Chemicals PFAS restriction proposal

On Monday 23^rd April 2024, the Commission published its long-awaited Communication on the essential use criterion, titled "Guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals". This non-binding document illustrates the core principles of the essential use concept and how it should be used and applied into sector-specific legislation on chemicals. 

In brief, the 'essential use' criterion will help accelerating the phase-out of the uses of the most harmful substance that are 'non-essential', while allowing uses still 'essential'. Also, specific conditions for 'essential uses' will be set to ensure that emissions and exposure of humans and the environment that are minimized for a certain period of time.

However, it is not yet clear how the introduction of this concept in EU law will influence the upcoming PFAS restriction proposal, in particular whether derogations will be granted on the basis of the 'essentiality test'.

Context

The Commission already in 2020, in its Communication on the Chemical Strategy for Sustainability ('CSS'), announced its intention to " ‘[…] define criteria for essential uses to ensure that the most harmful chemicals are only allowed if their use is necessary for health, safety or is critical for the functioning of society and if there are no alternatives that are acceptable from the standpoint of environment and health. These criteria will guide the application of essential uses in all relevant EU legislation for both generic and specific risk assessments’ (p. 10). In particular, the Commission committed to "ban all PFAS as a group in fire-fighting foams as well as in other uses, allowing their use only where they are essential for society" (p.14), anticipating the introduction of a derogation for essential PFAS in the upcoming PFAS restriction.

On 13 January 2023, the competent authorities of Germany, Sweden, the Netherlands, Denmark and Norway ("the Dossier Submitters") formally submitted to the European Chemicals Agency ("ECHA") an "Annex XV Restriction Report Proposal for a restriction for per- and polyfluoroalkyl substances (PFAS)" and its Annexes ("the Proposal") aimed at restricting a wide range of PFAS under Regulation (EC) No 1907/2006 ("REACH"). This Proposal is now being assessed by the ECHA's Committee for Socio-Economic Analysis ("SEAC") and Committee for Risk Assessment ("RAC"), who are delivering their opinions, respectively, on the socio-economic and health/environmental risks aspects pursuant to Articles 70 and 71 REACH.

At this juncture, the Proposal does not incorporate the essentiality criterion yet. The details of this criterion were merely outlined in the Commission Communication dated 23 April 2024 and do not carry legally binding force. Currently, stakeholders are contemplating whether the essentiality test will be introduced in the upcoming restriction on PFAS. Understanding this point would be crucial not only for reasons of predictability and legal certainty but also from a practical standpoint. In fact, it will allow to determine whether certain uses of PFAS should be considered essential, potentially granting a derogations.

The 'essentiality test' under the Commission Communication

According to the Commission Communication, the aim of this concept is to increase the protection by accelerating the phase-out of the uses of the most harmful substance that are non-essential.

A most harmful substance is deemed 'essential' only if the following two cumulative criteria are met:

1. That use is necessary for health or safety or is critical for the functioning of society, and
2. There are no acceptable alternatives.

The Communication further details how to conduct the analysis on these two points by providing examples of what should be deemed 'necessary for health or safety' or 'critical for the functioning of society'.

Possible impact on the upcoming PFAS restriction proposal

This Communication seems to anticipate a shift of the focus from assessing 'risk' to evaluating 'hazard' and from prioritizing 'safety' to emphasizing 'essentiality'. Indeed, the most harmful chemicals are identified not because of their risks from human health/environment but because of one or more hazardous properties, while the acceptability of their use is not contingent upon the ability to ‘contain’ their risks, but rather, on their essentiality for health/safety or their critical role in society.

As regards the implementation into sector-specific legislation, in particular in the context of the PFAS restriction Proposal, the Commission has already clarified in its Q&As that "the concept is not part of the REACH regulation, and hence not of current initiatives like the PFAS restriction".

However, given the lengthy procedure that will lead to the adoption of the PFS restriction with the amendment of Annex XVII of the REACH Regulation, i.e. the Annex listing all restricted substances, by introducing a new entry for PFAS and the commitments already undertaken by the Commission in the CSS, there are reasons to believe that this concept should be first embedded in REACH and in the upcoming Proposal.

If so, careful consideration should be first given to the peculiarities of the REACH Regulation, also in light its upcoming revision.

In that regard, the introduction of the concept will have to conciliate with other REACH rules such as the assessment of alternatives. In that respect, the Communication states that "needs and unique aspects of applicable sector-specific legislation" (p.2) will apply, especially in relation to the assessment of alternatives. Since the assessment of alternatives is conducted by the ECHA committees under REACH, it is possible that these committees will have to perform an assessment of the essential use criterion, based on the information provided by the company applying for the related derogation.

However, it is still yet not clear how this concept will be applied in practice. Is possible that certain applications, although deemed ‘useful,’ may not meet the criteria of essentiality. Notably certain fluoropolymers' applications, although considered crucial, may not pass the essentiality test.

Therefore, more clarity should be provided by the Commission to ensure efficiency and predictability for the industry, as the incorporation of this concept into the Proposal may lead to 'essential' derogations for certain uses of PFAS.