| | |
| Order of the National Health and Family Planning Commission | | 国家卫生和计划生育委员会令 |
| (No. 1) | | （第1号） |
| The Administrative Measures for the Safety Review of New Food Raw Materials, as deliberated and adopted at the executive meeting of the former Ministry of Health on February 5, 2013, are hereby issued and shall come into force on October 1, 2013. | | 《新食品原料安全性审查管理办法》已于2013年2月5日经原卫生部部务会审议通过，现予公布，自2013年10月1日起施行。 |
| Minister Li Bin | | 主任 李斌 |
| May 31, 2013 | | 2013年5月31日 |
| 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 |
| 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 National Center for Health Inspection and Supervision under the National Health and Family Planning Commission shall be responsible for accepting application materials for safety evaluation of new food raw materials, organizing the review of materials for safety evaluation of new food raw materials and other specific work. | | 国家卫生计生委所属卫生监督中心承担新食品原料安全性评估材料的申报受理、组织开展安全性评估材料的审查等具体工作。 |
| 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。 |
| ．．．．．． | | ．．．．．． |
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