Bivalve molluscs and bivalve mollusc products

Reference: MOL 11/2020

All biosecurity requirements must be met before Imported Food Inspection Scheme requirements apply.

Check our Biosecurity Import Conditions system (BICON) for import conditions.

Imported Food Inspection Scheme risk food

Bivalve molluscs have been grouped based on the hazard they present and any restrictions or tests that apply.

You must check the information in each group to determine the hazards and any restrictions and tests that apply to the bivalve molluscs you are importing. Some bivalve molluscs may be subject to tests from one or more groups.

It is the broker’s responsibility to accurately describe the bivalve molluscs at the time of lodging the consignment documentation. Importers and brokers should ensure that the goods description or other lodged documentation (for example, manufacturer’s declaration) clearly describes the bivalve molluscs. The clearer the information the easier it will be for the department to assess and exclude tests that may be inappropriate or not required. For example, if the goods are retorted bivalve molluscs, scallops with roe off, raw bivalve molluscs or dried, pickled or fermented bivalve molluscs.

If the goods description or other lodged documentation does not clearly describe the bivalve molluscs then the goods will be analysed for biotoxins (paralytic shellfish poison and domoic acid), Listeria monocytogenes and E. coli. Any delays, and inspection and analysis costs can be minimised if the bivalve molluscs are clearly described at the time of lodgement to enable us to determine if the bivalves are, or are not, risk food.

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Restrictions on the importation of oysters from the Republic of Korea and specified marine areas of Hiroshima Prefecture, Japan

Food safety concerns

Oysters that have been sourced from the Republic of Korea or from the Northern and Western marine areas of Hiroshima Bay and/or the marine area of Kure Bay in Hiroshima Prefecture, Japan, have been implicated in food poisoning outbreaks in Australia. The food poisoning has been attributed to norovirus contamination of the oysters. Food Standards Australia New Zealand (FSANZ) has advised that oysters sourced from these areas pose a serious and continuing risk to human health and therefore must not be sold as food in Australia.

Therefore, until further notice, raw oysters from these sources are not permitted to be imported into Australia.

Importers should note that it is an offence to import a food that does not meet applicable standards or poses a risk to human health. Severe penalties may apply.

Oysters that are not subject to the above restrictions

This notification does not apply to:

  • oysters imported from all other sources
  • oysters that are packaged in airtight containers that have been subjected to a thermal process (heat treatment) that has rendered the contents commercially sterile (e.g. canned oysters).

Identifying the origin of the oysters

Importers and customs brokers must ensure that they can identify and demonstrate the origin of imported oysters to imported food officers. The department will require that the source of the oysters be verified in writing by the competent national authority in the Republic of Korea or Japan.

Where the origin of a consignment of oysters cannot be verified to the department’s satisfaction, they will not be permitted entry.

Foreign government certificates (from 9 November 2022)

From 9 November 2022, consignments of bivalve molluscs and bivalve mollusc products, excluding those that are both retorted and shelf stable, or dried (not semi-dried) must be covered by a recognised foreign government certificate.

Find out more about foreign government certification arrangements.

Group 1 – Hazard: Biotoxin

Bivalve molluscs that are raw, cooked or processed, are classified as risk food in group 1.
Bivalve molluscs in group 1 include:

  • clams
  • cockles
  • mussels
  • oysters
  • pipis
  • scallops.

Food excluded from group 1

  • food containing less than 500 g/kg (50%) bivalve molluscs as an ingredient

Food for which paralytic shellfish poison analysis does not apply

  • food described as scallops with roe off – domoic acid analysis continues to apply
  • food described as pearl oysters (of the Pinctada or Pteria genus) where the only part of the product to be consumed is the adductor muscle – domoic acid analysis continues to apply

Testing

Table 1 shows the tests that apply and permitted results for food in group 1. When referred for inspection, a visual and label assessment will also apply.

Table 1 Hazard, test applied and permitted result - group 1
Hazard Test applied Permitted result
Biotoxins Paralytic shellfish poisons (PSP) Maximum level 0.8 mg/kg
Domoic acid Maximum level 20 mg/kg

Group 2 – Hazard: E. coli

Bivalve molluscs that are raw, cooked or processed, are classified as risk food in group 2.

Bivalve molluscs in group 2 include:

  • clams
  • cockles
  • mussels
  • oysters
  • pipis.

Food excluded from group 2

  • scallops
  • mixed food containing bivalve molluscs as an ingredient
  • food that is both retorted and shelf stable.

Testing

Table 2 shows the tests that apply and permitted results for food in group 2. When referred for inspection, a visual and label assessment will also apply.

Table 2 Hazard, test applied and permitted result - group 2
Hazard Test applied Permitted result
E. coli E. coli/g

n=5, c=1, m=2.3, M=7

n = the minimum number of sample units which must be examined from a lot of food.
c = the maximum allowable number of defective sample units.
m = the acceptable microbiological level in a sample unit.
M = the level which when exceeded (i.e. the level is greater than M) in one or more samples would cause the lot to be rejected

Group 3 - Hazard: Listeria monocytogenes

Bivalve molluscs that are heat treated and are ready-to-eat are risk food for group 3.

Bivalve molluscs in group 3 include:

  • clams
  • cockles
  • mussels
  • oysters
  • pipis
  • scallops.

Heat treated includes:

  • cooked
  • pasteurised
  • heated
  • smoked.

Food excluded from group 3

  • raw bivalve molluscs (chilled or frozen), for example, raw frozen half shell oysters or mussels
  • dried, pickled or fermented bivalve molluscs
  • mixed food containing bivalve molluscs as an ingredient
  • food that is both retorted and shelf stable.

Testing

Table 3 shows the tests that apply and permitted results for food in group 3. When referred for inspection, a visual and label assessment will also apply.

Table 3 Hazard, test applied and permitted result - group 3
Hazard Test applied Permitted result
Listeria monocytogenes Listeria monocytogenes n=5, c=0, m=not detected in 25 g
Note: An IFIS Importer declaration can be lodged for this food where it does not support the growth of Listeria monocytogenes

n = the minimum number of sample units which must be examined from a lot of food.
c = the maximum allowable number of defective sample units.
m = the acceptable microbiological level in a sample unit.
 

Glossary

Hermetically sealed container

A container that is airtight when sealed.

Ready-to-eat

  1. Food is ready-to-eat if it is ordinarily consumed in the same state as that in which it is sold.
  2. To avoid doubt, food is not ordinarily consumed in the same state as that in which it is sold if, before it is consumed, it requires further processing (such as cooking) in order to reduce any pathogenic microorganisms potentially present in the food to safe levels.

Retorted

Animal products are retorted if they are heated in a hermetically‑sealed container to a minimum core temperature of 100°C, obtaining an F0 value of at least 2.8.

Shelf stable

  1. The goods have been commercially manufactured; and
  2. The goods have been packaged by the manufacturer; and
  3. The goods are in that package; and
  4. The package has not been opened or broken; and
  5. The goods are able to be stored in the package at room or ambient temperature; and
  6. The goods do not require refrigeration or freezing before the package is opened.

Version history

Date Amendment details
10/11/2020 MOL 11/2020 From November 2022, consignments of bivalve molluscs and bivalve mollusc products, excluding those that are both retorted and shelf stable, or dried (not semi-dried) must be covered by a recognised foreign government certificate.
12/04/2017 MOL 04/2017 Commence analysis of biotoxins in retorted bivalve molluscs and reduce range of foods analysed for paralytic shellfish poisons.
1/5/2014 MOL 05/2014 Replaces Imported Food Notice 09/12 Tests applied to risk category foods
Last reviewed: 12 November 2020
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