FDA Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food
标准简介
Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于US。标准截图
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标准文档说明
标准文档类型为Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food: Guidance for FDA Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance at the phone number listed on the title page. *I. Introduction
The purpose of this document is to provide guidance for FDA staff on aflatoxins in human food. We revised this document to update the format and to include revisions for clarity, references to other aflatoxin Compliance Policy Guides (CPGs), and a reference to the Memorandum of Understanding between the Agricultural Marketing Service (AMS) of the United States Department of Agriculture (USDA) and FDA. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA guidance means that something is suggested or recommended, but not required. II. Background
Aflatoxins (B1, B2, G1, and G2) are toxic metabolites produced by the molds Aspergillus flavus, Aspergillus nomius, and Aspergillus parasiticus. Toxicological manifestations of aflatoxins include teratogenicity, mutagenicity, and carcinogenicity in susceptible animal species. Consumption of food with high levels of aflatoxins is associated with liver cancer in humans. Aflatoxins may occur in food as a result of mold growth in susceptible raw agricultural commodities. The growth of molds that produce aflatoxins is influenced by environmental factors such as temperature, humidity, and extent of rainfall during the pre-harvesting, harvesting, or post-harvesting periods. Foods most susceptible to molds that produce aflatoxins include: peanuts, corn, some tree nuts including Brazil nuts and pistachios, and some small
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