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On October 30, 2024, the European Chemicals Agency (ECHA) published findings from the Pilot Project Report on: Enforcement of Restrictions of PFCAs and Related Substances Focusing on Cosmetics, revealing that 285 cosmetic products were found to contain hazardous substances.1
Led by ECHA, the pilot project ran from November 2023 to April 2024. It aimed to examine the enforcement of substance restrictions under both the Regulation (EC) No 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation), and Regulation (EU) 2019/1021 on Persistent Organic Pollutants (POPs Regulation). In the project, authorities from 13 countries of the European Economic Area (EEA) conducted inspections on 4,686 products selected through a risk-based approach, including 4,475 cosmetic items and 208 other products, such as detergents and cleaning agents.
Inspections mainly focused on reviewing ingredient labels on the products or their respective websites. Among the inspected products, 285 products were found non-compliant, all in the cosmetics category, resulting in an 6.1% overall non-compliance rate and 6.4% specifically for cosmetics. Six restricted substances were identified in the non-compliant cosmetics, with perfluorononyl dimethicone and cyclopentasiloxane (D5) being the most frequently detected. Details of these substances, including associated risks and regulatory requirements, are summarized in the table below.
Substance | Non-compliant Products Count | Risks | Restrictions for Cosmetic Use |
Perfluorononyl dimethicone | 151 | These substances are persistent in the environment, toxicto reproduction, and suspected of causing cancer. | Under the REACH Regulation: Effective on February 25, 2023, the sum of C9-C14 perfluorocarboxylic acids (PFCAs) and their salts in mixtures shall not exceed 25 ppb; the sum of C9-C14 PFCA-related substances in mixtures shall not exceed 260 ppb.
Under the POPs Regulation: Effective on July 4, 2020, perfluorooctanoic acid (PFOA) or any of its salts in mixtures shall not exceed 0.025 mg/kg; any individual PFOA-related compound, or a combination of PFOA-related compounds in mixtures shall not exceed 1 mg/kg. |
Perfluorooctylethyl triethoxysilane | 5 | ||
Perfluorononylethyl carboxydecyl PEG-10 dimethicone | 4 | ||
Cyclopentasiloxane (D5) | 111 | These substances are known for their persistence, bioaccumulation, and potential toxicity. They are known to pose environmental risks, particularly to aquatic life, and raised concerns about endocrine disruption in humans. | Under the REACH Regulation: 1) Effective on January 31, 2020, the respective concentration of D4 and D5 in rinse-off cosmetics shall not exceed 0.1%; 2) Effective on June 6, 2027, the respective concentration of D4 and D5 in leave-on cosmetics, as well as the concentration of cyclohexasiloxane (D6) in both rinse-off and leave-on cosmetics, shall not exceed 0.1%. |
Cyclomethicone* | 12 | ||
Cyclotetrasiloxane (D4) | 11 | ||
* Cyclomethicone: a blend of D4, D5 and D6. | |||
In light of the findings, the project report outlines recommendations to stakeholders involved in the implementation of the legislation related to this project. Notably, it emphasizes that actors in the cosmetics industry should comply with not only the Regulation (EC) No 1223/2009 (Cosmetics Regulation), but also POPs and REACH Regulations. Additionally, close monitoring of regulatory changes regarding per- and polyfluoroalkyl substances (PFAS) and D4/D5/D6 is advised.
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