Overview
In Part 1 of our discussion regarding the European Chemicals Agency (ECHA) draft Proposal for restrictions on the use of per- and polyfluoroalkyl substances (PFAS) under the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, we discussed several matters of principle related to the structure and basis of the Proposal. Part 2 explores the provisions applicable to food contact materials and articles, and the importance of preparing for potential impacts on the food contact supply chain moving forward.
Scope and Exemptions
PFAS is defined under the Proposal as "any 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 presents two potential restriction options (ROs), each of which are deemed by ECHA to be “proportionate to the risk” presented by the continuing use of, and exposure to, PFAS:
(1) an immediate and complete prohibition on all manufacture, use, and marketing of PFAS and materials and articles containing PFAS (following an 18-month phase-out and transition period); or
(2) a complete prohibition, except for those specific uses that are the subject of an extension (“derogation”) ranging from five to 12 years, prior to phase-out.
ECHA is expected to open public consultation for comments on the Proposal from March 22, 2023 until September 22, 2023. Therefore, the earliest that any prohibition could potentially take effect under the Proposal – absent any administrative delay or legal challenge – would be no sooner than mid-2025. Derogations could further extend the imposition of prohibitions on PFAS in specific applications from 2030-2037.
Those derogations that currently appear in the Proposal for comment are based on combinations of quantitative and qualitative information collected and evaluated by ECHA from various sources, and focus primarily on the potential impact to human health and the environment, as well as the availability of alternatives to PFAS in those applications. Notably, certain applications are proposed to be excluded entirely (i.e., Plant Protection Products (PPP), Biocidal Products (BP), and human and veterinary Medicinal Products (MP)), as the EU separately regulates these products and their contents on a harmonized basis. Further, fully biodegradable PFAS chemistries, as specifically defined in the Proposal, are exempted from the scope of the regulation.
Under the Proposal, those materials containing PFAS above specified limits that are not subject to a derogation or an exemption shall no longer be manufactured, used, or placed on the market either individually, or as a component of another substance (as a constituent), a mixture, or an article, 18 months after the effective date. Applicable limitations include: (1) 25 parts per billion (ppb) for any individual PFAS substance; (2) 250 ppb for the sum of all individual PFAS in the substance; and (3) 50 parts per million (ppm) for polymeric PFAS.
Uses of PFAS in Food Contact Materials and Articles
The Proposal specifically addresses the use of PFAS in food contact materials and articles in various respects, including “industrial” and “professional” applications, as well as consumer applications. The draft Proposal currently suggests a time-limited derogation of 6.5 years for the following “industrial” applications:
- Components of drinking water treatment (i.e., piping and tubing)
- Filters used in food processing applications (i.e., steam filtration)
- Equipment (including belts, rollers, tanks, membranes, lubricants) and component of such equipment (including seals, gaskets, and expansion joints)
One significant potential existing application of PFAS in industrial food processing applications – the use of non-stick coatings in commercial bakeware – is “marked for reconsideration” following public comment and further consultation, thus indicating that ECHA does not yet have sufficient evidence to support the derogation (even though the agency believes that such a derogation may be warranted). Therefore, the burden to justify this derogation will largely fall to industry to further support in the months ahead.
Those remaining potential applications of PFAS in food contact applications, including the packaging of food and feed products, and the use of PFAS in most other consumer-facing food contact materials, are not currently the subject of a proposed derogation. Therefore, absent any decision to the contrary, applicable provisions of the regulation and related restrictions on the manufacture, use, or marketing of food contact materials containing PFAS would come into force 18 months after the effective date. Annex B, Section B.9.4 of the Proposal describes three significant known or historical uses of PFAS in food contact applications: (1) food packaging; (2) consumer and industrial cookware; and (3) industrial food and feed production equipment. Packaging applications are further described to include use of PFAS chemistries in the manufacture of paper and paperboard (e.g., as moisture, oil, and grease repellents), and to a lesser extent, to support technical functionalities in thermoplastic packaging, fluorinated high-density polyethylene (HDPE) materials and articles, and components of coatings for beverage cans, printing inks, and lacquers.
ECHA Identification and Evaluation of Alternatives
Annex E, Section E.2.3.4.1 discusses the factors used to conduct an alternatives assessment for potential alternatives to uses of PFAS, specifically referencing, among other factors, the presence or absence of known hazards of the alternative, potential exposure resulting from the intended use, technical performance, availability, and cost.
In terms of availability, ECHA cites the results of previous stakeholder consultations whereby 56% of respondents stated that they were actively working on identifying alternatives, as well as data from the Washington State Department of Ecology (US) stating that “readily available” alternatives in the form of both physical and chemical barriers already exist or are under active development to achieve the same or similar technical effect as PFAS chemistries in all of the most significant uses of PFAS in paper and paperboard applications (e.g., wraps and liners, bags and sleeves, dinnerware, and take-out containers). The term “readily available” under the Proposal is met when one of the following conditions is satisfied:
- “The percentage of PFAS-free alternative products in a specific food packaging application is above 50% and at least two manufacturers (or one large manufacturer), make a PFAS-free version of this alternative product; or
- The percentage of PFAS-free alternative products in a specific food packaging application is at or below 50% and at least three manufacturers (or one large manufacturer), make a PFAS-free version of this alternative product.”
As discussed further in the Annex, “[a]lternatives were considered cost comparable when data suggested the price of a PFAS-free alternative would not be more than 10% greater than the cost of a comparable PFAS-containing product.”
Limitations of Analysis and Potential Alternative Approaches
Despite the data evaluated by ECHA to support the proposed restrictions on the use of PFAS in food contact applications, the agency notes that extrapolation of information to full market – particularly with regard to the cost of implementing alternative chemistries – is “prone to substantial uncertainty, even for those elements where data are available.” During the forthcoming comment period, ECHA intends to take into consideration further information submitted by industry regarding the known or anticipated risks and hazards associated with PFAS use and disposal, as well as the presence or absence of readily available and cost-effective alternatives. To the extent that industry provides further evidence to demonstrate a rational basis for the addition or expansion of a derogation for a broader category of uses for PFAS in food contact applications, we expect ECHA to take such information into consideration.
One potential alternative approach to attempting to modify the scope and extent of the regulation with regard to the use or restriction of PFAS in food contact materials and articles may instead be to draw a parallel between those products that are exempted from regulation under this Proposal by virtue of separate, harmonized EU regulation elsewhere (e.g., Plant Protection Products, Biocidal Products, and human and veterinary Medicinal Products) and products that are similarly regulated on an EU-wide basis elsewhere, such as the use of food contact plastics under Regulation (EU) No. 10/2011. While food contact materials and articles such as paper and paperboard remain subject to national legislation, the regulation of food contact plastics at the EU level may provide an appropriate basis for the exemption from the need for separate and potentially redundant regulation by ECHA. Indeed, the European Food Safety Authority (EFSA) already has appropriate regulatory mechanisms in place to add, remove, or place appropriate limitations and restrictions on the use of certain materials (e.g., monomers and additives) in the manufacture of food contact plastics. For those substances regulated under the Plastics Regulation, the addition, removal, or modification of a listing continues to take into consideration internally recognized scientific risk-assessment principles, to which the same exposure and safety considerations described in this Proposal would apply. Regardless of the outcome, companies should continue to take appropriate steps to identify both intentional and unintentional sources of PFAS in food contact materials and articles throughout the supply chain and should expect further scrutiny of the same moving forward.
