Industry Information Session: Implementation of the 2011 Health Canada "Policy on Listeria monocytogenes in Ready-to-Eat Foods"
Topic 5: RTE Food Categories

RTE Food Categories

In the Listeria Policy, RTE foods have been classified into two categories, based upon health risk.

  • Category 1
  • Category 2 contains two subgroups:
    • Category 2A
    • Category 2B

Regardless of the RTE food categorization, industry must produce safe foods as per the Food and Drugs Act and Regulations.

Category 1

(Section 6.1, 7.3, Table 1 and Appendix A of the Listeria Policy)

Definition: RTE fresh-cut produce, which can support the growth of Lm throughout the stated shelf-life to levels > 100 CFU/g and which have a refrigerated shelf-life of > 5 days.

By default, a food is considered Category 1 if validated data is unavailable, insufficient, or inadequate to demonstrate it is either a Category 2A or 2B or its categorization has not been confirmed by the regulatory authorities (e.g., CFIA).

Sample Size: 5 units of minimum 100 g each

Samples should be representative of the lot and the production conditions, taken aseptically at random from each lot.

Laboratory Method: Any enrichment (presence/absence) method for Lm published in HC's Compendium of Analytical Methods.

Action Level: Detection in 125 g (5 x 25 g analytical units analysed either separately or composited).

Nature of Concern: Health Risk 1

A situation where there is a reasonable probability that the consumption/exposure to a food will lead to adverse health consequences which are serious or life-threatening or that the probability of a foodborne outbreak situation is considered high.

Level of Priority: High; for industry control, monitoring, verification and regulatory oversight/compliance activities.

Category 2A

(Section 6.1, 7.3, Table 1 and Appendix A of the Listeria Policy)

Definition: RTE fresh-cut produce, in which a limited potential for growth of Lm to levels ≤ 100 CFU/g can occur throughout the stated shelf-life.

  • RTE food with a refrigerated shelf-life of ≤ 5 days; validation not required.
  • RTE foods which are known to occasionally contain low levels of Lm and do not have a kill step that achieves a ≥ 5 log reduction in numbers of Lm; validation required.
  • If information is insufficient, inadequate or no information exists to demonstrate that there is limited growth of Lm throughout the shelf-life, as determined by validated data, the food will be considered as a Category 1 RTE food.

Sample Size: 5 units of minimum 100 g each

Laboratory Method: Any enumeration method for Lm published in HC's Compendium of Analytical Methods.

Action Level: > 100 CFU/g in any one sub-unit (5 x 10 g analytical units).

Nature of Concern: Health Risk 2

The health risk identified represents a situation where there is a reasonable probability that the consumption/exposure to a food will lead to temporary or non-life threatening health consequences, or that the probability of serious adverse consequences is considered remote.

Level of Priority: Medium to low; for industry control, monitoring, verification and regulatory oversight/compliance activities.

Category 2B
(Section 6.1. 7.3, Table 1 and Appendix A of the Listeria Policy)

Definition: RTE food, in which Lm cannot grow (i.e., < 0.5 log CFU/g throughout the stated shelf-life).

RTE food that meets the following criteria will not support the growth of Lm:

  • Stored under "frozen" conditions (until consumption), or
  • pH < 4.4, regardless of aw, or
  • aw < 0.92, regardless of pH, or
  • Combination of pH < 5.0 and aw < 0.94

* Validation not required.

Note: Products not meeting these physico-chemical parameters require scientific validated data to demonstrate that the food does not support the growth of Lm. This validation information must be reviewed and confirmed by the relevant regulatory authority.

Sample Size: 5 units of minimum 100 g each

Laboratory Method: Any enumeration method for Lm published in HC's Compendium of Analytical Methods.  

Action Level: > 100 CFU/g in any one sub-unit (5 x 10 g analytical units).

Nature of Concern: Health Risk 2

A situation where there is a reasonable probability that the consumption/exposure to a food will lead to temporary or non-life threatening health consequences, or that the probability of serious adverse consequences is considered remote.

Level of Priority: Low; for industry control, monitoring, verification and regulatory oversight/compliance activities.

RTE Food Categories

(Section 6.1 of the Listeria Policy)

RTE Foods Intended for High-Risk Population

  • Should receive the highest priority for industry control, monitoring and verification, as well as regulatory oversight and compliance activities.
  • May be considered to represent a Health Risk 1 concern, irrespective of product type and associated category rating (1, 2A ou 2B).
RTE Food Categories Summary Table
Category 1 Category 2A Category 2B
Definition RTE fresh-cut produce, which can support the growth of Lm throughout the stated shelf-life to levels > 100 CFU/g and which have a refrigerated shelf-life of > 5 days RTE foods, in which a limited potential for growth of Lm to levels no greater than 100 CFU/g can occur throughout the stated shelf-life RTE foods, in which Lm cannot grow
Sample Size 5 units of minimum 100 g each 5 units of minimum 100 g each 5 units of minimum 100 g each
Laboratory Method Any enrichment (presence/absence) method for Lm published in HC's Compendium of Analytical Methods Any enumeration method for Lm published in HC's Compendium of Analytical Methods Any enumeration method for Lm published in HC's Compendium of Analytical Methods
Action Level Detection in 125 g > 100 CFU/g in any one sub-unit > 100 CFU/gin any one sub-unit
Nature of Concern Health Risk 1 Health Risk 2
(Health Risk 1 if food is intended for high risk groups or intended for use in Cat. 1 food)
Health Risk 2
(Health Risk 1 if food is intended for high risk groups or intended for use in Cat. 1 food)
Level of Priority High Medium - Low
(unless the food is intended for high risk groups or intended for use in a Cat. 1 food)
Low
(unless the food is intended for high risk groups or intended for use in a Cat. 1 food)
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