European Proposal Would Restrict More Than 10,000 PFAS
Last week, the European Chemicals Agency (ECHA) published a dossier proposing new restrictions intended to significantly reduce releases of per- and polyfluoroalkyl substances (PFAS) into the environment.
ILMA members that export to the EU may be affected by the proposed PFAS restriction, even if their products do not intentionally contain PFAS. The issue will be discussed at the SHERA Committee’s meeting at ILMA Engage in Tucson, Arizona, on Thursday, April 20 at 2:00 p.m.
The chemicals industry already has criticized the dossier’s “one size fits all” treatment of thousands of PFAS as a single class and says that it is scientifically inaccurate and could undermine the use of PFAS in low-carbon energy technologies.
The proposed PFAS ban in the EU remains subject to a scientific review and a six-month public consultation period beginning in March 2023. It will take at least three to four years for the proposed restrictions to become effective.
Dossier Conclusions
The dossier concludes that the group of more than 10,000 PFAS substances used across many industries and consumer applications raise human health and environmental concerns, particularly because of their persistence in the environment, mobility and bioaccumulation in animals and plants, long-range transport potential, toxicological effects, and climate change potential. It sets forth multiple sources of entry into the environment, including manufacturing and chemical mixing processes, use of PFAS products by consumers, and industrial and consumer waste streams. It also estimates that the amount of PFAS introduced to the EU market without regulation will increase compared to a baseline scenario.
Proposed Restrictions
The dossier proposes a ban on the future manufacture, use, import and marketing of PFAS within the EU under either a “Plan A” or “Plan B” regulatory approach. Plan A would include a total ban on PFAS above threshold amounts after a limited, 18-month transition period. Plan B would include a similar ban and transition period, but would provide additional, time-limited exemptions or phase-ins (called “derogations”) for certain categories of PFAS use.
For comparison purposes with the U.S., either option above would utilize a single chemical definition of PFAS. This single-class approach differs from EPA and state regulatory efforts that define PFAS with finite lists of identified chemistries. The five nations that submitted the dossier contend that a unitary, open-ended definition will capture all of the more than 10,000 known and likely PFAS substances in existence, as well as prevent users from evading restrictions by simply transitioning to other nonrestricted and potentially problematic per- or polyfluorinated chemical substitutes, or by developing new PFAS chemistries.
Importantly for ILMA members, both Plan A and Plan B include mixtures and articles containing PFAS above a certain concentration. Further, both of the regulatory approaches are broad enough to include incidental or unintentional additions of PFAS into products.
Restriction Phase-In Periods
While Plan A does not distinguish any group or subset of PFAS users, some derogations could exist under Plan B. Time-limited derogations of either five or 12 years (after the end of the 18-month transition period) are proposed for groups of uses based on the strength of evidence that a ban would cause economic losses within the given sector. A small subset of PFAS (mainly in HVAC refrigerants required by safety or health standards) are essentially exempted from the ban. Additionally, certain PFAS uses are identified that have weak evidence supporting derogation and for which additional
information will need to be submitted.
Under Plan B, manufacturers and importers of products and mixtures that contain PFAS would be required to submit annual reports to ECHA, clarifying the basis of their derogations and identifying types and quantities of PFAS placed on the market in the previous year. Importers and downstream users of derogated substances would be required to prepare site-specific management plans detailing the identity of the PFAS substances and products they are used in.
Next Steps
The American Chemistry Council already has announced that it will challenge the EU proposal. As ILMA understands the REACH regulatory framework, there will be a lengthy, formal review of the dossier by ECHA before PFAS can be formally added to the REACH list of restricted substances and the proposed restriction becomes law.
Immediate next steps for the proposed restrictions:
- A review of the dossier by ECHA’s scientific committees for Risk Assessment and Socio-Economic Analysis, beginning next month.
- A six-month consultation period with the public, starting on March 22.
- ECHA’s online information session on April 5.
After the close of the six-month consultation period, ECHA’s committees will form opinions on which regulatory approach is most appropriate to reduce health and environmental risks and socio-economic impacts. Once these opinions are adopted, the proposed PFAS restriction would be subject to review by the European Commission and the EU member states, which will make a final decision regarding the inclusion of the restriction in REACH Annex XVII.
ILMA’s initial review of the dossier leads the Association to be concerned with the bluntness of the proposal and the lack of any scientific basis set forth in the dossier for distinguishing among PFAS in a way that reflects the significant variability in environmental and toxicological profiles of the substances.
ILMA members that export to the EU, depending on whether Plan A or Plan B is ultimately adopted, will be affected by the proposed PFAS restriction. Members are encouraged to review both the proposal itself along with Annexes A and B. Annex A reviews the many and varied uses of PFAS, some of which may be unfamiliar to ILMA members, while Annex B reviews hazards and risk. Please see: Registry of restriction intentions until outcome – ECHA (europa.eu) for links to the dossier itself and Annexes.