Sweden/Medical Products Agency Läkemedelsverket

Are tattoo inks and products safe?

The Swedish OCCL and the department for Cosmetics, Medicinal Products and Narcotics supervision, at the Swedish Medical Products Agency Läkemedelsverket, focused on the safety of tattoo inks and  permanent make-up in 2018 and 2019. This supervisory operation was aimed at assessing compliance with national legislation on tattoo inks which is based on the Council of Europe resolution ResAP(2008)1on requirements and criteria for the safety of tattoo inks and permanent make-up.

The department for Cosmetics, Medicinal Products and Narcotics supervision endeavoured to support companies operating in the tattoo sector in Sweden, including manufacturers and importers of tattoo products and tattoo parlours, by informing them of the regulatory framework. Work focused on assessing the safety of inks through microbiological  and chemical analyses performed at an OCCL Network laboratory. The department also sought to provide information (newsletters, for example) and training for Swedish municipalities concerned with the quality and safety of cosmetic products and tattoo ink.

The Swedish OCCL supports many market surveillance studies initiated by the department for Cosmetics, Medicinal Products and Narcotics supervision by performing laboratory analyses to assess compliance with Regulation (EC) No. 1223/2009 on cosmetic products. Recently, in a major market surveillance study on tooth whitening products, the Swedish OCCL analysed hydrogen peroxide content by using an analytical method validated within the OCCL Network. The Swedish OCCL also performed the analysis of cosmetic products claimed perfume-free to search for potential allergens in a market surveillance study organised by the OCCL Network.

Learn more at [email protected].