There are no known products that are prohibited for export to this market.

Australian products that do not meet European Union official requirements

The following animal products do not meet EU official requirements:

• inedible products containing sheep and goat milk.
  

Sourcing of milk and milk products

If intended for export to countries that adopt EU requirements, the following milk and milk products must be only processed in establishments that are on t​he E​U list of approved dairy establishments:

• milk, including milk powder, condensed milk
• cream, including UHT and cream products
  
• buttermilk, curdled milk and cream
• yoghurt
• butter, dairy spreads, and other fats and oils derived from milk
• cheese (including fresh cheese, canned cheese, hard cheese, processed cheese, semi-hard cheese, and cheese powder)
• ice cream and ice-cream mix
• infant powder
• casein, caseinates and other casein derivatives
• lactose and lactose syrup
• whey and whey powder albumins (including concentrates of two or more whey proteins, containing by weight more than 80% whey proteins, calculated on the dry matter)
• milk proteins (including concentrated milk proteins with a protein content of more than 85% by weight, calculated on the dry matter)
• processed dairy ingredients that are used in composite products
  

Final product testing for microbiological ​pathogens

Milk and milk products must be tested for the following microbiological pathogens and found to comply with the EU's food safety criteria. Testing must involve taking of random samples of each batch at the end of the manufacturing process. Only batches of product that are found to meet the EU food safety criteria are eligible for export to the EU.

Composite products

Composite products are defined as products containing both products of plant origin and products of animal origin such as chocolate bars, biscuits, soups, frozen cakes and pies.

Commission Delegated Regulation (EU) 2019/625 stipulates the following categories for composite products:

1. (1) non shelf stable composite products;


2. (2) shelf stable composite products that contain meat products; and


3. (3) shelf stable composite products that do not contain meat products.

A non shelf-stable composite product needs to be transported or stored under controlled temperature. It is not the case for shelf-stable composite products which can be kept at ambient temperature.

All processed products of animal origin (meat, dairy, eggs and fish), regardless of their percentage as an ingredient in the product, are required to be sourced from EU listed establishments to be eligible for import.

The Import of Composite Products into the EU Q & A (PDF 840 KB), dated 11 July 2022, is a useful reference document:

To export categories 1 and 2, a health certificate is required. Detail on available certificate template M492 (12/22) is provided below under section 5. Documentation requirements.

The Manufacturer's Private Attestation is for shelf stable composite products that do not contain meat products. It is required to be prepared and signed by the representative of the importing food business operator (in case of exemption from control at the border, it may accompany the products only at the time of the placing on the market). The Private Attestation is found in Annex V of Commission Implementing Regulation (EU) No 2022/2504. It is not an Australian Government document.

All export establishments must be listed with the EU and establishments supplying ingredients must also be EU listed. The composite products in these categories are subject to veterinary inspection at Border Control Posts.

Note

Please note Australia does not currently maintain an EU approved residue plans for porcine or poultry and therefore is not permitted to export those commodities or products containing these ingredients to the EU. However, Australia does maintain EU approved residue plans for meat, dairy and fish products and can export these products, and products containing these ingredients, to the EU provided the establishments are EU listed.

Details of EU-listed establishments are available on the EU website.

Composite products exempt from Border Control Post inspection

As per the Commission Delegated Regulation (EU) 2021/630 of February 2021, certain lower risk shelf-stable composite products not containing processed meat are exempted from official controls at border control posts (BCPs).

Instead, EU member states' competent authorities shall perform official controls on such composite products on a risk basis with appropriate frequency at:

• the place of destination
• the point of release for free circulation in the Union, or
• the warehouses or the premises of the operator responsible for the consignment.

The categories of products affected by this Regulation are:

• Confectionery (including sweets), chocolate and other food preparations containing cocoa
• Pasta, noodles and couscous
• Bread, cakes, biscuits, waffles and wafers, rusks, toasted bread and similar toasted products
• Olives stuffed with fish
• Extracts, essences and concentrates, of coffee, tea or maté and preparations with a basis of these products or with a basis of coffee, tea or maté thereof
• Roasted chicory and other roasted coffee substitutes, and extracts, essences and concentrates thereof
• Soup stocks and flavourings packaged for the final consumer
• Food supplements packaged for the final consumer, containing processed animal products (including glucosamine, chondroitin or chitosan)
• Liqueurs and cordials.

The applicable CN codes for products within these categories are listed in the Annex to the Regulation.

Composite products that must have an EU milk and milk product certificate

Some composite products need an EU Milk and Milk Product Certificate, because they are described as dairy products and classified under the customs tariff codes 04.01 to 04.06, 17.02. 21.05, 21.06 and 35.02.

The table below provides additional information about these products.

The only products under these tariff codes that need to be exported with an EU composite product certificate, are edible ice that contains dairy and meat, and protein concentrates or textured protein substances, such as cheese fondue that contain meat.

Dairy products needing an EU composite product certificate

Information in the certificate for composite foods imported into the EU

This certificate includes four sections that have attestations about the compliance of any processed meat ingredients, any processed dairy ingredients, processed fish ingredients, and processed egg ingredients. These sections should be crossed out if they do not apply.

The raw milk/ colostrum must have been collected from cows or buffaloes in accordance with requirements for human consumption.

Note

Sheep and goat milk does not meet EU animal by-product requirements.

The raw milk/ colostrum may be either:

• that which is downgraded after collection so it is no longer fit for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which there will be no risk to public or animal health
• centrifuge, separator sludge from milk processing, and
• milk from catering sources; for example, household kitchens, catering establishments, restaurants, etc.

The milk and colostrum must be subjected to pasteurisation that is equivalent to that specified for milk for human consumption in the Export Control (Milk and Milk Products) Rules 2021 or recognised in Australia as equivalent to 72°C for 15 seconds (that is, batch pasteurisation at 60°C for 30 minutes). If an alternative pasteurisation process that is not recognised in Australia as equivalent to 72°C for 15 seconds is used to achieve a negative reaction to a phosphatase test, evidence of phosphatase levels equal to or less than 10 ug/ml of p-nitrophenol and time and temperature of heat treatment is required to be made available at audit.

After completion of the processing, every precaution must be taken to prevent contamination of the products.

This processing must occur at establishments on the EU list of approved animal by-product establishments
that are export listed to produce dairy technical products for the EU. These establishments do not need to be approved to process milk for human consumption.

During transport and storage, products that are imported into the EU must have a label attached to the packaging, container or vehicle that:

• clearly indicates the category of the inedible by-products or of the derived products;
• describes the nature of the product;
• bear the following words visibly and legibly displayed on the packaging, a container or vehicle, as applicable: not for human consumption.

Provided the products meet the requirements listed above, they may be exported as Category 3 material.

Note

• Technical products include products intended for manufacture of biomedical, pharmaceutical or industrial products. There is an exemption from the requirements listed above for technical products that are intended for use as trade samples, in research, as educational products, as diagnostic products, or in museum displays.
• Consignments of inedible by-products that are not fully finished and still considered a risk must clearly indicate their EU category after entry into the EU.
• Milk/colostrum is NOT eligible to be exported as a Category 3 material, if it is:
• collected from animals treated with substances prohibited under Directive 96/22/EC(for example, hormonal growth promotants and beta-agonists)
• known to contain residues of environmental contaminants and other substances listed in Group B3 of Annex I of Council Directive 96/23/EC (for example, organochlorine compounds including PCBs, organophosphorus compounds, chemical elements, etc.)
• known to contain residues of authorised substances (such as antibiotics) or contaminants exceeding the permitted levels as referred to in Article 15 (3) of Directive 96/23/EC
• declared unfit for human consumption due to the presence of foreign bodies in the product.
• There are no additional hygiene, traceability or processing requirements for establishments that are already approved process milk for human consumption.
• Establishments that are NOT approved to process milk for human consumption must be subject to initial and ongoing audit by a Department-approved auditor against the requirements listed above and the following additional requirements:
• premises must be constructed in a way permitting their effective cleaning and disinfection, where appropriate
• premises must have appropriate arrangements for protection against pests, such as insects, rodents and birds
• installations and equipment must be kept in hygienic condition, where necessary
• products must be stored under conditions preventing contamination.

The raw milk/ colostrum must have been collected from cows or buffaloes in accordance with requirements for human consumption.

Note

Sheep and goat milk does not meet EU animal by-product requirements.

The raw milk/ colostrum may be either:

• that which is downgraded after collection so it is no longer fit for human consumption for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which there will be no risk to public or animal health
• centrifuge, separator sludge from milk processing, and
• milk from catering sources; for example, household kitchens, catering establishments, restaurants, etc.

The milk and colostrum must be subjected to pasteurisation that is equivalent to that specified for milk for human consumption in the Export Control (Milk and Milk Products) Rules 2021 or recognised in Australia as equivalent to 72°C for 13 seconds (that is, batch pasteurisation at 60°C for 30 minutes). If an alternative pasteurisation process that is not recognised in Australia as equivalent to 72°C for 15 seconds is used to achieve a negative reaction to a phosphatase test, evidence of phosphatase levels equal to or less than 10 ug/ml of p-nitrophenol and time and temperature of heat treatment is required to be made available at audit.

After completion of the processing, every precaution must be taken to prevent contamination of the products. The requirement in Regulation 142/2011 for milk to be held for 21 days prior to export to mitigate the risk of foot-and-mouth disease (FMD) does not apply because of Australia's official FMD freedom.

This processing must occur at establishments on the EU list of approved animal by-product establishments
that are export listed to produce dairy stockfeed for the EU. These establishments do not need to be approved to process milk for human consumption.

During transport and storage, products that are imported into the EU must have a label attached to the packaging, container or vehicle that:

• clearly indicates the category of the inedible by-products or of the derived products;
• describes the nature of the product;
• bear the following words visibly and legibly displayed on the packaging, a container or vehicle, as applicable: not for human consumption.

Provided the products meet the requirements listed above, they may be exported as Category 3 material.

Notes

• Consignments of inedible by-products that are not fully finished and still considered a risk must clearly indicate their EU category after entry into the EU.
• Milk/colostrum is NOT eligible to be exported as a Category 3 material, if it is:
• collected from animals treated with substances prohibited under Directive 96/22/EC(for example, hormonal growth promotants and beta-agonists)
• known to contain residues of environmental contaminants and other substances listed in Group B3 of Annex I of Council Directive 96/23/EC (for example, organochlorine compounds including PCBs, organophosphorus compounds, chemical elements, etc.)
• known to contain residues of authorised substances (such as antibiotics) or contaminants exceeding the permitted levels as referred to in Article 15 (3) of Directive 96/23/EC
• declared unfit for human consumption due to the presence of foreign bodies in the product.
• There are no additional hygiene, traceability or processing requirements for establishments that are already approved process milk for human consumption.
• Establishments that are NOT approved to process milk for human consumption must be subject to initial and ongoing audit by a Department-approved auditor against the requirements listed above and the following additional requirements:
• premises must be constructed in a way permitting their effective cleaning and disinfection, where appropriate
• premises must have appropriate arrangements for protection against pests, such as insects, rodents and birds
• installations and equipment must be kept in hygienic condition, where necessary
• products must be stored under conditions preventing contamination.

Pet milk and milk-based pet food

The EU requirements for animal food apply to pet milk or milk-based pet food. In addition, pet milk and milk-based pet food must meet the following specific requirements.

Note

Sheep and goat milk does not meet EU animal by-product requirements.

The processing establishment must be on the EU list of approved animal by-product establishments
, in particular for pet food processing and export listed to export dairy pet food. These establishments do not need to be approved to process milk for human consumption. The processing establishment must be subject to initial and ongoing audit by a Pet Food Industry Association of Australia or Departmental auditor

Note

Accreditation to AS5812 Australian Standard Manufacturing and marketing of pet food is not a pre-requisite for listing).

The final product must be subjected to the following testing protocols:

• a random sample must be taken from processed pet food during or after storage from each batch and found to comply with the standards in the following standards.
  

All milk, milk products, colostrum and colostrum products that are not fit for human consumption, including those classified in Australia as Manufacturing Grade (DM) must be exported under the EU's animal by-product requirements (Regulation 142/2011). The raw milk/ colostrum must have been collected in Australia from cows or buffaloes in accordance with requirements for human consumption.

Note

Sheep and goat milk does not meet EU animal by-product requirements.

The raw milk/ colostrum may be downgraded after collection so it is no longer fit for human consumption. This may be for commercial reasons or due to problems of manufacturing or packaging defects or other defects from which there will be no risk to public or animal health once the milk has been further processed in the EU.

This processing must occur at establishments on the EU list of approved animal by-product establishments
that are export registered.

Pasteurisation must be equivalent to that specified for milk for human consumption in the Export Control (Milk and Milk Products) Rules 2021 or recognised in Australia as equivalent to 72°C for 15 seconds (that is, batch pasteurisation at 60°C for 30 minutes). If an alternative pasteurisation process that is not recognised in Australia as equivalent to 72°C for 15 seconds is used to achieve a negative reaction to a phosphatase test, evidence of phosphatase levels equal to or less than 10 ug/ml of p-nitrophenol and time and temperature of heat treatment is required to be made available at audit.

After completion of the processing, every precaution must be taken to prevent contamination of the products. The requirement in Regulation 142/2011 for milk to be held for 21 days prior to export to mitigate the risk of foot-and-mouth disease (FMD) does not apply because of Australia's official FMD freedom.

During transport and storage, products that are imported into the EU must have a label attached to the packaging, container or vehicle that:

• clearly indicates the category of the inedible by-products or of the derived products
  
• describes the nature of the product
  
• bear the following words visibly and legibly displayed on the packaging, a container or vehicle, as applicable: not for human consumption.

Provided the products meet the requirements listed above, they may be exported as Category 3 material.

Note

Consignments of inedible by-products that are not fully finished and still considered a risk must clearly indicate their EU category after entry into the EU.

Raw milk

The EU's raw milk processing requirements in Regulation 853/2004 can be met by complying with the Export Control (Milk and Milk Products) Rules 2021.

Pasteurisation and heat treatment

The raw milk must be subjected to pasteurisation that is equivalent to that specified for milk for human consumption in the Export Control (Milk and Milk Products) Rules 2021 or recognised in Australia as equivalent to 72°C for 15 seconds (i.e. batch pasteurisation at 60°C for 30 minutes).

Hazard Analysis Critical Control Point (HACCP)

The EU's HACCP compliance requirements in Regulation 852/2004 can be met by complying with the Export Control (Milk and Milk Products) Rules 2021.

Refrigeration, transfer and loadout

Establishments are required to undertake their own checks to ensure that milk and milk products are fully compliant with EU requirements at the point of dispatch from the manufacturing establishment.

The EU requires the Department to undertake random inspections of container loadouts to verify the effectiveness of the establishment checks and accuracy of information on health certificates. This means exporters must lodge requests to process Requests for Permits (RFP) with the Dairy Export Program with sufficient time to enable arrangements to be made for the inspection (ideally at least 3 days notice). The load out inspection will need to occur at the establishment at which the goods will be loaded into the container.

Containers must be sealed prior to export of milk and milk products to the EU, and container and seal numbers must be included on EU health certificates.

To maintain access to the EU for milk products, Australia is required to implement a national residue monitoring plan. This national residue monitoring plan, the Australian Milk Residue Analysis (AMRA) Survey must be annually approved by the EU and shown to comply with Council Directive 96/23/EC. Australia's system must also be assessed by the EU as complying with the maximum residue levels for pesticides laid down in Regulation 396/2005, and maximum levels for contaminants laid down in Regulation 1881/2006.

All edible milk and milk products exported to the EU must have been tested for residues of antibiotic drugs in accordance with Regulation 853/2004, and be found to comply with the maximum residue limits for residues of antibacterial veterinary medicinal products laid down in Regulation 37/2010. This means that milk and milk products for export to the EU must not originate from any raw milk with a positive detection from farm vat and tanker testing for antibiotic residues.

Note

Testing is required to be performed on raw milk. Establishments must ensure that testing protocols do not include any processing steps that interfere with the detectability of antibiotic residues.

For more information, refer to Exporting dairy products to the European Union.

Microbial testing of milk

All edible milk and milk products exported to the EU must meet the plate and somatic cell count criteria laid down in Regulation 853/2004. This means that raw milk must meet the following criteria:

Each farm that supplies milk for export to the EU must meet these standards.

• Processing establishments that receive raw milk directly from farms the establishment must test somatic cell counts and total plate counts, maintain records of the test results and ensure farms take corrective action when requirements are not met.
• Somatic cell counts must be determined by rolling geometric average over a period of 3 months with at least one sample per month per farm.
• Total plate count must be determined by rolling geometric average over a period of 2 months with at least 2 samples per month per farm.
• Processing establishments that receive milk from suppliers other than farms must ensure that the supplier has systems in place to ensure that the raw milk meets EU requirements for total plate counts and somatic cell counts.

In addition, there are specific microbiological tests for finished products. Refer to Milk and milk products in section 5.1.

For information on how to meet these requirements, refer to Exporting dairy products to the European Union.

Sourcing of raw milk and dairy ingredients

• Establishments that export milk and milk products to the EU must be able to state, through a declaration of compliance that the product that is exported is only made from dairy ingredients that meet EU requirements. So that they can make a declaration of compliance, establishments must ensure that they have systems in place that demonstrate that all dairy ingredients (even if imported or used as part of contract manufacturing arrangement) used to produce milk and milk products for export to the EU meet EU requirements.
• Establishments that source milk directly from farms must have systems in place to ensure that the milk is collected in accordance with the EU's specific requirements for monitoring and controlling the temperatures and quality of raw milk. These systems must also ensure that raw milk collected for processing into products intended for export to the EU has been sampled at the tanker level for and tested negative for the presence of antibiotic residues.
• Establishments that source dairy ingredients or liquid milk from other establishments, or from overseas, need to obtain documentary evidence from their suppliers that confirms that the milk used in the production of dairy products complies with all relevant EU requirements. These systems must include the use of documents that specifically state whether the ingredients were produced in accordance with EU requirements.
• For information on how to comply with the requirement for declarations of compliance, use of documentary evidence, raw milk temperatures and raw milk quality, refer to Exporting dairy products to the European Union.
  

Milk cooling

This means that milk must be produced, collected, cooled, stored and transported in accordance with the milk cooling conditions laid down in Regulation 853/2004.

This means the following:

• if milk is collected from farms on a daily basis, the raw milk must be cooled to no more than 8°C within 2 hours of milking; or
• if milk is not collected from farms on a daily basis, The raw milk must be cooled to no more than 6°C within 2 hours of milking;

During transport, the cold chain must be maintained such that on arrival at the processing establishment, the raw milk temperature is no more than 10°C.

For information on how to meet these requirements, refer to Exporting dairy products to the European Union.

Water used during processing

Establishments must ensure that quality of water used in the processing of milk and milk products meet requirements that are equivalent to the EU's potable water requirements. This means that processing establishments must be aware of the parameters for, and frequency of, water testing being undertaken by municipal water suppliers to ensure compliance with the Australian Drinking Water Guidelines 6, 2011.

If results of water testing undertaken by municipal water suppliers identify risks that could affect food safety, EU listed processing establishments are required to undertake their own risk assessment and implement actions, which may include testing, to prevent contamination of dairy products as outlined in the Australian Drinking Water Guidelines 6, 2011.

For information on how to meet these requirements, refer to Exporting dairy products to the European Union.

Certificates for milk and milk products

Milk and milk products

This information applies to the ​export of the following milk and milk products from cows or buffaloes for human consumption:

• milk, including milk powder, condensed milk
• cream, including UHT and cream products
• buttermilk, curdled milk and cream
• yoghurt
• butter, dairy spreads, and other fats and oils derived from milk
• cheese (including fresh cheese, canned cheese, hard cheese, processed cheese, semi-hard cheese, and cheese powder)
• ice cream and ice-cream mix
• infant formula
• casein, caseinates and other casein derivatives
• lactose and lactose syrup
• whey and whey powder albumins (including concentrates of two or more whey proteins, containing by weight more than 80% whey proteins, calculated on the dry matter) and
• milk proteins (including concentrated milk proteins with a protein content of more than 85% by weight, calculated on the dry matter).

​From 29 April 2022, health certificates for milk and milk products exported to the European Union (EU) have been issued via the EU Trade Control and Export System (TRACES-NT) as an eCert (through the department’s Next Export Documentation (NEXDOC) system.

Use of transit certificates for milk and milk products

• Transit certificates for product transiting through the EU did not move onto eCert and remain paper based, through the department’s NEXDOC system. The dairy transit certificate for product transiting through the EU is ZDEUHT. The title of the certificate is Animal health Certificate for dairy for human consumption intended for transit through or storage in the EU.
  
  
• Transit certificates are required for all milk and milk products (including those made from non-bovine milk) that transit the EU or are stored in the EU.​
  

The transit certificate template only includes the attestations on the certificate for milk and milk products intended for import into the EU that relate to animal health (that is, diseases present in Australia).

1. Northern Ireland
   
   
   • Northern Ireland continues to use EU paper certificates. Please contact foodexports@aff.gov.au if you intend to export to Northern Ireland.

Countries included in the move to eCert

The eCert arrangement extends to:

• countries in the EU (Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden).
• countries in the EU single market (Iceland, Liechtenstein, Norway and Switzerland).
• Overseas territories of France (Reunion, French Guiana, Guadeloupe, Martinique, Mayotte).

​Milk and milk products from sheep or goats

Certificate for composite​ foods containing processed dairy products

The only template currently available for composite products is:

• M492 (12/22) – English only. This is a manual certificate.

Note

This certificate is only available in a manual format as it is difficult for EXDOC to automatically incorporate information from several export programs. The manual certificate will be issued from the Department regional offices after an assessment of the composite food's ingredients has been conducted to ensure they have been sourced from EU-listed establishments. Exporters are advised that this assessment may be a lengthy process and it is strongly recommended that exporters make allowances for the time this assessment will take when preparing composite foods for export. The Department will provide exporters with instructions on how to complete this certificate on request. Some guidance is provided at section 2 above.

If exporters are interested in having certificate template M492A made available, please contact ​the department at exportstandards@aff.gov.au.

Transition to eCert

From 29 April 2022, health certificates for milk and milk products exported to the European Union (EU) have been issued via the EU Trade Control and Export System (TRACES-NT) as an eCert (through the department’s Next Export Documentation (NEXDOC) system. Certificate templates have been re-named due to the move to eCert. The new eCert extract name is provided in the following table:

For more information regarding the eCert arrangement, refer to MAA 2022-08.

Manufacturing Grade (DM) milk and milk products

For export of Manufacturing Grade (DM) milk and milk products from cows or buffaloes, use EUEXS1 or bilingual templates with the same endorsements as the EUEXS1.

The 'F' product use indicator must be selected so that the commodity is certified for further processing.

Certificate templates are not available for transit of manufacturing grade milk and milk products through the EU. If exporters wish to transit these products through the EU, they may contact the Department to request the development of a certificate template.

Manufacturing Grade colostrum and colostrum products

Certificate templates are no longer available for export or transit of manufacturing grade colostrum and colostrum products. If exporters wish to export these products to the EU, or transit them through the EU, they may contact the Department to request the development of a certificate template.

Provision of certificates for Manufacturing Grade (DM) milk, milk products, colostrum and colostrum products

EU export and transit certificates must be signed on, or prior to, the nominated date of departure of the vessel.

EU transit certificates for inedible by-products contain the same endorsements as EU export certificates for these by-products.

Transition to eCert

From 29 April 2022, health certificates for milk and milk products exported to the European Union (EU) have been issued via the EU Trade Control and Export System (TRACES-NT) as an eCert (through the department’s Next Export Documentation (NEXDOC) system. Certificate templates have been re-named due to the move to eCert. The new eCert extract name is provided in the following table:

For more information regarding the eCert arrangement, refer to MAA 2022-08​.

Milk, milk-based products, and milk-derived products for use in technical products (including pharmaceuticals)

For export of milk, milk-based products and milk-derived products from cows or buffaloes, use EUEXS1 or bilingual templates with the same endorsements as the EUEXS1.

The 'T' product use indicator must be selected so that the commodity is certified for technical use.

Certificate templates are not available for transit of milk, milk-based products, and milk-derived products for use in technical products (including pharmaceuticals) through the EU. If exporters wish to transit these products through the EU, they may contact the Department to request the development of a certificate template.

Colostrum and colostrum-based products for use in technical products (including pharmaceuticals)

Certificate templates are no longer available for export or transit of colostrum and colostrum-based products for use in technical products (including pharmaceuticals). If exporters wish to export these products to the EU, or transit them through the EU, they may contact the Department to request the development of a certificate template.

Products used for research, education, diagnostic or museum purposes

An export certificate is not required for products exported for research or diagnostic purposes.

Exporters may be required to provide commercial documents that include sourcing and processing declarations.

Trade samples of technical products (including pharmaceuticals)

For export of trade samples, use M448 or bilingual templates with the same endorsements as M448.

Certificate templates are not available for transit of trade samples. If exporters wish to transit trade samples through the EU, they may contact the Department to request that a certificate template be developed.

Transition to eCert

From 29 April 2022, health certificates for milk and milk products exported to the European Union (EU) have been issued via the EU Trade Control and Export System (TRACES-NT) as an eCert (through the department’s Next Export Documentation (NEXDOC) system. Certificate templates have been re-named due to the move to eCert. The new eCert extract name is provided in the following table:

For more information regarding the eCert arrangement, refer to MAA 2022-08​.

Milk, milk-based products, and milk-derived products for use in animal food

For export of milk, milk-based products and milk-derived products from cows or buffaloes, use EUEXS1 or bilingual templates with the same endorsements as the EUEXS1.

The 'A' product use indicator must be selected so that the commodity is certified for animal food.

Certificate templates are not available for transit of milk, milk-based products, and milk-derived products for use in animal food through the EU. If exporters wish to transit these products through the EU, they may contact the Department to request the development of a certificate template.

Colostrum and colostrum-based products for use in animal food

Certificate templates are no longer available for export or transit of colostrum and colostrum-based products for use in animal food. If exporters wish to export these products to the EU, or transit them through the EU, they may contact the Department​ to request the development of a certificate template.

Trade samples of animal food

For export of trade samples, use M448 or bilingual templates with the same endorsements as M448.

Certificate templates are not available for transit of trade samples. If exporters wish to transit trade samples through the EU, they may contact the Department to request that a certificate template be developed.

Provision of certificates for animal food

EU export and transit certificates must be signed on, or prior to, the nominated date of departure of the vessel.

EU transit certificates for inedible by-products contain the same endorsements as EU export certificates for these by-products.

Pet milk and processed milk-based pet food

Certificate templates are no longer available for export or transit of pet milk and processed milk-based pet food. If exporters wish to export these products to the EU, or transit them through the EU, they may contact the Department ​to request the development of a certificate template.

Carry-on packs, personal consignments and trade samples

Carry-on packs, personal consignments and trade samples of milk and milk products must be fully compliant with EU requirements and bear a health certificate verifying this eligibility. This includes products that are part of traveller's luggage, or are sent as consignments to private persons.

The requirement also applies to product under 10 kg in weight.

The ZX01 Certificate as to Dioxin Status of Australian Dairy Products can be issued as an additional export certificate.

Additional certificate option for EU quota consignments only

• The IMA1 Certificate – Cheese for Processing, should be used for cheese processing (Common Customers Tariff 04069001).
• The IMA1UK Certificate – Cheddar Cheese, should be used for cheddar cheese (Common Customs Tariff 04069021).
  

There are no generic permits required for products imported into the EU, but individual member states may have permit requirements for imported products.

Exporters should ask their importer whether they need to obtain an import permit.

Consignments of imported animal products receive a documentary, identity, and physical checks at an EU Border Control Post (BCP) according to the frequency specified in the table below before being cleared for free circulation.

Intensified controls border control posts

From 14 December 2019 onwards, REGULATION (EU) 2019/1873 of 7 November 2019 on the procedures at Border Control Posts for a coordinated performance by competent authorities of intensified official controls on products of animal origin, germinal products, animal by-products and composite products, will implement the following intensified border controls for goods following a non-compliance notified to the European Commission. Following the notification, official controls on consignments, with the same use or origin and with an identifiable listed establishment of origin, including third country vessels, will be intensified at all border control posts (BCPs) in all member states of the EU.

Assessment of non-compliance

The Commission shall assess the non-compliance against the following requisite conditions, whether:

• suspected fraudulent or deceptive practices, or
• a potentially serious or repeated infringement of EU food and food safety rules Eg. where products of animal origin contain levels of contaminants or residues of veterinary medicinal products which exceed MRLs, or products do not comply with EU microbiological criteria,

Consignments excluded from the intensified controls

The competent authorities may exclude a consignment from the intensified controls, if the consignment is to be refused on grounds other than the infringement for which intensified controls are performed.

Identity and physical checks

Following a non-compliance deemed to be subject to EU Regulation 2019/1873, the Member State competent authorities shall carry out identity and physical checks on:

• each consignment coming from the same establishment of origin, and
• containing the same category of goods, for the same type of infringement, as indicated in the EU's Integrated Management System for Official Controls (IMSOC). IMSOC is an internal EU IT system that coordinates reporting between RASFF, EUROPHYT and TRACES.

If, during the intensified controls, three consignments entering the Union reveal the same type of infringement, the Commission shall request the competent authority of the third country (for Australia this is the Department):

• make the necessary investigations to identify the reasons for the infringements (called 'imposed checks')
• adopt an action plan to remedy the situation, and
• report back, including the results of the action plan.

Termination of the intensified controls

The intensified controls shall end under only one of the following three different sets of circumstances:

1. A Member State Competent Authority decides to withdraw its notification, reasons must be given
2. An uninterrupted sequence of 10 satisfactory results has been recorded in IMSOC [The results do not need to be from the first 10 consignments to be tested but from the first results to be known and submitted in IMSOC], AND
   The total weight of the consignments with satisfactory results reaches 10 times the weight of the consignment that caused the intensified controls procedure or reaches a net weight of 300 tons, whichever is the lowest.
3. Where 'imposed checks' have been requested, an uninterrupted sequence of at least 30 satisfactory results has been recorded in IMSOC, AND
   The competent authority of the third country has adopted a satisfactory action plan.

Costs

The costs of the coordinated performance of intensified official controls shall be at the expense of the operator responsible for the consignments that are subject to those controls. This could be anywhere from 10 to 30 tests.

Labels on foodstuffs intended for human consumption

The EU has published a new regulation (EU Regulation 1169/2011) which combines two existing Directives on labelling - Directive 2000/13/EC (labelling, presentation, and advertising) and Directive 90/496/EEC (nutritional labelling).

Some of the key requirements in the new EU legislation include:

• allergen information (for example, listing eggs, milk and/or gluten in the list of ingredients);
• ensuring that labels are legible (for example, having a minimum size of text);
• having labels in languages understood by consumers (that is, allows EU Member State countries to nominate languages required on labels); and
• mandatory nutrition information on processed foods.
  

The new rules will apply from 13 December 2014. The obligation to provide nutrition information will apply from 13 December 2016.

Timeline for implementation of this regulation

There is a transitional period in the new regulation which may allow for foods labelled prior to 13 December 2014 to be accepted by EU authorities until stocks are exhausted. While the Department's understanding is outlined below, exporters are encouraged to check the details of this transitional period with their importers, as it is likely that this ruling may be interpreted differently in various EU destinations.

Exporters and manufacturers should work closely with their customers to ensure they understand the requirements so that labels on exported foods continue to comply with EU requirements.

Prior to 13 December 2014:

• All labels on food sold in the EU must comply with existing labelling EU directives (2000/13/EC and 90/496/EEC);
• Food labelled before 13 December 2014 can continue to be exported to the EU after this date, but the establishment will need to maintain robust, auditable records that demonstrate the food was, in fact, labelled before 13 December 2014.

From 13 December 2014 and up to 13 December 2016:

• Labels on food manufactured from 13 December 2014 and up to 13 December 2016 (that is, new stock) must include all specifications in the new regulation (EU Regulation 1169/2011), but do not need to include nutritional information.
• Labels on food manufactured prior to this date can continue to comply with existing labelling EU directives.

After 13 December 2016:

• Labels on food manufactured from 13 December 2016 must include all specifications in the new regulation (EU Regulation 1169/2011), including nutritional information.

Further information

The EU has developed guidance material on these changes, including a list of frequently asked questions: Food information to consumers - legislation.

The tables below provide a summary of the requirements in the regulation as they apply to retail-ready finished foods and bulk-packed finished foods and a non-exhaustive list of the countries and language(s) each requires, and whether the requirement will be specified in new, special legislation or covered by existing consumer laws.

Note

If the foodstuff is a beverage which contains more than 1.2% alcohol by volume, the actual alcoholic strength by volume must be included.

Labels on inedible by-products

Inedible by-products

During transport and storage, inedible by-products that are imported into the EU must have a label attached to the packaging, container or vehicle that:

• clearly indicates the category of the inedible by-products or of the derived products
  
• describes the nature of the product
  
• bear the following words visibly and legibly displayed on the packaging, a container or vehicle, as applicable:
• general Category 3 material where there are no other labels required: not for human consumption
• research and diagnostic samples: for research and diagnostic purposes
• trade samples: trade sample not for human consumption

The European Union has no known specific requirements for shelf life restrictions other than those provided in the Export Control (Milk and Milk Products) Rules 2021.

The European Union has no known specific requirements for shipping marks (port marks).

Use-by date

Labels on consumer-ready edible products must include the date of minimum durability or, in the case of foodstuffs which, from a microbiological point of view are highly perishable, the 'use-by' date and any special storage conditions or conditions of use.