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Measures for the Administration of the Catalogue of Raw Materials of Dietary Supplements and the Catalogue of Health Functions [Effective]
保健食品原料目录与保健功能目录管理办法 [现行有效]
【法宝引证码】

Order of the State Administration for Market Regulation 

国家市场监督管理总局令

(No. 13) (第13号)

The Measures for the Administration of the Catalogue of Raw Materials of Dietary Supplements and the Catalogue of Health Functions, as deliberated and adopted at the 9th executive meeting of the State Administration for Market Regulation on December 18, 2018 and through consultation and reaching a consensus with the National Health Commission, are hereby issued and shall come into force on October 1, 2019. 《保健食品原料目录与保健功能目录管理办法》已于2018年12月18日经国家市场监督管理总局2018年第9次局务会议审议通过,经与卫生健康委协商一致,现予公布,自2019年10月1日起施行。
Director: Xiao Yaqing 局长 肖亚庆
August 2, 2019 2019年8月2日
Measures for the Administration of the Catalogue of Raw Materials of Dietary Supplements and the Catalogue of Health Functions 保健食品原料目录与保健功能目录管理办法
(Issued by Order No. 13 of the State Administration for Market Regulation on August 2, 2019) (2019年8月2日国家市场监督管理总局令第13号公布)
Chapter I General Provisions 

第一章 总 则

Article 1 For the purposes of regulating the administration of the Catalogue of Raw Materials of Dietary Supplements and the Catalogue of Permitted Health Functions Claimed by Dietary Supplements, these Measures are developed in accordance with the Food Safety Law of the People's Republic of China.   第一条 为了规范保健食品原料目录和允许保健食品声称的保健功能目录的管理工作,根据《中华人民共和国食品安全法》,制定本办法。
Article 2 These Measures shall apply to the formulation, adjustment and publication of the Catalogue of Raw Materials of Dietary Supplements and the Catalogue of Permitted Health Functions Claimed by Dietary Supplements that are produced and operated within the territory of the People's Republic of China.   第二条 中华人民共和国境内生产经营的保健食品的原料目录和允许保健食品声称的保健功能目录的制定、调整和公布适用本办法。
Article 3 The “Catalogue of Raw Materials of Dietary Supplements” means the list of information on raw materials of dietary supplements determined in accordance with these Measures, including the names, dosage and corresponding effects of raw materials.   第三条 保健食品原料目录,是指依照本办法制定的保健食品原料的信息列表,包括原料名称、用量及其对应的功效。
The Catalogue of Permitted Health Functions Claimed by Dietary Supplements (hereinafter referred to as the “Catalogue of Health Functions”) means the list of information on health functions with specific evaluation methods and judgment criteria determined in accordance with these Measures. 允许保健食品声称的保健功能目录(以下简称保健功能目录),是指依照本办法制定的具有明确评价方法和判定标准的保健功能信息列表。
Article 4 The formulation, adjustment and publication of the Catalogue of Raw Materials of Dietary Supplements and the Catalogue of Health Functions shall aim at guaranteeing food safety and promoting public health and follow the principles of legality, being scientific, openness and fairness.   第四条 保健食品原料目录和保健功能目录的制定、调整和公布,应当以保障食品安全和促进公众健康为宗旨,遵循依法、科学、公开、公正的原则。
Article 5 The State Administration for Market Regulation (“SAMR”) shall, in conjunction with the National Health Commission and the State Administration of Traditional Chinese Medicine, formulate, adjust and publish the Catalogue of Raw Materials of Dietary Supplements and the Catalogue of Health Functions.   第五条 国家市场监督管理总局会同国家卫生健康委员会、国家中医药管理局制定、调整并公布保健食品原料目录和保健功能目录。
Article 6 The food review body of the SAMR (hereinafter referred to as the “review body”) shall be responsible for organizing the drafting of the Catalogue of Raw Materials of Dietary Supplements and the Catalogue of Health Functions, and receiving the proposals of including in or adjusting the Catalogue of Raw Materials of Dietary Supplements and the Catalogue of Health Functions.   第六条 国家市场监督管理总局食品审评机构(以下简称审评机构)负责组织拟订保健食品原料目录和保健功能目录,接收纳入或者调整保健食品原料目录和保健功能目录的建议。
Chapter II Administration of the Catalogue of Raw Materials of Dietary Supplements 

第二章 保健食品原料目录管理

Article 7 Except for vitamins, minerals and other nutrients, a raw material included in the Catalogue of Raw Materials of Dietary Supplements shall satisfy the following requirements: 卡在了奇怪的地方  第七条 除维生素、矿物质等营养物质外,纳入保健食品原料目录的原料应当符合下列要求:
(1) It has been edible at home or abroad, its safety is definite and it has been used in any dietary supplement of which the registration is approved. (一)具有国内外食用历史,原料安全性确切,在批准注册的保健食品中已经使用;
(2) The corresponding effects of the raw material have been included in the current Catalogue of Health Functions. (二)原料对应的功效已经纳入现行的保健功能目录;
(3) The product technical requirements such as the raw material and its dosage range, corresponding effects, productive technology and testing methods may be subject to standardized management so as to ensure the consistent quality of products filed in accordance with the Catalogue. (三)原料及其用量范围、对应的功效、生产工艺、检测方法等产品技术要求可以实现标准化管理,确保依据目录备案的产品质量一致性。
Article 8 Any raw material falling under any of the following circumstances shall not be included in the Catalogue of Raw Materials of Dietary Supplements:   第八条 有下列情形之一的,不得列入保健食品原料目录:
(1) It has any food safety risk or its safety is indefinite. (一)存在食用安全风险以及原料安全性不确切的;
(2) Technical requirements cannot be developed for standardized management or the conditions for industrialized production are not met. (二)无法制定技术要求进行标准化管理和不具备工业化大生产条件的;
(3) It is prohibited from being eaten by any law, regulation or the relevant department of the State Council, violates the requirements of any law or regulation on ecological environment and resources or falls under any other circumstance prohibiting it from being included in the Catalogue. (三)法律法规以及国务院有关部门禁止食用,或者不符合生态环境和资源法律法规要求等其他禁止纳入的情形。
Article 9 Any entity or individual may, based on the relevant research, offer a proposal of including in or adjusting the Catalogue of Raw Materials of Dietary Supplements to the review body.
......
   第九条 任何单位或者个人在开展相关研究的基础上,可以向审评机构提出拟纳入或者调整保健食品原料目录的建议。
......

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