On December 15, 2020, the European Union issued a new regulation (EU) 2020/2081, revised Appendix XVII of the REACH Regulation, and added a new restriction entry to limit the content of toxic and hazardous substances in tattoo ink or permanent cosmetics. The new regulations will come into effect on the 20th day (January 4, 2021) after the official gazette is published. After this revision, there are 75 entries in Annex XVII of the REACH Regulation, which control the use of various chemical substances in consumer products.
Restricted substances and main requirements
Substance name:
Substances that meet at least one of the following requirements:
(a) Any substance classified in Part 3 of Annex VI of Regulation (EC) No 1272/2008;
(b) Substances listed in Annex II of Regulation (EC) No 1223/2009;
(c) Substances listed in Annex IV of Regulation (EC) No 1223/2009 and complying with any one of the conditions listed in the g, h and i columns of the appendix;
(d) Substances listed in Annex XVII of REACH Regulation
Applicable Products:
Mixture for tattoo purposes.
Limit requirements:
In the mixture used for tattoo purposes, the concentration of restricted substances shall meet the following requirements:
(a) The mixture is classified as 1A, 1B or 2 carcinogens in Part 3 of Annex VI of Regulation (EC) No 1272/2008, or 1A, 1B or 2 germ cell teratogenic substances <0.00005%;
(b) The mixture is classified as 1A, 1B or 2 reproductive toxic substances in Part 3 of Regulation (EC) No 1272/2008 Appendix VI <0.001%;
(c) The mixture is classified as 1, 1A or 1B skin irritant substance in Part 3 of Regulation (EC) No 1272/2008 Appendix VI <0.001%;
(d) The mixture is classified as a skin corrosive substance of category 1, 1A, 1B or 1C or category 2 skin irritant, or category 1 serious eye damage or category 2 in Part 3 of Annex VI of Regulation (EC) No 1272/2008 Eye irritants:
(i) Only as a pH regulator <0.1%;
(ii) Other uses <0.01%;
(e) Substances listed in Annex II of Regulation (EC) No 1223/2009 <0.00005%;
(f) The substances specified in column g (product type, body part) in Annex IV of Regulation (EC) No 1223/2009 are less than 0.00005% in a mixture of one or more of the following purposes:
(i)'Flushing products';
(ii) ‘Products that cannot be used on mucosa’;
(iii) ‘Products that cannot be used for eyes’;
(g) The substances listed in column h (maximum concentration of ready-to-use preparations) or column i (other) in Annex IV of Regulation (EC) No 1223/2009 must meet the conditions specified in this column;
(h) Meet the specific substance limit in Annex XVII of REACH Regulation.
Common applications
These substances may be present in colorants and adjuvants of mixtures for tattoo purposes, such as solvents, stabilizers, wetting agents, pH adjusters, emollients, preservatives, and thickeners.
Note: This restriction will be implemented from January 4, 2022.
Products that violate REACH Annex XVII regulations will face serious penalties such as being recalled, removed from the shelves, and fined. ZRLK recommends that such tattoo ink or permanent cosmetics related companies pay close attention to market trends and strengthen quality control to ensure product compliance.
