Tomorrow, on February 25, 2023, a ban on long-chain perfluorocarboxylic acids (PFCAs) goes into effect. This restriction prevents the placing on the market of products containing members of this subgroup of perfluoroalkyl substances (PFAS), or “forever chemicals,” albeit with a handful of transition periods for certain product applications. The same chemical subgroup is currently being considered for international restriction via the Stockholm Convention and is mentioned several times in the blanket PFAS restriction proposal published by the European Chemicals Agency (ECHA) earlier this month.
- Individual members of the perfluorocarboxylic acids subgroup containing chains of between nine and 14 carbon atoms (C9-C14 PFCAs) have been regulated in various ways by the European Union (EU) in recent years. For example, perfluorononan- 1-oic acid (PFNA) and nonadecafluorodecanoic acid (PFDA), containing nine and 10 carbon atoms, respectively, are current candidates for inclusion as substances of very high concern (SVHC) in the Reach Regulation (1907/2006/EC). They have also been assigned harmonized classifications in the CLP Regulation (1272/2008/EC) due to their potential to cause cancer and reproductive complications.
- In October 2017, Germany and Sweden jointly filed an Annex XV dossier with ECHA seeking restriction of manufacturing and placing on the market of C9-C14 PFCAs. Subsequently, both ECHA’s Risk Assessment Committee (RAC) and Socio-Economic Analysis Committee (SEAC) opined that a Union-wide restriction was the most appropriate avenue for mitigating an unacceptable level of risk stemming from this chemical group.
- Commission Regulation 1297/2021/EU introduces this ban on the placing on the market of linear and branched C9-C14 PFCAs. Specifically, the restriction is implemented through entry 68 of Annex XVII of the REACH Regulation.
- The threshold for restriction is 25 parts per billion (ppb) for the cumulative sum of C9-C14 PFCAs and their salts, and 260 ppb for their related substances. Any article or substance with a concentration exceeding these values is illegal to place on the European market.
- Much of the motivation for the restriction comes from the bloc’s desire to preempt the regrettable substitution of perfluorooctanoic acid (PFOA) with, chemically similar, PFCA. PFOA also represents a subgroup of PFAS and is currently restricted in the EU via the Persistent Organic Pollutants (POPs) Regulation 1021/2019/EU, which aligns the bloc with the Stockholm Convention. The EU is legislating proactively to make sure industry actors aren’t replacing PFOA with something every bit as hazardous.
- February 25, 2023, marks the end of the 18-month transition period granted to all stakeholders. However, there are a few product applications which have been afforded more time to comply.
- A few extra months are given for replacing C9-C14 PFCAs in repellant textiles used for workers’ safety as well as in polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) used in several medical and industrial applications. The transition period for these product applications ends on July 4, 2023.
- July 4, 2025 is the phase-in date for the restriction of PFCAs in a number of other product types.They include photolithography in semiconductor manufacturing, photographic coating in film, implantable medical devices, and fire-fighting foams used for reasons other than training or testing.
- Manufacturers of can coating for pressurized metered-dose inhalers and semiconductors used in spare or replacement parts benefit from the longest transition periods. The former category is not affected by this Commission Regulation until August 25, 2028. Semiconductors used in spare parts are not impacted until the end of the decade (December 31, 2030), although the regulation stipulates that this transition period is only for replacement parts in products placed on the market before December 31, 2023.
Other paths to regulation
- Canada has nominated long-chain PFCAs as a candidate for inclusion in the Stockholm Convention. A successful candidacy in this international agreement would automatically oblige member parties (185 countries + the European Union) to reduce or eliminate the use of PFCAs altogether, depending on which annex of the convention it is placed in. It is worth noting that a Stockholm Convention inclusion may have the potential to shorten the transition periods afforded. In other words, the EU may be obliged to transpose a PFCA entry in the Stockholm Convention to its own POPs Regulation with stricter transition periods than those included in this Commission Regulation. (For an in-depth analysis of the inclusion of PFHxS in the Stockholm Convention, please read AgencyIQ’s February 15 article here.)
- Documents from the 17th meeting of the Stockholm Convention’s Persistent Organic Pollutants Review Committee indicate the strength of PFCA’s candidacy. The Committee finds that PFCAs meet the convention’s qualification standards for persistence, bioaccumulation, potential for long-range environmental transport, and adverse effects.
- There is further potential for regulatory overlap with respect to PFCAs in the EU. Earlier this month, ECHA published the broadest PFAS restriction proposal yet, covering some 10,000 “forever chemicals.” A few of those 10,000 are C9-C14 PFCAs, including C9-C15 fluroalcohol phosphate, perfluorononyl demithicone, and ammonium C6-C16 perfluroalkylethyl phosphate. (For an in-depth analysis of this restriction proposal, please read AgencyIQ’s February 10 article here.)
Key Documents and Dates
- Commission Regulation (EU) 2021/1297 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards perfluorocarboxylic acids containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs), their salts and C9-C14 PFCA-related substances (August 4, 2021)