Cosmetics Regulation

02009R1223-20240404 → 02009R1223-20240424

ANNEX II LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS OJ L 159, 29.6.1996, p. 1 Modified INNM-name. OJ L 273, 10.10.2002, p. 1. for the individual ingredient see reference number 364 in Annex II. for the individual ingredient see reference number 413 in Annex II. From 23 August 2019 cosmetic products containing that substance shall not be placed on the Union market. From 23 August 2021 cosmetic products containing that substance shall not be made available on the Union market. From 1 May 2019 cosmetic products containing that substance shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance shall not be made available on the Union market. From 1 May 2019 cosmetic products containing that substance shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance shall not be made available on the Union market. From 22 November 2019 hair dye products, including eyebrow dye products, and eyelash dye products containing those substances shall not be placed on the Union market. From 22 February 2020 hair dye products, including eyebrow dye products, and eyelash dye products containing those substances shall not be made available on the Union market. From 3 September 2021 hair and eyelash dye products containing those substances shall not be placed on the Union market. From 3 June 2022 hair and eyelash dye products containing those substances shall not be made available on the Union market. From 1 February 2025 cosmetic products containing that substance shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance shall not be made available on the Union market. From 1 May 2025 products containing that substance shall not be placed on the Union market. From 1 May 2026 cosmetic products containing that substance shall not be made available on the Union market. Reference number Substance identification Chemical name/INN CAS number EC number a b c d 1 N-(5-Chlorobenzoxazol-2-yl)acetamide 35783-57-4 2 (2-Acetoxyethyl)trimethylammonium hydroxide (Acetylcholine) and its salts 51-84-3 200-128-9 3 Deanol aceglumate (INN) 3342-61-8 … 17,106 unchanged words … (nano) [INCI] , Colloidal Gold (nano) [INCI] [1] Gold Thioethylamino Hyaluronic Acid (nano) [INCI] [2] Acetyl heptapeptide-9 Colloidal gold (nano) [INCI] [3] 7440-57-5 [1] 1360157-34-1 [2] [3] 231-165-9 [1] [2] [3] 1729 Platinum (nano) [INCI] , Colloidal Platinum (nano) [INCI] [1] Acetyl tetrapeptide-17 Colloidal Platinum (nano) [INCI] [2] 7440-06-4 [1] [2] 231-116-1 [1] [2]1730 3-(4'-methylbenzylidene)-camphor ; [INCI: 4-Methylbenzylidene Camphor] 36861-47-9/38102-62-4 253-242-6/-

02009R1223-20240404 → 02009R1223-20240424

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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. … 40 unchanged lines … Cosmetic products containing that substance that do not comply with the restriction(s) may be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028. Since that substance is a monoterpene, it is subject to the restriction on peroxide value set out in entry 130. For use of Oil from the seeds of Laurus nobilis L., see Annex II, No 359. From 1 February 2025 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance shall not be made available on the Union market. From 1 February 2025 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market. From 1 February 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.’ From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 May 2027 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market. 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 … 2,284 unchanged lines … 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: [composed of] rod-shaped particles of which at least 95,8 % (in particle number) have an aspect ratio less than 3, and the remaining 4,2 % have an aspect ratio not exceeding 4,9; the particles are not coated or surface modified the particles are not coated or surface modified 373 Genisteol; 4',5,7-Trihydroxyisoflavone; 5,7-dihydroxy-3-(4-hydroxyphenyl)-4-benzopyrone Genistein 446-72-0 207-174-9 0,007 % 374 Daidzeol; 4',7-Dihydroxyisoflavone; 7-hydroxy-3-(4-hydroxyphenyl)-4-benzopyrone Daidzein 486-66-8 207-635-4 0,02 % 375 5-Hydroxy-2-(hydroxymethyl)-4H-pyrane-4-one Kojic Acid 501-30-4 207-922-4 Face and hand products 1 % 376 (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraen-1-ol Retinol 11103-57-4/ 68-26-8 234-328-2/ 200-683-7 (a) Body lotion (b) other leave-on and rinse-off products (a) 0,05 % Retinol Equivalent (RE) (b) 0,3 % RE For any cosmetic product containing Retinol, Retinyl Acetate or Retinyl Palmitate the following, labelling is obligatory: Contains Vitamin A. Consider your daily intake before use. [(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenyl] acetate Retinyl Acetate 127-47-9 204-844-2 [(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenyl] hexadecanoate Retinyl Palmitate 79-81-2 201-228-5 377 4-Hydroxyphenyl-alpha-D-glucopyranoside Alpha-Arbutin 84380-01-8 617-561-8 (a) Face cream (b) Body lotion (a) 2 % (b) 0,5 % Hydroquinone levels shall remain as low as possible in formulations containing alpha-Arbutin and shall not be higher than the unavoidable trace level. 378 4-Hydroxyphenyl-beta-D-glucopyranoside Arbutin 497-76-7 207-850-3 Face cream 7 % Hydroquinone levels shall remain as low as possible in formulations containing Arbutin and shall not be higher than the unavoidable trace level.

02009R1223-20240404 → 02009R1223-20240424

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 … 432 unchanged words … 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. Cosmetic products containing that substance that do not comply with the conditions may, provided that they comply with the conditions applicable on 23 April 2024, be placed on the Union market until 31 December 2024 and, if they have already been placed on the market before that date, continue to be made available on the Union market until 31 October 2025. 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 … 702 unchanged words … hexahydro-5-methyl- Hexetidine 141-94-6 205-513-5 0,1 % 20 5-Bromo-5-nitro-1,3-dioxane 5-Bromo-5-nitro-1,3-dioxane 30007-47-7 250-001-7 Rinse-off products 0,1 % Avoid formation of nitrosamines 21 Bronopol 2-Bromo-2-nitropropane-1,3-diol 52-51-7 200-143-0 0,1 % Avoid formation of nitrosamines 22 2,4-Dichlorobenzyl alcohol Dichlorobenzyl Alcohol 1777-82-8 217-210-5 0,15 % 23 1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) urea 1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl)urea Triclocarban 101-20-2 202-924-1 All cosmetic products, with the exception of mouthwash. 0,2 % Purity criteria: 3,3',4,4'-Tetrachloroazobenzene <1 ≤ 1 ppm 3,3',4,4'-Tetrachloroazoxybenzene <1 ≤ 1 ppm Not to be used in toothpaste intended for children under 6 years of age. For toothpaste containing Triclocarban the following labelling is obligatory: Not to be used for children under 6 years of age. 24 Chlorocresol p-Chloro-m-Cresol 59-50-7 200-431-6 Not to be used in products applied on mucuous membranes 0,2 % 25 5-Chloro-2- (2,4- dichlorophenoxy) phenol Triclosan 3380-34-5 222-182-2 (a) Toothpastes Toothpastes; Hand soaps soaps; Body soaps/Shower gels gels; Deodorants (non-spray) (non-spray); Face powders and blemish concealers concealers; Nail products for cleaning the fingernails and toenails before the application of artificial nail systems (a) systems; 0,3 % (b) Mouthwashes (b) 0,2 % Not to be used in toothpaste intended for children under 3 years of age. For toothpaste containing Triclosan the following labelling is obligatory: Not to be used for children under 3 years of age. 26 Chloro-xylenol Chloroxylenol 88-04-0 201-793-8 0,5 % 27 N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea] Imidazolidinyl urea 39236-46-9 254-372-6 0,6 % 28 Polyhexamethylene biguanide hydrochloride Polyaminopropyl biguanide 32289-58-0, 27083-27-8, 28757-47-3, 133029-32-0 608-723-9 608-042-7 0,1 % Not to be used in applications that may lead to exposure of the end-user's lungs … 623 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 %