Cosmetics

Amendments to the annexes to the Cosmetics Regulation

Amendments to the annexes to the Cosmetics Regulation

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:

  1. Annex II – prohibition of the use of another 15 cosmetic ingredients.
  2. Annex III – restrictions on the use of silver (CAS: 7440-22-4) and hexyl salicylate (CAS: 6259-76-3).
  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%.
  4. 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

https://docs.wto.org/dol2fe/Pages/FE_Search/ExportFile.aspx?id=315611&filename=2025/TBT/EEC/25_03493_00_e.pdf&Open=True
Ekotox website: https://ekotox.eu/cosmetics-2/

COSMETICS INGREDIENTS CHANGES

COSMETICS INGREDIENTS CHANGES

Cosmetics – changes in the cosmetics ingredients

On November 10, the European Commission published a new regulation amending the annexes to the Cosmetics Regulation. The change concerns:

– limitation Butylated Hydroxytoluene (BHT) to a maximum concentration of 0.001% in mouthwash, 0.1% toothpaste and 0.8% in other rinse-off and leave-on products

– limitation of Acid Yellow 3 to 0.5% in non-oxidative hair dye products

– limitation of Homosalate ingredient to 7.43% for face products

– Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and its nano form – maximum concentration up to 10% and limitation in inhalation exposure

This regulation shall enter into force on the twentieth day following its publication – 01.12.2022.

COMMISSION REGULATION (EU) 2022/2195
of 10 November 2022
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Butylated Hydroxytoluene, Acid Yellow 3, Homosalate and HAA299 in cosmetic products and correcting that Regulation as regards the use of Resorcinol in cosmetic products.

Ekotox cosmetic products webpages: https://ekotox.eu/cosmetics/