Omnibus VII: Prohibition of TPO and DIMETHYLTOLYLAMINE in the European Union

On 1 September 2025, Regulation (EU) 2024/1976, known as Omnibus VII, which amends the annexes to Regulation (EC) No 1223/2009 on cosmetic products, came into force. This update incorporates new restrictions arising from the classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR), in line with the CLP Regulation (Regulation (EC) No 1272/2008).

Table of contents

1. Affected substances

2. Regulatory implications

3. Regulatory context

4. Conclusion

Omnibus VII: Prohibition of TPO and DIMETHYLTOLYLAMINE in the European Union

Affected substances

From this date, cosmetic products containing the following substances may not be placed on the EU market:

• Trimethylbenzoyl Diphenylphosphine Oxide (TPO)

• N,N-Dimethyl-p-toluidine (DIMETHYLTOLYLAMINE)

Both compounds have been classified as CMRs and, therefore, their use in cosmetics is prohibited unless they have been specifically evaluated and authorized under very specific conditions, which has not occurred.

Regulatory implications

The entry into force of Omnibus VII implies:

1. Immediate withdrawal from the market of any cosmetic product containing these substances.

2. Direct responsibility of companies (manufacturers, importers, distributors) to verify formulas, update the Product Information File (PIF) and ensure that non-compliant products are not marketed.

3. Administrative sanctions and risks of product recall in the event of non-compliance by the competent authorities of each Member State.

   
   

Regulatory context

The Omnibus Regulations are published periodically to automatically integrate substances classified as CMRs under the CLP Regulation into European cosmetics regulations. This mechanism ensures that the list of prohibited ingredients remains up-to-date based on scientific and regulatory developments.

Conclusion

Omnibus VII strengthens consumer health protection by removing substances with an unacceptable toxicological profile from the market in cosmetics. For the sector, this measure requires constant monitoring of regulatory updates and the obligation to proactively review formulations. Compliance with these provisions not only avoids sanctions but also strengthens confidence in the safety of products offered in the European Union.