Art. 15 — Regulation (EC) No 1223/2009

CMR substances (Categories 1A, 1B and 2) in EU cosmetics

1,035CMR-classified substances

What are CMR substances?

CMR substances are those classified as Carcinogenic (Carc.), Mutagenic (Muta.) or Toxic for Reproduction (Repr.) under Regulation (EC) No 1272/2008 (CLP). The categories are: 1A (known effect, with evidence in humans), 1B (presumed effect, mainly based on animal data) and 2 (suspected effect, with limited evidence).

Article 15 of Regulation (EC) No 1223/2009 prohibits the use of CMR substances of categories 1A, 1B and 2 in cosmetic products. The exceptions differ depending on the category: a category 2 substance may be used only if the SCCS has assessed it and considered it safe for cosmetic use. For category 1A or 1B, all conditions of Article 15 must also be met: food safety (Regulation (EC) No 178/2002), absence of suitable documented alternatives, a specific use with known exposure, and a favourable SCCS opinion. How the complete mechanism works (CLP → Art. 15 → Annex II) →

This list is updated periodically through European Commission Regulations (the CMR 'Omnibus' Regulations), following updates to the CLP Regulation. BD-API synchronises these changes automatically and notifies connected systems, ensuring that formulations are always audited against the current version.

CMR substances in CosIng

INCI Name	CMR Classification	Annex	Ref. No.
Benzidine acetate	Carc. 1A	Anx. II	717
Benzidine dihydrochloride	Carc. 1A	Anx. II	713
Benzidine sulphate	Carc. 1A	Anx. II	716
Biphenyl-4-ylamine (4-Aminobiphenyl) and its salts	Carc. 1A	Anx. II	726
Chloromethyl methyl ether	Carc. 1A	Anx. II	664
Cobalt lithium nickel oxide	Carc. 1A	Anx. II	1464
Cobalt nickel gray periclase; C.I. Pigment Black 25; C.I. 77332 [1]; Cobalt nickel dioxide [2]; Cobalt nickel oxide [3]; Nickel arsenide [2]	Carc. 1A	Anx. II	1449
Crocidolite	Carc. 1A	Anx. II	762
Dialuminium nickel tetraoxide [1]; Nickel titanium trioxide [2]; Nickel titanium oxide [3]; Nickel divanadium hexaoxide [4]; Cobalt dimolybdenum nickel octaoxide [5]; Nickel zirkonium trioxide [6]; Molybdenum nickel tetraoxide [7]; Nickel tungsten tetraoxide [8]; Olivine, nickel green [9]; Lithium nickel dioxide [10]; Molybdenum nickel oxide [11]	Carc. 1A	Anx. II	1463
Diammonium nickel hexacyanoferrate	Carc. 1A	Anx. II	1439
Dinickel hexacyanoferrate	Carc. 1A	Anx. II	1443
Dinickel trioxide	Carc. 1A	Anx. II	456
Distillates (coal-petroleum), condensed-ring arom., if they contain > 0.005 % w/w benzo[a]pyrene	Carc. 1A	Anx. II	614
Distillates (petroleum), acid-treated heavy naphthenic	Carc. 1A	Anx. II	972
Distillates (petroleum), acid-treated heavy paraffinic	Carc. 1A	Anx. II	974
Distillates (petroleum), acid-treated light naphthenic	Carc. 1A	Anx. II	973
Distillates (petroleum), acid-treated light paraffinic	Carc. 1A	Anx. II	975
Distillates (petroleum), chemically neutralized heavy naphthenic	Carc. 1A	Anx. II	978
Distillates (petroleum), chemically neutralized heavy paraffinic	Carc. 1A	Anx. II	976
Distillates (petroleum), chemically neutralized light naphthenic	Carc. 1A	Anx. II	979
Distillates (petroleum), chemically neutralized light paraffinic	Carc. 1A	Anx. II	977
Distillates (petroleum), heavy naphthenic	Carc. 1A	Anx. II	971
Distillates (petroleum), heavy paraffinic	Carc. 1A	Anx. II	969
Distillates (petroleum), light naphthenic	Carc. 1A	Anx. II	970
Distillates (petroleum), light paraffinic	Carc. 1A	Anx. II	968
Erionite	Carc. 1A	Anx. II	761
Nickel barium titanium primrose priderite; C.I. Pigment Yellow 157; C.I. 77900	Carc. 1A	Anx. II	1458
Nickel boride (NiB) [1]; Dinickel boride [2]; Trinickel boride [3]; Nickel boride [4]; Dinickel silicide [5]; Nickel disilicide [6];Dinickel phosphide [7]; Nickel boron phosphide [8]	Carc. 1A	Anx. II	1462
Nickel chromate	Carc. 1A	Anx. II	1441
Nickel diarsenide [1]; Nickel arsenide [2]	Carc. 1A	Anx. II	1457
Nickel dicyanide	Carc. 1A	Anx. II	1440
Nickel dioxide	Carc. 1A	Anx. II	457
Nickel hydrogen phosphate [1]; Nickel bis(dihydrogen phosphate) [2]; Trinickel bis(orthophosphate) [3]; Dinickel diphosphate [4]; Nickel bis(phosphinate) [5]; Nickel phosphinate [6]; Phosphoric acid, calcium nickel salt [7]; Diphosphoric acid, nickel(II) salt [8]	Carc. 1A	Anx. II	1438
Nickel matte	Carc. 1A	Anx. II	1421
Nickel monoxide [1]; nickel oxide [2]; bunsenite [3]	Carc. 1A	Anx. II	455
Nickel oxalate [1]; Oxalic acid, nickel salt [2]	Carc. 1A	Anx. II	1445
Nickel selenide	Carc. 1A	Anx. II	1455
Nickel telluride	Carc. 1A	Anx. II	1446
Nickel tin trioxide; nickel stannate	Carc. 1A	Anx. II	1450
Nickel triuranium decaoxide	Carc. 1A	Anx. II	1451
Nickel(II) selenite	Carc. 1A	Anx. II	1454
Nickel(II) silicate [1]; Dinickel orthosilicate [2]; Nickel silicate (3:4) [3]; Silicic acid, nickel salt [4]; Trihydrogen hydroxybis[orthosilicato(4-)]trinickelate(3-) [5]	Carc. 1A	Anx. II	1442
Nickel(II) sulfite [1]; Nickel tellurium trioxide [2]; Nickel tellurium tetraoxide [3]; Molybdenum nickel hydroxide oxide phosphate [4]	Carc. 1A	Anx. II	1461
Trinickel bis(arsenate); nickel(II) arsenate	Carc. 1A	Anx. II	1444
Trinickel bis(arsenite)	Carc. 1A	Anx. II	1448
Trinickel tetrasulfide	Carc. 1A	Anx. II	1447
Vinyl chloride monomer	Carc. 1A	Anx. II	334
[[1,1'-Biphenyl]-4,4'-diyl]diammonium sulphate	Carc. 1A	Anx. II	714
Benzene	Carc. 1AMuta. 1B	Anx. II	47
Buta-1,3-diene, see also entries 464-611	Carc. 1AMuta. 1B	Anx. II	463
Butane, if it contains = >0,1 % w/w Butadiene	Carc. 1AMuta. 1B	Anx. II	465
Gases (petroleum), hydrogen absorber off, if they contain > 0,1% w/w Butadiene	Carc. 1AMuta. 1B	Anx. II	523
Isobutane, if it contains = >0,1% w/w Butadiene	Carc. 1AMuta. 1B	Anx. II	464
Petroleum, coal, tar and natural gas and their derivatives generated using distillation and/or other processing methods if they contain = 0,1 % w/w 1,3-butadiene	Carc. 1AMuta. 1B	Anx. II	1542
Tail gas (petroleum), isomerized naphtha fractionation stabilizer, if it contains > 0,1% w/w Butadiene	Carc. 1AMuta. 1B	Anx. II	476
Nickel (II) sulfide [1]; nickel sulfide [2]; millerite[3]	Carc. 1AMuta. 2	Anx. II	460
Trinickel disulfide; nickel subsulfied [1]; heazlewoodite [2]	Carc. 1AMuta. 2	Anx. II	458
Silicic acid, lead nickel salt	Carc. 1ARepr. 1A	Anx. II	1456
Nickel bis(tetrafluoroborate)	Carc. 1ARepr. 1BMuta. 2	Anx. II	1401
Nickel carbonate; basic nickel carbonate; carbonic acid, nickel (2+) salt [1]; carbonic acid, nickel salt [2]; [micro-[carbonato(2-)-O:O']]dihydroxy trinickel [3]; [carbonato(2-)]tetrahydroxytrinickel [4]	Carc. 1ARepr. 1BMuta. 2	Anx. II	1060
Nickel dihydroxide [1]; nickel hydroxide [2]	Carc. 1ARepr. 1BMuta. 2	Anx. II	1006
Nickel sulphate	Carc. 1ARepr. 1BMuta. 2	Anx. II	1100
Oxybis[chloromethane]; bis (Chloromethyl) ether	Carc. 1A· C≥0.001%	Anx. II	667
Benzidine	Carc. 1A· C≥0.01%	Anx. II	26
3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein (INN))	Carc. 1A· C≥1%Carc. 1BMuta. 2Repr. 2	Anx. II	417
(6-(4-Hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazine-2,4-diyl)bis[(amino-1-methylethyl)ammonium] formate	Carc. 1B	Anx. II	757
(Epoxyethyl)benzene (Styrene oxide)	Carc. 1B	Anx. II	656
(Methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1'-dipyridinium dichloride dihydrochloride	Carc. 1B	Anx. II	1155
1,2-Dibromoethane	Carc. 1B	Anx. II	651
1,2-Dichloropropane; propylene dichloride	Carc. 1B	Anx. II	1625
1,3-Dichloropropan-2-ol	Carc. 1B	Anx. II	648
1,3-Propanesultone	Carc. 1B	Anx. II	751
1,4,5,8-Tetraaminoanthraquinone (Disperse Blue 1)	Carc. 1B	Anx. II	700
1-(2-Amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochloride	Carc. 1B	Anx. II	1474
1-Chloro-2,3-epoxypropane (Epichlorohydrin)	Carc. 1B	Anx. II	657
2,4,5-Trimethylaniline [1]; 2,4,5-trimethylaniline hydrochloride [2]	Carc. 1B	Anx. II	1158
2-Nitroanisole	Carc. 1B	Anx. II	685
2-Nitronaphthalene	Carc. 1B	Anx. II	689
2-Nitropropane	Carc. 1B	Anx. II	683
3,3'-Dichlorobenzidine	Carc. 1B	Anx. II	712
3,3'-Dimethoxybenzidine (ortho-Dianisidine) and its salts	Carc. 1B	Anx. II	709
3-Amino-9-ethyl carbazole; 9-ethylcarbazol-3-ylamine	Carc. 1B	Anx. II	1523
4,4'-(4-Iminocyclohexa-2,5-dienylidenemethylene) dianiline hydrochloride	Carc. 1B	Anx. II	706
4,4'-Bi-o-toluidine (ortho-Tolidine)	Carc. 1B	Anx. II	721
4,4'-Bi-o-toluidine dihydrochloride	Carc. 1B	Anx. II	722
4,4'-Bi-o-toluidine sulphate	Carc. 1B	Anx. II	724
4,4'-Methylenedi-o-toluidine	Carc. 1B	Anx. II	707
4,4'-Thiodianiline and its salts	Carc. 1B	Anx. II	1159
4-Amino-3-fluorophenol	Carc. 1B	Anx. II	1242
4-Aminoazobenzene	Carc. 1B	Anx. II	990
4-Nitrobiphenyl	Carc. 1B	Anx. II	686
4-o-Tolylazo-o-toluidine	Carc. 1B	Anx. II	989
5-Nitroacenaphthene	Carc. 1B	Anx. II	691
6-Hydroxy-1-(3-Isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrile	Carc. 1B	Anx. II	756
6-Methoxy-m-toluidine (p-Cresidine)	Carc. 1B	Anx. II	1162
Absorption oils, bicyclo arom. and heterocylic hydrocarbon fraction, if they contain > 0.005 % w/w benzo[a]pyrene	Carc. 1B	Anx. II	632
Acrylonitrile	Carc. 1B	Anx. II	682
Alkanes, C12-26-branched and linear, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen	Carc. 1B	Anx. II	881
Anthracene oil	Carc. 1B	Anx. II	38
Anthraquinone; 9,10-anthraquinone	Carc. 1B	Anx. II	1603

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Annex II — Prohibited substances Annex III — Restricted substances Recently prohibited CosIng search Guide: ECHA, SVHC and CLP for cosmetics Guide: how to read the annexes Guide: CMR substances in cosmetics

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Data source: official CosIng from the European Commission. BD-API does not replace professional regulatory advice.

CMR substances (Categories 1A, 1B and 2) in EU cosmetics

What are CMR substances?

CMR substances in CosIng

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