Official Reply to 20 FAQs regarding Food for Special Medical Purposes Products Registration in China

On Aug. 25, 2021, Center for Food Evaluation (subordinated to State Administration for Market Regulation) replied to 20 frequently asked questions in terms of food for special medical purposes (FSMP) registration. These questions mainly involve documents preparation, ingredient compliance, labeling, product manufacture. ChemLinked selects some questions for your reference:

Q1 What information should the R&D capability proving materials include?

The applicant shall provide R&D capability proving materials as per “Administrative Measures of FSMP Registration” and “Requirements for Application Materials for Registration of Foods for Special Medical Purpose (For Trial)”. The enterprises should establish FSMP R&D institution, and the basic R&D work can be relied on the company or cooperated with universities or scientific research institutions. Some R&D works such as the process certification of three batches of sample products should be carried out in the manufacturing enterprises.

Q2 What information should the inspection capability proving materials include?

For enterprises carrying out self-inspection, the applicant should provide materials of inspection personnel, inspection equipment and basic information of inspection capability. For those having entrusted inspection, the applicant should offer the name of the institution which conduct batch-by-batch inspection, their legal qualification certificate, and commission contract. If both of the two inspection methods are used, the applicant needs to illustrate and list the self-inspection items and entrusted inspection items.

Q3 How to register FSMP products with different flavors?

Premising that the products’ food raw materials, auxiliary materials, nutritional fortification substances, food additives and processing technique are all the same except food flavors and fragrances, they can be regarded as one product when it comes to registration by the same applicant.

Q4 What materials should be provided for product formula design basis?

The applicant should provide the design reference of the product formula’s composition, the varieties, sources and contents of the nutrients, consumption group and the evidence proving that the product can satisfy the nutrient demands of the target groups, consumption methods and dosage, and relevant clinical materials.

The references provided can be the materials illustrating the products’ compliance with corresponding GB standards, scientific literature and experiment materials proving the consumption safety, nutritional sufficiency, good clinical effect as well as domestic and overseas medicine and nutriology guideline, specialist consensus, etc.

Q5 What should be noticed while preparing the food ingredient dosage list?

The food ingredients should be arranged by their addition amount in descending order. When it comes to compound food raw materials and compound food additives, their compositions need to be listed in full (including the embedding wall materials), and the content should be converted into corresponding dosage in the product. It is not required to list all the flavors used in food fragrances. However, if the food fragrances are used for infant formula food for special medical purposes and FSMP targeted at population between 1 and 10 years old, all the ingredients of the food fragrances shall be listed. The applicant should illustrate that the addition of these fragrances and their usage amount are compliant.

Q6 How to correctly indicate the food ingredient list?

The labeling of food ingredients whose addition amount exceeding 2% of the all should follow the requirements in GB 7718. If the addition amount is less than 2%, the food raw materials should be arranged in the order of protein, fat, carbohydrate, vitamins, minerals, optional ingredients, other ingredients (e.g. lutein), food additives, other auxiliary materials (e.g. edible strains). It is noteworthy that vitamins and minerals should be arranged as per the order in nutrition list.

Feel free to contact ChemLinked for the completed English version.