{"lang":"en","id":10000351,"reference":"A12/00112/20","notification_type":"A12","published":"2020-01-21T14:34:54.362Z","modified":"2020-06-17T12:29:40.194Z","weekly_report":"Report-2020-4","title":{"text":"Tattoo ink","en":"Tattoo ink","translated":false},"name":{"text":"Tattoo ink","en":"Tattoo ink","translated":false},"name_specific":"Product for permanent makeup","brands":["Icolor"],"models":["Nude Pink"],"barcodes":[],"batches":["Ch.nr. 947919"],"category":{"key":"chemical.products","source_key":"product.category.chemical.products","label":"Chemical products","en":"Chemical products","translated":false},"category_other":null,"risks":[{"key":"chemical","source_key":"riskType.chemical","label":"Chemical","en":"Chemical","translated":false}],"risk_other":null,"risk_description":{"text":"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).","en":"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).","translated":false},"legal_provisions":{"text":"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.","en":"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.","translated":false},"description":{"text":"10 ml of pink ink for lip permanent make-up.","en":"10 ml of pink ink for lip permanent make-up.","translated":false},"packaging":{"text":"Transparent plastic bottle with dispenser nozzle and white screw cap.","en":"Transparent plastic bottle with dispenser nozzle and white screw cap.","translated":false},"origin_country":{"code":"US","label":"United States","en":"United States","translated":false},"notifying_country":{"code":"SE","label":"Sweden","en":"Sweden","translated":false},"counterfeit":null,"sold_online":null,"online_trader":null,"professional_use":false,"corrigendum":null,"measures":[{"category":{"key":"measure.category.withdrawal.of.product.from.market","source_key":"measure.category.withdrawal.of.product.from.market","label":"Withdrawal of the product from the market","en":"Withdrawal of the product from the market","translated":false},"details":null,"type":{"key":"measure.type.voluntary","source_key":"measure.type.voluntary","label":"Voluntary measures","en":"Voluntary measures","translated":false},"taken_by":{"key":"measure.operator.other","source_key":"measure.operator.other","label":"Other","en":"Other","translated":false},"effective":"2019-11-05"}],"photos":[{"id":10003123,"thumb":"https://cdn.weblocally.com/safety-gate/10000351/10003123-t.webp","full":"https://cdn.weblocally.com/safety-gate/10000351/10003123-f.webp"}],"url":"https://safety.weblocally.com/en/alert/10000351","api_url":"https://safety.weblocally.com/api/v1/alerts/10000351?lang=en","source_url":"https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10000351","license":"Data © European Union, Safety Gate. Reuse authorised provided the source is acknowledged."}