Language selection

Search

Archived - Guide - Process Control Technical Information

This page has been archived

This page was archived due to the coming into force of the Safe Food for Canadians Regulations. Archived information is provided for reference, research or record-keeping purposes only. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. For current information visit Food.

Table of Contents

1. Purpose

This guide outlines the technical information which should be provided in the process control documents to demonstrate that canned and ready-to-eat (RTE) products were adequately processed and are safe to the end of their shelf life.

2. Scope

This guide applies to importers of fish and the CFIA inspection staff.

3. Reference and Tools

4. Technical Information

In order to demonstrate that a RTE or canned product was processed adequately and is safe to the end of its shelf life, technical information is required on the control measures, critical limits and critical factors used to prevent, eliminate and inhibit the growth of microbial food pathogens.

The technical information which should be included in the process control documents depends on the type of product as outlined in the product specific sections. These sections provide specific technical information recognized internationally as effective in eliminating/inhibiting/reducing and/or preventing the growth of microbial food pathogens and ensuring the safety of the product to the end of its shelf life. Other control measures, critical limits and critical factors may be effective however their effectiveness must be demonstrated through validation. Validation includes obtaining and evaluating technical, empirical and scientific information though a literature review and/or challenge study. A challenge study is where the relevant microorganisms are deliberately inoculated into the product to determine its ability to support survival or growth of the organisms during storage at defined temperatures.

Where heat is applied to cook, pasteurize or sterilize a product, the process authority or technically competent person is responsible for establishing the heat process using appropriate target organisms and log reduction. A more rigorous heat process than described in this guide may be required depending on the product and the source of ingredients.

4.1 Canned, Sterilized Products

General Description of this product group

Products which are packed in individual containers, hermetically sealed, then thermally processed to achieve commercial sterility.

Example: Canned Tuna

Technical Process Information

The process control documents for canned products should contain the following technical process information:

4.2 Ready-to-Eat (RTE) Products

General description of this product group

Fish products which do not require preparation except thawing or reheating before consumption.

Technical Process Information

The process control documents for RTE products should contain the following technical process information as well as the additional control measures discussed in the next product specific sections:

4.2.1 Ready-to-Eat (RTE) Cooked Products

General description of this product group

Products which are cooked in bulk and then packaged.

Product Examples:
Guide to Process Control Technical Information Requirements
Reference Number Table Note 2 Storage Condition Shelf Life Product Examples
A.1 Frozen Not Applicable hot smoked salmon, cooked crab sections, boiled baby clams, heat and serve fish soups/chowders or sauces
A.2 Refrigerated Short ≤5 days hot smoked salmon, fish cakes
A.3 Refrigerated Long >5 days kamaboko, heat and serve fish soups/chowders or sauces

Table Note

Table Note 2

Corresponds to the reference number used in the Summary table in Section 4.3.3 of the Process Description for Product Inspection of Imported Fish

Return to table note 2  referrer

Technical Process Information

The process control documents for RTE cooked products should also contain the following technical process information:

The control measures used to prevent the growth of spore and non-spore forming microbial food pathogens in the RTE cooked final product for the duration of its shelf life such as:

A.1 Storing the RTE product under "frozen" storage conditions.

These products are considered a Category 2B food under the Health Canada Policy on Listeria monocytogenes in Ready-to-Eat Foods.

A.2 Limiting the shelf life of refrigerated RTE products to 5 days or less (short shelf life):

These products are considered a Category 2A food under the Health Canada Policy on Listeria monocytogenes in Ready-to-Eat Foods.

A.3 The use of safety parameters to inhibit the growth of L. monocytogenes to the end of the product's stated shelf lifeFootnote 4

These products are considered a Category 2B food under the Health Canada Policy on Listeria monocytogenes in RTE Foods.

Or

For products with a refrigerated shelf life greater than 5 days (long shelf life), using one of the following three controls for Listeria monocytogenes (each in combination with controls for C. botulinum):

These products are considered a Category 2B food under the Health Canada Policy on Listeria monocytogenes in RTE Foods.

Or

These products are considered a Category 1 food under the Health Canada Policy on Listeria monocytogenes in RTE Foods.

Or

These products are considered a Category 1 food under the Health Canada Policy on Listeria monocytogenes in RTE Foods.

And in combination with any of the following controls for non-proteolytic C. botulinum:

Note: Using oxygen permeable packaging as the only control for non-proteolytic C. botulinum in product with a shelf life greater than 10 days may not be adequate for all product. For example, products packed in oil or in large containers may still pose a risk.

4.2.2 Ready-to-Eat (RTE), Pasteurized in the Container

General description of this product group

RTE products which are packaged or filled into individual containers, sealed and then heat processed.

Background information on Pasteurizing

The pasteurizing processes are normally developed by a process authority. The target organism for the heat process will depend on the chosen final product storage temperature and safety parameters.

A process that targets non-proteolytic Clostridium botulinum will control both spore and non-spore formers in a refrigerated product. A process that targets L. monocytogenes will prevent the growth of other non-spore formers but requires an additional control to prevent growth of spore formers. In the latter case, the additional controls for the spore formers are: freezing and storing the product frozen, a combination of storing the product refrigerated and final product safety parameters, or final product safety parameters alone.

Product Examples:
Guide to Product Examples for Process Control
Reference Number Storage Condition Shelf Life Safety parameters Product Examples
B.1 Frozen Not Applicable Not Applicable pasteurized crab meat, kamaboko
B.2 Refrigerated Long (>5 days) No pasteurized crab meat, kamaboko
B.3 Refrigerated Long (>5 days) Yes pasteurized caviar
B.4 Room Temperature Not Applicable Yes Oyster Sauce, other fish sauces
Information Expected to be Included in the Process Control Documents

A description of the product preparation steps prior to pasteurizing.

A description of the pasteurizing process should include the following information:

A description of the steps after pasteurizing which includes procedures to:

A description of the control measures used to prevent the growth of spore forming microbial food pathogens in the final product during its shelf life such as:

B.1 Listeria pasteurization and

B.2 non-proteolytic C. botulinum pasteurization and

B.3 Listeria pasteurization and

B.4 Listeria pasteurization and

Pasteurized RTE products are exempt from the Health Canada Policy on Listeria monocytogenes in RTE Foods.

Additional Information:

For fluid products, it may be possible to achieve a Listeria monocytogenes pasteurization in the sealed container by a hot filling, sealing and hot holding as specified by a process authority.

4.2.3 Ready-to-Eat (RTE), Safety Parameters

General description of this product group

RTE products which have not been subjected to a heat process and which rely on safety parameters to ensure their safety. These products, depending on the safety parameters used, may or may not require refrigeration to inhibit the growth of microbial food pathogens.

Background Information

The water activity of a product can be reduced by adding salt, sugar or other solids and draining the fluids extracted, drying, etc.; or a combination of reducing moisture and the addition of ingredients. The growth of spore and non-spore forming microbial food pathogens is inhibited when the water activity prevents the growth of Staphylococcus aureus. When water activity is adequately reduced to prevent the growth of Staphylococcus aureus, the product does not need to be stored under refrigeration.

When safety parameters are used to inhibit the growth of Listeria monocytogenes, the growth of other microbial food pathogens such as non-proteolytic C. botulinum is also inhibited. Refrigeration is required to prevent the growth of proteolytic C. botulinum.

Product Example:
Guide to Product Examples for Process Control
Reference Number Storage Condition Shelf Life Product Examples
C.1 Refrigerated Long (>5 days) Seafood Salad, fermented fish products, anchovies
C.2 Room Temperature Not Applicable dried fish, salted fish, fish jerky, shrimp crackers, fish soup base, unpasteurized fish sauces and pastes
Information Expected to be Included in the Process Control Documents

A description of the control measures to:

A description of the control measures to prevent the growth of spore forming microbial food pathogens during the duration of the product's shelf life such as:

C.1 For products with a long shelf life (>5 days) which are stored under refrigeration:

C.2 For products stored at room temperature:

These products are considered a Category 2B food under the Health Canada Policy on Listeria monocytogenes in RTE Foods.
Additional Information

Fish drying must occur under controlled, sanitary conditions. The process control documents should include a description of the premises and drying equipment.

For whole dried fish snacks, the importer should note that C. botulinum spores are associated with sediment found in the guts of fish. Whole fish, which has not been gutted, can contain these spores and provide the anaerobic conditions for spore growth and toxin production before the fish can be properly dried. The risk increases as the size of the fish increases due to the longer time the fish may be exposed to higher temperatures.

For dried fish products packed in oil, the fish and ingredients must be shelf stable (dry) prior to packing with oil. The use of ingredients such as fried fresh garlic or shallots may not be safe for these types of products.

4.2.4 Ready-to-Eat Products Uncooked and Without Safety Parameters

General description of this product group

RTE products which have not been subjected to a heating process or safety parameters and are thereby in a raw state.

Product Examples
Guide to Product Examples for Process Control
Reference Number Storage Condition Shelf Life Product Examples
D.1 Frozen Not Applicable cold smoked fish, sushi, caviar and other roe products
D.2 Refrigerated Short (≤5 days) cold smoked fish, sushi
D.3 Refrigerated Long (>5 days) cold smoked fish, caviar, salads, sandwiches
Information Expected to be Included in the Process Control Documents

A description of the control measures used to prevent product contamination and to inhibit the growth of microbial food pathogens and parasites which may be present (target organisms are L. monocytogenes and C. botulinum) for the duration of the product's shelf life.

D.1 Storing the The RTE product under "Frozen" storage conditions:

These products are considered a Category 2B food under the Health Canada Policy on Listeria monocytogenes in RTE Foods.

D.2 Limiting the shelf life of refrigerated RTE products to 5 days or less (short shelf life): For products stored under refrigeration:

These products are considered a Category 2A food under the Health Canada Policy on Listeria monocytogenes in RTE Foods.

D.3 For products with a refrigerated shelf life greater than 5 days (long shelf life), using one of the following controls for Listeria monocytogenes (each in combination with controls for parasites and C. botulinum):

These products are considered a Category 2B food under the Health Canada Policy on Listeria monocytogenes in RTE Foods.

Or

These products are considered a Category 1 food under the Health Canada Policy on Listeria monocytogenes in RTE Foods.

And in combination with the following controls for parasites:

And in combination with one of the following controls for C. botulinum:

Note: that using oxygen permeable packaging as the only control for non-proteolytic Clostridium botulinum in product with a shelf life greater than 10 days may not be adequate for all product. For example, products packed in oil or in large containers may still pose a risk.

Additional Information:

For products containing rice and/or pasta, the process controls should also describe the control measures used to:

5. References

Codex Alimentarius Commission (1999) Code of Hygienic Practice for Refrigerated Packaged Foods with Extended Shelf life - PDF (72 kb) (accessed May 10, 2011).

Embarek and Huss. (1993). Heat resistance of L. monocytogenes in vacuum packaged pasteurized fish fillets. International Journal of Food Microbiology, 20:85-95. Assessment and Management of Seafood Safety and Quality.

Health Canada, Health Products and Food Branch, Food Directorðate, Policy on Listeria monocytogenes in Ready-to-Eat Foods (2011).

Huss, H.H; Ababouch, L; Gram, L. (2003) Assessment and Management of Seafood Safety and Quality. Clostridium botulinum Fisheries Technical Paper. No. 444. Rome, Clostridium botulinum (accessed March 11, 2011).

United States Food and Drug Administration (2011) Fish and Fishery Products Hazards and Controls Guidance Fourth Edition (accessed May 11, 2011).

Date modified: