Tattoos are very popular among Europeans. According to recent surveys, about one in 10 Europeans has a tattoo. In the European Union, tattoo and permanent makeup (PMU) products must comply with the safety and health requirements set by the General Product Safety Directive (GPSD). Currently, there is no specific legislation for such products. Manufacturers of tattoo and PMU products must identify which GPSD requirements apply and be fully compliant before accessing the EU market. In addition to GPSD requirements, there might be national provisions as well.
Some regulatory requirements to sell in the European Union concern chemical restrictions, labelling and Instructions for Use (IFUs), and testing methods.
Chemical requirements for tattoo inks and PMU
Tattoos and permanent makeup are similar practices, with permanent makeup applied mainly to reproduce designs that resemble makeup. For inks used in tattoos and PMU products, manufacturers must be aware of the measures on hazardous chemicals under the REACH Regulation (Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals). Since January 2022, there has been a limitation on the use of more than four thousand chemicals present in tattoo inks and permanent makeup. These restrictions apply to tattoo ink thinners as well.
What should labels and IFUs of tattoo and PMU products display?
Labels and Instructions for Use (IFUs) must be in the languages of the Member States where the product is sold, unless specified differently by the Member State. Overall, GPSD products must have labels displaying the manufacturer’s details, authorised representative information, lot number, and warnings. The IFUs must provide – together with manufacturer’s details, authorised representative information, and warnings – also safety instructions.
With the REACH restrictions on tattoo inks and PMU, labels must also include mixtures’ use, a list of ingredients, and relevant safety statements. Safety instructions must provide tattoo artists with information on how to use the ink and specify any precautions. If the package is too small, the list of ingredients, reference number, and statements can be included in the IFUs. Nonetheless, the marking “mixture for use in tattoos or permanent make-up” must be on the ink bottle.
Test methods for assessing compliance
Manufacturers of inks need to perform a toxicological assessment of the product. There are no standardised testing methods for tattoo inks. However, the Forum for Exchange of Information on Enforcement – a network of authorities for chemicals regulations – has developed a database with recommended analytical methods to check compliance with REACH restrictions.
Manufacturers of ink mixtures must be aware of the ingredients’ characteristics and their concentration. Typically, the supplier provides detailed information on the composition. If there is no clear information, the manufacturer can request the necessary information, refer to a different supplier, or test the mixture themselves.
Do you want to sell tattoo inks and permanent makeup products in the European Union and the United Kingdom? Contact us today for more information! If you want to sell regular makeup in Europe, you can check all EU and UK regulatory information on COSlaw.eu.
ECHA (2022). Webinar: REACH restriction of hazardous substances in tattoo inks and permanent make-up – Questions and answers. Retrieved on 18/04/2023.