Perfluorooctanoic acid (PFOA) has been included in the European Union (EU) Persistent Organic Pollutants (POPs) Recast Regulation, effective as of July 4.
The European Commission’s draft delegated directive limits the use of:
- Perfluorooctanoic acid or any of its salts equal to or below 0.025 mg/kg (0.0000025 percent by weight) where they are present in substances, mixtures, or articles, and apply to concentrations of any individual PFOA-related compound.
- Combinations of PFOA-related compounds equal to or below 1 mg/kg (0,0001 percent by weight) where they are present in substances, mixtures, or articles.
This regulation will supersede the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation entry that restricted the use of PFOA above 25 ppb or 1,000 ppb of one or a combination of PFOA-related substances starting July 4 (with some exemptions that allowed for future restriction dates and types of products). The Stockholm Convention also restricts the use of PFOA (with some exclusions), starting in January 2021.
Perfluorooctanoic Acid to Be Removed From REACH Annex XVII
Due to different exclusions and expiry dates, PFOA will be removed entirely from the REACH Regulation Annex XVII, and covered by EU POPs instead. This means that some shortened expiry dates exist, and some exclusions, such as photolithography or etch processes in semiconductor manufacturing, now have an expiration date of July 4, 2025.
Companies with PFOAs in products will need to understand relevant changes to exclusions under the POPs and REACH regulations, as some Annex XVII exclusions do not exist in POPs.
For example, under the REACH Regulation, medical devices other than implantable medical devices within the scope of Directive 93/42/EEC had an exemption until July 4, 2032. Under POPs, the exemption is only effective until July 4, 2025.
Some of the products that may be impacted include:
- Photographic coatings applied to films.
- Textiles with oil and water repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety.
- Those made for specific fire-fighting purposes.
Assent helps companies manage their requirements under global product compliance regulations, and stay up to date with changes. To learn more about Assent’s supply chain data management solution, contact our experts.