Alert number: A12/00112/20
Name: Product for permanent makeup
Batch number / Barcode: Ch.nr. 947919
Type of alert: Serious
Category: Chemical products
Type / number of model: Nude Pink
Risk type: Chemical
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).
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 by economic operators: Withdrawal of the product from the market (By: Other)
Description: 10 ml of pink ink for lip permanent make-up.
Country of origin: United States
Alert submitted by: Sweden
Date Recalled : 24/01/2020