FDA Draft Guidance for Industry Best Practices for Convening a GRAS Panel
标准简介
Draft Guidance for Industry Best Practices for Convening a GRAS Panel[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于U.S。标准截图
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标准文档说明
标准文档类型为Draft Guidance for Industry Best Practices for Convening a GRAS Panel[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
Draft-Not for Implementation Best Practices for Convening a GRAS Panel: 1
Guidance for Industry This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance. I. Introduction This draft guidance document is intended to provide our recommendations on best practices for convening a “GRAS panel.” By “GRAS,” we mean “generally recognized as safe.” See section II.A for a discussion of the GRAS provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act). By “GRAS panel,” we mean a panel of qualified experts who independently evaluate whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in human food or animal food as part of an evaluation of whether adding that substance to food is lawful under the GRAS provision of the FD&C Act. In this document, we refer to a person who is responsible for a conclusion that a substance may be used in food on the basis of the GRAS provision of the FD&C Act as the “proponent” of GRAS status for that substance under the conditions of its intended use. In some cases, the process whereby the proponent evaluates whether the available data and information support a conclusion that a substance is GRAS under the conditions of its intended use includes considering the opinion of a GRAS panel. Depending on the outcome of the GRAS panel’s analysis, the proponent could either reach a conclusion regarding the safety of the substance under the conditions of its intended use, or be advised of one or more issues (such as gaps in the 1
This draft guidance has been prepared jointly by the Division of Biotechnology and GRAS Notice Review in the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition, and the Division of Animal Feeds in the Office of Surveillance and Compliance in the Center for Veterinary Medicine at the U.S. Food and Drug Administration. 4
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