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Parliamentary question - E-013827/2013(ASW)Parliamentary question

Answer given by Mr Mimica on behalf of the Commission

As a general rule, all tattooing products placed on the EU market and made available for purchase by consumers must be safe and comply with the provisions of the General Product Safety Directive 2001/95/EC[1]. Several Member States have adopted regulations regarding tattooing products that were notified to the Commission and other Member States in accordance with the information procedure set up by Directive 98/34/EC[2]. Several Member States also have called for the establishment of specific EU legislation on tattoo products. As mentioned in its answer to the Question E-011055/2013 the Commission is currently assessing the feasibility of this request.

As indicated in its answer to Question E-004078/2010, the Commission presented in September 2012 a proposal for a new Regulation to revise the medical device legislation[3], which contains an exhaustive list of implantable or other invasive products which shall be considered medical devices, regardless of whether or not they are intended to be used for a medical purpose. Tattoo inks were not included in this list as the vast majority of tattoo inks are intended for aesthetic purposes only and hence do not fit into the concept of a medical device which generally requires a medical purpose.

The Commission is aware that some laboratories provide test certificates regarding tattoo inks based on the Council of Europe Resolution ResAP (2008)1[4] on requirements and criteria for the safety of tattoos and permanent make-up. There is currently no EU-wide certification or authorisation system for tattooing products. The establishment of such a system could only be considered in the context of an assessment of the need and feasibility of EU wide rules in the field of tattoos.

OJ C 265, 13/08/2014