment work from SCHEER to SAM within the Commission. After considering all possible synergies from the reattributions, the pending resource needs for the work attributed to the EU Agencies without the resources and for the work to be attributed varies between 56 – 69 FTEs (34-38 TA + 19-31 CAs) per year and operational budget of EUR 1 051 000 – EUR 10 300 000 per year. The details are provided in Table 10. The majority of the resources is to be allocated to ECHA (46 – 55 FTEs and EUR 101 000 – EUR 8 666 000 per year), followed by EEA (3 – 5 FTEs and EUR 400 000 – EUR 766 000 per year), EFSA (2 – 5 FTEs and EUR 500 000 – EUR 670 000 per year), EMA (2 – 3 FTEs and EUR 0 – EUR 100 000 per year) and SAM (1 FTE per year). The details of allocations per agency are provided in Table 11.

Overall resources saved

It must be noted that some activities that have been reattributed were performed also before the reattribution and resources were used for those activities (see Table 12 below). The resources used for rapid risk assessment for serious cross-border threats, the operation of databases under the SEVESO directive and implementation work on chemicals under surface and ground water legislation consisted of 3.6 FTEs/year of regular staff, 7 FTEs per year of intramurous contractors or interim staff (ca. EUR 460 000 per year) and operational budget of EUR 127 000 per year. These resources will be saved at the institution that has performed the tasks so far.

Some tasks that are still to be (re-)attributed via the upcoming proposals are being currently performed and the resources are allocated to them (see Table 13 below). The resources currently used for the RoHS directive, POPs regulation, medical devices regulation, operation of IPCHEM, EUCLEF and observatory for nanomaterials, for scientific opinions on OELs, end-of-life vehicle directive, cosmetics regulation and toy safety directive amount to 12.8 FTEs per year of regular staff, 10.9 FTEs of intramurous contractors or interim staff (705 K€ per year) and an operational budget of EUR 2 023 000 – EUR 2 423 000 /year. As these tasks will be reattributed or formalised, the current resources used for these tasks will not be needed and will be saved at the institution that performs or finances the tasks today. Therefore, the total net increase in the resources is lower than indicated in the Table 10, and for the tasks to be still reattributed accounts for 32 – 45 FTEs per year and an operational budget of up to EUR 8 277 000 per year.

10.3Overall impacts on ECHA

Impact on ECHA’s resources

The proposals made by the Commission so far have already proposed to strengthen ECHA in the long term by 29 FTEs (see Table 14). An additional 48 FTEs are necessary in the long term to deal with the envisaged tasks that were already proposed by the Commission but without allocation of resources or are still to be proposed (see Table 15). Although the required reinforcement of ECHA seems significant, the allocation of 11 FTEs out of 48 will be de facto a regularisation of resources that already exist in ECHA via administrative agreements (4 FTEs for worker protection legislation and 3 FTEs for operation of EUON) or via a service level agreement (4 interim employees for operation of EUCLEF). In addition, the allocation of some additional 11 FTEs is a reattribution from other sources, mainly from contracting out the support (2.7 FTEs for RoHS directive, 1.5 FTEs for POPs regulation, 0.3 FTEs for medical devices, 3.5 FTEs for IPCHEM, 3 FTEs for cosmetics regulation, 0.3 FTEs for toy safety directive and 0.36 FTEs for end-of-life vehicle directive).