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CTL® Bielefeld GmbH:
7 November 2012

Heavy Metals in Colourants

There is a discussion in several countries of the EU concerning heavy metals in Tattoo- and PM-Colourants. According to ResAP(2008)1 the wording is "impurities" of heavy metals. Does this mean bio-available, i.e. soluble metals or does it mean the total amount irrespective of wether the metals are part of a chemical compound or not? 

Three of the listed heavy metals are of concern: Barium, Nickel and Copper. If a total count (using decomposition as the work-up method) of heavy metals is conducted the limits can be exceeded quite substantially. Does this make sense? If for example the total count of barium would be more than 50 ppm the colourant could be forbidden. This does not make sense at all, because Barium Sulfate is a product allowed in all colourants and cosmetics. It is totally harmless and used in medicine in large amount as a "barium meal" for x-rays etc. But if the barium was bio-available it would be harmful. This we would class as an impurity. The same can be said for nickel and copper. Copper based pigments are allowed, but a total count analysis would reveal several hundred ppm of copper, meaning the colourant is not allowed to be sold in Europe. But the copper is not bio-available in such products, it is not even soluble.

The problem behind this is that different analytical methods have to be used if testing for total count or bio-availability. 

We believe the wording "impurity" means bio-available, but some authorities see this in a different light. It once again means that there could be different laws and regulations in the various countries of the EU due to seeing the meaning of impurities differently. It also means higher costs for the analysis of colourants as possibly two methods will have to be used depending on which country the product is to be sold in.

If decomposition is to be used as a method it would mean Rubies and Emeralds in powder form being banned because they contain Chromium. Does this really make sense? You decide!

We do hope a unique agreement can be reached in all European countries in the near future.

7 November 2012. © CTL® Bielefeld GmbH

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