PFHxA Is Now Capped at 25 ppb in EU Cosmetics. The Limit Counts What You Never Added.
On 10 October 2026, the two-year transition in Commission Regulation (EU) 2024/2462 came to an end. Since that date, cosmetic products containing PFHxA, its salts or PFHxA-related substances above the set thresholds can no longer be placed on the EU market, or used, in the EU. The restriction sits in a new entry 79 of Annex XVII of REACH (Regulation (EC) No 1907/2006), not in the Cosmetics Regulation. That is exactly why many indie brands missed it: it will not appear as a new line in Annex II or III, CosIng will not flag it, and your CPNP notification will go through as usual.
The thresholds are strict: 25 ppb for the sum of PFHxA and its salts, and 1,000 ppb for the sum of PFHxA-related substances, measured in homogeneous material. This is not a ban on a named ingredient. It is a concentration limit set so low (25 ppb is 0.0000025%) that it reaches impurities, residues and breakdown products, not only what appears on your INCI list.
What exactly is restricted
PFHxA (undecafluorohexanoic acid) is a short-chain perfluorinated carboxylic acid. Entry 79 defines its scope by structure: substances with a linear or branched perfluoropentyl group (C5F11–) directly attached to another carbon atom, or with a perfluorohexyl group (C6F13–), are in scope, with a short list of exclusions. "PFHxA-related substances" are those that, based on their molecular structure, are considered able to degrade or transform into PFHxA (paragraph 9).
In cosmetics, that points mainly to fluorinated ingredients built on C6 chemistry, such as fluorotelomer-based surface treatments on pigments and powders, or fluorinated film formers used for long wear and water resistance. INCI names containing "perfluorohexyl" are the obvious flag, but not the only one. Note what is excluded: perfluorohexane itself (C6F14) falls outside this entry's definition. That does not protect it from the wider PFAS restriction discussed below.
Three features of the text deserve a careful read:
It applies to "cosmetic products as defined in Article 2(1), point (a), of Regulation (EC) No 1223/2009": every category, rinse-off and leave-on alike.
It covers placing on the market and use: formulating above the thresholds in an EU facility is caught, not only selling.
Products placed on the market before 10 October 2026 are exempt (paragraph 7), but "placed on the market" is assessed unit by unit, not product line by product line.
Why a chemicals regulation reaches your cosmetic
Most brands assume ingredient rules for cosmetics come only from Regulation (EC) No 1223/2009. REACH partly supports that intuition: under Article 67(2), Annex XVII restrictions do not apply to cosmetic products "with regard to restrictions addressing the risks to human health" within the scope of cosmetics legislation (the text still refers to Directive 76/768/EEC, now replaced by Regulation (EC) No 1223/2009). Human-health risks are the Cosmetics Regulation's job, through the SCCS and the Annexes.
Environmental risks are not. When a substance is a problem because of what happens after use (it persists in water, soil and wastewater), REACH can restrict it in cosmetics directly. PFHxA is restricted because it is very persistent and highly mobile in water. The same logic sits behind earlier REACH restrictions that reached cosmetics: the cyclosiloxanes D4, D5 and D6 (entry 70) and intentionally added microplastics (Regulation (EU) 2023/2055, entry 78). The durable takeaway: a compliance review that only checks the Cosmetics Regulation Annexes is incomplete.
What it means in practice
Who is responsible. A REACH restriction binds every actor placing the product on the EU market (manufacturer, importer, distributor), not only the Responsible Person named under Article 4 of the Cosmetics Regulation. In practice the brand and its RP carry the documentation burden, and a retailer's compliance team can ask you to prove it.
How to prove it. Recital 7 of Regulation (EU) 2024/2462 acknowledges that standardised analytical methods still need to be developed, even though methods are commercially available. At 25 ppb, the realistic proof of compliance is a documentation chain: supplier declarations specific to entry 79 (not a generic "PFAS-free" letter), raw-material composition data, and targeted analysis where a risk is identified.
What happens to stock. Units already supplied to a distributor or retailer, or already imported, before 10 October 2026 can be sold through. Units still in your own warehouse on that date, or not yet imported, are outside the exemption and must meet the limits.
Three mistakes we are already seeing
"We don't add PFAS, so this doesn't concern us." The thresholds apply to the sum present in the product, whatever the source. Fluorinated pigment treatments and raw-material residues are the usual route in.
"Our safety assessor signed the CPSR, so we're covered." The CPSR under Annex I is a human-health assessment under the Cosmetics Regulation. An environment-driven REACH restriction is a separate compliance question, and many CPSRs do not address it unless asked.
"Everything we produced before October is exempt." Only units placed on the market (supplied for distribution) before 10 October 2026 are exempt. Finished goods that never left your warehouse are not.
PFHxA is the first step, not the last
The bigger file is ECHA's universal PFAS restriction, which covers more than 10,000 substances, fluoropolymers such as PTFE included. The restriction proposal sets limits of 25 ppb for any individual PFAS, 250 ppb for the sum of PFAS and 50 ppm for total PFAS including polymers. RAC adopted its opinion in March 2026. SEAC's draft opinion, open for consultation until 25 May 2026, concluded that no derogation is justified for PFAS uses in cosmetic products. Its final opinion is expected by the end of 2026; the Commission will then draft an Annex XVII amendment for a vote in the REACH Committee.
France has already moved: Law No 2025-188 of 27 February 2025 prohibits the manufacture, import, export and placing on the market of cosmetics containing PFAS from 1 January 2026, with residual thresholds set by Decree No 2025-1376 of 28 December 2025 that mirror the EU proposal: 25 ppb for any individual PFAS, 250 ppb for the sum, and 50 ppm for PFAS including polymers. Products manufactured before 1 January 2026 could be sold or exported for a maximum of twelve months, so that sell-through window closes at the end of 2026. The practical consequence for reformulation is clear: replacing a C6 ingredient with another fluorinated one may only buy you a year or two. Reformulate toward non-fluorinated alternatives, and you only do it once.
A practical checklist
Screen every INCI list for fluorinated ingredients: "perfluoro", "polyperfluoro", "fluoro" and PTFE.
Ask pigment, powder and treated-filler suppliers for entry-79-specific declarations, with thresholds stated in ppb.
Map your stock as of 10 October 2026: placed on the market versus still in your warehouse.
Add REACH Annex XVII to your PIF compliance checks, alongside Annexes II to VI of the Cosmetics Regulation.
Plan reformulation against the universal PFAS proposal, not just PFHxA.
Selling in France? Check your range against Law No 2025-188 and its decree.
Not sure whether a pigment treatment or a long-wear base in your range falls under entry 79? Cláritas Regulatory can review your formulas and supplier documentation against REACH Annex XVII and the upcoming universal PFAS restriction, before a retailer or an authority asks. Get in touch.
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