In May 2025, the European Union introduced two significant updates to its cosmetics regulatory framework with the publication of Omnibus Acts VII and VIII. These acts are a recurring legislative tool used to incorporate substances classified as CMRs (carcinogenic, mutagenic, or toxic to reproduction) under the Adaptation to Technical Progress (ATP) of the Classification, Labelling and Packaging (CLP) Regulation.
Omnibus Act VII – Ban on 22 substances
Omnibus Act VII was officially published in the Official Journal of the European Union on 13 May 2025, following its notification to the World Trade Organization (WTO) in November 2024. The act amends Annex II (list of prohibited substances) of the EU Cosmetics Regulation, introducing a ban on 22 substances now classified as CMRs. The full list of these substances is available in Regulation (EU) 2025/877.
The ban will take effect from 1 September 2025, with no distinction between “placing on the market” and “making available on the market.” This means that from that date, any cosmetic products containing these substances must be removed from the EU market.
Omnibus Act VIII – Further upcoming restrictions
Although the Omnibus Act VIII has not yet been published in the Official Journal of the European Union, it was notified to the WTO on 24 May 2025. This means that we can expect its official publication in the next months.
Omnibus Act VIII will is amending Annexes II to V of the Cosmetics Regulation, namely:
- Annex II: Substances prohibited in cosmetic products
- Annex III: Substances allowed under specific restrictions
- Annex IV: Approved colorants
- Annex V: Approved preservatives
The full list of amendments can be found in the Annex to the WTO notification.
Omnibus Act VIII is scheduled to come into force on 1 May 2026. Like the previous Act, it makes no distinction between placing and making products available on the market. As a result, all non-compliant cosmetic products must be withdrawn before that date.
Your cosmetic products likely need a new formula review
As a result of newly introduced bans and restrictions, many cosmetic products on the EU market might no longer be compliant with the latest EU provisions. This could affect also products recently subject to reviews and safety assessments.
Obelis can perform a detailed and prompt review of your products’ formulas, labels, and complementary documentation, ensuring their compliance with the latest EU requirements.
Do you have any questions regarding the upcoming restrictions? Get in touch!
Chiara Lai
Regulatory Intelligence & Innovation Department
17/07/2025