F.B.14.19 Final product controls
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
1B. Refrigerated with a shelf-life of 5 days or less
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:
And one of the controls for Listeria monocytogenes below:
1D. Hot smoked fish products, refrigerated with a shelf-life of greater than 5 days and less than 14 days Must have:
And either of the controls for Listeria monocytogenes listed in 1C, or one of the following:
|
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
2B. Canned
2C. Salted
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
3B. Refrigerated
|
Any |
4. Ready-to-eat (RTE) cooked fish products (not smoked) 4A. Frozen
4B. Refrigerated with a shelf-life of 5 days or less
4C. Refrigerated with a shelf-life of greater than 5 days Must have:
And one of the controls for Listeria monocytogenes below:
4D. For fish products with a refrigerated shelf life greater than 10 days Must have:
And one of the following controls:
|
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)
5B. Refrigerated with a shelf-life greater than 5 days – Heat-treated to control for Clostridium botulinum (6D process) (e.g. pasteurized crab meat)
5C. Refrigerated with a shelf-life greater than 5 days – Heat-treated to control for Listeria monocytogenes (5D process)
5D. Shelf-stable – Heat-treated to control for Listeria monocytogenes
|
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)
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
7B. Refrigerated with a shelf-life of 5 days or less
7C. Refrigerated with a shelf-life greater than 5 days
7D. For other fish products with a refrigerated shelf life greater than 10 days
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
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Food Safety and Quality Act, 2001; O. Reg. 465/19 s. 5, 51, 52, 56
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- 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.
- 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).
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- 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.
- 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,
- the date the procedure was performed and monitored;
- the results of the monitoring, including any deviations from the process control procedures; and
- 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.
- The operator shall ensure that the process control procedures referred to in subsection (1),
- are reviewed as needed in order to,
- evaluate whether the procedures are being properly implemented, and
- verify the effectiveness of the implemented procedures with respect to producing a safe fish product; and
- are updated as needed.
- are reviewed as needed in order to,
- The operator shall ensure that at the time a review referred to in clause (3) (a) is undertaken, a record is created that includes,
- the date the review was performed; and
- the results of the review.
- The operator shall ensure that every record created under this section,
- is kept for at least one year from the date the record is created; and
- is readily accessible.
- 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.
- 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,
- processed, packaged, labelled or stored in accordance with this Regulation; and
- safe.
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