Omnibus VIII and CMR Restrictions: which will reshape the cosmetics market starting in 2026

The European Commission has notified the World Trade Organization (WTO) of the draft regulation that will amend Regulation (EC) 1223/2009 to incorporate the substances recently classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) by the 22nd Adaptation to Technical Progress (ATP 22) of the CLP Regulation. Internally, this package of changes is known as "Omnibus VIII" and consolidates the European policy of "zero tolerance" toward high-risk substances in cosmetics.

Table of contents

1. Regulatory framework in context

2. Why “Omnibus VIII”?

3. Main technical innovations

4. Compliance schedule

5. Conclusion

Omnibus VIII and CMR Restrictions: which will reshape the cosmetics market starting in 2026

Regulatory framework in context

• Article 15 of Cosmetic Regulation (EC) 1223/2009 : prohibits the use of CMR 1A/1B/2 except in justified exceptions.

• CLP Regulation (EC) 1272/2008 – ATP 22 (Reg. 2024/2564) : updates the classification of 27 substances, seven of which directly affect the cosmetics sector.

• Omnibus VIII takes these new classifications and transfers them to Annexes II (prohibition), III (restrictions), IV (colorants) and V (preservatives) of the Cosmetics Regulation, ensuring harmonious application throughout the internal market.

  
  

Why “Omnibus VIII”?

Since 2019, the Commission has published an annual "Omnibus" to rapidly adapt the Cosmetics Regulation to successive CLP amendments. The 2025 package is the eighth edition, and non-compliant products must be withdrawn from the market from the date of application.

Main technical innovations

Substance or group	Regulatory action	Scientific/regulatory basis
Sodium perborate, potassium perborate and other derivatives	Unification and prohibition in Annex II	CMR 1B classification and rationalization of duplicate entries.
Silver (macroscopic, powder and nano forms)	- Nano and bulk silver: prohibited - Micronized silver: permitted only under SCCS conditions (e.g. 0.2% in lip balms)	New classification Repr. 2 and SCCS opinion 27 Mar 2024.
Hexyl salicylate	Restriction in Annex III (0.2%–2% depending on category)	Repr. Classification 2 and SCCS opinion 25 Oct 2024.
O-Phenylphenol + sodium salt	Revised entry in Annex V with differentiated limits (0.2% in rinse, 0.15% in leave-on)	Classification Carc. 2 and SCCS opinion 25 Oct 2024.
20+ CMR substances without industrial defense	Added to Annex II (total ban)	Lack of exemption requests; automatic application of Article 15.

Compliance schedule

The regulation will enter into force 20 days after its publication in the Official Journal of the European Union and will be applicable on 1 May 2026. There is no coexistence period for the sale of stocks, so after that date, any product containing off-specification substances must be withdrawn or reformulated.

Conclusion

Omnibus VIII represents the consolidation of the European strategy to eliminate, or severely restrict, all CMR substances from cosmetic products. The May 1, 2026, horizon offers a limited but sufficient window of opportunity if planning begins now. Compliance is not just a legal obligation: it's an opportunity to strengthen consumer confidence and position ourselves as a safe and responsible brand in the European market.