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On June 24, 2024, EU notified WTO of a draft proposing amendments to the prohibited and restricted ingredients lists of Regulation (EC) No 1223/2009 (Cosmetics Regulation) in response to newly classified CMR substances (those classified as carcinogenic, mutagenic or toxic for reproduction) in Commission Delegated Regulation (EU) 2024/197. The draft is currently open for comments until August 23, 2024, and scheduled to take effect on September 1, 2025.1
Article 15 of the Cosmetics Regulation sets out provisions on the use of CMR substances in cosmetics. With an aim to thoroughly protect human health, as a general principle, these substances are prohibited for use in cosmetics. On January 5, 2024, EU released the Commission Delegated Regulation (EU) 2024/197, identifying new CMR substances. To ensure a consistent prohibition on these newly identified substances within the internal market, EU has developed this draft to transpose them into the Cosmetics Regulation, and scheduled to adopt the amendments from the same effective date as the Commission Delegated Regulation (EU) 2024/197.
Detailed amendments proposed in the draft are as follows (the text in red indicates changes to the previous lists):
1. List of Prohibited Ingredients: 1 revised, and 21 added
2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide (CAS No. 57966-95-7) is currently listed under Entry 1580 due to its reproductive toxicity. With the introduction of an additional chemical name for this substance in Commission Delegated Regulation (EU) 2024/197, EU plans to revise Entry 1580 accordingly. Furthermore, EU proposes to add newly classified CMR substances, which are not currently regulated in the Cosmetics Regulation, to the prohibited ingredients list.
Status | Ref No. | Chemical Name / INN | CAS No. | EC No. |
Revision | 1580 | Cymoxanil (ISO) / 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide [1] | 57966-95-7 [1] | 261-043-0 [1] |
Addition | / | Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide | 75980-60-8 | 278-355-8 |
/ | 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol / tetrabromobisphenol-A | 79-94-7 | 201-236-9 | |
/ | Transfluthrin (ISO) / 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate | 118712-89-3 | 405-060-5 | |
/ | Clothianidin (ISO) / (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine | 210880-92-5 | 433-460-1 | |
/ | Benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate | 577705-90-9 | 479-100-5 | |
/ | Benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1) | 75768-65-9 | 278-305-5 | |
/ | 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 | 18755-43-6 | 242-555-3 | |
/ | Dibutyltin maleate | 78-04-6 | 201-077-5 | |
/ | Dibutyltin oxide | 818-08-6 | 212-449-1 | |
/ | 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-hydroxymethyl butane | / | / | |
/ | 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol / bisphenol AF | 1478-61-1 | 216-036-7 | |
/ | Benfluralin (ISO) / N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine | 1861-40-1 | 217-465-2 | |
/ | N,N-dimethyl-p-toluidine | 99-97-8 | 202-805-4 | |
/ | 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. | 68953-84-4 | 273-227-8 | |
/ | 4-nitrosomorpholine | 59-89-2 | / | |
/ | Difenoconazole (ISO) / 1-({2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-yl}methyl)-1H-1,2,4-triazole / 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether | 119446-68-3 | / | |
/ | 4-methylimidazole | 822-36-6 | 212-497-3 | |
/ | 3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate | 91-97-4 | 202-112-7 | |
/ | 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 | 173159-57-4 | / |
2. List of Restricted Ingredients: 1 deleted
Trimethylbenzoyl Diphenylphosphine Oxide (CAS No. 75980-60-8), currently listed under Entry 311, has been newly classified as a reproductive toxicant under Commission Delegated Regulation (EU) 2024/197. As it is now one of the new additions to the prohibited ingredients list, EU plans to delete it from the restricted ingredients list.
Ref. No. | Substance Identification | Restrictions | Labelling of Use Conditions and Warnings | |||||
Chemical Name / INN | Name of Common Ingredients Glossary | CAS No. | EC No. | Product Type | Maximum Concentration | Others | ||
311 | Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide | Trimethylbenzoyl diphenylphosphine oxide | 75980-60-8 | 278-355-8 | Artificial nail systems | 5% | Professional use | - For professional use only |
Further Reading
EU Finalizes Amendments to Use Restrictions on D4, D5, D6 in Cosmetics
EU Adopts 11 Changes to the Use Requirements for Cosmetic Ingredients
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