,"European Comission Delegated Regulation amends Regulation (EU) 2019/1021 to incorporate long-chain perfluorocarboxylic acids (C9-21 PFCAs), their salts, and related compounds into Annex I, Part A, following their listing in Annex A of the Stockholm Convention at the 12th Conference of the Parties (28 April to 9 May 2025 in Geneva). The regulation prohibits or restricts their manufacture, placing on the market, and use to protect human health and the environment from these persistent organic pollutants (POPs), aligning with EU commitments under the Convention and the Protocol on Long-Range Transboundary Air Pollution. A subgroup (C9-14 PFCAs) was already restricted under REACH Annex XVII entry 68, with exemptions like can coatings for inhalers now expired or unnecessary, except for semiconductors in spare parts for pre-2023 electronic equipment in vessels and vehicles until 31 December 2030.
- Unintentional trace contaminant (UTC) limits match REACH: ≤0.025 mg/kg (0.0000025% by weight) for C9-21 PFCAs and salts; ≤0.26 mg/kg (0.000026%) for related compounds in substances, mixtures, or articles. Derogations include ≤10 mg/kg for transported intermediates under strict REACH conditions (Article 18(4)); ≤0.1 mg/kg in fluoroplastics/fluoroelastomers with perfluoroalkoxy groups (emissions to be minimized); and ≤1 mg/kg in polytetrafluoroethylene micropowders treated to reduce PFCAs below 0.025 mg/kg. The Annex defines C9-21 PFCAs as CnF(2n+1)COOH (n=8-20), salts, and degradable compounds with CnF(2n+1) moieties, listing specific CAS/EC numbers (e.g., 375-95-1, 335-76-2).
- Prior consultations involved Member State experts (POPs CA group), stakeholders (industry, civil society), and public feedback via the EU portal (open until 19 December 2025, midnight Brussels time). The act enters force 20 days post-publication in the Official Journal, directly applicable across Member States. This reflects Council Decision (EU) 2025/868 supporting the Convention listing with exemptions."
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