Cosmetics Regulation

02009R1223-20200501 → 02009R1223-20201203

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. 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 … 16,467 unchanged words … its sodium [2] 21049-39-8 [2] - [2] and ammonium [3] salts 4149-60-4 [3] - [3] 1637 Dicyclohexyl phthalate 84-61-7 201-545-9 1638 3,7-Dimethylocta-2,6- dienenitrile 5146-66-7 225-918-0 1639 Bupirimate (ISO); 5-butyl-2-ethylamino-6- methylpyrimidin-4-yl dimethylsulfamate 41483-43-6 255-391-2 1640 Triflumizole (ISO); (1E)-N-[4-chloro-2-(trifluoromethyl)phenyl]-1- (1H-imidazol-1-yl)-2- propoxyethanimine 68694-11-1 604-708-8 1641 tert-Butyl hydroperoxide 75-91-2 200-915-71642 1,2,4-Trihydroxybenzene when used as a substance in hair and eyelash dye products 533-73-3 208-575-1 1643 4-Amino-3-hydroxytoluene when used as a substance in hair and eyelash dye products 2835-98-5 220-620-7 1644 2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid when used as a substance in hair and eyelash dye products 117907-43-4 411-260-3

02009R1223-20200501 → 02009R1223-20201203

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. … 27 unchanged lines … 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. 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 … 1,711 unchanged lines … 290 Disodium 2,2′-(9,10-dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate) Acid Green 25 4403-90-1 224-546-6 Hair dye substance in non-oxidative hair dye products 0,3 % 291 Sodium, 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate Acid Violet 43 4430-18-6 224-618-7 Hair dye substance in non-oxidative hair dye products 0,5 % 292 1,4-Benzenediamine, 2-(methoxymethyl) 1,4-Benzenediamine, 2-(methoxymethyl)-, sulfate 2-Methoxymethyl-p-Phenylenediamine 2-Methoxymethyl-p-Phenylenediamine Sulfate 337906-36-2 337906-37-3 Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,8 % (calculated as free base) To be printed on the label: The mixing ratio. 337906-37-3 679-526-3 638-749-6 (a) Hair dye substance in oxidative hair dye products (b) Products intended for colouring eyelashes (a) (b) After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 1,8 % (calculated as free base) (b) Professional use (a) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. (b) To be printed on the label: The mixing ratio. This product can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase the risk of allergy. Eyelashes shall not be coloured if the consumer: has a rash on the face or sensitive, irritated and damaged scalp, has experienced any reaction after colouring hair or eyelashes, has experienced a reaction to a temporary black henna tattoo in the past. For professional use only. Rinse eyes immediately if product comes into contact with them. 293 1-N-Methylmorpholiniumpropylamino-4-hydroxyanthraquinone, methyl sulfate Hydroxyanthraquinone-aminopropyl Methyl Morpholinium Methosulfate 38866-20-5 254-161-9 Hair dye substance in non-oxidative hair dye products 0,5 % Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers To be printed on the label: … 126 unchanged lines … 311 Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide Trimethylbenzoyl diphenylphosphine oxide 75980-60-8 278-355-8 Artificial nail systems 5,0 % Professional use For professional use only Avoid skin contact Read directions for use carefully 312 2-Furaldehyde Furfural 98-01-1 202-627-7 0,001 % 312 2-Furaldehyde Furfural 98-01-1 202-627-7 0,001 % 313 2-Hydroxyethyl Methacrylate HEMA 868-77-9 212-782-2 Nail products Professional use only For professional use only Can cause an allergic reaction 314 11,14-Dioxa-2,9-diazaheptadec-16-enoic Acid, 4,4,6,16-tetramethyl-10,15-dioxo, 2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl ester DI-HEMA TRIMETHYLHEXYL DICARBAMATE 41137-60-4/72869-86-4 255-239-5/276-957-5 Nail products Professional use only For professional use only Can cause an allergic reaction 315 4-(3-aminopyrazolo[1,5-A]pyridin-2-yl)-1,1-dimethylpiperazin-1-ium chloride hydrochloride Dimethylpiperazinium Aminopyrazolopyridine HCl 1256553-33-9 813-255-5 Hair dye substance in oxidative hair dye products As from 3 June 2021, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % (calculated as free base) As from 3 December 2021, to be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. 316 1-(3-((4-Aminophenyl)amino)propyl)-3-methyl-1H-imidazol-3-ium chloride hydrochloride Methylimidazoliumpropyl p-phenylenediamine HCl 220158-86-1 Hair dye substance in oxidative hair dye products As from 3 June 2021, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % (calculated as free base) As from 3 December 2021, to be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. 317 Di-[2-[(E)-2-[4-[bis(2-hydroxyethyl)aminophenyl]vinyl]pyridin-1-ium]-ethyl]disulphide dimethanesulfonate HC Orange No 6 1449653-83-1 Hair dye substance in non-oxidative hair dye products As from 3 June 2021: 0,5 % Methanesulfonates impurities, in particular ethyl methanesulfonate shall not be present. 318 Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzene sulfonate Acid Orange 7 633-96-5 211-199-0 Hair dye substance in non-oxidative hair dye products As from 3 June 2021: 0,5 % 319 Phenol, 4,4'-(4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo- Tetrabromophenol Blue 4430-25-5 224-622-9 (a) Hair dye substance in oxidative hair dye products (b) Hair dye substance in non-oxidative hair dye products (b) As from 3 June 2021: 0,2 % (a) As from 3 June 2021, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,2 % (calculated as free base) (a) As from 3 December 2021, to be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary black henna tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary black henna tattoo in the past. 320 Indigofera tinctoria, dried and pulverised leaves of Indigofera tinctoria L Indigofera tinctoria leaf Indigofera tinctoria leaf powder Indigofera tinctoria leaf extract Indigofera tinctoria extract 84775-63-3 283-892-6 Hair dye substance in non-oxidative hair dye products As from 3 June 2021: 25 %

02009R1223-20200501 → 02009R1223-20201203

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 … 860 unchanged words … < 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. 32 2-ethoxyethyl (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