Cosmetics Regulation

02009R1223-20140701 → 02009R1223-20140829

compared line by line: this provision is too large to compare word by word, so a marked line is a line that changed somewhere

ANNEX III LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN 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.For use as a preservative, see Annex V, No. 5.Only if the concentration exceeds 0,05 %.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 2.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 and which remain in prolonged contact with the skin.For use as a preservative, see Annex V, No 9.For use as a preservative, see AnnexV, No 23.For use as a preservative, see Annex V, No 8.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. 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.For use as a preservative, see Annex V, No. 5.Only if the concentration exceeds 0,05 %.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 2.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 and which remain in prolonged contact with the skin.For use as a preservative, see Annex V, No 9.For use as a preservative, see AnnexV, No 23.For use as a preservative, see Annex V, No 8.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. Reference number Substance identification Restrictions 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 … 1,463 unchanged lines … has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary black henna tattoo in the past. Rinse eyes immediately if product comes into contact with them.286 C16-alkyltrimethylammonium chloride Cetrimonium chloride 112-02-7 203-928-6 (a) Rinse-off hair products (a) 2,5 % for the individual concentrations or the sum of the individual concentrations of cetrimonium chloride and steartrimonium chloride For purposes other than inhibiting the development of micro-organisms in the product. The purpose has to be apparent from the presentation of the product. C18-alkyltrimethylammonium chloride Steartrimonium chloride 112-03-8 203-929-1 (b) Leave-on hair products (b) 1,0 % for the individual concentrations or the sum of the individual concentrations of cetrimonium chloride and steartrimonium chloride (c) Leave-on face products (c) 0,5 % for the individual concentrations or the sum of the individual concentrations of cetrimonium chloride and steartrimonium chloride 287 C22-alkyltrimethylammonium chloride Behentrimonium chloride 17301-53-0 241-327-0 (a) Rinse-off hair products (a) 5,0 % for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and steartrimonium chloride set out in entry 286. For purposes other than inhibiting the development of micro-organisms in the product. The purpose has to be apparent from the presentation of the product. (b) Leave-on hair products (b) 3,0 % for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and steartrimonium chloride set out in entry 286. (c) Leave-on face products (c) 3,0 % for the individual concentration of behentrimonium chloride or the sum of the individual concentrations of cetrimonium chloride, steartrimonium chloride and behentrimonium chloride, while at the same time respecting the relevant maximum concentration for the sum of cetrimonium chloride and steartrimonium chloride set out in entry 286.

02009R1223-20140701 → 02009R1223-20140829

ANNEX V LIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS Preamble 1. 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. 2. All finished products containing formaldehyde or substances in this Annex and which release formaldehyde must be labelled with the warning contains formaldehyde where the concentration of formaldehyde in the finished product exceeds 0,05 %. For use other than as a 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. 13.For use other than as a preservative, see Annex III. No. 101.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. 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. 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 … 873 unchanged words … chloroacetamide 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 Phenoxyisopropanol 770-35-4 212-222-7 Only for rinse-off products 1,0 % 44 Alkyl (C 12-22) (C12-22) trimethyl ammonium bromide and chloride Behentrimonium chloride, chloride , 17301-53-0, 241-327-0, 0,1 % cetrimonium bromide, 57-09-0, 200-311-3, cetrimonium chloride, 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 17301-53-0, 57-09-0, 112-02-7, 1119-94-4, 112-00-5, 1120-02-1, 112-03-8 241-327-0, 200-311-3, 203-928-6, 214-290-3, 203-927-0, 214-294-5, 203-929-1 0,1 % 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 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 hydroxymethylamino acetate Sodium Hydroxymethylglycinate 70161-44-3 274-357-8 0,5 % 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 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 (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 (b) and (c) Not to be used for children under 3 years of age 57 2-Methyl-2H-isothiazol-3-one Methylisothiazolinone 2682-20-4 220-239-6 0,01 % 58 Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride Ethyl Lauroyl Arginate HCl 60372-77-2 434-630-6 0,4 % Not to be used in lip products, oral products 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

02009R1223-20140701 → 02009R1223-20140829

ANNEX VI LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS Not required if concentration is 0,5 % or less and when it is used only for product protection purposes.For use other than as a colorant, see Annex IV, No. 143. 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 Homosalate 118-56-9 204-260-8 10 % 4 2-Hydroxy-4-methoxybenzophenone/Oxybenzone Benzophenone-3 131-57-7 205-031-5 10 % Contains Benzophenone-3 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/Octocrilene Octocrylene 6197-30-4 228-250-8 10 % (as acid) 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 % 18 3-(4-Methylbenzylidene)-d1 camphor/Enzacamene 4-Methylbenzylidene Camphor 38102-62-4/36861-47-9 - / 253-242-6 4 % 19 3-Benzylidene camphor 3-Benzylidene Camphor 15087-24-8 239-139-9 2 % 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-tetramethyl-butyl)phenol) / Bisoctrizole Methylene Bis-Benzotriazolyl Tetramethylbutylphenol 103597-45-1 403-800-1 10 % 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 Titanium Dioxide 13463-67-7/1317-70-0/1317-80-2 236-675-5/205-280-1/215-282-2 25 % 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