Chapter: Operations and Documentation
Section: F.B.15 Allergens
Sub-section: N/A

Elements

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

F.B.15 (01) Processes or procedures used in the processing of fish products control hazards related to allergens and ensure a safe product. (Risk Ranking: High)

F.B.15 (02) Labelling of products with respect to allergens meet the requirements of the Food and Drugs Act (Canada) and regulations made under it. (Risk Ranking: Medium)

Rationale

A food allergy is an abnormal immune response to proteins found in food. The immediate response to an allergic reaction can range in severity from a skin rash to anaphylaxis (a very severe reaction involving failure of multiple organ systems), and death.

The only way for an allergic individual to protect themselves is to avoid the allergen.

In Canada, there are 10 priority allergens:

  1. eggs (including albumen, lysozyme, meringue and egg substitutes such as Egg Beaters®)
  2. milk (including calcium caseinate, casein, milk solids, lactose, modified milk ingredients and whey protein)
  3. mustard (including mustard seeds)
  4. peanuts (including beer nuts, goober nuts, calencias and earth peas)
  5. seafood (including fish, anchovy, shellfish, abalone, clam, octopus, escargot, crustaceans, crab and shrimp)
  6. sesame (including tahini and gingelly/gingelly oil)
  7. soy (including edamame, miso, tempeh, textured soy protein, soybeans and tofu)
  8. sulphites (including potassium bisulphite, sodium bisulphite, sulphur dioxide and sulphuric acid)
  9. tree nuts (including almonds or marzipan, Brazil nuts, cashews, hazelnuts or filberts, macadamia nuts, pecans, pine nuts, pistachio nuts and walnuts)
  10. wheat (including bulgur, couscous, durum, farina, gluten, spelt, triticale and semolina)

In this document, the term "allergens" refers to the priority allergens described above.

All fish products inherently contain allergens, as they are classified under the seafood priority allergen. Allergens are only considered to be contaminants when they are present in a product that they are not supposed to be in. Allergens are considered a chemical hazard.

Fish processing operations that process or package any of the other priority allergens listed above or products that contain these allergens, must have controls in place to prevent those allergens from contaminating fish products.

Allergen control includes documentation and procedures regarding the storage, handling, processing, packaging, and identification of allergenic foods and ingredients to ensure allergenic foods and ingredients do not find their way into products for which they are not intended.

Effective allergen control includes:

  • identification of all potential sources of allergens (such as ingredient specification sheets),
  • allergen identification in all recipes,
  • storing allergen-containing products in a manner that does not cause cross contamination,
  • operational controls during processing that prevent cross contamination between allergenic ingredients or products containing allergens and those that do not contain allergens (for example, dedicated line, scheduling manufacturing activities so that processes that use allergens are processed last, colour-coded utensils and equipment),
  • sanitation procedures for cleaning and sanitizing between processes containing allergens and those that do not,
  • labelling procedures and labels that properly declare priority allergens present in the product, either in the list of ingredients or in a “May Contain” statement,
  • complete, accurate and up-to-date records,
  • good hygienic practices that minimize cross contamination and include frequent handwashing and changing of protective clothing after working with an allergenic ingredient, or when going from a product containing an allergen to one that should not contain that allergen.

The presence of allergens does not make the food unsafe for all consumers. Any products that contain allergens must be labelled identifying the specific allergens.

An allergen present in a product must be declared by its common name on the label. See the Canadian Food Inspection Agency Food Labelling for Industry tool for accurate labelling requirements.

An undeclared allergen is an allergen that is not declared or is incorrectly declared on the label. For example, accidental cross contamination may occur during production, which leads to the presence of an allergen that was not part of the product recipe, and this allergen was not declared on the label of the finished product.

If all finished products from a fish processing operation identify the presence of an allergen on the label, then cross-contamination with that allergen is not an issue. The use of a “may contain” statement cannot be used as a substitute for good manufacturing and hygienic practices.

Operators must immediately notify OMAFRA if fish products containing undeclared allergens are shipped from the fish processing operation.

Regulatory References

  • Food Safety and Quality Act, 2001; O. Reg. 465/19 s. 5, 13(3), 35 (a)(c)(f), 37, 41, 42 (1)(2)(5), 47 (1)(a)(3), 51, 52, 53, 55 (1)(a)(2)(a), 56, 60
      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.
      3. 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).
      1. No labelling material or packaging material for a fish product may contain any wording or representations that are false, misleading or deceptive.
    3. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that every area of a fish processing plant used by the operation is operated and maintained in a manner that,
      1. facilitates the hygienic processing, packaging, labelling, handling, shipping, receiving and storing of fish products, ingredients, labelling materials and packaging materials;
      2. allows for incompatible activities to be done at different times or in separate areas;
      3. allows for fish products, ingredients, inedible materials, labelling materials and packaging materials to flow in a pattern that minimizes the risk of contamination of fish products, ingredients, labelling materials and packaging materials;
    4. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that the fish processing premises, equipment and utensils used by the operation are maintained and operated in a way that minimizes the risk of contamination of fish products, ingredients, labelling materials and packaging materials.
      1. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that a written sanitation program is developed, implemented and monitored and that the program,
        1. includes effective procedures to clean and sanitize the fish processing plant, equipment, utensils and food contact surfaces used by the operation;
        2. includes cleaning and sanitation schedules; and
        3. is updated as needed.
      2. The operator shall ensure that the cleaning and sanitizing procedures referred to in clause (1) (a) are performed in a way that minimizes the risk of contamination of the fish processing premises, equipment, utensils, fish products, ingredients, labelling materials and packaging materials.
      3. The operator shall ensure that on each day the cleaning or sanitation activities referred to in subsection (1) are performed, a record is created that includes,
        1. the date the activity was performed;
        2. the type of activity that was performed; and
        3. the results of the activity.
      4. The operator shall ensure that every record created under subsection (3),
        1. is kept for at least one year from the date the record is created; and
        2. is readily accessible.
      1. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that the fish processing plant, equipment, utensils and food contact surfaces are cleaned and sanitized for the start of each working day.
      2. The operator shall ensure that the equipment, utensils and food contact surfaces that have become contaminated are effectively cleaned and sanitized in a way that minimizes the risk of contamination of fish products, ingredients, labelling materials and packaging materials.
      3. The operator shall ensure that any equipment that is used to clean and sanitize a room, equipment or utensils is handled, maintained and stored in a way that minimizes the risk of contamination of fish products, ingredients, labelling materials and packaging materials.
      1. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that every person engaged in the processing, packaging, labelling, handling or storing of fish products, ingredients, labelling materials or packaging materials washes their hands thoroughly with soap and water,
        1. as frequently as is necessary to minimize the risk of contamination of fish products, ingredients, labelling materials and packaging materials;
      2. No person who is engaged in the fish processing operation’s processing, packaging, labelling, handling, shipping, receiving or storing of fish products, ingredients, labelling materials or packaging materials shall,
        1. engage in any activity, behaviour or practice that poses a risk of contaminating the fish products, ingredients, labelling materials or packaging materials; or
        2. wear an object or use a substance that poses a risk of falling into or otherwise contaminating the fish products, ingredients, labelling materials or packaging materials, unless effective steps are taken to mitigate that risk.
      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.
    9. 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.
      1. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that an up-to-date recipe is maintained in written form for each fish product prepared by the operation.
      2. The operator shall ensure that each recipe referred to in subsection (1) is,
        1. legible;
        2. complete;
        3. includes the percentage by weight of fish in the final product;
        4. includes the processing instructions; and
        5. is readily accessible.
      3. The operator shall ensure that each fish product referred to in subsection (1) is prepared in accordance with its corresponding recipe.
      1. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall ensure that fish products, ingredients, labelling materials and packaging materials involved in any regulatable activities engaged in by the operation are,
        1. stored and handled in a manner that minimizes the risk of contamination;
      2. With respect to the ingredients referred to in subsection (1),
        1. each ingredient must be labelled to indicate the name of the ingredient and, if the ingredient is comprised of more than one component, a list of the components; and
    12. 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.
      1. The operator of a fish processing operation in respect of which a licence is required under this Regulation shall immediately notify a director upon receiving information that indicates a fish product that was distributed from the plant by the operation,
        1. may not have been processed, packaged, labelled, handled, shipped or stored in accordance with this Regulation; or
        2. may not be safe.
      2. The notice referred to in subsection (1) must include the following information:
        1. A description of the fish product that may be affected.
        2. A description of how the fish product may not have been processed, packaged, labelled, handled, shipped or stored in accordance with this Regulation, if applicable.
        3. A description of how the fish product may not be safe, if applicable.
        4. The quantity of the fish product that may be affected.