The European Commission (“Commission”) has 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 a Initial impact assessment on the planned revision 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 control national application), the stated objectives of the Commission for the reform of REACH also include the following policy options for Titles VII (“Authorization”) and VIII (“Restrictions”) of REACH.
Access restrictions. Options include: (i) extending the ‘generic approach to risk’ (i.e. the assumption 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) the extension of the âgeneric risk approachâ to products marketed for professional use (as opposed to only industrial and general public use).
Achieve permissions. The options include: (i) clarification and simplification of 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 define the conditions and pathways for substitution; (iii) authorize national authorizations (for small applications); (iv) financing of cooperation projects between SVHC users and alternative service providers; or (v) remove the title of the authorization under REACH or merge / integrate it into the restriction procedure. Regarding option (v), the intention of the Commission would be to establish a generic / default ban for substances, whereby exemptions would be proposed not only by the authorities but also by industry, which in turn would then have the burden of proof.
For both 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 the society and there is no alternative “). 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 the requirements for exemptions in future restrictions.
In addition, the Commission also intends to launch a dedicated 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 to risk “.
The Commission’s proposal for a revision of REACH is expected at 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.
The Commission’s objective under the CSS is to ban all PFASs, unless the European Union deems their use essential. Thus, the future PFAS restriction could be the first application of the future REACH Essential Use concept, even if this new concept has not yet been 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 PFAS restriction on fire-fighting foams, the inclusion of which in Annex XVII of REACH in spring 2023, could serve as the basis for the general restriction on PFAS which would occur one to two years later. As a reminder, the five Member States in charge of preparing the PFAS restriction currently use a group definition of PFAS which would encompass approximately 4,700 substances.