Preamble

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the ordinary legislative procedure (2), Whereas: (1) The communication of the Commission of 11 December 2019 on the European Green Deal sets as an objective that chemical safety assessments should move towards a ‘one substance, one assessment’ approach, calling for more transparent and simpler risk assessment processes in order to reduce the burden on all stakeholders, accelerate decision-making and increase consistency and predictability of scientific decisions and opinions. The communication of the Commission of 14 October 2020 entitled ‘Chemicals Strategy for Sustainability Towards a Toxic-Free Environment’ concludes that, in order to achieve that objective, part of the scientific and technical work on chemicals performed at Union level in support of Union law needs to be reattributed to the most suitable Union agencies. This would simplify the current set-up, improve the quality and coherence of safety assessments across Union law, and ensure more efficient use of existing resources. This approach is also expected to promote cost-effectiveness and competitiveness by simplifying regulatory procedures and reducing the administrative burden, thereby ensuring that businesses can adapt efficiently to evolving regulatory frameworks. (2) The reattribution of certain scientific and technical tasks to the European Chemicals Agency (the ‘Agency’) is necessary in order to align processes and levels of scientific scrutiny and digitalisation with the current standards and processes of the Agency. The reattribution of such tasks is also necessary in order to ensure a consistent standard of scientific quality, transparency, data searchability and interoperability, in line with the ‘one substance, one assessment’ approach. Moreover, digitalisation and streamlining of processes will reduce the duplication of efforts and administrative delays, providing significant cost savings and efficiency gains for both Member States and economic operators. (3) The amendment of Directive 2011/65/EU of the European Parliament and of the Council (3) aims to expand the tasks, workload and remit of scientific committees of the Agency. In order to provide adequate expertise and support, and thorough scientific evaluations, appropriate and stable resources and governance of the scientific committees should be ensured. In this respect, it is appropriate to provide for a review clause to ensure that the Commission take account of any future regulatory developments relating to the governance of the scientific committees of the Agency in order, if necessary, to revise Directive 2011/65/EU accordingly. (4) Directive 2011/65/EU contains two procedures relating to the assessment of chemicals: the evaluation of economic operators’ applications for granting, renewing or revoking an exemption from the substance restrictions and the review of substances to be added to the list of restricted substances. There is a need to increase transparency by setting detailed procedural steps for the process of reviewing substances for potential inclusion in the list of restricted substances. (5) Data and information held by the Agency in the context of regulatory processes under Titles VII and VIII of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4) can be usefully deployed for the assessment of potential substance restrictions and for the assessment of applications for exemption under Directive 2011/65/EU. Established structures and procedures can help to build on the existing knowledge base, maximise synergies and make the best use of available expertise and resources. (6) To ensure consistency between the evaluation of economic operators’ applications for granting, renewing or revoking an exemption pursuant to Article 5 of the Directive 2011/65/EU, and to make the best use of existing chemicals-related expertise, the technical evaluation to assess the justification of such exemption applications should be carried out by the Agency and its committees in close coordination with the Commission. (7) The information submitted in the confidential version of an exemption application should be subject to an assessment by the Agency. Such assessment should comply with Union law concerning confidential data and protection of personal data, in particular regarding dissemination and confidentiality criteria established under Regulation (EC) No 1907/2006. (8) Most exemption applications are expected to require the expertise of the Committee for Socioeconomic Analysis set up pursuant to Regulation (EC) No 1907/2006. The Commission should consult Members States’ representatives when adopting guidelines on the involvement of the Committee for Risk Assessment. (9) To ensure that the restriction process of Directive 2011/65/EU is consistent with the restriction processes under other legal acts related to chemicals, and in particular the substance restriction process laid down in Regulation (EC) No 1907/2006, Directive 2011/65/EU should be amended in order to formally assign the Agency a role in the restriction process. In light of experience gained while carrying out substance reviews, it is essential for the quality of the related technical assessment and for enabling synergies, to make use of information and tools being used in the context of assessments for chemical restrictions under Regulation (EC) No 1907/2006. (10) The list of restricted substances referred to in Directive 2011/65/EU should be periodically reviewed to ensure a high level of protection of human health, the environment and consumer safety. It is appropriate for such reviews to take place at least every 4 years, taking into account market developments, technical and scientific progress, that restriction dossiers can be submitted by Member States at any time and that horizontal restriction measures can be initiated and adopted under Regulation (EC) No 1907/2006, Regulation (EU) 2019/1021 of the European Parliament and of the Council (5) or other Union law concerning sustainability criteria for hazardous substances and chemicals. (11) The Agency can develop guidance concerning the Annex to Directive 2011/65/EU introduced by this Directive. In addition, where relevant, reference can be made to the existing guidance concerning Annex XV to Regulation (EC) No 1907/2006 in respect of the specific aim of Directive 2011/65/EU and the criteria laid down in Article 6(1) of that Directive. (12) The two procedures described under Article 5 and Article 6 of Directive 2011/65/EU are applicable at Union level. National provisions should not deviate from those Articles. (13) In order to ensure that this Directive is consistent with any future amendment of Regulation (EC) No 1907/2006, and with other future Union legal acts concerning sustainability criteria for hazardous substances and chemicals, the Commission should assess whether further amendments of Directive 2011/65/EU are necessary in order to amend the rules concerning the adaptation of the Annexes to that Directive to scientific and technical progress and the rules concerning the amendment of the list of restricted substances in Annex II to that Directive. Where appropriate, the Commission should propose amendments to Directive 2011/65/EU in future proposals concerning sustainability criteria for hazardous substances and chemicals or in other future Union legal acts concerning sustainability criteria for hazardous substances and chemicals. (14) For amending procedural provisions under Directive 2011/65/EU, it is necessary to provide for a transitional period of 20 months to allow for appropriate resource allocation and task assignment in respect of the Agency. That timeframe is considered sufficient to allow potential applicants or Member States to adjust to the modified procedural steps under that Directive. (15) Directive 2011/65/EU should therefore be amended accordingly, HAVE ADOPTED THIS DIRECTIVE:

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Source: EUR-Lex (Cellar) · retrieved 2026-10-14 · Text as adopted (Official Journal); later amendments are not incorporated in this text.