Exporting dairy products to the European Union

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 program (AA) to ensure your AA has documented controls that specifically reflect meeting EU requirements. A checklist is available which you can use as a guide when developing procedures to ensure compliance with EU requirements. Contact the Dairy, eggs and fish program for more details.

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

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. Please be aware that there are charges associated to the time taken to review these procedures.  

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

Once the EU list your establishment, you will be permitted to manufacture and export to the EU from that date forward. Please Note: The department has no influence over the timeframe taken for notifications to be actioned by the EC your details published or amended on their website

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

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 not more than 8ºC in the case of daily collection or not 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.

Complying with 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 develop systems to demonstrate compliance with EU requirements, particularly when raw milk collection is outside maximum temperature requirements.

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

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 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 the presence of antibiotics are detected, including investigation of cause, disposition of milk and traceability
• maintaining records about noncompliant suppliers and the corrective actions taken, including at what point the milk will be excluded from use
• how Antibiotic positive milk is identified throughout processing where the presence of antibiotics was not detected prior to manufacturing, including identification and disposition.
• mandatory notification to the relevant regulatory authority (State Regulatory Authority or the Department of Agriculture, Fisheries and Forestry) for all antibiotic positive milk.
• 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 meeting the EU’s antibiotic requirements

Notification must include details of any primary dairy product produced from the antibiotic positive milk, or sold as ingredients for use in other dairy. 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, are not 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 and suitable corrective actions taken to ensure ongoing compliance.

An establishments AA must document the procedures followed where antibiotic positive milk is detected and include verification to ensure the action taken is effective.

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.

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 are used as an indicator of the health of a cow.

Sampling requirements

The EU has specific requirements for TPC and BMCC to ensure that milk collected from cows that are unhealthy is not used in the manufacture of dairy products.

TPC and BMCC levels must be monitored from each of your suppliers 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 rolling:

• 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.
• Keep records of corrective action and follow-up.

Milk collected from farms must be within EU limits for TPC and BMCC.

Where the rolling geometric average for a farm has been identified as exceeded EU requirements, the following month’s geometric average must be within the limits to allow the use of milk from that farm. Any farm identified that is still greater than the allowable limits post the following month’s geometric average must be excluded from milk and milk products for export to the EU until it has been determined that the farm is within allowable limits.

Demonstrating ongoing compliance with EU requirements in your approved arrangement (AA)

As a minimum your AA must include:

• documented  procedures ensuring raw milk samples are 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 into rolling geometric averages, or within limits where made by exception i.e. to order.
• 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 suppliers subjected to sampling and monitoring or EU approval) entering the processing establishment will be identified in the system and excluded from products exported to the EU or assessed for inclusion e.g. testing for the presence of antibiotics and TPC & BMCC are within limits
• procedures to ensure declarations of compliance and transfer include a statement about EU eligibility or not. 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 including at what point the milk is excluded from use.

Non-compliance

If during a regulatory 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 may be suspended or cancelled.

Establishments must ensure quality of water used in the processing of milk and milk products meet requirements of the Australian Drinking Water Guidelines. 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, establishments are required to undertake corrective actions, to prevent contamination of dairy products for export

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

All products produced at export registered establishments must as a minimum 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 some specified dairy products. See table below;

Additional testing required by the EU for specified dairy products.

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 (a_w) less than or equal to (≤) 0.92, or pH 5.0 and a_w ≤ 0.94).
3. If manufacturers can 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 a_w ≤ 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.

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) Rules 2021 and is an EU listed establishment (include establishment number).
• The imported dairy ingredients used in the production of dairy products has been sourced from a supplier or establishment that complies with the EU and is EU listed establishment (evidence available).
• The dairy products have been manufactured in accordance with EU requirements and in all other respects is eligible for export to the EU.

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

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.

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

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.

There are particular requirements to support the eligibility of dairy products destined for export to the EU. Non-compliance may result in regulatory sanctions including suspension.

Only department staff can authorise export permits to the EU, and approval is only granted when EU compliance is demonstrated.

Certification requirements include:

• Requests for export permits must be submitted within sufficient time to enable an inspection of the goods to occur, if required.
• Health certificates and export permits must be obtained prior to the date of departure from Australia
• Customs clearance must also be obtained via the Single Electronic Window (SEW), which is through the departments electronic documentation system

Supporting information required to be submitted with your request for an export permit:

• Manufacturers declaration of compliance (identifying EU eligibility)
  
  This is required for each batch of dairy product being exported.

• National Association of Testing Authorities, Australia (NATA) certification confirming compliance with EU microbiological requirements (for each batch) – where applicable.
   
• Your completed EU eligibility checklist

Download

Document	Pages	File size
European Union eligibility checklist PDF	4	256 KB
European Union eligibility checklist DOCX	4	96 KB

If you have difficulty accessing this file, visit web accessibility for assistance.

Countries which require EU certification

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

Other European countries adopting EU requirements

England (GB), 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.

Your EU listing may 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.

Consignments exported to the EU may be subject to verification to demonstrate Australia’s commitment to the EU of compliance with requirements by exporters and manufacturers. Verification activities may include but are not limited to supporting documentation, review of records, test results, labelling and loadout (sighting goods prior to export).

This activity is charged to the exporter of the product. Please refer to the cost recovery implementation statements.

Find out more about fees charged for services provided.