Cosmetics Regulation

02009R1223-20240404 → 02009R1223-20240424

ANNEX II LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS OJ L 159, 29.6.1996, p. 1Modified 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 … 17,123 unchanged words … 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

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.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.Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (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.For other uses of potassium hydroxide, see Annex III, No 15d.For other uses of potassium hydroxide, see Annex III, No 15a.From 25 September 2018 cosmetic products containing peanut oil, extracts and derivatives and not complying with that restriction shall not be placed on the Union market. From 25 December 2018 cosmetic products containing peanut oil, extracts and derivatives and not complying with that restriction shall not be made available on the Union market.From 25 September 2018 cosmetic products containing hydrolyzed wheat proteins and not complying with that restriction shall not be placed on the Union market. From 25 December 2018 cosmetic products containing hydrolyzed wheat proteins and not complying with that restriction shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 May 2019 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 August 2019 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.For use as a preservative, see Annex V, entry 32.From 27 November 2019 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those restrictions 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 restrictions shall not be made available on the Union market.From 3 June 2021 products containing that substance and not complying with those conditions shall not be placed on the Union market. From 3 September 2021 products containing that substance and not complying with those conditions shall not be made available on the Union market.From 3 June 2021 products containing that substance and not complying with those conditions shall not be placed on the Union market. From 3 September 2021 products containing that substance and not complying with those conditions shall not be made available on the Union market.From 26 January 2022 hair dye and self-tanning products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 22 April 2022 hair dye and self-tanning products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 21 August 2022 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 21 November 2022 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 July 2023 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 July 2023 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be made available on the Union market.For use as a colorant, see Annex IV, entry No 82.Cosmetic products containing that substance that do not comply with the restrictions may be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028.Cosmetic products containing that substance that do not comply with the restrictions may, provided that they comply with the restrictions applicable on 15 August 2023, be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028.For use as Verbena essential oils (Lippia citriodora Kunth.) and derivatives, see Annex II, No 450.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 27 February 2020 cosmetic products containing 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one and not complying with those restrictions shall not be made available on the Union market.From 3 June 2021 products containing that substance and not complying with those conditions shall not be placed on the Union market. From 3 September 2021 products containing that substance and not complying with those conditions shall not be made available on the Union market.From 3 June 2021 products containing that substance and not complying with those conditions shall not be placed on the Union market. From 3 September 2021 products containing that substance and not complying with those conditions shall not be made available on the Union market.From 26 January 2022 hair dye and self-tanning products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 22 April 2022 hair dye and self-tanning products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 21 August 2022 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 21 November 2022 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 July 2023 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.From 1 July 2023 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be made available on the Union market.For use as a colorant, see Annex IV, entry No 82.Cosmetic products containing that substance that do not comply with the restrictions may be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028.Cosmetic products containing that substance that do not comply with the restrictions may, provided that they comply with the restrictions applicable on 15 August 2023, be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028.For use as Verbena essential oils (Lippia citriodora Kunth.) and derivatives, see Annex II, No 450.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 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 … 2,055 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 … 431 unchanged words … 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. 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 … 707 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 … 633 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 %