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Tattoo inks become safer

06/2009, 30.04.2009

The Tattooing Agents Ordinance enters into force on 1 May 2009

Whether it’s a butterfly on your shoulder or a snake on your upper arm, tattoos are still very popular. Sometimes, however, the pretty images on the skin can cause inflammation or allergies. From 1 May 2009 onwards consumers are afforded better protection. With the entry into force of the German Tattooing Agents Ordinance, special statutory provisions have been introduced for the first time for agents for tattooing and permanent make up. Besides the health requirements to be met by these agents, they also encompass labeling provisions. "In order to ensure that tattooing agents are safe in the long term, scientific test criteria must be elaborated", says BfR President Professor Dr. Dr. Andreas Hensel. They are the prerequisite for the drawing up, in an approval procedure, of a positive list of substances for products of this kind.

Up to now, there were no specific provisions, only general provisions for the safety of substances in tattooing agents and permanent make-up. Unlike cosmetics that are applied to the skin, tattooing agents containing inks, solvents and preservatives as well as impurities are introduced into the skin. From there they can, for instance, reach the blood system or trigger immune reactions. There has been scarcely any research so far into the effects of these substances in the body. Hence, it is all the more important for tattooing agents and permanent make-up to only contain inks that do not constitute a health risk. BfR had, therefore, recommended that until there was statutory regulation of the components of tattooing agents, only those inks should be used that comply with the requirements of the European Cosmetics Directive and the German Cosmetics Ordinance and are thus approved for use in cosmetics.

The Tattooing Agents Ordinance now provides a binding regulatory construct for tattooing and permanent make-up agents. Furthermore, the use of many harmful substances is banned. For instance, carcinogenic azo dyes and allergenic p-phenylenediamine may not be used. BfR is of the opinion that in future the Ordinance should contain a list of approved components. The prerequisite for this are test criteria for the risk assessment of substances. To this end, a list would first have to be drawn up of the inks and other substances used in tattoos and permanent make-up. There is a need for research into how these substances are distributed in the body and the effect they have. Moreover, the manufacturers of tattooing agents would have to provide safety data on their products, including details of substance purity, auxiliary substances and stability. Toxicological data would also be needed on genotoxicity, irritation of the skin and mucosa, allergy potential and any cleavage products that could be formed. A risk assessment of the substances should at least meet the safety requirements for dyes in cosmetics and hair products. Studies on the subcutaneous effect of dyes would have to be conducted and the findings taken over into the assessment.



Date Title Size
BfR Opinion No. 012/2009
Requirements for the safety assessment of tattooing agents 31.6 KB