Department of Toxicology, Faculty of Health Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.
Department of European and International Law, Faculty of Law, Maastricht University, Maastricht, The Netherlands.
Regul Toxicol Pharmacol. 2014 Apr;68(3):475-87. doi: 10.1016/j.yrtph.2014.01.014. Epub 2014 Feb 10.
This article analyses the consequences of the implementation of the nutrition and health claim regulation in the field of food products containing antioxidants or food products claiming antioxidant activity. To this end, it first examines the origin and creation of the regulation and the involvement of EFSA in assessing scientific substantiation of health claims. Three criteria are regarded as critical in EFSA's opinions on the scientific substantiation of a health claim: the claimed effect (i) is well defined; (ii) is a clear beneficial physiological effect; and (iii) shows a cause effect relationship with the consumption of the food or functional ingredient. These criteria have implications for the research requested to substantiate health claims, although these implications do not all seem to fit nutrition research as it is currently executed. Looking at antioxidants, the complexity of the mechanisms and actions of antioxidants is not recognised by the criteria used to evaluate proposed health claims, nor by the methodologies used to assess the effects of antioxidants. These criteria should be adjusted with novel scientific insights after consulting stakeholders.
本文分析了在含有抗氧化剂的食品或声称具有抗氧化活性的食品领域实施营养和健康声称法规的后果。为此,它首先审查了该法规的起源和制定过程,以及 EFSA 在评估健康声称的科学依据方面的参与。EFSA 对健康声称科学依据的意见中,有三个标准被认为是关键的:所声称的效果(i) 定义明确;(ii) 是明确的有益生理效果;以及(iii) 显示出与食用食品或功能性成分之间的因果关系。这些标准对为证实健康声称而要求的研究有影响,尽管这些影响似乎并不完全适用于目前执行的营养研究。就抗氧化剂而言,用于评估拟议健康声称的标准,以及用于评估抗氧化剂效果的方法学,都没有认识到抗氧化剂的作用机制和作用的复杂性。在咨询利益相关者后,应该根据新的科学见解对这些标准进行调整。