European Commission Update: The Future REACH Revision and PFAS Restriction
The REACH reform recently announced by the European Commission is expected to substantially change the current rules for REACH restrictions and authorizations.
The European Commission ("Commission") has 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 Inception Impact Assessment on the planned revision of REACH. This Inception Impact Assessment is currently subject to public consultation until June 1, 2021. Among others (e.g., revision of the information requirements for registrations, simplifying communication in the supply chains, 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 following policy options for Titles VII ("Authorization") and VIII ("Restrictions") of REACH.
Reach Restrictions. The options include: (i) expanding the so-called "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, immunotoxicants, neurotoxicants, respiratory sensitizers, and substances that affect specific organs; and (ii) extending the "generic risk approach" to products marketed for professional use (as opposed to only industrial and consumer use).
Reach Authorizations. The options include: (i) clarifying and simplifying the procedure, including for substances in small quantities and minor changes to granted authorizations; (ii) boosting incentives for substitution over time by giving more options to the Commission to set conditions and substitution pathways; (iii) allowing national authorizations (for smaller applications); (iv) financing cooperation projects between users of SVHCs and alternative providers; or (v) removing the authorization title under REACH or merging/integrating it with the restriction procedure. In relation to option (v), the Commission's intention would be to set a generic/default ban for substances, whereby 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 the authorization and restriction procedures, the REACH reform is expected to "operationalize" the new concept of so-called "Essential Use" (the potential new legal principle that a substance may be used only if its use is "essential for society and there are no alternatives"). In the Commission's view, the implementation of the Essential Use concept into REACH, and in particular its application to restrictions, can be facilitated by reducing and simplifying the requirements for derogations in future restrictions.
In addition, the Commission also intends to initiate a dedicated study on the Essential Use concept in the upcoming months, as well as on the policy options for authorization and on the application of the new "generic risk approach."
The Commission's proposal for revision of REACH is expected at the end of 2022. Thus, the inclusion of the new Essential Use concept into REACH will not happen before 2023 at the very earliest.
The objective of the Commission under the CSS is to ban all PFAS, unless the European Union deems their use essential. Thus, the future PFAS restriction may be the first application of the future REACH Essential Use concept, even though that new concept is as yet undefined 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 firefighting foams, planned for inclusion into Annex XVII REACH in spring 2023, could serve as the basis for the broad restriction on PFAS that would come one to two years later. As a reminder, the five Member States in charge of preparing the PFAS restriction currently employ a group definition of PFAS that would encompass approximately 4,700 substances.
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