Safety of intradermal inks

Although the use of tattoos and permanent make-up (PMU) has become increasingly common across all sections of society, the practice still carries intrinsic risks. Cases of intradermal inks becoming microbiologically contaminated are well documented, and protocols for the toxicological risk assessment of tattoo inks and PMUs require further development by the international scientific community. With its scientific expertise, the EDQM aims to support and guide the work of health authorities and manufacturers concerned with the risk assessment of intradermal ink products.

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Toxicological assessment

Many substances, impurities and contami­nants present in inks may have harmful effects on human health, either as single ingredients or by interaction. The toxicological assessment of inks requires a different approach to that used for traditional cosmetic products due to their intradermal, rather than dermal, route of exposure. In addition, market surveillance for tattoos is rendered more complex by the facts that the typical ink may consist of up to 15 different ingredients and that the choice of ingredients allowed in tattoo inks is very wide.

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The EDQM on intradermal inks

In line with the Committee of Ministers’ Resolution AP (2008) 1 on tattoos and permanent make-up, the work on the safety of intradermal inks was carried out by the experts of the ad hoc Group on Safety of Tattoos and Permanent Make-up of the EDQM’s Consumer Health Protection Committee. The work of the EDQM experts supports national authorities concerned with risk as­sessment and guides ink manufacturers in assessing the specific risks of their products.

In October 2017, the EDQM published a compilation of safety and documentation requirements for tattoos and permanent make-up, which implements the recommendations of Council of Europe Resolution AP (2008) 1 on tattoos and permanent make-up.

 

All activities in this field are driven by the EDQM’s Consumer Health Protection Committee (CD-P-SC) composed of experts nominated by the member states.

The other EDQM publications in the field of consumer health protection can be found here.

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More information on this topic

The US Food and Drug Administration (FDA) presents key questions for consumers to consider before getting a tattoo. The FDA’s Office of Cosmetics and Colors explains what to do in the case of an infection or other reaction and provides information on the difficulties to remove a tattoo. For more information, please click here.

The Danish Environmental Protection Agency (EPA) published a report on allergy and tattoo in 2017 following the recommendations on the safety of tattoo ink given in 2014. Already in 2012, they analysed 65 tattoo inks and identified chemical substances such as lead, nickel, cadmium, PAH, aniline and o-anisidine. For more information, please click here.