In order to strengthen the management of probiotics-based health foods and to standardise the declaration and evaluation procedures, the State Administration for Market Regulation (SAMR) drafted The Declaration and evaluation Regulations on Probiotics-based Health Foods (Draft for Comment), which is now open for public comments.
 

Global Foodmate summarised the main points as follows:
 

Probiotics are ‘Live microorganisms which when administered in adequate amounts confer a health benefit on the host’. Probiotics-based health foods refer to microbial products that are using probiotics as the main functional ingredients with necessary excipients, and when administered in adequate amounts confers a health benefit on the human body. Probiotics-based health foods must be safe to eat and not cause acute, sub-acute or chronic harm to humans.
 

1. In addition to comply with Measures for Administration of Health Food Registration and Filing, the application of probiotics-based health foods also requires the following information:
 

  a. The reference of usage of the strain, inspection report of the raw materials, etc.

  b. Genus name, species name and strain number of the used strain. The genus name and species name shall be presented with a corresponding Latin name.

  c. Culture conditions (culture medium, culture temperature, etc.) of the strain.

  d. Source of the strain and the safely edible proof at home and abroad.

  e. Identification report of the strain, including the phenotypic and genotypic characteristics.

  f. Safety evaluation reports, such as, pathogenicity test and drug resistance test.

  g. Storage method of the strain.

  h. For domesticated strains, methods and agents for domestication shall be provided.

  i. Research reports and scientific literature on the function of the strain.
 

2. The viable count of each strain in probiotics-based health foods shall not be less than 10⁶ CFU/mL (g).
 

3. Labelling and instructions of probiotics-based health foods shall comply with Measures for Administration of Health Food Registration and Filing and other regulations, the name and number of the strain shall be clearly indicated in Chinese.
 

4. Genetically modified strains and their metabolites cannot be used in health foods.
 

5. Except for the culture medium, animals, plants and other substances with functional effect shall not be added during the fermentation process or into the finished health foods.
 

6. Production strain shall not be changed.