EU alert · Safety Gate Serious risk Chemical products
Tattoo ink Icolor “Product for permanent makeup” — risk: chemical
Published in the Safety Gate weekly report: · Ref. A12/00112/20
Summary
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…
A Safety Gate alert means that national authorities found a serious or relevant risk and took measures. The same product may also be sold under other names or online.
Product
Tattoo ink — Icolor
- Brand
- Icolor
- Name / model
- Product for permanent makeup · Nude Pink
- Batch number(s)
- Ch.nr. 947919
- Category
- Chemical products
- 10 ml of pink ink for lip permanent make-up.
What is the risk?
- 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
- Type of economic operator taking notified measure(s): OtherCategory of measure(s): Withdrawal of the product from the market
- Date of entry into force: 05/11/2019
Source: Safety Gate — European Commission
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