[Scientific basis in the setting of residue limits for veterinary drugs in food of animal origin taking into account the presence of their metabolites].

K Mitsumori
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Abstract

Maximum residue level (MRL) for veterinary drugs in food of animal origin has been proposed by FAO/WHO, as a new evaluation procedure taking into account the presence of metabolites for the regulation of veterinary drug residues. The MRL is the maximum concentration of residue resulting from the use of a veterinary drug that is recommended to be legally permitted as acceptable in a food. It is established from the Acceptable Daily Intake (ADI) obtained from the data of toxicological studies, the residue concentration of the drug when used according to good practice in the use of veterinary drugs, and the lowest level consistent with the practical analytical methods available for routine residue analysis. Among the veterinary drugs, some chemicals contain a large amount of bound residues that are neither extractable from tissues by the analytical method identical with that used in parent chemicals. Especially, the bioavailable residues which are probably absorbed when the food is ingested are of great toxicological concern. In this case, the FAO/WHO recommends that the MRL can be established after the calculation of daily intake of residues of toxicological concern by the addition of both the extractable and bioavailable bound residues.

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[考虑到动物源性食品中兽药代谢产物的存在,制定兽药残留限量的科学依据]。
粮农组织/世卫组织提出了动物源性食品中兽药的最大残留限量(MRL),作为一种新的评估程序,考虑到兽药残留监管中代谢物的存在。最大残留限量是指兽药在使用过程中产生的最大残留浓度,建议在法律上允许作为食品中可接受的残留浓度。它是根据毒理学研究数据获得的每日可接受摄入量(ADI),根据兽药使用良好规范使用药物时的残留浓度以及与常规残留分析可用的实际分析方法一致的最低水平建立的。在兽药中,一些化学品含有大量的结合残留物,这些残留物不能用与母体化学品相同的分析方法从组织中提取。特别是在食物被摄入时可能被吸收的生物可利用性残留物引起了很大的毒理学问题。在这种情况下,粮农组织/世卫组织建议,可通过添加可提取的和生物可利用的结合残留物,在计算具有毒理学意义的残留物的每日摄入量后,确定最大残留限量。
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