On 3 September 2026, the General Administration of Customs of the People’s Republic of China (GACC) issued Announcement No. 130 of 2026, opening the Chinese market to bovine gallstones imported from Brazil with immediate effect. The product — dried gallstones harvested from the gallbladder or bile duct of farmed cattle, known in the trade as calculus bovis or bezoar — is a prized ingredient in traditional Chinese medicine, and the new rule finally sets out a clear, bilateral framework for how it may lawfully enter China. For foreign trading companies, import agencies, and TCM ingredient suppliers, this announcement is both a genuine commercial opportunity and a demanding compliance obligation, because access hinges on strict conditions covering the source farm, the slaughterhouse, the processing facility, and the paperwork that travels with every shipment.
Table of Contents
- What the Announcement Changes for Importers
- What Counts as a Bovine Gallstone
- Source Animal Conditions: The Seven Farm-Level Rules
- Registered Facilities and Processing Controls
- Packaging, Labelling, and the Export Certificate
- Clearing the Goods at the Chinese Border
- A Practical Checklist for Foreign Importers
- Frequently Asked Questions
What the Announcement Changes for Importers
Before this announcement, there was no dedicated bilateral protocol governing the entry of Brazilian bovine gallstones, which left legitimate traders in a grey zone where shipments could be rejected for lack of an agreed sanitary basis. Announcement No. 130 of 2026 changes that by recording an agreed protocol between China’s GACC and Brazil’s Ministry of Agriculture and Livestock (MAPA), the federal body that supervises Brazilian farms, slaughterhouses, and processing plants. From the date of issuance, gallstones that satisfy every requirement in the protocol may be imported lawfully.
The legal foundation is deliberately broad. The entry conditions rest on four instruments: the Biosecurity Law of the People’s Republic of China; the Law on the Quarantine of Imported and Exported Animals and Plants and its implementing regulations; the Measures for the Supervision and Administration of Quarantine of Imported and Exported Chinese Medicinal Materials; and the specific protocol signed between GACC and MAPA. In practice this means an importer must satisfy not only the customs formalities but also the animal-health and medicinal-materials supervision regimes at the same time. That layered requirement is precisely why many foreign buyers engage a professional partner early rather than treat this as an ordinary purchase of goods.
It is worth reading this announcement alongside the broader policy direction. China has, since 2025, been piloting the use of imported calculus bovis in traditional Chinese medicine manufacturing, signalling sustained domestic demand for the ingredient. The 2026 Brazilian protocol is the supply-side counterpart: it formalises how that demand can be met through compliant imports. For a trading company deciding whether to enter the market, the demand signal is real, but so is the compliance burden described below.
What Counts as a Bovine Gallstone
The announcement defines the permitted product narrowly. Under the new rules, a “bovine gallstone” means the dried gallstone taken from the gallbladder or bile duct of farmed cattle raised in Brazil. It is classified in China’s customs tariff under heading 05.10 for products of animal origin, specifically the calculus bovis subheading (0510.00.1010), which sits alongside ambergris, musk, and other animal secretions of similar commercial standing. Nothing else is covered: synthetic or cultivated substitutes, gallstones of other animal species, and material of unknown origin all fall outside the scope of this protocol.
That narrow definition matters commercially. Because the product is animal-derived and destined for medicinal use, it attracts both customs inspection and phytosanitary-style animal-health controls. An importer who assumes this is a routine dry-goods shipment is likely to face delays or rejection at the border. Getting the tariff classification, the product description, and the declared origin exactly right from the first shipment is the cheapest way to avoid those problems.
Source Animal Conditions: The Seven Farm-Level Rules
The protocol traces compliance all the way back to the farm, not just the border. Donor cattle must satisfy seven conditions before their gallstones may be exported to China:
| Condition | Requirement in the Protocol |
|---|---|
| Origin and traceability | Born, raised, and slaughtered on farms and slaughterhouses under official Brazilian supervision, with an effective traceability system linking each donor animal back to its source farm. |
| Disease history (farm) | No outbreak of anthrax or foot-and-mouth disease on the source farm within the 12 months before slaughter. |
| Disease history (premises) | No quarantine restriction or surveillance imposed for other notifiable cattle diseases under World Organisation for Animal Health rules within the 6 months before slaughter. |
| Vaccination | Not vaccinated with a live anthrax vaccine in the 14 days before slaughter. |
| Slaughter inspection | No clinical signs or pathological changes of tuberculosis or brucellosis in ante-mortem or post-mortem inspection; if either disease is found in a batch, gallstones from that batch and the same farm cannot be exported to China. |
| Feeding and drugs | Never fed ruminant-derived feed (except milk and dairy, gelatin and collagen from hides, and dicalcium phosphate free of protein and fat residues), and never given veterinary drugs or feed additives prohibited by China or Brazil. |
| Residue monitoring | Covered by Brazil’s national residue monitoring plan, with residues of veterinary drugs, pesticides, heavy metals, contaminants, and other harmful substances within the maximum limits set by both countries. |
The takeaway for a buyer is straightforward: you are not simply purchasing a commodity, you are purchasing a compliant supply chain. The traceability and residue requirements mean you should ask a Brazilian supplier for documentation before contracting, because a deficiency discovered only at the Chinese border cannot be fixed retroactively.
Registered Facilities and Processing Controls
Where the gallstone is collected and dried matters as much as the farm it came from. The protocol requires that the processing enterprise hold five credentials and capabilities, including approval and registration with the relevant Brazilian authority, recommendation to China by the Brazilian side, registration on China’s approved list, and the physical capacity to low-temperature dry and store finished gallstones in a shaded, dry, and sanitary environment.
There is an important practical detail embedded here: the processing enterprise must be an establishment already approved by China to export beef. In other words, the gallstone supply chain rides on the back of Brazil’s established beef-export approvals. If your supplier processes gallstones at a facility that is not on China’s registered list, the shipment will fail the document review described below regardless of the quality of the goods. Confirming the facility’s GACC registration status before shipment is one of the single most valuable checks an importer can perform.
The processing rules themselves read like a hygiene manual. Donor cattle must pass ante-mortem and post-mortem inspection and show no signs of infectious disease; the slaughterhouse may not use compressed-air or gas injection into the cranial cavity or spinal-cord pithing; and the gallstones must be collected in a way that prevents contamination from the brain, skull, eyes, spinal cord, tonsils, or distal ileum. After collection, the surface bile and blood must be removed with clean gauze or absorbent paper — not by rinsing with water or by chemical means — and the cleaning must happen in a separate area within the same premises. Drying must remove moisture effectively without high-temperature damage, with regular disinfection of the drying equipment. These are process controls, not optional suggestions, and they are verified through the certification chain described next.
Packaging, Labelling, and the Export Certificate
Each consignment must be packaged in clean, sanitary, and brand-new materials, with gallstones of the same production date given independent packaging and labelling. The outer packaging must state the product name, weight, batch number, storage conditions, production date, and the name, address, and registration number of both the registered slaughterhouse and the processing enterprise. During storage and transport the goods must be protected from contamination by toxic or harmful substances, and the packaging may not be opened or changed in transit.
On the export side, Brazil is responsible for inspecting and quarantining the gallstones and for issuing a sanitary (health) certificate confirming that the product meets the protocol’s requirements. That certificate is the linchpin of the whole system: it is the document China’s customs officers check for authenticity and validity at the border, and a defective or absent certificate is a guaranteed clearance failure. Importers should treat the certificate as a condition of payment and shipment, not an afterthought.
Clearing the Goods at the Chinese Border
On arrival, Chinese customs runs a two-stage check. First is a document review that verifies three things: that an Entry Animal and Plant Quarantine Permit has been obtained, that the goods come from a registered enterprise, and that the sanitary certificate is genuine and valid. Second is a physical cargo inspection conducted in accordance with Chinese law, administrative regulations, and the protocol. Goods that pass quarantine are admitted; goods that fail are handled under the relevant laws, regulations, and the protocol, which can mean return, destruction, or other corrective measures.
The Entry Animal and Plant Quarantine Permit deserves special emphasis. It must be obtained before the goods are shipped, and it is tied to the specific product, origin, and facility. In our experience, this permit is the single most common lead item that delays first-time importers, because it cannot be issued overnight and it presupposes that the Brazilian facility is already registered. Working backwards from your target arrival date — permit first, then contract, then shipment — is the reliable sequence, and it is one area where a professional partner can compress the timeline meaningfully.
A Practical Checklist for Foreign Importers
For a foreign company weighing entry into this market, the compliance path can be reduced to a short working checklist. First, confirm your China entity and trading capability: a foreign-invested trading company must be properly incorporated and scoped for import and export before it can hold an import licence and apply for permits. Second, obtain the import and export licence if you do not already hold one — see our guide on how to get an import and export licence in China. Third, verify that your Brazilian supplier’s slaughterhouse and processing facility appear on GACC’s registered list and that the source farm meets the seven farm-level conditions. Fourth, secure the Entry Animal and Plant Quarantine Permit before contracting. Fifth, agree the packaging and labelling specification and the sanitary certificate with the seller in writing. Sixth, confirm the tariff classification under 0510.00.1010 so that duties and import VAT are declared correctly from the outset.
Beyond the goods themselves, the import triggers a chain of downstream obligations: import VAT and customs duty must be correctly recorded and reclaimed or offset, and a trading entity must maintain clean books to survive the periodic audits that importers attract. Our bookkeeping, tax, and audit practice routinely handles exactly this for import businesses. Where a shipment is flagged, the commercial and regulatory arguments are handled through our legal services team. And because an importer’s licences, annual reports, and registered address must stay current, the ongoing maintenance is covered by our company secretarial services, including a compliant registered office and business address in Guangzhou or elsewhere in Guangdong.
The honest summary is this: Announcement No. 130 of 2026 is a genuine market opening, but it is a market that rewards preparation. The buyers who succeed will be those who treat farm-level compliance, facility registration, and the quarantine permit as part of the purchase decision rather than as border formalities to be sorted out later.
Frequently Asked Questions
When did China open its market to Brazilian bovine gallstones?
The market opened on 3 September 2026, when GACC issued Announcement No. 130 of 2026 recording the protocol with Brazil’s Ministry of Agriculture and Livestock. The rules took effect immediately from the date of issuance.
What exactly is covered by the new rules?
Only dried gallstones from the gallbladder or bile duct of farmed cattle raised in Brazil are covered, classified under tariff subheading 0510.00.1010 (calculus bovis). Synthetic substitutes, gallstones from other species, and material of unknown origin are outside the protocol’s scope.
Do I need a permit before the goods ship?
Yes. An Entry Animal and Plant Quarantine Permit must be obtained before shipment, and it is tied to the specific product, origin, and facility. It should be secured before you sign a contract, not after the goods are already at sea.
Can any Brazilian facility supply gallstones to China?
No. The processing enterprise must be approved and registered with the Brazilian authority, recommended to China by the Brazilian side, and registered on China’s approved list — and it must already be approved by China to export beef. Confirm the facility’s GACC registration before contracting.
What happens if a shipment fails inspection at the border?
Goods that fail quarantine are handled under Chinese law, the relevant regulations, and the protocol, which can mean return, destruction, or other corrective measures. A missing or invalid sanitary certificate, an unregistered facility, or a missing quarantine permit will typically prevent clearance.
Does importing gallstones create ongoing tax and compliance duties?
Yes. Customs duty and import VAT must be correctly declared, recorded, and reclaimed or offset, and the importing entity must keep its licences, annual filings, and registered address current. Importers commonly retain professional help for this ongoing compliance burden.
If you are considering importing Brazilian bovine gallstones — or any animal-derived or medicinal ingredient — into China, the earlier you bring compliance into the deal, the fewer surprises you will meet at the border. Dan Young Business Consultancy advises foreign companies on entity setup, import and export licensing, customs and quarantine procedures, and the tax and bookkeeping obligations that follow. Contact our team to discuss your specific supply chain and timeline, and we will map out the permits, registrations, and documentation your first shipment needs before you commit capital.
Disclaimer: This article is provided for general informational purposes only and does not constitute legal, tax, or customs advice. Import requirements are subject to change, and the rules described here reflect GACC Announcement No. 130 of 2026 as of its issuance on 3 September 2026. You should confirm the latest requirements and your specific circumstances with a qualified professional before taking any action.
