FDA Draft Guidance for Industry Control of Listeria monocytogenes in Ready-To-Eat Foods

标准简介

Draft Guidance for Industry Control of Listeria monocytogenes in Ready-To-Eat Foods[附网盘链接]由Food&Drug Administration于之前发布，适用于U.S。

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标准文档类型为Draft Guidance for Industry Control of Listeria monocytogenes in Ready-To-Eat Foods[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

Control of Listeria monocytogenes in Ready-to-

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Eat Foods: Guidance for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic.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 FDA’s Technical Assistance Network by submitting the form available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm. I. Introduction This guidance is intended for those persons (“you”) who are subject to our regulation, in 21 CFR part 117 (part 117), entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-

Based Preventive Controls for Human Food” and who manufacture, process, pack, or hold 2

ready-to-eat (RTE) foods. This guidance is intended for you regardless of whether you are only subject to the current good manufacturing practice requirements for human food of part 117 (CGMP requirements), the requirements for hazard analysis and risk-based preventive controls for human food in part 117 (PCHF), or both the CGMP requirements and the PCHF requirements. See section II.A of this guidance for additional information about the CGMP and PCHF requirements. This guidance is intended to help you comply with the CGMP and PCHF requirements of part 117 with respect to measures that can significantly minimize or prevent the contamination of RTE food with L. monocytogenes whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to L. monocytogenes) that would significantly minimize L. monocytogenes. This guidance is not directed to processors of RTE foods that receive a listericidal control measure applied to the food in the final package, or applied to the food just prior to packaging in a system that adequately shields the product and food contact surfaces of the packaging from contamination from the food processing environment. This guidance also is not intended for food establishments that are not subject to part 117, such as farms. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance describes the Agency's current thinking on a topic and should 1

This guidance has been prepared by the Office of Food Safety at the U.S. Food and Drug Administration. 2

Ready-to-eat food (RTE food) means any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards. (21 CFR 117.3) 1

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