@techreport{JRC101601, number = {LB-NA-27947-EN-N (online),LB-NA-27947-EN-E (ePub)}, address = {Luxembourg (Luxembourg)}, issn = {1831-9424}, year = {2016}, author = {Piccinini P and Pakalin S and Contor L and Bianchi I and Senaldi C}, isbn = {978-92-79-58783-2 (online),978-92-79-63922-7 (ePub)}, publisher = {Publications Office of the European Union}, abstract = {Quick guide Nowadays, tattoos are considered body art and are largely spread. They are applied by injecting coloured inks into the dermis and are meant to stay life long, thus resulting in long term exposure to the chemicals injected including their degradation products. Permanent Make-up (PMU) consists in (semi)permanent tattoos used to resemble make-up. Policy context This report addresses the issue of the safety of tattoo/PMU products and practices with a view to contribute to consumers' health protection. It has been prepared on behalf of the Directorate General Justice and Consumers (DG JUST), however it might also be of interest to other stakeholders dealing with health, internal market and environment, as well as to the European Chemicals Agency (ECHA). The conclusions of this project aim to provide the European Commission (EC) with the scientific evidences needed to decide if European Union (EU) measures are necessary to ensure the safety of tattoo/PMU inks and processes. In fact, apart from the general safety requirements by the General Product Safety Directive (GPSD) currently there is no specific EU legislation on tattoos/PMU products. In particular with regards to chemical requirements, there are chemicals which are banned in consumer products that get into direct contact with the skin under different EU legislations, like the Cosmetic Product Regulation or REACH, but not in tattoo inks. The report presents an updated review of the national legislative framework, ink ingredients in use and reported adverse health effects, as well as new data on analytical methods, statistics, market surveillance and RAPEX (Rapid alert system for non-food dangerous products) notifications, risk perception and communication and experience with the implementation of the Council of Europe (CoE) Resolutions (ResAP). Main findings Specific legislation, based on the CoE ResAPs (either of 2003 or 2008), exists in 7 Member States (MS) and 3 EFTA (European Free Trade Association) countries. 3 MS notified their draft legal acts (currently on-hold). Statistics show that 12% of Europeans and up to 24% of United States' citizens are estimated to be tattooed, including teenagers. Tattoo prevalence in young adults may represent more than the double and is sometimes higher in women than in men, in particular in young generations. Tattoo/PMU inks contain several ingredients, plus impurities. More than 100 colorants and 100 additives are in use. Most tattoo inks on the EU market are imported from the US, while PMU inks are generally manufactured in Europe. The pigments used are not specifically produced for tattoo/PMU applications and generally show low purity. The majority of them is not authorised for the use in cosmetic products and several should not be present according to the CoE ResAP(2008)1. Over 80% of the colorants in use are organic and more than 60% of them are azo-pigments, some of which can release carcinogenic aromatic amines. This degradation may happen in the skin, particularly under solar/Ultra Violet radiation exposure or laser irradiation. Harmonised analytical methods for the analysis of tattoo/PMU inks are missing and need to be developed. For market surveillance purposes test methods developed for other products are used with some modifications. Tattoo/PMU products containing hazardous chemicals have been found on the European market. Polycyclic Aromatic Hydrocarbons (PAH) (43%), Primary Aromatic Amines (PAA) (14%), heavy metals (9%) and preservatives (6%), as well as microbiological contamination (11%) were detected in the indica