Regulatory eye: EU investigates permanent cosmetics and tattoo inks

“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​,” explains the ECHA.

“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​.”

Why tattoo and permanent makeup inks?​

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, says the ECHA.

The regulatory body says it is looking into the risks of currently used inks, and also considering safer alternatives. In a move intended to reassure industry players, the body says it will also be considering how any restriction of their use may affect manufacturing or service sector jobs.

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

What are tattoo inks and permanent makeup?​

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 makeup is similar to a tattoo, with the design aiming to resemble makeup.

How are tattoo inks and permanent makeup currently regulated in the EU?​

There isn’t any specific EU-wide legislation in place, says the ECHA, 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.