Tattoo inks: Minimum requirements and test methods

Tattoo inks contain pigments and additives. According to the provisions of the German Food, Consumer Goods and Feed Code (Lebensmittel-, Bedarfsgegenstände- und Futtermittelgesetzbuch, LFGB), tattoo inks may not be used if there is any doubt as to their safety to health. Substances or mixtures for tattooing purposes are regulated in the REACH Regulation [entry 75 of Annex XVII of the REACH Regulation (Regulation (EC) No 1907/2006)]. However, there are as yet no binding criteria according to which a safety assessment of tat-too inks should be carried out. There is also a lack of suitable test methods and data for a health risk assessment. For example, little is known about adverse effects that may be associated with the injection of tattoo inks into the skin or about possible effects that may be induced in other organs. Therefore, the German Federal Institute for Risk Assessment (BfR) has developed minimum requirements for tattoo inks as well as test methods for manufacturers and distributors who are primarily responsible for the safety of their products.

Test methods are already available for the minimum toxicological and analytical requirements presented, so that they can be applied immediately. In addition, the BfR indicates requirements for which further research is necessary or methods would have to be developed, i.e., which are therefore not yet operable at present. The BfR minimum requirements presented below are intended to mark the basis for a future health risk assessment of tattoo inks and the start of a comprehensive consultation process with all stakeholders from science, industry, politics and the public. As pigments form the main component of tattoo inks, they are particularly important for the health risk assessment for the protection of consumers. Therefore, the BfR has particularly considered pigments in this statement. The Institute expects that already by applying the operable minimum require-ments described here, the level of protection of tattooed persons can be significantly increased compared to the current situation. On the one hand, the minimum requirements are intended to help identify tattoo pigments that are not suitable for tattoos. On the other hand, the use of pigments that meet the minimum toxicological requirements will reduce potential health risks according to the current state of science and technology. However, due to a lack of data, the BfR does not currently make any recommendations for use.

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The complete opinion can be found on the BfR website: https://www.bfr.bund.de/cm/349/tattoo-inks-minimum-requirements-and-test-methods.pdf

The BfR study can also be found on Open Agrar: https://doi.org/10.17590/20211014-085829

More Information and opinions from the BfR on tattoo inks and tattooing: https://www.bfr.bund.de/en/a-z_index/tattoo-130164.html#fragment-2

About the BfR

The German Federal Institute for Risk Assessment (BfR) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany. The BfR advises the Federal Government and the States (‘Laender’) on questions of food, chemical and product safety. The BfR conducts its own research on topics that are closely linked to its assessment tasks.