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Administrative Measures for the Safety Review of New Food Raw Materials (2017 Amendment PKULAW Version) [Effective]
新食品原料安全性审查管理办法(2017修正) [现行有效]
【法宝引证码】

Administrative Measures for the Safety Review of New Food Raw Materials

 

新食品原料安全性审查管理办法

(Issued by the Order No. 1 of the National Health and Family Planning Commission on May 31, 2013 and amended according to the Order No. 18 of the National Health and Family Planning Commission, The Decision of the National Health and Family Planning Commission to Amend Seven Departmental Rules Including the Administrative Measures for the Safety Review of New Food Raw Materials on December 26, 2017) (2013年5月31日国家卫生和计划生育委员会令第1号公布 根据2017年12月26日国家卫生和计划生育委员会令第18号《国家卫生计生委关于修改〈新食品原料安全性审查管理办法〉等7件部门规章的决定》修正)

Article 1 In order to regulate the review of materials for safety evaluation of new food raw materials, these Measures are formulated in accordance with relevant provisions of the Food Safety Law of the People's Republic of China and the Regulation on the Implementation of the Food Safety Law.   第一条 为规范新食品原料安全性评估材料审查工作,根据《中华人民共和国食品安全法》及其实施条例的有关规定,制定本办法。
Article 2 The term “new food raw materials” refers to the following items which are not of traditional eating habits in China:   第二条 新食品原料是指在我国无传统食用习惯的以下物品:
(1) Animals, plants and microorganisms. (一)动物、植物和微生物;
(2) Ingredients extracted from animals, plants and microorganisms. (二)从动物、植物和微生物中分离的成分;
(3) Food ingredients the original composition of which has been changed. (三)原有结构发生改变的食品成分;
(4) Other newly developed food raw materials. (四)其他新研制的食品原料。
Article 3 New food raw materials shall have the quality of food raw materials, satisfy necessary nutritional requirements, be non-toxic and harmless and pose no acute, subacute, chronic or other potential harm to human health.   第三条 新食品原料应当具有食品原料的特性,符合应当有的营养要求,且无毒、无害,对人体健康不造成任何急性、亚急性、慢性或者其他潜在性危害。
Article 4 Only upon safety review by the National Health and Family Planning Commission, shall new food raw materials be used in food production and trading.   第四条 新食品原料应当经过国家卫生计生委安全性审查后,方可用于食品生产经营。
Article 5 The National Health and Family Planning Commission shall be responsible for the review of materials for safety evaluation of new food raw materials and issuance of license.   第五条 国家卫生计生委负责新食品原料安全性评估材料的审查和许可工作。
The technical review institution for new food raw materials (hereinafter referred to as the “review institution”) under the National Health and Family Planning Commission shall be responsible for conducting the technical review of the safety of new food raw materials and making comprehensive review conclusions and recommendations. 国家卫生计生委新食品原料技术审评机构(以下简称审评机构)负责新食品原料安全性技术审查,提出综合审查结论及建议。
Article 6 Any entity or individual (hereinafter referred to as the “applicant”) that intends to engage in production, use or import of a new food raw material, shall file an application and submit the following materials:   第六条 拟从事新食品原料生产、使用或者进口的单位或者个人(以下简称申请人),应当提出申请并提交以下材料:
(1) Application form. (一)申请表;
(2) Research and development report on the new food raw material. (二)新食品原料研制报告;
(3) Safety evaluation report. (三)安全性评估报告;
(4) Production techniques. (四)生产工艺;
(5) Relevant implemented standards applied to the material (including safety requirements, quality specifications and inspection measures) (五)执行的相关标准(包括安全要求、质量规格、检验方法等);
(6) Label and manual. (六)标签及说明书;
(7) Information on utilization thereof and domestic and international research thereon as well as relevant safety evaluation materials. (七)国内外研究利用情况和相关安全性评估资料;
(8) Other materials conducive to evaluation and review. (八)有助于评审的其他资料。
In addition, the applicant shall attach one sealed product sample or 30 grams of the raw material. 另附未启封的产品样品1件或者原料30克。
Article 7 When applying for import of a new food raw material, in addition to materials prescribed in Article 6, the applicant shall also submit the following materials:   第七条 申请进口新食品原料的,除提交第六条规定的材料外,还应当提交以下材料:
(1) Supporting documents issued by relevant authority or institution in the exporting country (region) allowing such product to be produced or sold in the exporting country (region). (一)出口国(地区)相关部门或者机构出具的允许该产品在本国(地区)生产或者销售的证明材料;
(2) Supporting documents for review or certification of the manufacturer issued by relevant institution or organization in the country (region) where the manufacturer is located. (二)生产企业所在国(地区)有关机构或者组织出具的对生产企业审查或者认证的证明材料。
Article 8 The applicant shall truthfully submit relevant materials and report true situations. The applicant shall be responsible for authenticity of contents of application materials and otherwise assume legal liability.   第八条 申请人应当如实提交有关材料,反映真实情况,对申请材料内容的真实性负责,并承担法律责任。
Article 9 When submitting materials prescribed in Items 2 through 6 of Paragraph 1 of Article 6 in these Measures, the applicant shall indicate the contents that do not involve trade secrets and may be disclosed to the public.
......
   第九条 申请人在提交本办法第六条第一款第二项至第六项材料时,应当注明其中不涉及商业秘密,可以向社会公开的内容。
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