CFDA released Detailed Regulations for Health Food Products Registration

In January 2017, the State Food and Drug Administration (SFDA) issued the Directory for Raw Materials of Health Care Food Products (1) and the Directory for Allowing the Health Care Functions of Health Care Food Products (1), which laid the foundation for the implementation of health food product registration system. In February 7, SFDA also officially released Detailed Regulations for Health Food Products Registration (exposure draft), including 8 main items and 22 pages. It provides detailed description of registration work in production enterprises.
These detailed regulations for touch upon several aspects of registration work, including scope of application, form of registration, contents of registration materials, registration requirements for domestic health care products, registration requirements for imported health care products, changes in registration, registration cancellation, information disclosure and so on.
I.            Subject of registration
The production and import of health care food products should be produced in accordance with laws. Among them, the application for registration of domestic health care products shall be submitted to the Food and Drug Administration at all provinces, autonomous regions and municipalities directly under the Central Government. The on-site application for registration of imported health care products shall be submitted to the administrative acceptance service department of SFDA. 
II.                Registration Procedures (as shown in the figure)

 

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备案人/申请登录账号/备案机构/发放登录账号/备案人/登录备案系/填写备案信息，提交成功后，扫描、上传（）系统，打印/30日内未递交纸质材料，系统（重返递交）状态/5个工作日通知备案人（递交）纸质资料/资料不符要求, 一次性告知

Registration applicant / Apply for the login account / Registration authority/ Issue the login account/ Registration applicant/ Log on the registration system/ Fill out the registration information, scan, upload to the system after successful submission, and print/ The system will return to the submission state if paper materials are not submitted within 30 days/ Notify the registration applicant within 5 working days to submit paper materials / One-time notification shall be made available if materials are inconsistent with requirements.

 
III.   Requirements for Registration Materials
There are five core requirements listed in these detailed regulations. Among them, it is stressed in the last provision that health care food products with different names that correspond to the same formula registration shall not be used by the same enterprise. The same name shall not be used in the registration of health care food products that correspond to different formulas. The same formula refers to the scenario in which the categories and amount of usage of raw materials and supplementary materials are all consistent. The same name refers to the scenario in which product trade name, common name and attribute name are all consistent.
This provision is a great impact on the industry, which means that many OEM health care product brands will receive a blow. In the health care food industry, OEM production is very common. In another word, one health care food product with one registered number of approval may be packaged into products with multiple brands and even dozens of brands after production and prior to sales. 
On one hand, this reduced the difficulty of entry of health care food brands into the market. On the other hand, the market order was disturbed by many non-standard enterprises through the utilization of OEM production.
IV.        Registration Materials for Domestic Health Care Food Products

 
 
Health care food product specification (template)
                                     Health care food registration
                     XXX brand XXX（Chinese name）
Raw material：
Supplementary material：
Functional ingredients or signature ingredient and content：
Commended user：
Commended user：
Healthcare function：
Recommended dosage & edible method:
Specification：
Storage method：
Quality guarantee period：
Attention ：
1. About the formula: The manufacturer should submit the product formula sheet automatically generated from the health care food registration management information system. The usage amount of raw materials and supplementary materials refer to the usage amount required for the production of 1000 minimum preparation units.
The vitamins, minerals and other nutrients supplemented in health care food products shall be arranged as per the sequence of nutrients specified in Directory for Raw Materials of Health Care Food Products. In case several kinds of chemical compounds are used in the same kind of nutrient, it is required to collate as per the size of usage amount. The raw materials for other products shall be sequenced as per the Directory for Raw Materials of Health Care Food Products.
2. About the health care function: For products complying with the Directory for Raw Materials of Health Care Food Products, health care function shall be marked according to relevant provisions. Nutritional supplements should list out all vitamins or minerals to be supplemented, with such representation as "XX supplemented". For products containing three or more vitamins or minerals, it is required to represent like this "Multivitamins or minerals supplemented". However, it is not allowed to represent in the form of "one or several kinds of raw materials+ multivitamins or minerals supplemented". Health care food products containing three and more vitamin B groups can be represented as "Vitamin B group supplemented".
3. About the denomination: The following names can be chosen as common names for nutrient supplement products:
  (1) Names of all nutrients shall be listed in accordance with the arrangement sequences specified in the Directory for Raw Materials of Health Care Food Products. For health care food products containing three or less nutrients, names of all nutrients shall be used as common names.
(2) For nutrients supplementation containing three and more Vitamins or minerals, common names can be called as "Multivitamins or minerals". However, it is not allowed to denominate in the form of "one or several kinds of raw materials+ multivitamins or minerals ".
(3) For nutrients supplementation containing three and more B vitamins (vitamin B1, vitamin B2, vitamin B6, vitamin B12, niacin, pantothenic acid, folic acid, etc.), it is required to denominate them as "Nicotinic acid Vitamins".

V.           Registration Materials for Imported Health Care Food Products
In addition to the submission of relevant materials required for domestic products, it is also required to submit the following documents, including   qualification documents of the registration applicant (i.e. overseas manufacturer of health care food products) and the documentary evidence of health care food products sold in the market for more than one year. Such qualification documents and documentary evidence shall be issued by the competent government authorities or legal services agency of the country (region) where products are produced. Reports to be submitted also include the safety report on products sold abroad and crowd consumption, or relevant original copies of technical regulations or standards for health care food products formulated by the country (region) or international organization where products are produced.