美国《食品企业实施GMP和HACCP》法规核心内容.docVIP

美国《食品企业实施GMP和HACCP》法规核心内容 信息来源： 辽宁检验检疫局 孙亚斌 小编注：美国时间2015年9月10日，美国正式发布《食品企业GMP和HACCP法规》（21CFR Part 117），千呼万唤使出来。这法规说啥？有啥影响？如何应对？有问题找谁？相关问题国家认监委正在陆续解答，欢迎登录认监委网站了解。 以下是国家认监委应对美国FSMA工作组成员、辽宁检验检疫局孙亚斌同学翻译整理的美国FDA网站发布的117法规要点。 原文 参考译文 Key Requirements 1. Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for a written food safety plan that includes: Hazard analysis: The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food). Preventive controls: These measures are required to ensure that hazards requiring a preventive control will be minimized or prevented. They include process, food allergen, and sanitation controls, as well as supply-chain controls and a recall plan. Oversight and management of preventive controls. The final rule provides flexibility in the steps needed to ensure that preventive controls are effective and to correct problems that may arise. Monitoring: These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, monitoring of a heat process to kill pathogens would include actual temperature values and be more frequent than monitoring preventive maintenance activities used to minimize metal hazards, which could be a simple record of the date on which the activity took place. Corrective actions and corrections: Corrections are steps taken to timely identify and correct a minor, isolated problem that occurs during food production. Corrective actions include actions to identify a problem with preventive control implementation, to reduce the likelihood the problem wi