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Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)

Type Regulation
Publication 2009-11-30
Last updated 2026-05-01
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 42
Reform history JSON API

ANNEX IV

Preamble

Without prejudice to other provisions in this Regulation, a colorant shall include its salts and lakes and when a colorant is expressed as a specific salt, its other salts and lakes shall also be included.

Reference number Substance identification Conditions Wording of conditions of use and warnings
Chemical Name Colour index Number/Name of Common Ingredients Glossary CAS number EC number Colour Product type, Body parts Maximum concentration in ready for use preparation Other
a b c d e f g h i j
1 Sodium tris(1,2-naphthoquinone 1-oximato-O,O')ferrate(1-) 10006 Green Rinse-off products
2 Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-) 10020 Green Not to be used in products applied on mucous membranes
3 Disodium 5,7-dinitro-8-oxidonaphthalene-2-sulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments 10316 Yellow Not to be used in eye products
4 2-[(4-Methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide 11680 Yellow Not to be used in products applied on mucous membranes
5 2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide 11710 Yellow Not to be used in products applied on mucous membranes
6 2-[(4-Methoxy-2-nitrophenyl)azo]-3-oxo-N-(o-tolyl)butyramide 11725 Orange Rinse-off products
7 4-(Phenylazo)resorcinol 11920 Orange
8 4-[(4-Ethoxyphenyl)azo]naphthol 12010 Red Not to be used in products applied on mucous membranes
9 1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol and its insoluble barium, strontium and zirconium lakes, salts and pigments 12085 Red 3 %
10 1-[(4-Methyl-2-nitrophenyl)azo]-2-naphthol 12120 Red Rinse-off products
11 3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide 12370 Red Rinse-off products
12 N-(4-Chloro-2-methylphenyl)-4-[(4-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide 12420 Red Rinse-off products
13 4-[(2,5-Dichlorophenyl)azo]-N-(2,5-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide 12480 Brown Rinse-off products
14 N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide 12490 Red
15 2,4-Dihydro-5-methyl-2-phenyl-4-(phenylazo)-3H-pyrazol-3-one 12700 Yellow Rinse-off products
16 Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate 13015 Yellow
17 Sodium 4-(2,4-dihydroxyphenylazo)benzenesulphonate 14270 Orange
18 Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate 14700 Red
19 Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate 14720 222-657-4 Red Purity criteria as set out in Commission Directive 95/45/EC (E 122)
20 Disodium 6-[(2,4-dimethyl-6-sulphonatophenyl)azo]-5-hydroxynaphthalene-1-sulphonate 14815 Red
21 Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments 15510 Orange Not to be used in eye products
22 Calcium disodium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]-4-sulphonatobenzoate] 15525 Red
23 Barium bis[4-[(2-hydroxy-1-naphthyl)azo]-2-methylbenzenesul-phonate] 15580 Red
24 Sodium 4-[(2-Hydroxy-1-naphthyl)azo]naphthalenesulphonate 15620 Red Rinse-off products
25 Sodium 2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments 15630 Red 3 %
26 Calcium bis[3-hydroxy-4-(phenylazo)-2-naphthoate] 15800 Red Not to be used in products applied on mucous membranes
27 Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate and its insoluble barium, strontium and zirconium lakes, salts and pigments 15850 226-109-5 Red Purity criteria as set out in Commission Directive 95/45/EC (E 180)
28 Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate and its insoluble barium, strontium and zirconium lakes, salts and pigments 15865 Red
29 Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate 15880 Red
30 Disodium 6-hydroxy-5-[(3-sulphonatophenyl)azo]naphthalene-2-sulphonate 15980 Orange
31 Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments 15985 220-491-7 Yellow Purity criteria as set out in Commission Directive 95/45/EC (E 110)
32 Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate 16035 247-368-0 Red Purity criteria as set out in Commission Directive 95/45/EC (E 129)
33 Trisodium 3-hydroxy-4-[(4'-sulphonatonaphthyl)azo]naphthalene-2,7-disulphonate 16185 213-022-2 Red Purity criteria as set out in Commission Directive 95/45/EC (E 123)
34 Disodium 7-hydroxy-8-(phenylazo)naphthalene-1,3-disulphonate 16230 Orange Not to be used in products applied on mucous membranes
35 Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments 16255 220-036-2 Red Purity criteria as set out in Commission Directive 95/45/EC (E 124)
36 Tetrasodium 7-hydroxy-8-[(4-sulphonato-1-naphthyl)azo]naphthalene-1,3,6-trisulphonate 16290 Red
37 Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments 17200 Red
38 Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate 18050 223-098-9 Red Not to be used in products applied on mucous membranes Purity criteria as set out in Commission Directive 95/45/EC (E 128)
39 2,7-Naphthalenedisulfonic acid, 3-((4-cyclohexyl-2-methylphenyl)azo)-4-hydroxy-5-(((4-methylphenyl)sulfonyl)amino)-, disodium salt 18130 Red Rinse-off products
40 Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-) 18690 Yellow Rinse-off products
41 Disodium hydrogen bis[5-chloro-3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxybenzenesulphonato(3-)]chromate(3-) 18736 Red Rinse-off products
42 Sodium 4-(3-hydroxy-5-methyl-4-(phenylazo)pyrazol-2-yl)benzenesulphonate 18820 Yellow Rinse-off products
43 Disodium 2,5-dichloro-4-(5-hydroxy-3-methyl-4-((sulphophenyl)azo)pyrazol-1-yl)benzenesulphonate 18965 Yellow
44 Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-((4-sulphophenyl)azo)pyrazole-3-carboxylate and its insoluble barium, strontium and zirconium lakes, salts and pigments 19140 217-699-5 Yellow Purity criteria as set out in Commission Directive 95/45/EC (E 102)
45 N,N'-(3,3'-Dimethyl[1,1'-biphenyl]-4,4'-diyl)bis[2-[(2,4-dichlorophenyl)azo]-3-oxobutyramide] 20040 Yellow Rinse-off products Maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
46 Sodium 4-amino-5-hydroxy-3-((4-nitrophenyl)azo)-6-(phenylazo)naphthalene-2,7-disulphonate 20470 Black Rinse-off products
47 2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] 21100 Yellow Rinse-off products Maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
48 2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide] 21108 Yellow Rinse-off products Maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
49 2,2'-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] 21230 Yellow Not to be used in products applied on mucous membranes
50 Disodium 4,6-dihydroxy-3-[[4-[1-[4-[[1-hydroxy-7-[(phenylsulphonyl)oxy]-3-sulphonato-2-naphthyl]azo]phenyl]cyclohexyl]phenyl]azo]naphthalene-2-sulphonate 24790 Red Rinse-off products
51 1-(4-(Phenylazo)phenylazo)-2-naphthol 26100 Red Not to be used in products applied on mucous membranes Purity criteria: aniline ≤ 0,2 % 2-naphtol ≤ 0,2 % 4-aminoazobenzene ≤ 0,1 % 1-(phenylazo)-2-naphtol ≤ 3 % 1-[2-(phenylazo)phenylazo]-2-napthalenol ≤ 2 %
52 Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate 27755 Black
53 Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate 28440 219-746-5 Black Purity criteria as set out in Commission Directive 95/45/EC (E 151)
54 Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo] benzenesulfonic acid, sodium salts 40215 Orange Rinse-off products
55 beta Carotene 40800 230-636-6 Orange Purity criteria as set out in Commission Directive 95/45/EC (E160a)
56 8'-apo-.beta.-Caroten-8'-al 40820 Orange Purity criteria as set out in Commission Directive 95/45/EC (E 160e)
57 Ethyl 8'-apo-.beta.-caroten-8'-oate 40825 214-173-7 Orange Purity criteria as set out in Commission Directive 95/45/EC (E 160f)
58 Canthaxanthin 40850 208-187-2 Orange Purity criteria as set out in Commission Directive 95/45/EC (E 161g)
59 Ammonium, (4-(alpha-(p-(diethylamino)phenyl)-2,4-disulfobenzylidene)-2,5-cyclohexadien-1-ylidene)diethyl-, hydroxide, monosodium salt 42045 Blue Not to be used in products applied on mucous membranes
60 Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) and its insoluble barium, strontium and zirconium lakes, salts and pigments 42051 222-573-8 Blue Purity criteria as set out in Commission Directive 95/45/EC (E 131)
61 Benzene-methanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino) phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt 42053 Green
62 Hydrogen (benzyl)4-[[4-[benzylethylamino]phenyl](2,4-disulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylideneammonium, sodium salt 42080 Blue Rinse-off products
63 Benzene-methanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino) phenyl)(2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt 42090 223-339-8 Blue Purity criteria as set out in Commission Directive 95/45/EC (E 133)
64 Hydrogen 4-[(2-chlorophenyl)[4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene(3-sulphonatobenzyl)ammonium, sodium salt 42100 Green Rinse-off products
65 Hydrogen 4-[(2-chlorophenyl)[4-[ethyl(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene(3-sulphonatobenzyl)ammonium, sodium salt 42170 Green Rinse-off products
66 (4-(4-Aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride 42510 Violet Not to be used in products applied on mucous membranes
67 4-[(4-Amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride 42520 Violet Rinse-off products 5ppm
68 Hydrogen [4-[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene(3-sulphonatobenzyl)ammonium, sodium salt 42735 Blue Not to be used in products applied on mucous membranes
69 [4-[[4-Anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride 44045 Blue Not to be used in products applied on mucous membranes
70 Hydrogen [4-[4-(dimethylamino)-.alpha.-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt 44090 221-409-2 Green Purity criteria as set out in Commission Directive 95/45/EC (E 142)
71 Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt 45100 Red Rinse-off products
72 Hydrogen 9-(2-carboxylatophenyl)-3-(2-methylanilino)-6-(2-methyl-4-sulphoanilino)xanthylium, monosodium salt 45190 Violet Rinse-off products
73 Hydrogen 9-(2,4-disulphonatophenyl)-3,6-bis(ethylamino)-2,7-dimethylxanthylium, monosodium salt 45220 Red Rinse-off products
74 Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate 45350 Yellow 6 %
75 4',5'-Dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one and its insoluble barium, strontium and zirconium lakes, salts and pigments 45370 Orange Not more than 1 % 2-(6-hydroxy-3-oxo-3H-xanthen-9-y1) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
76 Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate and its insoluble barium, strontium and zirconium lakes, salts and pigments 45380 Red Not more than 1 % 2-(6-hydroxy-3-oxo-3H-xanthen-9-y1) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
77 3',6'-Dihydroxy-4',5'-dinitrospiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one 45396 Orange 1 %, when used in lip products Only in free acid form, when used in lip products
78 Dipotassium 3,6-dichloro-2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate 45405 Red Not to be used in eye products Not more than 1 % 2-(6-hydroxy-3-oxo-3Η xanthen-9-yl) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
79 3,4,5,6-Tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid and its insoluble barium, strontium and zirconium lakes, salts and pigments 45410 Red Not more than 1 % 2-(6-hydroxy-3-oxo-3Η xanthen-9-yl) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
80 Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate and its insoluble barium, strontium and zirconium lakes, salts and pigments 45430 240-474-8 Red Purity criteria as set out in Commission Directive 95/45/EC (E 127)
81 1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline 47000 Yellow Not to be used in products applied on mucous membranes
82 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts 47005 305-897-5 Yellow Purity criteria as set out in Commission Directive 95/45/EC (E 104)
83 Hydrogen 9-[(3-methoxyphenyl)amino]-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, sodium salt 50325 Violet Rinse-off products
84 Sulfonated nigrosine color 50420 Black Not to be used in products applied on mucous membranes
85 8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3',2'-m]triphenodioxazine 51319 Violet Rinse-off products
86 1,2-Dihydroxyanthraquinone 58000 Red
87 Trisodium 8-hydroxypyrene-1,3,6-trisulphonate 59040 Green Not to be used in products applied on mucous membranes
88 1-Anilino-4-hydroxyanthraquinone 60724 Violet Rinse-off products
89 1-Hydroxy-4-(p-toluidino)anthraquinone 60725 Violet
90 Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate 60730 Violet Not to be used in products applied on mucous membranes
91 1,4-bis(p-Tolylamino)anthraquinone 61565 Green
92 Disodium 2,2'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate) 61570 Green
93 Sodium 3,3'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(2,4,6-trimethylbenzenesulphonate) 61585 Blue Rinse-off products
94 Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate 62045 Blue Rinse-off products
95 6,15-Dihydroanthrazine-5,9,14,18-tetrone 69800 Blue
96 7,16-dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone 69825 Blue
97 Bisbenzimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione 71105 Orange Not to be used in products applied on mucous membranes
98 2-(1,3-Dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one 73000 Blue
99 Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate 73015 212-728-8 Blue Purity criteria as set out in Commission Directive 95/45/EC (E 132)
100 6-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one 73360 Red
101 5-Chloro-2-(5-chloro-7-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-7-methylbenzo[b]thiophene-3(2H)-one 73385 Violet
102 5,12-Dihydroquino[2,3-b]acridine-7,14-dione 73900 Violet Rinse-off products
103 5,12-Dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione 73915 Red Rinse-off products
104 29H,31H-Phthalocyanine 74100 Blue Rinse-off products
105 29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32 copper 74160 Blue
106 Disodium [29H,31H-phthalocyaninedisulphonato (4-)-N29,N30,N31,N32] cuprate (2-) 74180 Blue Rinse-off products
107 Polychloro copper phthalocyanine 74260 Green Not to be used in eye products
108 8,8'-diapo-.psi.,.psi.-Carotenedioic acid 75100 Yellow
109 Annatto 75120 215-735-4/289-561-2/230-248-7 Orange Purity criteria as set out in Commission Directive 95/45/EC (E 160b)
110 Lycopene 75125 — Yellow Purity criteria as set out in Commission Directive 95/45/EC (E 160d)
111 CI Food Orange 5 75130 214-171-6 Orange Purity criteria as set out in Commission Directive 95/45/EC (E 160a)
112 (3R)-beta-4-Caroten-3-ol 75135 Yellow
113 2-Amino-1,7-dihydro-6H-purin-6-one 75170 White
114 Curcumins 75300 207-280-5 Yellow Purity criteria as set out in Commission Directive 95/45/EC (E 100)
115 Carmines 75470 215-680-6/215-023-3/215-724-4 Red Purity criteria as set out in Commission Directive 95/45/EC (E 120)
116 Trisodium (2S-trans)-[18-carboxy-20-(carboxymethyl)-13-ethyl-2,3-dihydro-3,7,12,17-tetramethyl-8-vinyl-21H,23H-porphine-2-propionato(5-)-N21,N22,N23,N24]cuprate(3-) (Chlorophylls) 75810 215-800-7/207-536-6/208-272-4/287-483-3/239-830-5/246-020-5 Green Purity criteria as set out in Commission Directive 95/45/EC (E 140, E 141)
117 Aluminium 77000 231-072-3 White Purity criteria as set out in Commission Directive 95/45/EC (E 173)
118 Aluminium hydroxide sulphate 77002 White
119 Natural hydrated aluminium silicate, Al2O3.2SiO2.2H2O, containing calcium, magnesium or iron carbonates, ferric hydroxide, quartz-sand, mica, etc. as impurities 77004 White
120 Lazurite 77007 Blue
121 Aluminum silicate coloured with ferric oxide 77015 Red
122 Barium sulfate 77120 White
123 Bismuth chloride oxide 77163 White
124 Calcium carbonate 77220 207-439-9/215-279-6 White Purity criteria as set out in Commission Directive 95/45/EC (E 170)
125 Calcium sulfate 77231 White
126 Carbon black 77266 1333-86-4, 7440-44-0 215-609-9, 231-153-3, 931-328-0, 931-334-3 Black Purity > 97 %, with the following impurity profile: Ash content ≤ 0,15 %, total sulphur ≤ 0,65 %, total PAH ≤ 500 ppb and benzo(a)pyrene ≤ 5 ppb, dibenz(a,h)anthracene ≤ 5 ppb, total As ≤ 3 ppm, total Pb ≤ 10 ppm, total Hg ≤ 1 ppm.
126a Carbon black 77266 (nano) Carbon Black (nano) 1333-86-4, 7440-44-0 215-609-9, 231-153-3, 931-328-0, 931-334-3 Black 10 % Not to be used in applications that may lead to exposure of the end user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: — Purity > 97 %, with the following impurity profile: Ash content ≤ 0,15 %, total sulphur ≤ 0,65 %, total PAH ≤ 500 ppb and benzo(a)pyrene ≤ 5 ppb, dibenz(a,h)anthracene ≤ 5 ppb, total As ≤ 3 ppm, total Pb ≤ 10 ppm, and total Hg ≤ 1 ppm; — Primary particle size ≥ 20 nm.
127 Charcoal, bone. A fine black powder obtained by burning animal bones in a closed container. It consists primarily of calcium phosphate and carbon 77267 Black
128 Coke black 77268:1 Black
129 Chromium (III) oxide 77288 Green free from chromate ion
130 Chromium (III) hydroxide 77289 Green free from chromate ion
131 Cobalt Aluminum Oxide 77346 Green
132 Copper 77400 Brown
133 Gold 77480 231-165-9 Brown Purity criteria as set out in Commission Directive 95/45/EC (E 175)
134 Iron oxide 77489 Orange
135 Iron Oxide Red 77491 215-168-2 Red Purity criteria as set out in Commission Directive 95/45/EC (E 172)
136 Iron Oxide Yellow 77492 51274-00-1 257-098-5 Yellow Purity criteria as set out in Commission Directive 95/45/EC (E 172)
137 Iron Oxide Black 77499 235-442-5 Black Purity criteria as set out in Commission Directive 95/45/EC (E 172)
138 Ferric Ammonium Ferrocyanide 77510 Blue free from cyanide ions
139 Magnesium carbonate 77713 White
140 Ammonium manganese(3+) diphosphate 77742 Violet
141 Trimanganese bis (orthophosphate) 77745 Red
142 Silver (powder) [100 nm < particle diameter < 1 mm] 77820 7440-22-4 231-131-3 White (a) Lip products (b) Eye shadow For (a) and (b): 0,2 %
143 Titanium dioxide (1) 77891 236-675-5 White — Purity criteria as set out in Commission Directive 95/45/E (E 171) — Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No 321
144 Zinc oxide (2) 77947 1314-13-2 215-222-5 White Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.
145 Riboflavin Lactoflavin 201-507-1/204-988-6 Yellow Purity criteria as set out in Commission Directive 95/45/EC (E 101)
146 Caramel Caramel 232-435-9 Brown Purity criteria as set out in Commission Directive 95/45/EC (E 150a-d)
147 Paprika extract, Capsanthin, capsorubin Capsanthin, capsorubin 207-364-1/207-425-2 Orange Purity criteria as set out in Commission Directive 95/45/EC (E 160c)
148 Beetroot red Beetroot Red 7659-95-2 231-628-5 Red Purity criteria as set out in Commission Directive 95/45/EC (E 162)
149 Anthocyanins (Cyanidin, Peonidin Malvidin Delphinidin Petunidin Pelargonidin) Anthocyanins 528-58-5 134-01-0 528-53-0 643-84-5 134-04-3 208-438-6 205-125-6 211-403-8 208-437-0 — 205-127-7 Red Purity criteria as set out in Commission Directive 95/45/EC (E 163)
150 Aluminium, zinc, magnesium and calcium stearates Aluminum stearate Zinc stearate Magnesium stearate Calcium stearate 7047-84-9 557-05-1 557-04-0 216-472-8 230-325-5 209-151-9 209-150-3 216-472-8 White
151 Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2-bromo-3-methyl-6-(1-methylethyl)-, S,S-dioxide Bromothymol blue 76-59-5 200-971-2 Blue Rinse-off products
152 Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo-3-methyl-,S,S-dioxide Bromocresol green 76-60-8 200-972-8 Green Rinse-off products
153 Sodium 4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonate Acid red 195 12220-24-5 — Red Not to be used in products applied on mucous membranes
(1) For use as a UV filter, see Annex VI, No 27 (2) For use as a UV-filter, see Annex VI, No 30 and No 30a.

ANNEX V

Preamble

1.

For the purposes of this list:

2.

All finished products containing substances which are listed in this Annex and which release formaldehyde shall be labelled with the warning ‘releases formaldehyde’ where the total concentration of formaldehyde released in the finished product exceeds 0,001 % (10 ppm), irrespective of whether the finished product contains one or more substances releasing formaldehyde.

However, all finished products containing substances referred to in the first subparagraph which comply with Regulation (EC) No 1223/2009 as applicable on 30 July 2022 may be placed on the Union market until 31 July 2024 and be made available on the Union market until 31 July 2026.

Reference number Substance identification Conditions Wording of conditions of use and warnings
Chemical name/INN Name of Common Ingredients Glossary CAS number EC number Product type, Body parts Maximum concentration in ready for use preparation Other
a b c d e f g h i
1 Benzoic acid and its sodium salt Benzoic acid Sodium Benzoate 65-85-0 532-32-1 200-618-2 208-534-8 Rinse-off products, except oral products 2,5 % (acid)
Oral products 1,7 % (acid)
Leave-on products 0,5 % (acid)
1a Salts of benzoic acid other than that listed under reference number 1 and esters of benzoic acid Ammonium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, MEA-benzoate, methyl benzoate, ethyl benzoate, propyl benzoate, butyl benzoate, isobutyl benzoate, isopropyl benzoate, phenyl benzoate 1863-63-4, 2090-05-3, 582-25-2, 553-70-8, 4337-66-0, 93-58-3, 93-89-0, 2315-68-6, 136-60-7, 120-50-3, 939-48-0, 93-99-2 217-468-9, 218-235-4, 209-481-3, 209-045-2, 224-387-2, 202-259-7, 202-284-3, 219-020-8, 205-252-7, 204-401-3, 213-361-6, 202-293-2 0,5 % (acid)
2 Propionic acid and its salts Propionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate 79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6 201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-4 2 % (acid)
3 Salicylic acid (1) and its salts Salicylic acid 69-72-7 200-712-3 0,5 % (acid) Not to be used in products for children under 3 years of age. Not to be used for children under 3 years of age (12)
Not to be used in oral products.
Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.
Calcium salicylate, magnesium salicylate, MEA- salicylate, sodium salicylate, potassium salicylate, TEA- salicylate 824-35-1, 18917-89-0, 59866- 70-5, 54-21-7, 578-36-9, 2174-16-5 212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-3 0,5 % (acid) Not to be used in products for children under 3 years of age, except for shampoos. Not to be used for children under 3 years of age (2)
4 Hexa-2,4-dienoic acid and its salts Sorbic acid, calcium sorbate, sodium sorbate, potassium sorbate 110-44-1, 7492-55-9, 7757-81-5, 24634-61-5 203-768-7, 231-321-6, 231-819-3, 246-376-1 0,6 % (acid)
—————
6 Moved or deleted
7 Biphenyl-2-ol; 2-phenylphenol; 2-hydroxybiphenyl Sodium 2-biphenylate o-Phenylphenol Sodium o-Phenylphenate 90-43-7 132-27-4 201-993-5 205-055-6 (a) Rinse-off products (b) Leave-on products (a) 0,2 % (as phenol (b) 0,15 % (as phenol) When o-Phenylphenol and Sodium o-Phenylphenate are used together, the combined concentration (as phenol) shall not exceed 0,2 % in rinse-off and 0,15 % in leave-on products. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Not to be used in oral products. Avoid contact with eyes
—————
9 Inorganic sulphites and hydrogen- sulphites (5) Sodium sulfite, ammonium bisulfite, ammonium sulfite, potassium sulfite, potassium hydrogen sulfite, sodium bisulfite, sodium metabisulfite, potassium metabisulfite 7757-83-7, 10192-30-0, 10196-04-0, 10117-38-1, 7773-03-7, 7631-90-5, 7681-57-4, 16731-55-8 231-821-4, 233-469-7, 233-484-9, 233-321-1, 231-870-1, 231-548-0, 231-673-0, 240-795-3 0,2 % (as free SO2)
10 Moved or deleted
11 Chlorobutanol Chlorobutanol 57-15-8 200-317-6 0,5 % Not to be used in aerosol dispensers (sprays) Contains Chlorobutanol
12 4-Hydroxybenzoic acid and its Methyl- and Ethyl-esters, and their salts 4-Hydroxybenzoic acid methylparaben potassium ethylparaben potassium paraben sodium methylparaben sodium ethylparaben ethylparaben sodium paraben potassium methylparaben calcium paraben 99-96-7 99-76-3 36457-19-9 16782-08-4 5026-62-0 35285-68-8 120-47-8 114-63-6 26112-07-2 69959-44-0 202-804-9 202-785-7 253-048-1 240-830-2 225-714-1 252-487-6 204-399-4 204-051-1 247-464-2 274-235-4 0,4 % (as acid) for single ester 0,8 % (as acid) for mixtures of esters
12a Butyl 4-hydroxybenzoate and its salts Propyl 4-hydroxybenzoate and its salts Butylparaben propylparaben sodium propylparaben sodium butylparaben potassium butylparaben potassium propylparaben 94-26-8 94-13-3 35285-69-9 36457-20-2 38566-94-8 84930-16-5 202-318-7 202-307-7 252-488-1 253-049-7 254-009-1 284-597-5 0,14 % (as acid) for the sum of the individual concentrations 0,8 % (as acid) for mixtures of substances mentioned in entry 12 and 12a, where the sum of the individual concentrations of butyl- and propylparaben and their salts does not exceed 0,14 % Not to be used in leave-on products designed for application on the nappy area of children under three years of age. For leave-on products designed for children under three years of age: ‘Do not use on the nappy area’
13 3-Acetyl-6-methylpyran-2,4 (3H)-dione and its salts Dehydroacetic acid, sodium dehydroacetate 520-45-6, 4418-26-2, 16807-48-0 208-293-9, 224-580-1 0,6 % (as acid) Not to be used in aerosol dispensers (sprays)
14 Formic acid and its sodium salt Formic acid, sodium formate 64-18-6, 141-53-7 200-579-1, 205-488-0 0,5 % (as acid)
15 3,3'-Dibromo-4,4'-hexamethylenedioxydi-benzamidine and its salts (including isethionate) Dibromohexamidine Isethionate 93856-83-8 299-116-4 0,1 %
16 Thiomersal Thimerosal 54-64-8 200-210-4 Eye products 0,007 % (of Hg) If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0,007 % Contains Thiomersal
17 Phenylmercuric salts (including borate) Phenyl Mercuric Acetate, Phenyl Mercuric Benzoate 62-38-4, 94-43-9 200-532-5, 202-331-8 Eye products 0,007 % (of Hg) If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0,007 % Contains Phenylmercuric compounds
18 Undec-10-enoic acid and its salts Undecylenic acid, potassium undecylenate, sodium undecylenate, calcium undecylenate, TEA-undecylenate, MEA-undecylenate 112-38-9, 6159-41-7, 3398-33-2, 1322-14-1, 84471-25-0, 56532-40-2 203-965-8, 222-264-8, 215-331-8, 282-908-9, 260-247-7 0,2 % (as acid)
19 5- Pyrimidinamine, 1,3-bis (2-ethylhexyl) hexahydro-5-methyl- Hexetidine 141-94-6 205-513-5 0,1 %
20 5-Bromo-5-nitro-1,3-dioxane 5-Bromo-5-nitro-1,3-dioxane 30007-47-7 250-001-7 Rinse-off products 0,1 % Avoid formation of nitrosamines
21 Bronopol 2-Bromo-2-nitropropane-1,3-diol 52-51-7 200-143-0 0,1 % Avoid formation of nitrosamines
22 2,4-Dichlorobenzyl alcohol Dichlorobenzyl Alcohol 1777-82-8 217-210-5 0,15 %
23 1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl)urea (22) (6) Triclocarban 101-20-2 202-924-1 All cosmetic products, with the exception of mouthwash. 0,2 % Purity criteria: 3,3',4,4'-Tetrachloroazobenzene ≤ 1 ppm 3,3',4,4'-Tetrachloroazoxybenzene ≤ 1 ppm Not to be used in toothpaste intended for children under 6 years of age. For toothpaste containing Triclocarban the following labelling is obligatory: ‘Not to be used for children under 6 years of age’.
24 Chlorocresol p-Chloro-m-Cresol 59-50-7 200-431-6 Not to be used in products applied on mucuous membranes 0,2 %
25 5-Chloro-2- (2,4- dichlorophenoxy) phenol (22) Triclosan 3380-34-5 222-182-2 Toothpastes; Hand soaps; Body soaps/Shower gels; Deodorants (non-spray); Face powders and blemish concealers; Nail products for cleaning the fingernails and toenails before the application of artificial nail systems; 0,3 % Not to be used in toothpaste intended for children under 3 years of age. For toothpaste containing Triclosan the following labelling is obligatory: ‘Not to be used for children under 3 years of age’.
26 Chloro-xylenol Chloroxylenol 88-04-0 201-793-8 0,5 %
27 N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea] Imidazolidinyl urea 39236-46-9 254-372-6 0,6 %
28 Polyhexamethylene biguanide hydrochloride Polyaminopropyl biguanide 32289-58-0, 27083-27-8, 28757-47-3, 133029-32-0 608-723-9 608-042-7 0,1 % Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation
29 2-Phenoxyethanol Phenoxyethanol 122-99-6 204-589-7 1,0 %
30 Methenamine Methenamine 100-97-0 202-905-8 0,15 %
—————
32 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one (20) Climbazole 38083-17-9 253-775-4 (a) Hair lotions (21) (b) Face creams (21) (c) Foot care products (21) (d) Rinse-off shampoo (21) (a) 0,2 % (21) (b) 0,2 % (21) (c) 0,2 % (21) (d) 0,5 % (21)
33 1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione DMDM Hydantoin 6440-58-0 229-222-8 0,6 %
34 Benzyl alcohol (7) Benzyl Alcohol 100-51-6 202-859-9 1,0  %
35 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine 50650-76-5, 68890-66-4 272-574-2 Rinse-off products 1,0 %
Other products 0,5 %
36 Moved or deleted
37 2,2'-methylenebis(6-bromo-4-chlorophenol) Bromochlorophene 15435-29-7 239-446-8 0,1 %
38 4-Isopropyl-m-cresol o-Cymen-5-ol 3228-02-2 221-761-7 0,1 %
39 Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one Methylchloroisothiazolinone (and) Methylisothiazolinone (17) 26172-55-4, 2682-20-4, 55965-84-9 247-500-7, 220-239-6 Rinse-off products 0,0015 % (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one)
—————
42 N,N″-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride Chlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Digluconate, Chlorhexidine Dihydrochloride 55-56-1, 56-95-1, 18472-51-0, 3697-42-5 200-238-7, 200-302-4, 242-354-0, 223-026-6 0,3 % (as chlorhexidine)
43 1-Phenoxypropan-2-ol (8) Phenoxyisopropanol 770-35-4 212-222-7 Only for rinse-off products 1,0 %
44 Alkyl (C12-22) trimethyl ammonium bromide and chloride Behentrimonium chloride (15), 17301-53-0, 241-327-0, 0,1 %
cetrimonium bromide, 57-09-0, 200-311-3,
cetrimonium chloride (16), 112-02-7, 203-928-6,
laurtrimonium bromide, 1119-94-4, 214-290-3,
laurtrimonium chloride, 112-00-5, 203-927-0,
steartrimonium bromide, 1120-02-1, 214-294-5,
steartrimonium chloride (16) 112-03-8 203-929-1
45 4,4-Dimethyl-1,3-oxazolidine Dimethyl Oxazolidine 51200-87-4 257-048-2 0,1 % pH > 6
46 N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl) urea Diazolidinyl Urea 78491-02-8 278-928-2 0,5 %
47 Benzenecarboximidamide, 4,4'-(1,6-hexanediylbis (oxy))bis- and its salts (including isethionate and p-hydroxybenzoate) Hexamidine, Hexamidine diisethionate, Hexamidine paraben 3811-75-4, 659-40-5, 93841-83-9 211-533-5, 299-055-3 0,1 %
48 Glutaraldehyde (Pentane-1,5-dial) Glutaral 111-30-8 203-856-5 0,1 % Not to be used in aerosols (sprays) Contains glutaral (9)
49 5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane 7-Ethylbicyclooxazolidine 7747-35-5 231-810-4 0,3 % Not to be used in oral products and in products applied on mucous membranes
50 3-(p-Chlorophenoxy)-propane-1,2 diol Chlorphenesin 104-29-0 203-192-6 0,3 %
51 Sodium N-(hydroxymethyl) glycinate Sodium Hydroxymethylglycinate 70161-44-3 274-357-8 0,5  % Not to be used unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is < 0,1 % w/w
52 Silver chloride deposited on titanium dioxide Silver chloride 7783-90-6 232-033-3 0,004 % (as AgCl) 20 % AgCl (w/w) on TiO2. Not to be used in products for children under 3 years of age, in oral products and in eye and lip products
53 Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chloride Benzethonium Chloride 121-54-0 204-479-9 (a) Rinse-off products (b) Leave-on products other than oral products 0,1 %
54 Benzalkonium chloride, bromide and saccharinate (10) Benzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate 8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9 264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-1 0,1 % (as benzalkonium chloride) Avoid contact with eyes
55 Methanol, (phenylmethoxy-) Benzylhemiformal 14548-60-8 238-588-8 Rinse-off products 0,15 %
56 3-Iodo-2-propynylbutylcarbamate Iodopropynyl butylcarbamate 55406-53-6 259-627-5 (a) Rinse-off products (b) Leave-on products (c) Deo-dorants/anti-perspirants (a) 0,02 % (b) 0,01 %, (c) 0,0075 % Not to be used in oral and lip products (a) Not to be used in products for children under 3 years of age, except in bath products/shower gels and shampoo (b) Not to be used in body lotion and body cream (13) (b) and (c)  Not to be used in products for children under 3 years of age (a) Not to be used for children under 3 years of age (11) (b) and (c)  Not to be used for children under 3 years of age (12)
57 2-Methyl-2H-isothiazol-3-one Methylisothiazolinone (18) 2682-20-4 220-239-6 Rinse-off products 0,0015 %
58 Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride (14) Ethyl Lauroyl Arginate HCl 60372-77-2 434-630-6 (a) Mouthwashes (a) 0,15 % (a) Not to be used in preparations for children under 10 years of age (a) Not to be used for children under 10 years of age
(b) Other products (b) 0,4 % (b) Not to be used in lip products, oral products (other than mouthwashes), and spray products
59 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, monohydrate and 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, silver(1+) salt, monohydrate Citric acid (and) Silver citrate — 460-890-5 0,2 %, corresponding to 0,0024 % of silver Not to be used in oral products and eye products
60 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one Hydroxyethoxyphenyl Butanone 569646-79-3 933-435-8 0,7 %
(1) For uses other than preservative, see Annex III, No 98. (2) Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin. (3) (4) (5) For use other than as a preservative, see Annex III, No. 99. (6) For use other than as a preservative, see Annex III, No. 100. (7) For other uses than preservatives, see Annex III, entry No 45. (8) For use other than as a preservative, see Annex III, No. 54. (9) Only if the concentration exceeds 0,05 %. (10) For use other than as a preservative, see Annex III, No. 65. (11) Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age. (12) Solely for products which might be used for children under 3 years of age. (13) Concerns any products aimed to be applied on a large part of the body. (14) For other uses than preservatives, see Annex III, entry No 197. (15) For use other than as a preservative, see Annex III, No 287. (16) For use other than as a preservative, see Annex III, No 286. (17) Methylisothiazolinone is also regulated in entry 57. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product. (18) Methylisothiazolinone is also regulated in entry 39 of Annex V in a mixture with methylchloroisothiazolinone. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product. (19) From 17 June 2019 cosmetic products containing Biphenyl-2-ol and not complying with those conditions shall not be placed on the Union market. From 17 September 2019 cosmetic products containing Biphenyl-2-ol and not complying with those conditions shall not be made available on the Union market. (20) For use other than as a preservative, see Annex III, entry 310. (21) From 27 November 2019 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those conditions shall not be placed on the Union market. From 27 February 2020 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those conditions shall not be made available on the Union market. (22) Cosmetic products containing that substance that do not comply with the conditions may, provided that they comply with the conditions applicable on 23 April 2024, be placed on the Union market until 31 December 2024 and, if they have already been placed on the market before that date, continue to be made available on the Union market until 31 October 2025.

ANNEX VI

Reference number Substance identification Conditions Wording of conditions of use and warnings
Chemical name/INN/XAN Name of Common Ingredients Glossary CAS number EC number Product type, body parts Maximum concentration in ready for use preparation Other
a b c d e f g h i
1
2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulfate Camphor Benzalkonium Methosulfate 52793-97-2 258-190-8 6 %
3 Benzoic acid, 2- hydroxy-, 3,3,5- trimethylcyclohexyl ester/Homosalate (8) Homosalate 118-56-9 204-260-8 Face products with the exception of propellent spray products 7,34 %
4 2-Hydroxy-4-methoxy-benzophenone/Oxybenzone (6) Benzophenone-3 131-57-7 205-031-5 a) Face products, hand products, and lip products, excluding propellant and pump spray products b) Body products, including propellant and pump spray products c) Other products a) 6 % b) 2,2 % c) 0,5 % For a) and b) Not more than 0,5 % to protect product formulation a) If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 5,5 %. b) If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 1,7 %. For a) and b): Contains Benzophenone-3 (1)
5 Moved or deleted
6 2-Phenylbenzimidazole-5-sulfonic acid and its potassium, sodium and triethanolamine salts/Ensulizole Phenylbenzimidazole Sulfonic Acid 27503-81-7 248-502-0 8 %(as acid)
7 3,3'-(1,4-Phenylenedimethylene) bis(7, 7-dimethyl-2-oxobicyclo-[2.2.1]hept-1-yl-methanesulfonic acid) and its salts/Ecamsule Terephthalylidene Dicamphor Sulfonic Acid 92761-26-7, 90457-82-2 410-960-6 10 %(as acid)
8 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione/Avobenzone Butyl Methoxydibenzoylmethane 70356-09-1 274-581-6 5 %
9 alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts Benzylidene Camphor Sulfonic Acid 56039-58-8 6 % (as acid)
10 2-Cyano-3,3-diphenyl acrylic acid, 2- ethylhexyl ester/Octocrylene (6) (7) Octocrylene 6197-30-4 228-250-8 a) Propellant spray products b) Other products a) 9 % b) 10 %
11 Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl} acrylamide Polyacrylamidomethyl Benzylidene Camphor 113783-61-2 6 %
12 2-Ethylhexyl 4-methoxycinnamate/Octinoxate Ethylhexyl Methoxycinnamate 5466-77-3 226-775-7 10 %
13 Ethoxylated ethyl-4-aminobenzoate PEG-25 PABA 116242-27-4 10 %
14 Isopentyl-4-methoxycinnamate/Amiloxate Isoamyl p-Methoxycinnamate 71617-10-2 275-702-5 10 %
15 2,4,6-Trianilino-(p-carbo-2'-ethylhexyl-1'-oxy)-1,3,5-triazine Ethylhexyl Triazone 88122-99-0 402-070-1 5 %
16 Phenol,2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl) Drometrizole Trisiloxane 155633-54-8 15 %
17 Benzoic acid, 4,4-((6-((4-(((1,1-dimethylethyl)amino)carbonyl)phenyl)amino)-1,3,5-triazine-2,4-diyl)diimino)bis-, bis (2-ethylhexyl) ester/Iscotrizinol (USAN) Diethylhexyl Butamido Triazone 154702-15-5 10 %
—————
—————
20 2-Ethylhexyl salicylate/Octisalate Ethylhexyl Salicylate 118-60-5 204-263-4 5 %
21 2-Ethylhexyl 4-(dimethylamino)benzoate/Padimate O (USAN:BAN) Ethylhexyl Dimethyl PABA 21245-02-3 244-289-3 8 %
22 2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid and its sodium salt/Sulisobenzone Benzophenone-4, Benzophenone-5 4065-45-6/6628-37-1 223-772-2 / - 5 % (as acid)
23 2,2′-Methylene- bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)/Bisoctrizole Methylene Bis-Benzotriazolyl Tetramethylbutylphenol 103597-45-1 403-800-1 10 % (5)
23a 2,2′-Methylene- bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)/Bisoctrizole Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano) 103597-45-1 403-800-1 10 % (5) Not to be used in applications that may lead to exposure of the end user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: — Purity ≥ 98,5 %, with 2,2′-methylene-bis-(6(2H-benzotriazol-2-yl)-4-(isooctyl)phenol) isomer fraction not exceeding 1,5 %; — Solubility < 5 ng/L in water at 25 °C; — Partition coefficient (Log Pow): 12,7 at 25 °C; — Uncoated; — Median particle size D50 (50 % of the number below this diameter): ≥ 120 nm of mass distribution and/or ≥ 60 nm of number size distribution.
24 Sodium salt of 2,2'-bis(1,4-phenylene)-1H-benzimidazole-4,6-disulfonic acid) / Bisdisulizole disodium (USAN) Disodium Phenyl Dibenzimidazole Tetrasulfonate 180898-37-7 429-750-0 10 % (as acid)
25 2,2'-(6-(4-Methoxyphenyl)-1,3,5-triazine-2,4-diyl)bis(5-((2-ethylhexyl)oxy)phenol) / Bemotrizinol Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 187393-00-6 10 %
26 Dimethicodiethylbenzalmalonate Polysilicone-15 207574-74-1 426-000-4 10 %
27 Titanium dioxide (2) Titanium Dioxide 13463-67-7/1317-70-0/1317-80-2 236-675-5/215-280-1/215-282-2 25 % (4) Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No 321. For the product types under letter (c) of column (f) in Annex III, No 321, the maximum concentration in ready for use preparation provided in column (g) of this entry applies.
27a Titanium dioxide (2) Titanium Dioxide (nano) 13463-67-7/1317-70-0/1317-80-2 236-675-5/215-280-1/215-282-2 25 % (4) Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Only nanomaterials having the following characteristics are allowed: — purity ≥ 99 %, — rutile form, or rutile with up to 5 % anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes, — median particle size based on number size distribution ≥ 30 nm, — aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m2/cm3, — coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone, or coated with one of the following combinations: — Silica at a maximum concentration of 16 % and Cetyl Phosphate at a maximum concentration of 6 %, — Alumina at a maximum concentration of 7 % and Manganese Dioxide at a maximum concentration of 0,7 % (not to be used in lip products), — Alumina at a maximum concentration of 3 % and Triethoxycaprylylsilane at a maximum concentration of 9 %, — photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped reference, — nanoparticles are photostable in the final formulation. For face products containing Titanium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide: Not to be used on the lips.
28 Benzoic acid, 2-[-4-(diethylamino)-2-hydroxybenzoyl]-. Hexylester Diethylamino Hydroxy benzoyl Hexyl Benzoate 302776-68-7 443-860-6 10 %
29 1,3,5-Triazine, 2,4,6-tris[1,1'-biphenyl]-4-yl-, including as nanomaterial Tris-biphenyl triazine Tris-biphenyl triazine (nano) 31274-51-8 — 10 % Not to be used in sprays. Only nanomaterials having the following characteristics are allowed: — median primary particle size > 80 nm; — Purity ≥ 98 %; — Uncoated
30 Zinc oxide Zinc Oxide 1314-13-2 215-222-5 25 % (3) Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.
30a Zinc oxide Zinc Oxide (nano) 1314-13-2 215-222-5 25 % (3) Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: — purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total, — median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm, — water solubility < 50 mg/L — uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane.
31 3,3′-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine) Phenylene Bis-Diphenyltriazine 55514-22-2 700-823-1 5 % Not to be used in applications that may lead to exposure of the end user's lungs by inhalation.
32 2-ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino) cyclohex-2-en-1-ylidene]acetate Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate 1419401-88-9 700-860-3 3 % — Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation — Do not use with nitrosating agents – Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers
33 1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine 919803-06-8 485-100-6 10 % (9)
34 1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano) 919803-06-8 485-100-6 10 % (9) Only nanomaterials having the following characteristics are allowed: — Purity ≥ 97 % — Median particle size D50 (50 % of the number below this diameter): ≥ 50 nm of number size distribution. Not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.
(1) Not required if concentration is 0,5 % or less and when it is used only for product protection purposes. (2) For use as a colorant, see Annex IV, No 143. (3) In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g. (4) In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g. (5) In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column g. (6) However, cosmetic products containing that substance and complying with the restrictions set out in Regulation (EC) No 1223/2009 as applicable on 27 July 2022 may be placed on the Union market until 28 January 2023 and be made available on the Union market until 28 July 2023. (7) Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level. (8) From 1 January 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 July 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market. (9) In case of combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano), the sum shall not exceed 10 %.

ANNEX VII

1. Reference to enclosed or attached information

2. Period-after-opening

3. Date of minimum durability

ANNEX VIII

This Annex lists the alternative methods validated by the European Centre on Validation of Alternative Methods (ECVAM) of the Joint Research Centre available to meet the requirements of this Regulation and which are not listed in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As animal testing may not be replaced completely by an alternative method, it should be mentioned in Annex VIII whether the alternative method fully or partially replaces animal testing.

Reference number Validated alternative methods Nature of replacement full or partial
A B C

ANNEX IX

PART A

Repealed Directive with its successive amendments

(referred to in Article 33)

Council Directive 76/768/EEC of 27 July 1976 (OJ L 262, 27.9.1976, p. 169)
Council Directive 79/661/EEC of 24 July 1979 (OJ L 192, 31.7.1979, p. 35)
Commission Directive 82/147/EEC of 11 February 1982 (OJ L 63, 6.3.1982, p. 26)
Council Directive 82/368/EEC of 17 May 1982 (OJ L 167, 15.6.1982, p. 1)
Commission Directive 83/191/EEC of 30 March 1983 (OJ L 109, 26.4.1983, p. 25)
Commission Directive 83/341/EEC of 29 June 1983 (OJ L 188, 13.7.1983, p. 15)
Commission Directive 83/496/EEC of 22 September 1983 (OJ L 275, 8.10.1983, p. 20)
Council Directive 83/574/EEC of 26 October 1983 (OJ L 332, 28.11.1983, p. 38)
Commission Directive 84/415/EEC of 18 July 1984 (OJ L 228, 25.8.1984, p. 31)
Commission Directive 85/391/EEC of 16 July 1985 (OJ L 224, 22.8.1985, p. 40)
Commission Directive 86/179/EEC of 28 February 1986 (OJ L 138, 24.5.1986, p. 40)
Commission Directive 86/199/EEC of 26 March 1986 (OJ L 149, 3.6.1986, p. 38)
Commission Directive 87/137/EEC of 2 February 1987 (OJ L 56, 26.2.1987, p. 20)
Commission Directive 88/233/EEC of 2 March 1988 (OJ L 105, 26.4.1988, p. 11)
Council Directive 88/667/EEC of 21 December 1988 (OJ L 382, 31.12.1988, p. 46)
Commission Directive 89/174/EEC of 21 February 1989 (OJ L 64, 8.3.1989, p. 10)
Council Directive 89/679/EEC of 21 December 1989 (OJ L 398, 30.12.1989, p. 25)
Commission Directive 90/121/EEC of 20 February 1990 (OJ L 71, 17.3.1990, p. 40)
Commission Directive 91/184/EEC of 12 March 1991 (OJ L 91, 12.4.1991, p. 59)
Commission Directive 92/8/EEC of 18 February 1992 (OJ L 70, 17.3.1992, p. 23)
Commission Directive 92/86/EEC of 21 October 1992 (OJ L 325, 11.11.1992, p. 18)
Council Directive 93/35/EEC of 14 June 1993 (OJ L 151, 23.6.1993, p. 32)
Commission Directive 93/47/EEC of 22 June 1993 (OJ L 203, 13.8.1993, p. 24)
Commission Directive 94/32/EC of 29 June 1994 (OJ L 181, 15.7.1994, p. 31)
Commission Directive 95/17/EC of 19 June 1995 (OJ L 140, 23.6.1995, p. 26)
Commission Directive 95/34/EC of 10 July 1995 (OJ L 167, 18.7.1995, p. 19)
Commission Directive 96/41/EC of 25 June 1996 (OJ L 198, 8.8.1996, p. 36)
Commission Directive 97/1/EC of 10 January 1997 (OJ L 16, 18.1.1997, p. 85)
Commission Directive 97/18/EC of 17 April 1997 (OJ L 114, 1.5.1997, p. 43)
Commission Directive 97/45/EC of 14 July 1997 (OJ L 196, 24.7.1997, p. 77)
Commission Directive 98/16/EC of 5 March 1998 (OJ L 77, 14.3.1998, p. 44)
Commission Directive 98/62/EC of 3 September 1998 (OJ L 253, 15.9.1998, p. 20)
Commission Directive 2000/6/EC of 29 February 2000 (OJ L 56, 1.3.2000, p. 42)
Commission Directive 2000/11/EC of 10 March 2000 (OJ L 65, 14.3.2000, p. 22)
Commission Directive 2000/41/EC of 19 June 2000 (OJ L 145, 20.6.2000, p. 25)
Commission Directive 2002/34/EC of 15 April 2002 (OJ L 102, 18.4.2002, p. 19)
Commission Directive 2003/1/EC of 6 January 2003 (OJ L 5, 10.1.2003, p. 14)
Commission Directive 2003/16/EC of 19 February 2003 (OJ L 46, 20.2.2003, p. 24)
Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 (OJ L 66, 11.3.2003, p. 26)
Commission Directive 2003/80/EC of 5 September 2003 (OJ L 224, 6.9.2003, p. 27)
Commission Directive 2003/83/EC of 24 September 2003 (OJ L 238, 25.9.2003, p. 23)
Commission Directive 2004/87/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 4)
Commission Directive 2004/88/EC of 7 September 2004 (OJ L 287, 8.9.2004, p. 5)
Commission Directive 2004/94/EC of 15 September 2004 (OJ L 294, 17.9.2004, p. 28)
Commission Directive 2004/93/EC of 21 September 2004 (OJ L 300, 25.9.2004, p. 13)
Commission Directive 2005/9/EC of 28 January 2005 (OJ L 27, 29.1.2005, p. 46)
Commission Directive 2005/42/EC of 20 June 2005 (OJ L 158, 21.6.2005, p. 17)
Commission Directive 2005/52/EC of 9 September 2005 (OJ L 234, 10.9.2005, p. 9)
Commission Directive 2005/80/EC of 21 November 2005 (OJ L 303, 22.11.2005, p. 32)
Commission Directive 2006/65/EC of 19 July 2006 (OJ L 198, 20.7.2006, p. 11)
Commission Directive 2006/78/EC of 29 September 2006 (OJ L 271, 30.9.2006, p. 56)
Commission Directive 2007/1/EC of 29 January 2007 (OJ L 25, 1.2.2007, p. 9)
Commission Directive 2007/17/EC of 22 March 2007 (OJ L 82, 23.3.2007, p. 27)
Commission Directive 2007/22/EC of 17 April 2007 (OJ L 101, 18.4.2007, p. 11)
Commission Directive 2007/53/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 19)
Commission Directive 2007/54/EC of 29 August 2007 (OJ L 226, 30.8.2007, p. 21)
Commission Directive 2007/67/EC of 22 November 2007 (OJ L 305, 23.11.2007, p. 22)
Commission Directive 2008/14/EC of 15 February 2008 OJ L 42, 16.2.2008, p. 43
Commission Directive 2008/42/EC of 3 April 2008 OJ L 93, 4.4.2008, p. 13
Commission Directive 2008/88/EC of 23 September 2008 OJ L 256, 24.9.2008, p. 12
Commission Directive 2008/123/EC of 18 December 2008 OJ L 340, 19.12.2008, p. 71
Commission Directive 2009/6/EC of 4 February 2009 OJ L 36, 5.2.2009, p. 15
Commission Directive 2009/36/EC of 16 April 2009 OJ L 98, 17.4.2009, p. 31

PART B

List of time-limits for transposition into national law and application

(referred to in Article 33)

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