Malachite green in food

Abstract

Malachite green (MG) has been used globally in aquaculture but is not registered for use in food-producing animals in the European Union. The European Commission requested EFSA to evaluate whether a reference point for action (RPA) of 2 lg/kg for the sum of MG and its major metabolite leucomalachite green (LMG) is adequate to protect public health. Available occurrence data were not suitable 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. Mean dietary exposure across different European dietary surveys and age classes would range from 0.1 to 5.0 ng/kg body weight (bw) per day. For high and frequent fish consumers, the exposure would range from 1.3 to 11.8 ng/kg bw per day. Both MG and LMG induced formation of DNA adducts in livers of rats 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 adenomas and carcinomas in female mice. Both MG and LMG may be considered as carcinogenic and as genotoxic 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 point for neoplastic effects. For non-neoplastic effects, a lower 95% confidence limit for a benchmark response of 5% extra risk (BMDL 05 ) of 6 mg/kg bw per day was selected for the effect of MG on liver weight and of LMG on body weight. The margins of exposure were 1.1 9 10 6 or greater for neoplastic effects and 4.9 9 10 5 or greater for non-neoplastic effects. The CONTAM Panel concluded that it is unlikely that exposure to food contaminated with MG/LMG at or below the RPA of 2 lg/kg represents a health concern.Acknowledgements: The Panel wishes to thank the members of the Standing Working Group on non-allowed pharmacologically active substances in food and feed and their reference points for action (2015)(2016)(2017)(2018):

Comparative Therapeutic Effects of Natural Compounds Against Saprolegnia spp. (Oomycota) and Amyloodinium ocellatum (Dinophyceae)

“…Following the discovery of its potential carcinogenicity, teratogenicity and mutagenicity in humans, and its environmental impact, the use of MG in the production of fish destined to human consumption is not authorized in the European Union (EU) (14). Nevertheless, EFSA established that food contaminated with MG or its metabolic product leucomalachite green (LMG) at or below the reference point for action (RPA) of 2 µg/kg is unlikely to represent a public health concern (15).…”

Nasopharyngeal Microbiome Composition is Different Among Children with Bronchial Asthma

“…Malachite green is quite abundant among fish as it has been used universally as a therapeutic treatment in aquaculture, and is known to cause pneumoconiosis upon long-standing inhalation. Malachite green is also mutagenic, carcinogenic and genotoxic (24). It causes lipid peroxidation, lung disease and lung adenomas.…”

Liquid Chromatography Analysis of Common Nutritional Components, in Feed and Food

“…Treatments for fish eggs include dosages of 5 mg L −1 is usually suggested for fish tanks. Laboratories usually measure malachite green with equipment able to detect tissue residues below 2 µg kg −1 (maximum permitted residue limit in fish tissue; [250]). A very interesting approach was made by Furusawa who developed a green chemistry method for malachite green and its metabolite [251].…”