Facing high popularity of tattoos in modern time around the world, it is no longer acceptable that tattoo inks remain so little and so variably regulated. Tattoo inks are injectables and a significant chemical and microparticle exposure of populations particularly the youngsters. The many details of exposure and risk and the level of toxicological, experimental, clinical, and epidemiological research have been reviewed [1‒4].

The EU tried in 2003 to launch a regulation but gave up due to lacking scientific insight. In 2003 and finally in 2008, the Council of Europe decided a nonbinding resolution on tattoo ink composition, the ResAp(2008)1 [1]. This was officially accepted in some 10 EU countries but not faithfully implemented. The council explored a test algorithm for new tattoo inks but recognized it was not feasible [5]. Known toxicological models were not routinely applicable. The ResAp(2008) [1] made no significant influence on ink product supplies. More than 90% of inks used in Europe are imported from the USA and manufactured according to the US industrial standard, which is loose. Tattoo inks are industrial products made from pigments shared with billion-dollar industries using huge amounts of colourants.

The EU in 2020 decided to regulate tattoo inks as chemicals under the REACH system (as annex XVII to EF 1907/2006), introduced in 2006 and managed by the ECHA chemical agency in Finland, regarding inks as a binding regulation every EU country must follow [1]. It became effective from January 4, 2022. However, REACH is essentially a system for single and pure substances used in the industry, aiming to protect workers from skin contacts and inhalants. REACH never had been applied to composite products used as injectables and made from industrial raw materials of low purity. It is a courageous experiment to use REACH for the purpose tattoo inks. The EU was reluctant with the intuitive misfit and for a period considered to regulate inks as consumer products. The EU was eager to squeeze tattoo inks into some system they already had. Exposurewise, the installation of ink under the skin surface is much closer to pharmaceutical injectables [2, 3]. The chemical barrier of the skin is in the stratum corneum; under that structure, the ink chemical or particle may potentially reach the system depending on the ADME profile of the specific ingredient. But inks used for tattooing are very special dosage forms meant for life-long colouring of the skin site where the tattoo is made. This implicates strong local binding and thus less systemic exposure. The colourful pigments are physical particles in the nano- and micrometre scale, and this is the reason why particles to a high degree stay where they were placed. Organs of primary concern are the tattooed skin itself and the regional lymph nodes. Dosing is single and not chronic, accumulative, or provocatory high-dosed as often used in toxicological experiments. The potential systemic exposure of the body from a typical tattoo over a lifetime must be ultralow. A valid toxicological model for such exposure is not existing, biokinetic profiles widely unknown why theoretical safety predictors such as margin of safety cannot be reliably calculated and applied to the problem.

The EU Joint Research Centre in Italy in the preparation of the new regulation performed a careful assessment of the science behind tattoo inks, their use, composition, and reported hazards and side effects on human health. Four extensive reports came out [6‒9]. The scientific knowledge gaps were tremendous as also concluded in 2003. The toxicological literature was nearly empty of significant research directly on tattooed human skin, and hypothetical extrapolations out of widely irrelevant research on small animals and cell cultures were used with high risk of translational error. A precautionary principle was decided based on carcinogenicity, mutagenicity, and reproduction toxicity. Warnings from many experts including clinicians with special insight were neglected as were critical notes from the European Society of Tattoo and Pigment Research (ESTP) and the entire tattoo industry. The regulation came out not relevant; despite tattooing being practised for decennia, the general experience and the medical literature indicated no tattoo-associated cancer risk and no birth defects. The known commonest complications of tattoos, namely, bacterial infections, allergies in red tattoos, granulomas and sarcoidosis triggered by black tattoos, sun sensitivity, painful neurosensitivity, urticarial reactions, etc., were completely out of scope of the regulation [4]. It cannot be envisaged, and it has not been convincingly argued or documented that the regulation reduces those tattoo complications hospital tattoo clinics really see. The postulated improved safety is despite good aims speculative and taped with limitations and shortcuts.

The manufacturing ink industry is facing the problem that they cannot produce guaranteed legal EU inks. No industry can guarantee that 4,150 chemicals are absent or only present in concentrations under 0.00005%, 0.001%, 0.01%, or 0.1%. Manufacturers cannot obtain purity guarantee at that level from their industrial raw material suppliers. Pigment supplies are not according to any pharmacopoeia but cheap and dirty and out of huge bulk production with other purpose. An important obstacle is that analytical methods for the widely insoluble pigment particles are not developed or validated, and low concentrations often may fall under analytical detection limits. Authorities have the same analytical challenge when they shall survey inks in use in studios, unless they close their eyes and refrain from such endeavour.

Precautionary regulation shall, recognized by the EU, build on proportionality, e.g., the intervention shall have an effect that justifies the burden of the intervention. The REACH regulation limits 4,150 chemicals with total ban of 91. Some 1,800 restrictions are uncritically imported form the EU cosmetic regulation including the total ban of Pigment Blue 15 and Pigment Green 7 despite no documentation that these pigments have been especially unsafe for tattooing exists; rather the opposite is indicated. And the blue pigment has no acceptable replacement! Regulation is loyal to EU bureaucracy but neglecting clinical reality and existing clinical science. Those two pigments are banned 1 year later, from January 4, 2023. Can such EU selfish regulation on such obscure premise realistically be expected to be followed by the floor and the entire tattoo industry? The EU has been warned about the risk of criminalization of the sector, which has rebellion root and operate in small private enterprises.

Another burning question is if the EU and national authorities can ever police the new situation. The answer is no. Only 2–3 countries have the peak competence to analyse inks in dept, Germany and Switzerland, and probably Italy. Most EU countries have very limited expertise in the field. The REACH regulation is a highly complex technical document difficult for users to read. Inspectors can only look at labels on bottles and check product certificates presented to them. There are presently roughly a handful of inks claiming in accordance with REACH. Analytical documentation is often nontransparent and far away from full documentation. The EU has declared in writing and at a webinar held on March 29, 2022, that it is entirely up to the manufacturer to decide which selected chemicals that shall be analysed in a particular product. The EU has released a list with a smaller number of substances suggested to be tested, signed off on December 14, 2020, by Ursula von der Leyen (EU 2020/2081). This is a document of EU surrender. It opens a cascade of uncertainties. Such list of limited restriction is not legalized in the REACH main document on inks and an unexpected act of rescue by the EU. From now on, manufacturers have free hands to omit analyses, which might be controversial. The list includes several azo pigments, which cannot be analysed reliably. We now see the certificate machines printing documentations that are highly controversial with no reliable guarantee of bottle content, safety, or safety improvement relative to “old” inks, which are still freely accessible on the world market. The tattoo business operates internationally and can buy inks everywhere on earth. For the tattooist, it is good enough to have some ink supplier certificate to present, being fake or not but preferably from a European supplier for the best legal coverage; the supplier or the manufacturer in the USA is at the end the legally responsible party. The tattooist can have “certified” inks on display in the studio to satisfy authority inspection and “old” inks for daily use in a separate cabin. This hidden traffic appears more widespread than one would ever believe. It is the unpleasant criminalizing effect of the REACH regulation the EU was warned about. Costumers generally do not care and often request the colours they are familiar with and already have in other tattoos. “Old” inks even can be postulated safer than the newcomers. The “old” inks passed the test of time, the parallel to clinical trials, and those sold for years are those which worked well in tattooists’ experience. An example of a new ink causing unusual problem in practical use is illustrated in Figure 1.

Fig. 1.

New tattoo made with newly launched tattoo inks of different colours from one manufacturer. The photo is taken 2 months after the tattoo was made. The tattoo was independent of colour swollen for weeks, associated with itch. This ink associated adverse reaction was unusual and unacceptable, and the tattooists gave up future use of the brand. The problem may have been related to the vehicle. Isopropanol banned under REACH and not associated with such problem has been replaced by another carrier. The manufacturer supplied with the ink analysis certificate and claimed the ink compatible with the EU REACH regulatory requirement on tattoo ink. Permission granted by tattooist Dorte Romain, Holstebro, Denmark.

Fig. 1.

New tattoo made with newly launched tattoo inks of different colours from one manufacturer. The photo is taken 2 months after the tattoo was made. The tattoo was independent of colour swollen for weeks, associated with itch. This ink associated adverse reaction was unusual and unacceptable, and the tattooists gave up future use of the brand. The problem may have been related to the vehicle. Isopropanol banned under REACH and not associated with such problem has been replaced by another carrier. The manufacturer supplied with the ink analysis certificate and claimed the ink compatible with the EU REACH regulatory requirement on tattoo ink. Permission granted by tattooist Dorte Romain, Holstebro, Denmark.

Close modal

The EU is rigid and cannot make retreat. The EU is likely to insist on the decided REACH regulation of inks years ahead and neglect the chaos it created. We shall live with this situation, which has its parallel in the alcohol ban in the USA in the 1920s. I will see as many tattoo complications in my clinic as I used to see, infections, allergy in red, granuloma and sarcoidosis in black tattoos, etc.

What went wrong in the EU in the development of the REACH regulation? The Joint Research Centre made a careful preparatory assessment with fair display of facts and challenges, with the paucity of science in the field exposed to decision makers. There were protests from all sides including the ESTP society. The ESTP stressed out that tattoo inks cannot be regulated as individual chemicals under REACH and need its own regulation specifically on inks, also including microbial safety and the special aspect of nano and microparticle behaviour in the skin responsible for granuloma formation and sarcoidosis. The EU has many focused regulations exemplified by the regulation of paints used for toys, colourants used for textiles, etc. The EU should develop a positive list on acceptable ingredients and pigments in tattoo inks inspired by the positive list for cosmetic products. Such a list would be a highly significant game changer with foreseeable universal acceptance. It was the political and bureaucratic levels of the EU that failed the good mission and made the regulation of inks in Europe go wrong.

We shall live with the new chaos in the tattooing sector and illegal activities for the coming decennium or longer but constantly remind regulator that a separate, targeted, and simple regulation of tattoo inks is needed. Safeguarded inks are demanded from many sides including the tattooists, who have done much to improve the profession and become respected. They unanimously supported the introduction of today’s hygienic tattooing facilitated by the recent EU CEN standard. Penetration of regulation is strongly dependent on good or bad will among users, trivial to say but a simple and lay fact. The EU was too self-confident and too neglectant and lost the opportunity to promote safer tattooing, this time. Efficient leadership is fulfilled on the background of realistic and respectful understanding of those laymen, who in good spirit shall be guided in a certain direction and follow you, expressed by the renowned Danish philosopher Søren Kierkegaard more than a century ago.

The photo was taken by Dorte Romain, who provided written consent to use it in publication, with the consent of the tattooed.

No conflict of interest to declare.

No funding was received for this article.

Jørgen Serup made the article solely.

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