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Yesterday, the European Commission notified the World Trade Organization (WTO) of a draft of Regulation (EC) No 1223/2009 (cosmetic products Regulation), prohibiting the use of certain CMR substances in cosmetic products.
The draft published will amend the Cosmetic Regulation to introduce the Omnibus Act VII (Commission Regulation (EU) No 2024/197), introducing the newly classified CMR substances.
Omnibus Act VII will apply from the 1st of September 2025 and there will be no differences between placing it on the market and making it available on the market. It means that from the application date, non-compliant cosmetics cannot be sold in the EU.
Why Omnibus Act VII is required?
The draft measure is required to enact the prohibition to use, as cosmetic ingredients, substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) by Commission Regulation (EU) No 2024/197, which has been adopted based on the CLP Regulation and will apply from 1 September 2025. The amendment of the Cosmetics Regulation is, therefore, needed to transpose the new CMRs classification provided by Commission Regulation (EU) No 2024/197.
This time, the industry did not submit any requests for using these substances in cosmetic products by way of exception, so all of them will be banned.
What are CMR substances under the EU Cosmetics Regulation?
Article 15 of the EU Cosmetics Regulation establishes the rules for the use of CMR substances in cosmetics. Normally, CMR substances of categories 1A and 1B are prohibited in cosmetic products (certain CMR substances of these categories can be used if they meet all conditions established in Article 15(2) of the Cosmetics Regulation). CMR substances of category 2 can be used in cosmetics if the Scientific Committee on Consumer Safety (SCCS) has evaluated them and found them safe.
To harmonize the existing regulations and restrictions, the European Commission regularly add all the new entries of the ATPs to Annex II to the EU Cosmetics Regulation (list of prohibited substances in cosmetic products). However, upon request of the cosmetic industry, the European Commission can allow their use by way of exception if they meet specific requirements. In such case, the substance will be added to Annex III of the EU Cosmetics Regulation (list of restricted substances in cosmetic products).
Omnibus Act VII Regulation: Application Date and Scope
Omnibus Act VII updates Annex II by adding several newly classified CMR substances.
Application date: 1 September 2025
Scope: products placed on the EU market must comply by the application date
No sell-through: there is no difference between placing on the market and making available in practice, so non-compliant stock cannot be sold after the date of application
CMR Substances Banned Under Omnibus Act VII
| List of prohibited ingredients |
|---|
| diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (INCI: Trimethylbenzoyl Diphenylphosphine Oxide) |
| 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol; tetrabromobisphenol-A |
| transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2dimethylcyclopropanecarboxylate |
| clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5ylmethyl)-3-methyl-2-nitroguanidine |
| benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4hydroxyphenyl)propan-2-yl]phenolate |
| benzyltriphenylphosphonium, salt with 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1) |
| reaction mass of 4,4′-[2,2,2-trifluoro-1(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1) |
| reaction mass of 4,4′-[2,2,2-trifluoro-1(trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4′-[2,2,2-trifluoromethyl)ethylidene]bis[phenol] (1:1) |
| dimethyl propylphosphonate |
| dibutyltin maleate |
| dibutyltin oxide |
| reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis((2,3-epoxypropoxy)methyl)butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethylbutane |
| 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF |
| benfluralin (ISO); N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine |
| N,N-dimethyl-p-toluidine (INCI: Dimethyltolylamine) |
| 1,4-benzenediamine, N,N’-mixed Ph and tolyl derivatives |
| 4-nitrosomorpholine |
| difenoconazole (ISO); 1-({2-[2-chloro-4-(4chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2yl}methyl)-1H-1,2,4-triazole |
| 3-chloro-4[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4chlorophenyl ether |
| 4-methylimidazole |
| 3,3′-dimethylbiphenyl-4,4′-diyl diisocyanate |
| foramsulfuron (ISO); 2-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-4-formamido-N,N-dimethylbenzamide |
| 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea |
Entry 1580 of annex II will be replaced to include new information, and finally, in Annex III, entry 311 is deleted, as Trimethylbenzoyl Diphenylphosphine Oxide use will not be allowed.
Commission Regulation (EU) 2025/877: Same Substances in Different Regulation
Commission Regulation (EU) 2025/877, of 12 May 2025, amends the Cosmetic Products Regulation, Reg. (EC) No 1223/2009 to include these substances, now forbidden in the use in cosmetic products, as they are classified as CMR substances.
Chemical substances, to be used in cosmetic products in the EU, must follow REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) rules. This is a European Regulation that aims to protect human health and the environment from the risks posed by chemicals.
Additionally, substances used in cosmetic products must also follow the Cosmetic Products Regulation (CPR), which applies to all cosmetics on the EU market. This regulation ensures consumer safety by mandating that products are safe for human health, closing the safety loop.
The substances that are classified as CMR (Carcinogenic, Mutagenic, or Reprotoxic) are included in regulatory lists, primarily at Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation), where they are assigned to Category 1A, 1B, or 2. These substances are typically prohibited from use in cosmetics, and now, the CMR substances listed were published in the CPR to ensure all cosmetic manufacturers are aware of the changes and that products placed on the market are safe for consumers.
How Cosmeservice Helps You Comply with EU Cosmetics Regulation
Omnibus Act VII and Commission Regulation (EU) No 2024/197 will apply as of the same date with no exceptions.
As a cosmetic brand, check whether any of your products contain the ingredients listed above. If so, you must proceed with a reformulation and all the necessary steps to ensure compliance of your products on the EU market.
Do you need any help or additional information? Contact us today!
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