Regulation (EU) 2024/197, also known as Omnibus Regulation VII, is a key update in European legislation concerning chemical and cosmetic products. It introduces new classifications for CMR substances (carcinogenic, mutagenic, or toxic to reproduction), which have a direct impact on product formulation and market compliance.
Starting from September 1, 2025, substances listed in this regulation may no longer be used in cosmetic products, except under strict exceptions. In this article, we analyze the contents of the regulation, its relationship with Regulation (EC) No 1223/2009 on cosmetic products, and its implications for manufacturers, importers, and distributors in the sector.
What Are CMR Substances?
The acronym CMR stands for substances with carcinogenic, mutagenic, or reproductive toxic properties. These substances pose a potential risk to human health due to their ability to cause cancer, alter genetic material, or negatively affect fertility or embryonic development.
Their classification is based on scientific criteria established in the CLP Regulation (Regulation (EC) No 1272/2008), which determines the level of hazard based on available evidence.
CMR substances are classified according to their degree of health hazard:
- 1- Category 1A: known to have CMR effects in humans, based on scientific evidence.
- 2- Category 1B: presumed to have CMR effects in humans, based on animal studies.
- 3- Category 2: suspected of being CMR, with limited evidence.
These classifications are defined in the CLP Regulation (EC No 1272/2008) on classification, labeling, and packaging of substances and mixtures.
Relationship with Regulation (EC) 1223/2009 on Cosmetic Products
Article 15 of Regulation (EC) 1223/2009 states:
- Substances classified as CMR Category 1A or 1B may not be used in cosmetic products.
- CMR Category 2 substances may only be used following a favorable evaluation by the Scientific Committee on Consumer Safety (SCCS) and if no suitable alternatives are available.
This means that with the entry into force of Omnibus Regulation VII, the newly classified CMR substances will be automatically banned in cosmetics starting September 1, 2025.
Which Substances Have Been Added in Omnibus Regulation VII?
Regulation (EU) 2024/197 updates Annex VI of the CLP Regulation by including various substances classified as CMR. While the full list can be found in the official document, some notable substances include:
- N,N-dimethylacetamide
- 2-butoxyethanol
- Formaldehyde (reclassified with a stricter CMR category)
To see the complete list of affected substances, visit the Regulation (EU) 2024/197 on EUR-Lex.
How CMR Substances Impact Cosmetic Products?
From September 2025:
- Formulas containing the new Category 1A or 1B CMR substances may no longer be used or marketed.
- Companies will need to review safety data sheets, compositions, and product claims.
- Substances must be replaced, requiring product reformulation.
- In some cases, new safety assessments and CPNP notifications will be necessary.
How to Manage CMR Substances in Your Cosmetics?
- Review the list in Omnibus Regulation VII.
- Audit existing formulations to identify any newly classified CMR substances.
- Replace prohibited substances with safe, authorized alternatives.
- Update the Product Information File (PIF) and Cosmetic Product Safety Report (CPSR).
- Submit updated regulatory notifications through CPNP.
This process should be completed by August 31, 2025 to ensure uninterrupted legal marketing.
Risks of Non-Compliance with CMR Substance Regulation
Failure to adapt in time can result in serious consequences:
- Withdrawal of non-compliant products from the market.
- Financial penalties for regulatory breaches.
- Loss of consumer and distributor trust.
- Reputational damage to the brand.
Therefore, regulatory monitoring and expert guidance are crucial to avoiding legal and financial risks.
SHAPYPRO Support for CMR Substance Compliance
At SHAPYPRO, we offer comprehensive regulatory consultancy and technical support to help you adapt your cosmetic products to the new regulation:
- Composition analysis and detection of CMR substances.
- Recommendation of safe alternatives.
- Review and update of PIF and CPSR files.
- Support with CPNP notifications and labeling compliance.
You can also read our page on cosmetic regulatory consultancy for more information.
Our multidisciplinary team, composed of regulatory, toxicology, and formulation experts, will support you throughout the transition.
📩 Contact us for personalized advice.
Conclusion
The implementation of Omnibus Regulation VII marks a significant change for the cosmetic industry. Companies must act proactively to adapt their products and ensure compliance before September 1, 2025.
At SHAPYPRO, we are ready to guide you through these changes with confidence, precision, and speed.