Cosmetics Regulation

02009R1223-20160810 → 02009R1223-20160812

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.For other uses of potassium hydroxide, see Annex III, No 15d.For other uses of Potassium hydroxide, see Annex III, No 15a. … 1,540 unchanged lines … 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. 295 4-Amino-5-hydroxy-3-(4-nitrophenylazo)-6-(phenylazo)-2,7-naphthalenedisulfonic acid, disodium salt Acid Black 1 1064-48-8 213-903-1 Hair dye substance in non-oxidative hair dye products 0,5 % 296 Disodium 3-hydroxy-4-[(E)-(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate Pigment Red 57 5858-81-1 227-497-9 Hair dye substance in non-oxidative hair dye products 0,4 % x 2-(2-Ethoxyethoxy)ethanol 295 4-Amino-5-hydroxy-3-(4-nitrophenylazo)-6-(phenylazo)-2,7-naphthalenedisulfonic acid, disodium salt Acid Black 1 1064-48-8 213-903-1 Hair dye substance in non-oxidative hair dye products 0,5 % 296 Disodium 3-hydroxy-4-[(E)-(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate Pigment Red 57 5858-81-1 227-497-9 Hair dye substance in non-oxidative hair dye products 0,4 % 297 2-(2-Ethoxyethoxy)ethanol Diethylene Glycol Monoethyl Ether (DEGEE) Ethoxydiglycol 111-90-0 203-919-7 (a) Oxidative hair dye products (a) 7 % (a) to (e): The level of ethylene glycol impurity in Ethoxydiglycol must be ≤ 0,1 %. Not to be used in eye products and oral products. (b) Non-oxidative hair dye products (b) 5 % (c) Rinse-off products other than hair dye products (c) 10 % (d) Other non-spray cosmetic products (d) 2,6 % (e) The following spray products: fine fragrances, hair sprays, antiperspirants and deodorants (e) 2,6 %

02009R1223-20160810 → 02009R1223-20160812

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.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. 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. Reference number Substance identification Conditions Wording of conditions of use and warnings Chemical name/INN Name … 1,291 unchanged words … 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 Rinse-off products 0,01 % 58 Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride 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