Last June 24, 2024, the European Commission published the draft of Regulation (EC) 1223/2009 banning come CMR substances in cosmetic products.
The amended Cosmetic regulation will introduce the prohibited CMR substances described in the Omnibus Act VII (Commission Regulation (EU) 2024/197).
BACKGROUND: CMR Substances
CMR substances are identified as mutagenic, mutagenic or reprotoxic. They can be divided into 3 categories:
- Category 1A: chemicals that are known to be CMR according to human evidence.
- Category 1B: chemicals that are supposed to be CMR according to data gathered from animal studies.
- Category 2: chemicals that are suspected to be CMR based on limited evidence on animal and human studies.
In Europe, ECHA (European Chemical Agency) is responsible for the classification of CMR substances. After that, the European Commission lists the CMR in the CLP Regulation. The European Commission regularly updates the CLP Regulation by the publication of ATP (Adaptation to Technical Progress).
HOW THIS AFFECT COSMETIC PRODUCTS?
As we know, cosmetic products are made of chemicals, and therefore, must comply with restrictions on CMR substances. Article 15 of the Regulation (EU) 1223/2009 establishes the rules for the use of CMR substances in cosmetics.
- Category 1A: prohibited in cosmetic products
- Category 1B: prohibited in cosmetic products
- Category 2: can be used in cosmetic products if SCCS has assessed the substances as safe.
In order to harmonize the CLP and Cosmetics Regulations, The European Commission add the new entries of the ATPs to Annex II of the Cosmetics Regulation. Doing so, all the CMR substances are added to the list of prohibited substances.
WHAT SUBSTANCES WILL BE BANNED?
According to the Omnibus Act VII, the following substances will be added to Annex II and, therefore, prohibited for their use in cosmetic products:
- diphenyl(2,4,6-trimethylbenzoyl)phosphine 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.
- 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-{[(4,6dimethoxypyrimidin-2-yl) carbamoyl]sulfamoyl}4-formamido-N,N-dimethylbenzamide; 1-(4,6dimethoxypyrimidin-2-yl)-3-(2dimethylcarbamoyl-5formamidophenylsulfonyl)urea
WHEN WILL THE NEW REGULATION ENTER INTO FORCE?
Omnibus VII will enter into force from 1st September 2025 without transitional periods. This means that, from the application date, all the cosmetic products that do not comply with the new regulation cannot be sold in the EU market.
Cosmetic companies should check their formulations to make sure do not contain any of the substances listed in Omnibus VII.
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