Toxicological Data:

For each ingredient, all available toxicological data have to be provided (e.g. by public safety dossiers, REACH registration dossiers published on the website of the European Chemical Agency (ECHA), scientific literature or other). The minimal toxicological requirements for tattoo ink ingredients must therefore be seen in addition to the requirements set out in paragraph 3.1 and 3.2. If any toxicological property is known for which threshold concentrations (Minimal Effect Levels, or similar) exist, it shall not be used in a concentration able to harm the health during their application as tattoo / PMU ink. A guidance document for assessment of safe us in tattoo ink with the appropriate safety factors and read-across from other routes of exposure shall be provided by the authorities.

Since the majority of substances in tattoo inks are known from other fields of industrial, medical or cosmetical applications, a vast amount of data is already available. Since tattooing and permanent make-up is a voluntary exposure, this does not justify additional animal testing. The minimal requirement for all of these substances are:

• irritation and corrosion in vitro (skin, mucous membranes);
• sensitization in vitro, including pre-treatment with UVA (AOP);
• phototoxicity (for substances absorbing light between 400-800 nm, e.g. pigments);
• investigation of light stability
• bacterial and mammalian genotoxicity in vitro 

Toxicological data for safety assessment should be obtained from test methods using guidelines whenever they exist (for example, Organisation for Economic Co-operation and Development OECD, European Union).