FSMA：第三方认证.ppt

* * * Final Rule 最终法规 Accredited Third-Party Certification认可第三方认证 * /fsma Jeffrey Read Policy Analyst, International Affairs Staff, Center for Food Safety and Applied Nutrition (CFSAN), FDA 杰夫·雷德 FDA食品安全与应用营养中心(CFSAN)国际事务部国际政策分析官员 What Does This Rule Do?该法规的作用？ It establishes a voluntary program for the accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. 该法规建立了对第三方审核者认可的自愿项目。第三方审核者即认证机构，对海外工厂及其食品和饲料进行食品安全审查并签发证书。 * When Are Certifications Needed? 何时需要证书？ Importers will not generally be required to obtain certifications. 一般不要求进口商取得证书。 Certifications will be used for two purposes: 使用证书有两种目的： Facility certifications will be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food. 进口商可用企业证书建立其参加自愿合格进口商项目(VQIP)的资格, 该项目能加速货物进口时的审核及通关。 * When Are Certifications Needed?何时需要证书？ Food or facility certifications will be used for admissibility of a food subject to a risk-based determination by FDA. FDA可用食品或企业的证书来判断风险, 决定该货物的放行 Requires a specific determination by FDA under section 801(q) of the FDC Act 依据美国食品药品化妆品法801(q)条规定，FDA做具体判断 Factors include consideration of the capability of the regulatory system of the exporting nation to ensure compliance with U.S. safety standards for the food. 相关因素包括考虑出口国法规体系对符合美国食品安全标准的保证能力 Exemptions for certain alcoholic beverages and products subject to USDA oversight at import 某些受美国农业部监管的含酒精进口饮料和产品除外 * * What Are Accreditation Bodies?什么是认可机构？ An accreditation body can be a foreign government/agency or a private third-party. 认可机构可以是外国政府或私营第三方机构 An accreditation body may use documentation of its conformance to ISO/IEC 17011, supplemented as necessary, in meeting FDA requirements. 认可机构可以使用其符合ISO/IEC17011要求的文件，并按需补充文件，从而满足FDA的要求