27 Jul CMR substances: New Regulation for Cosmetic Products
CMR substances: New Regulation for Cosmetic Products
What are CMR substances in cosmetics?
CMR substances are carcinogenic, mutagenic or toxic to reproduction. In the EU they are classified under the CLP Regulation (EC) No 1272/2008 into: Category 1A (known human evidence), 1B (presumed from animal data) and 2 (suspected). These classifications are used across chemical legislation and are the basis for cosmetic restrictions.
On July 19, 2023, the Commission adapted Regulation (2023/1490), which amends Annex II of the Cosmetic Products Regulation to include substances classified as carcinogenic, mutagenic or toxic to reproduction, in accordance with Delegated Regulation (2022/692).
Categories at a glance
- CMR 1A: known human carcinogen/mutagen/reprotoxic.
- CMR 1B: presumed based on animal data.
- CMR 2: suspected; limited evidence.
In cosmetics, these categories inform prohibitions or strict conditions under the EU Cosmetics Regulation (EC) No 1223/2009.
EU legal framework (Article 15)
Under Article 15 of Regulation (EC) No 1223/2009, substances classified as CMR (1A/1B/2) under the CLP are in principle banned in cosmetic products.
Exceptions are limited and require strict conditions, including a positive SCCS opinion on safety for the specific use; some Category 2 substances may be allowed if SCCS confirms safety.
What “exceptions” really mean
- A full risk assessment by the SCCS (exposure, margins of safety, specific uses).
- Compliance with other relevant EU laws and no suitable alternative in some cases.
- If allowed, the substance is typically listed/restricted in the Annexes of 1223/2009 (e.g., Annex III).
List of CMR substances
Annex II of Regulation (EC) No. 1223/2009 is amended as follows:
(1) Entry 1024 is replaced by the following
(2) the following entries are added:
Recent regulatory updates you should know
EU CMR controls are updated regularly via “Omnibus” amendments and ATPs to CLP. Examples include:
- Commission Regulation (EU) 2023/1490 updating Annex II to include newly classified CMR substances.
- Commission Regulation (EU) 2025/877 (Omnibus VII) prohibiting additional CMRs in Annex II and revising other Annexes.
Practical takeaway: ingredient status can change quickly; brands must track CLP classifications, Article 15, and SCCS opinions to keep PIFs and labels compliant.
What this means for brands & safety assessors
Ingredient screening & reformulation
- Screen all INCI against Annex II (prohibited) and Annex III (restricted) after each CLP ATP/Omnibus update.
- Replace flagged materials or seek SCCS-backed, Annex-listed uses where applicable.
Safety assessment, PIF & labeling
- Update PIF, Cosmetic Product Safety Report, and label claims when ingredient status changes.
- Ensure exposure scenarios and margins of safety reflect the latest SCCS conclusions.
Supply chain governance
- Obtain updated supplier statements (CMR/CLP status), latest SDS, and impurity profiles.
- Implement change control so regulatory updates trigger formula/pack copy reviews.
Cosmewax Regulatory Experts
The Regulation Department at Cosmewax is responsible for ensuring that all cosmetic products comply with international laws, safety standards, and labeling requirements before they reach the market. This department oversees the preparation of technical documentation, product safety assessments, ingredient compliance checks, and regulatory notifications in line with the legislation of each target country. It also monitors updates in global cosmetic regulations, guiding other departments such as R&D, production, and marketing to guarantee full legal compliance. By acting as a bridge between innovation and legal frameworks, the Regulation Department helps Cosmewax maintain high standards of product safety, transparency, and consumer trust.
Contact us:
FAQs
Are all CMR substances automatically banned in EU cosmetics?
Generally yes, but Article 15 allows narrow exceptions subject to strict conditions and a positive SCCS opinion.
What is the SCCS and why does it matter?
The Scientific Committee on Consumer Safety evaluates ingredient safety for cosmetics; its opinions underpin many Annex entries and Article 15 decisions.
How often do CMR lists change?
With each CLP update (ATP) and Omnibus act, classifications and Annexes can change—monitor at least twice per year.
Sorry, the comment form is closed at this time.