Surveillance of tattoo-related adverse events by the EU RAPEX system and by national monitoring.

Abstract

A resolution of the Council of Europe in 2008 (ResAP (2008)1) helped to define requirements and criteria for the safety of tattoos and permanent make-up in order to increase the level of consumer health protection for these products. Tattoo product usage is not without risk. These products are injected into the skin and may represent a risk to human health due to possible microbiological contamination and/or contamination by the presence of hazardous substances in the products. ResAP (2008) laid the foundation for the safety of tattoo products in Europe. This has generated awareness by European Member States and has encouraged them to adapt this resolution in their own law or to use it as a model to define their own regulation on tattoos. In order, to communicate on the hazard associated with these products between Member States and the European Commission, the European RAPEX system was created; this system will be further explained in this article. Finally, some Member States have created a specific vigilance system related to the adverse effects of tattoos. In this respect, a European national example will be presented.