CMR substances in cosmetics: what they are, what Art. 15 prohibits, and how to verify them

• CMR substances (carcinogenic, mutagenic or toxic for reproduction) are prohibited in EU cosmetics by Article 15 of Regulation (EC) 1223/2009, subject to strict exceptions that differ depending on the category.
• The CMR classification is decided under the CLP Regulation (Reg. 1272/2008); the cosmetic prohibition arrives separately through Omnibus Regulations that transfer each new classification into Annex II. Eight Omnibus regulations have been published to date; the most recent is Reg. (EU) 2026/78, applicable from 1 May 2026.
• Lilial (Butylphenyl Methylpropional, CAS 80-54-6) and Zinc Pyrithione (Pyrithione zinc, CAS 13463-41-7) are the two cases that best explain how the exception works — and why in practice it applies very rarely.

1. What is a CMR substance?

CMR stands for Carcinogenic, Mutagenic and Toxic for Reproduction. The classification is established by Regulation (EC) No 1272/2008 (CLP), which groups substances into three hazard categories:

The same categories — 1A, 1B and 2 — apply separately to each of the three hazard types: carcinogenicity (Annex I, section 3.6 of CLP), germ cell mutagenicity (section 3.5) and reproductive toxicity (section 3.7). A substance may be, for example, Repr. 1B without being carcinogenic.

The classification that triggers the cosmetic prohibition is the harmonised classification, meaning the one listed in Table 3 of Annex VI of the CLP — not a manufacturer's self-classification. It is the official decision, agreed at EU level through Adaptations to Technical Progress (ATPs).

If you want to go deeper into how the CLP, the SVHC Candidate List and ECHA's decision chain work, the post ECHA, SVHC and CLP for cosmetics covers the full mechanism without repeating it here.

2. What does Article 15 of Regulation 1223/2009 say?

Article 15 of Regulation (EC) 1223/2009 (consolidated text 2024-04-24) is the provision that converts a CLP classification into a cosmetic prohibition. Its structure is as follows:

Art. 15(1) — The general rule for category 2:

Substances classified as CMR category 2 under Regulation (EC) No 1272/2008 shall be prohibited in cosmetic products. However, such a substance may be used in cosmetic products where the SCCS has evaluated it and found it to be safe for use in cosmetic products.

Art. 15(2) — The general rule for categories 1A and 1B:

Substances classified as CMR categories 1A or 1B shall be prohibited in cosmetic products. The exception requires that all of the following conditions are met:

(a) they comply with the food safety requirements laid down in Regulation (EC) No 178/2002; (b) there are no suitable alternatives, documented in an analysis of alternatives; (c) the application is made for a particular use with known exposure; (d) the SCCS has evaluated the substance and found it to be safe for use in cosmetic products.

The practical difference between the two routes matters: for category 2, a favourable SCCS evaluation alone is sufficient. For categories 1A and 1B, all four conditions must be met simultaneously. In practice, condition (b) — no suitable alternatives — is the one that most frequently prevents a category 1A/1B exception from succeeding.

3. CLP categories 1A, 1B and 2 — definition and difference

The distinction between 1A, 1B and 2 is not merely a question of abstract hazard degree: it determines which exception route (if any) can be invoked and what conditions must be met. From the cosmetic standpoint, the key points are:

• Cat. 1A/1B → hard prohibition; exception requires meeting the four conditions of Art. 15(2) cumulatively.
• Cat. 2 → prohibition unless the SCCS finds the substance safe; technically a lower bar, though still not automatic.

Carcinogenicity, mutagenicity and reproductive toxicity each have their own harmonised classification tables in Annex VI of the CLP. A substance can appear in more than one — for instance, classified simultaneously as Carc. 1B and Repr. 1B.

4. When can a category 2 CMR substance be used? (exceptions)

The Art. 15(1) exception is the only one available for category 2, and it has a single requirement: the SCCS (Scientific Committee on Consumer Safety) must have evaluated the substance specifically for cosmetic use and concluded that it is safe.

For categories 1A/1B, Art. 15(2) additionally requires:

• Food safety (Reg. 178/2002): the substance must be considered safe in the food context, which rules out almost all agents with well-established carcinogenic effects in humans.
• No suitable alternatives: an analysis of alternatives must document that no technically viable option exists for that particular use.
• Specific use with known exposure: the exception cannot be generic; it must refer to a concrete application — concentration, product type, conditions of use — with a defined exposure profile.
• Favourable SCCS evaluation for that particular use.

The case of Zinc Pyrithione illustrates precisely how the exception can fail even when the SCCS issues a favourable opinion. The SCCS evaluated the antifungal preservative Pyrithione zinc (CAS 13463-41-7) and concluded it was safe at up to 1% in rinse-off products. However, when it was classified as CMR 1B, the Commission analysed condition (b) — no suitable alternatives — and determined that adequate alternatives existed for the relevant cosmetic uses. All four conditions were not met simultaneously: Zinc Pyrithione was incorporated into Annex II as entry 1670 (Omnibus Regulation IV, applicable from 1 March 2022), prohibited in cosmetics regardless of the SCCS opinion.

5. The Omnibus mechanism: from CLP classification to cosmetic prohibition

A harmonised CMR classification in the CLP does not automatically or instantly produce a cosmetic prohibition. The mechanism requires an intermediate step: a CMR Omnibus Regulation from the European Commission that explicitly transfers the new classification into Annex II of Regulation 1223/2009.

The process has three stages:

1. A CLP ATP classifies a new substance as CMR (or upgrades the category of an existing one).
2. The Commission publishes a CMR Omnibus Regulation amending Annex II, with an application date that typically aligns with the ATP application date.
3. The prohibition becomes operative from that application date, not before.

This interval — which can last months — is why early regulatory monitoring has real value: when an ATP is published, the Omnibus that will transfer its new CMRs is being prepared, and companies with alert systems can begin planning substitution before the prohibition becomes enforceable.

The Commission has published eight Omnibus regulations since 2019:

Omnibus VIII (Reg. (EU) 2026/78, adopted 12 January 2026, applicable from 1 May 2026) is the most recent one in force. It adds to Annex II the substances classified as CMR by Delegated Regulation (EU) 2024/2564, including perboric acid, carbon nanotubes and acetone oxime; it also reclassifies Silver as CMR cat. 2 reproductive toxicant.

Omnibus IX is expected by 1 February 2027, in line with upcoming CLP ATPs.

The Lilial case: the prohibition that came with Omnibus IV

The most widely cited example of the Omnibus mechanism is Lilial, the trade name of the fragrance ingredient Butylphenyl Methylpropional (INCI: Butylphenyl Methylpropional, CAS 80-54-6). It was widely used in perfumes, cosmetics and personal care products for decades.

When a CLP ATP classified it as Repr. 1B (toxic for reproduction, category 1B), the Commission included Lilial in Omnibus IV (Regulation (EU) 2021/1902, CELEX 32021R1902). It was listed as entry 1666 of Annex II of Regulation 1223/2009, with an application date of 1 March 2022.

Lilial also appears on ECHA's SVHC Candidate List for reproductive toxicity — an example of a substance that appears on both lists (ECHA and Annex II cosmetics) because the CLP classification connects both regulatory universes.

6. How to find CMR substances in CosIng

CosIng, the European Commission's cosmetic ingredient database, includes the CMR classification field in the data sheets of substances that carry this designation. However, searching by CMR category in CosIng is not designed to generate complete listings: the official interface does not offer filters by category 1A, 1B or 2.

The most direct way to consult the complete and up-to-date list of CMR substances under Regulation 1223/2009 — that is, those in Annex II due to CMR classification — is the BD-API CMR substances page. There you can see in real time each substance with its classification, its Annex II reference number and its INCI name, synchronised with the official CosIng.

For a complete introduction to what CosIng is, how it is organised and what you can search in it, the post What is CosIng and how do you use it? covers the database in depth.

To verify whether an Annex II entry corresponds to a CMR prohibition, the shortest path is:

1. Identify the INCI name or CAS number of the ingredient.
2. Search the CMR substances list to confirm whether it appears in Annex II via that route.
3. If the ingredient is not in Annex II but has a CMR classification in the CLP, it may be in a recent ATP whose Omnibus has not yet been published. The Regulatory Watch notifies when a new Omnibus is published.

The CosIng search tool also lets you search for a specific INCI to see its Annex restrictions and reference number.

7. Frequently asked questions

What is a CMR substance? A substance classified as Carcinogenic (Carc.), Mutagenic (Muta.) or Toxic for Reproduction (Repr.) under Regulation (EC) No 1272/2008 (CLP). Categories range from 1A (known effect in humans) to 1B (presumed, based primarily on animal evidence) to 2 (suspected, with limited evidence).

Does Article 15 prohibit all CMR substances? Yes, as a general rule. Categories 1A and 1B are prohibited unless all four conditions of Art. 15(2) are met simultaneously. Category 2 substances are prohibited unless the SCCS evaluates and finds them safe for that cosmetic use.

What is a CMR Omnibus Regulation? A Commission regulation that transfers newly CLP-classified CMR substances into Annex II. There is no automatic cosmetic prohibition from the mere fact of receiving a CMR classification: the Omnibus and its application date are required.

Why was Lilial (CAS 80-54-6) banned? Because a CLP ATP classified it as Repr. 1B. Omnibus IV (Reg. 2021/1902) incorporated it into Annex II as entry 1666, with application from 1 March 2022.

Why was Zinc Pyrithione banned if the SCCS evaluated it favourably? The Art. 15(2) exception for category 1B requires four conditions to be met simultaneously. The Commission determined that the "no suitable alternatives" condition was not satisfied for the cosmetic uses in question. The SCCS opinion is necessary but not sufficient when the other conditions are not met.

How many CMR Omnibus regulations have been published? Eight to date. The most recent, Omnibus VIII (Reg. (EU) 2026/78), is applicable from 1 May 2026. Omnibus IX is expected by 1 February 2027.

How do I verify whether my formula uses a prohibited CMR substance? Check the BD-API CMR list, where you can search by INCI or CAS. If you use the Regulatory Watch, you will receive notification whenever a new Omnibus is published with the affected substances.