On 27 November 2025, the European Commission notified the World Trade Organization (WTO) of a draft amendment to Annex VI of Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging (the CLP Regulation). This amendment constitutes the 24th Adaptation to Technical Progress (ATP) and introduces new harmonised classifications of certain chemical substances as carcinogenic, mutagenic, or toxic to reproduction (CMRs).
CMRs under the EU Cosmetics Regulation
Pursuant to Article 15 of Regulation (EC) No 1223/2009 (the EU Cosmetics Regulation), the use in cosmetic products of substances classified as CMRs under Annex VI of the CLP Regulation is by default prohibited. A substance classified as a CMR may only be used in cosmetic products if it has been evaluated by the Scientific Committee on Consumer Safety (SCCS) and found to be safe for such use.
Accordingly, unless the SCCS concludes that they are safe for use in cosmetic products, the substances newly classified as CMRs under the 24th ATP will be added to Annex II (the list of prohibited substances) of the EU Cosmetics Regulation.
Eight newly classified CMR substances
The following substances have been newly classified as CMRs under the 24th ATP:
- Lithium carbonate (CAS No 554-13-2) – CMR 1A (toxic to reproduction)
- Potassium borate (CAS No 1332-77-0) – CMR 1B (toxic to reproduction)
- Sodium EDTMP (CAS No 22036-77-7) – CMR 1B (carcinogenic)
- Potassium EDTMP (CAS No 34274-30-1) – CMR 1B (carcinogenic)
- Potassium bromide (CAS No 7758-02-3) – CMR 1B (toxic to reproduction)
- 2-pyrrolidone (CAS No 616-45-5) – CMR 1B (toxic to reproduction)
- Heliotropin (CAS No 120-57-0) – CMR 1B (toxic to reproduction)
- Melaleuca alternifolia (tea tree oil) (CAS Nos 68647-73-4 and 85085-48-9) – CMR 1B (toxic to reproduction)
Heliotropin and Tea Tree Oil
Two of the substances listed above – heliotropin and tea tree oil – are currently subject to ongoing discussions with the cosmetics industry.
The SCCS has already issued an opinion on the safety of tea tree oil, concluding that it is safe for use in cosmetic products at certain concentrations. As a result, tea tree oil is likely to be included in Annex III (the list of restricted substances) of the EU Cosmetics Regulation rather than Annex II.
In addition, the SCCS has accepted a mandate to assess the safety of heliotropin. Should the SCCS determine that heliotropin is safe for use at specified concentration limits, it would similarly be included in Annex III instead of being banned under Annex II.
References
WTO. (2025). Draft Commission Delegated Regulation amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances. Retrieved on 28 November 2025.
WTO. (2025). Draft Annex amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council as regards the harmonised classification and labelling of certain substances. Retrieved on 28 November 2025.
Leave a Reply