Cosmetics Regulation

02009R1223-20190813 → 02009R1223-20191127

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 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. 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.From 17 June 2019 cosmetic products containing Biphenyl-2-ol and not complying with those conditions shall not be placed on the Union market. From 17 September 2019 cosmetic products containing Biphenyl-2-ol and not complying with those conditions shall not be made available on the Union market.For use other than as a preservative, see Annex III, entry 310.From 27 November 2019 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those conditions shall not be placed on the Union market. From 27 February 2020 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those conditions shall not be made available on the Union market. 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 … 809 unchanged words … in applications that may lead to exposure of the end-user's lungs by inhalation 29 2-Phenoxyethanol Phenoxyethanol 122-99-6 204-589-7 1,0 % 30 Methenamine Methenamine 100-97-0 202-905-8 0,15 % 31 Methenamine 3-chloroallylochloride Quaternium-15 4080-31-3 223-805-0 0,2 % 32 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one Climbazole 38083-17-9 253-775-4 (a) Hair lotions (b) Face creams (c) Foot care products (d) Rinse-off shampoo (a) 0,2 % (b) 0,2 % (c) 0,2 % (d) 0,5 % 33 1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione DMDM Hydantoin 6440-58-0 229-222-8 0,6 % 34 Benzyl alcohol Benzyl Alcohol 100-51-6 202-859-9 1,0 % 35 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and 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 … 505 unchanged words … 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 60 4-(3-ethoxy-4-hydroxyphenyl)butan-2-one Hydroxyethoxyphenyl Butanone 569646-79-3 933-435-8 0,7 %

02009R1223-20190813 → 02009R1223-20191127

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 as a colorant, see Annex IV, No 143.In case of combined use … 454 unchanged words … 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/ 215-280-1/ 215-282-2 25 % 27a Titanium dioxide Titanium Dioxide (nano) 13463-67-7/ 1317-70-0/ 1317-80-2 236-675-5/ 215-280-1/ 215-282-2 13463-67-7/1317-70-0/1317-80-2 236-675-5/215-280-1/215-282-2 25 % Not to be used in applications that may lead to exposure of the end-user's end-user’s lungs by inhalation inhalation. Only nanomaterials having the following characteristics are allowed: purity ≥ 99 %, rutile form, or rutile with up to 5 % anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes, median particle size based on number size distribution ≥ 30 nm, aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m2/cm3, coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone; Simethicone, or coated with one of the following combinations: Silica at a maximum concentration of 16 % and Cetyl Phosphate at a maximum concentration of 6 %, Alumina at a maximum concentration of 7 % and Manganese Dioxide at a maximum concentration of 0,7 % (not to be used in lip products), Alumina at a maximum concentration of 3 % and Triethoxycaprylylsilane at a maximum concentration of 9 %, photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped reference, nanoparticles are photostable in the final formulation. For face products containing Titanium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide: Not to be used on the lips. 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 30 Zinc oxide Zinc Oxide 1314-13-2 215-222-5 25 % Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. 30a Zinc oxide Zinc Oxide (nano) 1314-13-2 215-222-5 25 % Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total, median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm, water solubility < 50 mg/L uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane. 31 3,3′-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine) Phenylene Bis-Diphenyltriazine 55514-22-2 700-823-1 5 % Not to be used in applications that may lead to exposure of the end user's lungs by inhalation.