Tattoos

The CNSC at ISS acts as REACH-CLP national reference laboratory (NRL) for the activities of the Italian network of REACH/CLP official control laboratories, and it is involved in the development and validation of new analytical methods for the enforcement of the REACH restriction on tattoo and permanent make-up (PMU) inks. Regulation (EU) No. 2081/2020 amends Annex XVII of Regulation (EC) No 1907/2006 (REACH) with entry No 75 on tattoo and PMU ink. This restriction is applicable after 4th January 2022 and covers a large number of chemical substances (over 4000 chemical substances). It represents the first regulatory measure on a Union-wide basis on tattoo inks, after several years of fragmented legislative frameworks across EU Member States. 

According to this restriction, concentration limits have been set for substances in Appendix No 13 and group of substances on the basis of their classification under Regulation (EC) No 1272/2008 (CLP) or the relevant conditions in Annexes II and IV to Cosmetic Product Regulation (Reg. (EU) No 1223/2009). All mixtures used for tattooing and PMU placed on the EU market shall be compliant with REACH Regulation, which also implies a proper CLP labelling of inks. 

CNSC is also involved in the official controls analysis on tattoo or PMU inks available on the Italian market for the determination of chemical substances with the aim of assessing the compliance with REACH restriction. As established by the Accordo Stato e Regioni/PA (No 88/CSR, 07/05/2015), CNSC performs the confirmatory analysis for those samples that were not compliant with REACH restriction at first analysis carried out by another national official laboratories during official controls (market surveillance, controls requested by Competent Authorities). 

Substances of interest are those indicated in the restriction entry No 75, which might pose a health risk to those undergone tattoo or PMU application. The development of a new analytical method, when applied to a new typology of sample is a complex process, which requires several experimental tests and optimisation of different parameters. The fitness for purpose of newly developed methods is evaluated on the basis of the performance characteristics, which are estimated according to international standards during the validation study. Once developed and validated, the methods are transferred to the laboratories belonging to the REACH-CLP national network for their use in the official controls.