COMMISSION REGULATION (EU) 2020/2081 of 14 December 2020
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards substances in tattoo inks or permanent make-up
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R2081&from=EN
Substances falling within one or more of the following points:
(a) substances classified as any of the following in Part 3 of Annex VI to Regulation (EC) No 1272/2008:
— carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, but excluding any such substances classified due to effects only following exposure by inhalation
— reproductive toxicant category 1A, 1B or 2 but excluding any such substances classified due to effects only following exposure by inhalation
— skin sensitiser category 1, 1A or 1B
— skin corrosive category 1, 1A, 1B or 1C or skin irritant category 2
— serious eye damage category 1 or eye irritant category 2
(b) substances listed in Annex II to Regulation (EC) No 1223/2009 of the European Parliament and of the Council
(c) substances listed in Annex IV to Regulation (EC) No 1223/2009 for which a condition is specified in at least one of the columns g, h and i of the table in that Annex
(d) substances listed in Appendix 13 to this Annex.
Shall not be placed on the market in mixtures for use for tattooing purposes, and mixtures containing any such substances shall not be used for tattooing purposes, after 4 January 2022 if the
substance or substances in question is or are present in the following circumstances:
(a) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as carcinogen category 1A, 1B or 2, or germ cell mutagen category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight;
(b) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as reproductive toxicant category 1A, 1B or 2, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight;
(c) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin sensitiser category 1, 1A or 1B, the substance is present in the mixture in a concentration equal to or greater than 0,001 % by weight;
(d) in the case of a substance classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 as skin corrosive category 1, 1A, 1B or 1C or skin irritant category 2, or as serious eye damage category 1 or eye irritant category 2, the substance is present in the mixture in a concentration equal to or greater than:
(i) 0,1 % by weight, if the substance is used solely as a pH regulator;
(ii) 0,01 % by weight, in all other cases;
(e) in the case of a substance listed in Annex II to Regulation (EC) No 1223/2009 (*), the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight;
(f) in the case of a substance for which a condition of one or more of the following kinds is specified in column g (Product type, Body parts) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration equal to or greater than 0,00005 % by weight:
(i) “Rinse-off products”;
(ii) “Not to be used in products applied on mucous membranes”;
(iii) “Not to be used in eye products”;
(g) in the case of a substance for which a condition is specified in column h (Maximum concentration in ready for use preparation) or column i (Other) of the table in Annex IV to Regulation (EC) No 1223/2009, the substance is present in the mixture in a concentration, or in some other way, that does not accord with the condition specified in that column;
(h) in the case of a substance listed in Appendix 13 to this Annex, the substance is present in the mixture in a concentration equal to or greater than the concentration limit specified for that
substance in that Appendix.