Analytical survey of tattoo inks-A chemical and legal perspective with focus on sensitizing substances.

BACKGROUND: Tattoo inks have been reported to elicit allergic contact dermatitis. OBJECTIVES: To investigate the labels and the contents of metals and pigments in tattoo inks, considering restrictions within the European Union. METHODS: Seventy-three tattoo inks currently available on the market, either bought or donated (already used), were investigated for trace metals and pigments by inductively coupled plasma mass spectrometry and by matrix-assisted laser desorption/ionization time of flight tandem mass spectrometry. RESULTS: Ninety-three percent of the bought tattoo inks violated European, legal requirements on labeling. Fifty percent of the tattoo inks declared at least one pigment ingredient incorrectly. Sixty-one percent of the inks contained pigments of concern, especially red inks. Iron, aluminium, titanium, and copper (most in green/blue inks) were the main metals detected in the inks. The level of metal impurities exceeded current restriction limits in only a few cases. Total chromium (0.35-139 µg/g) and nickel (0.1-41 µg/g) were found in almost all samples. The levels of iron, chromium, manganese, cobalt, nickel, zinc, lead, and arsenic were found to covary significantly. CONCLUSIONS: To prevent contact allergy and toxic reactions among users it is important for tattoo ink manufacturers to follow the regulations and decrease nickel and chromium impurities.

Histopathological evaluation of cutaneous reactions to tattoos: Study at a tertiary care center.

BACKGROUND: Tattooing has been around for many years and is becoming an increasingly common fashion trend. As there are often few regulatory laws regarding the practice, an increase in the incidence of cutaneous reactions to tattoo inks is noted. These include allergic reactions, granulomatous dermatitis, infections, lichenoid dermatoses, and sometimes malignancy. The present study examines the histopathological changes seen in patients with cutaneous reactions to tattoo ink. METHOD: A prospective observational study was conducted over 18 months in the dermatology clinic of a tertiary care center in western India. The study population included 22 patients with cutaneous reactions over the tattoos. Punch biopsy specimens were sent to study the pattern of histopathological response. RESULTS: All 22 patients studied were between the ages of 17 and 35 years. The mean duration of development of reaction was 8.1 months. Most of the reactions were seen in black ink tattoos performed by amateurs. Perivascular and spongiotic dermatitis suggestive of allergic response was the most common feature on histopathology. Granulomatous response and lichenoid response were seen in five and three biopsies, respectively. CONCLUSION: Legalization is needed for this practice to prevent tattoo reactions. Histopathological evaluation is important as tattoo reactions may be associated with skin infections and malignancies.

Current legislation on tattooing in France.

Since 2004, tattooing products have been recognized as such by French law. A tattooist must declare his activity to the ARS (French regional health agency). A tattooist is legally compelled to undergo training sessions on occupational safety and hygienic requirements and to deliver his certificate to the ARS. A tattooist commits himself to preliminarily informing his customers of the risks they possibly incur and of the precautions to be taken. He also commits himself to complying with general rules and regulations and with good practices of hygiene and safety; lastly, he signs an agreement pertaining to waste disposal (DASRI). Contrary to pharmaceutical products, tattooing products are not subject to authorization prior to their commercialization. Any adverse effect after tattooing must be the subject of a declaration addressed to the ANSM (French health products safety agency) by the customer, the tattooist or a health professional.

Safety of tattoos and permanent make-up: a regulatory view.

The continuous increase in the popularity of tattoos and permanent make-up (PMU) has led to substantial changes in their societal perception. Besides a better understanding of pathological conditions associated with the injection of highly diverse substances into subepidermal layers of the skin, their regulation has occupied regulatory bodies around the globe. In that sense, current regulatory progress in the European Union is an exemplary initiative for improving the safety of tattooing. On one hand, the compilation of market surveillance data has provided knowledge on hazardous substances present in tattoo inks. On the other hand, clinical data gathered from patients enabled correlation of adverse reactions with certain substances. Nevertheless, the assessment of risks remains a challenge due to knowledge gaps on the biokinetics of highly complex inks and their degradation products. This review article examines the strategies for regulating substances in tattoo inks and PMU in light of their potential future restriction in the frame of the REACH regulation. Substance categories are discussed in terms of their risk assessment and proposed concentration limits.

Body-decorating products: Ingredients of permanent and temporary tattoos from analytical and european regulatory perspectives.

This review summarizes the current regulatory status of tattoos in all their versions in the European Union framework, as well as the analytical approaches developed so far to control the safety of this type of products. Publications from the last two decades (2000-2019) have been reviewed in which body-decorating products have become more and more popular. Tattoo inks, permanent make-up, sticker tattoos, and henna-based products are covered. The report highlights that there is no unique regulation for body art products, conforming a complex legislative framework even within the European community. The labelling of tattoo related products is generally non-existent or incorrect. It is therefore very difficult to know their chemical composition in detail. Pigments are ingredients common to all types of tattoos, so they are the most covered compounds in this review, along with their impurities and degradation products, including aromatic amines, metals or PAH. Other types of undesirable compounds are also included, such as plasticizers or para-phenylenediamine. Although the development of methods of analysis has increased in recent times, there is still margin for improvement in the analytical coverage of this topic. The challenge is, indeed, a systematic analytical approach to control body-decorating products, but ideally within a clear and common harmonised regulatory framework. Finally, tattoo-based sensors for biomonitoring have also been included in this review, since although its purpose is not decorative; its clinical importance is very relevant.

Women and Tattoos: Fashion, Meaning, and Implications for Health.

Tattooing is a type of body modification that is both ancient and modern. Tattooing is rapidly increasing in popularity and prevalence, especially among younger people. Therefore, health care providers require knowledge about this form of artistic expression, including potential health implications and psychosocial significance. Tattooing is richly laden with cultural and personal meaning, but despite the increasingly mainstream status of this art form, individuals with tattoos may experience stigma, stereotyping, and discrimination in their personal and professional lives. The legal and regulatory aspects of tattoos have lagged behind the rapid growth of this art form, causing confusion and variation in practice. Particularly concerning is the multitude of largely unregulated tattoo inks marketed for human use but untested on humans. Common and uncommon side effects and complications of this procedure include hypersensitivity, infection, and regret. More women than men are now tattooed, and tattooing is associated with important implications for women's health care, including pregnancy, childbirth, and breastfeeding. Because of the frequency of regret, many individuals wish to be rid of previously acquired body art. Therefore, health care providers also need to be conversant with tattoo removal: motivations, techniques, risks, and factors influencing success. Familiarity with the many dimensions of body art will facilitate safe, compassionate health care provision and will enhance the therapeutic relationship enjoyed by clinicians and the individuals they serve.

The safety of tattoo inks: Possible options for a common regulatory framework.

Tattoo prevalence has been increasing in the last 25 years, but specific regulations on tattoo inks are still missing. In the European Union, no supranational regulation is available and only few national provisions cover them. In the United States, tattoo inks are classified as cosmetics but are not approved for injection into the dermis. Health risks for consumers may derive from microbiological contamination and the presence of toxic substances or nanomaterials. However, current regulations and non-binding recommendations, where present, only address the microbiological and chemical risks, completely overlooking nanotoxicity. The aim of this paper is to promote awareness of the risks associated with tattoo inks and the nanomaterials contained therein. In particular, the need for a harmonised regulation or, at least, a set of minimal requirements is highlighted to improve the safety of tattoo inks and market surveillance by regulatory authorities.

Allergic Contact Dermatitis Due to Paraphenylenediamine: An Update. / Actualización en la dermatitis de contacto alérgica por parafenilendiamina.

Paraphenylenediamine (PPD) is an amine that is mainly used as an ingredient in hair dyes and henna tattoos. The incidence of allergic contact dermatitis to PPD is increasing, particularly in younger patients. In this article, we review the main sources of PPD and the substances with which it can interact and present a practical algorithm for diagnosing and treating suspected cases of PPD allergy.

Centro de tatuajes y perforaciones corporales: norma técnica No. 25-2018 / Tattoo and Body Piercing Center: Technical Standard No. 25-2018

"El objeto de la presente Norma Técnica es regir las condiciones y requisitos mínimos que deben cumplir los establecimientos donde se realicen Tatuajes y Perforaciones por medio de procedimientos invasivos y/o perforaciones corporales, incluyendo los delineados en forma permanente que se realizan en las salas de estética, con el objetivo de lograr un servicio seguro y de calidad." Es de carácter obligatorio, por lo que se aplica en todo el territorio nacional. Contiene además, las definiciones de los conceptos relacionados al tema principal, además de la infraestructura que deberá tener cada clínica, incluidos el equipo y recurso humano y técnico.

Heavy metal and tattoo: an allergy and legislative problem.

We presented an interesting clinical case of a 23 years old man presented with a 2-week history of pruritus, erythema and papules on legs, arms and trunk. These lesions developed 2 months after tattooing. It showed positive patch test reaction to Copper and Disperse Blu.

A medical-toxicological view of tattooing.

Long perceived as a form of exotic self-expression in some social fringe groups, tattoos have left their maverick image behind and become mainstream, particularly for young people. Historically, tattoo-related health and safety regulations have focused on rules of hygiene and prevention of infections. Meanwhile, the increasing popularity of tattooing has led to the development of many new colours, allowing tattoos to be more spectacular than ever before. However, little is known about the toxicological risks of the ingredients used. For risk assessment, safe intradermal application of these pigments needs data for toxicity and biokinetics and increased knowledge about the removal of tattoos. Other concerns are the potential for phototoxicity, substance migration, and the possible metabolic conversion of tattoo ink ingredients into toxic substances. Similar considerations apply to cleavage products that are formed during laser-assisted tattoo removal. In this Review, we summarise the issues of concern, putting them into context, and provide perspectives for the assessment of the acute and chronic health effects associated with tattooing.

Constituting children's bodily integrity.

Children have a constitutional right to bodily integrity. Courts do not hesitate to vindicate that right when children are abused by state actors. Moreover, in at least some cases, a child's right to bodily integrity applies within the family, giving the child the right to avoid unwanted physical intrusions regardless of the parents' wishes. Nonetheless, the scope of this right vis-à-vis the parents is unclear; the extent to which it applies beyond the narrow context of abortion and contraception has been almost entirely unexplored and untheorized. This Article is the first in the legal literature to analyze the constitutional right of minors to bodily integrity within the family by spanning traditionally disparate doctrinal categories such as abortion rights; corporal punishment; medical decisionmaking; and nontherapeutic physical interventions such as tattooing, piercing, and circumcision. However, the constitutional right of minors to bodily integrity raises complex philosophical questions concerning the proper relationship between family and state, as well as difficult doctrinal and theoretical issues concerning the ever-murky idea of state action. This Article canvasses those issues with the ultimate goal of delineating a constitutional right of bodily security and autonomy for children.

The European landscape of national regulations of tattoo inks and businesses.

A rising number of tattooed people in all parts of society and increasing concerns regarding potential health effects triggered the development of specific regulatory measures at the beginning of the 21st century. The first principles considering chemical safety and hygienic aspects were laid down by two resolutions of the Council of Europe, in 2003 and 2008. The applied principle of 'negative lists' of substances that should not be used in tattoo inks has subsequently been transferred to national regulations. However, surveillance data show that in particular, the chemical quality of tattoo inks is still insufficient. The reasons are, amongst others, the lack of analytical methods, the implementation of different thresholds, and the lack of awareness of distributors and producers when it comes to potential health hazards.

Implementation of European Council resolution ResAP(2008)1 in Italy. National and regional regulation of tattoo practices: diversity and challenges.

In Italy, tattoos and permanent make-up have become increasingly popular in recent years. The number of tattoo parlours has increased from 257 in 2009 to 2,055 in 2014, wich is a eight-fold increase over the last 6 years. Although there is no specific legislation, the Italian Ministry of Health issued a document containing the 'Guidelines for the implementation of procedures for tattooing and piercing in safe conditions'. This document has not been adopted by all Italian regions, principally regarding training course requirements for tattoo professionals, creating a highly fragmented situation that resembles the European scene in miniature. ResAP(2008)1, which is not mandatory in Italy but was made binding by Italian Decree n. 206/2005, has been applied uniformly throughout the country. Thus, as far as the safety of inks is concerned, the surveillance system appears to be working well. However, surveillance has highlighted the presence of non-compliant inks and potentially unsafe preparations for tattoo removal in the market. Updating and rebalancing the situation will be the goal in order to face the challenge of combining well-being with the on-going social demand of looking after and beautifying the body. This would include the growing fashion of tattoos, provided that the products that are used are safe and that tattooing is performed in controlled hygienic conditions that fully guarantee the health of consumers.

EU actions to ensure the safety of tattoos and the protection of consumers.

The number of tattooed persons has been continuously increasing in the last few years, particularly in the younger population. At the same time, the possibility of purchasing tattoo inks online is easier than ever worldwide. Consumers are not always sufficiently aware of the possible health problems associated with this 'cool fashion' if hygiene conditions are not respected and/or if the injected mixtures contain dangerous chemicals. Concerns about the possible health risks associated with such practices arise from the absence of a clear legislative framework, the lack of proper risk assessment of the chemicals used, and non-harmonised or missing hygiene and purity requirements, among other factors. There is a general consensus among all active stakeholders that EU harmonised rules would help to ensure a consistent high level of protection of consumers across the EU.

Surveillance of tattoo-related adverse events by the EU RAPEX system and by national monitoring.

A resolution of the Council of Europe in 2008 (ResAP (2008)1) helped to define requirements and criteria for the safety of tattoos and permanent make-up in order to increase the level of consumer health protection for these products. Tattoo product usage is not without risk. These products are injected into the skin and may represent a risk to human health due to possible microbiological contamination and/or contamination by the presence of hazardous substances in the products. ResAP (2008) laid the foundation for the safety of tattoo products in Europe. This has generated awareness by European Member States and has encouraged them to adapt this resolution in their own law or to use it as a model to define their own regulation on tattoos. In order, to communicate on the hazard associated with these products between Member States and the European Commission, the European RAPEX system was created; this system will be further explained in this article. Finally, some Member States have created a specific vigilance system related to the adverse effects of tattoos. In this respect, a European national example will be presented.

The Amsterdam model for control of tattoo parlours and businesses.

In the early 1980s, an outbreak of hepatitis B in Amsterdam stood at the start of the development of the first hygiene guidelines for tattooists in The Netherlands. Ever since, infection control in tattoo practice has continued to prove its importance as tattoo-related outbreaks of infectious diseases have continued to be reported in Europe. Furthermore, the act of tattooing includes breaking the skin barrier but is performed by professionals who are not medically trained. The Ministry of Health has now implemented uniform regulations that apply to professionals who perform tattooing and apply permanent make-up. These regulations include hygiene guidelines that were developed by the National Institute for Public Health and the Environment in cooperation with representatives of the tattooing associations. The guidelines contain a list of requirements, including for the studio interior, the cleanness of the studio, the safe use of permitted equipment and products, sterilization methods, and the information provided to the customer. A permit may be granted after an inspection by the local health service, during which the act of tattooing has to be performed. It is now estimated that over 95% of all tattoos in The Netherlands were obtained at one of the almost 900 licensed studios. Reports of complications are generally low in number. We suggest that uniform European hygiene guidelines would further contribute to the safety of tattooing.