Cosmetics Regulation

02009R1223-20221006 → 02009R1223-20221217

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 … 17,007 unchanged words … (ISO); isopropyl [(2S)-3- methyl-1-{[1-(4- methylphenyl)ethyl] amino}-1-oxobutan-2- yl]carbamate 140923-17-7 - 1676 Dichlorodioctylstannane 3542-36-7 222-583-2 1677 Mesotrione (ISO); 2-[4-(methylsulfonyl)- 2-nitrobenzoyl]-1,3- cyclohexanedione 104206-82-8 - 1678 Hymexazol (ISO); 3-hydroxy-5-methylisoxazole 10004-44-1 233-000-6 1679 Imiprothrin (ISO); reaction mass of: [2,4- dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-cis-chrysanthemate; [2,4-dioxo-(2-propyn-1-yl) imidazolidin-3-yl] methyl(1R)-trans-chrysanthemate 72963-72-5 428-790-6 1680 Bis(α,α-dimethylbenzyl) peroxide 80-43-3; 80-43-3 201-279-31681 Tetrafluoroethylene 116-14-3 204-126-9 1682 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol;[DBMC] 119-47-1 204-327-1 1683 (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone; pyriofenone 688046-61-9 692-456-8 1684 (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate 1101132-67-5 701-225-3 1685 Azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate 35575-96-3 252-626-0 1686 3-methylpyrazole 1453-58-3 215-925-7 1687 N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide; pydiflumetofen 1228284-64-7 817-852-1 1688 N-{2-[[1,1'-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide; sedaxane 874967-67-6 688-331-2 1689 4-methylpentan-2-one; isobutyl methyl ketone (MIBK) 108-10-1 203-550-1 1690 Dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine 110488-70-5 404-200-2 1691 Imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid 114311-32-9 601-305-7 1692 Thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine 153719-23-4 428-650-4 1693 Triticonazole (ISO); (RS)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-methyl)cyclopentanol 138182-18-0 - 1694 Desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate 13684-56-5 237-198-5

02009R1223-20221006 → 02009R1223-20221217

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 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. 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 … 280 unchanged lines … Contains resorcinol. Rinse hair well after application. Rinse eyes immediately if product comes into contact with them. Do not use to dye eyelashes or eyebrows. Do not use to dye eyelashes. (b) Products intended for colouring eyelashes (b) For professional use only. (b) To be printed on the label: The mixing ratio. For professional use only. … 1,471 unchanged lines … Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers324 Methyl 2-hydroxybenzoate Methyl Salicylate 119-36-8 204-317-7 (a) Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic-based fragrances) and leave on hair products (except spray/aerosol products) (a) 0,06 % Not to be used in preparations for children under 6 years of age, with the exception of (k) Toothpaste (b) Face makeup (except lip products, eye makeup and makeup remover) (b) 0,05 % (c) Eye makeup and makeup remover (c) 0,002 % (d) Leave-on hair products (spray/aerosol) (d) 0,009 % (e) Deodorant spray/aerosol (e) 0,003 % (f) Body lotion spray/aerosol (f) 0,04 % (g) Rinse-off skin products (except hand wash) and rinse-off hair products (g) 0,06 % (h) Hand wash (h) 0,6 % (i) Hydroalcoholic-based fragrances (i) 0,6 % (j) Lip products (j) 0,03 % (k) Toothpaste (k) 2,52 % (l) Mouthwash intended for children aged 6–10 years (l) 0,1 % (m) Mouthwash intended for children above 10 years of age and adults (m) 0,6 % (n) Mouth spray (n) 0,65 % 325 2,6-Di-Tert-Butyl-4-Methylphenol Butylated Hydroxytoluene 128-37-0 204-881-4 a) Mouthwash b) Toothpaste c) Other leave-on and rinse-off products a) 0,001 % b) 0,1 % c) 0,8 % 326 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts (CI 47005), Acid Yellow 3 8004-92-0 305-897-5 Non-oxidative hair dye products 0,5 %

02009R1223-20221006 → 02009R1223-20221217

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 … 1,640 unchanged words … to be used in aerosols (sprays) Contains glutaral 49 5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane 7-Ethylbicyclooxazolidine 7747-35-5 231-810-4 0,3 % Not to be used in oral products and in products applied on mucous membranes 50 3-(p-Chlorophenoxy)-propane-1,2 diol Chlorphenesin 104-29-0 203-192-6 0,3 % 51 Sodium N-(hydroxymethyl)glycinate N-(hydroxymethyl) glycinate Sodium Hydroxymethylglycinate 70161-44-3 274-357-8 0,5 % Not to be used unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is < 0,1 % w/w 52 Silver chloride deposited on titanium dioxide Silver chloride 7783-90-6 232-033-3 0,004 % (as AgCl) 20 % AgCl (w/w) on TiO2. Not to be used in products for children under 3 years of age, in oral products and in eye and lip products 53 Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chloride Benzethonium Chloride 121-54-0 204-479-9 (a) Rinse-off products (b) Leave-on products other than oral products 0,1 % 54 Benzalkonium chloride, bromide and saccharinate Benzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate 8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9 264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-1 0,1 % (as benzalkonium chloride) Avoid contact with eyes 55 Methanol, (phenylmethoxy-) Benzylhemiformal 14548-60-8 238-588-8 Rinse-off products 0,15 % 56 3-Iodo-2-propynylbutylcarbamate Iodopropynyl butylcarbamate 55406-53-6 259-627-5 (a) Rinse-off products (b) Leave-on products (c) Deo-dorants/anti-perspirants (a) 0,02 % (b) 0,01 %, (c) 0,0075 % Not to be used in oral and lip products (a) Not to be used in products for children under 3 years of age, except in bath products/shower gels and shampoo (b) Not to be used in body lotion and body cream (b) and (c) Not to be used in products for children under 3 years of age (a) Not to be used for children under 3 years of age (b) and (c) Not to be used for children under 3 years of age 57 2-Methyl-2H-isothiazol-3-one Methylisothiazolinone 2682-20-4 220-239-6 Rinse-off products 0,0015 % 58 Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride Ethyl Lauroyl Arginate HCl 60372-77-2 434-630-6 (a) Mouthwashes (a) 0,15 % (a) Not to be used in preparations for children under 10 years of age (a) Not to be used for children under 10 years of age (b) Other products (b) 0,4 % (b) Not to be used in lip products, oral products (other than 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 %

02009R1223-20221006 → 02009R1223-20221217

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. level.From 1 January 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 July 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.In case of combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano), the sum shall not exceed 10 %. 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 2- hydroxy-, 3,3,5- trimethylcyclohexyl ester/Homosalate Homosalate 118-56-9 204-260-8 10 Face products with the exception of propellent spray products 7,34 % 4 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 … 886 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 33 1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine 919803-06-8 485-100-6 10 % 34 1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano) 919803-06-8 485-100-6 10 % Only nanomaterials having the following characteristics are allowed: Purity ≥ 97 % Median particle size D50 (50 % of the number below this diameter): ≥ 50 nm of number size distribution. Not to be used in applications that may lead to exposure of the end user’s lungs by inhalation.