![]() We intend this draft guidance to include the 16 chapters listed in the Table of Contents. However, such persons may find some of the principles and recommendations in this guidance helpful in manufacturing, processing, packing, and holding human food. This guidance is not directed to persons who are exempt under 21 CFR 117.5. This guidance is intended to help you comply with the following specific PCHF requirements established in subparts C and G of part 117: Risk-based preventive controls will not give you a "zero-risk” system for manufacturing, processing, packing, and holding food rather, risk-based preventive controls are designed to minimize the risk of known or reasonably foreseeable food safety hazards that may cause illness or injury if they are present in the products you produce. Establishing risk-based preventive controls enables you to apply a proactive and systematic approach to your food safety program through the establishment of preventive controls designed to protect your food, and the consumer, from biological, chemical (including radiological), and physical hazards. This document is directed to those persons (you) who are subject to the PCHF requirements of part 117. See 21 CFR 117.5 for a list and description of these exemptions. Part 117 includes several complete or partial exemptions from the PCHF requirements. The PCHF requirements implement the provisions of the FDA Food Safety Modernization Act (FSMA), established in section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. Part 117 establishes requirements for current good manufacturing practice for human food (CGMPs), for hazard analysis and risk-based preventive controls for human food (PCHF), and related requirements. In 21 Code of Federal Regulations (CFR) part 117 (part 117), we have established our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food.” We published the final rule establishing part 117 in the Federal Register of Septem(80 FR 55908). Center for Food Safety and Applied Nutrition ![]()
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