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| Order of the National Health and Family Planning Commission | | 國家衛生和計劃生育委員會令 |
| (No. 1) | | （第1號） |
| 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. | | 《新食品原料安全性審查管理辦法》已于2013年2月5日經原衛生部部務會審議通過，現予公布，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 | | 新食品原料安全性審查管理辦法 |
| 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. | | 第一條 為規範新食品原料安全性評估材料審查工作，根據《中華人民共和國食品安全法》及其實施條例的有關規定，制定本辦法。 |
| Article 2 The term “new food raw materials” refers to the following items which are not of traditional eating habits in China: | | 第二條 新食品原料是指在我國無傳統食用習慣的以下物品： |
| (1) Animals, plants and microorganisms. | | （一）動物、植物和微生物； |
| (2) Ingredients extracted from animals, plants and microorganisms. | | （二）從動物、植物和微生物中分離的成分； |
| (3) Food ingredients the original composition of which has been changed. | | （三）原有結構發生改變的食品成分； |
| (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. | | 第三條 新食品原料應當具有食品原料的特性，符合應當有的營養要求，且無毒、無害，對人體健康不造成任何急性、亞急性、慢性或者其他潛在性危害。 |
| 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. | | 第四條 新食品原料應當經過國家衛生計生委安全性審查後，方可用于食品生產經營。 |
| 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. | | 第五條 國家衛生計生委負責新食品原料安全性評估材料的審查和許可工作。 |
| 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. | | 國家衛生計生委所屬衛生監督中心承擔新食品原料安全性評估材料的申報受理、組織開展安全性評估材料的審查等具體工作。 |
| 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: | | 第六條 擬從事新食品原料生產、使用或者進口的單位或者個人（以下簡稱申請人），應當提出申請並提交以下材料： |
| (1) Application form. | | （一）申請表； |
| (2) Research and development report on the new food raw material. | | （二）新食品原料研制報告； |
| (3) Safety evaluation report. | | （三）安全性評估報告； |
| (4) Production techniques. | | （四）生產工藝； |
| (5) Relevant implemented standards applied to the material (including safety requirements, quality specifications and inspection measures) | | （五）執行的相關標准（包括安全要求、質量規格、檢驗方法等）； |
| (6) Label and manual. | | （六）標簽及說明書； |
| (7) Information on utilization thereof and domestic and international research thereon as well as relevant safety evaluation materials. | | （七）國內外研究利用情況和相關安全性評估資料； |
| (8) Other materials conducive to evaluation and review. | | （八）有助于評審的其他資料。 |
| In addition, the applicant shall attach one sealed product sample or 30 grams of the raw material. | | 另附未啟封的產品樣品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: | | 第七條 申請進口新食品原料的，除提交第六條規定的材料外，還應當提交以下材料： |
| (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）出口國（地區）相關部門或者機構出具的允許該產品在本國（地區）生產或者銷售的證明材料； |
| (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）生產企業所在國（地區）有關機構或者組織出具的對生產企業審查或者認證的證明材料。 |
| 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. | | 第八條 申請人應當如實提交有關材料，反映真實情況，對申請材料內容的真實性負責，並承擔法律責任。 |
| ．．．．．． | | ．．．．．． |
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