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Safety of tattoos and permanent make-up (PMU)

Introduction

    Tattoos have been part of human culture for thousands of years, with tattoed human remains having been found dating back to 3000 BCE. Nowadays, tattoos are considered body art and are largely spread, with a larger proportion in younger people and slightly more in women. This trend is accompanied by a growing trend in tattoo removal, either by laser or by chemical means. The present report by the Joint Research Center endeavours takes account of this new state of play, with a focus on quantifying the extent of the phenomenon: number and characteristics of nowadays tattoo/PMU recipients and removal candidates, incidence of adverse health effects, etc-

    Tattoos 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. PMU consists in (semi) permanent tattoos used to resemble make-up. For the sake of simplicity, unless the distinction is necessary, the term tattoo will be used to mean both tattoos and PMU in the following text.

    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.

    Are there harmful ingredients in tattoo inks?

      More than 100 colorants and 100 additives are in use. Tattoo/PMU products containing impurities including 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 a percentage of the analysed samples.

      The pigments used are not specifically produced for tattoo/PMU applications, they are generally of low purity and the majority of them is not authorised for the use in cosmetic products and several should not be present according to a resolution of the Council of Europe in 2008. Most tattoo inks on the EU market are imported from the US, while permanent make-up inks are generally manufactured in Europe. The colorants used are not specifically produced for tattoos.

      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.

      Over 80% of the colorants in use are organic and more than 60% of them are azo-pigments, some of which can degrade to release carcinogenic aromatic amines. This degradation may happen in the skin, particularly under solar/Ultra Violet radiation exposure or laser irradiation.

      What are the possible complications of tattoos and permanent makeup?

        Adverse effects can been subdivided into the following categories: acute aseptic inflammation, infectious risks (bacterial and viral), allergic/hypersensitivity and autoimmune type reactions, and other secondary effects.

        The potential long-term effects of exposure to the chemicals that are present in the inks are still unknown and might become critical with time due to the high number of tattooed people. People with certain medical conditions, like hemophilia, are strongly advised against getting tattoos.

        Any pathogenic contamination could be virtually eradicated if strict hygienic measures were duly applied by tattoo practitioners. Most of the complaints and documented complications are due to the tattooing process itself, since the tattooed area is essentially an open wound and is susceptible to infections, either bacterial or viral. Therefore the training of tattooists should be compulsory and cover at least some key topics.

        Acute allergy and delayed hypersensitivity prompted by the inks ingredients and tattoo/removal trauma represent the bulk of tattoo/PMU complications, affecting mostly the red and black parts of the tattoos. Such 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.

        How are tattoos regulated in Europe?

          There is no specific EU legislation on tattoos and permanent make-up products. The Council of Europe (CoE) adopted, also in 2003, a non-binding Resolution on the safety of tattoos and PMU, recommending inter alia some chemical, labeling and hygienic requirements. It recommended that certain chemicals should not be present (or released, in the case of aromatic amines) in tattoo and PMU inks. Negative lists of products were mentioned in this CoE report.

          Currently, although there are general guidelines that have been put forth by the European Commission, each Member State of the EU regulates the safety of tattoos in their own way and many have endorsed and, except in 3 Member states, enforced national legislation on tattoo/PMU products in line with the recommendations of the CoE resolutions of 2003 and 2008. Some others do implement the European chemicals legislation (CLP and REACH) and the general safety requirements of the General Product Safety Directive without referring specifically to tattoo/PMU products.

          Harmonised analytical methods should be developed to ensure reproducible results and allow a correct implementation of the chemical requirements of legislation in place.

          Most countries have also regulations requiring professional tattoo artists and studios to follow health and safety guidelines. In terms of ingredients found in inks, however, the regulations are a bit more fuzzy, and in one of them, manufacturers are even not required to label their products with the various ingredients they contain.

          Outside Europe, regulatory control of tattoo/PMU products and practices largely vary across the above-mentioned developed countries (Australia, Canada, Japan, New Zealand and United States of America), but also inside each national jurisdiction.

          The different rules and guidelines mainly lay down requirements for tattoo processes and hygiene standards, but less on chemical ingredients contained in tattoo and PMU inks. In the United States of America for example, the Food and Drug Administration (FDA) has not yet developed legal scheme covering tattoo inks and parlours at federal level, though specific requirements do exist at state level, leading to a wide variety across the USA.

          What is still lacking regarding risks management related to tattoos?

            There are still many data gaps and research needs identified, mainly in terms of the risk assessment of dyes used in tattoo inks. In the absence of such risk assessments, 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).

            The preparation of harmonised hygiene guidelines is highly recommended and periodic inspections of studios required.

            Market surveillance activities should be continued to identify hazardous products and be also carried out also on products sold on-line and clandestine backyard tattooing should be stopped.

            What are the changes in labeling and risk communication that are needed?

              The perception of the risks related to tattoos 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.

              Based on the experience gained from implementing national laws and the CoE Resolutions, experts of the Council of Europe agreed that an update of the chemical and labelling requirements would thus be desirable. Additional information campaigns on risks for potential clients, particular targeted to teenagers and young people should thus be undertaken, allowing an informed choice.

              Presently already hygienic and packaging requirements tattoo and PMU products must be supplied in a container that maintains the sterility of the product until application. The packaging size should be supplied for single use on an individual consumer. Tattoo and PMU application and activities, including sterilisation and disinfection of the instruments, must be carried out by the tattooist in conformity with the hygiene regulations laid down by national public health service.

              Many data gaps and research needs were identified, mainly in terms of the risk assessment of the dyes used in tattoo inks. 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). Prospective epidemiological studies would be needed to ascertain the risk of carcinogenicity from tattoo inks constituents, including their degradation products.

              As several adverse reactions linked to tattoo removal were registered in the last years, more studies on the techniques employed for tattoo removals and the development of tattoo pigments easier to be removed are required.

              Market surveillance activities should be continued to identify hazardous products and be carried out also on products sold on-line. In addition information campaigns on risks for potential clients, particular targeted to teenagers and young people should be undertaken, allowing an informed choice.


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