2023년 06월 19일, EU REACH 규정의 Annex XVII에서 운데카플루오로헥산산(PFHxA), 그 염 및 PFHxA 관련 물질을 제한하는 내용으로 TBT 통보문을 발표하였습니다.

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출처 : Chemlinked

Once the draft takes effect, the use of PFHxA, its salts and related substances will be prohibited in cosmetics, with a 24-month transitional period.

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 proposes to prohibit the use of Undecafluorohexanoic Acid (PFHxA), its salts, and related substances in various applications, including cosmetics. It is currently open for comment until August 18, 2023.¹

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 draft regulation.

Key Points in the Draft Regulation

1. Restricted and Excluded Substances

According to the draft, the proposed 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 restrictions:

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 carbons.

2. Prohibition Proposed 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 draft proposes 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 draft grants a 24-month transitional period. Moreover, the draft clarifies that the proposed prohibition will not apply to cosmetics put on the market 24 months prior to the regulation's entry into force.

Further Reading

• EU to Adopt 11 Changes to the Use Requirements for Cosmetic Ingredients
• EU to Amend the Use Requirements for 13 Nanomaterials in Cosmetics
• EU SCCS Releases the Preliminary Opinion on Benzyl Salicylate

Reference Links

[1] Draft Commission Regulation Amending Annex XVII to Regulation (EC) No 1907/2006 as Regards Undecafluorohexanoic Acid (PFHxA), Its Salts, and PFHxA-related Substance