Art. 15 — Reglamento (CE) 1223/2009

Sustancias clasificadas CMR (Categorías 1A, 1B y 2) en cosmética UE

1.035sustancias clasificadas CMR

¿Qué son las sustancias CMR?

Las sustancias CMR son aquellas clasificadas como Carcinógenas (Carc.), Mutágenas (Muta.) o Tóxicas para la Reproducción (Repr.) según el Reglamento (CE) n.º 1272/2008 (CLP). Las categorías son: 1A (efecto conocido, con evidencia en humanos), 1B (efecto presumido, principalmente con base en datos en animales) y 2 (efecto sospechado, con evidencia limitada).

El artículo 15 del Reglamento (CE) 1223/2009 prohíbe el uso de sustancias CMR categorías 1A, 1B y 2 en productos cosméticos. Las excepciones difieren según la categoría: una sustancia de categoría 2 puede usarse solo si el SCCS la ha evaluado y considerado segura para uso cosmético. Las de categoría 1A o 1B requieren además cumplir todas las condiciones del artículo 15: seguridad alimentaria (Reglamento (CE) 178/2002), ausencia de alternativas adecuadas documentada, uso concreto con exposición conocida, y evaluación favorable del SCCS. Cómo funciona el mecanismo completo (CLP → Art. 15 → Anexo II) →

Esta lista se actualiza periódicamente mediante Reglamentos de la Comisión Europea (los Reglamentos «Ómnibus» CMR), conforme a las actualizaciones del Reglamento CLP. BD-API sincroniza estos cambios automáticamente y notifica a los sistemas conectados, garantizando que las formulaciones se auditen siempre contra la versión vigente.

Sustancias CMR en CosIng

Nombre INCIClasificación CMRAnexoRef. No.
Benzidine acetateCarc. 1AAnx. II717
Benzidine dihydrochlorideCarc. 1AAnx. II713
Benzidine sulphateCarc. 1AAnx. II716
Biphenyl-4-ylamine (4-Aminobiphenyl) and its saltsCarc. 1AAnx. II726
Chloromethyl methyl etherCarc. 1AAnx. II664
Cobalt lithium nickel oxideCarc. 1AAnx. II1464
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. 1AAnx. II1449
CrocidoliteCarc. 1AAnx. II762
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. 1AAnx. II1463
Diammonium nickel hexacyanoferrateCarc. 1AAnx. II1439
Dinickel hexacyanoferrateCarc. 1AAnx. II1443
Dinickel trioxideCarc. 1AAnx. II456
Distillates (coal-petroleum), condensed-ring arom., if they contain > 0.005 % w/w benzo[a]pyreneCarc. 1AAnx. II614
Distillates (petroleum), acid-treated heavy naphthenicCarc. 1AAnx. II972
Distillates (petroleum), acid-treated heavy paraffinicCarc. 1AAnx. II974
Distillates (petroleum), acid-treated light naphthenicCarc. 1AAnx. II973
Distillates (petroleum), acid-treated light paraffinicCarc. 1AAnx. II975
Distillates (petroleum), chemically neutralized heavy naphthenicCarc. 1AAnx. II978
Distillates (petroleum), chemically neutralized heavy paraffinicCarc. 1AAnx. II976
Distillates (petroleum), chemically neutralized light naphthenicCarc. 1AAnx. II979
Distillates (petroleum), chemically neutralized light paraffinicCarc. 1AAnx. II977
Distillates (petroleum), heavy naphthenicCarc. 1AAnx. II971
Distillates (petroleum), heavy paraffinicCarc. 1AAnx. II969
Distillates (petroleum), light naphthenicCarc. 1AAnx. II970
Distillates (petroleum), light paraffinicCarc. 1AAnx. II968
ErioniteCarc. 1AAnx. II761
Nickel barium titanium primrose priderite; C.I. Pigment Yellow 157; C.I. 77900Carc. 1AAnx. II1458
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. 1AAnx. II1462
Nickel chromateCarc. 1AAnx. II1441
Nickel diarsenide [1]; Nickel arsenide [2]Carc. 1AAnx. II1457
Nickel dicyanideCarc. 1AAnx. II1440
Nickel dioxideCarc. 1AAnx. II457
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. 1AAnx. II1438
Nickel matteCarc. 1AAnx. II1421
Nickel monoxide [1]; nickel oxide [2]; bunsenite [3]Carc. 1AAnx. II455
Nickel oxalate [1]; Oxalic acid, nickel salt [2]Carc. 1AAnx. II1445
Nickel selenideCarc. 1AAnx. II1455
Nickel tellurideCarc. 1AAnx. II1446
Nickel tin trioxide; nickel stannateCarc. 1AAnx. II1450
Nickel triuranium decaoxideCarc. 1AAnx. II1451
Nickel(II) seleniteCarc. 1AAnx. II1454
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. 1AAnx. II1442
Nickel(II) sulfite [1]; Nickel tellurium trioxide [2]; Nickel tellurium tetraoxide [3]; Molybdenum nickel hydroxide oxide phosphate [4]Carc. 1AAnx. II1461
Trinickel bis(arsenate); nickel(II) arsenateCarc. 1AAnx. II1444
Trinickel bis(arsenite)Carc. 1AAnx. II1448
Trinickel tetrasulfideCarc. 1AAnx. II1447
Vinyl chloride monomerCarc. 1AAnx. II334
[[1,1'-Biphenyl]-4,4'-diyl]diammonium sulphateCarc. 1AAnx. II714
BenzeneCarc. 1AMuta. 1BAnx. II47
Buta-1,3-diene, see also entries 464-611Carc. 1AMuta. 1BAnx. II463
Butane, if it contains = >0,1 % w/w ButadieneCarc. 1AMuta. 1BAnx. II465
Gases (petroleum), hydrogen absorber off, if they contain > 0,1% w/w ButadieneCarc. 1AMuta. 1BAnx. II523
Isobutane, if it contains = >0,1% w/w ButadieneCarc. 1AMuta. 1BAnx. II464
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-butadieneCarc. 1AMuta. 1BAnx. II1542
Tail gas (petroleum), isomerized naphtha fractionation stabilizer, if it contains > 0,1% w/w ButadieneCarc. 1AMuta. 1BAnx. II476
Nickel (II) sulfide [1]; nickel sulfide [2]; millerite[3]Carc. 1AMuta. 2Anx. II460
Trinickel disulfide; nickel subsulfied [1]; heazlewoodite [2]Carc. 1AMuta. 2Anx. II458
Silicic acid, lead nickel saltCarc. 1ARepr. 1AAnx. II1456
Nickel bis(tetrafluoroborate)Carc. 1ARepr. 1BMuta. 2Anx. II1401
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. 2Anx. II1060
Nickel dihydroxide [1]; nickel hydroxide [2]Carc. 1ARepr. 1BMuta. 2Anx. II1006
Nickel sulphateCarc. 1ARepr. 1BMuta. 2Anx. II1100
Oxybis[chloromethane]; bis (Chloromethyl) etherCarc. 1A· C≥0.001%Anx. II667
BenzidineCarc. 1A· C≥0.01%Anx. II26
3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein (INN))Carc. 1A· C≥1%Carc. 1BMuta. 2Repr. 2Anx. II417
(6-(4-Hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazine-2,4-diyl)bis[(amino-1-methylethyl)ammonium] formateCarc. 1BAnx. II757
(Epoxyethyl)benzene (Styrene oxide)Carc. 1BAnx. II656
(Methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1'-dipyridinium dichloride dihydrochlorideCarc. 1BAnx. II1155
1,2-DibromoethaneCarc. 1BAnx. II651
1,2-Dichloropropane; propylene dichlorideCarc. 1BAnx. II1625
1,3-Dichloropropan-2-olCarc. 1BAnx. II648
1,3-PropanesultoneCarc. 1BAnx. II751
1,4,5,8-Tetraaminoanthraquinone (Disperse Blue 1)Carc. 1BAnx. II700
1-(2-Amino-5-chlorophenyl)-2,2,2-trifluoro-1,1-ethanediol, hydrochlorideCarc. 1BAnx. II1474
1-Chloro-2,3-epoxypropane (Epichlorohydrin)Carc. 1BAnx. II657
2,4,5-Trimethylaniline [1]; 2,4,5-trimethylaniline hydrochloride [2]Carc. 1BAnx. II1158
2-NitroanisoleCarc. 1BAnx. II685
2-NitronaphthaleneCarc. 1BAnx. II689
2-NitropropaneCarc. 1BAnx. II683
3,3'-DichlorobenzidineCarc. 1BAnx. II712
3,3'-Dimethoxybenzidine (ortho-Dianisidine) and its saltsCarc. 1BAnx. II709
3-Amino-9-ethyl carbazole; 9-ethylcarbazol-3-ylamineCarc. 1BAnx. II1523
4,4'-(4-Iminocyclohexa-2,5-dienylidenemethylene) dianiline hydrochlorideCarc. 1BAnx. II706
4,4'-Bi-o-toluidine (ortho-Tolidine)Carc. 1BAnx. II721
4,4'-Bi-o-toluidine dihydrochlorideCarc. 1BAnx. II722
4,4'-Bi-o-toluidine sulphateCarc. 1BAnx. II724
4,4'-Methylenedi-o-toluidineCarc. 1BAnx. II707
4,4'-Thiodianiline and its saltsCarc. 1BAnx. II1159
4-Amino-3-fluorophenolCarc. 1BAnx. II1242
4-AminoazobenzeneCarc. 1BAnx. II990
4-NitrobiphenylCarc. 1BAnx. II686
4-o-Tolylazo-o-toluidineCarc. 1BAnx. II989
5-NitroacenaphtheneCarc. 1BAnx. II691
6-Hydroxy-1-(3-Isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrileCarc. 1BAnx. II756
6-Methoxy-m-toluidine (p-Cresidine)Carc. 1BAnx. II1162
Absorption oils, bicyclo arom. and heterocylic hydrocarbon fraction, if they contain > 0.005 % w/w benzo[a]pyreneCarc. 1BAnx. II632
AcrylonitrileCarc. 1BAnx. II682
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 carcinogenCarc. 1BAnx. II881
Anthracene oilCarc. 1BAnx. II38
Anthraquinone; 9,10-anthraquinoneCarc. 1BAnx. II1603

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Fuente del dato: CosIng oficial de la Comisión Europea. BD-API no reemplaza el asesoramiento regulatorio profesional.