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食品检测机构 食品药品监管总局关于贯彻婴幼儿配方乳粉生产许可审查细则严格生产许可工作的通知
发布时间: 2014-01-17 - 标签: , , - 浏览 2,184 次
食品药品监管总局关于贯彻婴幼儿配方乳粉生产许可审查细则严格生产许可工作的通知
食药监食监一〔2013〕253号
2013年12月24日 发布
 
各省、自治区、直辖市食品药品监督管理局(质量技术监督局),新疆生产建设兵团食品药品监督管理局(质量技术监督分局):  为贯彻落实《国务院办公厅转发食品药品监管总局等部门关于进一步加强婴幼儿配方乳粉质量安全工作意见的通知》(国办发〔2013〕57号),严格婴幼儿配方乳粉生产企业许可条件,总局制定发布了《婴幼儿配方乳粉生产许可审查细则(2013版)》(总局2013年第49号公告,以下简称《细则》)。现就贯彻落实《细则》,开展婴幼儿配方乳粉生产许可工作通知如下:

  一、认真组织学习《细则》,准确把握内容要求
《细则》是实施婴幼儿配方乳粉生产许可的重要依据,是贯彻落实国务院加强婴幼儿配方乳粉质量安全工作部署的重要措施。《细则》参照药品管理的办法和措施,进一步严格婴幼儿配方乳粉生产许可条件,重点提高了企业质量安全管理、原辅料质量、产品配方、产品追溯、检验检测和自主研发能力等方面的要求。
各省级局要组织食品安全监管人员和企业有关人员认真学习,全面理解把握《细则》的内容和要求,着重学习《细则》中调整和新增加的内容,确保婴幼儿配方乳粉生产许可工作顺利进行。

  二、严格生产许可,规范婴幼儿配方乳粉生产
各省级局要按照《细则》内容和婴幼儿配方乳粉质量安全监管的要求,认真组织开展婴幼儿配方乳粉生产许可有效期届满换证审查和再审核工作。
(一)严格审查时间。要统筹安排,督促本地所有取得婴幼儿配方乳粉生产许可的企业按照要求及时提出审查申请,于2014年5月31日之前完成换证审查和再审核工作,并及时公布通过审查换发生产许可证的企业和产品名录。
(二)严格延期审查。对暂不能达到《细则》要求、不能按时提出审查申请的企业,以及未通过换证审查和再审核取得生产许可的企业,经省级局批准,可给予2年的停产整改时间,保留原生产许可证编号。
(三)严格组成审查组。总局统一组织婴幼儿配方乳粉生产许可审查员培训、考核和注册。各省级局要根据企业规模和审查工作量等情况成立审查组,每个审查组应从经总局注册的婴幼儿配方乳粉生产许可审查员中选取3~5名人员组成,并指定审查组长。各省级局要指派负责婴幼儿配方乳粉质量安全工作的监管人员参与审查工作。
(四)严格产品配方和标签管理。通过生产许可审查的企业应及时将产品配方和包装、标签式样报送当地省级局。按照《细则》有关生产0~6个月龄婴儿配方乳粉使用乳清粉和乳清蛋白粉的质量要求及产品分段要求,企业需要更改配方或改变产品名称、包装、标签的,给予1年的整改过渡期。
(五)严格发证检验。生产许可审查抽取的检验样品,应送经总局考核确定的婴幼儿配方乳粉生产许可检验机构进行发证检验。检验机构要严格按照婴幼儿配方乳粉国家标准和产品配方等进行检验,并准确、及时地出具检验报告,报送相关省级局和总局。
(六)严格干湿法复合工艺审查。对采用干湿法复合工艺生产婴幼儿配方乳粉的集团公司,其采用湿法工艺生产基粉的工厂和添加部分配料干混生产婴幼儿配方乳粉的工厂不在同一个厂区的,要对基粉工厂和婴幼儿配方乳粉工厂一并组织审查。对基粉工厂和婴幼儿配方乳粉工厂不在同一省(区、市)的,由婴幼儿配方乳粉工厂所在地省级局会同基粉工厂所在地省级局组成联合审查组进行审查。同时,增加对基粉储存、运输、使用管理制度的审查,确保基粉质量安全。基粉仅限集团公司内部工厂使用。
审查通过后,由工厂所在地省级局分别发证。对婴幼儿配方乳粉工厂发放婴幼儿配方乳粉生产许可证,在生产许可证书副页中注明所使用的基粉规格及其工厂名称;对基粉工厂发放乳制品生产许可证,在生产许可证书副页中注明基粉规格和使用的工厂名称。
对集团公司内部既生产婴幼儿配方乳粉又生产基粉的工厂,发放婴幼儿配方乳粉生产许可证,在生产许可证副页中注明生产的基粉规格和使用的工厂名称。
对集团公司所属基粉工厂和婴幼儿配方乳粉工厂不在同一个厂区的,各省级局根据集团公司申请,原则上给予3年的整改过渡期。
对使用基粉添加部分配料干混生产婴幼儿配方乳粉的企业,其基粉不是企业内部工厂提供的,不予生产许可审查。

  三、加强组织领导,确保工作质量
(一)加强组织领导。各省级局要充分认识婴幼儿配方乳粉生产许可工作的严肃性和重要性,严格按照法律法规的规定和总局的要求,结合实际情况,制定换证审查和再审核工作方案,严格审查程序,统一审查要求,确保婴幼儿配方乳粉生产许可工作取得实效。黑龙江省、内蒙古自治区、广东省、陕西省局要成立换证审查和再审核工作领导小组,切实加强统一领导和组织协调。
(二)强化监督管理。换证审查和再审核期间,各省级局应加强对婴幼儿配方乳粉生产企业的监督检查,加大对停产整改企业和处于过渡期企业的监管力度,要求企业严格落实主体责任,保证婴幼儿配方乳粉质量安全。
(三)加强督导检查。各省级局要加强对婴幼儿配方乳粉生产许可换证审查和再审核工作的督促指导,及时组织研究解决工作中的问题。总局将适时组织食品安全监管人员、纪检监察人员和专家等组成督查组,对各地开展婴幼儿配方乳粉生产许可工作进行督导检查。
国家食品药品监督管理总局
2013年12月24日

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