Cosmetics Regulation

02009R1223-20211001 → 02009R1223-20220301

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 … 16,822 unchanged words … 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 1658 Silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1) 409-21-2 308076-74-6 206-991-8 1659 Tris(2-methoxyethoxy) vinylsilane; 6-(2-methoxyethoxy)- 6-vinyl-2,5,7,10-tetraoxa-6-silaundecane 1067-53-4 213-934-0 1660 Dioctyltin dilaurate; [1] stannane, dioctyl-, bis (coco acyloxy) derivs. [2] 3648-18-8 [1] 91648- 39-4 [2] 222-883-3 [1] 293-901-5 [2] 1661 Dibenzo[def,p]chrysene; dibenzo[a,l]pyrene 191-30-0 205-886-4 1662 Ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1- (1H-1,2,4-triazol-1-ylmethyl)cyclopentanol 125225-28-7 115850-69-6 115937-89-8 - 1663 Bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme 143-24-8 205-594-7 1664 Paclobutrazol (ISO); (2RS,3RS)-1-(4-chlorophenyl)-4,4-dimethyl- 2-(1H-1,2,4-triazol-1- yl)pentan-3-ol 76738-62-0 - 1665 2,2-bis(bromomethyl) propane-1,3-diol 3296-90-0 221-967-7 1666 2-(4-tert-butylbenzyl) propionaldehyde 80-54-6 201-289-8 1667 Diisooctyl phthalate 27554-26-3 248-523-5 1668 2-methoxyethyl acrylate 3121-61-7 221-499-3 1669 Sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate] if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≥ 0,1 % w/w 70161-44-3 274-357-8 1670 Pyrithione zinc; (T-4)- bis[1-(hydroxy-.kappa.O)pyridine-2(1H)- thionato-.kappa.S]zinc 13463-41-7 236-671-3 1671 Flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one 61213-25-0 262-661-3 1672 3-(difluoromethyl)-1- methyl-N-(3',4',5'-trifluorobiphenyl-2-yl) pyrazole-4-carboxamide; fluxapyroxad 907204-31-3 - 1673 N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] 924-42-5 213-103-2 1674 5-fluoro-1,3-dimethyl-N-[2-(4- methylpentan-2-yl) phenyl]-1H-pyrazole- 4-carboxamide; 2'- [(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen 494793-67-8 - 1675 Iprovalicarb (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; 201-279-3

02009R1223-20211001 → 02009R1223-20220301

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. 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. 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 … 298 unchanged lines … 23 (a) Alkali sulphides (a) Depilatories (a) 2 % (as sulphur) pH ≤ 12,7 (a) (b) Keep out of reach of children Avoid contact with eyes (b) Alkaline earth sulphides (b) Depilatories (b) 6 % (as sulphur) 24 Water-soluble zinc salts with the exception of zinc 4-hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (entry 101 and Annex V, entry 8) Zinc acetate, zinc chloride, zinc gluconate, zinc glutamate 1 % (as zinc) 25 Zinc 4-hydroxybenzene sulphonate Zinc phenolsulfonate 127-82-2 204-867-8 Deodorants, antiperspirants and astringent lotions 6 % (as % anhydrous substance) Avoid contact with eyes 24 Water-soluble zinc salts with the exception of zinc 4- hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (Annex II, entry X) Zinc acetate, zinc chloride, zinc gluconate, zinc glutamate 1 % (as zinc) 25 Zinc 4-hydroxybenzene sulphonate Zinc phenolsulfonate 127-82-2 204-867-8 Deodorants, antiperspirants and astringent lotions 6 % (as % anhydrous substance) Avoid contact with eyes 26 Ammonium monofluorophosphate Ammonium Monofluorophosphate 20859-38-5 / 66115-19-3 — / — Oral products 0,15 % calculated as F. When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % Contains ammonium monofluorophosphate. For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. for adult use only) the following labelling is obligatory:Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor. … 1,448 unchanged lines … 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 % (b) 10 % 323 Methyl-N-methylanthranilate 85-91-6 201-642-6 (a) Leave-on products (a) 0,1 % For (a): Not to be used in sunscreen products and products marketed for exposure to natural or artificial UV light. (b) Rinse-off products (b) 0,2 % For (a) and (b): Do not use with nitrosating agents Maximum nitrosamine content: 50 μg/kg Keep in nitrite-free containers

02009R1223-20211001 → 02009R1223-20220301

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 … 1,581 unchanged words … 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 hydroxymethylamino acetate Sodium Hydroxymethylglycinate 70161-44-3 274-357-8 0,5 % Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, if 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 %