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A12/00112/20

Tattoo ink

Icolor · Product for permanent makeup

Country of origin
United States
Notifying country
Sweden
Open the alert on the European Commission website ↗

What is the danger

The product contains the aromatic amines 4-methyl-m-phenylenediamine and o-toluidine (measured values up to: 1.5 mg/kg and 1.0 mg/kg, respectively), nickel as well as an excessive amount of lead (measured values: 47 mg/kg and 4.5 mg/kg, respectively).

Requirements breached

4-methyl-m-phenylenediamine is a skin sensitiser, may cause cancer and might induce mutations and/or affect fertility. O-toluidine is genotoxic and may cause cancer. Nickel can cause skin irritation, induce sensitisation or elicit allergic responses. Lead is harmful to human health, accumulates in the body, can cause developmental neurotoxicity and may also affect breast-fed or unborn children. The Council of Europe Resolution ResAP (2008)1 on requirements and criteria for the safety of tattoos and permanent make-up, recommends that aromatic amines with carcinogenic mutagenic, reprotoxic or sensitising properties should neither be present in tattoos and permanent make-up products nor released from azo-colourants, that the levels of nickel are as low as technically achievable and that impurities of lead do not exceed 2 ppm.

Measures taken

  1. Withdrawal of the product from the market Voluntary measuresTaken by: OtherIn force from: 5 November 2019

Product

Description
10 ml of pink ink for lip permanent make-up.
Packaging
Transparent plastic bottle with dispenser nozzle and white screw cap.
Brand
Icolor
Model / type
Nude Pink
Batch
Ch.nr. 947919

Original source

Data comes from the official Safety Gate system of the European Commission.

Alert number
A12/00112/20 ↗
Weekly report
Report-2020-4
Published
21 January 2020
Modified
17 June 2020

© European Union, Safety Gate · https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10000351

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