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16 October 2013

New Law in Denmark - Summary

We have gone through the details and this is our summary:

Forbidden Amines:

The list of banned amines is NOT identical to the list of ResAP(2008)1. The ResAP(2008)1 list contains 22 amines. One minor difference is aniline. This is a minor difference with great influence. As approx. one third of all tattoo inks will produce aniline on reduction, about a third of all inks will be immediately banned as from 1st January 2014. It would have been much better to have banned free aniline, not aniline created by reduction.

There are 22 amines which are classed as harmful and they are even banned for textiles. The ResAP(2008)1 list contains these 22 amines.  It is not clear why the Danish Law has only included 8 of these. They are not only harmful but also quite common in several pigments.

Risk Assessment:

The required risk assessment will cause serious problems. No matter how pure the pigments used are, none have been produced for the use in Tattoo Colorants. Therefore, there is absolutely no information available to conduct an adequate and sensible risk assessment. In this case the MSDS is useless as it contains no relevant information for the use of the pigment in tattoo colorants or under the skin. Animal tests are forbidden in the EU and at present there are no reliable alternatives.

Limits and Methods:

These belong together, no limits without a defined method. The safety of toys in the EU is regulated by EN 71 - this not only includes limits but also methods. Without these methods the safety of toys in the EU could not be regulated.

All in all we cannot see a professional approach in the Danish Law.

16 October 2013. © CTL® Bielefeld GmbH

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