Update from the European Commission: The future revision of REACH and the restriction of PFAS | Jones Day
The European Commission (“Commission”) recently provided an important update on the two key initiatives included in the new strategy for the sustainability of chemicals (“CSS”): the future revision of Regulation (EC) No 1907/2006 on 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 others (eg revision of information requirements for registrations, simplification of communication in supply chains, revision of the substance evaluation procedure, more border controls and more power) for the European Union to verify application at national level), the objectives declared by the Commission for the REACH reform also include the following policy options for titles VII (“authorization”) and VIII (“restrictions”) of REACH.
Achieve restrictions. Options include: (i) expanding the so-called ‘generic approach to risk’ (i.e., assuming that the use of a substance constitutes a risk) to new hazard classes such as endocrine disruptors, PBT / vPvB substances, immunotoxics, neurotoxics, sensitizers and substances that affect specific organs; and (ii) extend the “generic risk approach” to products marketed for professional use (as opposed to only industrial and general public use).
Achieve permissions. The options include: i) clarifying and simplifying the procedure, including for substances in small quantities and minor modifications of the 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) authorize national authorizations (for small applications); (iv) funding of cooperation projects between SVHC users and alternative providers; or (v) the removal of the authorization title under REACH or its merger / integration with the restriction procedure. Regarding option (v), the intention of the Commission would be to set a generic / default ban for substances, whereby exemptions would be proposed not only by the authorities but also by industry, which to his turn would then have the burden of proof.
For authorization and restriction procedures, the REACH reform should “operationalize” the new concept of “essential use” (the potential new legal principle that a substance can only be used if its use is “essential for society”. and there are no alternatives ”). In the opinion of 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 requirements for exemptions in future restrictions.
In addition, the Commission also intends to launch a specific study on the concept of essential use in the coming months, as well as on the policy options for authorization and on the application of the new ‘generic approach’. risks”.
The Commission’s proposal for the review of REACH is expected by the end of 2022. Thus, the inclusion of the new essential use concept in REACH will not take place until 2023 at the earliest.
The Commission’s objective under the CSS is to ban all PFASs, unless the European Union deems their essential use. Thus, the future PFAS restriction could be the first application of the future concept of essential use of REACH, 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 shaping the PFAS restriction will handle this situation. In terms of timing, according to the Commission, the PFAS restriction on fire-fighting foams, scheduled for inclusion in Annex XVII of REACH in spring 2023, could serve as the basis for the broad restriction on PFAS that would occur one to two years later. As a reminder, the five Member States in charge of developing the PFAS restriction currently use a PFAS group definition which would encompass around 4,700 substances.