E.U., Canada Consider Broad PFAS Consumer Product Bans

Recent developments in the European Union and Canada could result in historically broad PFAS bans. The E.U.’s proposed REACH restriction (“REACH Proposal”) would ban all uses of PFAS, with very limited exceptions, effective 18 months after enactment. Canada has released a report in May 2023 previewing a similarly broad ban of PFAS in consumer products.

These international proposals highlight the need for consumer product manufacturers and retailers to proactively plan for PFAS compliance in the European and Canadian markets. U.S. PFAS regulations of products by and large remain a patchwork of state regulations,[1] but the timing of the U.S. bans is much later than the bans considered in the E.U. and Canada. As manufacturers and retailers plan their product design, inventory management, and compliance plans, they should factor in the shifting regulatory demands both domestically and internationally.

European Union – REACH Proposal

The E.U.’s chemical safety agency, the European Chemicals Agency (“ECHA”), is considering what would likely be the broadest ban on PFAS in the world. The REACH Proposal would be adopted under the Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH”),[2] a law that empowers the E.U. to restrict, limit, or ban the manufacture, sale, or use of a substance or group of substances, including a ban on the substance(s) in mixtures or articles. REACH restrictions may also provide specific use requirements or labeling requirements.

The REACH Proposal is currently under evaluation by two E.U. committees—the Risk Assessment Committee (“RAC”) and the Socio-Economic Analysis Committee (“SEAC”). The RAC evaluates the effectiveness of the proposed restriction including whether the restriction is targeted to the effects or exposures resulting in the risk, capable of reducing the risk in a reasonable time, and proportionate to the risk. The SEAC compares the net benefits to human health and the environment to the net costs to manufacturers, importers, distributors, and consumers. Each committee develops an opinion that is submitted to the European Commission based on their respective evaluation. The European Commission then reviews the opinion and drafts the language of the restriction. Subsequently, it sends the proposed law to the European Parliament and European Council for approval. If both bodies approve, the proposal becomes law.

Scope of REACH Proposal

If adopted, the REACH Proposal will become the broadest PFAS ban in the world. The REACH Proposal would ban over 10,000 types of PFAS for all but five sub-uses of PFAS (discussed further below).[3] It includes time-limited derogations—the REACH term for compliance deadline extension—for 78 sub-uses across 14 use sectors, which will provide industry up to 13.5 years to switch to chemical alternatives.[4]  The ban is designed to reduce PFAS emissions by 96% over 30 years.[5]

The REACH Proposal would ban “[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 limited exceptions. Certain fluorinated chemicals that meet this definition but are degradable under natural conditions are excluded from regulation.[6] Together, the broad definition and limited exceptions amount to coverage of nearly all PFAS.

The REACH Proposal also exempts PFAS below certain concentration thresholds. The REACH Proposal would exempt any PFAS on its own and any product below 25 ppb of any PFAS; a sum of PFAS of less than 250 ppb where individual PFAS analysis is possible; or a total of 50 ppm of total fluorine where individual PFAS analysis is not possible (such as with certain fluoropolymers). The 50 ppm total fluorine limit includes all fluorine in the constituent, mixture, or article, including fluorine that is not part of a PFAS—but to be enforced, at least some of the fluorine must come from PFAS.[7] The 50 ppm total fluorine threshold matches de minimis thresholds set in other jurisdictions, such as California.[8]

Timing of REACH Proposal

The REACH Proposal includes two timing options for implementation:

• Option 1 – a total ban on PFAS and PFAS use that would go into effect 18 months after approval;
• Option 2 – a total ban that goes into effect 18 months after approval with implementation delays for a limited set of uses; the E.U. member nations that spearheaded the REACH proposal recommended Option 2.[9]

The extensions of time to comply, known in this context as derogations, are complex and industry-specific in nature. Three specific uses would receive time-unlimited derogations: the use of PFAS in refrigerants in buildings where alternatives are prohibited by law, the use of PFAS in calibration of measurement instruments and as analytical reference materials, and the use of PFAS as active ingredients in Medicinal Products, Plant Protection Products, and Biocidal Products. Meanwhile, other uses would receive either 5-year or 12-year derogations.[10]

The E.U. is weighing the following factors in its derogation decisions:

• Whether alternatives already exist or whether there is sufficient evidence that alternatives are unavailable;
• Whether there is sufficient evidence that technically and economically feasible alternatives are in development or that alternatives exist but are not available in sufficient quantities and/or cannot be implemented in 18 months;
• Whether there is sufficient evidence that technically and economically feasible alternatives will not be available in the near future (i.e., additional research and development is needed) or certification or regulatory approval of PFAS-free alternatives cannot be achieved within a 5-year derogation period. [11]

Industry Derogations

Certain derogations are “proposed” while others are marked as “potential.” A proposed derogation means that there is sufficiently strong evidence that currently warrants derogation, but the derogation can be revoked if additional information shows that an alternative will be available sooner than expected.[12]

Potential derogation means that there is only weak evidence that does not warrant a derogation, but a derogation may be reconsidered based on additional evidence.

If a use is not specifically mentioned, the ban would apply 18 months after the REACH Proposal is entered by the Commission.

The table below provides a full picture of the proposed and potential derogations (with white cells being proposed, and yellow cells being potential):

Reporting requirements and management plans

The REACH Proposal will also require reporting and management plans to obtain information on the use of PFAS for derogated uses, and to ensure proper handling at end-of-life.

Reporting requirements will apply to manufacturers and importers of products with PFAS as an active substance, entities that use fluorinated gases and uses with a 12-year derogation period. [13]

Entities will be required to provide information on the use, including the identity and quantity of substance on the market and which use-category applicable to the article, mixture, or substance. The reporting period is 2 years for active substances, 1 year for use of fluorinated gases and other uses with a 12-year derogation period.

Manufacturers, importers, and downstream users of fluoropolymers will be required to develop management plans that: identify the substances used and the products they are used in, provide the justification for the use, describe the conditions of use, and identify safe disposal practices.[14]

Opportunities for Public Participation

Anyone can submit information that they consider relevant, including information on topics the RAC and SEAC have identified in specific information requests. ECHA encourages Use Sectors to submit joint comments. For example, comments may include whether a specific use should receive a derogation or whether Option 1 or Option 2 should be adopted. The comment period closes on September 25, 2023.[15]

Canada

Canada has currently only adopted limited PFAS regulations at the federal level. These regulations essentially mirror U.S. federal regulations adopted under the Toxic Substances Control Act. The regulations ban the manufacture, sale, and distribution of PFOA, PFOS, and long-chain perfluorocarboxylic acids (including salts and precursors thereof). Canada is currently weighing the removal of several exemptions for certain uses of these chemicals.

But Canada is poised to introduce a much broader ban on PFAS. On May 20, 2023, the Canada released the Draft State of Per- and Polyfluoroalkyl Substances (PFAS) Report[16] (“Draft PFAS Report”), which provides a qualitative assessment of the fate, sources, occurrence, and impacts of PFAS. The 118-page report concludes that PFAS cannot be practically regulated on an individual basis in a way that will meaningfully protect human health and the environment. Instead, the Draft PFAS Report concludes that a class-based approach to regulating PFAS is necessary and that authority exists under the Canadian Environmental Protection Act (“CEPA”) to regulate PFAS as a class.

The Draft PFAS Report proposes that PFAS as class “have or may have an immediate or long-term harmful effect on the environment or its biological diversity” and “constitute or may constitute a danger in Canada to human life or health” under CEPA paragraphs 64(a) and (c), respectively. If the Canadian Environmental Protection Agency makes this finding final, it would open the door to a total ban on PFAS as a class, similar to the REACH Proposal in the E.U.

There is no current timeline for a proposed ban in Canada. However, the comment period on the Draft PFAS Report ended in July and will be considered in the development of a final report which could be published as early as this year.

Conclusion

The last year has brought forth many changes in the PFAS regulatory environment worldwide. Those affected by these regulations should plan ahead because the E.U. bans may go into force regardless of whether manufacturers are prepared. Please contact Marten’s Products Team, including James Pollack, Victor Xu, and Jessica Ferrell, for assistance in navigating PFAS laws, green marketing issues, and other environmental compliance matters related to your products.