@ECHA EUROPEAN CHEMICALS AGENCY Appendix 1 Table of Contents: Supplementary Table C:Substances on Annex II of the Cosmetic Products Regulation ... 1 Supplementary Table D: Substances proposed to be restricted due their use restriction in CPR Annex IV column 9..,,.. 119 Supplementary Table E: Substances allowed in tattoo inks subject to the conditions specified in CPR Annex IV columns h and i ......r29 Annankatu 18. P.O. Box 400, FI-00121 Helsinki, Finland I Tel. +358 9 686180 | Fax +358 9 68618210 | echa.europa.eu ANNEX XV RESTRICTION REPORT - SUBSTANCES IN TATTOO INKS AND PERMANENT MAKE UP Su lemen Table C:Substances on Annex II of the Cosmetic Products Re ulationl Substance EC# cAs # Substance EC# cAs # R T T T A- s c R I T Name Name e b b b II s M 7 c I s I I I #4 5 6 D 9 2 1 2 3 a 3 3 3 N-(s- Chlorobenzoxa zol-2- 35783- vl)acetamide 57-4 1 (2- Acetoxyethyl)t rimethylammo (2- nium acetoxyethyl hydroxide )trimethyla 200- (Acetylcholine) 200- mmonium 124-9 5 1-84-3 and its salts t2a-9 51-84-3 2 Deanol Deanol 222- 3342- aceglumate 222- 3342- aceqlumate 085-5 61-8 (INN) 085-5 61-8 3 Spironolacto 200- Spironolactone 200- ne 133-6 52-O1-7 rINN) 133-6 52-0L-7 4 14-(4- Hydroxy-3- iodophenoxy)- 3,5- diiodophenylla cetic acid (Tiratricol 200- (INN)) and its 200- Tiratricol 086- 1 5r-24-7 salts 086- 1 5l-24-7 5 Methotrexat 200- Methotrexate 200- e 413-8 59-05-2 (INN) 413-8 59-05-2 6 Aminocaproic Aminocaproi 200- acid (INN) and 200- c acid 469-3 60-32-2 its salts 469-3 60-32-2 7 Cinchophen (rNN), its salts, derivatives and salts of 205- 132-60- these 205- 132-60- Cinchophen 067-r 5 derivatives 067-l 5 Thyropropic acid (INN) and its salts 5L-26-3 9 Trichloroacet 200- Trichloroacetic 200- ic acid 927-2 75-03-9 acid 927-2 76-03-9 l0 Aconitum napellus L. Aconitum (leaves, roots napellus, 283- 84603- and galenical 283- 84603- ext. 252-6 50-9 DreDarations) 252-6 50-9 11 Aconitine (principal alkaloid of Aconitum 206- 302-27- napellus L.) 206- 302-27- Aconitine t2l-7 2 and its salts t2L-7 2 t2 Adonis Adonis vernalis vernalis, 283- 84649- L. and its 243 84649- ext. 458-6 73-0 oreoarations 458-5 73-O 13 200- Epinephrine 200- Eoineohrine 098-7 57-43-4 (INN) 098-7 5L-43-4 I4 1 Extraction as of t2/Q812016 from Regulation (EC) No I223/2OO} of the European Parliament and of the Council of 30 November 2009 on cosmetic products 2 Substances registered under REACH 3 Substances on the Council of Europe ResAP(2008)1 tables (1, 2 and 3) a Substance on Annex II of the EU Cosmetic Products Regulation (CPR) s Substances with harmonised classification as skin sensitisers as per the CLP Regulation 6 Substances with harmonised classification as carcinogenic or mutagenic as per the CLP Regulation 7 Substances with harmonised classification as reprotoxic as per the CLP Regulation 8 Substances with harmonised classification as skin corrosive or irritant or eye damaging or irritant as per the CLP Regulation e Substances found in tattoo inks or PMU according to jRC report (JRC, 2015b) ANNEX XV RESTRICTION REPORT - SUBSTANCES IN TATTOO INKS AND PERMANENT MAKE UP Rauwolfia Rauwolfia serpentina 1., serpentina, 290- 90106- alkaloids and 290- 90106- ext- 234-t 13- 1 their salts 234-l 13-1 15 AIkyne alcohols, their esters, ethers and salts 16 23r- 7643- Isoprenaline 23r- 7683- Isoorenaline 687-7 59-2 (INN'} 647-7 59-2 17 Allyl isothiocyana 200- Allyl 200- te 309-2 57-06-7 isothiocvanate 309-2 57-06-7 18 Alloclamide (INN) and its 5486- salts 77-r 19 Nalorphine 200- (INN), its salts 200- Nalorohine 546-1 62-67-9 and ethers 546-r 62-67-9 20 Sympathicomi metic amines acting on the central nervous system: any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Amphetamin 206- 300-62- Council of 206- 300-62- e 096-2 9 EuroDe 096-2 9 2L Aniline, its salts and its halogenated and sulphonated 200- derivatives, 200- Aniline 539-3 62-53-3 Aniline 539-3. 62-53-3 22 Betoxycaine (INN) and its 3818- salts 62-0 23 Zoxazolamin 200- Zoxazolamine 200- e 519-4 5 1-80-3 {INN ) 5L9-4 61-80-3 24 Procainamide (INN), its salts Procaina mid 200- and 200- e 078-8 5 1-06-9 derivatives 078-8 51-06-9 25 202- 202 Benzidine 199- 1 92-87-5 Benzidine 199 1 92-47-s 6 26 Tuaminohepta ne (INN), its Tuaminohep 204- L23-82- isomers and 204- r23-82- tane 655-5 0 salts 655-s 0 27 Octodrine 208- 543-A2- (INN) and its 208- 543-82- Octodrine 851- 1 8 salts 851-1 8 2A 2-Amino-1,2- bis(4- methoxypheny l)ethanol and 530-34- its salts 7 29 1,3- 1,3- Dimethylpentyl dimethylpen 203- 105-41- amine and its 203- 105-41- tvlamine 296-L 9 salts 296-7 9 30 4- 4- Aminosalicylic aminosalicyli 200- acid and its 200- c acid 613-5 65-49-5 salts 613-5 65-49-5 31 Toluidines, 24A- 26915- their isomers, 244- 26915- Toluidine 105-2 L2-A salts and 105-2 12-A 32 ANNEX XV RESTRICTION REPORT - SUBSTANCES IN TATTOO INKS AND PERMANENT MAKE UP halogenated and sulphonated derivatives Xylidines, their isomers, salts and halogenated and 2 15- 1300- sulphonated 2L5- 1300- Xylidine 09t-4 73-8 derivatives 09 1-4 73-A 33 s-(3- Imperatorin methylbut- (e-(3- 2-enyloxy)- methylbut-2- 7H-furo[3,2- enyloxy)furo[3 glchromen- 207- 482-44- ,2-glchromen- 207- 442-44- 7-one 581-1 0 7-one) 581- 1 0 34 Ammi majus L. and its Ammi 29t- 90320- galenical 29t- 90320- maius, ext. 072-4 46-O oreoarations 072-4 46-O 35 2,3-Dichloro- 2- 507-45- methvlbutane I 36 Substances with androgenic effect 37 204- 120-L2- 204- t20-12- Anthracene 371-1 7 Anthracene oil 37t-t 7 38 Antibiotics 39 Antimony (Sb) , Antimony and its 237- 7440- compounds, 23L- 7440- 1 Antimonv 145-5 35-0 Antimonv (Sb) 146-5 36-0 1 40 Antimony (Sb) , Antimony and its compounds, 23t- 7440- 1 Antimonv (Sb) 146-5 36-0 1 40 Apocynum Apocynum cannabinum L. cannabinum, 283- 84603- and its 283- 84603- ext. 253-r 51-0 DreDarations 253- 1 5 1-0 4t Apomorphine ((R) 5,6,6a,7- tetrahydro-6- methyl-4H- dibenzolde,glq uinoline- Apomorphin 200- 10,11-diol) 200- 360-0 58-00-4 and its salts 350-0 58-00-4 42 L327- 53-3, Arsenic (As), Diarsen ic 215- 7440- Arsenic and its 23L- 7440- trioxide 48r-4 3A-2 comoounds 148-6. 38-2 1 43 Arsenic (As), 23r- 7440- Arsenic and its 23r- 7440- Arsenic 148-6 38-2 comoounds 144-6 38-2 1 43 Atropa belladonna L. Belladonna, 232- 8007- and its 232- 8007- ext. 355-9 93-0 preparations 365-9 93-0 44 Atropine, its 200- salts and 200- Atropine 104-8 51-55-8 derivatives 104-8 5 1-55-8 45 Barium salts, with the exception of barium sulphide under the conditions laid down in Annex III, and of barium sulfate, lakes, salts and 46 3 ANNEX XV RESTRICTION REPORT - SUBSTANCES IN TATTOO INKS AND PERMANENT MAKE UP pigments prepared from colouring agents when listed in Annex IV 7t-43-2, 200- 1076- 200- Benzene 753-7 43-3 Benzene 753-7 7L-43-2 47 2- hydroxybenz 210- 615- 16- Benzimidazol- 270- 615- 16- imidazole 4t2-4 7 2(3H)-one 4r2-4 7 48 Benzazepines and benzodiazepin 12794- es to-4 49 1- 1- Dimethylamino [(dimethyla methyl-1- mino)methyl methylpropyl l-1- benzoate methylpropy 2tt- 644-26- (amylocaine) 277- 644-26- I benzoate 411--l 8 and its salts 4T1-T 8 50 2,2,6- Trimethyl-4- piperidyl benzoate (eucaine) and 500-34- its salts 5 51 Isocarboxazi 200 Isocarboxazid 200- d 434-4 59-63-2 (INN) 438-4 59-63-2 52 Bendroflumeth iazide (INN) Bendroflume 200- and its 200- thiazide 800-1 73-44-3 derivatives 800-1 73-44-3 53 231- 7440- Beryllium and 23r- 7440- Beryllium 150-7 4L-7 its comDounds t50-7 4r-7 54 237- 7726- Bromine, 23t- 7726- Bromine 774-7 95-6 elemental 774-r 95-6 55 Bretylium 200- Bretylium 200- tosilate 5 15-8 6L-75-6 tosilate (INN) 516-8 6L-75-6 56 201- Carbromal 201- Carbromal 046-6 77-65-6 (INN) 046-6 77-65-6 57 207- 496-67- Bromisoval 207- 496-67- Bromisoval 425-7 3 rINN'I a25-7 3 58 Brompheniram Bromphenira 20r ine (INN) and 20L- mtne 657-A a6-22-6 its salts 657-8 86-22-6 59 Benzilonium 2L3- 1050- Benzilonium 2t3- 1050- bromide 885-5 4A-2 bromide (INN) 885-5 4A-2 60 Tetrylammo Tetrylammoniu nium 200- m bromide 200- bromide 769-4 71-9t-O (INN) 769-4 71-91 -0 61 206- 357-57- 206- 357-57- Brucine 6t4-7 3 Brucine 6t4-7 3 62 Tetracaine 202- (INN) and its 202- Tetracaine 316-6 94-24-6 salts 315-5 94-24-6 53 Mofebutazon 218- 22t0- Mofebutazone 2 18- 2210- 64t-L 63-1 (INN) 641-l 63- 1 64 200- Tolbutamide 200- Tolbutamide 594-3 64-77-7 (INN) 594-3 64-77-7 55 206- 339-43- Carbutamide 206- 339-43- Carbutamide 424-4 5 (INN) 424-4 5 55 Phenylbutaz 200- Phenylbutazon 200- one 029-0 50-33-9 e (INN) 029-0 50-33-9 67 Cadmium (cd) , Cadmium and its 23t- 7440- compounds, 231- 7440- Cadmium 152-8 43-9 Cadmium (Cd) 152-8- 43-9 3 68 Lytta Cantharides, vesicatoria, 296- 92457- Cantharis 296- 92457- ext.