A Major Shift in EU Cosmetic Compliance

As of 10 October 2026, the European Union’s strict restriction on perfluorohexanoic acid (PFHxA), its salts, and PFHxA-related substances in cosmetics is officially active. Enacted under Commission Regulation (EU) 2024/2462 as Entry 79 of Annex XVII to the REACH Regulation (EC) No 1907/2006, this regulatory milestone significantly impacts European beauty brands utilizing short-chain fluorinated chemistry in long-wear, transfer-proof, and water-resistant formulations.

Cosmetic brands, manufacturers, and importers placing new products on the EU market must now ensure full compliance with strict trace-level concentration thresholds (25 ppb for PFHxA/salts and 1,000 ppb for related substances), though inventory lawfully placed on the market prior to 10 October 2026 is exempt and may be sold through. If your beauty products rely on PFHxA, its salts, or related C6 fluorinated substances for water resistance, long-lasting wear, or smooth application, understanding these enforceable limits and immediate audit steps is vital.

What is PFHxA and Why Was It Used in Cosmetics?

PFHxA (undecafluorohexanoic acid) is a specific compound belonging to the broader family of per- and polyfluoroalkyl substances (PFAS), widely known as “forever chemicals”.

In cosmetic formulations, certain PFHxA-related precursor substances (such as 6:2 fluorotelomer compounds, fluorinated polymers, and surface-treated pigments) were historically incorporated for their hydrophobic (water-repellent) and lipophobic (oil-repellent) properties, while PFHxA and its salts themselves typically occur as unintentional impurities or breakdown residuals. These fluorinated chemistries (which can degrade into or contain trace PFHxA and related substances) provided key functional benefits in specific product categories:

• Long-wear Foundations & Concealers: Coated pigments to resist sweat and sebum, ensuring even coverage.
• Waterproof Mascaras & Eyeliners: Acted as durable film formers to prevent smudging.
• Lipsticks & Lip Stains: Improved barrier properties against saliva and oils for transfer resistance.
• Specialty Skincare & Shaving Products: Reduced surface tension to provide smooth slip and glide.
• Specialty Nail Coatings: Aided leveling and moisture resistance.

However, because PFHxA is extremely persistent and highly mobile in water, its resistance to degradation and potential to irreversibly contaminate groundwater and drinking water supplies drove significant environmental and regulatory concerns.

Understanding REACH Annex XVII Entry 79: Limits & Deadlines

Published on 20 September 2024, Commission Regulation (EU) 2024/2462 established Entry 79 under REACH Annex XVII to address risks posed by PFHxA and its related precursors.

Key Concentration Thresholds for Cosmetics

Effective 10 October 2026, cosmetic products placed on the EU market or used must:

• maintain concentrations strictly below 25 parts per billion (ppb) (0.025 mg/kg) for the sum of PFHxA and its salts,
• strictly below 1,000 ppb (1 mg/kg) for the sum of PFHxA-related substances, measured in homogeneous material.

Scope and Sectoral Timelines

The 10 October 2026 deadline applies directly to:

• Cosmetic products (as defined under Regulation (EC) No 1223/2009).
• Textiles, leather, furs, and hides in clothing and related accessories, as well as footwear, for the general public (note: other consumer textiles, such as upholstery and carpets, are deferred to 10 October 2027).
• Paper and cardboard used as food contact materials within the scope of Regulation (EC) No 1935/2004.
• Chemical mixtures for the general public.

Note on Stock Exemption: Mixtures and articles that were lawfully placed on the EU market prior to 10 October 2026 are grandfathered and exempt from immediate withdrawal, allowing existing stock to be sold through.

Why the EU Banned PFHxA: Health & Environmental Impact

PFHxA was frequently introduced as a functional substitute for perfluorooctanoic acid (PFOA), an earlier-generation PFAS chemical that was previously banned. However, scientific evaluations by the European Chemicals Agency (ECHA) demonstrated that while PFHxA is far less bioaccumulative and biologically toxic than PFOA, it poses severe and irreversible environmental risks due to its extreme environmental persistence and mobility in aquatic systems.

• Environmental Persistence & Mobility: PFHxA does not degrade naturally and spreads rapidly in groundwater, surface water, and soil systems.
• Human Exposure & Toxicity Concerns: While PFHxA is eliminated by the human body far more quickly than legacy PFAS and does not meet REACH bioaccumulation criteria, ongoing consumption of contaminated drinking water and food can lead to continuous internal exposure; high-dose animal studies indicate potential liver and developmental effects, though it lacks the classified carcinogenicity of legacy C8 compounds.

Recognizing these uncontrolled environmental risks to drinking water and ecosystems, the European Commission enacted a targeted Union-wide restriction prohibiting PFHxA in consumer goods—including cosmetics, apparel, and food contact paper—while maintaining derogations for critical industrial uses.

Immediate Compliance Steps for Cosmetic Brands

Now that the 10 October 2026 deadline is in effect, beauty brands manufacturing or importing into the EU must ensure all new batches placed on the market comply with REACH Entry 79, while confirming that any remaining non-compliant stock was legally placed on the market prior to the cutoff.

1. Conduct Raw Material & Supply Chain Audits: Obtain specific PFAS/PFHxA supplier declarations and certificates of analysis (CoAs), as standard Safety Data Sheets (SDSs) do not disclose impurities at parts-per-billion (ppb) thresholds.
2. Perform High-Precision Analytical Testing: Screen raw materials and finished formulas using accredited LC-MS/MS or GC-MS/MS testing methods capable of detecting trace concentrations down to ppb thresholds.
3. Execute Reformulation Strategies: Replace fluorinated film-formers, fluorinated surface-treated pigments, and fluorosilicones with compliant alternatives, such as non-fluorinated silicones, bio-based polymers, natural waxes, or synthetic film-forming esters.
4. Update Regulatory Documentation: Update the Product Information File (PIF) with supplier compliance certificates and analytical test reports demonstrating compliance with REACH Annex XVII Entry 79, and ensure the CPSR reflects any formula adjustments or altered raw material specifications.