Under the European Green Deal (2019) and the Chemicals Strategy for Sustainability “CSS” (2020) the European Commission aims to revise the rules governing the Registration, Evaluation, Authorisation and Restriction of chemicals in the EU, as currently set out in Regulation (EC) No 1907/2006 (REACH). This REACH Revision aims to further improve the protection of human health and the environment against hazardous chemicals and to encourage innovation to develop safe and sustainable alternatives.
In 2021 the Impact Assessment for the REACH Revision with broad stakeholder consultation activities was completed. The European Commission has started drafting the legal revision proposal(s) as a priority for 2023. The adoption of the proposal is expected by Q4 2023. It will then be sent to the European Parliament and the Council for the co-legislative procedure, for possible entry into force between 2025 – 2027.
Within industry the REACH Revision will affect all actors along the supply chains of substances, mixtures and articles placed on the EU/EEA market. This concerns in particular manufacturers, importers and downstream users of substances and mixtures, but also suppliers of articles and complex products.
The REACH Revision may potentially affect a large scope of substances as well as mixtures and articles containing them.
More specifically on registration, a new registration obligation for certain polymers is planned to be introduced. For endocrine disruptors (EDs), (other) substances with critical hazard properties, including effects on the nervous and the immune systems and low tonnage substances, the information requirements for registration should be increased.
Furthermore, the EU wants to simplify and accelerate regulatory risk management (through REACH authorisation and/or restrictions) for the most harmful chemicals, including the following substances: EDs, persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM) substances as new categories of SVHCs; these as well as PBTs, vPvBs, immunotoxicants, neurotoxicants, respiratory sensitisers or respiratory systems and substances toxic to specific organs (STOT) shall also be covered under the so-called “Generic Risk Management Approach” (GRA) for fast-track restrictions, in addition to CMRs. The Commission’s Restrictions Roadmap under the CSS published in April 2022 has already initiated the prioritization of defined groups of these substances under the current REACH restrictions system, until the REACH Revision is in place.
Based on the current information, the REACH Revision could result in the following new duties:
- New registration requirements for certain polymers of concern
- Update of existing registration dossiers to reflect enhanced information requirements / scrutiny
- Chemical Safety Report in all tonnage bands (incl. 1-10 tonnes per year)
- Stricter requirements for intermediates
- Electronic formats for Safety Data Sheets (SDSs)
- Update SDSs and Exposure Scenarios, incl. as result of new Mixture Assessment Factors
- Compliance with broad REACH restrictions, especially group-based
- Reporting to ECHA by downstream users of Candidate List substances
- Response to tightening enforcement – “Zero Tolerance Approach to Non-Compliance”
Note that additional obligations may arise from the parallel CLP Revision and the new Ecodesign for Sustainable Products Regulation (ESPR, see more information here )
Non-EU exporters to EU/EEA will be in the same role as under the current REACH, i.e. they may choose to operate through Only Representatives within the scope of REACH Article 8 and otherwise have to support their EU customers’ (importers’) REACH compliance. It should be noted that according to the CSS (“Zero Tolerance Approach to Non-Compliance”) the Commission aims to target known areas of high risk of non-compliance, including imported articles (among others).
The REACH Revision is currently expected to enter into force between 2025 – 2027. It is expected that the implementation of the REACH Revision will be subject to certain transition periods; they are still to be elaborated.
The industry impact will largely depend on the Commission proposal (currently expected in Q4 2023) and subsequently the final version of the REACH 2.0 as well as its implementation by the European Commission, ECHA and the EU/EEA Member States. Key open questions today include the outcome of the planned REACH Authorisation and Restriction Reform, the criteria for granting “essential uses” and to what extent new obligations are eventually introduced for manufacturers, importers and downstream users. However, the number of new hazard classes to be addressed (see above) and the Commission’s on-going activities (such as the CSS Restrictions Roadmap) show that the impact is likely to be significant for the actors covered by it (e.g. planned “universal” PFAS restriction).
Companies placing on the EU market substances, mixtures and articles containing SVHCs are advised to start assessing the possible impacts of the REACH Revision for their products, monitor the adoption of the new legislation and start getting prepared for the upcoming regulation. This concerns especially products containing the substances listed above. Ongoing activities (e.g. CSS Restrictions Roadmap) should also be followed and input for ECHA public consultations be gathered.
Our services bring together our regulatory expertise and your product know-how, guiding you through the various elements of the REACH Revision and helping you take the appropriate actions.
REACHLaw can support your preparations for the REACH Revision in various ways; our services include:
- REACH Revision impact / change analysis and monitoring
- Position development for Commission calls for feedback and ECHA public consultations
- Training / awareness raising for industry associations and upstream suppliers
- Consultancy (Regulatory, Technical, Legal)