Renwick A G
University of Southampton, UK.
Food Addit Contam. 1991 Mar-Apr;8(2):135-49. doi: 10.1080/02652039109373964.
The acceptable daily intake (ADI) of food additives and other foreign compounds is derived usually by the application of a 100-fold safety factor to the 'no observable adverse effect' level in animal experiments. This safety factor is recognized as comprising two 10-fold factors to allow for possible differences between animals and humans, and for possible differences between individual humans. This paper reviews the adequacy of these safety factors in relation to published data on inter-species and inter-individual differences in both the kinetics and dynamics of foreign compounds. Although the 100-fold factor is reasonable, situations can be envisaged where the scientific data base indicates that considerably higher or lower factors would be more appropriate. A scheme is proposed that would allow structured flexibility to be available in the choice of safety factor to be used in the regulation of foreign compounds.
食品添加剂和其他外来化合物的每日允许摄入量（ADI）通常是通过在动物实验的“未观察到不良影响”水平上应用100倍的安全系数得出的。这个安全系数被认为包括两个10倍的系数，以考虑动物和人类之间可能存在的差异，以及个体人类之间可能存在的差异。本文回顾了这些安全系数相对于已发表的关于外来化合物动力学和动态学种间和个体间差异数据的充分性。尽管100倍的系数是合理的，但可以设想在某些情况下，科学数据库表明更高或更低的系数会更合适。提出了一个方案，该方案将允许在选择用于外来化合物监管的安全系数时具有结构化的灵活性。
