
Tattoo ink
Icolor · Product for permanent makeup
- Country of origin
- United States
- Notifying country
- Sweden
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
- 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
- Model / type
- Batch
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