Cosmetic Regulation Update -CMR substances added from Omnibus Act VII


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.

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?

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).

Banned substances:

The following substances will be added to Annex II, the list of banned substances for use in cosmetic products, not allowing its use from the 1st of September 2025 onwards:

List of banned substances
diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (INCI name 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-trifluoro-1-(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-(2,3epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2hydroxymethyl butane
4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF
benfluralin (ISO); N-butyl-N-ethyl-α,α,αtrifluoro-2,6-dinitro-p-toluidine
N,N-dimethyl-p-toluidine (INCI name Dimethyltolylamine)
1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.
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
3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate
foramsulfuron (ISO); 2-{[(4,6dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}4-formamido-N,N-dimethylbenzamide
; 1-(4,6dimethoxypyrimidin-2-yl)-3-(2dimethylcarbamoyl-5formamidophenylsulfonyl)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.

What to do now

Omnibus Act VII and Commission Regulation (EU) No 2024/197 will apply as of the same date with no exceptions. Even if this is a draft text, action is required!

As a cosmetic brand, please 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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