PLANNED EU RULING MAY REGULATE TATTOO INKS FOR THE FIRST TIME TO AVOID HEALTH RISKS

BY DIANA YORDANOVA, in Brussels and KEITH NUTHALL, in OttawaBody artists in Europe may have to reconsider the pigments that they use in future, with the European Union (EU) drafting new rules that could regulate what chemicals can be used in tattoo inks.

While today 12 out of every 100 Europeans are tattooed or have some sort of permanent cosmetic treatment, experts are increasingly concerned that these skin colouring agents may contain hazardous substances, known or suspected to have adverse health effects causing cancer, allergies or mutations.

As a result, the EU executive, the European Commission has asked the EuropeanChemicals Agency (ECHA) to investigate, evaluating whether EU consumers’ health is actually under risk from tattoo inks and advising on whether EU legislation is necessary. “The EU is not [considering] banning tattoo inks or tattooing but aims to ensure that all substances present in tattoo inks are safe for citizens”, a Commission spokesperson underlined.

 

SOME REFORMULATION WILL BE REQUIRED

A formal proposal was released by ECHA’s Committee for Socio-Economic Analysis (SEAC) in March (2019) – see https://echa.europa.eu/documents/10162/2b4533aff717-4bff-939b-2320fb43b462 – which stated clearly that some tattoo inks would need to be reformulated. The text includes that inks should not include carcinogenic or mutagenic substances in concentrations greater than 0.00005% w/w (proportionate weight of a chemical within a solution).

It would also block substances prohibited for use in cosmetic products in annex II of the EU Cosmetics Regulation (EC) 1223/2009 in concentrations greater than 0.00005% w/w; and in annex IV of the regulation in concentrations greater than 0.00005%, where such chemicals are listed as used in rinse-off products; a risk to mucous membranes and should not be used in eye products.

Also, skin sensitisers, listed in category 1, 1A and 1B under the EU’s 2007 classification, labelling and packaging of substances and mixtures (CLP) regulation 1272/2008 would be banned from tattoo inks in concentration greater than 0.001% w/w, with some exceptions. Skin corrosive or irritant substances, in CLP regulation category 1, 1A, 1B, 1C and 2 and serious eye damage/eye irritant substances, in category 1 and 2, in concentrations greater than 0.01% w/w would be blocked. And so would substances deemed toxic to reproduction under CLP category 1A, 1B or 2 in concentrations greater than 0.001% w/w.

 

COSTS MAY RISE

The promise of the chemical agency is that any proposed restriction will be proportionate to the risks, bringing significant health benefits, without harming the tattoo ink sector. But it is hard to imagine that such reformulation will come without consumers paying the costs of ink manufacturers reassessing what substances to include in their products.

“Compliance costs are likely to be passedon to consumers through the price increase of tattoo services, and that this price increase will remain affordable”, an ECHA spokesperson told Polymers Paint Colour Journal (PPCJ). He argued that a proposed one-year transitional period for any reformulation mooted by the SEAC committee would be designed “to provide sufficient time for reformulations and allow stakeholders to prepare to comply with the restriction”.

Overall, “the restriction is not expected to have significant negative economic impacts on supply chains”, he said. ECHA’s committee has suggested that to aid this work and avoid ink makers replacing a hazardous substance with another one that also poses risks, the agency should group similar materials in a technical annexe to a tattoo ink regulation.

Some background work on the topic has already been undertaken by the EU’s Joint Research Centre (JRC), which released a ‘Safety of tattoos and permanent make-up’ report in 2016. This assessed existing tattoo ink and permanent make-up controls in EU member countries and also considered the overall dangers of tattooing. The bulk of tattoo health complications involve allergic reactions and hypersensitivity, mostly in red or black areas of tattoos, noted the report.

The JRC also discovered that many tattoo and permanent make-up products available in the EU contain dangerous substances or have been contaminated by microbes. The main risks identified are the presence of polycyclic aromatic hydrocarbons, primary aromatic amines, micro-organisms, heavy metals and preservatives. Noted examples included the skin irritant benzoisothiazolinone and the carcinogen, formaldehyde, as well as metals, such as nickel, chromium and cobalt.

What is more, the study points out that some pigments that could be used in inks are not specifically made for tattoo or permanent make-up use, with some banned for use in cosmetics under the EU’s cosmetics regulation (a concern followed up by the ECHA committee in its proposal). The JRC report noted banned harmful impurities and by-products, such as chromium VI in chromium oxides; nickel, chromium, copper and cobalt in iron oxides; aromatic amines in azo-colourants; and polycyclic aromatic hydrocarbons in carbon black dyes – stressing that these should not be used in tattoo inks.

Answering one of the greatest fears associated with tattooing – the possibility it may cause cancer – scientists highlighted in the report that the risk of tattoo-induced tumours cannot be excluded because of the inks’ impurities.

 

HEALTH THREATS FROM TATTOOING PRACTICES

The health threats are not just posed by the inks themselves – tattooing practices can worsen risks. For instance, mixing black ink with tap water to produce a grey colour, poor hygiene or improper needle sterilisation. In a span of 10 years, EU’s rapid alert system for non-food dangerous products (RAPEX) has received more than 120 notifications about risks in tattoo inks, for instance about red, caramel, yellow, green or pink inks containing aromatic amine o-anisidine. Two-thirds of the hazardous pigments included in these alerts were produced in the USA, another quarter were made in China but also some Japanese and European products sparked alerts.

Despite these concerns and a flurry of academic studies highlighting health concerns about tattoo inks, EU legislation on the topic has largely been absent.

Tattoo inks are covered by the 2001 general product safety directive but not other binding legislation. Also, the Council of Europe (the non-EU body that has a wider membership, including Russia), has adopted a non-binding resolution on safety of tattoos, including a negative list of ink ingredient it says should not be used. It recommends that aromatic amines with carcinogenic, mutagenic, reprotoxic or sensitising properties should neither be present in tattoo inks and permanent make-up products, for instance. The resolution was revised in 2008. In the meantime, EU governments have been handling the issue nationally, in divergent ways.

A German regulation, a 2009 Regulation on Inks Used in Tattoos Including Certain Comparable Substances and Mixtures Made up of Individual Substances, refers to the European cosmetics regulation “as a workaround solution”, a spokesman for the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung – BfR), Mike Kortsch explained. He noted that “compounds that are restricted or banned for use in cosmetic products are also not allowed in tattoo inks”. Besides Germany, another six EU countries – Belgium, France,

The Netherlands, Spain, Sweden and Slovenia – have put in place their own national legislation on tattoo inks, which try to follow the principles of the Council of Europe resolution. By contrast, Bulgaria, Croatia, Cyprus, Estonia, Greece, Ireland, Luxembourg, Poland and Portugal have adopted a light touch approach, relying on existing consumer product safety laws. Beyond Europe, New Zealand has established a list of 27 aromatic amines and 35 colourants that should not be present in tattoo inks, its restrictions based on the Council of Europe guidelines. Consumer organisations have been important in drafting what legislation has been approved this far.

Alana Valero, the Assistant Programme Manager of ANEC, an organisation promoting European consumer interests in standardisation, had some concerns if the EU response was based on its chemical control system REACH. This, she said, was “not the appropriate framework as it does not allow for positive lists”. Together with ANEC, the BfR has also asked for the establishment of positive approved lists of tattoo ink ingredients.

“Only substances that have been found safe for intradermal application should be allowed in tattoo inks”, said Mr Kortsch. So far, however, Spain has been the only country able to achieve this, he said. But at ECHA, the development of EU controls is moving forward. The SEAC committee’s final opinion will now be sent to the European Commission, which should this year prepare a draft decision based on its recommendations. In the meantime, Europeans are still getting new tattoos, regardless of whether their inks are dangerous or safe.

 

This article was previously published in “Polymers Paint Colour Journal” (PPCJ).

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