LegalizeRegulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)
These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.
The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column g.
The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column g.
For use as a preservative, see Annex V, No. 34.
For use as a preservative, see Annex V, No 43.
For use as a preservative, see Annex V, No. 54.
For use as a preservative see Annex V, No 3.
Solely for products which might be used for children under 3 years of age.
For use as a preservative, see Annex V, No 9.
For use as a preservative, see AnnexV, No 23.
Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22).
This limit applies to the substance and not to the finished cosmetic product.
The sum of those substances used in combination should not exceed the limits given as ‘Maximum concentration in ready for use preparation’.
The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.
For use as a preservative, see Annex V, No 58.
For use as a preservative, see Annex V, entry No 44.
For other uses of potassium hydroxide, see Annex III, No 15d.
For other uses of potassium hydroxide, see Annex III, No 15a.
From 25 September 2018 cosmetic products containing peanut oil, extracts and derivatives and not complying with that restriction shall not be placed on the Union market. From 25 December 2018 cosmetic products containing peanut oil, extracts and derivatives and not complying with that restriction shall not be made available on the Union market.
From 25 September 2018 cosmetic products containing hydrolyzed wheat proteins and not complying with that restriction shall not be placed on the Union market. From 25 December 2018 cosmetic products containing hydrolyzed wheat proteins and not complying with that restriction shall not be made available on the Union market.
From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.
From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.
From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.
From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.
For use as a preservative, see Annex V, entry 32.
From 27 November 2019 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those restrictions 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 restrictions shall not be made available on the Union market.
From 3 June 2021 products containing that substance and not complying with those conditions shall not be placed on the Union market. From 3 September 2021 products containing that substance and not complying with those conditions shall not be made available on the Union market.
From 3 June 2021 products containing that substance and not complying with those conditions shall not be placed on the Union market. From 3 September 2021 products containing that substance and not complying with those conditions shall not be made available on the Union market.
From 26 January 2022 hair dye and self-tanning products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 22 April 2022 hair dye and self-tanning products containing that substance and not complying with the restrictions shall not be made available on the Union market.
From 21 August 2022 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 21 November 2022 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.
From 1 July 2023 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.
From 1 July 2023 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be made available on the Union market.
For use as a colorant, see Annex IV, entry No 82.
Cosmetic products containing that substance that do not comply with the restrictions may be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028.
Cosmetic products containing that substance that do not comply with the restrictions may, provided that they comply with the restrictions applicable on 15 August 2023, be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028.
For use as Verbena essential oils (Lippia citriodora Kunth.) and derivatives, see Annex II, No 450.
Cosmetic products containing that substance that do not comply with the restriction(s) may be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028.
Since that substance is a monoterpene, it is subject to the restriction on peroxide value set out in entry 130.
For use of ‘Oil from the seeds of Laurus nobilis L.’, see Annex II, No 359.
From 1 February 2025 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.
From 1 February 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.’
From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 May 2027 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.
[^E0065]: (46)
From 1 January 2027 cosmetic products containing these substances and not complying with the restrictions shall not be placed on the Union market. From 1 July 2028 cosmetic products containing these substances and not complying with the restrictions shall not be made available on the Union market.
From 1 January 2027 cosmetic products containing these substances and not complying with the restrictions shall not be placed on the Union market. From 1 August 2028 cosmetic products containing these substances and not complying with the restrictions shall not be made available on the Union market.
ANNEX IV
LIST OF COLORANTS ALLOWED IN COSMETIC PRODUCTS
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 | Substance identification | Substance identification | Substance identification | Substance identification | Conditions | Conditions | Conditions | Wording of conditions of use and warnings |
|---|---|---|---|---|---|---|---|---|---|
| Reference number | 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 | Wording of conditions of use and warnings |
| 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 [^E0067] | 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 [^E0068] | 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 |
[^E0067]: (1)
For use as a UV filter, see Annex VI, No 27
For use as a UV-filter, see Annex VI, No 30 and No 30a.
ANNEX V
LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS
Preamble
-
- For the purposes of this list:
- — ‘Salts’ is taken to mean: salts of the cations sodium, potassium, calcium, magnesium, ammonium and ethanolamines; salts of the anions chloride, bromide, sulphate, acetate.
- — ‘Esters’ is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl, isobutyl, phenyl.
-
- 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 | Substance identification | Substance identification | Substance identification | Conditions | Conditions | Conditions | Wording of conditions of use and warnings | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reference number | Chemical name/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body parts | Maximum concentration in ready for use preparation | Other | Wording of conditions of use and warnings | |||||
| 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) | |||||||
| 1 | Benzoic acid and its sodium salt | Benzoic acid Sodium Benzoate | 65-85-0 532-32-1 | 200-618-2 208-534-8 | Oral products | 1,7 % (acid) | |||||||
| 1 | Benzoic acid and its sodium salt | Benzoic acid Sodium Benzoate | 65-85-0 532-32-1 | 200-618-2 208-534-8 | 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 [^E0069] 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 [^E0080] | ||||||
| 3 | Salicylic acid [^E0069] and its salts | Salicylic acid | 69-72-7 | 200-712-3 | 0,5 % (acid) | Not to be used in oral products. | Not to be used for children under 3 years of age [^E0080] | ||||||
| 3 | Salicylic acid [^E0069] and its salts | Salicylic acid | 69-72-7 | 200-712-3 | 0,5 % (acid) | Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. | Not to be used for children under 3 years of age [^E0080] | ||||||
| 3 | Salicylic acid [^E0069] and its salts | 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 [^E0070] | ||||||
| 3 | Salicylic acid [^E0069] and its salts | ||||||||||||
| 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 | Moved or deleted | Moved or deleted | Moved or deleted | Moved or deleted | Moved or deleted | Moved or deleted | 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 [^E0073] | 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 | Moved or deleted | Moved or deleted | Moved or deleted | Moved or deleted | Moved or deleted | Moved or deleted | 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 [^E0090] [^E0074] | 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 [^E0090] | 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 [^E0088] | Climbazole | 38083-17-9 | 253-775-4 | (a) Hair lotions [^E0089] (b) Face creams [^E0089] (c) Foot care products [^E0089] (d) Rinse-off shampoo [^E0089] | (a) 0,2 % [^E0089] (b) 0,2 % [^E0089] (c) 0,2 % [^E0089] (d) 0,5 % [^E0089] | |||||||
| 33 | 1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione | DMDM Hydantoin | 6440-58-0 | 229-222-8 | 0,6 % | ||||||||
| 34 | Benzyl alcohol [^E0075] | 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 % | |||||||
| 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 | Other products | 0,5 % | |||||||
| 36 | Moved or deleted | Moved or deleted | Moved or deleted | Moved or deleted | Moved or deleted | Moved or deleted | Moved or deleted | Moved or deleted | |||||
| 37 | 2,2'-methylenebis(6-bromo-4-chlorophenol) | 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine | 50650-76-5, 68890-66-4 | 272-574-2 | 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 [^E0085] | 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 [^E0076] | 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 [^E0083], | 17301-53-0, | 241-327-0, | 0,1 % | ||||||||
| 44 | Alkyl (C12-22) trimethyl ammonium bromide and chloride | cetrimonium bromide, | 57-09-0, | 200-311-3, | 0,1 % | ||||||||
| 44 | Alkyl (C12-22) trimethyl ammonium bromide and chloride | cetrimonium chloride [^E0084], | 112-02-7, | 203-928-6, | 0,1 % | ||||||||
| 44 | Alkyl (C12-22) trimethyl ammonium bromide and chloride | laurtrimonium bromide, | 1119-94-4, | 214-290-3, | 0,1 % | ||||||||
| 44 | Alkyl (C12-22) trimethyl ammonium bromide and chloride | laurtrimonium chloride, | 112-00-5, | 203-927-0, | 0,1 % | ||||||||
| 44 | Alkyl (C12-22) trimethyl ammonium bromide and chloride | steartrimonium bromide, | 1120-02-1, | 214-294-5, | 0,1 % | ||||||||
| 44 | Alkyl (C12-22) trimethyl ammonium bromide and chloride | steartrimonium chloride [^E0084] | 112-03-8 | 203-929-1 | 0,1 % | ||||||||
| 44 | Alkyl (C12-22) trimethyl ammonium bromide and chloride | ||||||||||||
| 45 | 4,4-Dimethyl-1,3-oxazolidine | Dimethyl Oxazolidine | 51200-87-4 | 257-048-2 | 0,1 % | 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 [^E0077] | ||||||
| 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 [^E0078] | 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 [^E0081] (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 [^E0079] (b) and (c) Not to be used for children under 3 years of age [^E0080] | |||||
| 57 | 2-Methyl-2H-isothiazol-3-one | Methylisothiazolinone [^E0086] | 2682-20-4 | 220-239-6 | Rinse-off products | 0,0015 % | |||||||
| 58 | Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride [^E0082] | 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 | |||||
| 58 | Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride [^E0082] | Ethyl Lauroyl Arginate HCl | 60372-77-2 | 434-630-6 | (b) Other products | (b) 0,4 % | (b) Not to be used in lip products, oral products (other than mouthwashes), and spray products | (a) Not to be used for children under 10 years of age | |||||
| 58 | Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride [^E0082] | Ethyl Lauroyl Arginate HCl | 60372-77-2 | 434-630-6 | |||||||||
| 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 | (a) Not to be used for children under 10 years of age | ||||||
| 60 | 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one | Hydroxyethoxyphenyl Butanone | 569646-79-3 | 933-435-8 | 0,7 % | ||||||||
| 61 | Silver zinc zeolite | Ammonium Silver Zinc Aluminium Silicate | 130328-20-0 | 603-404-0 | (a) Deodorant spray (b) Powder foundation | (a) and (b) 1 % | For (a) and (b) the silver content in Ammonium Silver Zinc Aluminium Silicate must not exceed 2,5 %. | ||||||
For uses other than preservative, see Annex III, No 98.
Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.
For use other than as a preservative, see Annex III, No. 99.
For use other than as a preservative, see Annex III, No. 100.
For other uses than preservatives, see Annex III, entry No 45.
For use other than as a preservative, see Annex III, No. 54.
Only if the concentration exceeds 0,05 %.
For use other than as a preservative, see Annex III, No. 65.
Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age.
Solely for products which might be used for children under 3 years of age.
Concerns any products aimed to be applied on a large part of the body.
For other uses than preservatives, see Annex III, entry No 197.
For use other than as a preservative, see Annex III, No 287.
For use other than as a preservative, see Annex III, No 286.
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.
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.
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.
For use other than as a preservative, see Annex III, entry 310.
[^E0089]: (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.
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
LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS
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