The Rapid Alert System for Non-Food Products (RAPEX)

Alert number: A12/00099/20

Product:  Tattoo ink

Name: Permablend

Barcode:  00815579028849
Batch number:  Batch: B20209, Best By: 08/28/21, LOT: PBTDBL181508

Type of alert: Serious

Category: Chemical products

Brand: Tina Davies

Type / number of model:  2 Blonde, REF: PBTDBL 1/2

Counterfeit: UNKNOWN

Risk type: Chemical
The product contains the aromatic amines o-anisidine and 4-methyl-m-phenylenediamine (measured values: 6.2 mg/kg and 0.77 mg/kg, respectively) and an excessive amount of barium and nickel (measured values: 1200 mg/kg and 2.8 mg/kg, respectively) as well as polycyclic aromatic hydrocarbons (PAHs)(measured total value: 1.3 mg/kg). / 4-methyl-m-phenylenediamine is a skin sensitiser and, as o-anisidine and PAHs, may cause cancer. Barium can be easily absorbed and have toxic effects on the body impairing muscle, kidney and heart activity, leading to arrythmia, paralysis or gastrointestinal alterations. Nickel can cause skin irritation, 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 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 and that PAHs do not exceed 0.5 mg/kg, barium 50 mg/kg and nickel as low as technically achievable.

Measures taken by economic operators: Withdrawal of the product from the market (By: Retailer)

Description:  16 ml of yellow tattoo ink.

Packaging description:  The product is sold in a transparent plastic bottle with dispensing nozzle and screw cap.

Country of origin: United States

Alert submitted by: Sweden