European tattoo ingredient ban: Implications for North America

Abstract

Capsule Summary •Adverse reactions to tattoo ingredients are prompting stricter regulations in the European Union, while Canada and the United States are lacking similar oversight. •Dermatologists should be aware of tattoo related adverse reactions and educate patients on tattoo safety, while also petitioning North American policymakers to increase regulation. Despite increasing evidence regarding the carcinogenic properties and cutaneous complications of tattoo inks, there are limited regulations governing the permanent makeup and tattoo industries across North America. On January 4, 2022, in response to this growing evidence, the European Union restricted >4000 substances in tattoo inks and implemented stricter labeling and safety information (Table I). 1 European Parliament and Council concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)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 (Text with EEA relevance). https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R2081&rid=7Date accessed: February 22, 2022 Google Scholar The United States and Canada do not have similar restrictions, despite higher estimated prevalence of adult tattoos (31%) than that reported in the European Union (12%). 1 European Parliament and Council concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)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 (Text with EEA relevance). https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R2081&rid=7Date accessed: February 22, 2022 Google Scholar ,2 Kluger N. An update on cutaneous complications of permanent tattooing. Expert Rev Clin Immunol. 2019; 15: 1135-1143https://doi.org/10.1080/1744666X.2020.1676732 Crossref PubMed Scopus (19) Google Scholar Table IBrief summary of categories of chemicals limited and labeling requirements under the Registration, Evaluation, Authorisation, and Restriction of Chemicals restriction of hazardous substances in tattoo inks and permanent makeup Categories of chemicals limited under the EU-wide classification Labeling requirements Carcinogen and mutagen •Statement “Mixture for use in tattoos or permanent make-up” •Reference number to uniquely identify the batch •List of ingredients •The statement of the presence of any nickel and/or chromium (VI) and their potential to cause allergic reactions if under the specified concentration limit •The presence of any pH regulating substances •Relevant safety instructions Toxic to reproduction Skin sensitizer Skin corrosive, skin irritant, eye irritant, or eye damaging Adapted from European Parliament and Council concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH). 1 European Parliament and Council concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)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 (Text with EEA relevance). https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R2081&rid=7Date accessed: February 22, 2022 Google Scholar EU, European Union. Open table in a new tab Adapted from European Parliament and Council concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH). 1 European Parliament and Council concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH)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 (Text with EEA relevance). https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R2081&rid=7Date accessed: February 22, 2022 Google Scholar EU, European Union.