Tattoo or permanent make-up ink

Requirements breached

The ink contains arsenic (measured value: 5.47 mg/kg), lead (measured value: 4.73 mg/kg), cobalt (measured value: 72.3 mg/kg), nickel (measured value: 91.1 mg/kg) and zinc (measured value: 90.07 mg/kg). Arsenic is carcinogenic, exposure to lead is harmful for human health and can cause developmental neurotoxicity and nickel can cause skin irritation and induce sensitisation or elicit allergic responses. The Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up recommends that the levels of arsenic and lead in tattoo inks do not exceed 2 mg/kg, that the level of cobalt in tattoo inks does not exceed 25 mg/kg, that the content of nickel in tattoo inks be as low as technically achievable and that the level of zinc in tattoo inks does not exceed 50 mg/kg.

Measures taken

1. Ban on the marketing of the product and any accompanying measures Compulsory measuresTaken by: OtherIn force from: 19 April 2017

Product

Description

Ink for tattoos or permanent make-up.

Brand

Derma International

Model / type

#9 Black

Batch

Batch: X2009777; Exp. 12/18