Cosmetics Regulation

02009R1223-20220301 → 02009R1223-20220731

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 which are listed in this Annex and which release formaldehyde must shall be labelled with the warning contains releases formaldehyde where the total concentration of formaldehyde released in the finished product exceeds 0,05 0,001 % (10 ppm), irrespective of whether the finished product contains one or more substances releasing formaldehyde. However, all finished products containing substances referred to in the first subparagraph which comply with Regulation (EC) No 1223/2009 as applicable on 30 July 2022 may be placed on the Union market until 31 July 2024 and be made available on the Union market until 31 July 2026. For uses other than 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 … 1,832 unchanged words … 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 %

02009R1223-20220301 → 02009R1223-20220731

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 of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g. In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g. In case of combined use of Methylene Bis-Benzotriazolyl Tetramethylbutylphenol and Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (nano), the sum shall not exceed the limit given in column g. However, cosmetic products containing that substance and complying with the restrictions set out in Regulation (EC) No 1223/2009 as applicable on 27 July 2022 may be placed on the Union market until 28 January 2023 and be made available on the Union market until 28 July 2023. Benzophenone as an impurity and/or degradation product of Octocrylene shall be kept at trace level. Reference number Substance identification Conditions Wording of conditions of use and warnings Chemical name/INN/XAN 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 1 2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulfate Camphor Benzalkonium Methosulfate 52793-97-2 258-190-8 6 % 3 Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester/Homosalate Homosalate 118-56-9 204-260-8 10 % 4 2-Hydroxy-4-methoxybenzophenone/Oxybenzone 2-Hydroxy-4-methoxy-benzophenone/Oxybenzone Benzophenone-3 131-57-7 205-031-5 a) Face products, hand products, and lip products, excluding propellant and pump spray products b) Body products, including propellant and pump spray products c) Other products a) 6 % b) 2,2 % c) 0,5 % For a) and b) Not more than 0,5 % to protect product formulation a) If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 5,5 %. b) If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 1,7 %. For a) and b): Contains Benzophenone-3 5 Moved or deleted 6 2-Phenylbenzimidazole-5-sulfonic acid and its potassium, sodium and triethanolamine salts/Ensulizole Phenylbenzimidazole Sulfonic Acid 27503-81-7 248-502-0 8 %(as acid) 7 3,3'-(1,4-Phenylenedimethylene) bis(7, 7-dimethyl-2-oxobicyclo-[2.2.1]hept-1-yl-methanesulfonic acid) and its salts/Ecamsule Terephthalylidene Dicamphor Sulfonic Acid 92761-26-7, 90457-82-2 410-960-6 10 %(as acid) 8 1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione/Avobenzone Butyl Methoxydibenzoylmethane 70356-09-1 274-581-6 5 % 9 alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts Benzylidene Camphor Sulfonic Acid 56039-58-8 6 % (as acid) 10 2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester/Octocrilene 2- ethylhexyl ester/Octocrylene s Octocrylene 6197-30-4 228-250-8 a) Propellant spray products b) Other products a) 9 % b) 10 % (as acid) 11 Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl} acrylamide Polyacrylamidomethyl Benzylidene Camphor 113783-61-2 6 % 12 2-Ethylhexyl 4-methoxycinnamate/Octinoxate Ethylhexyl Methoxycinnamate 5466-77-3 226-775-7 10 % 13 Ethoxylated ethyl-4-aminobenzoate PEG-25 PABA 116242-27-4 10 % 14 Isopentyl-4-methoxycinnamate/Amiloxate Isoamyl p-Methoxycinnamate 71617-10-2 275-702-5 10 % 15 2,4,6-Trianilino-(p-carbo-2'-ethylhexyl-1'-oxy)-1,3,5-triazine … 701 unchanged words … (2Z)-2-cyano-2-[3-(3-methoxypropylamino) cyclohex-2-en-1-ylidene]acetate Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate 1419401-88-9 700-860-3 3 % Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation Do not use with nitrosating agents – Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers