Cosmetics Regulation

02009R1223-20150416 → 02009R1223-20150716

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. 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 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. 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 … 845 unchanged words … 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 % Other products 0,5 % 36 Moved or deleted 37 2,2'-methylenebis(6-bromo-4-chlorophenol) 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 with magnesium chloride and magnesium nitrate Methylchloroisothiazolinone and (and) Methylisothiazolinone 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 (2H)-one) 40 2-Benzyl-4-chlorophenol Chlorophene 120-32-1 204-385-8 0,2 % 41 2-Chloroacetamide Chloroacetamide 79-07-2 201-174-2 0,3 % Contains 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 % … 377 unchanged words … 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