New Prohibited Substances in EU Cosmetics
The European Commission has published a new draft amendment to Regulation (EC) 1223/2009 with the aim of strengthening EU cosmetics safety on the European market. This update is aligned with the CLP Regulation and introduces significant changes in the classification and permitted use of certain substances, placing consumer protection and industry competitiveness at the forefront.
The draft text focuses on tightening controls over ingredients classified as CMR (carcinogenic, mutagenic, or toxic to reproduction). As a result, several key substances will see a change in their regulatory status:
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Perboric acid and its salts → banned due to toxicological risk.
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Silver (micronised) → permitted only under safe-use conditions.
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Hexyl salicylate → subject to restricted use.
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O-phenylphenol and sodium salt → authorised as preservatives but under specific controls.
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Other CMR substances without justification → transferred to Annex II (prohibited).
This update pursues three main objectives: strengthening consumer safety, ensuring administrative simplification, and driving innovation and competitiveness in the European cosmetics sector. By providing clearer and more coherent rules, the Commission seeks to foster new investment in research and development.
When will the new cosmetic restrictions apply?
The expected date of application for these provisions is 1 May 2026. Cosmetic companies will therefore need to begin reformulating products, updating Product Information Files (PIF), managing existing stock, and ensuring compliance within the Cosmetic Product Notification Portal (CPNP).
This regulatory step follows the recent Omnibus Regulation VII (EU 2025/877), in force since June and applicable as of 1 September 2025, demonstrating the EU’s continued commitment to stricter and more demanding standards.
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You can find the complete updated Regulation following this link: CELEX