[Updated] EU to Implement a Union-wide Ban on PFHxA in Cosmetics

Editor's note: This article was originally published on June 21, 2023, and was updated on September 20, 2024, as per the latest developments. The updated contents are marked in red below.

On June 19, 2023, the EU notified WTO of a draft regulation aiming at amending the Annex XVII to Regulation (EC) No 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). This draft proposed to prohibit the use of Undecafluorohexanoic Acid (PFHxA), its salts, and related substances in various applications, including cosmetics.¹ On September 20, 2024, EU published the finalized regulation titled Commission Regulation (EU) 2024/2462 in its Official Journal, which will come into effect on October 10, 2024.²

Reasons for Restricting the Use of PFHxA

PFHxAs are a subgroup of per- and polyfluoroalkyl substances (PFAS) that are known to be persistent in the environment. They are widely used in many sectors, including paper and cardboard for food contact materials, textiles, and fire-fighting foams. PFHxA, its salts and related substances have been used as replacements for the restricted perfluorinated substances, such as Perfluorooctanoic Acid (PFOA) and Perfluorocarboxylic Acids (PFCAs). However, these substances have demonstrated hazardous properties due to their high persistence and mobility, making them difficult to be eliminated from water. Their continued use can lead to accumulation in the environment, thus bring increased exposure for both the environment and humans.

To minimize PFHxA emissions, in December 2019, Germany submitted a dossier to the European Chemicals Agency (ECHA), proposing restrictions on PFHxA, its salts and related substances. In response to Germany's proposal, both the Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) offered opinions in June 2021 and December 2021, respectively. Based on Germany's proposal and the Committees' opinions, the European Commission has prepared this regulation. 

Key Points in the Regulation

1. Restricted and Excluded Substances

According to the regulation, the restriction applies to PFHxA, its salts and related substances that:

1. have a linear or branched perfluoropentyl group with the formula C₅F₁₁- directly attached to another carbon atom as one of the structural elements; or

2. have a linear or branched perfluorohexyl group with the formula C₆F₁₃-.

However, the following substances are excluded from the restriction:

1. C₆F₁₄;

2. C₆F₁₃-C(=O)OH, C₆F₁₃-C(=O)O-X' or C₆F₁₃-CF₂-X′ (where X′ = any group, including salts);

3. any substance having a perfluoroalkyl group C₆F₁₃- directly attached to an oxygen atom at one of the non-terminal carbon atoms.

2. Prohibition for Cosmetics

In its opinion, SEAC concluded that prohibiting the use of PFHxA, its salts and related substances in cosmetics was likely an appropriate measure to address associated risks, taking into account socio-economic benefits and costs. Accordingly, the regulation stipulates that these substances shall not be used in cosmetics in a concentration equal to or greater than 25 ppb for the sum of PFHxA and its salts, or 1,000 ppb for the sum of PFHxA-related substances, measured in homogeneous material.

To provide sufficient time for cosmetic stakeholders to comply with the prohibition, the regulation grants a 24-month transitional period until October 10, 2026. Additionally, it clarifies that the prohibition will not apply to cosmetics placed on the market before this date. 

Further Reading

• EU to Ban 21 CMR Substances in Cosmetics from September 2025

• EU Finalizes Amendments to Use Restrictions on D4, D5, D6 in Cosmetics

• Borderline Products in the EU: Cosmetic Products or Not?