ECHA Publishes Proposal to Restrict More Than 10,000 PFAS under REACH
On February 7, 2023, the European Chemicals Agency (ECHA) announced the availability of a much anticipated detailed proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden (dossier submitters) submitted the proposal after finding risks in the manufacture, placement on the market, and use of PFAS that are not, in their view, adequately controlled and need to be addressed throughout the European Union (EU) and the European Economic Area (EEA). The proposal suggests two restriction options — a full ban and a ban with use-specific derogations — to address the identified risks.
According to the restriction proposal, the main concern for all PFAS and/or their degradation products that are within the scope of the proposal “is the very high persistence, exceeding the criterion for very persistent (vP) according to Annex XIII of the REACH Regulation by far.” The restriction proposal states that PFAS and their degradation products may persist in the environment “longer than any other man-made chemical.” Further supporting concerns are their bioaccumulation, mobility, long range transport potential (LRTP), accumulation in plants, global warming potential, and (eco)toxicological effects. According to the proposal, PFAS enter the environment via emissions during manufacture, the use phase, and the waste stage.
The chemical scope of the restriction proposal is defined as “[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).” The proposal notes that this definition is aligned with the Organization for Economic Cooperation and Development (OECD) definition of PFAS that was published in 2021, “and that has been scrutinized by the international scientific community and is widely accepted.” According to the proposal, this definition encompasses more than 10,000 PFAS, “including a few fully degradable PFAS subgroups.” Because these fully degradable subgroups do not fulfil the underlying concern of high persistence, the dossier submitters excluded them from the scope of their restriction proposal.
Main Restriction Options Assessed
The restriction proposal analyzes various risk management options and concludes that a REACH restriction is the preferred risk management option. The restriction proposal states that the proposed restriction should avoid releases of PFAS to the environment as much as possible. The proposal notes that since PFAS are chemically very stable, it is important to consider releases during all stages of the life cycle, including the waste stage. According to the restriction proposal, the best option to avoid PFAS emissions to the environment during manufacture, production, and use of PFAS-containing articles and at the waste stage is to prohibit the manufacture and use of PFAS to the largest extent possible. The restriction proposal analyzes the proportionality of a full ban (Restriction Option 1 (RO1)) of all PFAS. The national authorities suggest that RO1 enter into force after a transition period of 18 months. The restriction proposal compares RO1 to Restriction Option 2 (RO2), a ban of all PFAS except, in most cases, time-limited defined use-specific derogations of either a duration of five or 12 years after the end of the transition period. The duration of the transition period and derogations are summarized below:
|Restriction Option||Transition Period before Restriction Option Takes Effect||Duration of Derogation|
|RO1: Full ban||18 months||Not applicable|
|RO2: Ban with use-specific derogations||18 months||Five years after transition period ends|
|12 years after transition period ends|
|Time-unlimited (only for specific uses)|
Under RO2, two types of time-limited derogations are considered. The first one is for a five-year derogation that is proposed when sufficiently strong evidence is available that:
- Points to the non-existence of technically and economically feasible alternatives on the market at the entry-into-force (EiF) date but where possible alternatives to the PFAS use have already been identified that are still in the development phase, however; or
- Known alternatives are not available in sufficient quantities on the market at the EiF date or known alternatives cannot be implemented before the transition period ends.
The 12-year derogation is proposed when sufficiently strong evidence is available that:
- Points to the non-existence of technically and economically feasible alternatives on the market at the EiF date, e.g., research and development (R&D) efforts did not identify possible PFAS-free alternatives so that it is likely that they will not become available in the near future; or
- Certification or regulatory approval of PFAS-free alternatives cannot be achieved within a five-year derogation period.
According to the restriction proposal, the dossier submitters “consider these time periods normally sufficient for industry to take benefit from technical progress and to carry out scientific R&D activities to find and deploy technically and economically feasible alternatives.” The proposal acknowledges that for some specific uses, there may be reasons of a practical nature where time-unlimited derogations could be necessary. At submission of the restriction proposal, the dossier submitters consider such time-unlimited derogations justified for: use of PFAS in refrigerants in heating, ventilation, air conditioning, and refrigeration (HVACR) equipment in buildings where national safety standards and building codes prohibit the use of alternatives; use of PFAS in calibration of measurement instruments and as analytical reference materials (because this is necessary for the targeted analysis of PFAS in the monitoring of these substances in various matrices); and use of PFAS as active ingredients (but not as co-formulants) in plant protection products, biocidal products, and human and veterinary medicinal products.
Table 8 includes a detailed summary of alternatives and cost impacts for PFAS manufacture and major PFAS use sectors resulting from a full ban (RO1). Table 9 includes a summary of derogations (“proposed” or “for reconsideration”) for PFAS manufacture and major PFAS use sectors, with substantiation for the derogation period (five or 12 years) and with cost impacts for the five- and 12-year derogation periods.
The restriction proposal states that the dossier submitters “consider that RO1 could be proportionate in the medium and long-term due to the expected progressively increasing amounts of PFASs that would be emitted without a ban (under the baseline scenario).” According to the proposal, societal costs associated with a continued use of PFAS will likely progressively increase as well “and eventually outweigh the societal costs of the restriction option RO1.” The dossier submitters “consider RO2 the most appropriate RO balancing the trade-offs between short term (costs of the PFASs restriction) and long term (societal costs of continued PFASs use) impacts.” According to the restriction proposal, while RO2 is expected to have a lower total emission reduction, it will cause less severe economic impacts to society in the short-term compared to RO1. Furthermore, specific use sectors will have time to adjust their production processes and products towards a replacement of PFAS. The restriction proposal notes that “this delay of a full ban of PFASs will shift the cost burden arising from health and environmental impacts to future generations,” however.
ECHA’s Scientific Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) will check that the proposed restriction meets the legal requirements of REACH in their March 2023 meetings. If it does, RAC and SEAC will begin their scientific evaluation of the proposal. ECHA plans to begin a six-month consultation on March 22, 2023. ECHA states in its February 7, 2023, press release that it will hold an online information session on April 5, 2023, to explain the restriction process and help those interested in participating in the consultation.
ECHA notes that the opinions of RAC and SEAC are typically ready within 12 months of the start of the scientific evaluation, in accordance with REACH. In view of the complexity of the proposal and the extent of information that is expected from the consultation, however, RAC and SEAC “may need more time to finalise their opinions.” Once the opinions are adopted, they will be sent to the European Commission (EC), who together with the EU member states, will then decide on a potential restriction.
The highly anticipated proposed restriction is a lot to take in. There is understandable concern among EU stakeholders with the sheer scope of the proposal which by some counts (and there are many) exceed 10,000 PFAS. Their commercial ubiquity and the complexity of the supply chains in the industry sectors where they likely are found confound greatly a clear understanding of the financial impact of the proposal. Others in the EU and elsewhere, including in the United States, are concerned with the bluntness of the proposal and the lack of any scientific basis in it for distinguishing among PFAS in a way that reflects the significant variability in environmental and toxicological profiles of PFAS. This enormous category of chemicals is being regulated on a definitional basis as opposed to a critical examination of their unique properties and functionalities.
Stakeholders will wish to monitor carefully the information session noted above and the consultation process. The EU’s approach to PFAS regulation and restriction will be influential globally.