UnitedStatesFoodSafetyModernizationAct食品安全现代法.pptVIP

The United StatesFood Safety Modernization Act食品安全现代法案 Compliance by Foreign Suppliers 适用于国外供应商 Source: Background of the FSMA食品安全现代法案的产生背景 FSMA Signed into Law by President Obama on January 4, 2011 食品安全现代法案由奥巴马总统于2011年1月4日签署通过 FSMA shifts the focus of the FDA from that of response to prevention 食品安全现代法案将食品及药物管理局的工作重点由后期的反馈转向前期的预防 FSMA Mandates to FDA食品安全现代法案授权于食品及药物管理局 The FSMA directs the FDA to create two new programs for foreign food and drug companies: Foreign Supplier Verification Program (FSVP) and Voluntary Qualified Importer Program (VQIP).? 在食品安全现代法案的指导下，食品及药物管理局为外国食品及医药公司制定了两个新计划： --外国供应商检验计划 --合格进口商自愿计划 The FSVP – Generally外国供应商检验计划-概要 By January 4, 2012, the U.S. FDA must issue specific FSVP regulations issue a guidance document to assist importers in developing FSV programs.? 截止至2012年1月4日，美国食品及药物管理局必须： --发布具体的检验计划条例 --发布指导性文件，以便在计划中协助进口商的相关事务 The FSVP – Generally外国供应商检验计划-概要 FSVP requires importers to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported is produced safely, unadulterated, and not mis-branded.? 检验计划要求进口商在风险控制的基础上对外国供应商进行检验，目的是为了确保所进口的食品生产是安全和纯正的，而并非仅仅是根据产品的品牌来引进。 The FSVP – Generally外国供应商检验计划-概要 Verification activities: monitoring shipping records for shipments lot-by-lot certification compliance annual on-site inspections checking the hazard analysis and risk-based preventative control plan of the FS periodically testing and sampling shipments.? 检验内容： 监控货物运输记录 ?对每披货物进行检验 ?每年现场视察 ?核查食品安全中的危险性分析和以风险防范为基础的预防控制计划定期测试和取样的检查 The FSVP – Generally外国供应商检验计划-概要 Importers are required to maintain records for two years and are required to allow a U.S. FDA inspector to review these records? U.S. FDA is required to publish and maintain a list of FSVP participants which includes the name and location of suppliers? All of the new FSMA requirements for this program are required to be in place and functional by January 4, 2013. 进口商必须保存两年的进货记录，并且配合美国食品与药物管理局的检查员审