Regulatory requirements: Preventive controls
3.0 Hazards identification, analysis, and control measures

SFCR: Sections 47 and 48

Rationale

Hazards may be inherent to food, or they may be introduced during its preparation, movement, or storage. The presence of hazards in food can cause a risk of injury to human health. It is therefore important that you identify and analyze the hazards associated with the food, whether they will be sent or conveyed from one province or territory to another, imported, or exported, and use control measures that are effective to prevent, eliminate or reduce the hazards to an acceptable level.

What this means for your food business

To help you understand these requirements, specific criteria and examples are outlined below. The examples are not exhaustive but help illustrate the intent of the requirement and offer examples of what you could do to comply. For best practices on how to comply, guidance materials have been hyperlinked throughout the examples boxes.

In addition, key terms throughout the text have been hyperlinked to the SFCR glossary.

Subsection 47(1): Hazard identification and analysis

• You identify and analyze all hazards, biological, chemical and physical, that present a risk of contamination of a food.

  Examples:

  • You prepare a list of all hazards that may reasonably be expected to occur from ingredients, packaging material, and the environment, or steps in the manufacturing, preparation, storage, movement, packaging, and labelling of the food
  • To help you identify hazards, you refer to the Reference database for hazard identification
  • For additional information, refer to the guidance material on Conducting a hazard analysis and the list of guidance materials on Preventive controls for food business

Subsection 47(2): Effective control measures for the identified hazards

• For each hazard you identified, you use control measures to prevent, eliminate or reduce them to an acceptable level

  Examples:

  • You pasteurize raw milk to destroy harmful pathogens
  • You use protected light fixtures to prevent broken glass from contaminating exposed food
  • You inspect incoming materials and refuse shipments that are not safe or suitable for use in food
• For each control measure (including any treatment or process), you have evidence to show that it is effective

  Examples:

  • Evidence could include:
    • scientific literature
    • validation studies
    • scientifically valid sampling and testing
      • performed at an accredited laboratory, such as a laboratory accredited to the International Organization for Standardization 17025 standard, and
      • using recognized test methods such as those found in Health Canada's Compendium of food allergen methodologies, Compendium of methods for chemical analysis of foods, and Compendium of analytical methods
    • a history of good performance validated by independent bodies
    • guidelines from internationally recognized organizations, such as the Codex Alimentarius (for example, Codes of Practice for specific foods)
  • For additional information, refer to the guidance material on Evidence showing a control measure is effective and Control measures for Listeria monocytogenes in ready-to-eat foods
• In the case of meat products, you also use the control measures that are found in the document called Preventive control requirements for biological hazards in meat products that are applicable to your food business

Subsection 47(3): Hazard identification and analysis for persons who import

• You identify and analyze all biological, chemical and physical hazards that present a risk of contamination to the food that you import

  Examples:

  • You prepare a list of all hazards that may be associated with the food you import
  • You request information from your supplier or person you are dealing with in the foreign state on the identification and analysis of the hazards associated with the food you import
  • To help you to identify hazards, you refer to the Reference database for hazard identification
  • For additional information, refer to the guidance material on Conducting a hazard analysis and the Guide for preparing a Preventive Control Plan - For importers

Subsection 48(1): Scheduled process for low-acid food in a hermetically sealed package

• If you package a low-acid food in a hermetically sealed package that is not intended to be refrigerated or frozen, you apply a scheduled process to achieve commercial sterility
• If you apply batch thermal treatment, you use a temperature-sensitive indicator that visually indicates that the package has been thermally treated

  Examples:

  • Prior to starting the batch thermal treatment, you apply to each basket, truck, cart or crate, a temperature sensitive indicator that is capable of visually indicating that the food has been thermally treated
  • You do not move the batch of packages out of the processing area unless the visual indicator shows that it has been thermally processed

Subsections 48(3) and 48(4): Documents and retention period for scheduled processes

• For each low-acid food, you prepare documents that set out:
  • a description of the scheduled process that you will apply
  • the name of the person that developed the scheduled process; and
  • the formulation of the food

    Examples:

    • The description of the scheduled process could include:
      • the processing parameters such as the initial temperature of the product, the process temperature, the process time and pressure
      • other critical factors that affect commercial sterility such as water activity, pH, viscosity, percent solids, fill weight, headspace, particle size and starch addition
      • the container dimensions and type
      • the container orientation and spacing in retort where appropriate
      • the venting procedures, (these should be determined on fully loaded retorts only); and
      • the date the scheduled process was developed or last modified
    • The formulation of the food could include:
      • the names and quantities of all the ingredients, including food additives that make up the low-acid food
• Each time you apply a scheduled process you prepare documents that set out:
  • the name of the food
  • the production volume
  • the equipment that is used for the treatment
  • the parameters of the treatment, such as:
    • the start and end times
    • temperatures, and
    • pressure
  • a description of any maintenance to the equipment
  • a description of any modifications to the equipment
  • any deviations from the scheduled process
  • any corrective action taken due to the deviation
  • the incubation results
  • a description of any treatment of the cooling water
• You keep these documents for a period of three years after the day you applied the scheduled process

Subsection 48(2): Exception from the application of a scheduled process to low-acid food in hermetically sealed packages

• You would not have to apply a scheduled process if:
  • the food is kept refrigerated or frozen; and
  • you label the food on the principal display panel with the expressions: "Keep Refrigerated" and "garder réfrigéré" or "Keep Frozen" and "garder congelé", as the case may be
    Note: For additional information on labelling requirements, refer to the Industry labelling tool