What’s new?
On 8 July 2025, the European Commission published an Omnibus Proposal (COM(2025)531) proposing significant amendments to Regulation (EC) No 1223/2009 on cosmetic products, alongside modifications to the CLP Regulation.
This reform initiative directly responds to industry concerns raised during a “Reality Check” stakeholder consultation in May 2025, where representatives identified key regulatory challenges affecting over 70% of cosmetic formulations.
The proposal addresses the perceived rigidity of current regulatory interpretation, particularly concerning the classification of natural substances as CMR materials (carcinogenic, mutagenic, or reprotoxic), burdensome nanomaterial pre-notification procedures, and complex derogation processes under Article 15. The amendments represent the Commission’s commitment to regulatory simplification without compromising consumer safety standards.
Key proposed amendments
New Article 14a
- Introduction of structured procedure for requesting inclusion of new substances as colorants, preservatives, or UV filters in relevant Annexes
- Clear procedural framework for applicants seeking regulatory approval of innovative cosmetic ingredients
Change of Article 15
- CMR bans to apply only when classification is based on dermal exposure relevance
- Substances classified as CMR based solely on ingestion or inhalation hazards will not trigger automatic cosmetic bans for dermal application
- Clarification that CMR classification of individual constituents does not automatically ban the entire natural complex, though SCCS assessment may still be required
- Simplified process for obtaining Article 15(2) exemptions while maintaining fundamental safety principles
Change to Article 16
- Complete removal of mandatory 6-month pre-market notification requirement for nanomaterials in cosmetic products
- Nanomaterial safety data to be incorporated into Cosmetic Product Safety Report under Responsible Person oversight
Change to Article 22
- Removal of mandatory Member State surveillance reporting obligations every four years
- Administrative burden reduction justified by real-time data sharing through existing Information and Communication System on Market Surveillance (ICSMS)
Removal of Article 33
- Complete removal of common ingredient names glossary maintained under Article 33
- Transition to exclusive use of internationally recognized INCI nomenclature throughout all regulatory documentation
- Consistent INCI implementation across all regulatory annexes for ingredient identification
Enhancement of Annex I
- Addition of comprehensive nanomaterial specifications including IUPAC chemical names, particle size, and physicochemical properties to CPSR Part A.
- Detailed documentation standards for nanomaterial characterization in Cosmetic Product Safety Reports
What now?
Proposal will undergo European Parliament and Council review with standard co-decision procedure timelines extending 12-24 months.
