Official Clarification on Updated Risk Classification for Special Goods Entering and Exiting China

 

 

Administrative Regulations for entry-exit health quarantine on special goods shall follow the risk management principle, with quarantine approval, inspection, and supervision measures implemented based on risk levels assessed through risk evaluation. To further optimize risk-tiered supervision, strengthen national biosecurity defenses, and enhance regulatory efficiency as well as service standard, the General Administration of Customs has promulgated adjustments to the risk classification framework for special goods entering and exiting China.

In response to frequent inquiries from enterprises,

the following clarifications are provided:

1. Discontinuation of Category D from Risk Classification for Special Goods

Pursuant to the amended Frontier Health and Quarantine Law of the People's Republic of China (effective January 1, 2025), all previously designated Category D special goods having obtained valid certification issued by relevant Chinese regulatory authorities, are domestically regulated under China's pharmaceuticals, veterinary drugs, and medical devices management frameworks targeting at goods and items. They shall hereafter undergo standard customs inspection procedures applicable to ordinary goods and items, being exempt from supervision of special goods entering and exiting China and no longer requiring health quarantine approval for cross-border movement.

In addition, pursuant to the amended Frontier Health and Quarantine Law of the People's Republic of China (effective January 1, 2025), the following items shall undergo standard customs inspection procedures applicable to ordinary goods and items, being exempt from supervision of special goods entering and exiting China and no longer requiring health quarantine approval for cross-border movement, namely microbial preparations for environmental use and non-pathogenic microorganisms for medical purposes.

2. Identification of Pathogenic Microorganisms
The list of human pathogenic microorganisms formulated by the National Health Commission of the People's republic of China serves as the authoritative reference for pathogenicity determination of submitted microorganisms, classification under pathogen risk categories, required biosafety laboratory level for research activities and prescribed transport packaging specifications.

Besides, unlisted microorganisms being proven to demonstrate equivalent biosafety hazards to cataloged pathogenic microorganisms shall remain subject to special item regulations.

3. Regulatory Status of Animal-derived Cells

Animal-derived cellular materials are excluded from the classification of special items.

4. Regulatory Status and Classification of Reagents containing trace amounts of Bovine Serum Albumin (BSA)/Fetal Bovine Serum (FBS) and chemical buffers

BSA/FBS are categorized as biological materials, and therefore excluded from the classification of special items.

5. Regulatory Status and Classification of Competent Cells (e.g., Escherichia coli)

Pursuant to the newly amended Frontier Health and Quarantine Law of the People's Republic of China, microorganisms other than pathogenic microorganisms are not classified as special items. Competent cells, which are rendered physiologically capable of optimal uptake and maintenance of foreign DNA through physical/chemical induction, therefore fall outside the scope of special items.

Note: If the competent cells contain inserted vectors, the specific genetic content of such inserts must be evaluated to determine whether they qualify as special items and to assign corresponding risk classification.

6. Interim Measures for Sub-classification of A1, A2, B1, B2, C1, C2,before the Upgrading of Approval and Analysis System for Entry-exit Health Quarantine on Special Goods

Prior to the completion of upgrades to the Approval and Analysis System for Entry-exit Health Quarantine on Special Goods, the primary classification tiers of A/B/C shall be applied. Further sub-classification will be implemented upon system upgrading.

 

 

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