In the EU, functional barrier polymers are subject to multiple overlapping regulatory frameworks depending on product category. For food contact packaging, a ban on PFAS under the Packaging and Packaging Waste Regulation entered into force on 11 February 2025. Separately, REACH Annex XVII Entry #68 imposes a group restriction on certain PFAS, and an Annex XV dossier proposes broader PFAS restrictions. For fluoropolymers specifically, proposed C9-C14 PFCA limits are 2000 ppb (for 36 months after entry into force) and 400 ppb thereafter, while a PFHxA proposal sets 25 ppb for PFHxA and salts or 1000 ppb for related substances in polymers. No non-EU market data is available.
1 regulation
jurisdiction: EU; framework: Packaging and Packaging Waste Regulation; REACH (as referenced); Annex XV restriction dossier for PFAS; listing_status: ban in food contact packaging under Packaging and Packaging Waste Regulation (entered into force 11 February 2025); annex_or_entry: Annex XV dossier proposing restrictions on PFAS; related to food contact materials and packaging; EU Regulation banning PFAS in food contact packaging
Key conditions include concentration limits for PFAS impurities in fluoropolymers: 2000 ppb for C9-C14 PFCAs in fluoropolymers with perfluoroalkoxy groups (until 36 months after entry into force) and 400 ppb thereafter. For PFHxA, proposed limits are 25 ppb for the sum of PFHxA and its salts or 1000 ppb for related substances in a polymer/structural element, and 500 ppm for low molecular weight substances in fluoropolymers. The food contact packaging ban under the Packaging and Packaging Waste Regulation is a categorical prohibition, not a concentration-based limit. These thresholds directly determine formulation choices and compliance testing requirements.
Before launch, a product containing functional barrier polymers should have documented evidence of compliance with the EU food contact packaging PFAS ban (effective 11 February 2025) and with REACH Annex XVII Entry #68 restrictions. For fluoropolymers, analytical data demonstrating concentrations below the applicable C9-C14 PFCA limits (2000 ppb or 400 ppb) and PFHxA-related limits (25 ppb/1000 ppb or 500 ppm) would be necessary. Given the proposed nature of some restrictions, monitoring regulatory developments and preparing for potential additional documentation is prudent. No specific documentation format is specified in the evidence.
The regulatory position is incomplete for a final decision because several key restrictions are still proposals or subject to derogations. The C9-C14 PFCA limits (2000 ppb/400 ppb) are tied to a restriction proposal and POP Regulation derogations, not final adopted text. The PFHxA limits (25 ppb/1000 ppb, 500 ppm) are from an Annex XV proposal. The food contact packaging ban is in force, but its scope relative to functional barrier polymers as a class is not fully defined. These uncertainties mean compliance assessments must be revisited as final regulations are adopted.
The most material recent change is the EU ban on PFAS in food contact packaging under the Packaging and Packaging Waste Regulation, which entered into force on 11 February 2025. This is a categorical ban, not a concentration-based limit, and directly affects any functional barrier polymer used in food contact. Additionally, the REACH Annex XVII Entry #68 group restriction (August 2021) is already in force. Proposed changes include the C9-C14 PFCA restriction with derogations and the PFHxA Annex XV restriction, both of which could impose new concentration limits on fluoropolymers. These effective dates and proposals should drive compliance timelines.