To protect European citizens, thousands of hazardous chemicals that could potentially be used in tattoo inks and permanent make-up (both here after referred to simply as tattoo inks) are restricted in the EU under the Reach regulation, Reach Annex XVII entry 75. Entry 75 in Annex XVII came into force January 4th, 2022. For Pigment Blue 15:3 and Pigment Green 7 entry 75 no. 1 applied from January 5th, 2023.
The restriction covers different categories of substances that are considered to pose risks to human health if they are used for tattooing purposes.
The restriction covers substances that are classified according to the CLP Regulation (EC) No 1272/2008 as causing or suspected of causing cancer, genetic mutations, and adverse effects to human reproductive function, fertility, or foetal development and growth as well as skin sensitizers, skin corrosives, skin and eye irritants, and eye damagers. The restriction also covers substances listed in Annex II (a list of forbidden substances) and substances with specific restrictions according to Annex IV (colourants) to Regulation 1223/2009 (EC) as well as substances listed in appendix 13 to Reach annex XVII entry 75.
Beyond restrictions on the inclusion of hazardous substances above limit values, there are also labelling requirements for tattoo inks and for the user of the tattoo ink (the professional carrying out the tattoo) to provide information to the person receiving treatment with the tattoo ink.
The labelling elements to be placed on the mixture are:
The mandatory statement "Mixture for use in tattoos or permanent make-up"
A reference number to uniquely identify the batch
A list of ingredients in accordance with the nomenclature established in the glossary of common ingredient names pursuant to Article 33 of Regulation (EC) No 1223/2009, or in the absence of a common ingredient name, the IUPAC name. In the absence of a common ingredient name or IUPAC name, the CAS and EC number, by decreasing order (weight or volume)
Special labelling for compliant levels of Ni, Cr (VI) and pH regulators
Instructions for safe use.
Where necessary because of the size of the package, the information listed above, except for the mandatory statement, shall be included instead in the instructions for use. The label shall be in the national language(s) unless the Member State decide otherwise.