On February 7, The European Chemical Agency (ECHA) proposed a ban on per- and poly-fluoroalkyl substances (PFAS) as part of the European Union’s Registration, Evaluation, Authorization, and Restriction of Chemicals (“REACH”) regulation. The ban, which would include about 10,000 PFAS substances, could greatly impact US companies that export virtually any product to the European Union (“EU”). These companies will need to examine whether their products contain PFAS before exporting products to the EU.
The proposed ban is the EU’s largest-ever chemicals prohibition. It is intended to achieve the EU’s goal of a non-toxic environment by 2050. ECHA proposes banning chemicals, mixtures, and articles with 25 parts per billion (ppb) or more of a particular PFAS or 250 ppb of a combination of PFAS. ECHA defined PFAS 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).” According to ECHA, this definition encompasses more than 10,000 PFAS. The proposal explains that this definition is aligned with the definition of PFAS published in 2021 by the OECD. Excluded from the scope of the proposed ban are PFAS substances that are fully degradable as they do not fulfill the underlying concern of high persistence. The ban would begin 18 months following the finalization of the restriction, which is anticipated for some time in 2025.
The initial regulation will include a variety of exemptions with phase-out periods of five or 12 years. Pesticides (referred to as biocides in the EU), along with human and veterinary medicines, would also be exempted from the restriction. PFAS used in specialized fire-fighting suppressants, called aqueous film-forming foam (AFFF), are also exempt as they are being phased out through a separate restriction.
The proposed regulation would supersede existing regulations that allow PFAS in products such as food packaging, pesticides (referred to as biocides in the EU), and human and veterinary medicines. PFAS used in firefighting suppressants (aqueous film-forming foam) used largely by airports, fire departments, and military bases, are being phased out through a separate restriction.
Affected businesses may need to evaluate thousands of products for the presence of PFAS, ranging from camping gear to mobile phones. The ban is likely to have a significant impact on any US company selling products in the EU.
ECHA will accept public comments on the proposal until September 2023. EU companies, working through their trade associations, are already commenting on the proposed ban suggesting a longer phase-out period of 32 months instead of the proposed 18 months and additional exemptions where alternatives are not yet available. The final restriction is expected in 2025.