On February 7, 2023, the European Chemicals Agency (ECHA) released a 211-page proposal regarding PFAS restrictions.1 The restrictions are being proposed pursuant to EU Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals ('REACH'), the European Union's main regulation governing chemicals that are placed on the market for use and distribution. If implemented without change, the restrictions would largely eliminate the production and use of per- and polyfluoroalkyl substances (PFAS) in Europe in most applications above certain very low levels. The proposal also would prohibit PFAS above those levels in substances and mixtures as well as in manufactured articles. The proposed restrictions are contained in a lengthy document spanning more than 200 pages and another set of annexes containing nearly 2,000 pages of supporting material. The restriction proposal was prepared based on a dossier submitted in January by authorities in Denmark, Germany, the Netherlands, Norway, and Sweden.
Various restrictions on a range of PFAS have been proposed in the past, but the current proposal is very broad in its potential application. Economic operators in the EU will be aware that certain PFAS substances are already restricted under the EU's Persistent Organic Pollutants (POPs) Regulation implementing the Stockholm Convention. Perfluorinated carboxylic acids (C9-14 PFCAs), their salts and precursors are being restricted in the EU/EEA from February 2023 onwards. Some PFAS have also been identified pursuant to REACH as Substances of Very High Concern (SVHC) based on their persistence, mobility and toxicity, and are subject to the regulatory consequences of the SVHC designation, e.g. restrictions on use and informational requirements. The results of the current regulatory process may overlap with existing restrictions or processes encouraging substitution under REACH and/or other legislation, and it will be interesting to see how this is ultimately managed. In the meantime economic operators should also ensure that they are aware of any EU regulatory limitations on their use of PFAS that are currently in place or likely to come into force sooner than the broad restrictions now proposed.
The newly proposed restrictions are themselves complicated and should be reviewed with care. While we will certainly be providing lengthier and more nuanced analyses at later dates, in the interim, this post identifies the five key points about the proposed restrictions that are important for readers to know immediately.
- The scope of substances subject to the proposed
restrictions is enormous. The proposal defines the scope
of substances affected based on a "structural definition.
Specifically, PFAS is "[a]ny substance that contains at least
one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon
atom (without any H/Cl/Br/I attached to it)," with certain
exceptions. This differs from other restrictions which are more
often chemical-specific in nature. The definition aligns with the
Organisation for Economic Co-operation and Development definition
for PFAS published in 2021.
ECHA reports the definition could include as many as 10,000 individual substances (however, it is not clear how many such substances are currently on the market in the EU). A few substances within the scope of the definition are more readily degradable, and would not qualify under REACH persistence standards; these are excluded from the restrictions proposed. Specifically, "a substance that only contains the following structural elements is excluded from the scope of the restriction: CF3-X or X-CF2-X', where X = -OR or -NRR' and X' = methyl (-CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C(O)-), -OR'', -SR'' or –NR''R'''; and where R/R'/R''/R''' is a hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(O)-)."
As currently proposed, the restrictions also will not apply to active substances in biocidal products (Regulation (EU) 528/2012), plant protection products (Regulation (EC) 1107/2009), or human and veterinary medicinal products (Regulation (EC) No 726/2004, Regulation (EU) 2019/6, and Directive 2001/83/EC), as these products/uses are addressed under separate EU regulations.
- The proposal sets concentration limits below which the presence of PFAS would not be restricted. ECHA's proposal will generally prohibit the manufacture, use, or placing on the market of PFAS on their own or in another substance, as a constituent, a mixture, or an article, in a concentration (1) at or above 25 parts per billion (ppb) for any PFAS as measured with targeted PFAS analysis (polymeric PFAS excluded from quantification); (2) 250 ppb for the sum of PFAS measured as the sum of targeted PFAS analysis (polymeric PFAS excluded from quantification); or (3) 50 ppm for PFAS (with polymeric PFAS included). The proposal discusses in greater detail how a polymeric material must qualify as being below this threshold limit.
- None of the proposed restrictions will occur
immediately. It is important to recognize the proposal is
just that; it is not a final restriction. While an outright ban was
the first of two restriction options that were apparently seriously
entertained, both the complete and immediate ban and the second
alternative proposal eventually published envisaged an 18-month
"transition" period. However, the restriction proposal
that ultimately emerged as the one to be considered for potential
adoption by the European Commission would phase in many of the
restrictions immediately following the initial 18-month transition
period or over the course of either 5- or 12- year
"derogation" periods for certain uses articulated in the
proposal. In the near term, before those timelines would become
established, there is an administrative procedure under REACH that
will be followed in the EU.
Commencing with the announcement and publication of the proposed restrictions, ECHA's scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will review the proposal to verify that it meets REACH's legal requirements. If it does, the committees will begin their respective evaluations of the proposal, and these reports are not likely to be completed until 2024. In the interim, ECHA will open a six-month consultation period planned to begin on March 22, 2023, and conclude September 22, 2023, if not extended. An online information session also will be held on April 5, 2023, to explain the restriction process and to help persons interested in participating in the consultation.
The RAC and SEAC ultimately will provide opinions on the restriction proposals, taking into account the comments received from the public consultations. These opinions, if supporting the proposal, eventually will be transmitted to the European Commission, which, together with the EU member countries, must make the final decision with respect to the proposed restrictions. Restrictions are enacted via amendments of Annex XVII to REACH.
At present, ECHA estimates that the European Commission would not take up formal consideration of the proposal until perhaps 2025, and if adopted, the restrictions could begin to come into effect in 2026 or 2027.
- Proposed derogations to provide time to move to
alternative chemistries. The proposed derogations are
based on ECHA's assessment that there are, or will be, suitable
alternatives available for each type of PFAS uses identified by the
end of the derogation period. Thus, some 5-year exemptions cover
PFAS in polymerization aids, certain refrigerants, and
fluoropolymers and perfluoropolyethers used in food contact
materials as needed for industrial and professional food and feed
production. Some 12-year exemptions include PFAS uses in textiles
used in personal protective equipment, other refrigerants,
diagnostic laboratory testing, certain lubricants, and implantable
Not all of the derogations are definitively supported in the information gathered by ECHA and included in the numerous annexes accompanying the proposed restrictions. ECHA advises that the various analyses provided by the countries submitting dossiers advocating for the restrictions also identified uses for which a derogation could be warranted, but for which the evidence base is considered to be "weak". These uses are between brackets in the ECHA Report on the proposed restrictions. The brackets denote which PFAS uses for which additional information will be needed and should be provided during the third-party consultation to substantiate and sustain the derogation. It is critical that stakeholders be aware that "only if substantial evidence is provided" will ECHA and the pertinent Committees assess whether a final derogation is warranted. The consultation process also provides an opportunity to advocate for derogations that may not have been considered and which should be provided for essential PFAS uses for which alternatives may not exist in the foreseeable future.
- The proposal ultimately must adhere to the legal standards of REACH. The procedures and requirements for proposing and adopting restrictions under REACH are generally intended to be risk-based, and are governed by Chapter 2 of the legislation covering the Restrictions Process. In particular, Article 68 provides that restrictions are to be undertaken when there is an identified "unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis." Consideration of risks (by definition) involve assessing both hazard and exposure. While the proposal presumes all PFAS within the scope of the structural definition are persistent and it further presumes the presence of PFAS in manufactured products, in humans, and in the environment will grow if not arrested, it is not clear whether there is a technical basis to conclude that all of the substances within the scope of the proposal are toxic and that human exposures and environmental releases are occurring at levels presenting a risk. Entities that are considering how to respond to the proposal should become actively engaged now in gathering competent evidence that is pertinent to both the hazard and exposure sides of the risk equation.
Conclusion: Importance of Engaging Through Consultation
The global nature and interrelationships of major market economies will ensure that ECHA's proposed restrictions will have a profound consequence across all sectors of the economy, well beyond the borders of the EU member states. ECHA has clarified that for the upcoming consultation process, all stakeholders may comment on the proposal. Typically, ECHA anticipates that commenters are likely to include companies, organizations representing industry or civil society, individuals, as well as public authorities from within and beyond the EU. Potentially affected businesses and trade organizations should carefully review all features of the restrictions and critically assess the derogations. Particular attention must be paid to determining: (a) what ongoing PFAS uses are not identified (as those which are not mentioned will nevertheless be considered within scope of the restrictions); (b) the adequacy of the derogations as well as the time periods provided; and (c) the availability of technical feasible chemical alternatives (to the extent such non-PFAS alternatives can be identified), as well as the timelines required for testing, qualification, necessary certifications and deployment of such alternatives. Substantive, data-driven submissions are more likely to be considered seriously by ECHA personnel than merely rhetorical statements of concern.
1. See ECHA, Annex XV Restriction Report: Proposal for a Restriction (Feb. 7, 2023); Press Release, ECHA, ECHA Publishes PFAS Restriction Proposal (Feb. 7, 2023).
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.