EU proposes a restriction of tattoo inks under REACH XVII

The composition of permanent make-ups (PMU) and tattoo inks raises numerous concerns for public health. (e.g. allergies caused by substances used in inks and possible carcinogenicity). In June, a PMU ink is notified on the RAPEX as it violates against the Council of Europe Resolution ResAP (2008)1.

Case notified:

Date	10 June 2016
Category	Chemical
Product Name	permanent make-up inks
Notifying Country	Germany
Risk	Chemical
Measures adopted	Withdrawal of the product from the shelf by distributors
Reason	The product contains dangerous levels of nickel, arsenic and lead, not complying with the Council of Europe Resolution ResAP (2008)1.
Interpretation	The Council of Europe Resolution ResAP (2008)1 is an EU standard specifically designed for the safety of tattoo inks and PMU. It provides for composition and labelling of tattoo inks and PMU, risk assessment before their placing on the market, application and obligation to give notification. The concentration of lead and arsenic is less than 2ppm and nickel shall be below the detectable limit as per the above standard.

As the chemicals classified as CMR or skin sensitisers contained in tattoo inks pose a risk to human health that is currently not adequately controlled and needs to be addressed, the Commission asks ECHA to assess this risk and assess relevant socio-economic impacts and the need for European Union-wide action beyond any national measures already in place by preparing an Annex XV dossier for restriction. A recent report from the Commission's JRC provides a comprehensive overview of the regulatory situation in the Member States and in some 3rd countries, as well as of analytical measures that can be used to detect substances in tattoo inks.

It is estimated that further amendment shall be made to Annex XVII to REACH Regulation. In this case, specific limits for the composition of tattoo inks or restrictions on their use may be added. C&K Testing advises businesses should track on the latest news to make prompt response.

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