Cosmetics Regulation

02009R1223-20250501 → 02009R1223-20250901

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 … 16,268 unchanged words … Cycloxydim (ISO); 2-(N-ethoxybutanimidoyl)-3-hydroxy-5-(tetrahydro-2H-thiopyran-3-yl)cyclohex-2-en-1-one 101205-02-1 405-230-9 1572 Fluazinam (ISO); 3-chloro-N-[3-chloro-2,6-dinitro-4-(trifluoromethyl)phenyl]-5-(trifluoromethyl)pyridin-2-amine 79622-59-6 616-712-5 1573 Penconazole (ISO); 1-[2-(2,4-dichlorophenyl)pentyl]-1H-1,2,4-triazole 66246-88-6 266-275-6 1574 Fenoxycarb (ISO); ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate 72490-01-8 276-696-7 1575 Styrene 100-42-5 202-851-5 1576 Tetrahydro-2-furylmethanol; tetrahydrofurfuryl alcohol 97-99-4 202-625-6 1577 Formaldehyde 50-00-0 200-001-8 1578 Paraformaldehyde 30525-89-4 608-494-5 1579 Methanediol; methylene glycol 463-57-0 207-339-5 1580 Cymoxanil cymoxanil (ISO); 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide 57966-95-7 261-043-0 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide; [1] 57966-95-7; [1] 261-043-0; [1] (2E)-2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide; [2] 166900-80-7; [2] - [2] 1581 Tributyltin compounds — — 1582 Tembotrione (ISO); 2-{2-chloro-4-(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl}cyclohexane-1,3-dione 335104-84-2 608-879-8 1583 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear 68515-50-4 271-093-5 1584 Spirotetramat (ISO); (5s,8s)-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4,5]dec-3-en-4-yl ethyl carbonate 203313-25-1 606-523-6 1585 Dodemorph acetate; 4-cyclododecyl-2,6-dimethylmorpholin-4-ium acetate 31717-87-0 250-778-2 1586 Triflusulfuron-methyl; methyl 2-({[4-(dimethylamino)-6-(2,2,2- trifluoroethoxy)-1,3,5-triazin-2- yl]carbamoyl}sulfamoyl)-3- methylbenzoate 126535-15-7 603-146-9 1587 … 1,061 unchanged words … 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/-1731 diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide; INCI: Trimethylbenzoyl Diphenylphosphine Oxide 75980-60-8 278-355-8 1732 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol; tetrabromobisphenol-A 79-94-7 201-236-9 1733 transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate 118712-89-3 405-060-5 1734 clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine 210880-92-5 433-460-1 1735 benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate 577705-90-9 479-100-5 1736 benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1) 75768-65-9 278-305-5 1737 reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1) - - 1738 reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (1:1) - - 1739 dimethyl propylphosphonate 18755-43-6 242-555-3 1740 dibutyltin maleate 78-04-6 201-077-5 1741 dibutyltin oxide 818-08-6 212-449-1 1742 reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane - - 1743 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF 1478-61-1 216-036-7 1744 benfluralin (ISO); N-butyl-N-ethyl-α,α,α-trifluoro-2,6-dinitro-p-toluidine 1861-40-1 217-465-2 1745 N,N-dimethyl-p-toluidine 99-97-8 202-805-4 1746 1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs. 68953-84-4 273-227-8 1747 4-nitrosomorpholine 59-89-2 - 1748 difenoconazole (ISO); 1-({2-[2-chloro-4-(4-chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2-yl}methyl)-1H-1,2,4-triazole; 3-chloro-4-[(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4-chlorophenyl ether 119446-68-3 - 1749 4-methylimidazole 822-36-6 212-497-3 1750 3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate 91-97-4 202-112-7 1751 foramsulfuron (ISO); 2-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-4-formamido-N,N-dimethylbenzamide; 1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-dimethylcarbamoyl-5-formamidophenylsulfonyl)urea 173159-57-4 -

02009R1223-20250501 → 02009R1223-20250901

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. … 610 unchanged lines … The presence of the substance or substances shall be indicated as Rose Ketones in the list of ingredients referred to in Article 19(1), point (g), when the concentration of the substance or substances exceeds: 0,001 % in leave-on products 0,01 % in rinse-off products. trans-Rose ketone 1 24720-09-0 246-430-4 1-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one(16) Rose ketone 4 (Damascone) 23696-85-7 245-833-2 1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-1-one(16) Rose ketone 3 (delta-Damascone) 57378-68-4 260-709-8 1-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one Rose ketone 4 (Damascone) 23696-85-7 245-833-2 1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-1-one Rose ketone 3 (delta-Damascone) 57378-68-4 260-709-8 trans-Rose ketone 3 71048-82-3 275-156-8 (Z)-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-buten-1-one (16) cis-Rose ketone 2 (Z)-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-buten-1-one cis-Rose ketone 2 (cis-beta-Damascone) 23726-92-3 245-843-7 (E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one(16) trans-Rose ketone 2 (E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one trans-Rose ketone 2 (trans-beta-Damascone) 23726-91-2 245-842-1 158 trans-Rose ketone-2; (E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one (trans-beta-Damascone) trans-Rose ketone-2 23726-91-2 245-842-1 (a) Oral products (b) Other products (b) 0,02 % 159 trans-Rose ketone-5; (E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one (Isodamascone) trans-Rose ketone-5 39872-57-6 254-663-8 0,02 % 160 Rose ketone-4; 1-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) Rose ketone-4 23696-85-7 245-833-2 (a) Oral products (b) Other products (b) 0,02 % … 1,223 unchanged lines … (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 325 2,6-Di-tert-butyl-p-cresol; 2,6-Di-tert-butyl-4- methylphenol BHT 128-37-0 204-881-4 a) Mouthwash b) Toothpaste c) Other leave-on and rinse-off products a) 0,001 % b) 0,1 % … 218 unchanged lines … 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.