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Safety of tattoos and permanent make-up: Final report

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 indicated percentages of the analysed samples. In the absence of systematic data gathering, the actual prevalence of tattoo complications (mainly of dermatological nature) is currently unknown. Most complaints are transient and inherent to the wound healing process, but in some cases, up to 5% of the tattooed persons, bacterial infections may occur, especially in unhygienic settings. Acute allergy and delayed hypersensitivity prompted by i.e. the inks ingredients and tattoo/removal trauma represent the bulk of tattoo/PMU complications, affecting mostly the red or black parts of the tattoos. Such nonspecific reactions, frequently exacerbated by sun exposure, are unpredictable and may sometimes appear after a long latency (decades), giving rise to chronic sequels in connection with underlying auto-immune pathologies. Additional adverse health effects, like skin pigmentation disorders may be encountered in 5-15% of patients having laser therapy, which is not always effective in removing completely the undesired tattoos. (Skin) cancer risk from tattoo procedures has been neither proved nor excluded. Based on the experience gained from implementing national laws and the CoE ResAPs, experts agreed that an update of the chemical and labelling requirements would be desirable. Risk perception is mainly based on the information given by tattooists, parents or friends, or read in mass media and internet. Among students, awareness about infectious risks seems to be higher that on non-infectious ones, but that knowledge is often only superficial. Many data gaps and research needs were identified. Key conclusions This report provides an up-to-date snapshot of the tattoo/PMU phenomenon. Due to the wide variety of legislative frameworks across Member States, some products can be sold in some MSs but not in others, because of different chemical or authorisation requirements, thus resulting in a fragmentation of the internal market. This might also have an impact on the protection of consumers' health. Tattooing is an increasing fashion phenomenon which already involves over 60 million Europeans. In parallel, removal procedures are becoming more frequent. Adverse health effects linked to the application and removal of tattoos are reported in the literature; in addition the potential long term effects of exposure to the chemicals in the inks are still unknown and might become critical with time due to the high number of tattooed people. To bring light into this unknown area, even if costly, epidemiological studies and research on the fate of ingredients in the whole body are needed. In particular, prospective cohort studies should be conducted to investigate the correlation between tattoos and possible carcinogenesis. Good Manufacturing Practices for manufacturing tattoo/PMU inks, as well as guidelines for their risk assessment should be developed. A full risk assessment of the ingredients, in particular colorants, used in tattoo/PMU inks is needed, including their phototoxicity, absorption level, distribution, metabolism and excretion, as well as Derived No Effect Level (DNEL), data which are largely missing so far. Further to this, it needs to be assessed whether the risks arising from the use of certain chemicals in tattoo/PMU inks are adequately controlled or need to be addressed by an EU measure. In the absence of this risk assessment, for azo pigments a precautionary approach would consist in not using those that contain in their structure aromatic amines classified as Carcinogenic, Mutagenic or Reprotoxic (CMR). Harmonised analytical methods should be developed to ensure reproducible results and allow a correct implementation of the chemical requirements of legislation in place. Market surveillance activities should be continued to identify hazardous products and be carried out also on products sold on-line. Additional information campaigns on risks for potential clients, particular targeted to teenagers and young people should be undertaken, allowing an informed choice. The training of tattooists should be compulsory and cover at least some key topics. The preparation of harmonised hygiene guidelines is highly recommended and inspections of studios required. The phenomenon of clandestine backyard tattooing should be stopped. Related and future JRC work Three detailed reports on specific part of this project were published in 2015 and 2016 [1-3].