Health Food Registration and Filing
In China health food is usually defined as food product that have specific health function or supply vitamins and (or) minerals. With the goal of regulating body's function,health food is suitable for specific groups of people. However, it is not used for the purpose of curing disease and causes no acute, sub-acute or chronic health effect to human body.
The definitions/names of these food products in different countries are different:
1. China: Health Food
2. EU: Food Supplement
3. USA:Dietary Supplement
4. Canada: Natural Health Product
5. Australia:Complementary Medicines
6. Korea: Health Functional Food
7. Japan:Food with Health Claims (FHC)
Classification of Health food
I.Nutrition supplement:
Food that replenishes the vitamins and (or) minerals but without providing energy or other active ingredients.
II. Functional health food:
Food that labeled with health function claim has physiological effects on the human body.
Regulation Background
In accordance with Food Safety Law of the People’s Republic of China (2015 version), companies who plan to place health food in Chinese market shall apply and obtain the health food registration certificate or filing certificate. For domestic health foods produced in China, the registration shall be conducted with CFDA, whereas, the filing shall be carried out with Provincial FDA. For imported health foods produced in oversea factories, both the registration and filing shall be applied with CFDA. Meanwhile, oversea companies shall have a permanent Chinese representative office or appoint a Chinese agent to deal with registration or filingand obtain such certificates.
Health food registration and filling shall be carried out according to Administrative Measures on Health Food Registration and Filing which was released on 1st March 2016 and will come into force on 1st July, 2016.
Part I Health Food Filing
Applicable Scopeof Filing
I. The domestic functional health food of which the raw materials meet the requirements in the Health Food Raw Materials Directory.
II. The domestic and imported nutrition supplement of which the vitamins and (or) minerals meet the requirements in the Health Food Raw Materials Directory.
Applicant's Qualification of Filing
I. The filing applicant of domestic health food shall be the factory who has the production certificate.
II. The filing applicant could be the oversea manufacturer (oversea manufacturer refers to the legal person and other organization).
Filing Procedure
Dossier Requirements of Filing
According to the Measures, the following documents are required for health food filing:
1. Health food filing application form;Letter of commitment for authenticity of the materials;
2. Copies of legally registered certificates of the applicant;
3. Product formulation materials (APIs and excipients);
4. Product production process materials;
5. Safety and function assessment material; andtests reports of functional components/characteristic ingredients, stability, hygiene health and others if necessary;
6. Information of packaging materials in direct contact with the product;
7. Samples of product label and package insert;
8. Product technical requirements;
9. Test according to product technical requirements;
10. Other materials proving product safety and health function.
For imported health food filing, besides the above documents, the following supplementary documents also should be submitted:
1. Qualification certifying documentsissued by government authoritiesor legal service agencies in the producing country (region) of origin proving that the filing applicant is the oversea manufacturer of the health foodmarketed;
2. Certifying documents issued by government authorities or legal service agencies in the producing country (region) of origin proving that the product has been marketed more than a year, or safety report of oversea sales and consumer’s feedback;
3. Health food-associated standards issued by the product producing country (region) of origin or international organizations;
4. Packaging, labels, package inserts for products marketed in the producing country (region)of origin;
5. For filing affairs run by oversea manufacturer’s Permanent Representative in China, a copy of the "registration certificate of oversea enterprise’s permanent Chinese representative offices" shall be provided; for filing affairs run by domestic agencies entrusted by oversea manufacturers, the applicant shall provide the original notarized certificate of entrustment and copies of business license of the agencies entrusted.
Part II Health Food Registration
Applicable Scope of Registration
I. Domestic health food of which the food raw materials are out of the scope of Health Food Raw Material Directory
II. Imported health food (excluded nutrition supplementof which the vitamins and (or) minerals meet the requirements in the Health Food Raw Materials Directory.)
Applicant's Qualification of Registration
I. The registration applicant of domestic health food could be the legal person or other organization registered in China.
II. The registration applicant of Imported health food could be the oversea manufacturer (oversea manufacturer refers to the legal person and other organization).
Registration Procedure
According to the Measures, the following documents are required for health food registration:
1. Health food registration application form;Letter of commitment for authenticity of the materials;
2. Copies of legally registered certificates of the applicant;
3. Product development report including the product technical requirements;
4. Product formulation materials (APIs and excipients);
5. Product production process materials;
6. Safety and function assessment material; and tests reports of functional components/characteristic ingredients, stability, hygiene health and others if necessary;
7. Information of packaging materials in direct contact with the product;
8. Samples of product label and package insert;
9. 3 samples with the minimum sales packaging;
10. Other materials pertaining to the product registrationtechnical evaluation.
For imported health food registration, besides the above documents, the following supplementary documents also should be submitted:
1. Qualification certifying documents issued by government authorities or legal service agencies in the producing country (region) of origin proving that the registration applicant is the oversea manufacturer of the health foodmarketed;
2. Certifying documents issued by government authorities or legal service agencies in the producing country (region) of origin proving that the product has been marketed more than a year, or safety report of oversea sales and consumer’s feedback;
3. Health food-associated standards issued by the product producing country (region) of origin or international organizations;
4. Packaging, labels, package inserts for products marketed in the producing country (region)of origin;
5. For registration affairs run by oversea manufacturer’s Permanent Representative in China, a copy of the "registration certificate of oversea enterprise’s permanent Chinese representative offices" shall be provided; for registration affairs run by domestic agencies entrusted by oversea manufacturers, the applicant shall provide the original notarized certificate of entrustment and copies of business license of the agencies entrusted.
Our Services
CIRS is providing one-stop services of China food regulatory compliance. We also deliver the most up-to-date regulatory information about food safety controlin China. For health food, we offer the following services:
I. Training on Health Food Regulation
II. Health Food Regulation Update Monitoring
III. Health Food Registration
IV. Health Food Filing
V. Single Technology Services
1) Pre-market Investigation
2) Classification Analysis and Formula Review
3) Chinese Label and Package Insert Design
4) Dossier Preparation
5) Translation
6) Test Arrange and Monitoring
Contact us
Ms. Cathy Yu Team Leader of Food Safety and Regulatory Affairs Department, CIRS China
11F Dongguan Building, 288 Qiuyi Road, Binjiang District, Hangzhou, China, 310020
Tel: +86 571 8720 6538 | Fax: +86 571 8720 6533
Email: cathy.yu@cirs-group.com
