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企业标准备案程序
发布时间: 2014-01-24 - 标签: , - 浏览 2,132 次

甘肃省食品安全企业标准备案程序

为保障食品安全企业标准备案工作的公平、公正、公开,根据《中华人民共和国食品安全法》和卫生部《食品安全企业标准备案办法》(卫政法发〔2009〕54号)的要求,制定本食品安全企业标准(以下简称企业标准)备案程序。

 一、备案受理范围 

(一)在甘肃省行政区域内,食品生产企业制定下列企业标准,应当在组织生产之前向省卫生厅备案。

1、没有食品安全国家标准或者地方标准的企业标准;

2、严于食品安全国家标准或者地方标准的企业标准。

(二)集团公司所属企业适用统一的企业标准的,可以由集团公司总部或者其所属任一生产企业向省卫生厅备案。该企业标准备案时,应当注明适用的各企业名称及地址。

(三)委托加工或者授权制造的食品,委托方或者授权方已经备案的企业标准,受托方或者被授权方无需重复备案。但委托方或者授权方在备案时,应当注明受托方或者被授权方的名称及地址。委托方或者授权方无相关企业标准的,以及受托方或者被授权方不执行委托方或者授权方标准的,受托方或者被授权方应当制定企业标准,并按照规定备案。

 二、备案程序

(一)申请

食品生产经营单位在组织生产之前,到省政府政务大厅卫生厅窗口申请企业标准备案并提交以下材料:

1、企业标准备案登记表(一式二份);

2、企业标准文本(一式八份)及电子版;

3、企业标准编制说明(一式二份);

4、相关试验验证报告和查新技术资料;

5、工商营业执照复印件(一式二份加盖单位公章);

6、食品生产许可证复印件(一式二份加盖单位公章);

7、企业法人代表身份证复印件(一式二份加盖单位公章);

8、企业要求不公开涉及商业秘密的企业标准内容的,应当提出书面意见,并同时提供可向社会公布的企业标准文本;

9、申办代理人需有食品生产企业的授权委托书及本人身份证明。

10、其他材料

(二)受理

省卫生厅卫生监督所收到企业标准备案材料时,应当对备案材料的完整性和是否符合形式要求进行核对和审查,并根据下列情况分别做出处理:

1、企业标准依法不需要备案的,应当即时告知当事人不需备案;

2、提交的材料不齐全或者不符合规定要求的,应当立即或者在5个工作日内告知当事人补正;

3、提交的材料齐全,符合规定要求的,受理其备案,并出具企业标准备案受理通知书;

4、按要求完成企业标准备案的前期准备工作,提出初步意见,上报省卫生厅。

(三)审核与备案

省卫生厅收到备案申请材料后10个工作日内进行审核,备案材料齐全并符合规定的,在备案登记表上标注备案号并加盖备案章,以此作为企业标准备案凭证。组织召开专家评审会的时间不计入办理时限。

三、材料要求

(一)备案登记表

企业标准备案前,企业须填写《食品安全企业标准备案登记表》,《食品安全企业标准备案登记表》由企业法人代表或其授权的企业主管领导审批同意,加盖企业公章。备案的企业标准由企业的法定代表人或者主要负责人签署。企业应当确保备案的企业标准的真实性、合法性,确保根据备案的企业标准所生产的食品的安全性,并对其实施后果承担全部法律责任。

(二)企业标准文本

1、标准文本格式包括:标准封面、前言、首页、中间页和末页。

2、企业制定(修订)的企业标准应当包括:食品、食品相关产品中的致病性微生物、农药残留、兽药残留、重金属、污染物质以及其他危害人体健康物质的限量规定;食品添加剂的品种、使用范围、用量;专供婴幼儿和其他特定人群的主辅食品的营养成分要求;对与食品安全、营养有关的标签、标识、说明书的要求;食品生产经营过程的卫生要求;与食品安全有关的质量要求;食品检验方法与规程;其他需要制定为企业标准的内容。

3、企业标准还应当包括食品原料(包括主料、配料和使用的食品添加剂)、生产工艺以及与食品安全相关的指标、限量、技术要求。

4、企业标准的编写应当符合GB/T1.1《标准化工作导则第1部分:标准的结构和编写规则》的要求。

5、企业标准的编号格式为:Q/(企业代号)(四位顺序号)S──(年号)。企业标准编号按下述规定执行。

Q/ ××  ×××× S××××
          |        |          |
|         |          |
|         |          |     ①年代号(四位)
|        |                ②顺序号(四位)
|                           ③企业代号

注释:企业标准代号Q/ 代表企业制定、批准、发布的企业标准。

①年代号为标准发布的年代,用四位数表示。如:2010

②顺序号是企业自己制定的企业标准的顺序号,用四位阿拉伯数字表示。如:0001

③企业代号由企业定,一般用企业名称的汉语拼音字头或英文缩写的三个字母表示。如:金吉利食品有限公司代号是JJL。

(三)编制说明

1、企业标准编制说明应当详细说明企业标准制定过程和与相关国家标准、地方标准、国际标准、国外标准的比较情况。

标准比较适用下列原则:

(1)有国家标准或者地方标准时,与国家标准或者地方标准比较;

(2)没有国家标准和地方标准时,与国际标准比较;

(3)没有国家标准、地方标准、国际标准时,与两个以上国家或者地区的标准比较。

2、编制说明的内容

(1)任务来源,制订该标准的目的和意义,工作简要过程。其中包括:调研、试验、验证、起草过程等。

(2)采用和借鉴国内外标准资料的情况,包括国内外标准水平分析。

(3)标准主要内容的解释,修订标准时应有新旧内容的对比,同时还要写出修订的理由。

(4)贯彻该标准的措施、要求、建议。

(5)技术经济效果分析及其他应说明的问题。

四、标准审定

(一)审定要求

企业标准审定由企业自行组织,通过审定形成的审定纪要即是企业批准发布企业标准的技术依据,也是企业标准备案的必备材料。

(二)审定人员

1、参加企业标准审定的专家必须是“甘肃省食品安全企业标准评审专家库”的成员,专家组成员须经省卫生厅批准同意方可进行标准审定。

2、专家组审定企业标准,实行组长负责制,总人数不得少于5人,同一单位不得超过2人,直接参与企业标准起草的人员不得作为审定人员参加审定。标准审定必须经专家组全体人员三分之二以上同意方可通过。

3、参与企业标准审定工作的专家和技术人员应当具有副高以上专业技术职称和五年以上从事卫生、食品、农业、药品等行业相关工作经历,熟悉食品安全国家法律、法规、规章及标准,掌握相关食品生产工艺、技术要求和国内外该领域技术、标准发展的状况。

(三)审定纪要

专家组应当根据审定结果填写纪要,审定纪要包括:

1、审定情况:包括审定日期、地点、起草单位、组织审定机构、参加审定人员名单;

2、审定结论:主要包括评价意见,主要修改意见和采纳意见,标准文本送审稿是否符合法律、法规和强制性标准的规定,是否予以通过审定等内容。

(四)参加标准审定的人员在审定工作中应当坚持实事求是的原则和严肃认真的态度,保证审定结果的正确性和合理性和科学性,并对审定结论负责。审定人员还应当保守标准审定活动中涉及的技术秘密和商业秘密。

五、企业标准修订、复审、延续与注销

(一)修订

经备案的企业标准如有修改或补充及技术性的实质内容时,应当按照相关的规定,对企业标准进行复审,并按程序重新进行备案。

(二)复审

1、有下列情形之一的,企业应主动对企业标准进行复审:

(1)有关法律、法规、规章和食品安全国家标准、地方标准发生变化时;

(2)企业生产工艺或者食品原料(包括主料、配料和使用的食品添加剂)及配方发生改变时;

(3)其他需要复审的情形。

2、复审要求

企业标准复审时,企业应组织专家对企业标准进行复审,并携带本程序要求的材料,到省卫生厅办理确认继续有效或废止手续。经复审,被确认有效的企业标准,标准文本重新打印。

(三)延续与重新备案

1、延续

企业标准备案有效期为三年。企业在标准备案有效期满前一个月内,填写“延续备案登记表”,到省卫生厅重新办理延续手续。

2、重新备案

企业标准备案后超过三年的和复审时提出重新修订企业标准,企业应到省卫生厅重新办理备案手续。

(四)注销

被废止的企业标准,应当由省卫生厅加盖标准注销印章。有下列情形之一的企业标准应予以注销:

1、企业在企业标准备案有效期满30日内未到省卫生厅办理延续、复审手续的,应当予以注销;

2、复审时被认为需要重新修订的企业标准,应当予以注销;

3、发现备案的企业标准弄虚作假的,应当予以注销;

4、接到有关监管部门通报,企业没有按照备案的企业标准组织生产时,应当予以注销。

六、标准公布

企业标准经标准评审会评审专家审查通过后,省卫生厅卫生监督所将企业标准备案材料和企业标准审查意见表,上报省卫生厅备案。省卫生厅在发给企业备案凭证之日起20个工作日内向社会公布备案的企业标准。

 

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