According to the “Administrative Measures for Registration and Filing Management of Health Food”, the State will implement filing management for the health food in which the used raw materials have been included in the “List of raw materials of health food” and the health food that is im
ported at the first time included the supplemented vitamin, mineral and other nutrients.
On May 2, 2017, CFDA has formulated and published the “Guideline for filing of health food (trial)”, and it has taken effect since the date of promulgation.
The filing of health food refers to such process that the health food manufactures submit the materials indicating the safety, health functions and quality co
ntrol of the products to the food and drug administration department for filing, publicity and future reference in accordance with legal procedures, co
nditions and requirements.
This guideline mainly stipulates the application scope, filing subject, filing process and requirements, requirements of filing materials format of health food filing, as well as the requirements of the filing materials for domestic & im
ported health food.
Application Scope
This guideline applies to the filing of health food stipulated in the “Administrative measures for registration and filing management of health food”.
Filing Subject
This guideline provides technical guidance for the filing of health food. Domestic and im
ported health food enterprises shall strictly follow this Guideline.
Filing process
1 Obtain the login ID of filing system
2 Fill and submit the filing information of product
3 Release the filing number, file and make it public.
The items for filing materials of domestic health food
1 The registration form for filing of health food, and letter of commitment on legal liability of filing person respo
nsible for the authenticity of the submitted materials
2 The supporting docu
ment of subject registration of the filing person
3 The product formula materials
4 The materials of product manufacturing process
5 Materials of e
valuation on safety and healthcare function
6 The type, name and standards of packaging materials directly co
ntacting with health food
7 The manus
cript of product label and instruction
8 The materials of product technical requirements
9 The all-items inspection report issued by the inspection agency entitled with legal qualification and in co
nformity with the product technical requirements
10 Related searching materials of product name
11 The other materials indicating the safety and health function of products
The items for filing materials of imported health food
In addition to the relevant materials submitted as domestic products, the following materials shall also be submitted:
1 The supporting docu
ments for registration of filing person subject
2 The supporting docu
ments certifying that the health food has been put into the market for more than one year
3 The original texts of technical regulations or standards related to the filed health food of producing country (region) or internatio
nal organizations
4 The actual samples of packaging, label and specification of product sold in the producing country (region)
5 Wher
e the filing affairs are handled by the permanent representative organization to China of the overseas filing person, the scanned copy of “Registration Certificate of the Permanent Representative Organization to China of Foreign Enterprises” shall be submitted
6 The original supporting docu
ments, and power of attorney (agreement), etc. issued by overseas organizations
7 The supporting docu
ments of production and sales, quality management system or GMP, and manufacturing co
nsignment agreement