F.B.14.19 Final product controls

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Chapter: Operations & Documentation
Section: Process Controls
Sub-Section: F.B.14.19 Final Product Controls

Element

The regulatory requirements contained in this guideline will be met when:

F.B.14.19 (01) Packaging methods, product labelling, and post-processing controls are suitable for each type of fish product in order to control pathogens of concern. (Risk Ranking: High)

Rationale

Many fish products (e.g. smoked fish) rely on a combination of the processing methods, the type of packaging, the storage conditions (e.g. refrigerated, frozen), the product shelf-life, and other post-processing controls to control or prevent growth or toxin formation of Clostridium botulinum, Listeria monocytogenes and other bacterial pathogens within the product up until consumption.

Packaging

The oxygen transmission rate (OTR) of the film used to wrap the fish product determines whether the product is considered aerobically packaged or anaerobically packaged.

For smoked fish products, an OTR equal to or greater than 2000 cc/m²/24h at 24 degrees Celsius and 1 atmosphere is required for aerobic packaging and an OTR of less than 2000 cc/m²/24 hours at 24 degrees Celsius and 1 atmosphere results in anaerobic packaging (refer to sections 1, 2 and 3 in the table below).

For some ready-to-eat (RTE) products, an OTR equal to or greater than 10 000 cc/m²/24h at 24 degrees Celsius and 1 atmosphere is considered aerobic packaging, and an OTR less than 10 000 cc/m²/24 hours at 24 degrees Celsius and 1 atmosphere is considered anaerobic packaging (refer to sections 4 and 7 in the table below).

Packaging OTR specifications must be confirmed by the packaging or film supplier with supporting documentation. Additionally, records of the the type of films used with fish products must be kept. In addition, any gases that come into contact with the fish product during packaging must be food-grade and permitted for use on food.

Best practices for products in aerobic packaging include:

avoid stacking packaged fish products in a manner that will inhibit the oxygen permeability of the film (e.g. full contact of adjacent packages),
avoid labels that cover large surfaces of the films.

Labelling

During labelling, accurate representation of the required storage conditions (e.g. “keep refrigerated” or “keep frozen”) and product shelf-life are critical factors for food safety, as temperature is an important control for many pathogens (Refer to FPG - Labelling and Packaging).

During packaging and labelling activities, proper handling and storage procedures should be followed to control post-processing contamination (Refer to FPG – Handling and Storage).

When re-packaging fish products, ensure the shelf-life (best-before date) takes into account the total amount of time since the fish product was initially packaged. When fish products are re-packaged, packaging records should be kept.

Process Controls for Shelf-stable products

Any fish product may be processed to achieve shelf-stability. Methods to achieve shelf-stability include:

the container has been heat-processed after sealing at a temperature and for a time sufficient to destroy all spores of the species Clostridium botulinum [12D process] (i.e. Low-Acid Foods in Hermetically-sealed Containers), or
lowering the pH in the finished product to 4.6 or lower (i.e. Acidified Low-acid Foods in Hermetically-sealed Containers), or
drying or dehydrating the product to a water activity of 0.85 or lower, or
adding salt to the product such that a water phase salt of 20% or higher is achieved.

Processing Controls for specific product types in aerobic and anaerobic packaging

Operators must identify and implement final product controls specific to the products they process.

Examples of acceptable process controls for fish products are shown in the table below. Any methods not shown in the table below must be reviewed and approved by Food Safety Inspection Delivery Branch.

Product	Packaging
1. Smoked (hot and cold) and smoke flavoured 1A. Frozen Storing the RTE product under "frozen" storage conditions Labelling of the product with the terms "Keep Frozen" 1B. Refrigerated with a shelf-life of 5 days or less Labelling of the product with the terms "Keep refrigerated" 1C. Fish products that are not hot-smoked, refrigerated with a shelf-life of greater than 5 days and less than 14 days Must have: Labelling of the product with the terms "Keep refrigerated" and held at a temperature of 4 degrees Celsius or less Is labelled with a durable life date (best-before date) And one of the controls for Listeria monocytogenes below: Validated Listeria monocytogenes growth inhibitors such as additives or processing aids, or Validated post-processing lethality treatments for Listeria monocytogenes 1D. Hot smoked fish products, refrigerated with a shelf-life of greater than 5 days and less than 14 days Must have: Labelling of the product with the terms "Keep refrigerated" and held at a temperature of 4 degrees Celsius or less Is labelled with a durable life date (best-before date) And either of the controls for Listeria monocytogenes listed in 1C, or one of the following: Controlling the water activity to less than 0.92, regardless of pH Controlling the pH to less than 4.4 regardless of water activity Achieving a pH of < 5.0 and water activity < 0.94 When pH is used to control Listeria monocytogenes, validated control measures must exist to ensure the pH does not rise during the shelf-life of the product as a result of the growth of spoilage organisms such as yeast or mold. Examples of suitable controls may include: hot filling the packages at 85°C or higher, or the use of validated preservatives, or having validated information or other data (e.g. shelf-life study) that demonstrates the pH is stable and within the safety parameters throughout the stated shelf-life	Aerobic packaging (the smoked fish is placed and wrapped in a single layer of film, which has an oxygen permeability equal to or greater than 2000 cc/m²/24 hours at 24 degrees Celsius and 1 atmosphere)
2. Smoked (hot and cold) and smoke flavoured 2A. Frozen Storing the RTE product under "frozen" storage conditions Labelling of the product with the terms "Keep Frozen" 2B. Canned The container has been heat-processed after sealing at a temperature and for a time sufficient to destroy all spores of the species Clostridium botulinum [12D process] 2C. Salted The contents of the container contain not less than 9% [water phase] salt, as determined by official method FO-38, Determination of Salt in Smoked Fish, dated March 15, 1985 2D. Uncooked The contents of the container are customarily cooked before eating [raw fish products]	Anaerobic
3. Multi-ingredient products containing smoked fish (e.g. mousses, pâtés, dips, soups, quiches, stuffed olives, sandwiches, all of which contain smoked fish, and smoked fish in oil) 3A. Frozen Storing the RTE product under "frozen" storage conditions Labelling of the product with the terms "Keep Frozen" 3B. Refrigerated Kept refrigerated at 4 degrees Celsius or less, and labelled with a statement "Keep Refrigerated", and Each component in a multi-ingredient product containing smoked fish should have: a pH of less than 5.0, or a water activity of less than 0.97, or received a thermal treatment resulting in a 6D process to control spores of Clostridium botulinum (Refer to FPG Process Controls – Cooking or Pasteurizing)	Any
4. Ready-to-eat (RTE) cooked fish products (not smoked) 4A. Frozen Storing the RTE product under "frozen" storage conditions Labelling of the product with the terms "Keep Frozen" 4B. Refrigerated with a shelf-life of 5 days or less Labelling of the product with the terms "Keep refrigerated" 4C. Refrigerated with a shelf-life of greater than 5 days Must have: Labelling of the product with the terms "Keep refrigerated" And one of the controls for Listeria monocytogenes below: Controlling the water activity to less than 0.92, regardless of pH Controlling the pH to less than 4.4 regardless of water activity Achieving a pH of < 5.0 and water activity < 0.94 When pH is used to control Listeria monocytogenes, validated control measures must exist to ensure the pH does not rise during the shelf-life of the product as a result of the growth of spoilage organisms such as yeast or mold. Examples of suitable controls may include: hot filling the packages at 85 degrees Celsius or higher, or the use of validated preservatives, or having validated information or other data (e.g. shelf-life study) that demonstrates the pH is stable and within the safety parameters throughout the stated shelf-life Validated Listeria monocytogenes growth inhibitors such as additives or processing aids Validated post-processing lethality treatments for Listeria monocytogenes 4D. For fish products with a refrigerated shelf life greater than 10 days Must have: Labelling of the product with the terms "Keep Refrigerated" Using packaging material with an OTR of 10 000 cc/m²/24 hours at 24 degrees Celsius and 1 atmosphere or greater And one of the following controls: Controlling the water activity to less than 0.97 Controlling the pH to less than 5.0 and having validated control measures to ensure the pH does not rise during the shelf life of the product as a result of the growth of spoilage organisms such as yeast or mold. Examples of suitable controls may include: hot filling the packages at 85 degrees Celsius, or higher, or the use of validated preservatives, or having validated information or other data (e.g. shelf-life study) that demonstrates the pH is stable and within the safety parameters throughout the stated shelf-life. Applying sanitation and processing methods (e.g. sanitary, enclosed filling) sufficient to minimize the risk of re-contamination of the final product by Clostridium botulinum.	Any
5. Ready-to-Eat (RTE), Pasteurized in the Container (RTE products which are packaged or filled into individual containers, sealed and then heat processed) 5A. Frozen (e.g. pasteurized crab meat) Storing the RTE product under "frozen" storage conditions Labelling of the product with the terms "Keep Frozen" 5B. *Refrigerated with a shelf-life greater than 5 days – Heat-treated to control for Clostridium botulinum* (6D process) (e.g. pasteurized crab meat) Labelling of the product with the terms "Keep refrigerated" 5C. Refrigerated with a shelf-life greater than 5 days – Heat-treated to control for Listeria monocytogenes (5D process)** labelling of the product with the terms "Keep Refrigerated" the use of safety parameters to inhibit the growth of Clostridium botulinum, which will also control the growth of other spore formers in a refrigerated product: water activity <0.97, or pH <5.0 5D. Shelf-stable – Heat-treated to control for Listeria monocytogenes The use of safety parameters to prevent the growth of Clostridium botulinum which will control the growth of other spore formers at room temperature in a pasteurized product: water activity <0.94, or pH <4.6	Any
6. Ready-to-eat (RTE) products which have not been subjected to a heat treatment and which rely on safety parameters 6A. Refrigerated with a shelf-life greater than 5 days (e.g. seafood salad, fermented fish products, anchovies) Labelling of the product with the terms "Keep refrigerated", and The use of safety parameters to prevent the growth of Listeria monocytogenes: water activity <0.92, regardless of pH, or pH <4.4 regardless of water activity, or pH 5.0 and water activity <0.94, and When pH is used to control Listeria monocytogenes validated control measures must exist to ensure the pH does not rise during the shelf-life of the product as a result of the growth of spoilage organisms such as yeast or mold. Examples of suitable controls may include: hot filling the packages at 85 degrees Celsius or higher, or the use of validated preservatives, or having validated information or other data (e.g. shelf-life study) that demonstrates the pH is stable and within the safety parameters throughout the stated shelf-life 6B. Shelf-stable (e.g. dried fish, salted fish, fish jerky, shrimp crackers, fish soup base, unpasteurized fish sauces/pastes) Controlling the water activity to 0.85 or lower	Any
7. Raw Ready-to-eat (RTE) fish products (RTE products which have not been subjected to a heating process or safety parameters and are thereby in a raw state, e.g. sushi, caviar) 7A. Frozen Storing the RTE product under "frozen" storage conditions Labelling of the product with the terms "Keep Frozen" 7B. Refrigerated with a shelf-life of 5 days or less Labelling of the product with the terms "Keep Refrigerated" 7C. Refrigerated with a shelf-life greater than 5 days Labelling of the product with the terms "Keep Refrigerated" Validated Listeria monocytogenes growth inhibitors (additives, processing aids) 7D. For other fish products with a refrigerated shelf life greater than 10 days Using packaging material with an OTR of 10 000 cc/m²/24 hours at 24 degrees Celsius and 1 atmosphere Labelling of the product with the terms “Keep Refrigerated” Validated Listeria monocytogenes growth inhibitors (additives, processing aids)	Any

Sources:

Guide-Process Control Technical Information (CFIA)
Guidance Document on Ready-to-Eat Smoked Fish and Multi-Ingredient Products Containing Smoked Fish (Health Canada 2018)
Section B.21.025, Food and Drug Regulations

The process control procedures for fish products should include a description of all control measures required for each product type.

Regulatory References

Food Safety and Quality Act, 2001; O. Reg. 465/19 s. 5, 51, 52, 56
1. 1. No operator, employee or contractor of a fish processing operation in respect of which a licence is required under this Regulation shall sell, offer for sale, hold in possession for sale, transport or distribute any fish product processed, packaged, labelled, stored or handled at a fish processing plant that is intended for human consumption if the fish product is contaminated.
  2. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that no employee or contractor of the operation sells, offers for sale, holds in possession for sale, transports or distributes any fish product described in subsection (1).
2. 1. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that written process control procedures are developed, implemented and monitored to effectively identify any risk of contamination of fish products, ingredients, labelling materials and packaging materials and to prevent, eliminate or minimize any identified risk.
  2. The operator shall ensure that at the time the process control procedures referred to in subsection (1) are performed and monitored, a record is created that includes,
    1. the date the procedure was performed and monitored;
    2. the results of the monitoring, including any deviations from the process control procedures; and
    3. the actions taken in response to any deviations from the process control procedures, including disposing of the fish product or taking measures to produce a safe fish product.
  3. The operator shall ensure that the process control procedures referred to in subsection (1),
    1. are reviewed as needed in order to,
      1. evaluate whether the procedures are being properly implemented, and
      2. verify the effectiveness of the implemented procedures with respect to producing a safe fish product; and
    2. are updated as needed.
  4. The operator shall ensure that at the time a review referred to in clause (3) (a) is undertaken, a record is created that includes,
    1. the date the review was performed; and
    2. the results of the review.
  5. The operator shall ensure that every record created under this section,
    1. is kept for at least one year from the date the record is created; and
    2. is readily accessible.
3. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that any regulatable activities engaged in by the operation are performed in a manner that minimizes the risk of contamination of fish products, ingredients, labelling materials and packaging materials and produces fish products that are safe.
4. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that every fish product processed, labelled or packaged by the operation is,
  1. processed, packaged, labelled or stored in accordance with this Regulation; and
  2. safe.

Updated: November 30, 2023

Published: October 13, 2020