Malachite green in food

Jans Alexander, Lars Barregård, Margherita Bignami, Sandra Ceccatelli, Bruce Cottrill, Michael Dinovi, Lutz Edler, Bettina Grasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Helle Katrine Knutsen, Carlo Stefano Nebbia, Isabelle Oswald, Annette Petersen, Vera Maria Rogiers, Martin Rose, Alain-Claude Roudot, Tanja Schwerdtle, Christiane Vleminckx, Günter VollmerHeather Wallace, EFSA Panel on Contaminants in the Food Chain (CONTAM)

Research output: Contribution to journalArticle

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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 μg/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 (BMDL10) 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 (BMDL05) 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 × 106 or greater for neoplastic effects and 4.9 × 105 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 μg/kg represents a health concern.
Original languageEnglish
Article numbere04530
Pages (from-to)1-80
Number of pages80
JournalEFSA Journal
Volume14
Issue number7
Early online date4 Jul 2016
DOIs
Publication statusPublished - 27 Jul 2016

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Food
Body Weight
Liver Cell Adenoma
Benchmarking
Hepatocellular Carcinoma
Liver
Fishes
Fish Products
Aquaculture
DNA Adducts
European Union
Human Mammary Glands
leucomalachite green
malachite green
Transgenes
Adenoma
Thyroid Gland
Public Health
Breast Neoplasms
Carcinoma

Keywords

  • malachite green
  • leucomalachite green
  • fish and fish products
  • crustaceans
  • reference point for action
  • dye
  • risk assessment

Cite this

Alexander, J., Barregård, L., Bignami, M., Ceccatelli, S., Cottrill, B., Dinovi, M., ... EFSA Panel on Contaminants in the Food Chain (CONTAM) (2016). Malachite green in food. EFSA Journal, 14(7), 1-80. [e04530]. https://doi.org/10.2903/j.efsa.2016.4530

Malachite green in food. / Alexander, Jans ; Barregård, Lars; Bignami, Margherita; Ceccatelli, Sandra; Cottrill, Bruce; Dinovi, Michael; Edler, Lutz; Grasl-Kraupp, Bettina ; Hogstrand, Christer ; Hoogenboom, Laurentius (Ron) ; Knutsen, Helle Katrine ; Nebbia, Carlo Stefano ; Oswald, Isabelle ; Petersen, Annette ; Rogiers, Vera Maria; Rose, Martin ; Roudot, Alain-Claude ; Schwerdtle, Tanja ; Vleminckx, Christiane ; Vollmer, Günter ; Wallace, Heather; EFSA Panel on Contaminants in the Food Chain (CONTAM).

In: EFSA Journal, Vol. 14, No. 7, e04530, 27.07.2016, p. 1-80.

Research output: Contribution to journalArticle

Alexander, J, Barregård, L, Bignami, M, Ceccatelli, S, Cottrill, B, Dinovi, M, Edler, L, Grasl-Kraupp, B, Hogstrand, C, Hoogenboom, LR, Knutsen, HK, Nebbia, CS, Oswald, I, Petersen, A, Rogiers, VM, Rose, M, Roudot, A-C, Schwerdtle, T, Vleminckx, C, Vollmer, G, Wallace, H & EFSA Panel on Contaminants in the Food Chain (CONTAM) 2016, 'Malachite green in food', EFSA Journal, vol. 14, no. 7, e04530, pp. 1-80. https://doi.org/10.2903/j.efsa.2016.4530
Alexander J, Barregård L, Bignami M, Ceccatelli S, Cottrill B, Dinovi M et al. Malachite green in food. EFSA Journal. 2016 Jul 27;14(7):1-80. e04530. https://doi.org/10.2903/j.efsa.2016.4530
Alexander, Jans ; Barregård, Lars ; Bignami, Margherita ; Ceccatelli, Sandra ; Cottrill, Bruce ; Dinovi, Michael ; Edler, Lutz ; Grasl-Kraupp, Bettina ; Hogstrand, Christer ; Hoogenboom, Laurentius (Ron) ; Knutsen, Helle Katrine ; Nebbia, Carlo Stefano ; Oswald, Isabelle ; Petersen, Annette ; Rogiers, Vera Maria ; Rose, Martin ; Roudot, Alain-Claude ; Schwerdtle, Tanja ; Vleminckx, Christiane ; Vollmer, Günter ; Wallace, Heather ; EFSA Panel on Contaminants in the Food Chain (CONTAM). / Malachite green in food. In: EFSA Journal. 2016 ; Vol. 14, No. 7. pp. 1-80.
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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 μg/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 (BMDL10) 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 (BMDL05) 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 × 106 or greater for neoplastic effects and 4.9 × 105 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 μg/kg represents a health concern.",
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author = "Jans Alexander and Lars Barreg{\aa}rd and Margherita Bignami and Sandra Ceccatelli and Bruce Cottrill and Michael Dinovi and Lutz Edler and Bettina Grasl-Kraupp and Christer Hogstrand and Hoogenboom, {Laurentius (Ron)} and Knutsen, {Helle Katrine} and Nebbia, {Carlo Stefano} and Isabelle Oswald and Annette Petersen and Rogiers, {Vera Maria} and Martin Rose and Alain-Claude Roudot and Tanja Schwerdtle and Christiane Vleminckx and G{\"u}nter Vollmer and Heather Wallace and {EFSA Panel on Contaminants in the Food Chain (CONTAM)}",
note = "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 (2015–2018): Metka Filipič, Peter F{\"u}rst, Laurentius (Ron) Hoogenboom, Anne-Katrine Lundebye, Carlo Stefano Nebbia, Michael O'Keeffe and Rolaf Van Leeuwen for the preparatory work on this scientific output, the hearing expert: Eva Persson, and EFSA staff members: Katleen Baert and Sofia Ioannidou for the support provided to this scientific opinion. The CONTAM Panel acknowledges all European competent institutions and other stakeholders that provided occurrence data on malachite green and leucomalachite green in food, and supported the data collection for the Comprehensive European Food Consumption Database.",
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AU - Alexander, Jans

AU - Barregård, Lars

AU - Bignami, Margherita

AU - Ceccatelli, Sandra

AU - Cottrill, Bruce

AU - Dinovi, Michael

AU - Edler, Lutz

AU - Grasl-Kraupp, Bettina

AU - Hogstrand, Christer

AU - Hoogenboom, Laurentius (Ron)

AU - Knutsen, Helle Katrine

AU - Nebbia, Carlo Stefano

AU - Oswald, Isabelle

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AU - Rogiers, Vera Maria

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AU - Roudot, Alain-Claude

AU - Schwerdtle, Tanja

AU - Vleminckx, Christiane

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AU - Wallace, Heather

AU - EFSA Panel on Contaminants in the Food Chain (CONTAM)

N1 - 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 (2015–2018): Metka Filipič, Peter Fürst, Laurentius (Ron) Hoogenboom, Anne-Katrine Lundebye, Carlo Stefano Nebbia, Michael O'Keeffe and Rolaf Van Leeuwen for the preparatory work on this scientific output, the hearing expert: Eva Persson, and EFSA staff members: Katleen Baert and Sofia Ioannidou for the support provided to this scientific opinion. The CONTAM Panel acknowledges all European competent institutions and other stakeholders that provided occurrence data on malachite green and leucomalachite green in food, and supported the data collection for the Comprehensive European Food Consumption Database.

PY - 2016/7/27

Y1 - 2016/7/27

N2 - 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 μg/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 (BMDL10) 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 (BMDL05) 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 × 106 or greater for neoplastic effects and 4.9 × 105 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 μg/kg represents a health concern.

AB - 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 μg/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 (BMDL10) 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 (BMDL05) 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 × 106 or greater for neoplastic effects and 4.9 × 105 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 μg/kg represents a health concern.

KW - malachite green

KW - leucomalachite green

KW - fish and fish products

KW - crustaceans

KW - reference point for action

KW - dye

KW - risk assessment

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DO - 10.2903/j.efsa.2016.4530

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