Cosmetics Regulation

02009R1223-20191127 → 02009R1223-20191218

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 … 2,729 unchanged words … in Annex III, and the zirconium lakes, pigments or salts of the colouring agents when listed in Annex IV 7440-67-7 231-176-9 392 Moved or deleted 393 Acetonitrile 75-05-8 200-835-2 394 Tetrahydrozoline (Tetryzoline (INN)) and its salts 84-22-0 201-522-3 395 Hydroxy-8-quinoline and its sulphate 148-24-2 bis(8-hydroxyquinolinium) sulphate, except for the uses of the sulphate provided for in entry 51 of Annex III 148-24-3 134-31-6 205-711-1 205-137-1 396 Dithio-2,2-bispyridine-dioxide 1,1' (additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate) 43143-11-9 256-115-3 397 Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts 3468-63-1 222-429-4 398 Colouring agent CI 45170 and CI 45170:1 (Basic … 11,477 unchanged words … ethanal 75-07-0 200-836-8 1392 1-Cyclopropyl-6,7-difluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid 93107-30-3 413-760-7 1393 N-Methyl-2-pyrrolidone; 1-methyl-2-pyrrolidone 872-50-4 212-828-1 1394 Diboron trioxide; boric oxide 1303-86-2 215-125-8 1395 Boric acid [1] Boric acid [2] 10043-35-3 [1] 11113-50-1 [2] 233-139-2 [1] 234-343-4 [2] 1396 Borates, tetraborates, octaborates and boric acid salts and esters, including: Disodium octaborate tetrahydrate anhydrous [1] 12280-03-4 12008-41-2 [1] 234-541-0 [1] Disodium octaborate tetrahydrate [2] 12280-03-4 [2] 234-541-0 [2] 2-Aminoethanol, monoester with boric acid [2] [3] 10377-81-8 [2] [3] 233-829-3 [2] [3] 2-Hydroxypropyl ammonium dihydrogen orthoborate [3] [4] 68003-13-4 [3] [4] 268-109-8 [3] [4] Potassium borate, boric acid potassium salt [4] [5] 12712-38-8 [4] [5] 603-184-6 [4] [5] Trioctyldodecyl borate [5] [5] — [5] [6] - [6] - [6] Zinc borate [6] [7] 1332-07-6 [6] [7] 215-566-6 [6] [7] Sodium borate, disodium tetraborate anhydrous; boric acid, sodium salt [7] [8] 1330-43-4 [7] [8] 215-540-4 [7] [8] Tetraboron disodium heptaoxide, hydrate [8] [9] 12267-73-1 [8] [9] 235-541-3 [8] [9] Orthoboric acid, sodium salt [9] [10] 13840-56-7 [9] [10] 237-560-2 [9] [10] Disodium tetraborate decahydrate; borax decahydrate [10] [11] 1303-96-4 [10] [11] 215-540-4 [10] [11] Disodium tetraborate pentahydrate; borax pentahydrate [11] [12] 12179-04-3 [11] [12] 215-540-4 [11] [12] 1397 Sodium perborate [1] Sodium peroxometaborate; sodium peroxoborate [2] 15120-21-5 [1] 239-172-9 [1] 7632-04-4 [2] 10332-33-9 [2] 10486-00-7[2] 231-556-4 [2] 1398 Perboric acid (H3BO2(O2)), monosodium salt trihydrate [1] 13517-20-9 [1] 239-172-9 [1] Perboric acid, sodium salt, tetrahydrate [2] 37244-98-7 [2] 234-390-0 [2] Perboric acid (HBO(O2)), sodium salt, … 1,155 unchanged words … 432-270-4 1501 Reaction mass of: triammonium 6-amino-3-((2,5-diethoxy-4-(3-phosphonophenyl)azo)phenyl)azo-4-hydroxy-2-naphthalenesulfonate; diammonium 3-((4-((7-amino-1-hydroxy-3-sulfo-naphthalen-2-yl)azo)-2,5-diethoxyphenyl)azo)benzoate 163879-69-4 438-310-7 1502 N,N′-Diacetylbenzidine 613-35-4 210-338-2 1503 Cyclohexylamine 108-91-8 203-629-0 1504 Piperazine 110-85-0 203-808-3 1505 Hydroxylamine 7803-49-8 232-259-2 1506 Hydroxylammonium chloride; hydroxylamine hydrochloride [1] 5470-11-1 [1] 226-798-2 [1] Bis(hydroxylammonium) sulfate; hydroxylamine sulfate (2:1) [2] 10039-54-0 [2] 233-118-8 [2] 1507 Methyl-phenylene diamine; diaminotoluene — — Diaminotoluene, methyl-phenylenediamine, technical product-reaction mass of [4-methyl-m-phenylenediamine and 2-methyl-m-phenylenediamine] – – 1508 Mepanipyrim; 4-methyl-N-phenyl-6-(1-propynyl)-2-pyrimidinamine 110235-47-7 600-951-7 1509 Hydroxylammonium hydrogensulfate; hydroxylamine sulfate(1:1) [1] 10046-00-1 [1] 233-154-4 [1] Hydroxylamine phosphate [2] 20845-01-6 [2] 244-077-0 [2] Hydroxylamine dihydrogenphosphate [3] 19098-16-9 [3] 242-818-2 [3] Hydroxylamine 4-methylbenzenesulfonate [4] 53933-48-5 [4] 258-872-5 [4] 1510 (3-Chloro-2-hydroxypropyl) trimethylammonium chloride 3327-22-8 222-048-3 1511 Biphenyl-3,3′,4,4′-tetrayltetraamine; diaminobenzidine 91-95-2 … 698 unchanged words … the source, in the mixture as placed on the market is ≥ 0,1 % w/w — — 1608 Methylhydrazine 60-34-4 200-471-4 1609 Triadimenol (ISO); (1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol; α-tert-butyl-β-(4-chlorophenoxy)-1H-1,2,4-triazole-1-ethanol 55219-65-3 259-537-6 1610 Thiacloprid (ISO); (Z)-3-(6-chloro-3-pyridyl-methyl)-1-3-thiazolidin-2-ylidenecyanamide; {(2Z)-3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene}cyanamide 111988-49-9 601-147-9 1611 Carbetamide (ISO); (R)-1-(ethylcarbamoyl) ethyl-carbanilate; (2R)-1-(ethylamino) -1-oxopro-pan-2-yl-phenylcarbamate 16118-49-3 240-286-61624 Pirimicarb (ISO); 2-(dimethylamino)-5,6-dimethylpyrimidin-4-yl dimethylcarbamate 23103-98-2 245-430-1 1625 1,2-Dichloropropane; propylene dichloride 78-87-5 201-152-2 1626 Phenol, dodecyl-, branched [1] 121158-58-5 [1] 310-154-3 [1] Phenol, 2-dodecyl-, branched [2] 1801269-80-6 [2] - [2] Phenol, 3-dodecyl-, branched [3] 1801269-77-1 [3] - [3] Phenol, 4-dodecyl-, branched [4] 210555-94-5 [4] 640-104-9 [4] Phenol, (tetrapropenyl) derivatives [5] 74499-35-7 [5] 616-100-8 [5] 1627 Coumatetralyl (ISO); 4- hydroxy-3-(1,2,3,4-tetrahydro-1-naphthyl) coumarin 5836-29-3 227-424-0 1628 Difenacoum (ISO); 3-(3- biphenyl-4-yl-1,2,3,4- tetrahydro-1-naphthyl)- 4-hydroxycoumarin 56073-07-5 259-978-4 1629 Brodifacoum (ISO); 4-hydroxy-3-(3-(4′-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin 56073-10-0 259-980-5 1630 Flocoumafen (ISO); reaction mass of: cis-4- hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin and trans-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin 90035-08-8 421-960-0 1631 Acetochlor (ISO); 2- chloro-N-(ethoxymethyl)-N-(2-ethyl-6- methylphenyl)acetamide 34256-82-1 251-899-3 1632 e-Glass microfibres of representative composition - - 1633 Glass microfibres of representative composition - - 1634 Bromadiolone (ISO); 3- [3-(4′-bromobiphenyl- 4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy- 2H-chromen-2-one 28772-56-7 249-205-9 1635 Difethialone (ISO); 3-[3-(4′-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]- 4-hydroxy-2H-1-benzothiopyran-2-one 104653-34-1 600-594-7 1636 Perfluorononan-1-oic acid [1] 375-95-1 [1] 206-801-3 [1] and 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 75-91-2 200-915-7

02009R1223-20191127 → 02009R1223-20191218

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.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. … 138 unchanged lines … 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) Hair dye substance in non-oxidative hair dye products (b) As from 3 September 2017: 1,5 % 9 Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of the substances under reference numbers 9a and 9b of this Annex and substances under reference numbers 364, 1310 and 1313 in Annex II Hair dye substance in oxidative hair dye products (a) General use (a) To be printed on the label: 9 Methylphenylenediamines, their N- substituted derivatives and their salts, with the exception of the substance listed under reference numbers 9 a and 9 b of this Annex and the substances listed under reference numbers 364, 413, 1144, 1310, 1313 and 1507 of Annex II Hair dye substance in oxidative hair dye products (a) General use (a) To be printed on the label: The mixing ratio. Hair colourants 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. Contains phenylenediamines (toluenediamines). Do not use to dye eyelashes or eyebrows. (b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base (b) To be printed on the label: The mixing ratio. For professional use only Hair colourants can cause severe allergic reactions. (b) Professional use (b) To be printed on the label: For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base The mixing ratio.For professional use only. Hair colourants 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. … 215 unchanged lines … 5,4 % (as zirconium) 1. The ratio of the number of aluminium atoms to that of zirconium atoms must be between 2 and 10 2. The ratio of the number of (Al + Zr) atoms to that of chlorine atoms must be between 0,9 and 2,1 3. Not to be used in aerosol dispensers (sprays) Do not apply to irritated or damaged skin 51 Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphate Oxyquinoline and oxyquinoline sulfate 148-24-3/134-31-6 205-711-1/205-137-1 Stabilizer for hydrogen peroxide in rinse-off hair- products 0,3 % (as base) Stabilizer for hydrogen peroxide in leave-on hair products 0,03 % (as base) 52 Methanol Methyl alcohol 67-56-1 200-659-6 Denaturant for ethanol and isopropyl alcohol 5 % (as a % ethanol and isopropyl alcohol) 53 (1-Hydroxyethylidene-diphosphonic acid) and its salts Etidronic acid 2809-21-4 220-552-8 (a) Hair- product 1,5 % (as etidronic acid) (b) Soap 0,2 % (as etidronic acid) 54 1-Phenoxypropan-2-ol Phenoxyisopropanol 770-35-4 212-222-7 Use only in rinse-off products 51 Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphate Oxyquinoline and oxyquinoline sulfate 148-24-3/134-31-6 205-711-1/205-137-1 Stabilizer for hydrogen peroxide in rinse-off hair- products 0,3 % (as base) Stabilizer for hydrogen peroxide in leave-on hair products 0,03 % (as base) 51 Bis(8-hydroxyquinolinium) sulphate Oxyqui-noline sulphate 134-31-6 205-137-1 Stabilizer for hydrogen peroxide in rinse-off hair products (0,3 % as base) Stabilizer for hydrogen peroxide in leave-on hair products (0,03 % as base) 52 Methanol Methyl alcohol 67-56-1 200-659-6 Denaturant for ethanol and isopropyl alcohol 5 % (as a % ethanol and isopropyl alcohol) 53 (1-Hydroxyethylidene-diphosphonic acid) and its salts Etidronic acid 2809-21-4 220-552-8 (a) Hair- product 1,5 % (as etidronic acid) (b) Soap 0,2 % (as etidronic acid) 54 1-Phenoxypropan-2-ol Phenoxyisopropanol 770-35-4 212-222-7 Use only in rinse-off products Not to be used in oral products 2 % For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product 55 Moved or deleted 56 Magnesium fluoride Magnesium Fluoride 7783-40-6 231-995-1 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 magnesium fluoride. … 1,319 unchanged lines … Avoid skin contact Read directions for use carefully 312 2-Furaldehyde Furfural 98-01-1 202-627-7 0,001 %