EU - Amendment on Annex XVII to REACH Regulation as Regards Substances in Tattoo Inks or Permanent Make-up

​Annex XVII to Regulation (EC) No 1907/2006 lays down restrictions on the manufacture, placing on the market and use of certain substances on their own, in mixtures or in articles.

The number of people in the Union with tattoos or permanent make-up has been increasing steadily, in particular in the young population. The procedures used for tattooing or permanent make-up (referred to collectively as ‘tattooing’), whether involving the use of needles or the application of some other technique such as micro-blading, inevitably cause an injury to the skin barrier. As a result, the inks or other mixtures used for tattooing are absorbed into the body. Mixtures used for tattooing generally consist of colorants and auxiliary ingredients such as solvents, stabilisers, wetting agents, pH regulators, emollients, preservatives and thickeners. The mixtures are introduced into the human skin, inside the eyeball or into mucous membranes. The colorants mostly remain close to where the mixture is administered, so that the tattoo or permanent make-up will remain visible.

However, the soluble ingredients in the mixture are distributed within a matter of hours or days across the entire body. In consequence, the skin and other organs are exposed to the effects of those soluble substances over an extended period. Some of those substances have hazardous properties that pose a potential risk to human health. In addition, metabolism of the colorants in the skin, decomposition due to solar radiation exposure and laser irradiation may also lead to the release of hazardous chemicals from the area of the body where the tattoo or permanent make-up is located.

On March 12, 2015, the Commission asked the European Chemicals Agency (‘the Agency’) pursuant to Article 69(1) of Regulation (EC) No 1907/2006 to prepare a dossier in order to assess the risks to human health of certain chemicals contained in mixtures used for tattooing purposes.

Mixtures placed on the market for use for tattooing purposes are administered for a variety of reasons, including both aesthetic and medical reasons. Such mixtures may fall within the scope of Regulation (EU) 2017/745 of the European Parliament and of the Council. When placed on the market or used exclusively for medical purposes within the meaning of Regulation (EU) 2017/745, the restriction established by this Regulation should not apply to them. In order to ensure a consistent regulatory approach between Regulations (EU) 2017/745 and (EC) No 1907/2006 and to guarantee a high level of protection of human health, when the placing on the market or use of such mixtures may be for both, medical and non-medical purposes, the specific obligations and requirements laid down in both Regulations should apply cumulatively.  

Therefore, a new restriction entry (Entry 75) and a new appendix (Appendix 13) are planned to add to the REACH Regulation on January 4, 2021 and the restriction of most of the substances will be implemented 1 year thereafter except Pigment Blue15:3 and Pigment Green 7 which will be restricted 2 years after the amendment of the REACH Regulation, thus January 4, 2023.