EFSA has assisted the European Commission in assessing the risks posed to the health of humans (and other animals) by the presence of the mycotoxin moniliformin (MON) in cereal-based food and feed. The experimental data on MON are limited. Although it is genotoxic in vitro, no data have been identified on its in vivo genotoxic or carcinogenic potential. Studies in experimental and farm animals suggest the primary adverse effects of subacute MON exposure to be on the blood and heart. Margins of exposure (MoEs) between a no-observed-adverse-effect level (NOAEL) of 6 mg/kg bw for cardiotoxicity in rats and human acute exposures were reassuring. The same was true for MoEs between a BMDL05 (the lower confidence limit of the benchmark dose for a 5% response) of 0.2 mg/kg bw/day for haematological effects in pigs and human chronic dietary exposures. However, it was noted that the uncertainty associated with these margins is high, and that additional toxicity and occurrence data would be required for a more comprehensive human health risk assessment.

EFSA has also considered the setting of a group health-based guidance value (HBGV) for fumonisins B1 and B2 (FB1 and FB2) and their modified forms. A tolerable daily intake (TDI) of 1 µg/kg bw was established for FB1 based on liver lesions in a chronic dietary study in mice, with a BMDL10 of 0.1 mg/kg bw/day. Given the structural and toxicological similarity of FB2, FB3 and FB4 to FB1 it was considered appropriate to include these together under a group TDI of 1 µg/kg bw. The paucity of data on FB5 and FB6, and on the modified forms (including hydrolysed, partially hydrolysed, N-(1-deoxy-D-fructos-1-yl)-, N-(carboxymethyl)-, N- or O-fatty acyl-, and N-palmitoyl-hydrolysed fumonisins) meant that it was not considered appropriate to include these in a group TDI.

European Food Safety Authority (2018). Panel on Contaminants in the Food Chain (CONTAM). Appropriateness to set a group health-based guidance value for fumonisins and their modified forms. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5172/epdf

Risks to human and animal health related to the presence of moniliformin in food and feed. http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5082/epdf


The above items were taken from the April 2018 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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