EU restricts undecafluorohexanoic acid in cosmetic formulations

GLOBAL – The European Union has enforced new limits on PFHxA and related substances in cosmetics, effective October 10, 2026. 

Under the rules, cosmetics may not be placed on the EU market or used if they contain 25 parts per billion (ppb) or more of undecafluorohexanoic acid(PFHxA) and its salts combined, or 1,000 ppb or more of PFHxA-related substances combined.

Some may be identifiable from ingredient names containing “perfluorohexyl.” 

Cosmetics rarely list PFHxA as a primary ingredient; it can appear as an impurity or form when other intentionally added per- and polyfluoroalkyl substances (PFAS) degrade.

The restrictions are part of Commission Regulation (EU) 2024/2462, which amended Annex XVII of REACH, the EU’s chemicals registration, evaluation, authorisation and restriction framework. 

Adopted in September 2024, the regulation gave cosmetics companies a two-year transition period to adjust formulations and supply chains.

Cosmetics manufacturers must ensure that their products meet the new concentration limits. Because the thresholds are low, companies may need to test raw materials for trace contamination and check whether restricted substances were intentionally used. 

The limits apply to the cosmetic formula itself, for example, a cream or mascara, not to the combined weight of the product and its packaging.

Products placed on the EU market before October 10, 2026, are exempt from the restriction and can continue to be sold. 

This includes products already supplied to a retailer or distributor, as well as those already imported into the EU. 

Products still held by the manufacturer or not yet imported must comply with the new limits before entering the market.

The European Commission says PFHxA is highly persistent and mobile in water, and that certain uses pose an unacceptable risk to human health and the environment. 

Its mobility and persistence make it difficult to remove from drinking water, wastewater and contaminated sites, potentially contributing to prolonged human exposure. 

The Commission also says alternatives are available for the uses covered by the restriction and expects the resulting economic costs to be limited relative to the health and environmental benefits.

PFHxA has been used as a substitute for PFOA, another PFAS that is already banned. The Commission’s restriction targets uses for which alternatives are available. 

The European Chemicals Agency’s Committee for Risk Assessment has also concluded that PFHxA is likely to be absorbed through the skin, meaning cosmetics could represent an additional source of human exposure. 

Meanwhile, environmental groups have raised concerns about the enforcement of existing REACH requirements, citing continued PFAS pollution.

The PFHxA rules are separate from a proposed broader restriction on the PFAS group as a whole, which the European Chemicals Agency (ECHA) is assessing. 

In March 2026, ECHA’s scientific committees supported an EU-wide restriction, while recognizing that some uses may need exemptions where substitutes are not yet available.

For cosmetics, ECHA’s Committee for Socio-Economic Analysis said in its draft opinion that exemptions were not justified. 

The committee was expected to issue its final opinion by the end of 2026, after which the European Commission would prepare a proposal for member states to consider.

Some jurisdictions have already introduced broader rules. 

France’s national PFAS cosmetics ban took effect on January 1, making it the second European country after Denmark to adopt comprehensive national restrictions, according to the source article. 

In the United States, around 14 states have enacted restrictions on intentionally added PFAS in cosmetics.

At the federal level, however, the US Food and Drug Administration said in December 2025 that available evidence was insufficient to determine the safety of PFAS in cosmetics. 

Its report, required under the Modernization of Cosmetics Regulation Act of 2022, resulted in no federal ban or specific regulation prohibiting intentionally added PFAS in cosmetics. 

The FDA said toxicological data for most PFAS were incomplete or unavailable, leaving substantial uncertainty about consumer safety. 

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