Regulations on Declaration and Evaluation of Health Food Containing Fungi (Trial)

Regulations on Declaration and Evaluation of Health Food Containing Fungi (Trial)
(Draft for Comments)

Article 1: To standardize the review process for fungal health foods and ensure their safety for consumption, these regulations are formulated in accordance with the relevant provisions of the "Food Hygiene Law of the People's Republic of China" and the "Measures for the Registration of Health Foods (Trial)".

Article 2: Fungal health food products refer to products produced from the fruiting bodies or mycelium of edible macrofungi and microfilamentous fungi. These products must be safe and reliable, meaning they are non-toxic, harmless, and produced using fungal strains with well-defined and stable biological, genetic, and functional characteristics.

Article 3: Except for the fruiting bodies and mycelium of edible fungi commonly used over a long period, the list of fungal strains suitable for health food shall be published by the National Medical Products Administration.

Article 4: The National Medical Products Administration shall certify or recognize institutions responsible for identifying fungal strains in health foods. The list of such institutions shall be published by the National Medical Products Administration.
Fungal health supplement strain identification must be conducted at a certification or recognition agency designated by the State Food and Drug Administration.

Article 5: In addition to the documents required for health food applications under relevant regulations, applications for fungal health foods must also include the following:

(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 Starter Cultures (Including Virulence Tests). Starter cultures and their metabolites must be non-toxic and harmless. No toxic, harmful, or allergenic substances shall be added to the production media. For starter cultures capable of producing antibiotics, mycotoxins, or other bioactive compounds, relevant test reports on these substances must also be included.
(VI) Preservation, rejuvenation, and subculture methods for the culture strain, along with measures to prevent strain mutation.
(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) Technical specifications and guarantees provided by the manufacturing enterprise.
(9) Proof that the enterprise's production conditions comply with the "Good Manufacturing Practice for Health Food".
To develop, produce, or manufacture health foods using fungal strains not listed in the "List of Fungal Strains Approved for Use in Health Foods," applicants must also submit: research reports and relevant literature documenting the strain's efficacy, as well as data demonstrating that the strain and its metabolites do not produce any toxic or harmful effects. The National Medical Products Administration will first convene subject-matter experts to evaluate the safety of edible use and the functional basis of the strain. Following this preliminary review, the application will proceed through the standard health food evaluation process.

Article 6: For applicants producing health foods using fermented or cultured starter cultures, where the production process involves only mixing and filling, copies of the documents listed in Article 5, Items 5 through 9, may be provided by the starter culture supplier (stamped with the supplier's official seal), along with proof of purchase and sale.

Article 7: The sample production unit shall designate a dedicated department and personnel to manage production strains. Strain records must be established, documenting the source, history, screening, verification, storage methods, quantities, and opening/usage details in their entirety.

Article 8: Premises for producing trial fungal health food products shall meet the following requirements:
(1) Complies with Good Manufacturing Practice (GMP) requirements for health food and establishes a Hazard Analysis and Critical Control Points (HACCP) quality assurance system.
(2) Must have pilot-scale production capacity, i.e., the ability to produce at least 500 L per day, and submit regulatory approval based on pilot products.
(3) A dedicated facility or workshop with specialized production equipment and infrastructure is required. A mycology laboratory must be established, and culture strains must be managed by qualified personnel under the supervision of a microbiologist with at least an intermediate-level technical title. Detailed technical specifications and assurance measures must be developed accordingly.

Article 9: The production strains and manufacturing processes shall not be altered.

Article 10: For health foods produced via mycelial fermentation of fungi, if the fruiting body is readily obtainable, the product (including raw materials) may be named by combining the fruiting body name with "mycelium." Otherwise, it must be named using the actual species name followed by "mycelium" and shall not use the fruiting body name.

Article 11: During fermentation, no animal or plant materials with active ingredients, other than the culture medium, may be added to the fungal strains used.

Article 12: Strains that have been genetically modified shall not be used to produce health food.

Article 13: This regulation shall be interpreted by the China Food and Drug Administration.

Article 14. These Regulations shall take effect on the date of [insert date]. Any prior regulations inconsistent with these Regulations shall be superseded by them.

Attachment 1: List of Fungal Strains Approved for Health Food Use

Brewer's yeast Saccharomyces cerevisiae
Candida utilis
Lactic Kluyveromyces lactis
Karl's Yeast Saccharomyces carlsbergensis
Paecilomyces hepiali Chen et Dai, sp. Nov.
Hirsutella hepiali Chen et Shen
Ganoderma lucidum
Ganoderma sinensis
Ganoderma tsugae
Red yeast Monascus anka
Monascus purpureus

Attachment 2: List of Units for Fungal Strain Identification