Cosmetics Regulation

02009R1223-20140829 → 02009R1223-20150416

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.For use as a preservative, see Annex V, entry No 44. … 486 unchanged lines … Pinus Palustris Oil Pinus Palustris Twig Leaf Extract Pinus Palustris Twig Leaf Oil 97435-14-8 / 8002-09-3 306-895-7 / — Peroxide value less than 10 mmoles/L 113 Pinus pinaster oil and extract Pinus Pinaster Twig Leaf Oil; Pinus Pinaster Twig Leaf Extract 90082-75-0 290-166-2 Peroxide value less than 10 mmoles/L 114 Pinus pumila oil and extract Pinus Pumila Twig Leaf Extract Pinus Pinaster Twig Leaf Extract 90082-75-0 290-166-2 Peroxide value less than 10 mmoles/L 114 Pinus pumila oil and extract Pinus Pumila Twig Leaf Extraćt Pinus Pumila Twig Leaf Oil 97676-05-6 307-681-6 Peroxide value less than 10 mmoles/L 115 Pinus species oil and extract Pinus Strobus Bark Extract; Pinus Strobus Cone Extract; Pinus Strobus Twig Oil … 230 unchanged lines … Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. temporary black henna tattoos may increase your risk of allergy. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, … 87 unchanged lines … Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. temporary black henna tattoos may increase your risk of allergy. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, … 69 unchanged lines … you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. (b) Hair dye substance in non-oxidative hair dye products (b) 1,5 % (as hydrochloride) 228 3-Methyl -1- phenyl -5-pyrazolone Phenyl methyl pyrazolone 89-25-8 201-891-0 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 % To be printed on the label: 228 3-Methyl -1- phenyl -5-pyrazolone Phenyl methyl pyrazoloné 89-25-8 201-891-0 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 % To be printed on the label: The mixing ratio. Hair colourants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. … 123 unchanged lines … The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. temporary black henna tattoos may increase your risk of allergy. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, … 156 unchanged lines … you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. (b) Hair dye substance in non-oxidative hair dye products (b) 0,5 % 250 1-Amino-2-nitro-4-(2’,3’-dihydroxypropyl)amino-5-chlorobenzene + 1,4-bis-(2’,3’-dihydroxypropyl)amino-2-nitro-5-chlorobenzene HC Red No 10 + HC Red No 11 95576-89-9 + 95576-92-4 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % 250 1-Amino-2-nitro-4-(2’,3’-dihydroxypropyl)amino-5-chlorobenzene + 1,4-bis-(2’,3’-dihydroxypropyl)amino-2-nitro-5-chlorobenzene HC Red No 10 + HC Red No 11 95576-89-9+ 95576-92-4 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % For (a) and (b): Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers (a) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. temporary black henna tattoos may increase your risk of allergy. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. (b) Hair dye substance in non-oxidative hair dye products (b) 2,0 % 251 2-(4-Amino-3-nitroanilino)ethanol HC Red No 7 24905-87-1 246-521-9 Hair dye substance in non-oxidative hair dye products 1,0 % Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. temporary black henna tattoos may increase your risk of allergy. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, … 27 unchanged lines … Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. temporary black henna tattoos may increase your risk of allergy. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. (b) Hair dye substance in non-oxidative hair dye products b) 1,0 % 256 4-[(2-Nitrophenyl)amino]phenol HC Orange No 1 54381-08-7 259-132-4 Hair dye substance in non-oxidative hair dye products 1,0 % 257 Polidocanol Laureth-9 3055-99-0 221-284-4 (a) Leave-on products (a) 3,0 % (b) Rinse-off products (b) 4,0 % 258 2-Nitro-N1-phenyl-benzene-1,4-diamine HC Red No 1 2784-89-6 220-494-3 Hair dye substance in non-oxidative hair dye products 1,0 % Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. temporary black henna tattoos may increase your risk of allergy. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. 259 1-Methoxy-3-(β-aminoethyl)amino-4-nitrobenzene, hydrochloride HC Yellow No 9 86419-69-4 415-480-1 Hair dye substance in non-oxidative hair dye products 0,5 % (calculated as hydrochloride) Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers 260 1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl) aminobenzene HC Yellow No 7 104226-21-3 146-420-6 Hair dye substance in non-oxidative hair dye products 0,25 % 261 N-(2-Hydroxyethyl)-2-nitro-4-trifluormethyl-aniline HC Yellow No 13 10442-83-8 443-760-2 (a) Hair dye substance in oxidative hair dye products (a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % For (a) and (b): Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers (a) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. temporary black henna tattoos may increase your risk of allergy. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, … 198 unchanged lines … (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.

02009R1223-20140829 → 02009R1223-20150416

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 … 597 unchanged words … 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 and esters, other than the esters of isopropyl, isobutyl, phenyl, benzyl and pentyl 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, ester 0,8 % (as acid) for mixtures of esters methylparaben 99-76-3 202-785-7 butylparaben 94-26-8 202-318-7 potassium ethylparaben 36457-19-9 253-048-1 potassium paraben 16782-08-4 240-830-2 12a Butyl 4-hydroxybenzoate and its salts Propyl 4-hydroxybenzoate and its salts Butylparaben propylparaben 94-13-3 202-307-7 sodium methylparaben 5026-62-0 225-714-1 sodium ethylparaben 35285-68-8 252-487-6 sodium propylparaben 35285-69-9 252-488-1 sodium butylparaben 36457-20-2 253-049-7 ethylparaben 120-47-8 204-399-4 sodium paraben 114-63-6 204-051-1 potassium methylparaben 26112-07-2 247-464-2 potassium butylparaben 38566-94-8 254-009-1 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 calcium paraben 69959-44-0 274-235-4 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 … 406 unchanged words … 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 (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 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 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