ABSTRACT

The EU Food Supplements Directive (2002/46/EC) mandates the determination of both maximum and minimum permitted levels (MPLs) for micronutrients. In order to determine MPLs which are feasible for particular population groups, a scientific approach should be used in which risk of high intake, risk of inadequacy and benefits are assessed in an integrated way taking all available data and severity and incidence of effect into account. In 2004, Renwick et al. (ILSI Europe) published a scientifically valid, flexible and pragmatic basis for a risk–benefit approach, which has been further developed here to make it a practical and quantifiable approach to be used by risk managers. The applicability of the approach is demonstrated using demo cases on iron and folate. The proposed approach has the capacity to utilize all relevant data available, including data from human studies, bioavailability data showing variability between specific forms of micronutrients and, in the case of animal studies, data on species comparability. The approach is therefore both practical and flexible, making it well suited to risk managers tasked with determining safe intake levels for micronutrients in different forms and for particular population groups.

摘要

欧盟食品补充指令（2002/46 / EC）要求确定微量营养素的最大和最小允许水平（MPL）。为了确定对特定人群而言可行的MPL，应采用一种科学的方法，在综合考虑所有可用数据以及影响的严重性和发生率的情况下，对高摄入量，不足和利益的风险进行评估。2004年，Renwick等人。（ILSI欧洲）发布了风险收益方法的科学有效，灵活和务实的基础，此处已对其进行了进一步开发，以使其成为风险管理人员可以使用的实用且可量化的方法。通过演示铁和叶酸的案例，证明了该方法的适用性。拟议的方法有能力利用所有可用的相关数据，包括来自人体研究的数据，显示特定形式的微量营养素之间差异的生物利用度数据，以及在动物研究中的物种可比性数据。因此，该方法既实用又灵活，非常适合负责确定不同形式的微量营养素和特定人群的安全摄入量的风险管理人员。