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根据欧盟法规评估与孕妇食品补充剂中的叶酸相关的健康声称。

Assessment of Health Claims Related to Folic Acid in Food Supplements for Pregnant Women According to the European Regulation.

机构信息

Nutrition and Food Science Department, Pharmacy Faculty, Complutense University of Madrid (UCM), Plaza Ramón y Cajal, s/n, E-28040 Madrid, Spain.

出版信息

Nutrients. 2021 Mar 14;13(3):937. doi: 10.3390/nu13030937.

Abstract

Pregnant women are a vulnerable group with increased nutritional requirements. The daily intake of folic acid, a crucial vitamin for embryonic development, must be reinforced through supplementation, as sometimes diets are not well equilibrated. As consumers increasingly rely on food supplements, it is vital to properly inform them about the health benefits provided by supplements' consumption to ensure their safe use. The objective of this work was to assess the compliance level of health claims related to folic acid in food supplements commercialized in Spain according to the European regulation. Authors performed (1) a review of health-related claims approved for folic acid in Europe, (2) a market research of food supplements commercialized in Spain with those claims, and (3) a selection of food supplements for chemical analysis in the lab to assess these claims. The results showed that nine health-related claims are currently approved for folic acid in Europe. The analytical results for folic acid content in the selected samples were consistent with the declared values and within the tolerance ranges established in the European Guidance document. All samples included accurate dosages and met the legal requirements (European Regulations 1924/2006, 432/2012, 1169/2011) for all approved claims for folic acid.

摘要

孕妇是一个脆弱的群体,她们的营养需求增加。叶酸是胚胎发育的关键维生素,孕妇必须通过补充剂来增加叶酸的日常摄入量,因为有时饮食无法很好地平衡。由于消费者越来越依赖膳食补充剂,因此必须正确告知他们补充剂消费带来的健康益处,以确保其安全使用。本研究的目的是评估根据欧洲法规,在西班牙销售的含有叶酸的膳食补充剂的健康声称符合规定的程度。作者进行了以下操作:(1)回顾了欧洲批准的叶酸相关健康声称;(2)对在西班牙销售的含有这些声称的膳食补充剂进行了市场研究;(3)选择了一些膳食补充剂进行实验室化学分析,以评估这些声称。结果表明,欧洲目前批准了 9 种叶酸相关健康声称。对选定样本中叶酸含量的分析结果与申报值一致,且在欧洲指导文件中规定的公差范围内。所有样本的剂量都准确,符合所有批准的叶酸健康声称的法律要求(欧洲法规 1924/2006、432/2012、1169/2011)。

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