Council for Responsible Nutrition, 1828 L St., NW, Suite 510, WA 20036, USA.
Regul Toxicol Pharmacol. 2011 Oct;61(1):115-8. doi: 10.1016/j.yrtph.2011.07.001. Epub 2011 Jul 23.
For nutrients and related substances, the Tolerable Upper Intake Level (UL) has become the internationally accepted risk assessment method. The major limitation of the UL method as applied by authoritative groups thus far is that no UL has been set for nutrients without established adverse effects. In contrast to the limitations inherent in the UL method, an alternative approach is available; it identifies a risk assessment value termed the Highest Observed Intake (HOI). In the absence of a UL, the HOI is the highest intake with adequate data to show, with acceptable confidence, the absence of adverse effects up to that intake. With this concept defined and accepted in a report by the authoritative international organizations FAO and WHO, a complete risk assessment for the nutrients and related substances would have to identify UL values for those with known adverse effects and HOI values for those without known adverse effects. The need for the HOI concept and value is illustrated by the unjustified policy and regulatory actions taken in relation to vitamin B12. Regulatory utility is explained and tentative HOI values are identified for several vitamins and non-essential nutrients. Endorsement of the concept and development of HOI values by authoritative bodies is likely to be required for broad acceptance and use.
对于营养素和相关物质，可耐受最高摄入量 (UL) 已成为国际上公认的风险评估方法。迄今为止，权威机构应用 UL 方法的主要局限性是，对于没有确定不良反应的营养素，尚未设定 UL。与 UL 方法固有的局限性相比，目前还有另一种替代方法可用；它确定了一个称为最高观察摄入量 (HOI) 的风险评估值。在没有 UL 的情况下，HOI 是摄入量最高的数据足以充分显示，在该摄入量下，不良反应的可能性可以接受。在 FAO 和世卫组织等权威国际组织的报告中定义并接受了这一概念后，对营养素和相关物质的完整风险评估必须确定已知有不良反应的营养素的 UL 值和无已知不良反应的营养素的 HOI 值。HOI 概念和值的必要性由与维生素 B12 相关的不合理政策和监管行动所说明。对几种维生素和非必需营养素的监管效用进行了说明，并确定了暂定的 HOI 值。权威机构对该概念的认可和 HOI 值的制定，可能是广泛接受和使用的必要条件。
