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ECHA Reports 6.4% Non-Compliance in EU Cosmetic Products for Restricted Chemicals

General
30
January 2025
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500
Dr Steven Brennan
Authorities issued 80% written advice, 6% orders, and escalated severe cosmetic non-compliance cases to prosecutors.
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The EU Forum Stakeholder Workshop on restricted substances in cosmetics revealed that 6.4% of inspected products were non-compliant, primarily due to PFAS and siloxane-related restrictions. Industry concerns include lack of clear guidance, enforcement inconsistencies, and difficulties in linking INCI names with regulatory substances. The findings highlight the need for improved due diligence and supplier verification, particularly for importers and SMEs, as EU authorities prepare for stricter enforcement actions.

How can cosmetics companies ensure compliance with REACH and the POPs Regulation?

To comply with REACH and POPs restrictions, cosmetics manufacturers should regularly review ingredient lists, ensure Safety Data Sheets (SDS) are up to date, and verify supplier compliance with EU regulations. Businesses should also monitor ECHA’s regulatory updates, particularly on PFAS and upcoming siloxane restrictions, to avoid enforcement penalties.

Why are PFAS and siloxanes (D4, D5, D6) a major regulatory focus in cosmetics?

PFAS and siloxanes (D4, D5, D6) have been linked to environmental persistence and potential health risks, leading to REACH and POPs restrictions. Enforcement actions target wash-off cosmetics, where these substances are banned. Compliance challenges arise due to differences in regulatory definitions, such as "wash-off" vs "rinse-off" classifications.

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The European Chemicals Agency (ECHA) reported a 6.4% non-compliance rate in European Economic Area (EEA) cosmetic products after a pilot enforcement project. The project, concluded in October 2024, focused on identifying non-compliant use of specific restricted chemicals under the Persistent Organic Pollutants (POPs) and REACH regulations, particularly in products containing per- and polyfluoroalkyl substances (PFAS), such as perfluorononyl dimethicone and cyclopentasiloxane (D5).

Widespread Inspections Across Member States

Between November 2023 and April 2024, the ECHA's Forum for Exchange of Information on Enforcement coordinated inspections across 13 member countries, including Germany, Italy, and Sweden. Inspectors reviewed 4,686 products, mostly cosmetics, with a focus on wash-off products containing restricted compounds. Non-compliant products accounted for 6.4% of the total, with infractions in 285 of 4,478 inspected cosmetic products.

Restricted Substances Identified in Cosmetics

The most common restricted substances found were:

  • Perfluorononyl dimethicone: Present in 151 non-compliant products, this PFAS substance is restricted under both the POPs and REACH regulations due to its persistence in the environment.
  • Cyclopentasiloxane (D5): Found in 111 non-compliant wash-off cosmetics, this substance is regulated under REACH due to environmental concerns.

Other identified substances included cyclotetrasiloxane (D4), cyclomethicone (a blend of D4, D5, and D6), and perfluorooctylethyl triethoxysilane, all flagged for their potential environmental and health impacts.

Enforcement Measures Taken

In response to non-compliance, enforcement authorities applied various measures. Written advice was the most common action, used in 80% of cases, while administrative orders were issued in 6% of cases. Although no fines were issued, some cases were escalated to public prosecutors, indicating the serious nature of the violations.

Challenges and Recommendations

The report highlighted several enforcement challenges, including difficulties in verifying the presence of restricted substances based on International Nomenclature of Cosmetic Ingredients (INCI) names. To address these issues, ECHA recommends:

  • For Companies: Increased diligence in verifying product ingredients and using precise substance identifiers to comply with POPs and REACH regulations.
  • For Consumers: Checking product ingredient labels for substances like perfluorononyl dimethicone and D5, which had the highest non-compliance rates.
  • For the European Commission: Expanding testing capabilities across member states and providing clearer guidance on structure-based restrictions to support enforcement.

Moving Forward

ECHA aims to address regulatory and enforcement gaps by developing new inspection practices and advancing collaboration across member states. A follow-up project on cosmetics containing PFAS and D4/D5/D6 substances may be launched to monitor ongoing compliance and further reduce the presence of restricted substances in consumer products across the EEA.

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