On 4th January 2022, Commission Regulation (EU) 2020/2081 of 14 December 2020 came into force. This Regulation is binding in its entirety and directly applicable in all Member States. Tattoo and permanent make-up inks that do not comply with the criteria set out in this Regulation may not be placed on the market or used from the above mentioned date (in the case of restrictions concerning blue pigment 15:3 and green pigment 7, from 4 January 2023).
Tattoo inks and permanent make-up are considered personal care products, and in Spain are regulated by Royal Legislative Decree 1/2015 of 24 July 2015, which approves the revised text of the Law on guarantees and rational use of medicines and health products, as well as by the second additional provision of Royal Decree 1599/1997 on cosmetic products.
Within personal care products, these inks are classified as cosmetic products, defined as those products for application to the skin that do not have the legal consideration of cosmetics, medicines or medical devices, due to their composition, indications, mechanism of action, application or duration.
Its marketing as a cosmetic product in Spain requires prior authorisation from the Spanish Agency for Medicines and Health Products (AEMPS). For this purpose, the technical documentation relating to the product must be submitted, including safety-related documentation: technical information, stability, sterility, analytical information and toxicological information.
Regulation 2020/2081, which was published on 14 December 2020, amends Annex XVII of the above-mentioned Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards substances contained in permanent make-up and tattoo inks, and adds entry 75. Its application is mandatory in all its elements and directly applicable in each Member State.
