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REACH

Overall State of Play:

Evaluation finalised, second REACH review COM(2018)116, SWD(2018) 58
Legal acts:
• Implementing Regulation (EU) 2016/9 on joint submission of data and data-sharing adopted in January 2016
• Commission Regulation (EU) 2018/1881 as regards REACH Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances
Commission Implementing Regulation (EU) 2019/1692 of 9 October on the application of certain registration and data-sharing provisions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council after the expiry of the final registration deadline for phase-in substances
• Commission Regulation (EU) 2020/507 of 7 April 2020 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the percentage of registration dossiers to be selected for compliance checking
• Commission Implementing Regulation (EU) 2020/1435 of 9 October 2020 on the duties placed on registrants to update their registrations under Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Commission proposal: ongoing work for targeted revision of REACH Regulation (EC) No 1907/2006 announced in the Chemicals Strategy for Sustainability

State of play, main conclusions, outlook

The Commission adopted an Implementing Regulation on joint submission of data and data-sharing in January 2016. The second REACH review was adopted on 5 March 2018.

On 3 December 2018 a number of Annexes of REACH were amended to address nanoforms of substances, with changes entering into mandatory application by 1 January 2020.

The evaluation of REACH has identified some needs for further improvement, in particular:

• Improving compliance of registration dossiers: data gaps in registration dossiers need to be addressed through improved compliance and evaluation procedures.

• Simplification of the authorisation process: authorisation is still a relatively new process under REACH that has faced challenges as it became operational and it needs to become easier and more predictable for companies.

• Ensuring a level playing field between EU and non-EU companies: EU manufacturers are at a disadvantage compared to non-EU companies with respect to imports of articles containing Substances of Very High Concern (SVHC) that are subject to authorisation. The Commission is looking into ways of addressing this disadvantage by enhancing the enforcement by national authorities and the import controls by customs authorities.

• Coherence by clarifying the interface between REACH and worker protection legislation (OSH) as well as with waste legislation.

Based on the findings of the evaluation, the second REACH review has concluded that the legal requirements and obligations are well tuned to addressing the needs and achieving the objectives pursued. A few areas for improvement were identified, and as a follow-up, the Commission proposed 16 concrete actions to improve the workability of several processes under REACH.

Additional legislation was adopted by the Commission:

• in 2019, the Commission adopted an Implementing Regulation on the application of certain registration and data-sharing provisions of REACH after the expiry of the final registration deadline for phase-in substances;

• in 2020, the Commission amended Article 41 (5) as regards the percentage of registration dossiers to be selected for compliance checking and adopted an Implementing Regulation on the duties placed on registrants to update their registrations.

The Chemicals Strategy for Sustainability was adopted on 14 October 2020 as the first delivery of the zero-pollution ambition under the European Green Deal. As part of the Strategy, the Commission announced a targeted revision of REACH, supported by an impact assessment. Accordingly, the inception impact assessment was published on 4 May 2021. A public consultation on the REACH revision was carried out from 20 January until 15 April 2022 and the Commission is finalising the impact assessment. The overall objective of the revision is to ensure that the provisions of the REACH Regulation reflect the ambitions of the Commission on innovation and a high level of protection of health and the environment, while preserving the internal market, as provided for in the Strategy. The findings of the 2018 REACH review are taken into account as part of the evidence base of the impact assessment and the Commission has considered a range of different possible options to fill gaps and to simplify and strengthen the legal provisions.

REFIT Platform

The REFIT Platform adopted in 2016 an opinion on the interface between REACH and occupational health and safety (Ref. II.2.a). It recommended that the Commission should raise awareness and issue guidance on the implementation of legislation in this area. In response, the Commission has been working on clarifying the interface between the two legislations in order to reduce the existing overlaps through the implementation of an action of the Communication on the REACH review 2018.

The REFIT Platform adopted in 2017 also an opinion on the REACH authorisation process (Ref. II.4.a) in which it recommended to identify simplification measures, in order to improve the effectiveness of this process. This opinion has fed the evaluation of REACH.

Fit for Future Platform

The Fit for Future Platform adopted in December 2022 an opinion on REACH (Ref. 2022/SBGR2/06) in view of the upcoming Commission proposal for a targeted revision of REACH. In the opinion, the Platform makes the following six recommendations:

1. Improve communication up and down the supply chain in relation to safety-data-sheets, other risk-/hazard-communication and worker protection;

2. Facilitate registration and evaluation by optimizing resources and procedures;

3. Develop IT-tools more adequate for SMEs;

4. Enhance transparency supporting regulatory actions and innovation by optimizing enforcement, decision-making-procedures, data-foundation and applied R&D;

5. Strengthen enforcement by focusing on problematic areas and dedicating more resources for concrete activities of enforcement bodies;

6. Streamline authorisation and restriction by better focusing on problematic areas, introducing incentives for the development and marketing of substitutes and streamlining regulatory procedures.

The Commission is considering the proposals of the Platform amongst the options assessed on how to revise the REACH regulation.

As regards the first suggestion, two options to improve the supply chain communication via changes to the safety data sheets are being assessed. Improving the interface between REACH and, e.g. OSH at the candidate list stage, is also being discussed.

The Commission agrees that existing funding possibilities should be exploited to support SMEs with the REACH processes, including the use of the REACH national helpdesks. However, this is a matter that does not concern the legislative changes assessed in the REACH revision impact assessment. Improving the evaluation process and introducing the possibility of revoking registration numbers are taken into account in one of the specific options assessed.

When it comes to suggestion 3, the Commission considers this a matter of implementation that could be discussed with ECHA.

The Commission has assessed some of the issues under suggestion 4 in order to improve the evaluation process. Possible requirements for downstream users to provide more information on the use and exposure of SVHCs were assessed as part of the impact assessment. The creation of one-stop-shop for funding opportunities is not explored in the impact assessment but could be part of the implementation stage.

The Commission has assessed several options to strengthen the enforcement of REACH as pointed to in suggestion 5, including the creation of a European Audit Capacity, the increased controls of imports (also of online sales) or facilitating the access to justice.

The Commission has considered three options to reform the authorisation and restriction processes. Some of the options may be more favourable for SMEs than the current authorisation requirement. The Commission is considering to establish criteria to define which professional uses would be comparable to consumer uses. The creation of a substitution centre is not assessed in the impact assessment, but the importance of the role of substitution is recognised in the options assessed to reform authorisation and restriction. The Commission has assessed the extension of the generic risk management approach to the most harmful chemicals.

State of Play:

Finalised: 5 March 2018, COM(2018) 116, SWD(2018) 58

Scope:

Second evaluation of the REACH Regulation (EC) No 1907/2006

Evaluation findings:

The second assessment of REACH has identified some areas for further improvement, in particular:

• Improving compliance of registration dossiers: data gaps in registration dossiers need to be addressed through improved compliance and evaluation procedures.

• Coherence by clarifying the interface between REACH and worker protection legislation (OSH) as well as with waste legislation.

The second REACH review has concluded that the legal requirements and obligations are well tuned to addressing the needs and achieving the objectives pursued. As a follow-up, the Commission proposed 16 concrete actions to improve the workability of several processes under REACH.

A Joint Action Plan was agreed between the Commission and ECHA in June 2019. The Joint Evaluation Action Plan includes further measures to increase the efficiency of the dossier evaluation under REACH and describes its role under the integrated regulatory strategy: by 2023, the dossiers for all high volume substances and, by 2027, for all the remaining substances, will be assessed for potential regulatory action, with compliance check decisions requiring generation of any still necessary information.

State of Play:

Ongoing: Commission proposal for a targeted revision of REACH Regulation (EC) No 1907/2006 to be adopted by the Commission in 2023 (cf. 2023 Commission Work Programme).

Which objectives will the Commission pursue?

As presented in the inception impact assessment published on 4 May 2021, the overall objective of the revision of REACH is to ensure that the provisions of the regulation reflect the ambitions of the Commission on innovation and a high level of protection of human health and the environment, while preserving the internal market, as provided for in the Chemicals Strategy for Sustainability.

Referring specifically to simplification and burden reduction, the Commission builds on the objectives in the Strategy and the conclusions from the two previous REACH reviews to develop and assess potential options that would allow to, inter alia, improve the communication in the supply chains, clarify and simplify the current provisions in the authorisation title, reduce the administrative burden of authorisations for companies and authorities, ensure an international level playing field, and improve the interface of REACH with other pieces of legislation.

State of Play:

• Commission implementing Regulation (EU) 2016/9 was adopted by the Commission on 5 January 2016
• Commission Regulation (EU) 2018/1881 was adopted by the Commission on 3 December 2018. Changes will enter into mandatory application by 1 January 2020
• Commission Implementing Regulation (EU) 2019/1692 of 9 October on the application of certain registration and data-sharing provisions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council after the expiry of the final registration deadline for phase-in substances
• Implementing Regulation (EU) 2020/1435 of 9 October 2020 on the duties placed on registrants to update their registrations
• Commission Regulation (EU) 2020/507 of 7 April 2020 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the percentage of registration dossiers to be selected for compliance checking

Which objectives did the Commission pursue?

Commission implementing Regulation (EU) 2016/9

The Commission wanted to improve the implementation of REACH by ensuring that the objectives of REACH, protection of human health and the environment, promotion of alternative methods and free circulation of substances in the internal market are achieved. As such, an Implementing Regulation was put forward in 2016 setting rules to ensure that the system for data-sharing established by REACH is operating effectively and promotes good management practices that ensure the efficient functioning of agreements pertaining to sharing such data. One element that is clarified in the Implementing Regulation is that potential registrants of a substance for which a data-sharing agreement has already been reached by previous registrants have the right to request a breakdown of the study and of the administrative costs that make up the price for that potential registrant to comply with his joint registration obligation.

Commission Regulation (EU) 2018/1881

Nanomaterials are chemical substances like any other and as such subject to REACH. The amendments of the technical Annexes introduce for nanomaterials clarifications of existing requirements and new provisions for their characterisation, chemical safety assessment and standard information requirements. These changes shall ensure that the objectives of REACH are effectively pursued also for substances in nanoform.

Commission Implementing Regulation (EU) 2019/1692

After the expiry of the final REACH registration deadline for phase-in substances on 1 June 2018, questions have been raised on the application of certain registration and data-sharing provisions for phase-in substances. In order to respond to these queries, to uphold legal certainty and to ensure that the provisions of REACH Registration are working effectively, it was necessary to specify a clear cut-off date for the application of the definition of "phase-in substances" in REACH and to clarify that although the formal operation of Substance Information Exchange Forums will no longer be obligatory in REACH after 1 June 2018, the existence of such discussion platforms among registrants is still strongly recommended after that date in order to enable registrants to meet their ongoing registration and data-sharing obligations.

Commission Regulation (EU) 2020/507

Article 41(5) of REACH specified that ECHA must select at least 5% of registration dossiers per tonnage band for compliance checking. As part of the Joint Evaluation Action Plan agreed among ECHA and the Commission in June 2019, it was agreed that this percentage should be increased to 20% of dossier per tonnage band. This was done, on the one hand, to help address the lack of compliance in registration dossiers and encourage industry to improve their safety data on chemicals and, on the other hand, to reflect the fact that ECHA had exceeded the 5% target for the higher tonnage bands already.

Commission Implementing Regulation (EU) 2020/1435

The 2018 REACH Review highlighted that registration dossiers are not updated as frequently as envisaged. This was partly ascribed to the fact that the provisions in Article 22(1) to update in certain situations “without undue delay” do not provide clear guidance to the registrants and in addition made enforcement by the Member States difficult. Therefore, this Implementing Regulation which provides timeframes within which updates as per the situations described in Article 22(1) should be submitted, should better explain the updating duties to registrants and facilitate enforcement.

State of Play:

Actions as follow-up to the second REACH review

The Commission has discussed the outcomes and follow-up actions of the second REACH review with the European Parliament, the Council as well as with national competent authorities and stakeholders. The Commission and ECHA, in cooperation with the Member States, have initiated the work to deliver on the actions proposed in the second REACH review.

On 22 June 2018, the Commission adopted the Implementing Regulation (EU) 2018/895, that lowered the fees for joint applications for authorisation, in order to enable downstream users to apply jointly at no additional cost compared to single applications.

The Commission has adopted an implementing regulation on the application of certain registration and data-sharing provisions after the expiry of the final registration deadline for phase-in substances (October 2019), an implementing regulation specifying when registrations should be updated (October 2020), and a regulation on the revision of the target for the number compliance checks ECHA must carry out (April 2020).