Draft Guidance for Industry on Novelty Determination of High Pressure Processing (HPP)-Treated Food Products

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September 2012

Table of Contents

Purpose and Scope

The purpose of this document is to clearly identify High Pressure Processing (HPP)-treated food products that would be considered novel, as defined under Division 28 of Part B of the Food and Drug Regulations. This document will allow food manufacturers to determine whether their HPP-treated product requires a safety assessment by Health Canada, as set out in Division B.28, prior to sale in the Canadian marketplace.

This document pertains only to the novelty of an HPP-treated product. It does not supersede any existing policies related to microbial food safety. HPP-treated products are still subject to all regulatory and statutory requirements, as well as Good Manufacturing Practices (GMPs) and existing Hazard Analysis and Critical Control Points (HACCP), as appropriate.

HPP-Treated Food Products that have Received a Letter of No Objection from Health Canada

An active list of all HPP-treated food products that have received a Letter of No Objection from Health Canada can be found in Appendix I. Given that this is an active list, it is advised to consult the online version of the list available on Health Canada's website.

Products listed in Appendix I are no longer considered novel under B.28 of the Food and Drug Regulations. The definition of a novel food can be found in Appendix II.

Novelty Determination of an HPP-Treated Food Product

As set out in B.28.001 of the Food and Drug Regulations, an HPP-treated food product is considered a novel food under the following part of the definition of a novel food:

"A food that has been manufactured, prepared, preserved or packaged by a process that:

  1. has not been previously applied to that food, and
  2. causes the food to undergo a major change."

A major change means, in respect of a food, a change in the food that, based on the manufacturer's experience or generally accepted nutritional or food science theory, places the modified food outside the accepted limits of natural variations for that food with regard to

  1. the composition, structure or nutritional quality of the food or its generally recognized physiological effects;
  2. the manner in which the food is metabolized in the body; or
  3. the microbiological safety, the chemical safety or the safe use of the food.

Any food not previously treated with HPP, and any HPP-treated food product that is subjected to a new set of treatment conditions (e.g., pressure, holding cycle time, etc.) and/or treated for a different purpose than those previously approved by Health Canada (see Appendix I), will be considered novel as defined under Division B.28 of the Food and Drug Regulations. A pre-market notification will be required to determine the safety of these HPP-treated food products. For guidance on this regulatory process, please see the Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms.

Food manufacturers who determine that their HPP-treated food product is not novel are not required to notify Health Canada's Food Directorate prior to sale of the product in the Canadian marketplace. Food manufacturers who are unsure if their HPP-treated food product is novel, or have determined that their HPP-treated food product is novel, may request a pre-notification consultation with the Food Directorate for further guidance.

Other Considerations

Incomplete Cycle

Under standard operating conditions, approximately 5 % of all cycles will result in an incomplete cycle, translating to a maximum of 2-3 incomplete cycles in a typical operational shift.

To address this deviation, Health Canada issued a letter of no objection to expand upon the original submission for RTE meat and poultry products treated with HPP (Health Canada, 2006a) to include such products that have been treated with up to three consecutive cycles of HPP treatment at 87,000 psi/600 MPa, and ranging from 3 min up to 9 min per cycle (Health Canada, 2010).

When making a Novel Food Submission for an HPP-treated food product, food manufacturers should provide data on the safety of their product post-treatment for the maximum length of time requested for approval. Demonstrating the safety of an HPP-treated food product subjected to a treatment beyond the intended length of a single cycle is recommended so that operators may restart the HPP process in the event of an incomplete cycle.

Additional information regarding Health Canada's position on incomplete cycles can be found in Appendix III.

Scope of Submission

In preparation of a novel food submission for an HPP-treated product, petitioners should consider the scope of their submission. Foremost, petitioners should identify each product/food type they intend to treat with HPP, or consider providing data on a range of similar products covering the highest-risk scenario (e.g., based on pH, Aw, etc.), and the range of defined treatment conditions (e.g., varying pressure, duration of treatment, etc.). Data regarding the safety of each HPP-treated product, under all treatment conditions, must be included in the submission.

Each process must be validated to ensure safety and supporting data provided.

Packaging

The safety of packaging materials is controlled under Division B.23 of the Food and Drug Regulations. The Food Packaging Materials and Incidental Additives Section within the Food Directorate's Bureau of Chemical Safety is able to determine the acceptability of packaging materials that can be used for HPP-treated products. Food manufacturers of HPP-treated products can request that their packaging materials provider obtain a letter of no objection from the Food Packaging and Incidental Additives Section regarding the acceptability of their packaging materials for HPP treatment. Further information on the regulation and pre-market assessment of packaging materials can be found on Health Canada's Packaging Materials webpage. In addition, a complete list of all packaging materials accepted by the Canadian Food Inspection Agency (CFIA) including those acceptable for HPP treatment is available on CFIA's website.

Comments

Comments on this document may be submitted in writing electronically, between September 20 and December 3, 2012, to bmh_bdm@hc-sc.gc.ca. Please use the words "HPP Guidance Document " in the subject line of your e-mail. Comments must be received by 11:59 p.m. EST, December 3, 2012.

References

Appendix I

High Pressure Processing (HPP)-treated food products that have received a Letter of No Objection from Health Canada
Food HPP Treatment Purpose Date of Decision
Pressure Holding Cycle Time (min)Table 1 footnote 1 Maximum Treatment Length (min)

Table 1 footnotes

Table 1 footnote 1

The minimum holding time required to achieve the desired outcome.

Return to table 1 footnote 1 referrer

Table 1 footnote 2

On October 27, 2010, Health Canada issued a Letter of No Objection to expand upon the original submission for RTE meat and poultry products treated with HPP to permit such products to be treated with up to three consecutive cycles of HPP treatment in addition to expanding the HPP treatment holding cycle time from 3 min up to 9 min. This decision allowed for the re-treatment of HPP-treated RTE meat and poultry products in the event of an incomplete cycle.

Return to table 1 footnote 2 referrer

Apple sauce and apple sauce/fruit blends 80,000 psi/550 MPa 1 1 Alternative to thermal processing for shelf-life extension November 18, 2004
Ready-To-Eat (RTE) meats and poultry products 87,000 psi/600 MPa 3 27 Post-lethality treatment to reduce Listeria monocytogenes microbial count October 26, 2006
October 27, 2010Table 1 footnote 2
Ready-To-Eat (RTE) meat-containing entrees, meat-containing salads and meat products 87,000 psi/600 MPa 3 3 Post-lethality treatment for shelf-life extension December 13, 2006

Appendix II

Definition of a Novel Food

As defined under Division 28, Part B of the Food and Drug Regulations, a novel food is:

  1. A substance, including a microorganism, that does not have a history of safe use as a food;
  2. A food that has been manufactured, prepared, preserved or packaged by a process that:
    1. has not been previously applied to that food, and
    2. causes the food to undergo a major change; and
  3. A food that has been derived from a plant, animal or microorganism that has been genetically modified such that:
    1. the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism;
    2. the plant, animal or microorganism no longer exhibits characteristics that were previously observed in the plant, animal or microorganism; or
    3. one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism.

A major change means, in respect of a food, a change in the food that, based on the manufacturer's experience or generally accepted nutritional or food science theory, places the modified food outside the accepted limits of natural variations for that food with regard to

  1. the composition, structure or nutritional quality of the food or its generally recognized physiological effects;
  2. the manner in which the food is metabolized in the body; or
  3. the microbiological safety, the chemical safety or the safe use of the food.

Appendix III

Incomplete cycle (cont'd)

In the context of food safety, a complete cycle of HPP treatment (under conditions specific to a particular food product) is required to ensure the safety of the treated product. If a food product is subjected to partial exposure as consequence of an incomplete cycle, it must still be treated by a complete cycle. Health Canada considers that any partial exposure to HPP treatment during the holding time of a cycle (whether incomplete or complete), at the target treatment pressure, will be counted towards the total accumulated treatment time of an HPP-treated food product. A manufacturer may treat their food product for any number of cycles (whether incomplete or complete), while ensuring that: the minimum holding time required to achieve the desired outcome of the treatment is met in a single complete cycle and the total accumulated treatment time does not exceed the maximum length of treatment for which data has been provided to Health Canada to demonstrate the product's safety.

In the event that an HPP cycle has been initiated, but fails to achieve the target treatment pressure during pressurization (i.e., the cycle stops before the holding portion of the cycle begins), the time would not be counted towards the total accumulated treatment time.

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