ECHA

Tattoos symbolise originality, personality and freedom. They are also more popular than ever. In Europe, around 12 % of adults have a tattoo. In some countries and younger age groups, this proportion is even higher. But, little attention has been paid to the chemicals in your tattoos and whether the inks used could harm your health. ECHA Newsletter reports on the current regulatory developments.

When you get a tattoo, needles make multiple puncture wounds and insert colour pigments into your skin or even into other parts of your body, like your eyeballs or under your tongue.

The substances in the ink might cause effects such as allergic reactions, or result in more serious health concerns. These effects can even occur years after you have had the tattoo, suggesting that exposure to the substances is lifelong.
 

What is in tattoo inks?

Tattoo inks, as well as permanent make-up such as eyeliner inks, are mixes of several chemicals, such as colourants and auxiliary ingredients like fillers, binding agents or pre-servatives.

These chemicals may be known to cause or suspected of causing cancer, genetic mutations, toxic effects on reproduction, allergies or other adverse effects in animals or humans. For example, colourants can contain heavy metals and allergenic substances, but often little data is available on whether they can cause mutations or cancer, if they are harmful to fertility or if they affect children’s development.

Moreover, substances used for tattoos are not specifically produced for this purpose, and may contain such levels of impurities that they should not be injected directly into your skin.
 

How are tattoo inks regulated?

Currently, there is no European-wide legislation specifically regulating the chemical composition of tattoo inks and permanent make-up.

Seven Member States (Belgium, France, Germany, the Netherlands, Spain, Slovenia and Sweden) have developed their own laws based on the Council of Europe’s resolution on the safety of tattoos and permanent make-up.

Apart from the Council resolution, tattoo inks are covered by the General Product Safety Directive, the Classification, Labelling and Packaging (CLP) Regulation in terms of labelling products and, of course, the individual ingredients are also covered by REACH.

However, to ensure harmonised, high-level protection of human health throughout Europe, the risks of tattoo inks need to be specifically regulated.
 

EU-wide restriction proposal for substances in tattoo inks

Due to the growing popularity of tattoos and no harmonised EU-wide measures to control tattoo and permanent make-up inks, the European Commission requested ECHA to assess the human health risks associated with the inks, the relevant socio-economic impacts, and the need for EU-wide action beyond any national measures already in place.

In response, ECHA prepared a report that proposes to restrict the intentional use of or the concentration limit for some substances contained in tattoo inks.

This restriction is based on a risk assessment of substances such as colourants, impurities, and other auxiliary ingredients.

Due to the large number of substances and the complexity of the assessment, ECHA was supported by Denmark, Italy and Norway in developing the proposal. Germany also contributed significantly to this work.

ECHA’s proposal does not suggest to ban tattoo inks or tattooing, but aims to regulate the ingredients in the inks so that they are safe.

The restriction is proposed for approximately 4 000 substances that are:

• already banned in cosmetic products;
• subject to harmonised classification, such as those that are carcinogenic, mutagenic and toxic to reproduction (CMR), skin sensitisers, corrosives or irritants, and eye-damaging or eye-irritant; and
• covered by the Council of Europe’s resolution on tattoo inks.

Only some of the substances covered by the proposal have been found in tattoo inks. The remaining substances are included to prevent their potential use as substitutes in the future.

For certain colourants, an exemption is suggested because there are no suitable alternatives yet available for their use.
 

Next steps

The restriction report was published on ECHA’s website on 25 October 2017. From mid-December 2017, it will be open for interested parties to give their comments and submit supporting documents.

ECHA’s scientific Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) are expected to give their expert opinions on the proposal by the end of next year.

All relevant information received during the public consultations will be taken into account.

RAC and SEAC’s opinions are then sent to the Commission, which has three months to draft an amendment to the list of restrictions. If the Council or the European Parliament do not oppose the restriction, the Commission will adopt it and it will be published in the Official Journal after the Commission receives the opinions.
 

What would a restriction mean?

If the Commission adopts the restriction, manufacturers of the inks and tattoo artists will need to comply with the law.

They should be buying from a supplier that complies with this new restriction under REACH and they should be able to tell their customers about the chemicals they are using. The restriction would reduce the potential health risks for people getting new tattoos, such as allergic reactions to tattoo inks and possible long-term effects from exposure to hazardous substances injected under the skin.
 

Did you know?   Tattoo – A permanent skin marking or design, which is made by injecting tattoo ink into the skin. Tattoo ink – A mixture of colourants and auxiliary ingredients. It can also include impurities. Permanent make-up – Also a mixture of colourants and auxiliary ingredients. It is used to enhance the contours of the face or to restore other parts of the human body that may have been affected by a medical condition, injury or ageing.

 

Further information:

Restriction proposal

Hot topics - tattoo inks and permanent make-up

Call for evidence to gather information on substances in tattoo inks

Proposal to restrict hazardous substances in tattoo inks and permanent make-up, Press release - 25 October 2017

Council of Europe's resolution on the safety of tattoo inks

German Federal Institute for Risk Assessment's FAQs on tattoo inks

 

Text by Nedyu Yasenov

Published on: 16 November 2017

Top image: © iStock.com/Portra

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