Guidance on food products treated with high pressure processing (HPP)

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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).

During HPP, the solid or liquid food product is placed in a pressure vessel and subjected to very high pressure using a pressure-transmitting medium (usually water). HPP can inactivate microorganisms and enzymes in the food and alter certain characteristics of the food.Footnote 1

HPP has a variety of applications. For example, it could be used

  • to reduce or eliminate pathogens found in food,
  • to extend the shelf-life of certain products,
  • for reconditioningFootnote 2,
  • for specific technical processes, including shell removal of crustaceans.

Although HPP has validated parameters for certain specific uses, in some cases, the food manufacturer or importer would be required to provide additional validation information demonstrating the safety of the treatment and the final product.

Background

For over a decade, HPP-treated foods sold in Canada were regulated as Novel Foods under Division 28 (B.28.002) of the Food and Drugs Regulations. However, on December 22, 2016, Health Canada published a position indicating that there is sufficient knowledge and data available on the safe use of HPP to remove the novel status.

Therefore, 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.

Purpose

This document provides guidance on the types of information to be documented by food manufacturers when they use, or plan to use, an HPP treatment on a food product.

It also provides information on the validation of food safety controls for HPP-treated foods. Known parameters that have already been validated as effective for specific HPP purposes are outlined, as well as instances where further validation would be necessary to demonstrate safe food production (see Annex 1).

Considerations for food manufacturers and importers

Although HPP-treated foods are no longer considered novel, HPP-treated foods sold in Canada must comply with all applicable legislative and regulatory requirements, including Section 4 (1) of the Food and Drugs Act relating to the sale of safe food.

Food establishments using HPP must ensure that the process is carried out in a safe and effective manner. Manufacturers who plan to use HPP should consider

  • the sensitivity of microorganism(s) of concern to HPP,
  • the intended purpose of the HPP treatment,
  • the characteristics of the food product,
  • the storage conditions of the end product,
  • the potential for the introduction of food safety hazards due to shelf-life extension resulting from HPPFootnote 3.

As with any type of process, manufacturers and importers of HPP-treated foods may be required to provide validation information for HPP processes. The validation of food safety control measures is an integral part of an effective food safety system.

Documenting information on HPP-treated food products

When a food manufacturer uses, or plans to use, a HPP treatment for a specific purpose using parameters that have already been validated, the Canadian Food Inspection Agency (CFIA) recommends documenting the following information. In cases where additional validation is required (see Annex 1), the following information would be required:

  • a description of the food item being processed
  • a description of the HPP treatment being applied (for example: pressure applied, holding time, number of cycles, temperature)
  • a description of the intended purpose of the HPP treatment (for example, shelf-life extension, pathogen reduction, critical control point (CCP), post-lethality, re-conditioning)
  • justification or data demonstrating that the HPP treatment is effective for its intended purpose and that the final product meets all food safety requirements. This could include information such as process schedules, shelf-life studies, manufacturer's declarations for packaging materials etc.

The CFIA also recommends that food importers obtain this information from the foreign manufacturer of any HPP-treated foods they import. If the imported food has been treated with HPP for a purpose where additional validation is required, the importer would be required to provide this information.

Note: For manufacturers required to have a written preventive control plan (HACCP or other), documented validation of processes critical to the safety of the product is required. However, all food manufacturers are responsible for producing safe food and any available information regarding the food product may be collected by the CFIA to verify the safety of the product.

Validation of HPP processes

The table in Annex 1 contains information that may be used to help determine validation measures for HPP-treated foods.

Packaging requirements for HPP-treated food products

It is the responsibility of the manufacturer to ensure that packaging materials associated with HPP-treated foods are appropriate and do not pose a health safety risk to consumers, as found in Division 23 (B.23.001) of the Food and Drug Regulations.

Annex 1: HPP treating parameters and validation requirements for specified purposes

Purpose Validated Maximum PressuresTable Note 4 (psi/MPa) Validated Maximum TimeFootnote 4 at 87,000 psi (min) Validation Requirements
Shelf-life extension 87 000/600 27 Addition validation is not required unless a food safety hazard(s) may be introduced by the extended shelf life. Table Note 5
Pathogen reduction where HPP treatment is not a critical control point 87 000/600 27 Additional validation is not required unless the post-lethality treatment is associated with re-classification of the product to a lower risk level. Table Note 6
Other technical processes (e.g. shell removal of crustaceans) 87 000/600 27 Additional validation is not required.
Pathogen reduction where HPP treatment is a critical control point None None Validation is required. Consult with your CFIA inspector or your local CFIA office.
Reconditioning Table Note 7 None None Validation is required. Consult with your CFIA inspector or your local CFIA office.

Table Notes

Table Note 4

The maximum parameters were established as the maximum time and pressure that could be used to treat the food product without negative impact on the nutritional quality or chemical safety of the treated food, as well as on the integrity of the packaging material. Furthermore, the typical parameters of an HPP treatment are more commonly 87 000 psi/600 MPa for 1 to 5 minutes.

Return to table note 4  referrer

Table Note 5

For instance, a potential hazard of non-proteolytic Clostridium botulinum must be considered for fish and seafood containing products where HPP is used to extend the shelf life.

Return to table note 5  referrer

Table Note 6

For instance, ready-to-eat (RTE) meat and poultry products may qualify for a lower relative risk level for sampling purposes if a post-lethality treatment is used to achieve a minimum 3-log reduction in Listeria monocytogenes (see the CFIA's Meat Hygiene Manual of Procedures, Chapter 4, Annex H, Sections 3.2-3.4). HPP treatment of RTE meat and poultry products for 3 minutes at 87 000 psi has been validated to achieve a minimum 3-log reduction of Listeria monocytogenes.

Return to table note 6  referrer

Table Note 7

Reconditioning, for the purposes of this guidance document, means to bring a product known to be contaminated with a pathogen into compliance.

Return to table note 7  referrer

Annex 2: Definitions

Control measure

Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.Footnote 8

Critical control point (CCP)

A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.Footnote 8

Hazard analysis critical control point (HACCP)

A system which identifies, evaluates, and controls hazards which are significant for food safety.Footnote 8

High pressure processing (HPP)

A food processing technique in which a solid or liquid food is subjected to high pressures to inactivate microorganisms and enzymes in the food or to alter certain characteristics of the food.Footnote 1

Novel food

Foods that have been produced through new processes that do not have a history of safe use as a food, or that have been modified by genetic manipulation.Footnote 9

Validation

Obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome.Footnote 10

Annex 3: References and further reading

Canadian Food Inspection Agency. (2015). "Meat Hygiene Manual of Procedures," [Online]. [2016 August].

Codex Alimentarius. (2011). "General Principles of Food Hygiene (CAC/RCP 1-1969)," [Online]. [2017 June].

Codex Alimentarius. (2013). "Guidelines for the Validation of Food Safety Control Measures (CAC/GL 69-2008)," [Online]. [2017 June].

Health Canada. (2010). "Novel Foods," [Online]. [2016 August].

Health Canada. (2016). "Health Canada Position – High Pressure Processing (HPP) Is No Longer a Novel Process," [Online]. [2017 January].

San Martín, M. F., Barbosa-Cánovas, G. V. and B. G. Swanson (2002). "Food Processing by High Hydrostatic Pressure", Critical Reviews in Food Science and Nutrition, 42:6, 628, DOI: 10.1080/20024091054274.

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