Regulatory Standard - Process Control Document Requirements

Table of Contents
  1. Purpose
  2. Scope
  3. Legislative Authorities
  4. Process Control Document Requirements
  5. Appendices
    • Appendix A - Product and Process Information Form - Canned Fish
    • Appendix B - Product and Process Information Form - Ready-to-Eat Fish
  6. References

1. Purpose

This standard outlines the regulatory requirements for process control documents that an importer must obtain for imported canned and Ready-to-Eat (RTE) fish products, as required by the Fish Inspection Regulations (FIR). It also outlines the control measures recognized as effective in ensuring the adequate processing and safety of RTE products and the type of processing information required to demonstrate that these products are safe to the end of their shelf life.

2. Scope

This standard applies to importers and the Canadian Food Inspection Agency (CFIA) inspection staff.

3. Legislative Authorities

The authority for the requirement to maintain process control documents is provided by:

4. Process Control Document Requirements

4.1 General

Process control documents must demonstrate that effective control measures are used to eliminate and/or control known food safety hazards in canned and ready-to-eat (RTE) products to the end of the product's shelf life while stored under reasonably foreseeable conditions of distribution, storage and use. Importers are required to obtain and maintain these documents as part of their fish import licence record keeping requirements.

Internationally recognized control measures or standards are included in this document and in the supporting Process Control Document Guide. The CFIA acknowledges that other control measures and critical limits may be effective in ensuring adequate processing and the safety of a RTE or canned product. In such cases, the process control document must include scientific references and validation information from the technical competent person or process authority that developed the process demonstrating the effectiveness of these control measures or critical limits. This validation information is assessed to determine whether the control measures and critical limits are effective in eliminating/reducing and/or preventing the growth of food pathogens and ensuring the safety of the product to the end of its shelf life.

The specific information that must be provided in the process control documents is outlined in the FIR:

  • Section 6.1(3)(c) for canned fish, and
  • Section 6.1(3)(d) for RTE fish

The information on the process control requirements is organized as follows:

  • FIR requirements
    Canned Fish - Section 4.2, RTE Fish - Section 4.3
  • Example of a "product and process control information" form
    Canned Fish - Appendix A, RTE Fish - Appendix B

4.2 Canned Fish [FIR, 6.1(3)(c)]

4.2.1 Identity of the Process Authority

The process control documents must identify the name, address, and telephone number of the process authority who developed the thermal process.

The information must include the name of the individual, their organization or company, and their position.

4.2.2 Product and Process Description, and sterilizing value (F0)

The process control document must include information on the sterilizing value (F0) of the thermal process; the container type, size, and specifications; style of pack and species packed.

The process control documents must describe the product and process and the control measures used to ensure adequate processing and the safety of the canned product to the end of its shelf life while stored under reasonably foreseeable conditions of distribution, storage and use.

The information on the control measures required include:

  • sterilizing value(F0)1, as specified by the process authority
  • information on the critical factors which impact the commercial sterility and the container integrity of a sterilized product.
Critical factors which impact commercial sterility Critical factors which impact container integrity
  • can dimensions (size)
  • product species and style of pack
  • thermal process - minimum initial product temp at start of thermal process; temp and time of thermal process
  • type of retort and heating medium
  • other critical factors as identified by the process authority
  • container material (e.g., metal, glass, pouch, other)
  • closure/lid material and type
  • method of closure (e.g., heat seal, double seam, lid or cap)
  • assessment criteria for closure (e.g., overlap and % tightness for double seams; seal strength for flexible containers)

4.2.3 Process Authority's Product Safety Attestation

The process control document must include a statement in writing signed by the process authority that attests that the thermal process results in the production of a commercially sterile and safe fish product.

The process authority must attest that the thermal process described in Section 4.2.2 results in a safe canned fish product.

4.3 Ready-to-Eat Fish [FIR, 6.1(3)(d)]

4.3.1 Identity of the Process Developer

The process control document must identify the name, address and telephone number of the person who developed the process.

The information must include the name of the individual, their organization or company, and their position.

4.3.2 Product and Process Description

The process control document must include the container type and size; style of pack and species packed; the type of process and the description of the process.

The process control document must describe the product, process, and the control measures used to ensure adequate processing and the safety of the RTE product to the end of its shelf life while stored under reasonably foreseeable conditions of distribution, storage and use.

Control Measures for eliminating or reducing microbial food pathogens in a RTE product Control Measures to inhibit the growth of microbial food pathogens in a RTE product Control Measures to eliminate/reduce microbial food pathogens in the processing environment
  • Cooking
  • Pasteurization in final container
  • Processing aids
  • Post-lethality treatments
  • pH or aw
  • Approved food additive
  • Freezing storage conditions
  • Refrigeration shelf life ≤5 days2from day of packing
  • Permeability of package (for refrigerated product)
  • Sanitation and Hygiene programs
  • Sanitary zones

4.3.3 Product Safety Attestation

The process control documents must include a statement in writing signed by the person who developed the process that attests that the process results in the production of a safe fish product.

The person who developed the process must attest that the described process results in a safe fish product.

4.3.4 Specific Technical Information for Ready-to Eat Products

The safety of RTE product is complex and is dependent on a combination of the preservation method, the product formulation, storage temperature and shelf life and the use of additives or post-lethality treatments.

Based on the preservation method, the RTE products are organized into 4 RTE groups:

  • cooked;
  • Pasteurized in the Container;
  • Safety Parameters;
  • No Safety Parameters or Heat.

Some products may require a combination of preservation methods in order to ensure their safety.

A) RTE Cooked Fish Products

Fish products which have been subjected to a heat treatment (kill step) prior to packing.

For cooked fish product, the cooking step must results in 5 log reduction3 or more for Listeria monocytogenes; and...

To demonstrate that the thermal control measure (cooking step) results in a 5 log reduction, the Critical limits of the internal time and temperature applied must be provided.

... during cooling (after the cooking step), product contamination and the growth of microbial pathogenic spores must be prevented; and...

The process controls must describe the control measures to:

  • prevent, during the cooling step after cooking, product contamination and the germination and growth of microbial pathogenic spores which may be present.
... the growth of microbial food pathogens, which may be present in the final product, must be inhibited.

The process controls must describe the control measures to inhibit the growth of pathogenic organisms in the finished product.

B) RTE Fish Product Pasteurized in the Container
For fish product pasteurized in the container, the process control documents must include the pasteurizing thermal process and the number of log reductions achieved by the process; and...

The process control must include information on the microorganism targeted by pasteurizing thermal process, the accumulated lethality (F-value) the stated reference temperature and z-value.

When the thermal processes target Listeria monocytogenes, it must result in 5 or more log reductions or more of the organism. When the thermal processes target non-proteolytic Clostridium botulinum it must result in 6 log reductions or more of the organism. (Peck M.W., 2006)

... during cooling (after the pasteurization step), product contamination must be prevented; and...

The process description must include the control measures used during cooling to prevent contamination with microbial pathogen.

... the growth of microbial food pathogens, which may be present in the final product must be inhibited.

For the thermal process which target non-spore forming microbial pathogens (e.g., Listeria monocytogenes), the process description must include the control measures used to inhibit, during cooling and storage, the germination and growth of microbial pathogenic spores which may still remain in the product (e.g., non-proteolytic C. botulinum.)

C) RTE Fish Product preserved by safety parameters
For RTE fish products which rely on safety parameters to inhibit the growth of microbial pathogens, the critical limits of the control measures used must demonstrate the safety of the product to the end of its shelf life while stored under reasonably foreseeable conditions of distribution, storage and use.

For refrigerated products, the critical limits for the safety parameters used as control measures must meet the following criteria in order to demonstrate that the growth of microbial pathogens (e.g., Listeria monocytogenes), yeasts and molds (if applicable) in a product is inhibited to the end of its shelf life while stored under reasonably foreseeable conditions of distribution, storage and use:

  • aw <0.92, regardless of pH or
  • pH <4.4 regardless of aw plus prevent yeast and mold growth; or
  • pH <5.0 and aw <0.94 plus prevent yeast and mold growth (CAC, 2009).

For products stored at room temperature, the critical limits for the safety parameters used as control measures must meet the following criteria in order to demonstrate that the growth of all microbial pathogens (e.g., Listeria monocytogenes) yeasts and molds (if applicable) in a product is inhibited to the end of its shelf life while stored under reasonably foreseeable conditions of distribution, storage and use:

  • aw ≤0.85 (Government of Canada, 2011; CAC, 1993)

The process controls must also describe the control measures to prevent the growth of microbial pathogens and the production of microbial toxins during processing.

D) RTE Fish Product with no safety parameters or heat
For RTE fish product with no safety parameters or heat treatment, the process control documents must describe the sanitary and process controls to eliminate and prevent contamination with microbial pathogens.

The document must include a description of the sanitary and hygiene control measures and process control measures to eliminate and prevent, during processing, product contamination with microbial pathogen.

4.3.5 Additional Technical Information Requirements

RTE Fish Products with a Long Refrigerated Shelf Life
For RTE products with a long refrigerated shelf life (greater than 5 days from day of packing), the process control documents must include critical limits or validation information demonstrating that the growth of spore and non-spore forming pathogenic microorganisms is inhibited.

If the product has a refrigerated shelf-life greater than 10 days, the process controls must include a description of the critical limits or validation information that demonstrates that the growth of non-proteolytic Clostridium botulinum is inhibited until the end of the product shelf-life while stored under reasonably foreseeable conditions of distribution, storage and use (CAC, 1999).

For unpasteurized refrigerated RTE products with a long refrigerated shelf life (≥ 5 days) it must be determined whether Listeria monocytogenes can grow or not in the product while stored under reasonably foreseeable conditions of distribution, storage and use.
  • If it is determined that Listeria monocytogenes cannot grow <0.5 log increase) or would not proliferate over 100 Colony Forming Units (CFU) per gram of product, validation information to substantiate this must be provided (CAC, 2009).
  • If it is determined that Listeria monocytogenes can grow, information on the sanitation and hygiene controls to eliminate and prevent product contamination must be provided.
RTE Fish Products that Rely on pH for Safety
For RTE products that rely on pH for safety, the process control documents must describe the control measures to ensure that the pH is maintained to the end of the shelf life.

The growth of yeasts or molds can cause the pH to rise therefore the process controls must describe how these organisms are eliminated or their growth is inhibited.

5. Appendices

Appendix A - Canned Fish - Product and Process Control Form (PDF 18 kb)
Appendix B - Ready-to-Eat Fish - Product and Process Information Form (PDF 18 kb)

6. References

Codex Alimentarius Commission (CAC.) (1993) Recommended International Code of Hygiene Practice for Low and Acidified Low Acid Canned Foods (accessed March 11, 2011)

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

Codex Alimentarius Commission (CAC). (2009) Food Hygiene Basic Texts. 4th edition Recommended International Code of Practice. General Principles of Food Hygiene

Government of Canada. (2011) Food and Drug Regulations (accessed March 11, 2011)

Health Canada, Health Products and Food Branch, Food Directorate, 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. FAO Fisheries Technical Paper. No. 444. Rome, FAO (accessed March 11, 2011)

Official Journal of the European Union. Commission Regulations (EC) No 1441/2007 of 5 December 2007 Amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs

Peck M.W. (2006) Clostridium botulinum and the safety of minimally heated, chilled foods: an emerging issue? Journal of Applied Microbiology vol 101, issue 3: 556-570

1It is internationally accepted that a minimum sterilizing value of 3.0 minutes is required to render a low-acid canned food microbiologically safe (Huss H.H et al., 2003).

2 Official Journal of the European Union Commission Regulation (EC) No 1441/2007 of 5 December 2007 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs

3Codex Alimentarius Commission). (2009) Food Hygiene Basic Texts. 4th ed. Recommended International Code of Practice. General Principles of Food Hygiene.