On February 7, the EU Chemical Agency (“ECHA”) issued the plan – known as the “Universal Restriction Proposal” – that would ban the use of PFAS in many of the most common applications (such as clothing, food packaging, cookware, and cosmetics) within 18 months of enactment. For products where PFAS-free alternatives are known but not widely available (e.g., technical textiles for medical applications, industrial food and feed production, hard chrome plating), a five-year phase-in ban would apply. For products where alternatives are currently unknown (e.g., professional protective apparel, certain specialty textiles, laboratory refrigerants), the ban would be phased-in over 12 years. The ban would apply to imports as well as domestically-produced goods.

The proposed ban would apply to nearly 10,000 different PFAS chemical formulations, with few exceptions, and is intended to cover the vast majority of PFAS uses. The chemical scope of the restriction proposal is broadly defined 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 – which was crafted by Germany and the Netherlands with support from Norway, Sweden and Denmark, after the countries compiled a “dossier” reflecting several years of research – recommends that the chemicals be restricted under the EU’s Registration, Evaluation, Authorisation and Restriction of Chemicals (“REACH”) regulation.

“This proposal is actually the broadest restriction proposal that has ever been prepared and submitted.”

- Frauke Averbeck, German Federal Institute of Occupational Safety and Health, February 7

Following release of the proposal, ECHA’s two scientific subdivisions, the Risk Assessment Committee (“RAC”) and the Socio-Economic Analysis Committee (“SEAC”), will now conduct their own scientific evaluation. This process usually takes about a year, but, given the complexity of the matter, some experts anticipate an even longer review period.

A six month public comment process (“open consultation” period in EU parlance) is scheduled to start on March 22. During this process, interested parties can submit comment on the proposed restrictions to ECHA, as well as provide information on the availability of PFAS-free alternatives or lack thereof. An online information session will be held April 5.

Once ECHA reviews the committees’ scientific evaluations and stakeholder comments, the agency will finalize recommendations to submit to the European Commission, which, together with the EU Member States, will then vote on the potential restriction. The proposal is expected to be issued as a final rule sometime in 2025, potentially going into effect in 2026 or 2027.

The proposed restrictions will have global ramifications. In addition to EU-based product manufacturers and end-users, imported products also are covered by the ban. Such a broad ban will necessitate careful supply chain communication and oversight to ensure that product components and raw materials do not contain banned PFAS. Such supply chain management can be particularly challenging given the widespread historical use of PFAS and their presence as impurities or residuals in a wide variety of recycled materials and other raw materials. Further, demand for PFAS-free alternatives is likely to become intense and lead to potential shortages of needed production inputs.

While the ban is not likely to come into force for several years, companies are advised to start planning now to evaluate the presence of PFAS in their products and throughout their supply chain, as well as to develop and secure PFAS-free alternatives.

The regulation specifies acceptable de minimis levels for the 33 substances, ranging from as low as 1 mg/kg to 3,000 mg/kg. Amounts above these levels, whether present intentionally or as an impurity, would be prohibited.

The restrictions do not apply to (a) products made exclusively of natural leather, fur or hide; (b) non-textile fasteners and non-textile decorative attachments; (c) second-hand clothing or other products; (d) carpets, rugs, and other textile floor coverings; or (e) medical devices or personal protective equipment, as well as disposable (i.e., single or limited use) textiles.

While a two year phase-in is provided to allow for manufacturers to conform to the new restrictions, a number of companies reportedly already have reformulated away from the listed substances and adopted (supposedly) less hazardous alternatives or are on track to do so.

The full text of the new EU regulation can be found here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2018.256.01.0001.01.ENG&toc=OJ:L:2018:256:TOC.