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The EFSA Panel on Contaminants in the Food Chain (CONTAM) established a tolerable daily intake (TDI) for fumonisin B 1 (FB 1 ) of 1.0 lg/kg body weight (bw) per day based on increased incidence of megalocytic hepatocytes found in a chronic study with mice. The CONTAM Panel considered the limited data available on toxicity and mode of action and structural similarities of FB 2-6 and found it appropriate to include FB 2 , FB 3 and FB 4 in a group TDI with FB 1 . Modified forms of FBs are phase I and phase II metabolites formed in fungi, infested plants or farm animals. Modified forms also arise from food or feed processing, and include covalent adducts with matrix constituents. Non-covalently bound forms are not considered as modified forms. Modified forms of FBs identified are hydrolysed FB 1-4 (HFB 1-4 ), partially hydrolysed FB 1-2 (pHFB 1-2 ), N-(carboxymethyl)-FB 1-3 (NCM-FB 1-3 ), N-(1deoxy-D-fructos-1-yl)-FB 1 (NDF-FB 1 ), O-fatty acyl FB 1 , N-fatty acyl FB 1 and N-palmitoyl-HFB 1 . HFB 1 , pHFB 1 , NCM-FB 1 and NDF-FB 1 show a similar toxicological profile but are less potent than FB 1 . Although in vitro data shows that N-fatty acyl FBs are more toxic in vitro than FB 1 , no in vivo data were available for N-fatty acyl FBs and O-fatty acyl FBs. The CONTAM Panel concluded that it was not appropriate to include modified FBs in the group TDI for FB 1-4 . The uncertainty associated with the present assessment is high, but could be reduced provided more data are made available on occurrence, toxicokinetics and toxicity of FB 2-6 and modified forms of FB 1-4 . and Alexander J, 2018. Scientific opinion on the appropriateness to set a group health-based guidance value for fumonisins and their modified forms. EFSA Journal 2018;16(2):5172, 75 pp. https://doi.This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. HBGV for fumonisins and their modified forms www.efsa.europa.eu/efsajournal 2 EFSA Journal 2018;16(2):5172 HBGV for fumonisins and their modified forms www.efsa.europa.eu/efsajournal 3 EFSA Journal 2018;16(2):5172Although FBs are poorly absorbed, unchanged FBs excreted into urine have been used as a biomarker of exposure in humans. In animal studies changes in sphinganine (Sa) and sphingosine (So) and the Sa/So ratio can be determined in urine following FB exposure. A dose related increase in the sphinganine 1-phosphate (Sa 1-P)/sphingosine 1-phosphate (So 1-P) ratio in blood spots which correlated with urinary FB 1 levels has been reported in human studies. This result is consistent with fumonisin inhibition of CerS in humans.Toxicity studies deal mainly with effects of FB 1 , but FB 2-4 are considered as having similar toxicological profiles and potencies. FB 1 is considered not to be acutely toxic. In repeated dose st...
The EFSA Panel on Contaminants in the Food Chain (CONTAM) established a tolerable daily intake (TDI) for fumonisin B 1 (FB 1 ) of 1.0 lg/kg body weight (bw) per day based on increased incidence of megalocytic hepatocytes found in a chronic study with mice. The CONTAM Panel considered the limited data available on toxicity and mode of action and structural similarities of FB 2-6 and found it appropriate to include FB 2 , FB 3 and FB 4 in a group TDI with FB 1 . Modified forms of FBs are phase I and phase II metabolites formed in fungi, infested plants or farm animals. Modified forms also arise from food or feed processing, and include covalent adducts with matrix constituents. Non-covalently bound forms are not considered as modified forms. Modified forms of FBs identified are hydrolysed FB 1-4 (HFB 1-4 ), partially hydrolysed FB 1-2 (pHFB 1-2 ), N-(carboxymethyl)-FB 1-3 (NCM-FB 1-3 ), N-(1deoxy-D-fructos-1-yl)-FB 1 (NDF-FB 1 ), O-fatty acyl FB 1 , N-fatty acyl FB 1 and N-palmitoyl-HFB 1 . HFB 1 , pHFB 1 , NCM-FB 1 and NDF-FB 1 show a similar toxicological profile but are less potent than FB 1 . Although in vitro data shows that N-fatty acyl FBs are more toxic in vitro than FB 1 , no in vivo data were available for N-fatty acyl FBs and O-fatty acyl FBs. The CONTAM Panel concluded that it was not appropriate to include modified FBs in the group TDI for FB 1-4 . The uncertainty associated with the present assessment is high, but could be reduced provided more data are made available on occurrence, toxicokinetics and toxicity of FB 2-6 and modified forms of FB 1-4 . and Alexander J, 2018. Scientific opinion on the appropriateness to set a group health-based guidance value for fumonisins and their modified forms. EFSA Journal 2018;16(2):5172, 75 pp. https://doi.This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. HBGV for fumonisins and their modified forms www.efsa.europa.eu/efsajournal 2 EFSA Journal 2018;16(2):5172 HBGV for fumonisins and their modified forms www.efsa.europa.eu/efsajournal 3 EFSA Journal 2018;16(2):5172Although FBs are poorly absorbed, unchanged FBs excreted into urine have been used as a biomarker of exposure in humans. In animal studies changes in sphinganine (Sa) and sphingosine (So) and the Sa/So ratio can be determined in urine following FB exposure. A dose related increase in the sphinganine 1-phosphate (Sa 1-P)/sphingosine 1-phosphate (So 1-P) ratio in blood spots which correlated with urinary FB 1 levels has been reported in human studies. This result is consistent with fumonisin inhibition of CerS in humans.Toxicity studies deal mainly with effects of FB 1 , but FB 2-4 are considered as having similar toxicological profiles and potencies. FB 1 is considered not to be acutely toxic. In repeated dose st...
Fumonisins, mycotoxins primarily produced by Fusarium verticillioides and Fusarium proliferatum, occur predominantly in cereal grains, especially in maize. The European Commission asked EFSA for a scientific opinion on the risk to animal health related to fumonisins and their modified and hidden forms in feed. Fumonisin B 1 (FB 1 ), FB 2 and FB 3 are the most common forms of fumonisins in feedstuffs and thus were included in the assessment. FB 1 , FB 2 and FB 3 have the same mode of action and were considered as having similar toxicological profile and potencies. For fumonisins, the EFSA Panel on Contaminants in the Food Chain (CONTAM) identified no-observed-adverse-effect levels (NOAELs) for cattle, pig, poultry (chicken, ducks and turkeys), horse, and lowest-observed-adverseeffect levels (LOAELs) for fish (extrapolated from carp) and rabbits. No reference points could be identified for sheep, goats, dogs, cats and mink. The dietary exposure was estimated on 18,140 feed samples on FB 1-3 representing most of the feed commodities with potential presence of fumonisins. Samples were collected between 2003 and 2016 from 19 different European countries, but most of them from four Member States. To take into account the possible occurrence of hidden forms, an additional factor of 1.6, derived from the literature, was applied to the occurrence data. Modified forms of fumonisins, for which no data were identified concerning both the occurrence and the toxicity, were not included in the assessment. Based on mean exposure estimates, the risk of adverse health effects of feeds containing FB 1-3 was considered very low for ruminants, low for poultry, horse, rabbits, fish and of potential concern for pigs. The same conclusions apply to the sum of FB 1-3 and their hidden forms, except for pigs for which the risk of adverse health effect was considered of concern.Acknowledgements: The CONTAM Panel wishes to acknowledge all European countries and other stakeholder organisations that provided feed consumption data and chemical occurrence data on fumonisins, modified forms and hidden forms in feed.This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. Fumonisins in feed www.efsa.europa.eu/efsajournal 2 EFSA Journal 2018;16(5):5242 Fumonisins in feed www.efsa.europa.eu/efsajournal 3 EFSA Journal 2018;16(5):5242Ruminants are considered less sensitive than horses and pigs. Gross and histopathological lesions, as well as changes in serum enzymes and biochemistry indicate an impairment of liver and possibly kidney function. Taking as endpoints the increase in serum enzymes, cholesterol and bilirubin as well as the decrease in lymphocyte blastogenesis a no-observed-adverse-effect level (NOAEL) of (31 mg FB 1-3 /kg feed) could be set only for cattle....
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