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CTL® Bielefeld GmbH:
10 April 2013

Italy - Heavy Metals once again.

We have been notified by the Italian Authorities that Heavy Metals are being analysed using decomposition (i.e. total count) and the highest permitted values are those mentioned in ResAP(2008)1.

These values are as follows:

Element - maximum ppm 

Arsenic (As)  - 2 ppm

Barium (Ba) - 50 ppm

Cadmium (Cd) - 0.2 ppm

Cobalt (Co) - 25 ppm

Chromium (Cr) (VI)6 - 0.2 ppm

Copper (Cu) (soluble) - 25 ppm

Mercury (Hg) - 0.2 ppm

Nickel (Ni) - As low as technically achievable

Lead (Pb) - 2 ppm

Selenium (Se) - 2 ppm

Antimony (Sb) - 2 ppm

Tin (Sn)  - 50 ppm

Zinc (Zn) - 50 ppm

This procedure has negative influences:

1. Barium Sulphate is forbidden in Italy. You may enjoy a healthy barium meal at your doctors before the x-ray of your digestion system, but it is not allowed in Tattoo or Permanent Make-Up colorants.

2. Iron Oxides, proven for years on end, are no longer permitted, because the permitted values of nickel will always be exceeded.

3. No metal equipment should be used when manufacturing tattoo products, small amount of metals due to abrasion will exceed the limits.

4. Copper Phthalocyanine products should not be used (greens, blues etc.).

5. Water used for production should be tridestillate. De-ionised is no longer sufficient.

6. Titanium Dioxide should not be used as it always contains Barium Sulphate as an impurity.

7. Zinc or Zinc-Coated vessels are not to be used in production. Zink will erode and lead to higher values than permitted.

8. Should there still be lead pipes in your building, get rid of them. You are bound to be above the levels permitted in Italy.

9. Still got copper pipes and tubes in the building? Throw them out and have them replaced with plastic materials. There may then be higher amounts of phthalates in your products (softeners), but these are not forbidden in Tattoo- and Permanent Make-Up in Italy.

10. In Oncology the use of Iron Oxide Pigments is no longer allowed, although proven for decades with no adverse effects. If you have lost your breast due to cancer and need a remake of your nipples using technology based on pigmenting, then go to a different country, because this is now forbidden in Italy. 

In Italy Tattoo- and Permanent Make-Up are not regulated by the EU Cosmetics Directive. What they are regulated by is unknown. It seems ResAP(2008)1 is being used in whatever way seems feasible. 

CTL has conducted a lot of investigations into the content of heavy metals in the mentioned products, by extraction and also by total decomposition. If the limits are to be set using ResAP(2008)1 while using total decomposition then this will leave hardly any products on the market. All the hard work of the past years was for nothing.

A possible solution: put a label with "not for sale in Italy" on your products. Of course the amount of fakes and imports from the Far East are going to increase substantially. What does it mean for the customers of Tattoo Studios? Tattooing and Permanent Make-Up are becoming more dangerous. All of these regulations in Italy are a setback for the hospitals dealing with breast cancer. You may have your breast removed in Italy but further cosmetic treatment will be outside of the country.

Of course the products could be diluted by the power of ten to meet the requirements of heavy metals in Italy. This means you have your lips touched up 10 times instead of once. In order to get a visible tattoo you go not just once but 10 times to your tattoo artist. Is this a feasible solution? We do not think so. Does it make sense? We do not think so.

All in all this is a very neagtive development. ResAP(2008)1 is surely not to be interpreted in this way. Why the Italian Authorities have opted for this method whilst using the limits denoted in ResAP(2008)1 is beyond our understanding. The problem is that there is no described method for the analysis of heavy metals in ResAP(2008)1. This is why the authorities are using their proven method for food analysis, i.e. decomposition. Would it be too much work to devise a new and more sensible method? It seems so.

The biggest loser in this development is the end-user. 

10 April 2013. © CTL® Bielefeld GmbH

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Contact - Bielefeld

CTL® Bielefeld
Chemisch-Technologisches Laboratorium
Krackser Str. 12
33659 Bielefeld

Tel. +49 521 400 82 89 0