Safety of tattoos and permanent make-up: a regulatory view

Abstract

The continuous increase in the popularity of tattoos and permanent make-up (PMU) has led to substantial changes in their societal perception. Besides a better understanding of pathological conditions associated with the injection of highly diverse substances into subepidermal layers of the skin, their regulation has occupied regulatory bodies around the globe. In that sense, current regulatory progress in the European Union is an exemplary initiative for improving the safety of tattooing. On one hand, the compilation of market surveillance data has provided knowledge on hazardous substances present in tattoo inks. On the other hand, clinical data gathered from patients enabled correlation of adverse reactions with certain substances. Nevertheless, the assessment of risks remains a challenge due to knowledge gaps on the biokinetics of highly complex inks and their degradation products. This review article examines the strategies for regulating substances in tattoo inks and PMU in light of their potential future restriction in the frame of the REACH regulation. Substance categories are discussed in terms of their risk assessment and proposed concentration limits.

Tattoo toxicology, an upcoming complex scientific issue

“…In the February issue of this journal Giulbudagian et al ( 2020 ) reviewed current regulatory considerations in the European Union. An exemplary initiative for improving the safety of tattooing is warranted.…”

“…Nevertheless, the assessment of risks remains a challenge, owing to knowledge gaps on biokinetics of highly complex inks and their degradation products. Giulbudagian et al ( 2020 ) point to strategies for regulating substances in tattoo inks in the light of potential future restrictions in the frame of the European REACH regulation.…”

Einfluss von Permanent Make-up auf die Meibomdrüsen und den Tränenfilm

“…Auch eine direkte mechanische Verletzung der Meibomdrüsen bei zu großer Eindringtiefe ist im Prinzip vorstellbar [18]. Darüber hinaus sind die Inhaltsstoffe der applizierten Tinte nicht standardisiert und können verschiedenste Substanzen bis hin zu Arsen enthalten [32,[34][35][36].…”

Safety of Tattoos and Permanent Make up (PMU) Colorants

“…Tattoos have become a very popular form of body and face art in the last two decades. There is evidence that 12 % of Europeans have at least one tattoo on their body especially in the 18-35 age group [1][2][3]. The most common tattoos are usually made with black ink or have various colors located on almost all areas of the human body.…”