EU Enforcement Reveals Compliance Gaps in Restricted Substances for Cosmetics

Non-Compliant Substances and Key Findings

The pilot project, involving 13 EU member states, inspected 486 cosmetic products, uncovering 285 non-compliant cases. The most frequently detected restricted substances were:

• Per- and polyfluoroalkyl substances (PFAS), including Perfluorodecalin and C9-C14 Perfluorocarboxylic Acids (PFCA).
• Cyclotetrasiloxane (D4), Cyclopentasiloxane (D5), and Cyclohexasiloxane (D6) – all under scrutiny for environmental and health risks.

The enforcement also exposed discrepancies between cosmetic ingredient names (INCI) and regulatory substance classifications, making compliance complex for manufacturers and retailers.

Regulatory Challenges and Industry Concerns

PFAS and Siloxanes: Complex Compliance Landscape

PFAS restrictions under REACH (Entry 68) and the POPs Regulation continue to create enforcement difficulties, as industry stakeholders struggle to match ingredient lists to regulatory substance identifiers. The lack of a definitive, publicly available restricted substances list was a key concern raised during the workshop.

For siloxanes (D4, D5, D6), compliance is hindered by ambiguities in the definition of "wash-off" vs "rinse-off" products. Under REACH, wash-off cosmetics containing these substances are restricted, yet under the EU Cosmetics Regulation, only D4 is explicitly banned. This misalignment has led to confusion among manufacturers and importers, increasing the risk of non-compliance.

SMEs and Importers Face Higher Risks

The enforcement data suggests that small and medium-sized enterprises (SMEs) and importers face the greatest compliance challenges. Many non-compliant products originated from third-country imports, with limited regulatory oversight before entering the EU market. Stakeholders called for better supplier verification processes and enhanced regulatory guidance to support compliance efforts.

Impact on the Chemicals Industry and Supply Chain

Regulatory Pressure on Cosmetics Manufacturers

The findings reinforce the need for stronger due diligence across the cosmetics value chain, affecting raw material suppliers, formulators, and distributors. Companies placing cosmetic products on the EU market must:

• Regularly review safety data sheets (SDS) and supply chain documentation.
• Ensure ingredient lists align with REACH and POPs restrictions.
• Monitor upcoming restrictions on D4, D5, and D6 to avoid regulatory penalties.

Potential Stricter Enforcement and Future Actions

Following the workshop discussions, ECHA recommended:

• Developing publicly accessible substance lists to aid compliance.
• Stronger collaboration between cosmetics regulators and REACH enforcement authorities.
• More targeted enforcement actions focusing on e-commerce and online marketplaces.

With increasing regulatory scrutiny on PFAS and siloxanes, further restrictions could impact chemical manufacturers, raw material suppliers, and end-product formulators, making compliance monitoring a business-critical priority.

Summary

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.