The Department of Agriculture, Fisheries and Forestry (the Department) is the Australian government authority responsible for export registration, inspection and certification of Australian food and agricultural exports.

All premises involved in the production of fish and fish products for export, including fishing vessels where fish is prepared for export, must be registered with the Department. For more information or assistance with the export registration process contact the department's Dairy, Eggs and Fish program at dairyeggsfish@agriculture.gov.au.

Encapsulated fish oil for human consumption

Fish oil capsules which contain a cellulose or gelatine-based component are considered by the EU to be composite products. Please refer below for composite product requirements.

Composite Products for human consumption

Composite products are defined by the EU as products composed of both products of plant origin and processed products of animal origin such as biscuits, dips, soups and pies. EU Regulation (EC) 2017/625 provides the following categories for composite products:

1. non shelf stable composite products;
2. shelf stable composite products that contain meat products; and
3. shelf stable composite products that contain products of animal origin other than processed meat.

Under EU regulation (EC) 2019/625, all processed composite products of animal origin (meat, dairy, eggs and fish), regardless of their percentage as an ingredient in the product, must be sourced from EU listed establishments to be eligible for import into the EU. For further information on exporting composite product containing fish please refer to EU Non-prescribed goods.

Establishment listing for EU

Export Registered Establishments that prepare fish and fish products to the EU must be included on the list on the European Commission website: Establishment Lists - TRACES NT (europa.eu) (Select Country: Australia, Chapter: Food, Section: Fishery Products) administered by Directorate- General for Health and Food Safety (DG-SANTE) prior to commencing processing of these products if intended for export to the EU.

Cold storage establishments storing, handling and loading fish and fish products are also required to be on the applicable EU lists as part of EU supply chain requirements

Registered vessels are required to be EU listed if the fish and fish products frozen on-board are to be eligible for export to the EU (either as packaged on board the vessel or to be eligible for reprocessing at a land-based establishment for export to the EU).

Also refer to: Section 2.1 – Sourcing of fish and fish products.

Listing process – land-based establishments – pre-approval

The Department is responsible for making requests for the listing of land-based establishments by entering information into the EU TRACES portal and will advise establishments of their listing status or if additional information is required.

The land-based establishment is responsible for making an application to the Department for EU listing by requesting a variation to operations (EX26b form).

On receipt, the Department will assess the application to confirm that the Occupier of the registered establishment:

1. Has nominated the product they intend to prepare for export to the EU
2. has an approved arrangement in place that includes any additional controls where required to ensure that EU requirements are met if implemented as documented

Assessment of the application may include a site inspection to confirm implementation of any additional controls required to be in place at the establishment to ensure that importing country requirements are met. 

Listing process – vessels – pre-approval

The process for requesting the listing of registered vessels is the same, with the requirement for additional documentation to be submitted to verify the ownership and flag state of the vessel.

Applications will need to be accompanied by:

1. fishing licences held by the vessel
2. the vessels IMO number or List of Registered Ships number as issued by AMSA
   

Listing process – modifications and deletions from EU list

Establishments requesting modifications to their existing EU listing (for example, establishment name) must ensure that all export documentation and labelling does not include new details until the EU list is officially amended to reflect the new information and the validity date has been reached.

Deletions are considered to be effective immediately upon submission to DG-SANTE. EU health certificates may only be issued until the last day prior to the date on which the request has been submitted to the European Commission.

Australia is not currently authorised to export crocodile meat to the EU.

Note

Exporters are encouraged to verify import eligibility of their specific product with their importers prior to export as requirements may vary between individual EU Member States.

Sourcing of fish and fish products for preparation for export

Section 5-16 of the Export Control (Fish and Fish Products) Rules 2021 (the Rules) details the requirements for the sourcing of fish and fish products for export, including when product may be sourced from a catcher boat.

Sourcing of fish and fish products for preparation for export to the EU

Fish and fish products exported to countries that adopt EU requirements must be processed by establishments (including vessels) and stored in cold storage establishments that are on the EU list of approved fishery product establishments.

The EU requires traceability of all products to the point of harvest, with additional documentation being required to confirm the origin of some species. Refer to Section 6 - Documentation requirements - Additional documentation requirements – IUU Catch Certificates.

Catcher boats and aquaculture farms

Sourcing of product from catcher boats and direct from aquaculture farms is limited to product that is live, chilled and has not been dismembered (other than killing, bleeding, and gutting) and held chilled until delivered directly to an EU listed land-based establishment.

If iced, chilled fish must be held aboard the vessel in such a way as to allow any melt water to drain.

Bi-valve Molluscs (not including scallops harvested from open ocean)

Under EU Regulation (EC) 853/2004, live bivalve molluscs (except for scallops) and their products must be harvested from an EU approved harvest area. Link to approved EU harvest areas in Australia: Establishment Lists - TRACES NT (europa.eu) (Select Country: Australia, Chapter: Food, Section: Bivalve molluscs).

Use of imported fish and fish products for preparation for export to the EU

Where fish or fish products have been imported into Australia for further processing and export to the EU, the imported products must be sourced from an establishment that is part of the EU supply chain. That is – the source establishment must be listed in the applicable third country list/s.

Refer to: Establishment Lists - TRACES NT (europa.eu)

Product Standards – EU specific requirements

Fish and fish products exported to the European Union are required to meet the physical, chemical, and microbiological requirements detailed in the applicable Commission Regulations

Where EU product or process requirements differ from the requirements of the Rules, establishments are required to identify and document any additional controls required to ensure there are monitored process controls in place. If additional product testing is required to verify process, a testing schedule must be documented to ensure product testing is undertaken as per the requirements of the Commission Regulations.

Fish and fish products exported to the European Union are required to meet the microbiological requirements detailed in the annexes of Commission Regulation (EC) 2073/2005.

Establishments conducting routine product testing to verify controls in place are not required to duplicate tests to demonstrate EU requirements are being met where EU requirements are more stringent, provided tests are carried out in a NATA laboratory utilising NATA approved EU specified test methods. Note that sub-sample numbers and permissions around consolidating sub-samples may differ from Australian and other importing country requirements.

EU legislation requires compliance by establishments with Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin

In the majority of instances, operational hygiene requirements are consistent with the requirements of the Export Control (Fish and Fish Products) Rules 2021.

The following section highlights where additional controls may be required. Establishments that are EU listed (including vessels) must be aware of these additional requirements and, where applicable, incorporate controls into their approved arrangement. Inclusion and effectiveness of controls will be verified by the Department.

Chemical requirements

Includes limits for histamines, heavy metals, permitted additives and contaminates including dioxins PCBs and PAHs in fish oils, smoked fish and bivalve molluscs.

Also included in Regulations are permitted levels of histamines and shellfish toxins.

Food Additives

For permitted additives, information is as found in the Annexes of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. For more information on permitted additives please consult the DG-SANTE database on Food Additives.

Regulation (EC) N0 1333/2008 contains information on calcium disodium ethylene diamine tetra-acetate (Calcium disodium EDTA), maximum levels and restrictions/exceptions, as they apply to canned molluscs, Under Part E of Annex II.​

Contaminates – Heavy metals, dioxins, PCBs, PAHs

For other contaminants, information is as found in the Annex of Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs.

Residues and contaminants – therapeutants and antibiotics

The Annex of Commission Regulation (EU) No. 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, contains the maximum permitted levels of these products in the muscle tissue of all fish and fish products intended for export to the EU.

Establishments preparing fish of aquaculture origin for export to the EU must ensure that substances used to treat fish are also approved for use in Australia and, if used, withholding periods have been determined to ensure maximum residues are not exceeded.

Farm specific NRS test results may be utilised in lieu of annual verification testing of individual suppliers by processing establishments.

Evidence that EU MRLs are being met must be verified annually for each aquaculture suppler, noting this may include a statement from the supplier that no antibiotics are used or present in fish feed.

Note: Where EU establishes lower limits than Australia

Maximum residue limits (MRLs) or import tolerances for residues of specific agricultural and veterinary chemicals approved for use in Australia may not exist in the EU or may be established at levels lower than those established in Australia. Respective limits for contaminants may also vary between the EU and Australia.

Establishments eligible to prepare fish and fish products for export to the EU should note that:

1. These differences can be interrogated case-by-case by considering the EU standards (here for pesticides, veterinary drugs and contaminants) and the Australian standards (here for pesticides & veterinary drugs and here for contaminants).
2. Any detection of a residue above the EU MRLs/MLs (if applicable) at the EU border would result in rejection of the consignment and trigger an information, alert and/or border rejection notification in the EU Rapid Alert System for Food and Feed (RASFF)

Parasites, biotoxins and TVB-Ns

Commission Regulations (EU) 2074/2005 provide specific requirements for parasites and biotoxin testing methodology in bi-valve molluscs and fishery products for export to the EU. This Regulation includes requirements for determine the Total Volatile Basic Nitrogen (TVB-N) as an indication of freshness for some species.

Commission Regulation (EC) 853/2004 Annex III provides details of the health standards required to be met for live bivalve molluscs and includes biotoxin limits product placed on the market live or dead.

Parasites

All fish intended for export to the EU are required to be visually inspected for the presence of parasites / nematodes.

Parts of fish which contain visible live or dead nematodes are to be removed and must not be prepared for export. Processors should make every effort to achieve this through a non-destructive examination of the fish and fish products during processing by qualified personnel.

When processing conditions do not allow for the examination of each individual fish (example: mechanical evisceration and/or filleting operations), the processor must develop a sampling plan for each batch of processed fish. The sampling plan for mechanically eviscerated fish must include a representative number of samples of not less than 10 fish per batch.

Biotoxin limits for bi-valve molluscs

Chapter 1 of Commission Regulations (EU) 2074/2005 details the methodology for the testing of biotoxins in the edible parts of molluscs.

Chapter 5 of Annex III Commission Regulation (EC) 853/2004 details the health standards and biotoxin limits for bi-valve molluscs, noting that these limits are in addition to or are lower than the limits set in the Australian New Zealand Food Standards Code.

TVB-Ns

Chapter II of Section II of Commission Regulations (EU) 2074/2005 details the levels of TVB-Ns that when exceeded in specified species of unprocessed fishery products are taken as an indication that the product is regarded as unfit for human consumption.

Where organoleptic assessment has raised doubts as to the freshness of the product to be exported, processors are required to confirm as per the test methodology described in this section.

Land based establishments that are freezing product must have freezing equipment with sufficient capacity to lower the temperature rapidly so as to achieve a core temperature of not warmer than -18^°C and storage holds able to maintain this product core temperature.

Note

Annex I of the Regulation includes definitions of types of fishing vessels. The department has listed Australian vessels as "Factory vessels" in recognition of the level of processing that is permitted to occur under the Export Control (Fish and Fish Products) Rules 2021 (with the exception of shucking of bi-valves other than scallops).

Vessels that are freezing product must have freezing equipment with sufficient capacity to lower the temperature rapidly so as to achieve a core temperature of not warmer than -18^°C and storage holds able to maintain this product core temperature.

​Refer to Section 3 - Production.

​Refer to Section 3 - Production.

​Under Article 23 of Regulation (EU) 2021/405, Australia is not currently authorised to export crocodile meat to the EU.

​Regulation (EU) 853/2004 outlines the EUs requirements regarding labelling, health standards, harvest, handling, packaging, transport and storage.

Annex II of regulation (EC) 853/2004 requires that all product in the EU supply chain has an identification mark applied when packaged product leaves the establishment at which it is packaged. This requirement is met by labelling that identifies the product as of Australian origin by including the word 'Australia' or 'AU' and the export establishment number allocated to the establishment by the department.

Shelf-life and freezing

Refer to Annex X of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 for requirements for durability date markings and requirement to label frozen fishery products with the initial date of freezing.

Snake Mackerel, Escolar and Oilfish

Snake Mackerel (Gempylus serpens), Escolar (Lepidocybium flavobrunneum) and Oilfish (Ruvettus pretiosus) must be labelled with both the scientific and Australian Fish Names (AS 5300) of the fish and must provide information on consumer preparation and a warning about presence of substances that may have a gastrointestinal effect. Commission Regulation (EC) No 1020/2008 amending Annexes II and III to Regulation (EC) No 853/2004).

Live Bivalve molluscs: Identification Marking

The label, including the identification mark, must be waterproof. The following information must be present on the label:

• the species of bivalve mollusc (common name and scientific name); and
• the date of packaging, comprising at least the day and the month.
• the date of minimum durability may be replaced by the entry "these animals must be alive when sold".
  

​The EU has no known specific requirements for shelf-life restrictions that differ from the Export Control (Fish and Fish Products) Rules 2021.

​The EU has no known specific requirements for shipping marks, that differ from the relevant Export Control (Fish and Fish Products) Rules 2021.

​Fish and Fish product prepared for export to the EU must be stored, handled and loaded at temperatures no warmer than -18^°C.

Vessels

Note

Annex I of the Regulation includes definitions of types of fishing vessels. The Department has listed Australian vessels as "Factory vessels" in recognition of the level of processing that is permitted to occur under the Export Control (Fish and Fish Products) Rules 2021 (with the exception of shucking of bi-valves other than scallops).

Vessels that are freezing product must have freezing equipment with sufficient capacity to lower the temperature rapidly so as to achieve a core temperature of not warmer than -18^°C and storage holds able to maintain this product core temperature.

​Exporters should confirm with their importer or agent if an import permit is required for their product.

​The Department has no specific knowledge of port-of-entry inspection and testing for imports into EU. Exporters should confirm requirements with their importer or agent.

​Refer to Section 6 - Documentation requirements.

​Refer to Section 6 - Documentation requirements.

There is no agreed certification for crocodiles for human consumption to the EU.

Fish and fish products which are for not human consumption are not regulated by the Export Control (Fish and Fish Products) Rules 2021. Establishments processing such products are not required to be export registered with the Department.

Note

However, if the EU requires a government certificate for the entry of the above goods, a certificate can be issued by the Department – provided that the goods have been prepared in an export registered establishment that has the required overseas listing.

​Exporters should check with their importers to determine if products not for human consumption are permitted for import to EU.