Overview
Today, the European Chemicals Agency (ECHA) published the proposal for EU REACH restrictions for the largest group of chemically-related substances ever considered, per- and polyfluoroalkyl substances (PFAS). The Agency is expected to open the public consultation for comments on March 22, 2023 until September 22, 2023.
The Steptoe team will issue a series of client alerts and contributions related to this most important proposal. This first note raises several matters of principle related to the structure and basis of the proposal. Our next analysis will examine the merits of the proposed exemptions, and what steps can be taken during the soon-to-be-opened consultation.
At the outset, we note that any proposal for restrictions must meet the test set out in the currently applicable version of the REACH Regulation. The changes to REACH announced in the Chemicals Strategy for Sustainability (such as the concept of essential use or the extension of the generic approach to risk assessment), have not yet been implemented into law. Authorities must thus show that the proposal meets the current rules for any restriction proposal, as they are clearly laid out in Article 68 of the REACH Regulation: it must be established that the manufacture, placing on the market or use of a substance "poses a risk to human health or the environment that is not adequately controlled and needs to be addressed" (emphasis added). These are the terms under which the proposed PFAS restriction must be tested.
Stakeholders will peruse the proposal and its details over the next months, and discussions may well focus on the particular assessments for product groups, or sectors, and corresponding exemptions. The fundamentals should not be forgotten.
The immediate next steps in the process require the ECHA committees RAC and SEAC (Risk Assessment Committee and Socio-Economic Assessment Committee) to provide opinions to the European Commission ("Commission"). Although the legal responsibility for the final restriction rests with the Commission (for example, in case of a legal challenge), the ECHA committees are also bound by the rules of the REACH Regulation and general principles of EU law.
Any and all comments submitted to the ECHA committees during the public consultation must be comprehensive and plead for the committees to conduct their assessment under the current relevant legal provisions.
Scope of the proposed restriction
The proposal would apply to the manufacture, placing on the market and the use of PFASs as such but also as constituents in other substances, in mixtures and in articles above a certain concentration. PFASs are defined as "any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it)." This is presented as taking into account the 2021 OECD definition of PFASs. It is also noteworthy that the scope is defined in such a way as to cover substances not currently on the EU market, including "theoretical" PFASs.
Several subgroups of PFASs that are fully degradable subgroups (described by key structural elements) are excluded from this scope. The reasoning for this exclusion is that these subgroups do not meet the high persistence test, which is the concern underlying this large group proposal, confirming that the scope of the restriction proposal is concern-based.
In addition, there are a number of proposed derogations, which – with the exception of a few cases – are all time-limited. The few cases in which derogations are not time-limited are cases where PFASs are already regulated under other EU regimes: PFASs used as active substances in plant protection products, in biocidal products and in human and veterinary medicinal products.
For other uses, the exemptions are limited in scope and in time. Only fluoropolymers and perfluoropolyethers are allowed for use in food contact materials for the purpose of industrial and professional food and feed production; in implantable medical devices (not including meshes, wound treatment products, tubes and catheters), in tubes and catheters in medical devices, in coatings of Metered Dose Inhalers (MDIs); in proton-exchange membrane (PEM) fuel cells and as fluoropolymer applications in petroleum and mining industry.
The proposal also leaves the door open for reconsideration of potential derogations after the public consultation, such as hard chrome plating and foam blowing agents. This should encourage those sectors to contribute to the public consultation starting in March, while other sectors should also make their views heard where further derogations should be granted.
Risk assessment in the light of Article 68 of the REACH Regulation
Article 68 of the REACH Regulation requires authorities to demonstrate an unacceptable risk, which requires consideration of hazard and exposure. Whilst the proposal recognizes and acknowledges the differences in properties and in exposure for different (groups of) PFASs, these differences do not result in a different assessment of the level of risk and the need for the risk to be controlled.
"Poses a risk to human health or the environment"
The restriction proposal presents significant challenges in this respect, from a legal perspective. The substances in scope of the proposal are presented as being "very persistent" and presenting "concerns associated with their persistent nature", combined with a variety of alleged properties. However, none of these considerations are recognized under EU legislation as a "hazard" (high potential for ubiquitous, increasing and irreversible exposures of the environment and humans, difficulty to decontaminate intake water for drinking water production, low effectiveness of end-of-pipe risk management measures and difficulty to treat contaminated sites, high potential for human exposure via food and drinking water, potential for intergenerational effects and delay of effects, potential for causing serious effects although those would not be observed in standard tests, estimation of future exposure levels and safe concentration limits is highly uncertain, global warming potential).
While these may be legitimate to discuss from a political perspective, the Commission's mandate under the current rules of Article 68 of the REACH Regulation is clear: the substances must "pose a risk to human health or the environment." This requires, first and foremost, a demonstration of hazard. The current proposal does not appear to be within the limits of the Commission's mandate.
Risk "is not adequately controlled and must be addressed"
The second part of demonstrating risk – i.e. use and exposure considerations – takes a similar approach. The proposed restriction does not seek or allege to examine the specific uses of PFASs and determine whether the risk is "not adequately controlled and must be addressed" for specific uses.
Rather, it appears to be based on a (pre-)determination that this is never the case, and any exception is examined under the premise that it is time-limited depending on the availability of alternatives (an examination of the availability of technically and economically feasible alternatives). Here again, the current proposal does not appear to be within the limits of the Commission's mandate.
Stay tuned for our next analysis where we will examine further the merits of the proposed exemptions.
This alert was also published in World Food Regulation Review, Vo. 22, Number 9, February 2023, (subscription required) https://cloud.3dissue.com/170388/199109/233437/WFRR-Vol32nr09-Feb2023/index.html.
