Cosmetics Regulation

02009R1223-20150716 → 02009R1223-20150810

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. 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 1a Boric acid, borates and tetraborates with the exception of substance No 1184 in Annex II Boric acid 10043-35-3/11113-50-1 233-139-2/234-343-4 (a) Talc (a) 5 % (as boric acid) (a) Not to be used in products for children under 3 years of age Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (as boric acid) (a) Not to be used for children under 3 years of age Not to be used on peeling or irritated skin (b) Oral products (b) 0,1 % (as boric acid) (b) Not to be used in products for children under 3 years of age (b) Not to be swallowed Not to be used for children under 3 years of age (c) Other products (excluding bath products and hair waving products) (c) 3 % (as boric acid) (c) Not to be used in products for children under 3 years of age Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (as boric acid) (c) Not to be used for children under 3 years of age Not to be used on peeling or irritated skin 1b Tetraborates, see also 1a) (a) Bath products (a) 18 % (as boric acid) (a) 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) Hair products (b) 8 % (as boric acid) (b) Rinse well 2a Thioglycolic acid and its salts Thioglycolic acid 68-11-1 200-677-4 (a) Hair products 8 % General use 2a Thioglycolic acid and its salts Thioglycolic acid 68-11-1 200-677-4 (a) Hair waving or straightening products (a) (i) 8 % (ii) 11 % (a) (i) General use ready for use pH 7 to 9,5 (ii) Professional use ready for use pH 7 to 9,5 Conditions of use: (a) (b) (c) (a) (b) (c) (d) Avoid contact with eyes In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice (a) (c) Rinse eyes immediately if product comes into contact with them. (a) (c) (d) Wear suitable gloves Warnings: (a) (b) (c) Warnings to be printed on the label: (a)(i) (b) (c) Contains thioglycolate Follow the instructions Keep out of reach of children (a) For professional use only 11 % Professional use (a)(ii) (d) For professional use only Contains thioglycolate Follow the instructions (b) Depilatories (b) 5 % (b) ready for use pH 7 to 12,7 (c) Other hair rinse-off products (c) 2 % (c) ready for use pH 7 to 9,5 (d) Products intended for eyelash waving (d) 11 % The abovementioned percentages are calculated as thioglycolic acid (d) For professional use ready for use pH 7 to 9,5 (b) Depilatories 5 % ready for use pH 7 to 12,7 (c) Hair rinse-off products 2 % The abovementioned percentages are calculated as thioglycolic acid ready for use pH 7 to 9,5 2b Thioglycolic acid esters Hair waving or straightening products (a) 8 % General use ready for use pH 6 to 9,5 Conditions of use: (a) (b) … 1,437 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.