Exporting dairy products to the European Union

The Department of Agriculture and Water Resources manages the registration and ongoing compliance of dairy exporters and export establishments with:

We certify dairy products for export to assure our trading partners that the goods comply with their requirements.

Before you export dairy products to the European Union (EU):

Details of the exporting process can be found in our step by step guide to exporting dairy products.

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Listing requirements

To export to the EU, an establishment must be export registered and listed with the EU.

If you are seeking approval to manufacture prescribed milk and milk products for export to the EU, information about exporting dairy products from Australia will help you gain an understanding of the general approval process.

If you decide to proceed with EU listing, it is our expectation that you will already have an approved arrangement (AA) in place that demonstrates compliance with EU requirements.

To demonstrate compliance with EU requirements you will need to undertake an assessment of your food safety management system to ensure compliance with EU specific requirements. A checklist is available which you can use as a guide when developing procedures to ensure compliance with EU requirements.

Find out more about requirements of an AA for dairy export establishments.

Contact us at Dairy Eggs Fish for a copy of the EU checklist.

Once you have developed programs to manage compliance with EU requirements, they will need to be assessed for approval.

Contact us at Dairy Eggs Fish and we will advise of the next steps in arranging the assessment.

Where assessment is undertaken by your state regulatory authority, they will notify us of their recommendation.

The department sends details of amended, new and cancelled establishment details to the EU on a monthly basis.

Once the EU list your establishment, which generally occurs within two months, you will be permitted to manufacture and export to the EU from that date forward.

Check for your details on the EU third country establishments list.

Raw milk temperatures

The EU has requirements for farm pick up, delivery and transportation of raw milk used for the production of milk and milk products:

  • milk must be cooled immediately (within two hours from the end of milking) to no more than 8ºC in the case of daily collection or no more than 6ºC if collection is not daily
  • during transport, the cold chain must be maintained and on arrival at the establishment, the temperature must not be more than 10ºC.

Understanding Food Standards Australia New Zealand (FSANZ) guidelines for raw milk collection will ensure you comply with EU requirements.

Find out more about raw milk temperatures, the milk cooling curve and how to demonstrate compliance with EU requirements, particularly when raw milk collection is outside maximum temperature requirements.

Antibiotic free milk

Only raw milk which tests negative for the presence of antibiotics is eligible for use in products exported to the EU.

The EU does not allow for testing to involve heating of samples as this may remove the presence of antibiotic residues.

Requirements for antibiotic free milk

Documented procedures about compliance with importing country requirements for antibiotic free milk must be included in your approved arrangement (AA). As a minimum, procedures must include:

  • antibiotic testing will be undertaken for every tanker or individual farm milk received at the processing establishment (procedures should include how this is performed and monitored)
  • record keeping of the relevant antibiotic test results in raw milk
  • corrective action when limits are exceeded, including investigation of cause, disposition of milk, requirements for retesting and traceability
  • maintaining records about noncompliant suppliers and the corrective actions taken, including at what point the milk will be excluded from use
  • how non eligible milk is identified throughout processing
  • mandatory notification to your relevant regulatory authority (State Regulatory Authority or the Department of Agriculture and Water Resources) for all antibiotic positive milk.

Notification should include details of any primary dairy product produced from the antibiotic positive milk. Primary dairy product includes, but is not limited to:

  • pasteurised milk
  • cream
  • yoghurt
  • cheese
  • milk powders
  • butter
  • dips

These products, if produced from antibiotic positive milk, will not be eligible for export.

Actions required for antibiotic positive milk

The milk must be excluded from use and not used in the manufacture of dairy products for export.

Antibiotic positive milk must be traced back to the farm and the farm advised of the unsatisfactory result.

Establishments should satisfy themselves that appropriate action has been taken on farm before collecting more milk, or consider suspending collection until appropriate action has been taken.

Your AA must document the procedures followed if antibiotic positive milk is detected at receival and include verification to ensure the action taken is effective.

Your declaration of compliance and transfer declarations must indicate the goods are not EU eligible.

Total plate count (TPC) and bulk milk cell count (BMCC) requirements

The term TPC (in relation to raw milk), refers to the total number of bacteria per millilitre that can grow at a specific temperature in a sample of milk taken prior to pasteurisation. This can be used to monitor the effectiveness of milking equipment sanitation and hygiene during milking, and the efficiency of milk cooling.

The term BMCC (also known as a somatic cell count), refers to the number of white blood cells per millilitre of raw milk. All milk naturally contains some of these cells, so cows can fight infection. High BMCCs can be used to predict the prevalence of mastitis in a herd.

Sampling requirements

The EU has specific requirements for milk cooling, TPC and BMCC to ensure that milk is not collected from cows that are unhealthy.

TPC and BMCC levels must be monitored from each of your supply farms using rolling geometric averages.

Samples must be taken from each supply farm at a minimum frequency of:

  • twice a month for TPC
  • once a month for BMCC.

Each farm must have a:

  • TPC average over two months of less than or equal to 100,000 bacteria/mL
  • BMCC average over three months of less than or equal to 400,000 cells/mL.

Herds (farms) with greater than average limits

Where average TPC limits are greater than (>) 100,000 bacteria/mL or BMCC limits are greater than (>) 400,000 cells/mL:

  • Advise the farm of the result and ensure action is taken to correct the problem, preferably within the next monitoring period—two months for TPC, or three months for BMCC.
  • Keep records of corrective action and follow-up.

Milk collected from farms that do not meet EU TPC or BMCC limits in a reasonable period (see note), must not be used in dairy products to be exported to the EU.

Note: The EU specifies three months after the first monitoring period.

Demonstrating compliance in the Approved Arrangement

As a minimum your AA must include:

  • a sourcing policy requiring raw milk samples to be taken from all supply farms at the required EU frequencies (twice a month for TPC and once a month for BMCC)
  • where relevant, a formula that converts milk quality test results collected as part of a grading and payment scheme for farms, such as Bactoscan and single BMCC results, into rolling geometric averages
  • a system for monitoring TPC and BMCC results for raw milk for all supply farms using the EU specified period for rolling geometric averages (two months for TPC, and three months for BMCC)
  • procedures and records for farm advisory services and audits including triggers for on-farm corrective actions when limits (TPC > 100,000 bacteria/mL, BMCC > 400,000 cells/mL) are exceeded
  • procedures for suspending collection for EU production if farms cannot meet EU TPC or BMCC limits
  • procedures to ensure any milk or dairy ingredients bought in from other processors (including imported milk or dairy ingredients) intended to be included in products for EU export is accompanied by documentary evidence of compliance with the EU’s TPC and BMCC requirements
  • procedures to ensure how non EU eligible milk (i.e. milk that has not been sourced from farms subjected to sampling and monitoring) will be identified in the system and excluded from products exported to the EU
  • procedures to ensure declarations of compliance and transfer declarations include a statement about EU eligibility. This is particularly important when processors sell product to 3rd party manufacturers who may use the product for further processing and then shipment to the EU
  • procedures to record and manage any non-compliances
  • procedures to begin corrective action when limits (>100,000 cells per mL for TPC and >400,000 cells per mL for BMCC) are exceeded, including at what point the milk is excluded from use.

Note:There is no maximum number of failed samples that would determine when a product should be excluded from export to the EU; however, there is an expectation that if the corrective action to reduce TPC or BMCC is not effective the milk should be excluded from EU production.

Non-compliance

If during audit it is found you are not complying with EU requirements for BMCC and TPC, or there are no records available to verify export eligibility, your EU listing will be suspended or cancelled.

Water testing requirements

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.

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.

Your AA must include the testing regime required to meet general export requirements and those specified by the EU.

Find out more about general water testing requirements and documenting these requirements in your AA.

Microbiological testing requirements

All products produced at export registered establishments must meet the microbiological limits specified by the Australia New Zealand Food Standards Code, and in accordance with the company requirements documented in the approved arrangement (AA).

The EU requires additional testing for specified dairy products.

This involves testing random samples of final product against the EU standard and must be conducted on each batch of product being exported.

Additional testing required by the EU for specified dairy products.

Microorganism

Type of final product

EU standard (see note 1)

Listeria monocytogenes

Ready-to-eat products intended for infants and special medical purposes (see note 2)

n = 10, M = absence in 25 g

Listeria monocytogenes

Other ready-to-eat products (see notes 2 and 3)

n = 5, M = absence in 25 g

Salmonella

Infant formula and dried dietary foods for special medical purposes

n = 30, M = absence in 25 g

Salmonella

Milk powder and whey powders (see note 4)

n = 5, M = absence in 25 g

Salmonella

Ice cream and other frozen dairy desserts (see note 5)

n = 5, M = absence in 25 g

Enterobacter sakazakii

Infant formula and dried dietary foods for special medical purposes

n = 30, M = absence in 10 g

Staphylococcal enterotoxins

Ripened cheese and unripened soft cheeses (see note 6)

n = 5, M = absence in 25 g

Staphylococcal enterotoxins

Milk powder and whey powder that is not intended for further processing prior to consumption (see note 6)

n = 5, M = absence in 25 g

Notes:

  1. Where n = number of samples and M = maximum number of bacteria allowed in a sample.
  2. Testing for L. monocytogenes is not required for ready-to-eat products that have been processed to eliminate L. monocytogenes, or are unable to support the growth of L. monocytogenes (i.e. products with pH 4.4 or water activity (aw) less than or equal to (≤) 0.92, or pH 5.0 and aw ≤ 0.94).
  3. If manufacturers are able to demonstrate that products will not exceed 100 cfu/g throughout their shelf-life, they do not need to demonstrate absence in a 25 g sample.
  4. This testing is not required for products where the aw ≤ 0.95.
  5. Testing is not required for products where the manufacturing process or composition of product will eliminate the risk of Salmonella in the product.
  6. Testing is not required for products where the manufacturing process or composition of the product results in the product having coagulase positive staphylococci < 100,000 cfu/g, and this eliminates the risk of staphylococcal enterotoxins in the product. Manufacturers that respond to detections of coagulase positive staphylococci in accordance with National Guidelines—Pathogen Management, do not need to undertake this testing.

You are expected to have evidence to support any decision not to test.

Eligibility of dairy ingredients sourced from other establishments

Establishments eligible to export milk and milk products to the EU must have documented systems in place demonstrating the raw milk or other dairy ingredients used to produce milk and milk products for export to the EU meet all the relevant requirements.

If your establishment sources dairy ingredients or liquid milk from another establishment (including an overseas supplier) suitable evidence from the supplier is required that indicates:

  • The dairy ingredients used in the production of dairy products has been sourced from a supplier or establishment that complies with Export Control (Milk and Milk Products) Orders and is an EU listed establishment (include establishment number).
  • The dairy products have been manufactured in accordance with Export Control (Milk and Milk Products) Orders and EU requirements and in all other respects is eligible for export to the EU.

These requirements must be built into the approved supplier program, updated for each new dairy ingredient and reviewed at least annually.

Declarations of compliance

EU eligibility must be reflected on your declaration of compliance, that is, the declaration of compliance must state if the product is eligible for the EU or not.

This is particularly important if you sell your product to a third party manufacturer who may use the product for further processing and then export to the EU.

Find out more about manufacturer’s declarations of compliance for milk and milk products.

Transferring goods

A transfer declaration is a documented statement made by the dispatching establishment regarding the export eligibility of the dairy goods being moved.

If you are EU listed, you need to reflect EU eligibility on each transfer document. That is, the transfer declaration must state if the product is eligible for the EU or not. This is particularly important when you sell or transfer your product to a third party manufacturer or exporter who may use the product for further processing and then export to the EU.

Find out more about transferring goods between export registered establishments.

Certification requirements

There are particular requirements for the demonstration of compliance and certification for exports to the EU. Non-compliance may result in your listing being withdrawn or other sanctions including suspension.

Requirements include:

  • Health certificates and export permits must be obtained prior to the date of departure from Australia.
  • Requests for an EU export permit must be submitted for approval, at least three days prior to shipment (this will enable an inspection of the goods to occur if required).
  • Manufacturers’ declarations of compliance (identifying EU eligibility) for each batch of dairy product being exported must be submitted with your export permit application.
  • National Association of Testing Authorities, Australia (NATA) certification confirming compliance with EU microbiological requirements (for each batch) must be submitted with your export permit application (where applicable).
  • Your completed Exporter EU checklist.
  • Applications for export permits and health certificates must made through the department’s electronic export documentation system, EXDOC.
  • Customs clearance must also be obtained via the EXDOC system (known as the Single Electronic Window).

The department must approve the export permit and approval is only granted when EU compliance is demonstrated.

Countries which require EU certification

Check the up to date list of countries requiring EU certification.

Other European countries adopting EU requirements

Croatia (HR), Faroe Islands (FO), Iceland (IS), Liechtenstein (LI), Macedonia (MK), Norway (NO), and Switzerland (CH) are not formally part of the EU, but have agreements allowing for free movement of goods between the EU and these countries.

Dairy products exported to these countries must also be EU compliant.

Non-compliance with EU requirements

Your EU listing will be suspended or cancelled if it is found that:

  • your AA does not clearly document EU requirements
  • EU requirements are not being followed
  • there are no records available to verify EU eligibility.

Inspections of EU exports

EU shipments are subject to a minimum of five per cent inspection (determined on a random basis).

These inspections involve verifying the information on the request for permit with the product being exported. These inspections are charged to the exporter of the product. Please refer to the cost recovery implementation statements.

Find out more about fees charged for services provided.