Page 29 - An Introduction to Laser Tattoo Removal
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Chapter 2 – Fundamentals of Laser Tattoo Removal v1.0
The American FDA have chosen not to approve any inks for injection into the skin, nor to regulate the activities of tattoo artists or PMU specialists. Read an interesting article on this subject here.
An excellent EU study in the safety of tattoo inks was conducted in 2016. The published report “Safety of tattoos and permanent make-up” revealed some concerns across the EU Member States and stated the following Key Conclusions:
“This report provides an up-to-date snapshot of the tattoo/PMU phenomenon. Due to the wide variety of legislative frameworks across Member States, some products can be sold in some MSs but not in others, because of different chemical or authorisation requirements, thus resulting in a fragmentation of the internal market. This might also have an impact on the protection of consumers’ health.
Tattooing is an increasing fashion phenomenon which already involves over 60 million Europeans. In parallel, removal procedures are becoming more frequent.
Adverse health effects linked to the application and removal of tattoos are reported in the literature; in addition, the potential long term effects of exposure to the chemicals in the inks are still unknown and might become critical with time due to the high number of tattooed people. To bring light into this unknown area, even if costly, epidemiological studies and research on the fate of ingredients in the whole body are needed. In particular, prospective cohort studies should be conducted to investigate the correlation between tattoos and possible carcinogenesis.
Good Manufacturing Practices for manufacturing tattoo/PMU inks, as well as guidelines for their risk assessment should be developed. A full risk assessment of the ingredients, in particular colorants, used in tattoo/PMU inks is needed, including their phototoxicity, absorption level, distribution, metabolism and excretion, as well as Derived No Effect Level (DNEL), data which are largely missing so far.
Further to this, it needs to be assessed whether the risks arising from the use of certain chemicals in tattoo/PMU inks are adequately controlled or need to be addressed by an EU measure. In the absence of this risk assessment, for azo pigments a precautionary approach would consist in not using those that contain in their structure aromatic amines classified as Carcinogenic, Mutagenic or Reprotoxic (CMR).
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Chapter 2 LEVEL A Laser Tattoo Removal
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