Regulation (EU) 2025/877 (Omnibus VII): Strengthens the ban on CMR substances in cosmetics

The European Commission has taken a further step in protecting consumer health with the publication of Regulation (EU) 2025/877, known as Omnibus VII , which amends Regulation (EC) 1223/2009 on cosmetic products. The regulation, dated May 12 and published in the Official Journal of the EU on May 13, 2025, updates the list of prohibited substances and introduces significant changes that will affect manufacturers, importers, and distributors in the cosmetics sector.

Table of contents

1. Why was this new Omnibus necessary?

2. Main news

3. Implementation schedule

4. Impact on the industry

5. Conclusion

Why was this new Omnibus necessary?

Every year, the EU automatically adapts the Cosmetics Regulation to the latest update of the CLP Regulation (1272/2008) on the classification and labeling of chemical substances. Delegated Regulation (EU) 2024/197 reclassified numerous ingredients as carcinogens, mutagens, or toxic for reproduction (CMR). To ensure legal consistency and a high level of protection, Omnibus VII moves these classifications to the annexes of Regulation 1223/2009, prohibiting their use in cosmetics with limited exceptions.

Main news

Exchange rate	Key detail	Consequence
New emblematic ban	Trimethylbenzoyl Diphenylphosphine Oxide (TPO) is no longer permitted in artificial nail systems (previously 5% max.).	Reformulate all gels/polishes that contain it.
Mass addition to Annex II	Twenty-one CMR substances are added, including tetrabromobisphenol-A, transfluthrin, clothianidin, bisphenol AF, 4-methylimidazole, dibutyltin oxide and several organophosphate photoinitiators.	Total ban on any gathering.
Technical amendment	Entry 1580 (cymoxanil) is corrected to include alternate chemical name and additional CAS.	Clarifies inspections and prevents legal loopholes.
Deletions in Annex III	Entry 311 (TPO) is removed.	“Restricted” use disappears; it becomes prohibited.

(The full list of CAS and references 1731–1751 is given in the Annex to the Regulations.)

Implementation schedule

• Entry into force : 20 days after publication → June 2, 2025 .

• Mandatory applicability : September 1, 2025 (coincides with the validity of the CLP classification 2024/197).

From that date, no products containing these added substances may be legally marketed in the EU.

Impact on the industry

1. Immediate reformulation : Product managers must review formulas and eliminate the affected substances.

2. Product Information File (PIF) Update : Incorporate revised safety assessments and replacement tests.

3. Inventory management : plan withdrawals or liquidations before September 1.

4. Supply chain : Require updated composition certificates from raw material suppliers.

5. Labeling and claims : Check that there is no reference to ingredients that are already prohibited and that the section on misleading statements is not violated.

Conclusion

Regulation (EU) 2025/877 reinforces the trend toward "zero tolerance" for CMR substances in cosmetics and requires the industry to accelerate the transition to safer formulations. Compliance by September 1, 2025 , not only avoids sanctions but also preserves European consumer confidence in a market where safety is the top priority.

Contact an expert in cosmetic regulation