Cosmetics Regulation

02009R1223-20180711 → 02009R1223-20180801

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 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. 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 (INN) 3342-61-8 … 14,013 unchanged words … Isobutylparaben 84930-15-4 284-595-4 1376 Phenyl 4-hydroxybenzoate (INCI: Phenylparaben) 17696-62-7 241-698-9 1377 Benzyl 4-hydroxybenzoate (INCI: Benzylparaben) 94-18-8 1378 Pentyl 4-hydroxybenzoate (INCI: Pentylparaben) 6521-29-5 229-408-9 1379 3-Benzylidene Camphor 15087-24-8 239-139-9 1380 3- and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC) 51414-25-6/ 31906-04-4/ 257-187-9/ 250-863-4/ 1381 2,6-Dihydroxy-4-methyl-benzaldehyde (atranol) 526-37-4 — 1382 3-Chloro-2,6-Dihydroxy-4-methyl-benzaldehyde (chloroatranol) 57074-21-2 —1383 Tagetes erecta flower extract 90131-43-4 290-353-9 Tagetes erecta flower oil 90131-43-4 290-353-9/-

02009R1223-20180711 → 02009R1223-20180801

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 and which remain in prolonged contact with the skin.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.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. 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 and which remain in prolonged contact with the skin.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.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. 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 … 1,678 unchanged lines … Sodium Peanutamphoacetate Sodium Peanutate 61789-57-9 263-070-3 Sulfated Peanut Oil 73138-79-1 277-298-6 307 Hydrolyzed wheat protein Hydrolyzed Wheat Protein 94350-06-8 / 222400-28-4 / 70084-87-6 / 100209-50-5 305-225-0 Maximum molecular weight average of the peptides in hydrolysates: 3,5 kDa 309-358-5308 Tagetes minuta flower extract Tagetes minuta flower oil Tagetes minuta flower extract Tagetes minuta flower oil 91770-75-1; 91770-75-1/8016-84-0 294-862-7; 294-862-7 (a) Leave-on products (a) 0,01 % For (a) and (b): Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0,35 %. For (a): Not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light. For (a) and (b): In case of combined use with Tagetes patula (entry 309), the total combined content of Tagetes in ready for use preparation shall not exceed the maximum concentration limits set out in column (g). (b) Rinse-off products (b) 0,1 % 309 Tagetes patula flower extract Tagetes patula flower oil Tagetes patula flower extract Tagetes patula flower oil 91722-29-1; 91722-29-1/8016-84-0 294-431-3; 294-431-3/- (a) Leave-on products (a) 0,01 % For (a) and (b): Alpha terthienyl (terthiophen) content in the extract/oil ≤ 0,35 %. For (a): Not to be used in sunscreen products and products marketed for exposure to natural/artificial UV light. For (a) and (b): In case of combined use with Tagetes minuta (entry 308), the total combined content of Tagetes in ready for use preparation shall not exceed the maximum concentration limits set out in column (g). (b) Rinse-off products (b) 0,1 %