Record of Decision - Pasteurization Requirements for Dairy Powders

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Question or Description of Problem

What are the labelling requirements for powder products produced from milk/cream/whey which have not been legally pasteurized or pasteurized and subsequently not hygienically handled?


The production of some dairy powders does not include all components of a High Temperature Short Time (HTST) system as per Chapter 11 of Dairy Establishment Inspection Manual (DEIM). Although many dairy powder production systems use a process which achieves pasteurization temperatures or higher, there may not be all the controls to ensure that every particle is pasteurized (e.g. no flow diversion devices).

Powder manufacturers maintain that the use of an HTST system in dairy powder production is not only cost prohibitive, but would prevent them from producing powders that meet the functional properties demanded by their clients. They believe that the treatment received in the evaporator is more severe than pasteurization and is sufficient to achieve a negative phosphatase result.

Internationally, the U.S. Food and Drug Administration requires HTST controls. This means that the system must have divert valves after the holding tube. Other countries including Australia, New Zealand and those of the European Union which account for 95% of all exported dairy powders do not require the use of automatic divert valves after the pasteurization holding tube.

Regulatory Requirements

Section B.08.002.2 of the Food and Drug Regulations (FDR) states that all dairy products must undergo pasteurization prior to sale with the exception of cheese and products sold for further manufacturing or processing in order to pasteurize it:

(1) Subject to subsection (2), no person shall sell the normal lacteal secretion obtained from the mammary gland of the cow, genus Bos, or of any other animal, or sell a dairy product made with any such secretion, unless the secretion or dairy product has been pasteurized by being held at a temperature and for a period that ensure the reduction of the alkaline phosphatase activity so as to meet the tolerances specified in official method MFO-3, Determination of Phosphatase Activity in Dairy Products, dated November 30, 1981.
(2) Subsection (1) does not apply to

(a) Cheese; or
(b) any food that is sold for further manufacturing or processing in order to pasteurize it in the manner described in subsection (1)."

Where food, in Division 8, is defined as dairy product (B.08.001).

According to the Dairy Products Regulations (DPR):

"pasteurized, with respect to a dairy product, means that the product or that the milk product from which it was made was subjected, under controlled conditions, to heat at a temperature and for a time sufficient to destroy all of the pathogenic types of micro-organisms and most of the other organisms present"

This definition is interpreted in the Dairy Establishment Inspection Manual (DEIM) to mean that products must be processed under the conditions outlined in Chapter 11 – HTST Pasteurization Tasks, Chapter 12 – Batch Pasteurization Tasks or Chapter 14 – Aseptic Processing and Packaging Systems.

Dairy Establishment Inspection Manual Transportation

The transportation of pasteurized dairy products in bulk multi-use containers without re-pasteurization is strongly discouraged as there is no guarantee that equipment is adequately cleaned. Plastic totes are not acceptable for the transporting of pasteurized product. For establishments who do not wish to re-pasteurize already pasteurized product, food carriers, tanks, transport lines and transfer pumps must be dedicated to pasteurized product only. This practice must be limited to certain products such as whey or condensed milk destined for drying, ice cream mix or cream cheese mix but would not be acceptable for fluid milk and cream. As well, documented protocol and written records for this practice are required to maintain the pasteurized product integrity. This practice will have to be assessed on a case by case basis.

National Dairy Code

56. (4) Subsection (1) does not apply to dairy products which have not been pasteurized that are sold or distributed for further manufacturing or processing to a facility approved by the Regulatory Agency in order to pasteurize it in a manner in accordance with Schedule I and are clearly and prominently labelled: Not for Retail Sale – Product not Pasteurized – Subsequently Must be Pasteurized or Thermally Processed.


Dairy Powders

The following options are proposed for the manufacture of dairy powders.

Option 1: Product produced using an HTST system to ensure proper pasteurization prior to drying. HTST system must meet all the criteria of Chapter 11 of the Dairy Establishment Inspection Manual (DEIM). Product is not required to, but may be, labelled as Pasteurized.

Option 2: If the HTST system does not meet all the criteria of Chapter 11 of the Dairy Establishment Inspection Manual the product must be labelled as Not for Retail Sale – Product not Pasteurized – Subsequently Must be Pasteurized or Thermally Processed. (National Dairy Code),

Option 3: If no HTST system is used but the product is intended for sale as equivalent to pasteurized product, each lot must be tested for alkaline phosphatase using a validated method such as MFO-3, Charm Paslite™, or Fluorophos® by in-house or accredited labs. There must be representative sampling within each lot: a minimum of one sampling per pallet or tote. At least five sub-samples in total must be taken.  These sub-samples may be composited for one analysis. Continuous sampling to produce a representative composited sample of the lot is permitted. If the lot is negative, it can be packaged and sold as pasteurized. If the results are positive the product must be labelled as per option 2. Records of these tests must be well documented and available to inspection staff.

All options will meet the requirements of FDR and DPR. Option three, requiring lot by lot testing, would allow manufacturers to continue producing the powders without a large capital investment in equipment while still allowing Canadian Food Inspection Agency (CFIA) signoff on export certificates requiring a pasteurization statement.

Whey Powders

a) Whey from Pasteurized Cheese Milk:

i) Whey powders using whey from cheese made with pasteurized milk do not need to undergo an additional pasteurization step before drying as long as the whey is handled in a hygienic manner to ensure no possibility of contamination. (DEIM There must be a documented protocol and written records to prove hygienic whey handling practices are followed to maintain the integrity of the pasteurized product. These practices will be assessed on a case by case basis. If these requirements are satisfied, no further pasteurization is necessary and the product may be labelled as pasteurized.

ii) If the whey is not handled hygienically it can either be subject to:

Option 1 - Whey could be re-pasteurized as in option 1 above

Option 2 - Finished product could be labelled as per option 2 above

Option 3 - Each lot of finished product could undergo phosphatase testing as per option 3 above to ensure no contamination with unpasteurized product and further microbiological testing with finished product meeting the requirements of Section 14.(2) Dairy Products Regulations. Product could be packaged and sold as pasteurized product.

b) Whey from Unpasteurized Cheese Milk or a Mixture of Pasteurized and Unpasteurized Cheese Milk:

If the whey is from cheese made with unpasteurized milk or a mixture of pasteurized and unpasteurized cheese milk, it will be subject to options one, two or three above.

Instruction to Inspectors

This task will be scored under section of the Dairy Establishment Inspection Manual for the manufacturer of the powder and under section for the receivers of these powders. In Hazard Analysis Critical Control Point (HACCP) plans, these controls must be made critical control points.

Implementation Date: April 1, 2007

Ann Fillmore
Recommended by: Program Chief
January 16, 2007
Tom Hauschild
Approved by: National Manager
January 24, 2007
Date modified: