Proposal to restrict hazardous substances in tattoo inks and permanent make-up

ECHA/PR/17/18

Together with the competent authorities of Denmark, Italy and Norway, ECHA has prepared a restriction proposal to reduce the risks caused by hazardous substances contained in some tattoo inks. These include some substances already banned in cosmetics but also additional substances.

Helsinki, 25 October 2017 – Due to the growing popularity of tattoos and no harmonised control in the EU on tattoo and permanent make-up inks, ECHA was asked by the European Commission to assess the chemical-related risks associated with the inks, the need for Union-wide action, and the relevant socio-economic impacts. ECHA asked Member States if they wanted to be involved in developing the proposal and Denmark, Italy and Norway became co-responsible. In addition, Germany contributed significantly to the proposal. As a conclusion to this assessment, the dossier submitters have made the proposal for a restriction.

The aim of the proposal is not to ban tattoo inks or tattooing. Instead, the aim is to regulate specific hazardous substances present in tattoo inks so that they are safe for people.

The proposal suggests to restrict the intentional use or concentration limit of approximately 4 000 substances when contained in tattoo inks. These include those substances already banned in cosmetic products or subject to certain harmonised classifications, such as carcinogens or skin sensitisers. Only some of these substances have been found in tattoo inks, but they are included in the proposal to prevent their potential use as substitutes in the future. Most of the substances are also covered by the recommendation by the Council of Europe on tattoo inks (ResAP(2008)1 and its predecessor) on which seven Member States have based their national legislation.

Stakeholders are expected to be able to comply with the proposed restriction as it is largely similar to the national measures on tattoo inks of the seven Member States. The proposal also takes into account other socio-economic impacts on the industry and the people who get tattoos.

It is expected that the restriction will significantly 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.

ECHA plans to launch a six-month public consultation on the proposed restriction in mid-December 2017. Stakeholders and the public at large are invited to provide comments on the proposal and its anticipated impacts. ECHA’s Committees for Risk Assessment and Socio-economic Analysis are expected to give an expert opinion on the proposal by the end of 2018, taking into account the submitted information. A draft decision by the European Commission is expected after that.

If you have any questions or concerns about tattooing, contact your local healthcare service provider.