Appendix 2. Figure 1: Decision Tree - Determination of Ready-To-Eat (RTE) Product Category

Appendix 2. Figure 1: Decision Tree - Determination of the ready-to-eat 1 (RTE) product category that a fish product falls under in accordance with the Health Canada "Policy on Listeria monocytogenes in Ready-to-Eat Foods".

1. Does the product require preparation (except thawing and re-heating) prior to consumption?

If yes - product is not ready-to-eat1. The HC Listeria policy does not apply.

If no

2. Has the product received a heat treatment in the final package sufficient to eliminate Listeria monocytogenes (e.g. canning, pasteurization)?

If yes - the HC Listeria policy does not apply.

If no

3. Is the product intended to be kept frozen from the time of production and over the course of its stated shelf life 2, and thawed only at the time of consumption?

If yes - product falls under category 2B - growth of L. monocytogenes cannot occur.

If no

4. Does the product meet one of the following criteria? pH < 4.4 or Aw < 0.92 or a combination of pH < 5.0 and Aw < 0.94.

If yes - product falls under category 2B - growth of L. monocytogenes cannot occur.

If no

5. Is there evidence, obtained through validation3, demonstrating that L. monocytogenes cannot grow in the product by more than 0.5 log CFU/g4 throughout its stated shelf life2?>

If yes - product falls under category 2B - growth of L. monocytogenes cannot occur.

If no

6. Does the packaged product have a stated shelf life2 of 5 days or less?

If yes - product falls under category 2A - growth of L. monocytogenes can occur to levels no greater than 100 CFU/g4.

If no

7. Is there evidence, obtained through validation3, demonstrating that levels of L. monocytogenes will not exceed 100 CFU/g4 before the end of the product stated shelf life2?

If yes - product falls under category 2A - growth of L. monocytogenes can occur to levels no greater than 100 CFU/g4.

If no

Product falls under category 1 - growth of L. monocytogenes can occur and exceed 100 CFU/g4. The processor must be able to validate that the control measures are effective in preventing L. monocytogenes from being introduced in the product throughout the process and that the final product is consistently free of L. monocytogenes.

1. Ready-to-eat (RTE): foods not requiring any further preparation before consumption, except perhaps washing/rinsing, thawing or warming.

2. Shelf life: the period, commencing on the day on which a pre-packaged product is packaged for retail sale, during which the product, when it is stored under conditions appropriate to that product, will retain, without any appreciable deterioration, its normal wholesomeness, palatability, nutritional value and any other qualities claimed for it by the manufacturer. (Food and Drug Regulations B.01.001)

3. Validation refers to obtaining evidence that a control measure or combination of control measures, if properly implemented, is capable of controlling the hazard to a specified outcome. For example, challenge tests (through the inoculation with L. monocytogenes of a representative product batch) have demonstrated that throughout the stated shelf life, the growth of L. monocytogenes cannot occur (category 2B) or will not exceed 100 CFU/g (category 2A), while stored under reasonably foreseeable conditions of distribution, storage and use.

4. Colony Forming Unit per gram(CFU/g): a measure of viable (living) cells in a sample per millilitre (mL) or gram (g).