Chapter 1 General Provisions

Article 1 [Basis of formulation] is to standardize the management of health food labeling. According to the "Food Safety Law of the People's Republic of China" (hereinafter referred to as "Food Safety Law") Safety Law") and its implementation regulations, and the "Health Food Registration and Filing Management Measures" formulate these measures.

Article 2 [Scope of Application] These Measures shall apply to the labeling and management of health food produced and sold within the territory of the People's Republic of China.

Article 3 [Definition] Health food labels as mentioned in these Measures refer to the general term for words, symbols, numbers, patterns, etc. used to express basic information about products and companies, such as instructions, labels, logos, etc. Health food labels refer to the text, graphics, symbols and all explanations attached to the product sales package used to identify the characteristics, functions, safety warnings and other information of health food. Health food instructions refer to separate materials produced by the health food registrant or filer to further explain product information. Health food logo refers to a unified symbol that is attached to the product and is sufficient to distinguish it from other foods.

Article 4 [Regulatory Responsibilities] The State Food and Drug Administration is responsible for formulating management regulations for health food labeling and guiding the supervision and management of health food labeling nationwide.

The food and drug supervision and administration departments of local people's governments at or above the county level are responsible for the supervision and management of the labeling of health foods produced and operated within their respective administrative regions.

Article 5 [Subject Responsibility] Health food manufacturers and operators are responsible for the legality and authenticity of their health food labels.

Imported health food manufacturers and operators are responsible for the legality and authenticity of the labels of the health food they import.

Chapter 2 Content Requirements for Labeling

Article 6 [Content Requirements] Health food labels should indicate the manufacturer’s information, product information, usage information, storage information and the information specified by laws and regulations. Other information etc. The content of the logo should be true, accurate and easy to understand.

The enterprise information identified in Article 7 [Enterprise Information] shall meet the following requirements:

(1) The name of the production enterprise registered in accordance with the law, the address of the production license, and the number of the production license , the contact information of the production enterprise;

(2) The entrusted production of health food should be marked with the entrusting enterprise and contact information, the name and address of the entrusted enterprise, and the production license number of the entrusted enterprise;

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(3) In addition to the address, the contact information should also indicate at least one of the following: telephone, fax, online contact information, etc.;

(4) The imported health food label should also indicate The country of origin, as well as the name, address and contact information of the domestic agent.

The product information identified in Article 8 [Product Information] shall include the following content and comply with relevant requirements:

(1) Product name shall consist of a trademark name, a common name and an attribute name composition. The trademark name should be unique to the product and distinguish the product from other similar products. The common name should be named after the main functional raw materials or other methods. Attribute names should be named after product dosage forms or food attributes;

(2) For raw materials and excipients, the names of all raw materials and excipients should be listed in accordance with the content and order of approval or filing.

If the original approval certificate does not include the names of all raw materials and auxiliary materials, the raw materials and auxiliary materials should be listed in descending order of the amount added according to the actual production situation;

(3) Functional ingredients/iconic ingredients and their contents should be listed Label the names of functional ingredients/iconic ingredients according to the approved content, and specify the content of functional ingredients/iconic ingredients in products per unit mass or volume;

(4) For health care functions, standardized functional names should be used;

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(5) The health food mark shall be the pattern specified by the State Food and Drug Administration;

(6) The health food approval number or registration number shall be the "Health Food Registration Number" The approval number stated on the Certificate or the registration number obtained during filing;

(7) Product specifications and net content. Product specifications are the minimum preparation unit mass or volume, and net content is the information in the sales package. Including product quality or volume;

(8) Production date and shelf life, production batch number;

(9) Irradiated health food or the use of irradiated raw and excipients, "This product has been irradiated" or "XX raw materials have been irradiated" should be marked;

(10) Nutrient supplement products should be marked with the words "nutrient supplement" and the words "nutritional supplement" in the health function item. "Supplement XX nutrients";

(11) Health foods that use genetically modified raw materials should be labeled in accordance with relevant regulations.

The usage information of Article 9 [Usage Information] logo should include the following contents:

(1) Consumption method and consumption amount;

(2) Appropriateness Population, unsuitable population;

(3) Precautions;

(4) Statement that “this product cannot replace drugs”; registered products should also be marked with “This product has not been approved for food use” Evaluation by the Drug Supervision and Administration Department”.

The storage information marked in Article 10 [Storage Information] shall include information on storage conditions and methods such as storage temperature and humidity.

Article 11 [Other information] Health food labels should also indicate other matters or information that need to be indicated in accordance with laws, regulations or national food safety standards.

Article 12 [Requirements for label content of instructions] The contents of instructions should include product name, raw materials and excipients, functional ingredients/iconic ingredients and content, health functions, suitable groups, unsuitable groups, consumption and Consumption methods, specifications, shelf life, storage methods and precautions, etc.

If the label already covers all the contents of the instruction manual, no additional instruction manual is required.

Article 13 [Consistency Requirements] The corresponding content of the health food instructions and labels should be consistent. If the content of the health food approval certificate is involved, it should be consistent with the approved content.

Article 14 [Active Change] Health food production and operation enterprises should strengthen the monitoring of the safety and health functions of health food after listing. If it is necessary to modify the labeling content of health food instructions and labels, they should do so in a timely manner. Make changes as specified.

Article 15 [Passive Change] Based on the progress of scientific research, emerging food safety situations, and changes in technical standards and specifications, the State Food and Drug Administration may also require companies to modify the content of health food labels. Enterprises should register or file changes in labeling content in accordance with the relevant requirements of the State Food and Drug Administration.