13 FAQs on Food for Special Medical Purpose (FSMP) Registration

1. Is it necessary to obtain food production license before applying for FSMP registration?

For the domestic manufacturers who plan to produce and distribute FSMP in China:

• Step 1: get business license for manufacturer;
• Step 2: apply for FSMP registration and get the registration certificate for product;
• Step 3: apply for FSMP production licensing for manufacturer. The domestic manufacturers can carry out FSMP production after getting the corresponding food production license.

2. How to carry out the overseas on-site inspection for imported FSMP products?

Due to the location restriction of overseas manufacturers, the timeline of overseas on-site inspection will be determined case by case.

3. Is it necessary to provide the composition of food flavoring?

a) The food flavoring shall comply with GB 30616 food flavoring. The specific components of the food flavoring are not required to provide, but the usage of them shall comply with GB 2760-2014 the usage of food additives.

b) If you directly use an individual flavor (such as vanillin), its usage shall comply with GB 2760-2014, and its name and dosage shall be provided.

4. Can probiotic be an individual FSMP product under the category of incomplete nutritional formula food?

According to GB 29922-2013, the incomplete nutritional formula foods include (1) Nutrient components (protein components, fat components, carbohydrate components), (2) Electrolyte formula, (3) Thickening components, (4) Liquid formulation, (5) Amino acid metabolism disorder formula. At present, only the listed categories are available for FSMP registration. In terms of probiotic, it is not listed.

5. Can we add ingredients which belongs to both food ingredient and medicine ingredient, or traditional Chinese medicine into FSMP?

The product formula shall comply with GB25592/GB29922. Except for the nutrients and optional components stipulated in above standards, it is forbidden to add neither other bioactive substances nor drugs in the formula.

6. How to indicate compound ingredients in the formula?

Compound ingredients refer to the ingredients consist of two or above other ingredients, such as mixed vegetable oil, pre-mixed vitamins and minerals, commercialized nutrition enhancers, compound food additives, etc. When using a compound ingredient, you shall list the specific components, and calculate dosage of each component in final product.

7. How to indicate the suitable crowds of full nutritional formula food and specific full nutritional formula food?

a) For full nutritional formula food, its suitable crowds shall be indicated in accordance with product characteristics and FSMP definition.

b) For specific full nutritional formula food, the suitable crowds shall be determined in accordance with the relevant contents of clinical trials.

8. How to indicate the nutrients in the nutrition information table?

The nutrients shall be indicated in the order of energy, protein, fat, carbohydrate, vitamins, minerals, optional components, and other components.

9. What are the differences between the manuscript of label/instruction book submitted for registration application, and the real label/instruction book designed for product launch?

The manuscript shall include 12 items as follows. The Review Center will carry out the technical review on the contents of these 12 items. For the real label/instruction book that used for product launch, it shall be further designed according to relevant laws and regulations in China.

If you would like to know more information about the labelling requirements, please kindly click Labeling Requirements of Foods for Special Medical Purpose (FSMP) in China

10. Can we entrust other manufacturers to produce the 3 batches of product samples for tests?

The 3 batches of samples for tests (including stability tests) shall be produced under commercial production conditions, and meet the requirements of GB 29923-2013 Good Manufacturing Practices of FSMP. It is forbidden to entrust other manufacturers to produce the test samples.

11. What tests should be designed for the FSMP stability study?

It shall at least include influencing factor test, accelerated test and long-term test. Based on the product characteristic and package, etc., the applicant can add other optional tests (e.g., stability test after the product is opened).

12. What are the requirements of food ingredients, food additives, and nutrition enhancers used in FSMP?

a) COAs of food ingredients, food additives and nutrition enhancers that used in FSMP shall be provided, and the quality results shall meet corresponding food safety national standards (GB) and/or relevant regulations. In addition, the quality of each ingredients used in compound ingredient shall meet their own GB and/or relevant regulations as well.

b) For imported FSMP products, if the standards of their food ingredients, food additives, and nutrition enhancers are different with corresponding GBs in China, materials proving that these ingredients can meet the requirements of corresponding GBs shall be provided.

13. What are the requirements of index limits and their test methods?

The index limits and their test methods shall comply with GB 29922, GB 25596 and relevant regulations. If the applicant does not take the test method that stipulated in corresponding GB, or take his own test method due to the lack of test method in corresponding GB, the test method source and/or methodology verification materials shall be provided.

For more information about FSMP registration, please kindly click Foods for Special Medical Purpose (FSMP) Registration in China

Q&A Reference

CFDA Health Food Review Center