美国FDA《食品现行良好操作规范和危害分析及基于风险的预防控制》法规简介及对我国的启示

Brief introduction on USA FDA's rule for current good manufacturing practice,hazard analysis,and risk-based preventive controls for human food and enlightenment to China

美国FDA《食品现行良好操作规范和危害分析及基于风险的预防控制》最终法规于2015年9月17日发布,并于2015年11月16日生效。本文介绍了法规的框架和主要特点,不同类型和规模的企业满足法规要求的日期,供应链计划符合法规的日期,现行良好操作规范失效日期并对法规的主要内容:总则、现行良好操作规范、危害分析及基于风险的预防控、更改的要求、取消受限制企业的豁免、建立并保持记录的要求、供应链计划等7个方面进行简要介绍,便于输美食品生产企业和官方监管人员及早了解法规的主要内容,以满足法规的要求;同时提出了4个方面的启示,便于今后我国在制订食品法规方面进行借鉴。

ABSTRACT:USA FDA’sRule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (final rule) is promulgated on Sep 17, 2015 , and will take effect on Nov 16, 2015. This article described the main framework and features of the rule, dates of rule compliance for different types and sizes of the business, and for supply-chain program, ineffective dates for current good manufacturing practice, which briefly introduced the 7 main aspects of the rule,i.e. general provisions, current good manufacturing practice, hazard analysis and risk-based preventive controls, modified requirements, withdrawal of a qualified facility exemption, and requirements applying to records that must be established and maintained and supply-chain program, in order to facilitate food businesses for export to the USA and official regulators to understand the rule and to meet the rule as early as possible. At the same time, the essay puts forward 4 pieces of enlightenment to facilitate for us to formulate food regulations in the future.