China’s biological materials regime: four risk levels, rewritten for the whole country in December 2025

If your last shipment of research material into China was planned against the regulations as they stood in 2024, the plan is out of date. GACC announcement No. 254 of 2025, issued on 24 December 2025 and in force from 30 December 2025, took the reform that had been piloted in Beijing, Tianjin, Hebei and Shanghai and applied it nationally, while rewriting the risk classification itself.

Two things changed that affect scheduling directly: laboratory animal isolation quarantine is now fourteen days in the general case, and level 2 approvals are targeted at no more than three working days at the directly-affiliated customs office. Several categories also moved between levels, which means material you have imported before may now sit under different requirements.

First, the distinction that decides which regime applies

Biological material and special articles are governed by different laws, different authorities and different procedures. Confusing them is the most common structural error in this category.

	Biological materials	Special articles
Concern	Animal and plant disease risk	Human health risk
Governing law	Law on Entry and Exit Animal and Plant Quarantine	Frontier Health and Quarantine Law, and its implementing rules
Procedure	Entry animal and plant quarantine approval	Health quarantine approval

Biological material means material imported for research, development, prevention, diagnosis, registration, testing or preservation that could transmit animal or plant disease:

• microorganisms and parasites;
• animal or plant tissue, cells, secretions and extracts;
• animal organs, excreta, blood and blood products, and proteins;
• culture media, diagnostic reagents, enzyme preparations, monoclonal and polyclonal antibodies, biosynthetics, antitoxins and cytokines made from these;
• SPF-grade and higher laboratory animals.

One scope note that saves argument: biological material does not include goods regulated as medicines, veterinary medicines or medical devices. Those follow their own regimes.

The four levels

Level 1 — special quarantine approval before entry

Animal pathogenic microorganisms on the national classification list, for research, including strains and virus stocks, and animal cells, tissue, blood, body fluids, secretions and excreta carrying them. Plant pathogens, pests and other harmful organisms for research, and plants, plant products and other quarantine material from areas with plant disease outbreaks. Biosynthetics prepared by molecular biology techniques that are pathogenic to animals or plants.

Requirements: special quarantine approval before entry, an official quarantine certificate from the exporting country, inspection on entry, and storage and use at a designated site afterwards.

Level 2 — quarantine approval before entry

The broadest and most commercially significant level. It covers:

• laboratory mice, rats, guinea pigs, cotton rats and naked mole rats;
• aquatic laboratory animals, including zebrafish, African killifish, aquatic worms and African clawed frogs;
• the semen, embryos and egg cells of those animals;
• commercial animal blood products such as bovine serum and bovine serum albumin;
• effectively inactivated animal pathogens for research;
• non-infectious animal organs, tissue, cells, blood, body fluids, secretions, excreta and extracts;
• animal-derived monoclonal and polyclonal antibodies that have not been effectively purified;
• commercial animal cells produced under standardised quality control;
• in-vivo animal diagnostic reagents, and non-commercial diagnostic or research reagents containing non-infectious animal-derived components;
• model Drosophila and C. elegans.

Requirements vary within the level. Laboratory animals and commercial animal blood products need quarantine access, and blood products need overseas facility registration as well. Laboratory animals go into isolation quarantine on arrival, while semen, embryos and egg cells go to a designated site. Most of the rest require approval, an official certificate, inspection on entry and designated storage.

Level 3 — certificate and inspection

Culture media containing non-infectious animal-derived components; organs, tissue, cells, blood, body fluids, secretions, excreta and extracts from SPF-grade and higher laboratory animals. An official quarantine certificate from the exporting country, and inspection on entry.

Level 4 — safety declaration and inspection

Commercial in-vitro diagnostic and research reagents containing animal-derived components. Animal cell lines from the recognised commercial cell banks — ATCC, NVSL, DSMZ, ECACC, KCLB, JCRB and RIKEN. DNA and RNA of non-infectious and non-pathogenic microorganisms outside the animal pathogen classification list and the plant quarantine pest lists, and plant and animal plasmids and DNA/RNA. Effectively purified interferons, hormones, toxins, toxoids, enzymes and enzyme preparations, antibodies, cytokines, microsomes and proteins. Tissue, organs and sections effectively chemically denatured. And non-infectious animal-derived material serving as a preservation matrix inside cells or antibodies.

Requirements: a biosafety declaration from the overseas manufacturer — covering raw materials, process, packaging and the absence of biosafety risk — and inspection on entry.

That last level 4 entry is quietly valuable. Bovine serum or bovine serum albumin present only as a storage matrix within imported cells or purified antibodies is managed at level 4, rather than dragging the whole consignment up to level 2. The disease-based import prohibitions for affected countries still apply.

What moved in the December 2025 revision

• Plant pathogens, pests and other harmful organisms for research, and material from plant-disease areas, were added to level 1.
• New level 2 entries: aquatic laboratory animals such as zebrafish and African killifish, effectively inactivated animal pathogens for research, unpurified animal-derived antibodies, and commercial animal cells produced under standardised quality control.
• In-vivo animal diagnostic reagents, non-commercial diagnostic and research reagents with non-infectious animal components, and model fruit flies and nematodes moved from level 3 up to level 2.
• Culture media with non-infectious animal components moved to level 3, requiring an official certificate on entry.
• Preservation-matrix material was confirmed at level 4.
• Animal-derived gelatine for research is no longer managed as biological material and now follows the non-edible animal product rules.

Anything not on the list is assessed by customs and managed at the corresponding level, so an unlisted material is not thereby unregulated.

The operational changes worth planning around

Isolation quarantine is fourteen days. Down from thirty, uniformly, for laboratory animals — except that research mice failing health monitoring requirements remain at thirty.

Isolation and experiment can run together. With the approval of the customs office where the isolation facility is located, and where biosafety is assured, experimental work may begin during isolation.

The designated isolation facility certificate is now reusable. Obtained once, usable repeatedly within its validity period, instead of per consignment.

Level 2 approvals target three working days at the directly-affiliated customs office. Where GACC review is required, the district office submits its preliminary opinion within the set period and GACC responds within seven days.

Intelligent approval removes attachments for materials already handled that way — foetal bovine serum and bovine serum albumin among them. For other level 2 materials other than laboratory animals, the basic information form for level 2 biological material quarantine approval is required.

Export registration is lighter. Where the destination country has no registration requirement, production, processing and storage units for outbound biological material are no longer subject to registration management. Where the destination does require it, registration is applied for in advance and, once granted, runs for five years.

How to fill in the application, in the two places people get it wrong

This is the most immediately useful part of the current guidance, because both errors return the application rather than merely delaying it.

Name the source animal, not just the cell line. The product name must identify the animal species the material comes from.

• Correct: Chinese hamster ovary cells
• Incorrect: CHO cells

Do not use a category where a product is required.

• Correct: bovine serum albumin
• Incorrect: protein

Two further points on the same form: the entry date must fall after the quarantine approval is obtained, and the domestic processing and storage unit field takes the unit name and full address, with the warehouse address where a filed trading unit has one.

Filings and records

Consignees of level 2 material file with their local customs office, take responsibility for biosafety in their own right, and apply effective biosafety measures to transport, storage, isolation and rearing, use and harmless disposal. Sales and using units for level 2 material also file. Importers selling on file with the port customs office before or at first declaration and keep a trading file recording declaration numbers, product names, quantities, the overseas exporter and onward destinations.

Records run to a defined content and a defined life. For research or production use: declaration number, product name, quantity or weight, exporting country or region, overseas exporter, domestic warehouse entry number and date, user name and contact details, and date of use. For resale: the same trade details plus purchaser name and contact, sale date, warehouse release number and date, and invoice serial number. Retention is not less than three years.

How “effectively inactivated” and “non-infectious” are judged

Since these words move material between levels, it matters how customs decides. The approach is technical verification documents first, then multi-factor assessment:

• The company’s technical description of source and preparation process, with an official undertaking
• Assessment of the material’s original risk — whether it was a class 1 or class 2 animal pathogen to begin with
• The final physical form and packaging: whether the product is genuinely in a non-infectious form such as a lysate or purified protein, whether inner and outer packaging is intact, and whether labels clearly state inactivated or non-infectious

The label is doing evidentiary work here. A correctly inactivated product in packaging that does not say so is harder to clear than the same product labelled properly.

Where to start

Establish the level before anything else, then work backwards:

• Level 1 needs special quarantine approval and a designated site.
• Level 2 needs approval, quite possibly access and facility registration, a filing by the consignee and — for animals — an isolation facility.
• Level 3 needs the exporting country’s official certificate.
• Level 4 needs a manufacturer’s biosafety declaration in the right form.

Where a research institute has no import qualification of its own, that is common rather than exceptional in this category, and it is one of the situations we handle as importer of record — including obtaining the baseline registrations the institute does not hold.