Proposal for a Regulation of the European Parliament and of the Council on (re-)attribution of scientific and technical work on chemicals to the EU agencies
Date: 2022-03-14
Institutions: Directorate-General for Environment, European Commission
Subjects: EU environmental policy



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CALL FOR EVIDENCE


FOR AN INITIATIVE  (without an impact assessment)











Title of the initiative




Chemicals – making best use of EU agencies to streamline scientific assessments






Lead DG – responsible unit 




ENV B.2 






Likely Type of initiative




Proposal for a Regulation






Indicative Timing




Q4 2022






Additional Information




Implementation of the chemicals strategy - Implementation (europa.eu).






This document is for information purposes only. It does not prejudge the final decision of the Commission on whether this initiative will be pursued or on its final content. All elements of the initiative described by this document, including its timing, are subject to change.









A. Political context, problem definition and subsidiarity check






Political context






The Commission committed in the European Green Deal to present a chemicals strategy for sustainability and, as part of this work, 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 identified a number of actions to deliver on the commitment to move towards the process of ‘one substance, one assessment’. This initiative implements one of the key actions announced in the strategy, namely ‘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)’.






Problem the initiative aims to tackle






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, 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 initiated by various actors, at different points in time, using different data and involving various EU agencies (European Chemicals Agency (ECHA), European Food Safety Authority (EFSA), European Environment Agency (EEA) and European Medicine Agency (EMA)), scientific committees, expert groups, Commission services or contractors. This situation sometimes leads to inconsistent outcomes across legislation (in respect of the same chemicals), inefficient use of resources, slow procedures and unnecessary costs. 


The fitness check of all chemicals legislation (except REACH) showed that there are significant opportunities for streamlining the technical and scientific work through EU agencies. It will make the functioning of chemicals legislation more efficient (e.g. avoiding duplication of efforts and making the best use of available expertise in EU agencies) and more coherent (e.g. reducing the risk of diverging outcomes of hazard/risk assessments at EU level). It will also simplify the current set-up, reduce the need to provide information to multiple interlocutors, improve the quality of assessments, and ensure predictability for stakeholders and the general public.


The initiative relates to other actions on ‘one substance, one assessment’ announced in the chemicals strategy for sustainability. New technical tools supporting implementation of the chemicals legislation and of the ‘one substance, one assessment’ approach will be developed, including: 


-extending the use of the public activities coordination tool to other legislation; 


-establishing an EU repository of human and environmental health-based limit values; and


-establishing a common, open data platform on chemicals and tools for accessing relevant academic data.


The initiative should attribute responsibility for operating these new technical tools.






Basis for EU action (legal basis and subsidiarity check)











Legal basis






Article 114 TFEU, or possibly others (e.g. Article 192 TFEU) depending on acts being amended.






Practical need for EU action






The initiative aims to revise, in a targeted manner, existing legislative instruments, including those based on Article 114 of the Treaty on the Functioning of the European Union, that harmonise provisions to improve the functioning of the internal market on chemicals at EU level. The revision will target the attribution of responsibility for performing scientific and technical work that is done at the EU level. This cannot be sufficiently achieved by Member States alone, because of its scale and effects, and therefore can only be achieved at EU level. 






B. What does the initiative aim to achieve and how






The initiative aims to consolidate in EU agencies the technical and scientific work on chemicals performed at EU level under, or in support of, EU legislation. The objective is to ensure high-quality deliverables, to use resources more efficiently, avoid duplication of efforts, exploit synergies, make best use of expertise in EU agencies, and ensure more coherent safety assessments for chemicals across legislation. 


The horizontal legislative proposal is envisaged to take the form of an omnibus regulation amending relevant provisions on the allocation of tasks and responsibilities in various pieces of existing legislation.


(Re-)attribution of technical and scientific work will be considered to one or more of the EU agencies (ECHA, EFSA, EEA or EMA).


The technical and scientific work on chemicals will be considered in a broad sense. It will include: assessments of risk from hazard of and exposure to chemicals; determination of safe levels for chemicals; development of guidance documents; managing scientific committees and expert groups; collecting, hosting and processing data on chemicals (including on hazard, occurrence, and emissions); hosting and operating information platforms; and managing data flows on chemicals and defining data formats. 


The initiative will consider existing technical and scientific work on chemicals performed at EU level under, or in support of, all relevant EU legislation. The initiative will focus in particular on amending those pieces of legislation that will not be reopened to meet other objectives of the chemicals strategy; for those pieces that will be reopened, the reattribution will be primarily made as part of that reopening. The analysis underlying this initiative will take into account these other proposals to reflect fully the impacts on the resource needs of the agencies concerned.


The initiative will also propose to attribute the responsibilities for operating new technical tools to be developed as part of the chemicals strategy for sustainability, such as the extended public activities coordination tool, the open data platform on chemicals, the repository of health-based limit values, or tools to improve access and uptake of academic data in regulatory work.






Likely impacts






 The initiative is expected to have positive impacts as regards simplification and administrative burden. It will be beneficial for all stakeholders, including economic operators (industry, SMEs, etc.), civil society organisations, as well as for Member State authorities, Commission services and EU agencies. 



It is expected that the initiative will have no significant economic, social or environmental impact. The initiative will have impact on the resource needs of EU agencies, but will overall improve efficiency in the use of resources.







Future monitoring






The impact of the initiative will be assessed specifically through a stakeholder survey as part of future evaluations of chemicals legislation to establish the level of improvement in coherence and efficiency in performing technical and scientific work on chemicals. This will complement the information that is currently collected in relation to the operation of relevant agencies and legislation.






C. Better regulation






Impact assessment 






The fitness check of all chemicals legislation (except REACH) delivered conclusions on the risk of duplication of efforts by different EU agencies and scientific committees. It stated that there are opportunities for simplifying and streamlining their current set-up and activities. There is no need for an impact assessment as there is little discretion on the policy choices, and no significant economic, social or environment impact is expected. The impact on resources and capacity for Member States, agencies and the Commission will be identified, together with costs and benefits, quantified to the extent possible (in particular for administrative costs and any cost savings). 






Consultation strategy 






Given the technical nature of the changes, no open public consultation will be undertaken.


However, it is planned to carry out targeted consultation of Member State authorities, EU agencies, businesses, non-governmental organisations and other relevant stakeholders. This will be conducted through online surveys, meetings or interviews. 


In addition, the expert working group of Member States, Commission services and EU agencies on ‘one substance, one assessment’ will be consulted to receive input from Member State experts and EU agencies.






Why we are consulting?






The consultation will collect views of stakeholders, EU agencies and Member States – based on their experience – on the reattribution of technical and scientific work on chemicals performed under the relevant pieces of legislation. 






Target audience






Member State authorities, EU agencies, businesses, non-governmental organisations, and other relevant stakeholders