The European Commission has presented another proposal to amend the annexes of the Cosmetics Regulation 1223/2009 as part of the Omnibus programme, which proposes amendments to the annexes II, III, IV, V. The amendment implements the opinions of the SCCS Committee on the safety of cosmetic ingredients and also implements Delegated Regulation (EU) 2024/2564 on substances classified as CMR.
On 21 May 2025, the European Commission published a proposal for Omnibus VIII to Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. The amendment takes into account the latest opinions of the Scientific Committee on Consumer Safety (SCCS) on the safety of individual cosmetic ingredients and their concentration limits for use in different product types. In addition, the amendment implements substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) contained in Delegated Regulation (EU) 2024/2564.
The proposed changes include:
- Annex II – prohibition of the use of another 15 cosmetic ingredients.
- Annex III – restrictions on the use of silver (CAS: 7440-22-4) and hexyl salicylate (CAS: 6259-76-3).
- Annex IV – inclusion of silver powder (CAS: 7440-22-4) as a colouring agent, permitted for use only in lip and eye shadow products, with an appropriate concentration level of 0.2%.
- Annex V – update of the list of permitted preservatives.
The draft is a proposal, so it is not yet a binding legal act. However, the proposal assumes that the regulation will apply from 1 May 2026, which in practice means that cosmetic products that do not meet the requirements cannot be sold on the EU market.
Entrepreneurs can already prepare for the proposed changes and:
- Verify the composition of cosmetic products and their compliance with the proposed changes.
- Plan the modification of the composition and take into account the time for updating: the product tests, its documents, notification in the CPNP and the label.
- Plan to sell out by May 1, 2026 to minimize disposal of non-compliant products.
European Comission Drafts: https://docs.wto.org/dol2fe/Pages/FE_Search/ExportFile.aspx?id=315611&filename=2025/TBT/EEC/25_03493_01_e.pdf&Open=True
Ekotox website: https://ekotox.eu/cosmetics-2/
