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美FDA发布婴儿配方奶粉标示行业指南

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9月16日,美国FDA发布婴儿配方奶粉标示行业指南,涉及婴儿配方奶粉生产商和销售商如何正确标示的相关要求,包括对婴儿配方奶粉品种确认、功能声称标注、以及对婴儿配方奶粉产品的正确标示。

9月16日,美国FDA发布婴儿配方奶粉标示行业指南,涉及婴儿配方奶粉生产商和销售商如何正确标示的相关要求,包括对婴儿配方奶粉品种确认、功能声称标注、以及对婴儿配方奶粉产品的正确标示。

指南主要内容

指南主要包含下列6个方面内容:产品品种声明;有关产品营养成份偏差标注“豁免”;营养成分声称标注;健康声称标注和具备健康功能声称标注;其他方面的标示要求,包括产品使用说明、图示、最佳使用

日期、用水量说明和图示、警示声明、以及医生建议;总的标示要求,包括中间材料、外文标示、宗教标示(满足特定宗教需要)、过敏源标示等。

美国环保署发布最终条例制定的过硫酸铵作为防腐剂在加工农产品中的最大残留限量为0.05%,并于发布之日起生效,反对或有听证要求的按40 CFR§178的说明在2016年11月15日前提交。

美FDA发布婴儿配方奶粉标示行业指南

部分原文如下:

I. Introduction

The Food and Drug Administration (“FDA” or “we”) is publishing this reminder to infant formula manufacturers and distributors (“you”) about certain labeling requirements for infant formula products. While this guidance provides information about the labeling requirements for infant formula products generally, we are concerned particularly about the number of infant formula products that bear the same or similar statements of identity but are different in composition or intended use. We have also noticed an increased use of nutrient content claims that render products misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance provides information that can help you understand and comply with relevant labeling requirements. This guidance does not provide an exhaustive list of all regulations covering the labeling of infant formula. We encourage you to review your product labels to ensure they comply with FDA’s regulations, especially—but not limited to—the regulations discussed in this guidance. We also encourage you to refer to our guidance documents at for additional information. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidances means that something is suggested or recommended, but not required.

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