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Friday, Jan 16, 2026
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Australia Tightens Import Rules: US Bivalve Exporters Must Obtain FDA Certificate
From mid-February, Australian biosecurity requirements will mandate official certification for shellfish imports, prompting changes for US seafood exporters
Australia’s Department of Agriculture, Fisheries and Forestry has updated its import requirements for bivalve molluscs and related products, introducing a mandatory foreign government certificate that take effect from February sixteenth.
The change means that consignments of bivalve shellfish, including clams, mussels, oysters, scallops and similar products destined for Australian markets must be accompanied by a recognised certification issued by the competent authority in the exporting country.
For exporters in the United States, this requirement translates to obtaining a Certificate to a Foreign Government issued by the U.S. Food and Drug Administration under arrangements accepted by Australian authorities.
The certification is intended to serve as evidence that the products meet Australia’s risk-based food safety and biosecurity standards, which aim to protect public health and prevent the introduction of hazards that may arise from importation of these risk food items.
Non-viable molluscs — those processed by chilling, freezing, cooking, marinating or smoking — are among the products covered by this rule.
Australia classifies bivalve molluscs and their products as risk foods under its imported food safety framework, requiring both biosecurity and food safety conditions to be met before shipment clearance.
Countries that export to Australia must have a negotiated government certification arrangement in place, with the United States currently listed as negotiating such an arrangement with Australian authorities.
Until the necessary certification framework is fully established, importers and exporters need to ensure that each consignment includes the appropriate FDA certificate data elements specified by Australia’s Department of Agriculture, Fisheries and Forestry.
These measures are designed to streamline border inspections and ensure that imported shellfish continue to meet evolving safety standards in Australian markets, while giving exporters and regulatory bodies a clear process for compliance under the updated import regime.
The change means that consignments of bivalve shellfish, including clams, mussels, oysters, scallops and similar products destined for Australian markets must be accompanied by a recognised certification issued by the competent authority in the exporting country.
For exporters in the United States, this requirement translates to obtaining a Certificate to a Foreign Government issued by the U.S. Food and Drug Administration under arrangements accepted by Australian authorities.
The certification is intended to serve as evidence that the products meet Australia’s risk-based food safety and biosecurity standards, which aim to protect public health and prevent the introduction of hazards that may arise from importation of these risk food items.
Non-viable molluscs — those processed by chilling, freezing, cooking, marinating or smoking — are among the products covered by this rule.
Australia classifies bivalve molluscs and their products as risk foods under its imported food safety framework, requiring both biosecurity and food safety conditions to be met before shipment clearance.
Countries that export to Australia must have a negotiated government certification arrangement in place, with the United States currently listed as negotiating such an arrangement with Australian authorities.
Until the necessary certification framework is fully established, importers and exporters need to ensure that each consignment includes the appropriate FDA certificate data elements specified by Australia’s Department of Agriculture, Fisheries and Forestry.
These measures are designed to streamline border inspections and ensure that imported shellfish continue to meet evolving safety standards in Australian markets, while giving exporters and regulatory bodies a clear process for compliance under the updated import regime.
