The European Union has published a draft amendment to Regulation (EC) No 1223/2009 on cosmetic products, introducing proposed updates to Annex II (List of Prohibited Substances), Annex III (List of Restricted Substances), and Annex V (List of Preservatives Allowed in Cosmetic Products). The public consultation period is open until 6 September 2026, and the Regulation is expected to be adopted during the last quarter of 2026, entering into force 20 days after its publication in the Official Journal of the European Union.
Purpose of the Amendment
The proposed amendment aims to update the EU Cosmetics Regulation in line with the latest classifications of carcinogenic, mutagenic, and toxic for reproduction (CMR) substances. Certain substances newly classified as CMR are proposed to be prohibited in cosmetic products, while the conditions of use for several existing cosmetic ingredients are being revised based on the latest scientific opinions issued by the Scientific Committee on Consumer Safety (SCCS).
Key Proposed Changes
The main amendments include:
- Updating Annex II by adding certain newly classified CMR substances to the list of prohibited ingredients.
- Revising Annex III by updating maximum concentration limits, product categories, and labelling requirements for specific substances.
- Updating the conditions of use for Benzyl Salicylate in accordance with the latest SCCS safety assessment.
- Revising the permitted use conditions for aluminium compounds across different cosmetic product categories.
- Updating the authorised conditions of use for the preservatives o-Phenylphenol and Sodium o-Phenylphenate.
- Clarifying and updating the existing provisions relating to mercury and mercury compounds.
What Does This Mean for the Cosmetics Industry?
Once adopted, the amendment will require cosmetic manufacturers, importers, and Responsible Persons to review their product portfolios to ensure compliance with the revised Annex II, III, and V requirements. Companies should assess the raw materials used in their formulations, identify ingredients affected by the proposed changes, plan reformulation activities where necessary, and update Cosmetic Product Safety Reports (CPSRs), Product Information Files (PIFs), and other technical documentation accordingly.
Although the proposal is still under review, companies are encouraged to assess its potential impact at an early stage and begin preparing for compliance to ensure a smooth transition once the amendment enters into force.