Product standards guideline - fish exports

​Department of Agriculture and Water Resources, June 2016

The Australian Government Department of Agriculture and Water Resources has created this set of guidelines to assist those wishing to prepare dairy, egg and fish products in Australia for export, as well as those wishing to export the final products.

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This guideline sets out mandatory minimum testing requirements for export establishments that prepare fish products. The document also contains EU-specific requirements for fish products exported to the European Union. The requirements are mandatory, must be incorporated into the manufacturing establishment’s Approved Arrangement and will be verified through regular export audits.

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Background

Product testing assesses the performance of an export registered establishment’s food management system (Approved Arrangement) in producing compliant fish and fish products. A regular programme of product testing provides the Australian Government with a level of assurance, which allows them to issue export health certification. See the Department of Agriculture and Water Resources website for more information on registration, Approved Arrangements and government export health certification.

Where the importing country has a different food standard to Australia, establishments must demonstrate compliance with this standard for all fish intended for export to that market.

Additional testing

This guideline mandates minimum testing requirements for some fish and fish products. Additional product testing may be required to verify that controls documented in your Approved Arrangement are effective in producing compliant fish and fish products. Accurate product descriptions and thorough hazard analysis of all product lines for the potential presence of contaminants, natural toxicants (for example, ciguatoxin) and residues will assist in determining where additional product testing is required to verify the adequacy of your Approved Arrangement.

Additional testing may also be required:

  • when food additives that may have regulated limits are used (for example, sulphur dioxide in crustacea)
  • to verify that product complies with the relevant regulatory levels as detailed in the Australian New Zealand Food Standards Code (FSC) or as set by importing country authorities
  • to verify that action taken to address non-compliance has been effective
  • to verify that a specific shipment meets importing country requirements
  • as a result of sanctions.

Minimum testing requirements for export to the European Union are provided at Appendix A. Known requirements of other importing countries can be found in the Manual of Importing Country Requirements (MICoR).

When the department must be notified

Under Australia’s export legislation a registered establishment must notify the department when product has been found to be or is suspected of being unsafe and an export permit has been issued. Procedures for this must be covered in the export registered establishment’s Approved Arrangement.

Testing requirements

The minimum testing required for export is outlined in Tables 1 to 4. Table 1 outlines specific testing for contamination that may occur before harvest (sourcing requirements). Tables 2 to 4 outline specific testing for contamination that may occur post harvest and during manufacture (HACCP verification).

The testing requirements can be integrated into other testing that the establishment undertakes for domestic or commercial arrangements.

Who conducts testing

If required by an importing country or if declarations relating to test results are required on certification, all testing must be carried out in a NATA or IANZ accredited laboratory. If not required for these purposes, testing can be conducted in-house or at non NATA-accredited laboratories.

What testing methods can be used

Alternate test methods are permitted for sourcing and HACCP verification in Tables 1, 3 and 4 only where the laboratory has determined equivalence to the test methods prescribed by the FSC (if one is prescribed), but may not be allowable for confirming specific declarations on certification.

Chemical and micro testing notes

The FSC (Standard 1.1.1) requires that foods comply with the prescribed microbiological limits at any stage of their manufacture or sale. Consideration should be given to sampling product at intervals that can verify shelf life and where ‘use by’ labelling is applied to packaging.

Testing may be minimised for certain environmental or sourcing hazards where valid technical data can be provided that supports the likelihood that fish taken from particular areas will contain levels of environmental contaminants within acceptable limits. For example, data from the Department of Agriculture’s Fisheries Branch or National Residue Survey can be used to reduce the minimum testing tabled in this document on a case-by-case basis after consultation with the Dairy, Egg and Fish Export Programme.

Where the test is a presence/absence test for a specific food pathogen, the testing laboratory may composite the sub-samples and conduct one test. You should discuss your product testing needs with the laboratory before sending samples for analysis.

Antibiotic testing

Documented evidence of nil use of antibiotics, including in feed, may be used to justify minimum testing of one sample per year per supplier for antibiotic testing of product. National test results for antibiotics can be substituted for this test (if they are within 12 months) or where the supplier provides laboratory test results.

Product testing: supplier assurance verification testing

Tables 1 to 4 detail fish products that require testing, according to risk, and provides corresponding minimum testing frequencies.

Table 1 Testing requirements to verify the source of fish and fish products

Product type

Test required

Frequency of sampling

Sample size

Regulatory levels

Notes

Scallops exported roe-on and whole

Amnesic Shellfish Poison (ASP)
Diarrhoeic Shellfish Poison (DSP)
Paralytic Shellfish Poison (PSP)

At least once per year for each area/zone (relevant to the state fishery) that scallops are sourced from.

One 100g sample per lot aa

ASP maximum level of 20 mg/kg
DSP maximum level of 0.2 mg/kg
PSP maximum level of 0.8 mg/kg
As per Australia New Zealand Food Standards Code (FSC) Standard 1.4.1

Whenever there are indications, such as severe storms and algal blooms, that increase the potential for contamination with biotoxins, additional biotoxin testing should be considered. The test results must identify the area/zone of the fishery.
Biotoxin testing is not required for scallops harvested under an export approved Australian Shellfish Quality Assurance Program (ASQAP) management plan that includes biotoxin management.

Aquaculture fish (including crocodile, crustacea and gastropods but excluding bivalve molluscs)

Antibiotics—general screen

A minimum of one annual test per aquaculture farm is required.

One 100g sample per lot

As per FSC Standard 1.4.2

Finfish of the following families: Scrombridae (tuna and mackerels), Clupeidae (including herrings and sardines), Engraulidae (anchovy), Coryphaenidae (dolphin fish)

Histamine

At least once per year per catcher vessel/aquaculture farm.

One (5 x 100g sub-sample) per lot

Maximum level of 200 mg/kg
As per FSC Standard 1.4.1 (for all fish)

When there is an indication that temperature control has not been maintained, additional histamine testing should be considered.
Additional finfish species should be considered for testing where there have been previous known incidents with histamine levels.
This testing is only required if finfish are exported as whole (whether gilled and gutted or not).

a A ‘lot’ is declared as a quantity of processed food of the same type, processed or packed under essentially the same conditions, during a particular period of time (not generally exceeding 24 hours) and usually from a particular processing or packing line. For shellfish, a ‘lot’ means a single species of shellfish harvested from a particular harvest area and designated by a single harvest record number.

Product testing: Verification testing of processing conditions (i.e. HAACP)

The frequency for testing of fish products will depend on whether the establishment prepares the product types detailed and the intended use of these products.

Table 2 Frequency of testing for product types specified in Tables 3 and 4

Product type

Test frequency

Low

Live fish and crustacea

6 monthly

Medium

Fish and fish products intended to be cooked or further processed before consumption

4 monthly

High

Ready-to-eat fish and fish products

3 monthly

Table 3 Minimum testing regime of fish and fish products to verify HACCP—microbiological

Product type

Micro-organisms

Sampling plan (1)

Regulatory levels
(Food Standards Code, Standard 1.6.1)

n

c

M (cfu/g)

M (cfu/g)

Raw crustacea

Coagulase positive staphylococci/g

5

2

100

1000

SPC/g

5

2

500 000

5 000 000

Cooked crustacea

Coagulase positive staphylococci/g

5

2

100

1000

Salmonella/g

5

0

Not detected in 25g

SPC/g

5

2

100 000

1 000 000

Ready-to-eat food in which growth of Listeria monocytogenes will not occur

Listeria monocytogenes/g

5

0

100

Ready-to-eat food in which growth of Listeria monocytogenes can occur

Listeria monocytogenes/g

5

0

Not detected in 25g

0

Bivalve molluscs (does not include scallops)

Escherichia coli/g

5

1

2.3

7

Bivalve molluscs (including scallops) that have undergone processing other than depuration, shucking or freezing.

Listeria monocytogenes/g

5

0

Not detected in 25g

c The maximum allowable number of defective sample units. m The acceptable microbiological level in a sample unit. M The level that when exceeded in one or more samples would cause the lot to be rejected.

Table 4 Minimum testing regime of fish and fish products to verify HACCP—other standards

Food category

Contaminant or chemical

Sample size

Regulatory level

Notes

Finfish of the families: Scrombridae (tuna and mackerels), Clupeidae (including herrings and sardines), Engraulidae (anchovy), Coryphaenidae (dolphin fish)

Histamine

One (5 x 100g sub-sample) per lot

Maximum level of 200 mg/kg

Additional finfish species should be considered for testing where there have been previous known incidents with histamine levels.
This testing is not applied where the finfish being exported are whole (whether gilled and gutted or not) and testing to verify the source of the product is in place.

Table 5 Biotoxin and contaminants testing for the European Union

Food category

Micro-organisms /their toxins, metabolites

Sample size

EU regulatory levels

Frequency of testing

When the criterion applies

Analytical reference method

Sampling—plan

Scallops (including both roe-on and roe-off) harvested in the open ocean (i.e. off-shore areas).
Abalone (regardless of whether from aquaculture or wild origin)

Amnesic Shellfish Poison (ASP) (Domoic acid)

100g

Maximum level of 20mg/kg of Domoic acid

once every 10 shipments

End of the manufacturing process

High-performance liquid chromatography (HPLC) or equivalent

A biotoxin test must be carried out at least once per year for each area/zone (relevant to the state fishery) and whenever there are indications, such as algal blooms that increase the potential for contamination with biotoxins.
Testing methodology: liquid chromatography mass spectrometry (LCMS). This test must be covered under the laboratory’s NATA/IANZ scope of accreditation.

Paralytic Shellfish Poison (PSP)

100g

Maximum PSP level 0.8mg/kg

once every 10 shipments

End of the manufacturing process

Pre-column HPLC (Lawrence method) or equivalent

Okadaic acid, dinophysistoxis and pectenotoxins together

100g

Okadaic acid maximum level 0.16mg equivalents/kg

once every 10 shipments

End of the manufacturing process

Liquid Chromatography Mass Spectrometry (LC-MS/MS) or equivalent

Yessotoxins

100g

Maximum level 1mg equivalents/kg

once every 20 shipments

End of the manufacturing process

Azaspiracids

100g

Maximum level 0.16mg equivalents/kg

once every 20 shipments

End of the manufacturing process

Prawns

Cadmium

100g

Maximum level 0.5mg/kg

One sample every 6 months

End of the manufacturing process—as packaged for export

As the European Union may test product from each vessel on arrival you are strongly advised to discuss what test results are required with your agent or buyer before the consignment is consolidated for export.

Table 6 Microbiological criteria for the European Union

Food category

Micro-organisms, their toxins, metabolites

Sampling plan (1) n

Sampling plan (1) c

EU regulatory levels

Analytical reference method

When the criterion applies

Frequency of testing

1.2. Ready to eat foods able to support the growth of L. monocytogenes, other than those intended for infants and for special medical purposes

Listeria monocytogenes

5

0

Absence
in 25g

EN/ISO 11290-2 or AS 5013.24.1-2009

Before the food has left the immediate control of the food business operator who has produced it

As per Table 2

1.16. Cooked crustacea and cooked molluscan shellfish

Salmonella

5

0

Absence
in 25g

EN/ISO 6579 or
AS 5013.10.2009

Products placed on the market during their shelf life

As per Table 2

1.17. All live bivalve molluscs, echinoderms, tunicates and gastropods

Salmonella

5

0

Absence
in 25g

EN/ISO 6579 or
AS 5013.10.2009

Products placed on the market during their shelf life

As per Table 2

1.24. All live bivalve molluscs, echinoderms, tunicates and gastropods

E.coli

1 (min. 10 individual animals)

0

230 MPN/100g of flesh and intra-valvular liquid

ISO TS 16649-3 or
AS 5013.15.2006

Products placed on the market during their shelf life

As per Table 2

1.25. Fishery products from fish species associated with a high amount of histamine (—Scrombridae (tuna and mackerels), Clupeidae (including herrings and sardines), Engraulidae (anchovy), Coryphaenidae (dolphin fish), Pomatomidae (tailor), Scombresosidae (sauries))

Histamine

9

2

m
100mg/kg

M
200mg/kg

High performance liquid chromatography or AS 4884.2008

Products placed on the market during their shelf life

As per Table 2

1.26. Fishery products which have undergone enzyme maturation treatment in brine, manufactured from fish species associated with a high amount of histamine

Histamine

9

2

m
200mg/kg

M
400mg/kg

High performance liquid chromatography or AS 4884.2008

Products placed on the market during their shelf life

As per Table 2

c The maximum allowable number of defective sample units. m The acceptable microbiological level in a sample unit. M The level that when exceeded in one or more samples would cause the lot to be rejected.

Table 7 Process hygiene criteria for the European Union

Food category

Micro-organisms

Sampling
plan (1)

EU regulatory levels

Analytical reference method

When the criterion applies

Action in case of unsatisfactory results

Frequency of testing

n

c

m

M

2.4.1. Shelled and shucked products of cooked crustacea and cooked molluscan shellfish

E.coli

5

2

1 MPN or cfu/g

10 MPN or cfu/g

ISO TS 16649-3 or AS 5013.15.2006

End of the manufacturing process

Investigation to identify where the breach is occurring, then corrective action

As per
Table 2

Coagulase-positive staphylococci

5

2

100 cfu/g

1 000 cfu/g

EN/ISO 6888-1 or 2 or AS 5013.12

End of the manufacturing process

Investigation to identify where the breach is occurring, then corrective action

As per
Table 2

c The maximum allowable number of defective sample units. m The acceptable microbiological level in a sample unit. M The level that when exceeded in one or more samples would cause the lot to be rejected.

Appendix 1: Testing requirements for products intended for export to the European Union

The information in this appendix is from Commission Regulation No. 853/2004 laying down the specific hygiene rules for food of animal origin; Commission Directive No 22/2001 laying down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3-MCPD in foodstuffs; and Commission Regulation No 2073/2005 on microbiological criteria for foodstuff. Commission Regulation No. 2074/2005, 1664/2006 and 15/2011 are also referenced. Commission Regulations and directives are available from the European Union’s official website.

Information on EU requirements for additives and flavourings is available from the EU Foods system application.

Useful links

Other guidelines for Australian export registered establishments and exporters

The department’s website has further information on:

  • Approved Arrangements
  • becoming export registered
  • department audit regime
  • government issued export permits and certificates.

Contact

Dairy, Egg and Fish Programme
Residues and Food Branch
Exports Division
Department of Agriculture and Water Resources
Phone: 1800 900 090
GPO Box 858, Canberra ACT 2601
Email: Dairy, Egg and Fish Export Programme

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