Cosmetics Regulation

02009R1223-20210823 → 02009R1223-20211001

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 … 16,735 unchanged words … 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 1645 Cobalt 7440-48-4 231-158-0 1646 Metaldehyde (ISO); 2,4,6,8-tetramethyl- 1,3,5,7-tetraoxacyclooctane 108-62-3 203-600-2 1647 Methylmercuric chloride 115-09-3 204-064-2 1648 Benzo[rst]pentaphene 189-55-9 205-877-5 1649 Dibenzo[b,def]chrysene; dibenzo[a,h]pyrene 189-64-0 205-878-0 1650 Ethanol, 2,2'-iminobis-, N- (C13-15-branched and linear alkyl) derivs. 97925-95-6 308-208-6 1651 Cyflumetofen (ISO); 2-methoxyethyl (RS)-2- (4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate 400882-07-7 - 1652 Diisohexyl phthalate 71850-09-4 276-090-2 1653 halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6- dimethoxypyrimidin-2-yl) carbamoyl]sulfamoyl}-1- methyl-1H-pyrazole-4- carboxylate 100784-20-1 - 1654 2-methylimidazole 693-98-1 211-765-7 1655 Metaflumizone (ISO); (EZ)-2'-[2-(4-cyanophenyl)-1-(α,α,α -trifluoro-m- tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl] carbanilohydrazide [E-isomer ≥ 90 %, Z-isomer ≤ 10 % relative content]; [1] (E)-2'-[2-(4-cyanophenyl)- 1-(α,α,α -trifluoro-m-tolyl) ethylidene]-[4-(trifluoromethoxy)phenyl]carbanilohydrazide [2] 139968-49-3 [1] 852403-68-0 [2] - 1656 Dibutylbis(pentane-2,4- dionato-O,O')tin 22673-19-4 245-152-0 1657 4-[(tetrahydro-2H-pyran-2-yl)oxy]phenol (Deoxyarbutin, Tetrahydropyranyloxy Phenol) 53936-56-4

02009R1223-20210823 → 02009R1223-20211001

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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.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. … 1,748 unchanged lines … 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 % 321 1,3-Dihydroxy-2-propanone Dihydroxyacetone 96-26-4 202-494-5 (a) Hair dye substance in non-oxidative hair dye products Indigofera tinctoria extract 84775-63-3 283-892-6 Hair dye substance in non-oxidative hair dye products As from 3 June 2021: 25 % 321 Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm Titanium Dioxide 13463-67-7/1317-70-0/1317-80-2 236-675-5/215-280-1/215-282-2 (a) face products in loose powder form (b) hair aerosol spray products (c) other products (a) 25 %; (b) 1,4 % for general consumers, and 1.1 % for professional use. (a) (b) Only in the pigmentary form (c) Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation 322 1,3-Dihydroxy-2-propanone Dihydroxyacetone 96-26-4 202-494-5 (a) Hair dye substance in non-oxidative hair dye products (b) Self-tanning products (a) 6,25 % (b) 10 %

02009R1223-20210823 → 02009R1223-20211001

ANNEX IV LIST OF COLORANTS ALLOWED IN COSMETIC PRODUCTS Preamble Without prejudice to other provisions in this Regulation, a colorant shall include its salts and lakes and when a colorant is expressed as a specific salt, its other salts and lakes shall also be included. For use as a UV-Filter, UV filter, see Annex VI, No. 27.For No 27For use as a UV-filter, see Annex VI, No 30 and No 30a. Reference number Substance identification Conditions Wording of conditions of use and warnings Chemical Name Colour index Number/Name of Common Ingredients Glossary CAS number EC number Colour Product type, Body parts … 1,890 unchanged words … manganese(3+) diphosphate 77742 Violet 141 Trimanganese bis (orthophosphate) 77745 Red 142 Silver 77820 231-131-3 White Purity criteria as set out in Commission Directive 95/45/EC (E 174) 143 Titanium dioxide 77891 236-675-5 White Purity criteria as set out in Commission Directive 95/45/EC 95/45/E (E 171) Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No 321 144 Zinc oxide 77947 1314-13-2 215-222-5 White Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. 145 Riboflavin Lactoflavin 201-507-1/204-988-6 Yellow Purity criteria as set out in Commission Directive 95/45/EC (E 101) 146 Caramel Caramel 232-435-9 Brown Purity criteria as set out in Commission Directive 95/45/EC (E 150a-d) 147 Paprika extract, Capsanthin, capsorubin Capsanthin, capsorubin 207-364-1/207-425-2 Orange Purity criteria as set out in Commission Directive 95/45/EC (E 160c) 148 Beetroot red Beetroot Red 7659-95-2 231-628-5 Red Purity criteria as set out in Commission Directive 95/45/EC (E 162) 149 Anthocyanins (Cyanidin, Peonidin Malvidin Delphinidin Petunidin Pelargonidin) Anthocyanins 528-58-5 134-01-0 528-53-0 643-84-5 134-04-3 208-438-6 205-125-6 211-403-8 208-437-0 — 205-127-7 Red Purity criteria as set out in Commission Directive 95/45/EC (E 163) 150 Aluminium, zinc, magnesium and calcium stearates Aluminum stearate Zinc stearate Magnesium stearate Calcium stearate 7047-84-9 557-05-1 557-04-0 216-472-8 230-325-5 209-151-9 209-150-3 216-472-8 White 151 Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2-bromo-3-methyl-6-(1-methylethyl)-, S,S-dioxide Bromothymol blue 76-59-5 200-971-2 Blue Rinse-off products 152 Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo-3-methyl-,S,S-dioxide Bromocresol green 76-60-8 200-972-8 Green Rinse-off products 153 Sodium 4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonate Acid red 195 12220-24-5 — Red Not to be used in products applied on mucous membranes

02009R1223-20210823 → 02009R1223-20211001

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 … 444 unchanged words … salt of 2,2'-bis(1,4-phenylene)-1H-benzimidazole-4,6-disulfonic acid) / Bisdisulizole disodium (USAN) Disodium Phenyl Dibenzimidazole Tetrasulfonate 180898-37-7 429-750-0 10 % (as acid) 25 2,2'-(6-(4-Methoxyphenyl)-1,3,5-triazine-2,4-diyl)bis(5-((2-ethylhexyl)oxy)phenol) / Bemotrizinol Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 187393-00-6 10 % 26 Dimethicodiethylbenzalmalonate Polysilicone-15 207574-74-1 426-000-4 10 % 27 Titanium dioxide Titanium Dioxide 13463-67-7/ 1317-70-0/ 1317-80-2 236-675-5/ 215-280-1/ 215-282-2 13463-67-7/1317-70-0/1317-80-2 236-675-5/215-280-1/215-282-2 25 % Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No 321. For the product types under letter (c) of column (f) in Annex III, No 321, the maximum concentration in ready for use preparation provided in column (g) of this entry applies. 27a Titanium dioxide Titanium Dioxide (nano) 13463-67-7/1317-70-0/1317-80-2 236-675-5/215-280-1/215-282-2 25 % 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: purity ≥ 99 %, rutile form, or rutile … 382 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