Safety of tattoos and permanent make-up. Adverse health effects and experience with the Council of Europe Resolution (2008)1.

In the last decades, the proportion of the tattooed population has been increasing all over the world, particularly in the young generations. Concerns about the possible health problems associated to tattoos and permanent make up (PMU) have also grown together with the number of tattoo/PMU applications and removals. The Council of Europe Resolution (CoE ResAP)(2008)1 [1], on requirements and criteria for the safety of tattoos and permanent make-up, is a non-binding internationally recognised benchmark that was taken as a reference for the development of national legislation adopted in a number of European countries. The European Commission launched the 18-month project "Tattoos - Permanent Makeup" with the aim of collecting data about the use, the ingredients, the European Union (EU) market and the possible health problems associated to tattoo and permanent make-up inks. This project is divided into 4 Work Packages: 1) preparatory work; 2) state of play; 3) assessment and update of the CoE ResAP(2008)1; 4) conclusions. The reports on Work Packages 1 and 2 [2, 3] are available at http://bookshop.europa.eu/. The present report is the outcome of Work Package 3 which aims to gather data about adverse health effects and complications linked to tattoo/PMU application and/or removal, risk perception and communication, data gaps and research needs, as well as to evaluate the lessons learned from the experience in implementing the recommendations of the CoE ResAP(2008)1. The information was collected through the following sources. (1) Two questionnaires were developed: one addressed to dermatologists on adverse health effects and the other one to national authorities on complications, experience with the CoE ResAP(2008)1, risk perception and communication, data gaps and research needs. They were sent to all EU Member States and European Free Trade Association (EFTA) countries and to 36 dermatologist associations in Europe with the request to circulate among their members. 14 Member States and 19 dermatologists filled-in the questionnaires. (2) A systematic review of the literature from 2003 on was carried out according to the PRISMA (Preferred Reporting Items for Systematic reviews and Meta- Analysis) methodology. (3) The outcome of the meetings of the Consumer Safety Network Subgroup Tattoos and Permanent Make-up was taken into account. The main findings show that: It is not possible to conclude on an exact incidence of adverse health effects following tattoo/PMU applications. The majority of tattoo/PMU recipients report minor short-term discomfort and complaints during the wound healing process following the tattoo application. This could be confused with other more serious complications and makes the accurate calculation difficult. Short term complications, such as skin infections, may appear some days after the tattoo placing, or within weeks, for allergic reactions. In the long run chronic inflammatory dermatoses may develop, sometimes after decades. The precise frequency of microbiological (mainly bacterial, more rarely viral) contamination through inks, tools or procedures used in the tattoo application remains unknown, though it has been generally estimated at up to 5% of the tattoo-recipients in the case of bacterial infections. The vast majority of tattoo/PMU adverse reactions are due to delayed and unpredictable hypersensitivity, involving allergy and/or autoimmunity. Direct causal relationship between tattooing and (skin) cancer has been so far neither proved nor excluded. However, tattoos may blur and hence delay a melanoma diagnosis. They can also interfere with diagnosis imaging, and should be avoided in patients with prior cardiac, blood or autoimmune pathologies, inter alia. Similarly, also the process of tattoo removal is associated with side effects. The modern removal techniques, based on the use of Q-switched lasers, have improved the safety, efficiency and selectivity of the removal procedure, still side effects might occur, especially when incorrect parameters are applied to the laser device. The frequency of skin pigmentation disorders following laser therapy have been encountered in 5-15% of patients. Henna based preparations are not permanently injected in the skin and therefore they cannot be considered as tattoos. However, as the use of henna for temporary body decoration has become also widespread it has been included in this report for completeness. Henna has been used for centuries for body painting and it is generally well tolerated. When p-phenylendiamine (PPD) is added to make the painting darker, side effects due to sensitisation to PPD have been reported in the literature. The majority of the national authorities who replied to the questionnaire indicate that, in order to improve the safety of tattoo/PMU inks and practices, it would be necessary to update the list of recommendations in the CoE ResAP(2008)1. In particular, suggestions were put forward to include additional substances to the negative lists and to modify and/or introduce new limits. Other suggestions were to add new labelling requirements, such as the period of maximum durability after opening, to envisage the compilation of a register of complaints and to include information on the ink and tool sterilisation methods. Furthermore, several Member States pointed out the need to establish Good Manufacturing Practices for tattoo/PMU inks, to control products sold on-line, to establish compulsory training for tattooists, to enhance the collaboration among manufacturers and authorities and to ban backyard tattooing. Risk communication has been addressed by means of information campaigns targeted to various audiences and using a variety of means in nine Member States, out of the twelve who filled-in this section of the questionnaire. Beside this, national authorities generally agreed on the need to organise further actions to reach tattooists and potential clients, particularly adolescents, to give them the correct instruments to be able to take an informed decision. Actually risk perception is based on the information given by the tattooist (e.g. via an informed consent form), or received through parents or friends, or read in mass media and internet. In addition, some studies estimated the level of knowledge of possible health risks among students, either school or university ones. In general, infectious risks were better known that non-infectious ones, even though the level of knowledge was in many cases only superficial and, for example, not specifically linked to the transmittable agents of possible infections or to the various possible noninfectious risks. These evidences support the need of further additional information campaigns. Data gaps and research needs were identified, such as development of guidelines for risk assessment of tattoo/PMU products, harmonised analytical methods, data on normal usage of and exposure to tattoo inks, including their characteristics (physical-chemical properties, chemical composition, ingredients' purity and concentration). In order to carry out a risk assessment of tattoo/PMU inks, data are missing on absorption, distribution, metabolism and excretion (ADME) of ingredients, including migration in the body of pigments and their (photo)-degradation products, DNEL (Derived No Effect Level), as well as chemical and toxicological properties of ingredients. Moreover, several authors considered that, although costly, prospective cohort studies should be conducted to investigate the association between tattoos and (skin) carcinogenesis.JRC.E.7-Knowledge for Security and Migratio