Understanding and complying with European Union
requirements for raw milk temperatures
What are the European Union (EU) requirements for 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 2 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.
How is compliance with EU requirements for raw milk
temperatures demonstrated?
Food Standards Australia New Zealand (FSANZ) guidelines for raw milk collection advise milk should be
cooled on farm to 5ºC within 3.5 hours from the start of milking. This is more stringent than the EU
requirements. FSANZ guidelines also allow manufacturers to collect milk at times and temperatures other
than 5ºC after 3.5 hours provided the manufacturer undertakes a risk assessment of the milk and
processes it accordingly to ensure its safety.
(http://www.foodstandards.gov.au/code/primaryproduction/dairy)
As manufacturers can meet the EU requirements in a number of ways, the minimum procedures that
should be documented in the company’s approved arrangement (AA) include:
 temperatures under which raw milk will be collected from farms (FSANZ guidelines, EU or milk cooling
curve limits)
 temperatures under which milk will be received at the establishment
 triggers for corrective action when limits are exceeded and what corrective action will include
 how non-compliant milk will be managed
 how non EU eligible milk is identified in the system.
Records that must be kept include:
 temperature of raw milk collected at farm and received at the establishment
 Final product declarations of compliance and transfer declarations including a statement about EU
eligibility or otherwise.
What is the milk cooling curve and how can I use this information?
Attachment 1 provides the outcomes of the Milk Cooling Curve undertaken by the University of Tasmania
for the Australian dairy industry in 2014. The food safety of milk collected at time/temperatures outside
the FSANZ guidelines (ie 5ºC after 3.5 hours from the start of milking) was assessed.
When the temperature of raw milk collected from a dairy farm is greater than 5ºC or 8ºC (EU limits)
because it is picked up early, then diagrams 1 or 2 in attachment 1 can be used to assess whether the
milk is acceptable within food safety parameters. Provided the milk temperature and time of pick up falls
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Understanding and complying with European Union requirements for raw milk temperatures
Date published: December 2015
Version no.: 2
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below the curves, the milk has been validated by the Milk Cooling Curve as safe and no further assessment
is needed.
If the milk temperature doesn’t fall within these parameters, your establishment must separately validate
the safety of milk and have records to support the decision.
How do I validate the safety of milk accepted that doesn’t meet
the parameters in the milk cooling curve?
Where milk is collected at time-temperature that does not meet the FSANZ guidelines or does not meet the
milk cooling curves, a risk assessment to ensure the safety of the milk must be conducted. Table 1 in
attachment 1 provides a validated example of how to do this risk assessment. Evidence you must have to
support the risk assessment includes:
 time after milking commenced
 temperature of milk at collection
 initial bacterial load (e.g. B. cereus) in the vat at milk collection or information that can be used to
determine/correlate to the growth of bacteria of concern.
Do EU requirements apply to the dairy ingredients I use and to the
milk I receive from another establishment?
Yes, establishments eligible to export milk and milk products to the EU must ensure they have systems in
place which demonstrate the dairy ingredients used to produce milk and milk products for export to the
EU met temperature requirements for the raw milk component stage of their production. This includes
imported ingredients or those used as part of contract manufacturing arrangements.
When sourcing dairy ingredients or liquid milk from another establishment or overseas, you need to obtain
evidence from the supplier indicating the milk used in the production of dairy products complies with the
specific EU requirements for temperature. If you cannot obtain or verify this information the products you
produce are not eligible for export to the EU.
What should I do if my milk does not comply?
You must take corrective action in accordance with your documented procedures. Advise the farm of the
unsatisfactory result and ensure action is taken to correct the problem. You may decide ongoing failures by
the farm will result in the milk not being collected, if so, a policy of this nature needs to be fully detailed in
your AA.
Your procedures must also ensure corrective action is demonstrated when high temperatures are
identified and steps are taken to verify the corrective action has been effective. These procedures reflected
in your AA will be subject to audit.
Importantly, if the milk or ingredients do not comply they must be excluded from the EU and your
declaration of compliance and transfer declarations must indicate the goods are not EU eligible.
Do I need to reflect EU eligibility on my declaration of compliance
& transfer documents?
Yes, this is particularly important when you sell your product to a third party manufacturer who may use
the product for further processing and then shipment to the EU.
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Understanding and complying with European Union requirements for raw milk temperatures
Date published: December 2015
Version no.: 2
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Further information
Can be found on the department’s website: agriculture.gov.au/export/food/dairy
Manual of Importing Country Requirements: micor.agriculture.gov.au/Dairy/Pages/Dairy.aspx
Contact us via email [email protected]
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Understanding and complying with European Union requirements for raw milk temperatures
Date published: December 2015
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Attachment 1—Milk cooling envelope (University of Tasmania)
Validation of food safety for early collection of raw milk
The guidelines to Standard 4.2.4 Primary Production & Processing Standard for dairy products require
milk to be cooled to less than 5°C within 3.5 hours after the commencement of milking or effectively
treated under an alternate cooling regime.
Manufacturers may pick up milk from farms earlier at a higher temperature provided the manufacturer is
able to manage the food safety risks.
Scientific modelling work undertaken by the University of Tasmania supports milk can be picked up
earlier, at a higher temperature, as long as it is on or below the time-temperature curve in either of the
following diagrams.
Diagram 1: The cooling envelope assumes the average time to milk a herd is 2 hours and the maximum
time available for cooling after milking is therefore 1.5 hours to meet the FSANZ guidelines for milk to be
cooled to 5°C by 3.5 hours from the commencement of milking.
Diagram 1: FSANZ Guidelines for milk
Temp, degC
Proposed post-milking cooling envelope
20
18
16
14
12
10
8
6
4
Temp after 1st milking
Temp after 2nd milking
0
0.5
1
1.5
2
Time, hours post milking
Diagram 2: The EC/Codex requirement is milk shall be cooled to 8°C within 2 hours after milking. Diagram
2 is based on an assumed maximum temperature of vat milk of 20ºC at the end of the 1st milking and 14ºC
at end of the 2nd milking.
Diagram 2: EC/Codex requirements for heat treated milk products
Temp, degC
Proposed post-milking cooling envelope
20
18
16
14
12
10
8
6
4
Temp after 1st milking
Temp after 2nd milking
0
0.5
1
1.5
2
2.5
Time, hours post milking
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Understanding and complying with European Union requirements for raw milk temperatures
Date published: December 2015
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Assessing the safety of milk that doesn’t fit the curve
Milk processors/dairy manufacturers may collect milk early (within 2 hours of milking) provided they
have evidence about each vat of milk collected to support their risk assessment of the milk’s safety.
Modelling data supports milk collected at temperatures higher than regulatory requirements or sits
outside the milk cooling envelopes may be safe as bacterial load may not have increased to a point where
pathogen levels or spoilage organisms will cause illness in humans (i.e. 105 cells/mL for B. cereus or 107
cells/ml for Pseudomonas).
The below time-temperature growth rates of two fast growing, pathogenic and milk-spoilage bacteria, B.
cereus and Pseudomonas have been validated by the University of Tasmania. The data below assumes milk
is held at the same temperature from the time of pick-up.
Milk processors/dairy manufacturers can compare their information to table 1 below to decide from
which farm milk can be picked up early or on a case by case basis, assess the safety of milk to determine the
bacterial growth over a period of time at a given starting temperature.
To be able to do a risk assessment about the potential growth of pathogens and spoilage organisms, an
establishment must have data on the level of bacteria at time of milk collection, the time milk has been held
since milking and milk pickup temperature.
Table 1: Estimated time (hours) before the threshold level is reached for B. cereus and
Pseudomonas
Temperature (˚C) at time of collection
Initial concentration of B. cereus (cells/ml)
1 log
2 log
3 log
4 log
20
15.5
11.6
7.7
3.9
15
*29.1
21.8
14.5
7.3
10
*73.3
*55.0
*36.6
18.3
8
*125.3
*94.0
*62.7
*31.3
6
*261.5
*196.1
*130.7
*65.4
Initial concentration of Pseudomonas (cells/ml)
1 log
2 log
3 log
4 log
20
18.6
14.9
11.2
7.5
15
*27.3
22.2
17.0
11.9
10
*44.8
*36.8
*28.7
20.7
8
*57.0
*46.9
*36.8
*26.7
6
*74.9
*61.9
*48.8
*35.7
Note: The cells with an asterisk (*) are the times available before milk at the specified temperature would
reach the concentrations of concern (i.e. 105 cells/mL for B. cereus or 107 cells/ml for Pseudomonas),
assuming an initial concentration in the vat at the time of milk pick-up of 1 log B. cereus or Pseudomonas in
the first column increasing to 4 log in the final column.
This is a CONTROLLED document. Any documents appearing in paper form are not controlled and should be checked prior to use.
Understanding and complying with European Union requirements for raw milk temperatures
Date published: December 2015
Version no.: 2
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