Cosmetic Regulation Update: CMR Substances Banned Under EU Omnibus Act VII

As part of the EU’s continuous efforts to ensure the safety of cosmetic products, Commission Regulation (EU) No 2025/877 introduces a new set of banned substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). These updates, known collectively as Omnibus Act VII, take effect from 1 September 2025 with no grace period.

From this date, it will be prohibited to place on the EU market or make available any cosmetic product that contains one or more of the newly banned substances. This regulatory change directly amends Annex II (banned substances) of the EU Cosmetics Regulation (EC) No 1223/2009.

What Are CMR Substances?

CMR substances are chemicals classified as:

• Carcinogenic: substances that may cause cancer

• Mutagenic: substances that may alter genetic material

• Toxic for reproduction: substances that may impair fertility or development

Under Article 15 of the Cosmetics Regulation:

• CMR Category 1A and 1B substances are strictly prohibited unless they meet specific exemption criteria.

• CMR Category 2 substances may be permitted if the Scientific Committee on Consumer Safety (SCCS) confirms their safety.

In the case of Omnibus Act VII, no exemption requests were submitted; therefore, all substances listed are fully banned.

Newly Banned Substances in Annex II (Effective 1 September 2025)

The following substances will be banned from use in cosmetic formulations, along with their CAS numbers:

• Trimethylbenzoyl Diphenylphosphine Oxide (TPO) – CAS 75980-60-8

• Tetrabromobisphenol-A – CAS 79-94-7

• Transfluthrin – CAS 118712-89-3

• Clothianidin – CAS 210880-92-5

• Benzyl(diethylamino)diphenylphosphonium derivatives – CAS 577705-90-9

• Benzyltriphenylphosphonium derivatives – CAS 75768-65-9

• Reaction masses of phosphonium–bisphenol compounds

• Dimethyl propylphosphonate – CAS 18755-43-6

• Dibutyltin maleate – CAS 78-04-6 and Dibutyltin oxide – CAS 818-08-6

• Reaction masses of epoxybutane derivatives

• Bisphenol AF – CAS 1478-61-1

• Benfluralin – CAS 1861-40-1

• N,N-Dimethyl-p-toluidine (Dimethyltolylamine) – CAS 99-97-8

• Mixed derivatives of 1,4-Benzenediamine – CAS 68953-84-4

• 4-Nitrosomorpholine – CAS 59-89-2

• Difenoconazole – CAS 119446-68-3

• 4-Methylimidazole – CAS 822-36-6

• 3,3′-Dimethylbiphenyl-4,4′-diyl diisocyanate – CAS 91-97-4

• Foramsulfuron – CAS 173159-57-4

Additionally:

• Annex II, entry 1580 is updated to reflect new classifications.

• Annex III, entry 311 is deleted, removing the previously restricted use of TPO.

What Does This Mean for Cosmetic Brands?

This update requires immediate attention from all companies marketing cosmetic products in the European Union. Brands must:

• ✅ Review all product formulations against the updated Annex II

• ✅ Reformulate any products containing banned substances

• ✅ Update CPSRs, CPNP notifications, and PIFs as necessary

• ✅ Discontinue or withdraw non-compliant products from EU distribution channels before 1 September 2025

Cosmereg – Your Partner in EU Compliance

At Cosmereg, we support cosmetic brands worldwide in meeting regulatory requirements in the EU, UK, US, Canada, and the UAE.

Our services include:

• ✅ Ingredient and formulation compliance assessments

• ✅ Label reviews in line with Annexes II–VI

• ✅ CPSR and PIF updates

• ✅ CPNP re-notifications for reformulated products

Don’t wait until the deadline. Let our experts help you stay ahead of EU compliance changes.

📩 Get in touch with Cosmereg today to ensure your products meet all regulatory requirements.

References

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32025R0877

http://data.europa.eu/eli/reg/2009/1223/2025-05-01