Tattoo inks and permanent make-up

Tattoos are a popular form of body art – 12 % of Europeans have them. They are made by injecting coloured inks under the skin to leave a permanent design. The health risks of using dirty needles to inject the inks have already been under scrutiny for some time, but there may be chemical-related concerns to consider, too. Tattoo inks, as well as permanent make-up such as eyeliner inks, are a mix of several chemicals. As these chemicals may stay in the body for life, there is also the possibility for long-term exposure to the potentially harmful ingredients in tattoos and permanent make-up products. These chemicals may cause adverse health effects, but little is known about the consequences of their use.

What are tattoo inks and permanent make-up?

A tattoo is made by penetrating the outer layer of the skin with a needle and injecting ink into the area beneath to create a design. The top layer of skin – the epidermis – regenerates itself continuously, so to make a tattoo last, the ink is injected into the second, deeper layer of skin – the dermis.

Permanent make-up is similar to a tattoo, with the design aiming to resemble make-up.

Why is ECHA working on tattoo inks and permanent make-up?

Tattoo inks and permanent make-up may contain hazardous substances that are known or suspected to cause cancer, genetic mutations, toxic effects on reproduction, allergies or other adverse effects in animals or humans.

Due to the lack of information on tattoo inks and permanent make-up, the European Commission has asked ECHA to assess the risks of the substances in tattoo inks on human health and to examine the need for EU-wide restrictions on their use.

In its analysis, in addition to examining the risks to human health, ECHA is looking into the availability of safer alternatives. The socio-economic impact of restricting their use, for example through effects on manufacturing and service sector jobs, is also examined.

ECHA is looking at the substances known to be used in tattoo inks and permanent make-up that may be hazardous to human health, as well as the substances that we want to prevent being used in the future. Special attention is being given to substances that cause cancer, are mutagenic and toxic for reproduction, sensitisers, as well as other substances in the Council of Europe resolution on requirements and criteria for the safety of tattoos and permanent make-up.

This work builds on previous reports produced by the EU Commission and the Council of Europe.

How are tattoo inks and permanent make-up regulated in the EU?

There isn’t any specific EU-wide legislation in place, but seven Member States have developed their own laws based on the 2008 Council of Europe resolution on the safety of tattoos and permanent make-up or its 2003 predecessor. Apart from that, tattoo inks are covered by the General Product Safety Directive in terms of the manufacturers’ obligation not to provide an unsafe product; the Classification, Labelling and Packaging (CLP) Regulation in terms of labelling products that contain classified substances in excess of their classification limits; and REACH in terms of registration requirements and information provision.

As many of the hazardous substances may be present in tattoo inks or permanent make-up in small quantities, the obligations under CLP and REACH may not apply.

What are the current obligations of downstream users and suppliers in the tattoo ink and permanent make-up supply chain?

Downstream users – including formulators of mixtures – have specific duties under REACH regarding the tattoo inks or permanent make-up inks that they produce. Formulators of tattoo inks need to identify the ingredients in their products to manufacturers and importers, so that these can be taken into account in complying with any registration requirements. If the registrants haven’t covered the use in tattoo inks and formulators use any registered hazardous substance at or above one tonne, then they need to carry out a downstream user chemical safety assessment to show that it is safe to use the substance in tattoo inks and permanent make-up.

Furthermore, a company selling hazardous substances or mixtures to another company must provide the purchaser with a safety data sheet on the product. The safety data sheet gives guidance on how to use the substance safely, providing information about the properties of the substance or mixture, its hazards and instructions for handling, disposal, and transport, as well as recommended first-aid, fire-fighting and exposure control measures.

Manufacturers of individual substances – in quantities at or above one tonne per year – must comply with REACH: the chemical must be registered with ECHA, and the submission must be accompanied by data on the hazardous properties of the substance. ECHA can then take action to control the use of the chemical if it is hazardous. This regulation applies to all chemicals, not only those used in tattoo inks and permanent make-up.

Finally, manufacturers, importers and downstream users have to classify substances and mixtures according to the criteria of the CLP Regulation and ensure that the labelling and packaging requirements for hazardous chemical products are met. A notification to ECHA is needed for each substance classified as hazardous and placed on the market on its own or in a mixture.

What happens next with ECHA’s analysis of tattoo inks?

ECHA and its partners have reviewed the risk from certain substances in tattoo inks and permanent make-up and concluded that a restriction is needed. The proposal was submitted in October 2017.

The next steps in the process are for ECHA’s scientific committees to check that all the required information has been submitted. If the proposal passes this conformity check, a six-month public consultation begins where anyone can comment on the proposal. ECHA’s scientific committees consider the evidence submitted and produce an opinion on whether the substances should be restricted or not. These scientific opinions, together with the background documents, are sent to the European Commission and published on ECHA's website. Within three months, the European Commission decides whether to restrict the chemicals’ use or not. If the decision supports a restriction, this will come into force following consultations with the World Trade Organisation (WTO), a vote by Member States, and scrutiny by the European Council and Parliament.

It is a long process, about 2-2.5 years since conformity is established, but it ensures that all decisions are based on the strongest available research evidence and advice from experts in the scientific community.

Should I be concerned about my tattoos?

The assessment by ECHA’s scientific committees is ongoing and an opinion has not yet been reached.

If it is concluded that a restriction is needed, it would certainly make sense to talk to your tattooist before having any new ones. They should be buying from a source that complies with REACH and they should be able to talk to you about the chemicals they are injecting into your skin.

If you have concerns about your current tattoos, you can contact your healthcare provider for advice. If you are considering the removal of a tattoo, you should take into account that laser removal is a procedure in which pigments and other substances are broken down into smaller particles – these may include harmful chemicals, which are then free to circulate in your body.

If you would like to get a new tattoo, do your research not only about the skills of the tattoo artists and the measures they take to avoid infections, but also the tattoo inks that they use. Get all the information, don’t be afraid to ask questions!

Your tattoo artists should be able to provide you with extensive information on the inks used, including sourcing details, possible health risks, and compliance with the relevant laws and regulations.

For example, you should be able to trace inks back to a reliable vendor, or be able to check products against current national legislation (in place in Belgium, France, Germany, the Netherlands, Slovenia, Spain, Sweden, Norway, and Liechtenstein) or the recommendations of the Council of Europe resolution on the safety of tattoo inks and permanent make-up.

You might want to check the EU Rapid Alert System for dangerous non-food products (RAPEX) for any inks reported to have presented serious risks in the past, or contact your national agency responsible for the enforcement of chemical or tattoo inks legislation.

It may also be useful to keep a record of the tattoo ink used, in case you develop a reaction outside of the normal healing process. Contact your healthcare provider right away if you have medical issues or experience any symptoms that seem out of the ordinary.

Further information
ECHA
European Commission
External links