Cosmetics Regulation

02009R1223-20170727 → 02009R1223-20170903

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. 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. 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) 3342-61-8 222-085-5 4 Spironolactone (INN) 52-01-7 200-133-6 5 [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid (Tiratricol (INN)) and its salts 51-24-1 … 13,985 unchanged words … Salts of Isopropylparaben 4191-73-5 224-069-3 1375 Isobutyl 4-hydroxybenzoate (INCI: Isobutylparaben) 4247-02-3 224-208-8 Sodium salt or Salts of 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 15087-24-8 239-139-91380 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 —

02009R1223-20170727 → 02009R1223-20170903

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, see Annex VI, No. 27. 27.For 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 Maximum concentration in ready for use preparation Other a b c d … 1,886 unchanged words … (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 (E 171) 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

02009R1223-20170727 → 02009R1223-20170903

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 of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g.In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g. Reference number Substance identification Conditions Wording of conditions of use and warnings Chemical name/INN/XAN 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 2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulfate Camphor Benzalkonium Methosulfate 52793-97-2 258-190-8 6 % 3 Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester/Homosalate Homosalate 118-56-9 204-260-8 10 % 4 2-Hydroxy-4-methoxybenzophenone/Oxybenzone Benzophenone-3 131-57-7 205-031-5 10 6 % Not more than 0,5 % to protect product formulation Contains Benzophenone-3 5 Moved or deleted 6 2-Phenylbenzimidazole-5-sulfonic acid and its potassium, sodium and triethanolamine salts/Ensulizole Phenylbenzimidazole Sulfonic Acid 27503-81-7 248-502-0 8 %(as acid) 7 3,3'-(1,4-Phenylenedimethylene) bis(7, 7-dimethyl-2-oxobicyclo-[2.2.1]hept-1-yl-methanesulfonic acid) and its salts/Ecamsule Terephthalylidene Dicamphor Sulfonic Acid 92761-26-7, 90457-82-2 410-960-6 10 %(as acid) … 488 unchanged words … number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm, water solubility < 50 mg/L uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane.