Foods treated with high pressure processing (HPP)
Requirements for the Safe Food for Canadians Regulations
Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements may apply in 2020 and 2021 based on food commodity, type of activity and business size. For more information, refer to the SFCR timelines.
High pressure processing (HPP) has become more common in the food processing industry. It is also known as high hydrostatic pressure processing (HHP) or ultra-high pressure processing (UHP). For over a decade, HPP-treated foods sold in Canada were regulated as Novel Foods under Division 28 of the Food and Drug Regulations. However, in December 2016, Health Canada published a position indicating that HPP is no longer a novel process given that there is sufficient knowledge and data available supporting that HPP can be safely applied to food.
HPP is a non-thermal method of preservation in which a solid or liquid food is placed in a pressure vessel and subjected to very high pressure using a pressure-transmitting medium (usually water). HPP can inactivate vegetative microorganisms and enzymes in the food and alter certain characteristics of the food.
HPP has a variety of food applications. For example, it could be used
- to reduce or eliminate pathogens
- to extend the shelf-life
- for reconditioningFootnote 1
- for specific technical processes, such as shell removal of crustaceans
Manufacturers and importers of foods treated with HPP are no longer required to notify Health Canada of their intention to sell or advertise HPP-treated foods in Canada. However, the Safe Food for Canadians Regulations requires food businesses to have evidence showing that the control measures they use are effective at controlling hazards (validated). The validation of control measures is an integral part of an effective preventive control plan.
The Canadian Food Inspection Agency (CFIA) created this document as guidance to help food businesses comply with the Safe Food for Canadians Regulations.
This document provides guidance on when food businesses need to validate the HPP treatment they use on a food.
What's not included
Detail related to the tools, techniques, and statistical principles used to validate specific HPP treatments are not included. Refer to Evidence showing a control measure is effective for more guidance in this area.
Roles and responsibilities
Food businesses are responsible for complying with the law. They demonstrate compliance by ensuring that the commodities and processes for which they are responsible meet regulatory requirements. If a written preventive control plan (PCP) is required, the food business develops a PCP with supporting documents, monitors and maintains evidence of its implementation, and verifies that all control measures are effective.
The CFIA verifies the compliance of a food business by conducting activities that include inspection and surveillance. When non-compliance is identified, the CFIA takes appropriate compliance and enforcement actions.
As with any type of process, manufacturers and importers of HPP-treated foods may be required to provide evidence that their HPP process is effective (validated) depending on the intended purpose.
If you plan to use HPP, you should consider
- the intended purpose of the HPP treatment
- the sensitivity of microorganism(s) of concern to HPP
- the characteristics of the food
- the storage conditions of the end product
- the potential for the introduction of food safety hazards due to shelf-life extension resulting from HPPFootnote 2
HPP treatment purposes that require validation
In general, HPP treatment requires validation when it is used to control a biological hazard in a food product, and when extending the shelf-life introduces other hazards to the food product. Table 1 provides some specific examples of when validation would or would not be required for HPP-treated foods.
Health Canada has concluded that HPP treatment of no more than 87 000 psi (600 MPa) for no more than 27 minutes can be applied to a food without negatively impacting nutritional quality or chemical safety relative to its untreated counterpart. The typical parameters of an HPP treatment are more commonly 87 000 psi/600 MPa for 1 to 5 minutes, however you will need to validate your treatment parameters when food safety is implicated.
When validation is required, the type and depth of evidence needed depends on the purpose of the treatment and whether the treatment parameters have been previously validated. For more information on depth and type of evidence, refer to Evidence showing a control measure is effective.
Where validation is required, you should have
- a description of the food item being processed
- a description of the purpose of the HPP treatment (for example, shelf-life extension)
- a description of the HPP treatment being applied (for example: pressure applied, holding time, number of cycles, temperature)
- justification or data demonstrating that the HPP treatment is effective for its intended purpose, for example, process schedules, shelf-life studies, challenge studies, literature reviews, collection of data, and manufacturer's declarations for packaging materials
As an importer you will need to obtain this information from the foreign manufacturer of any HPP-treated foods you import. If the imported food has been treated with HPP for a purpose where validation is required, you are responsible for providing this information.
Table 1: Validation requirements for specific HPP applications
|Purpose of HPP treatment||Validation Requirement|
1. Shelf-life extension
Example: treating fresh ground beef with HPP to extend the refrigerated shelf life
|Validation is not required unless a food safety hazard(s) may be introduced by the extended shelf lifeFootnote 2|
2. Technical effect
Example: treating crustaceans with HPP to facilitate shell removal
|Validation is not required for non-food safety purposes|
3. Lethality treatment
Examples: pasteurization of raw milk (in place of heat pasteurization); reconditioningFootnote 1 of noncompliant food
|Validation is required demonstrating the intended log reduction is achieved|
4. Post-lethality treatment of ready-to-eat (RTE) food to support applying a reduced Listeria monitoring frequency based on a lowered risk (see Control measures for L. monocytogenes in RTE foods, Tables 1 to 3)
Example: in-package HPP treatment of sliced deli meat to reduce the recommended environmental sampling frequency by half
Validation is required demonstrating at least a 3-log reduction of L. monocytogenes is achieved
Note: Treating RTE meat and poultry products for 3 minutes at 87 000 psi (600 MPa) has been validated as achieving at least a 3-log reduction in L. monocytogenes
Packaging requirements for HPP-treated foods
You are also responsible for ensuring that packaging materials used for HPP-treated foods are appropriate (for example, they can withstand the process) and do not introduce any hazards to the food, as found in Division 23 of the Food and Drug Regulations and Section 186 of the Safe Food for Canadians Regulations.
Tell me more! Further reading
Evidence showing that a control measure is effective
Codex Alimentarius. Guidelines for the Validation of Food Safety Control Measures (CAC/GL 69-2008), 2013
Health Canada Position – High Pressure Processing (HPP) Is No Longer a Novel Process, 2016
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