Overview
As industry continues to grapple with the possible implications of the proposed universal ban on all PFAS ("the Proposal"), a leaked draft scientific opinion creates additional cause for concern.
As part of the pending legal process, the European Chemicals Agency (ECHA) has to issue two opinions on the Proposal:
- One on the risk assessment part of the Proposal, by ECHA's Risk Assessment Committee (RAC), and
- One on the socio-economic assessment part of the Proposal, by ECHA's Socio-Economic Assessment Committee (SEAC).
An early draft of SEAC's draft opinion has been leaked in the press. Albeit not complete, the leaked draft already signals a somewhat different take to exemptions and derogations than the Proposal - bound to generate concern.
What does the leaked draft say?
The leaked version of the draft opinion, dated July 5 (the Draft Opinion) largely endorses the approach taken by the authors of the Proposal, but adds even more conservative and hazard-based factors in the decision-making process.
A first potentially consequential difference relates to the assessment of alternatives to the use of PFAS substances. While supporting the approach taken in the Proposal overall (derogations are only allowed if there are no, or no sufficiently developed alternatives), the Draft Opinion does not find it appropriate that the authors of the Proposal chose to use the absence of alternatives as the sole basis for whether or not a derogation from the ban would be justified. SEAC thus proposes its own assessment of the need for derogations for the different sub-sectors covered in the Proposal, adding to the assessment "the evaluation of associated emissions and socio-economic impacts."
This appears un-balanced with the basis for the ban in the first place. The ban is proposed without any assessment of emissions relevant to specific uses – it is a blanket ban, subject to time-limited derogations. Assessing the potential emissions of proposed derogated uses is disproportionate and should only be accepted if accompanied by an initial assessment of the emissions – and the imposition of a ban, per sector, only in those cases in which emissions are judged to pose an unacceptable risk.
Additionally, it must be examined whether SEAC actually has the competence to propose a different basis for derogations, especially one which appears to spread beyond a "mere" analysis of the socio-economic merits of the proposed derogations.
The Draft Opinion does not yet contain SEAC's conclusion for all sectors. The analysis for the "Food contact materials and packaging" section, however, already shows that applying this different assessment framework can lead to a different conclusion on the need for derogations. In the case of industrial food, drink and feed production, the Draft Opinion does not agree with the Proposal that a derogation should be granted to the whole sector. Applying the same approach to other sectors could lead to further reductions in the number/scope of derogations in the Proposal.
Another key cause for concern with the Draft Opinion is the conclusion on the exclusion of biocidal products, plant protection products and human and veterinary medicinal products from the scope of the Proposal. The Draft Opinion considers that this exclusion is "not fully justified and inconsistent", pointing among others to the volumes of substances used in some of those sectors and to the opinion that persistence would not be sufficiently taken into account under the regulatory regimes applicable to these products. This is bound to create not only surprise but also concern for these sectors, who have so far been treated differently under the Proposal and may now be faced with significant legal uncertainty regarding their fate under the Proposal and how this may interact with the regulatory instrument already applicable.
There is still time to (re-)act
The public consultation on Proposal is open until September 25, 2023. Sectors who risk seeing their position under the Proposal affected if the SEAC opinion is adopted in this form should seek this opportunity to make their views heard in this context, without waiting for the (more limited in scope) consultation on the SEAC draft opinion.
Steptoe has been supporting many companies and industry sectors in preparing and submitting their comments for the public consultation. Do not hesitate to get in touch with the authors for more information about the opinion, this process, confidentiality and legal support.
This alert was also published in World Food Regulation Review, Vol. 33, Number 4, September 2023, (subscription required) https://cloud.3dissue.com/170388/199109/233437/WFRR-Vol33nr04Sep2023/index.html.
