EU Amends Cosmetics Regulation: 21 CMR Substances Added to the List of Prohibited Substances | regulatory trends

EU,Cosmetic,Ingredient,CMR,Prohibition,Regulation

On May 12, 2025, the European Commission published Regulation (EU) 2025/877, amending the EU Cosmetics Regulation (EC) No 1223/2009. This amendment incorporates a new group of substances classified as carcinogenic, mutagenic, or toxic to reproduction (CMR substances)-as identified under the Classification, Labelling and Packaging (CLP) Regulation- into Annex II, the List of Substances Prohibited in Cosmetic Products. Additionally, Entry 311 of Annex III has been deleted and its content transferred to Entry 1730 of Annex II. This regulation will enter into force on September 1, 2025.

Amendments to Annex II of the EU Cosmetics Regulation (EC) No 1223/2009

Addition of the following entries

Reference number	Substance identification
Reference number	Chemical name/INN	CAS number	EC number
a	b	c	d
1731	diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide; INCI: Trimethylbenzoyl Diphenylphosphine Oxide	75980-60-8	278-355-8
1732	2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol; tetrabromobisphenol-A	79-94-7	201-236-9
1733	transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate	118712-89-3	405-060-5
1734	clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine	210880-92-5	433-460-1
1735	benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl) propan-2-yl]phenolate	577705-90-9	479-100-5
1736	benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene] bis[phenol] (1:1)	75768-65-9	278-305-5
1737	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)	-	-
1738	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]diphenol (1:1)	-	-
1739	dimethyl propylphosphonate	18755-43-6	242-555-3
1740	dibutyltin maleate	78-04-6	201-077-5
1741	dibutyltin oxide	818-08-6	212-449-1
1742	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	-	-
1743	4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene] diphenol; bisphenol AF	1478-61-1	216-036-7
1744	benfluralin (ISO); N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine	1861-40-1	217-465-2
1745	N,N-dimethyl-p-toluidine	99-97-8	202-805-4
1746	1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs.	68953-84-4	273-227-8
1747	4-nitrosomorpholine	59-89-2	-
1748	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	-
1749	4-methylimidazole	822-36-6	212-497-3
1750	3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate	91-97-4	202-112-7
1751	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	-

Amendment to Entry No. 1580

Reference number	Substance identification
Reference number	Chemical name/INN	CAS number	EC number
a	b	c	d
1580	cymoxanil (ISO); 2-cyano-N-[(ethylamino) carbonyl]-2-(methoxyimino)acetamide; [1] (2E)-2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide; [2]	57966-95-7; [1] 166900-80-7; [2]	261-043-0; [1] - [2]

Regulatory Interpretation

1. CLP Regulation

Regulation (EC) No 1272/2008 of the European Union, commonly referred to as the Classification, Labelling and Packaging (CLP) Regulation, is a key legislative framework established to ensure the safe circulation of chemical substances on the EU market. It has been in force since 20 January 2009. Based on the scientific assessments conducted by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA), this regulation sets forth harmonized classification criteria for determining whether a substance is carcinogenic, mutagenic, or toxic to reproduction (CMR). According to Commission Delegated Regulation (EU) 2024/197, 28 substances have been newly added to Annex VI of the CLP Regulation (EC) No 1272/2008, and this amendment will enter into force on 1 September 2025. At that time, these substances will be subject to CMR regulatory control.

2. CMR Substances

Based on their carcinogenic, mutagenic, or reproductive toxicity properties, relevant substances may be classified as CMR Category 1A, 1B, or 2. In accordance with Article 15 of the EU Cosmetics Regulation (EC) No 1223/2009, substances classified as CMR Category 1A, 1B, or 2 are, in principle, prohibited from use in cosmetic products. However, exemptions from this prohibition may be granted if all of the following conditions are fulfilled:
(a) they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety;

(b) there are no suitable alternative substances available, as documented in an analysis of alternatives;

(d) they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population groups.

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Further Information

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202500877

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