Tattoo inks and permanent make-up

ECHA has proposed to restrict hazardous substances used in tattooing inks and permanent make up. ECHA is not proposing to ban tattoos or tattooing colours but to make tattooing safer.

The proposal includes carcinogenic, mutagenic and reprotoxic (CMR) substances, skin sensitisers or irritants, substances corrosive or damaging to the eye, metals as well as other substances already regulated under the Cosmetic Products Regulation.

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 ECHA worked 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 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 looked into the availability of safer alternatives. The socio-economic impact of restricting their use, for example through effects on manufacturing and service sector jobs, were also examined.

ECHA looked 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 was 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.

ECHA submitted a restriction proposal in October 2017 to the Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) for their evaluation. ECHA's work built 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.

In addition, the use of preservatives in tattoo inks is subject to the Biocidal Products Regulation (BPR).  Only active substances in the Biocidal Review Programme, or approved, for Product type 6 "in-can preservatives" can be made available on the market and used in the EU by EU manufacturers of tattoo inks. Preservatives that meet one of the criteria in the restriction would not be allowed in tattoo inks in the event that the restriction enters into force as proposed.

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.

Should I be concerned about my tattoos?

If the Commission decides 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.

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