Elements of an Approved Arrangement

Approved suppliers must be able to show that their goods comply with the Food Standards Code.

For dairy specific ingredients to be added into export eligible products, an important requirement is that it must be sourced from an export registered manufacturing or storage establishment.

There is a list of export registered establishments on the department website which you can access here. However, it is recommended that you make your own enquiries with the supplying companies to confirm their export registration.

Prescribed milk and milk products must not be sourced from areas where there is reason to believe that potentially harmful pathogens or substances are present and could result in unacceptable levels in the milk or milk products.  For example, pesticides, fungicides, heavy metals, natural toxicants or other contaminants.

Approved suppliers must ensure the goods they supply (ingredients and packaging) are fit for purpose and where applicable, the goods are 'food safe' and will not pose a risk for the food product. 

When developing your program you should consider the following:

• How will you assess and approve new suppliers?
• Do you have an up to date approved Supplier list?
• Does your list include all suppliers of ingredients, packaging, chemicals or any other inputs, as well as service providers?
• Are suppliers of dairy ingredients to be used in export eligible products only sourced from an export registered establishment?
• Have you nominated a person to be responsible for this list?
• How do you review suppliers on this list?  Is there a documented procedure for ongoing performance reviews?  How frequent is this review?  Are records kept?
• Do all suppliers have an effective traceability system in place?
• Do you have a corrective action process in place for managing supplier non-conformances?

Additional requirements for Raw milk and Cream

As a dairy manufacturer, demonstrating that the milk used for production is safe to use, is vital. Your establishment must have a documented system in place to manage the supply of raw milk and cream you receive at your site.

All farm milk, processed milk, cream and all ingredients you receive into your facility must be from an approved supplier. Your approved arrangement should state what is acceptable for the supply of farm milk, including any ongoing failures from a supplier which may result in ceasing milk collection from them.  For example, where non-compliant milk is received, the farm must be notified and corrective action taken must be recorded and verified as effective.

Temperature controls must be clearly defined.  If your site receives hot milk into your site, (above the FSANZ acceptable temperature of 5°C) you will need to ensure your procedures include how you assess this against validated methods and the corrective actions you take.

To find out more about raw milk temperatures and hot milk validation (when outside maximum temperature limits), refer to the Department’s Raw Milk Guidelines.

All Australian dairy companies must also ensure that antibiotic residues (as well as other chemicals) are not present in dairy products above permitted levels (known as Maximum Residue Levels or MRLs), as stated in the Food Standards Code.  Your procedures must include what measures and controls you have in place to ensure the raw milk you receive meets other importing country requirements. For example, if your products are intended to be exported to the EU, you must only use raw milk which has tested negative for the presence of antibiotics. Your approved arrangement must document how you intend to meet importing country requirements for antibiotic free milk. Your documented program must manage any residues detected and follow your corrective action procedures.

For more information on importing country requirements, please refer to Micor (the Manual of Importing Country Requirements).

If you are to export to the EU, you must develop procedures which will ensure you comply with EU requirements. If applicable, total plate count (TPC) and somatic cells (bulk milk cell count or BMCC) should be appropriately managed as per EU requirements. TPC refers to the number of bacteria in a sample of milk taken prior to pasteurisation to indicate raw milk quality. BMCC refers to the number of white blood cells in raw milk to assess the health of a cow/herd.

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.

You must notify the relevant authorities if antibiotics are detected in your milk and engage with the affected supplier/s to ensure that the cause of the contamination is identified and that effective corrective actions are taken.

For more detailed information on the requirements for Antibiotics in milk, please refer to the department website’s information section on Requirements for Antibiotic free milk.

When documenting and reviewing raw milk and cream procedures, you should consider:

• Does your approved arrangement include procedures for antibiotic testing/ other residues or TPC/BMCC (if applicable) raw milk to meet importing country requirements?
• How often do you test for antibiotics?  Have you documented how this is performed? How is this monitored?
• Are results kept for antibiotic testing in raw milk?
• If antibiotics are detected, is corrective action taken?  Is the cause determined and recorded?  Do you have traceability to the source?  Is action taken against non-compliant suppliers? Do you dispose of the affected milk?  Is a record kept of this?
• Do your procedures state that you must notify the relevant regulatory organisation if any milk tests positive for antibiotics?
  What do you do if raw milk collection is outside the maximum temperature requirements?  Is it recorded?  Is corrective action taken and recorded?

Do you ensure your approved supplier procedure is linked back into your corrective action, internal audit and management review systems?

Imported ingredients

Imported ingredients must be included as part of your approved supplier program. You must be able to provide evidence to demonstrate that the ingredients are fit for purpose.  You must ensure that ingredients can be used in a food environment and not pose a risk to the safety of the food being produced.  This may include, but not limited to microbiological test reports, overseas manufacturer declarations, and import clearance documents from the department.

For export, if your dairy ingredients or liquid milk are from another establishment or overseas, you must have evidence from the supplier to prove it complies with the relevant importing country requirements.

For the EU, all imported raw milk or other dairy ingredients used to produce milk and milk products for export must meet all the relevant EU requirements and must be reviewed at least annually.

You will not be able to export products made using imported ingredients unless you can verify that the ingredients meet EU requirements.

When documenting and reviewing imported ingredients procedures, you should consider:

• Labelling meets the requirements of the Trade Practices Act
• If you use imported ingredients, does your finished product labelling comply with the Trade Practices Act and accurately reflect the country of origin?
• Does all imported raw milk meet temperature requirements for the importing country of the finished product?
• Do you have evidence/records from your supplier indicating the milk used in the production of dairy products complies with the specific importing country requirements?