European Union: Update from the European Commission: the future revision of REACH and the restriction of PFAS
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The REACH reform recently announced by the European Commission should substantially change the current rules on REACH restrictions and authorizations.
The European Commission (“Commission”) recently provided an important update on the two key initiatives enshrined in the new Chemicals Sustainability Strategy (“CSS”): the future revision of Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (“REACH”) and the ongoing Restriction on Per- and Polyfluoroalkyl Substances (“PFAS”).
On May 4, 2021, the Commission published an initial impact assessment on the planned review of REACH. This initial impact assessment is currently subject to public consultation until June 1, 2021. Among other things (e.g. revision of information requirements for registrations, simplification of communication in supply, revision of the substance evaluation procedure, more border controls and more power for the European Union to audit national enforcement), the Commission’s stated objectives for the REACH reform also include the options following policies for Titles VII (“Authorization”) and VIII (“Restrictions”) of REACH.
Access restrictions. Options include: (i) extending the “generic risk approach” (i.e. assuming that the use of a substance constitutes a risk) to new hazard classes such as endocrine disruptors, PBT/vPvB substances, immunotoxins, neurotoxins, respiratory substances, sensitizers and substances that affect specific organs; and (ii) the extension of the “generic risk approach” to products marketed for professional use (as opposed to only industrial and consumer uses).
Achieve Permissions. Options include: (i) clarification and simplification of the procedure, including for substances in small quantities and minor modifications of authorizations granted; (ii) strengthen the incentives for substitution over time by giving more options to the Commission to set the conditions and pathways for substitution; (iii) allow national permissions (for small apps); (iv) the financing of cooperation projects between SVHC users and alternative suppliers; or (v) delete the authorization title under REACH or merge/integrate it into the restriction procedure. As regards option (v), the intention of the Commission would be to establish a generic/default ban for substances, under which derogations would be proposed not only by the authorities but also by the industry, which in turn would then have the burden of proof.
For both authorization and restriction procedures, the REACH reform should “operationalise” the new concept of “essential use” (the potential new legal principle that a substance can only be used if its use is “essential for the society and there is no alternative”). According to the Commission, the implementation of the essential use concept in REACH, and in particular its application to restrictions, can be facilitated by reducing and simplifying the requirements in regarding derogations in future restrictions.
In addition, the Commission also intends to launch a specific study on the essential use concept in the coming months, as well as on policy options for authorization and on the application of the new “generic risk approach”. “.
The Commission’s proposal for the revision of REACH is expected by the end of 2022. Thus, the inclusion of the new concept of essential use in REACH will not take place before 2023 at the earliest.
Restriction of PFAS
The Commission’s objective under the CSS is to ban all PFAS unless the European Union deems their use essential. Thus, the future restriction of PFAS could be the first application of the future REACH Essential Use concept, even if this new concept is not yet defined and will only be developed in parallel. It remains to be seen how the five member states currently developing the PFAS restriction will handle this situation. In terms of timing, according to the Commission, the restriction of PFAS on fire-fighting foams, whose inclusion in Annex XVII of REACH is planned for spring 2023, could serve as the basis for the broad restriction on PFAS that would take place one to two years later. As a reminder, the five Member States in charge of preparing the restriction of PFAS currently use a group definition of PFAS which would encompass around 4,700 substances.
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