European Union notifies WTO of the draft 24th ATP to CLP Regulation – Impact of new CMR substances on cosmetics
Topic: Draft 24th to CLP Regulation

Date of publication: 27 November 2025

The European Commission (EC) notified the World Trade Organization's (WTO) Technical Barriers to Trade (TBT) Committee about the 24th Adaptation to Technical and Scientific Progress (ATP) to Regulation (EC) 1272/2008, also known as CLP Regulation. This update amends 48 substances or substance groups, potentially impacting a total of 14 ingredients which can be used in cosmetics.

Background:

The objectives of Regulation (EC) No 1272/2008 (CLP) are to ensure the protection of human health or safety and the environment while facilitating the free movement of substances, mixtures, and articles. These objectives are achieved by establishing a harmonized list of substances with their classifications and labeling elements at the European Union (EU) level. 

Article 37(5) of CLP grants the European Commission the authority to include substances in Table 3 of Part 3 of Annex VI if it considers harmonization of classification and labeling appropriate. The CLP Regulation is updated through an “Adaptation to Technical Progress (ATP)” which is issued yearly by the European Commission. 

Based on opinions from the Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA), along with feedback from EU Member States and industry stakeholders, it was deemed necessary to introduce or update harmonized classification and labeling for specific substances and amend Table 3 of Part 3 of Annex VI to CLP Regulation, accordingly. 

What’s new?

On the 27thof November 2025, the European Commission notified the World Trade Organization’s (WTO) Technical Barriers to Trade (TBT) Committee about its intention to publish the 24th ATP to Regulation CLP. 

The purpose of the draft text of what will become the 24th ATP is to amend Table 3 of Part 3 of Annex VI to the CLP Regulation, by introducing 38 new harmonised classifications, modifying 10 preexisting entries. 

Some cosmetic ingredients will be impacted due to their hazardous harmonized classification as CMR (Carcinogenic, Mutagenic or Toxic for Reproduction). 

CMR substances of category 1, under Part 3 of Annex VI to Regulation (EC) No 1272/2008, shall be tipically directly prohibited in cosmetics. 

CMR substances of category 2, shall be either directly prohibited or may be allowed where the substance has been evaluated by the Scientific Committee on Consumer Safety (SCCS) and found safe for use in cosmetic products. 

Amongst the substances listed, 14 can be used in cosmetics and 2 are already prohibited. From these, the following substances that can be used in cosmetics have received a CMR classification, and to secure the continuation of its, it is necessary a positive opinion from the SCCS: 

  • Lithium Carbonate (CAS No. 554-13-2) – Repr. 1A, Lact. 
  • Lithium Chloride (CAS No. 7447-41-8) – Repr. 1A, Lact. 
  • Lithium Hydroxide (CAS No. 1310-65-2) – Repr. 1A, Lact.  
  • Potassium Borate (CAS No. 1332-77-0) – Repr. 1B 
  • Sodium EDTMP (CAS No. 22036-77-7) – Carc. 1B 
  • Potassium EDTMP (CAS No. 34274-30-1) – Carc. 1B 
  • Potassium Bromide (CAS No. 7758-02-3) – Repr. 1B, Lact., STOT SE 3, STOT RE 1 
  • Heliotropin (CAS No. 120-57-0) – Repr. 1B, Skin Sens. 1 
  • Melaleuca Alternifolia Leaf Oil (CAS No. 68647-73-4 / 85085-48-9) – Flam. Liq. 3, Repr. 1B, Acute Tox. 4, Asp. Tox. 1, STOT SE 3, Skin Irrit. 2, Skin Sens. 1B, Aquatic Acute 1, Aquatic Chronic 2 
  • 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol (CAS No. 107534-96-3) – Rep. 1B, Acute Tox. 4, STOT RE 2, Aquatic Acute 1, Aquatic Chronic 1 

Key notes:

  • Potassium Borate and 1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol are already prohibited by the Annex II of the Cosmetics Regulation (EC) No. 1223/2009. 
  • Lithium Hydroxide is already listen in Annex III of the Cosmetics Regulation (entry III/15b), with concentration and pH restrictions. 
  • The SCCS has already issued a preliminary opinion on the safety of Heliotropin, where it concluded that it can be used up to 1.8% in cosmetics intended for adults. 
  • The SCCS has already published an opinion on the safe concentrations of use of Melaleuca Alternifolia Leaf Oil in dermal cosmetic products.  

What now?

The draft is open for comments until the 26th of January 2026.  

The updates shall enter into force on the twentieth day following its publication in the Official Journal of the European Union (expected in the first quarter of 2026). It shall apply following 18 months after the date of entry into force. 

References:

World Trade Organization (WTO) – Committee on Technical Barriers to Trade, G/TBT/N/EU/1172

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