Derogation (EU PFAS Restriction)

A derogation is a time-limited exemption that permits the continued manufacture, placing on the market, or use of a restricted substance for specific applications where technically feasible alternatives are not yet available. In the EU’s universal PFAS restriction proposal under REACH Annex XVII, the dossier submitters have proposed multiple derogations for sectors including medical devices, semiconductors, defense, aerospace, and certain industrial applications. Derogation periods typically range from 5 to 13.5 years after the restriction enters into force.

REACH Annex XV Restriction Report (January 2023, updated August 2025); ECHA RAC/SEAC Opinions (March 2026); REACH Regulation (EC) No 1907/2006, Article 68.

Derogations are critical for industries that cannot immediately replace PFAS due to performance, safety, or technical requirements. However, derogations are not permanent—they expire on fixed dates, and companies must prepare transition plans. The SEAC draft opinion (March 2026) noted that full proportionality assessment was difficult due to incomplete industry data, making the current SEAC consultation (closing May 2026) the decisive moment for companies to submit socio-economic evidence supporting sector-specific derogations.

A medical device manufacturer using PTFE tubing in implantable devices may receive a 13.5-year derogation under the EU restriction proposal, allowing continued use while biocompatible alternatives are developed and clinically validated. The manufacturer must document why no alternative currently meets medical safety requirements.