Provisions on the Declaration and Evaluation of Health Food Containing Probiotics (Trial)

Article 1: To standardize the evaluation of probiotic health foods and ensure their safe consumption, this regulation is formulated in accordance with the "Food Hygiene Law of the People's Republic of China" and the "Measures for the Registration of Health Foods (Trial)".

 

Article 2: Probiotic health foods are microecological products that promote a balanced intestinal flora and provide beneficial effects to the human body.

 

Article 3: Probiotic strains must be members of the human normal flora and may utilize their live bacteria, dead bacteria, and metabolic products.

Probiotic health supplements must be safe and reliable, meaning they are safe for consumption with no adverse reactions. The biological, genetic, and efficacy characteristics of the starter cultures used in production must be well-defined and stable.

Article 4: The list of probiotic strains approved for use in health food products shall be published by the National Medical Products Administration.

Article 5: The National Medical Products Administration shall certify or accredit institutions responsible for identifying probiotic strains in health foods. The list of such accredited institutions shall be published by the National Medical Products Administration.
Strain identification for probiotic health supplements must be conducted at a certification-recognized testing facility approved by the FDA.

Article 6: In addition to submitting declaration materials in accordance with the relevant regulations for health foods, applications for probiotic health foods must also provide the following documents:
(1) The product formulation and its supporting rationale must include the determined genus name, species name, and strain number of the microorganism. The genus and species names must be accompanied by their corresponding Latin binomials.
(II) Culture conditions for the microbial strain (e.g., culture medium, temperature).
(3) Source of the microbial strain and domestic and international data on safe consumption.
(4) Bacterial strain identification report issued by a certification or recognized agency of the National Medical Products Administration.
(5) Safety evaluation data for the microbial strain (including virulence tests).
(VI) Strain Preservation Methods.
(7) For strains that have been domesticated or mutagenized, provide documentation on the domestication and mutagenesis methods, as well as details of the agents used.
(VIII) Health food products whose primary functional factors are dead bacteria and/or their metabolic byproducts must provide the names of the functional factors or characteristic components, along with their detection methods.
(ix) Technical specifications and guarantees from manufacturing enterprises.
(10) Certificate demonstrating that the enterprise's production conditions comply with the Good Manufacturing Practice for Health Food.
For probiotic strains not listed in the "List of Probiotic Strains Suitable for Health Food," submit research reports and relevant literature demonstrating their efficacy, along with data confirming that the strains and their metabolites produce no toxic or harmful effects. The National Medical Products Administration shall convene experts to evaluate the safety of consumption and functional basis of the strain; following this assessment, proceed with the standard health food evaluation process.

Article 7: If an applicant produces health food directly using freeze-dried probiotic powder, and the production process involves only mixing and filling, the documents listed in Items 5 through 10 of Article 6 may be provided as copies by the freeze-dried probiotic powder supplier (stamped with the supplier's official seal), along with proof of purchase and sale.

Article 8: Strains used in the production of probiotic health foods must meet the following requirements for registration.
(1) The seed lot system shall be used for菌种 in health food production. The Master Seed Lot (MSL) must be verified for its records, history, source, and biological characteristics. The MSL is derived from the Original Seed Lot through subculturing and expansion. The Working Seed Lot (WSL) is derived from the MSL through subculturing and expansion. The WSL must maintain biological consistency with the Original Seed Lot. Both MSL and WSL batches must be stored, tested, and used in accordance with prescribed procedures. On suitable media, the MSL shall not exceed 10 subcultures, and the WSL shall not exceed 5 subcultures.
(2) The trial production unit shall have a dedicated department and personnel to manage production strains, maintain strain records that include complete documentation on strain origin, history, screening, verification, preservation methods, quantities, and usage.
(3) Strains and their metabolites must be non-toxic and harmless. No toxic, harmful, or allergenic substances shall be added to the production culture medium.
(4) Viable bacteria capable of being isolated from probiotic health supplements must match the strain submitted for approval and indicated on the label.

Article 9: The facility for pilot production of probiotic health food samples shall meet the following requirements:
(1) Complies with Good Manufacturing Practice (GMP) requirements for health food production and establishes a Hazard Analysis and Critical Control Points (HACCP) quality assurance system.
(II) Possess pilot-scale production capacity, i.e., the ability to produce at least 500 L per day, and submit for approval using pilot products.
(3) A dedicated facility or workshop with specialized production equipment and infrastructure is required. A probiotics laboratory must be established, with strain management handled by a designated specialist. Oversight shall be provided by technical personnel holding at least a mid-level professional title in bacteriology. Detailed technical specifications and assurance protocols must be developed.

Article 10: The production strains and manufacturing processes shall not be altered.

Article 11: Liquid production of probiotic health food products containing live bacteria is not recommended.

Article 12: The viable count of probiotic health foods containing live bacteria shall not be less than 106cfu/mL(g) during their shelf life.

Article 13: If probiotic health foods require storage under special conditions, such conditions must be indicated on the label and in the instructions.

Article 14: During the fermentation process of the probiotic strains used, no animal or plant materials with functional ingredients, other than the culture medium, shall be added.

Article 15: Genetically modified strains shall not be used in health food products.

Article 16: This regulation shall be interpreted by the State Food and Drug Administration.

Article 17: These regulations shall take effect on [date]. In the event of any inconsistency between these regulations and previously issued regulations, these regulations shall prevail.

Attachment 1: List of Probiotic Strains Suitable for Health Foods

Bifidobacterium bifidum
Bifidobacterium infantis
Bifidobacterium longum
Bifidobacterium breve
Bifidobacterium adolescentis
Lactobacillus delbrueckii subsp. bulgaricus
Lactobacillus acidophilus
Lactobacillus casei subsp. casei
Streptococcus thermophilus
Lactobacillus reuteri

Attachment 2: List of Probiotic Strain Identification Units

Institute of Nutrition and Food Safety, Chinese Center for Disease Control and Prevention
Institute of Microbiology, Chinese Academy of Sciences