European companies that manufacture tattoo inks and permanent makeup have a few days to adapt to Commission Regulation (EU) 2020/2081 of December 14th, 2020, which will come into force on January 4th and which amends Annex XVII of Regulation 1907/2006 of the European Parliament and of the Council on the registration, evaluation, authorization and restriction of chemical substances and mixtures with regard to substances contained in tattoo inks or permanent makeup.
The new regulation, called REACH, bans ingredients such as isopropanol alcohol, which can be found in most pigments on the market. The regulations establishes the restriction of the use of more than 4,000 hazardous chemical substances and introduces maximum concentration limits for individual substances or groups of substances used in tattoo inks or permanent makeup, among which it highlighted certain dyes, metals or methanol.
Several European tattoo artists are concerned about the new rules. They fear it could have a sever impact on their business. In the case of blue pigment 15:3 and green pigment 7, the new regulations will be applied at European level as of January 4, 2023, because ink manufacturers complained those pigments will prove particularly difficult to replace. According to Politico, one EU-wide petition called “Save the Pigments” complains about an upcoming ban on two ink colors. It has collected more than 170,000 signatures so far.
This regulation also requires that mixtures intended for tattoos and permanent makeup must mention this use on their labels, which, in turn, must include a list of the ingredients and the relevant safety declarations.
To ensure long-term protection of humans, regulation 2020/2081 limits chemicals that are classified in the EU as carcinogens, germ cell mutagens or reproductive toxicants of various categories, but it excludes substances of this type classified due to inhalation exposure only.
Skin sensitizers, skin corrosives, skin and eye irritants of different categories as well as certain substances that cause serious eye damage are also restricted, as are substances prohibited in cosmetic products and substances prohibited for use on mucous membranes and eyes under the Cosmetic Products Regulation (EC) 1223/2009.