EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2016. Scientific opinion on malachite green in food.:EFSA-Q-2014-00815

In: EFSA Publication 2016 , EFSA CONTAM Panel (EFSA Panel on Contaminants in the Food Chain), 2016. Scientific opinion on malachite green in food. EFSA-Q-2014-00815 . the EFSA Journal , no. 4530 , vol. 14(7) , Europen Food Safety Authority , Parma, Italy . https://doi.org/10.2903/j.efsa.2016.4530

Open Access

Abstract

Malachite green (MG) has been used globally in aquaculture but is not registered for use infood-producing animals in the European Union. The European Commission requested EFSA to evaluatewhether a reference point for action (RPA) of 2 lg/kg for the sum of MG and its major metaboliteleucomalachite green (LMG) is adequate to protect public health. Available occurrence data were notsuitable for a reliable exposure assessment. The hypothetical dietary exposure was calculated,considering the RPA as occurrence value for all types of fish, fish products and crustaceans. Meandietary exposure across different European dietary surveys and age classes would range from 0.1 to5.0 ng/kg body weight (bw) per day. For high and frequent fish consumers, the exposure would rangefrom 1.3 to 11.8 ng/kg bw per day. Both MG and LMG induced formation of DNA adducts in livers ofrats and/or mice, and of micronuclei in mice. LMG also induced cII transgene mutations in mouse liver.MG caused a small, not dose-related, increase in thyroid gland follicular adenomas and carcinomas,and of mammary gland carcinomas in female rats. LMG caused an increase in hepatocellular adenomasand carcinomas in female mice. Both MG and LMG may be considered as carcinogenic and asgenotoxic in vivo. A lower 95% confidence limit for a benchmark response of 10% extra risk (BMDL 10 )of 13 mg/kg bw per day for hepatocellular adenomas and carcinomas was selected as reference pointfor neoplastic effects. For non-neoplastic effects, a lower 95% confidence limit for a benchmarkresponse of 5% extra risk (BMDL 05 ) of 6 mg/kg bw per day was selected for the effect of MG on liverweight and of LMG on body weight. The margins of exposure were 1.1 9 10 6 or greater for neoplasticeffects and 4.9 9 10 5 or greater for non-neoplastic effects. The CONTAM Panel concluded that it isunlikely that exposure to food contaminated with MG/LMG at or below the RPA of 2 lg/kg representsa health concern.