24th CLP ATP: New CMR classifications and their impact on the Cosmetic Industry

The European Commission continues to make progress in updating the CLP Regulation and, at the end of November 2025, notified the World Trade Organization of a new draft corresponding to the 24th Adaptation to Technical Progress (ATP).

This proposal introduces new harmonized classifications for certain substances as carcinogenic, mutagenic or toxic to reproduction (CMR), which automatically generates regulatory implications in other legislative frameworks, especially in cosmetics.

Table of contents

1. Why is this relevant to the cosmetics industry?

2. Substances included in the new ATP

3. Ingredients under special regulatory attention

24th CLP ATP: New CMR classifications and their impact on the Cosmetic Industry

Why is this relevant to the cosmetics industry?

This is particularly important because, according to Article 15 of Regulation (EC) 1223/2009, substances classified as CMR under CLP are prohibited by default in cosmetic products, unless the Scientific Committee on Consumer Safety (SCCS) assesses their safety and confirms that they can be used under specific conditions.

Substances included in the new ATP

This new ATP includes eight substances with CMR classification:

• Lithium carbonate (CAS 554-13-2) — CMR 1A (toxic to reproduction)

• Potassium borate (CAS 1332-77-0) — CMR 1B (toxic to reproduction)

• Sodium EDTMP (CAS 22036-77-7) — CMR 1B (carcinogenic)

• Potassium EDTMP (CAS 34274-30-1) — CMR 1B (carcinogenic)

• Potassium bromide (CAS 7758-02-3) — CMR 1B (toxic to reproduction)

• 2-pyrrolidone (CAS 616-45-5) — CMR 1B (toxic to reproduction)

• Heliotropin (CAS 120-57-0) — CMR 1B (toxic to reproduction)

• Melaleuca alternifolia / Tea Tree Oil (CAS 68647-73-4 and 85085-48-9) — CMR 1B (toxic to reproduction)

Not all of these substances are commonly used in cosmetics, but some do generate direct interest in the industry, especially Heliotropin and Tea Tree Oil, which are currently at the center of regulatory discussions.

Ingredients under special regulatory attention

In the case of Tea Tree Oil, the SCCS has previously published an opinion concluding that it can be considered safe at certain concentrations and conditions of use, so it is likely that it will eventually be included in Annex III (list of restricted substances) of the Cosmetic Regulation rather than being banned.

Heliotropin, meanwhile, is currently under evaluation by the SCCS. The outcome of this evaluation will be key in determining whether it can remain on the market with concentration limits or whether it will end up in Schedule II (prohibited substances).

This type of situation reflects very well how the European regulatory system works: a toxicological classification under CLP does not automatically imply a definitive ban in cosmetics, but it does activate a scientific review process that may end in restriction or prohibition depending on the risk assessment.

From an industry perspective, although the ATP is not yet fully adopted, this is a good time to review ingredient portfolios, identify potential regulatory exposures, and anticipate reformulation strategies if necessary.

Experience shows that companies that anticipate these changes avoid supply problems, product recalls, or hasty decisions later on.

The regulatory trend in the EU remains clear: the strengthening of the principle of preventive consumer protection and the increasing interconnection between horizontal chemical legislation (CLP) and sectoral regulations, such as cosmetics.

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