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5 December 2012

Nickel again

The Facts from ResAP(2008)1 concerning Heavy Metals:

1 - The wording is "impurities" of Heavy Metals incl. Nickel

2 - The limit for nickel is "as low as technically achievable"

3 - The Analytical Method : none defined

The Problems caused:

1 - Impurities can be defined as bio-available or total amount, even if not plausible

2 - This is not a real limit; is it zero or is it 100 ppm? How can this limit be dealt with or defined as a number?

3 - An indefined analytical method leads to different Labs, including the authorities, using different methods from other fields. These are not necessarily correct or truely applicable to Tattoo- or Permanent Make-Up Products

At present the Authorities have been using the method "decomposition/total count" which is normal practise for food analysis. They have found concentrations of Nickel above zero in several cases. Due to many discussions, also with CTL, and the mentioned uncertainties no colorants have been withdrawn from the market due to these findings. This leaves room for hope and shows how careful some authorities are. We are quite impressed!

But what is the real problem on the market?

CTL has been searching for Iron Oxide pigments of the highest quality on the World Market. The best Iron Oxide Pigments we found (classed as high purity in the trade) still contains 60 ppm Nickel. If one assumes the final product contains 30% of this pigment (which is quite realistic) then the limit which is "technically achievable" acc. to ResAP(2008)1 would be 20 ppm. The majority of Iron Oxide pigments contain 150ppm or more Nickel, even Synthetic Iron Oxide pigments contain such high amounts.

Irrespective of wether we are talking about an impurity or not and irrespective of the method used 20ppm Nickel would be the best any manufacturer could achieve at present. This is a limit which could and should only be used for anorganic pigments where Iron Oxide pigments are being used. For colorants on the basis of organic pigments the limits could be set to zero and cause no problems.

What has CTL done?

During the past weeks CTL has been analysing many Tattoo- and Permanent Make-Up Colorants using decomposition.

Scenario 1 - The limit for nickel is defined as zero and decomposition/total count is the used method for ALL colorants. This would lead to the following:

Approx. 75% of all Permanent Make-Up Colorants would have to be withdrawn from the market. They are nearly all based on Iron Oxide pigments.

Approx. 20% of Tattoo Colorants would have to be withdrawn

Scenario 2 - The Limit for anorganic based colorants (i.e. Iron Oxide based pigments) and also for organic-based colorants is 20ppm and the method used is decomposition/total count. This would mean:

Approx. 20% of all Permanent Make-Up Colorants would have to be withdrawn from the market

Approx. 5 - 10% of Tattoo Colorants would have to be withdrawn

Conclusion

It is feasible to set a limit of 20ppm for Nickel for anorganic based pigments when using the method decomposition/total count. This limit is "technically achievable" and in accordance with ResAP(2008)1. The manufacturers would have to use the best Iron Oxide pigments on the market, i. e. those classed as "high purity pigments".

A limit of zero could be used with the mentioned method for Colorants based on organic pigments. This would also be in accordance with ResAP(2008)1. The established method decomposition, which is used in food analysis, could be used by the authorities. Why some tattoo colorants contain higher levels of Nickel will not be discussed here.

It is necessary to distinguish between organic and anorganic pigments before analysing the product. There would be different limits based on wether the pigments are organic or anorganic. Different limits based on different ingredients are not uncommon and easy to handle.

5 December 2012. © CTL® Bielefeld GmbH

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