China Biologicals Risk Classifications

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Here is the summary of the biological product risk classifications in China custom and quarantine system.

Risk LevelBiological ScopeEntry Quarantine ApprovalForeign Official Quarantine CertificateAdditional StatementsPort InspectionFollow-up Supervision
Class A* Animal pathogenic microorganisms in the “Catalogue of Animal Pathogenic Microorganisms” (No. 53 of the Ministry of Agriculture, 2005)
* Animal parasites for animal use, animal-borne infectious substances (including organs, tissues, cells, body fluids, blood, excretions, feathers, infectious biosynthetics, etc.)
* Animal vaccine registration, inspection and preservation bacteria (poison) species
* Blind sample for disease detection for international comparison testing or proficiency testing
Yes Yes Yes Yes Yes
Class B * SPF and above experimental animals
* Genetic material such as semen, embryo, egg, etc. of experimental animals of SPF level and above
* Non-infectious animal organs, tissues, cells, blood and its products, secretions, excretions, extracts, and the like. (excludes biological materials derived from experimental animals of the SPF class and above)
Yes Yes No Yes Yes
Class C * In vivo diagnostic reagents, non-commercial diagnostic reagents containing animal-derived components
* Gelatin for research (pig skin gelatin, cowhide gelatin, fish skin gelatin only)
* Medium containing more than 5% of animal-derived ingredients
* Organs, tissues, cells, blood and products, secretions, excretions, extracts and the like of experimental animals of the SPF class and above.
* Experimental mode Drosophila, model nematode
Class D* Medium containing animal-derived ingredients ≤5%
Commercialized in vitro diagnostic reagent for detecting biologically active substances such as antigens and antibodies
* Detection of biochemical commercial in vitro diagnostic reagents such as enzymes, sugars, lipids, proteins and non-protein nitrogens and inorganic elements
* Animal passage cell lines from commercial cell banks (ATCC, NVSL, DSMZ, ECACC, KCLB, JCRB, RIKEN)
Microorganisms outside the Catalogue of Animal Pathogenic Microorganisms (No. 53 of the Ministry of Agriculture, 2005), DNA/RNA of non-pathogenic microorganisms, genetic material and biosynthetics such as non-infectious animal plasmids and bacteriophages
* Animal interferons, hormones, toxins, toxoids, enzymes and enzyme preparations, single (multi) cloned antibodies, antitoxins, cytokines, microsomes, etc.
* Chemically denatured animal tissues, organs and their sections
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