Conducting a hazard analysis
Requirements for the Safe Food for Canadians Regulations
Although the Safe Food for Canadians Regulations (SFCR) came into force on January 15, 2019, certain requirements may apply in 2020 and 2021 based on food commodity, type of activity and business size. For more information, refer to the SFCR timelines.
A hazard is a biological, chemical or physical agent in a food, that, when not controlled, has the potential to cause illness or injury to a person who consumes it. Food businesses need to determine the biological, chemical and physical hazards that present a risk of contamination of the food and prevent, eliminate or reduce to an acceptable level those hazards using control measures.
Conducting a hazard analysis is the first principle of a Hazard Analysis Critical Control Point (HACCP) system. This approach is effective in identifying, for each food you prepare or import, the food safety hazards at each step of your activities.
The Canadian Food Inspection Agency (CFIA) created this document as guidance to help regulated parties comply with the requirements of the Safe Food for Canadians Regulations.
You may use other guidance developed by provincial governments, industry associations, international partners or academic bodies as long as they can achieve the same outcome. Always ensure that your hazard analysis is relevant for your particular business, product or products, and market requirements.
What is included
This document provides information on:
- what hazards are and where they come from
- how to conduct a hazard analysis and identify all potential hazards
- how to evaluate the significance of a hazard identified
Refer to the Tell me more! section for additional sources of information that may help you with your hazard analysis.
What is not included
There are different approaches to analyzing hazards which are not discussed. The method for hazard analysis depends on the size and complexity of the food business. The examples provided are therefore not exhaustive. The actual hazards will be unique for each business.
Roles and responsibilities
Food businesses are responsible for complying with the law. They demonstrate compliance by ensuring that the commodities and processes for which they are responsible meet regulatory requirements. If a written Preventive Control Plan (PCP) is required, the food business develops a PCP with supporting documents, monitors and maintains evidence of its implementation, and verifies that all control measures are effective.
The CFIA verifies the compliance of a food business by conducting activities that include inspection, and surveillance. When non-compliance is identified, the CFIA takes appropriate compliance and enforcement actions.
Conducting a hazard analysis
When conducting a hazard analysis, you identify and evaluate all hazards that present a risk of contamination of the food, and you determine how you control these hazards.
Types of hazards
To identify hazards, you need to understand the types of hazards that your food business needs to control:
- biological hazards
- chemical hazards
- physical hazards
Biological hazards include microorganisms such as bacteria, viruses, parasites, fungi and moulds. Some microorganisms, such as Salmonella spp., Listeria monocytogenes, Bacillus cereus, E. coli O157:H7 and Campylobacter jejuni are pathogenic and able to cause foodborne illnesses. Other microorganisms, such as Clostridium botulinum and Staphylococcus aureus, produce harmful toxins. Botulism in particular can have severe health consequences.
Examples of sources of biological hazards include:
- incoming ingredients, including raw materials
- cross-contamination in the processing or storage environment
- food contact surfaces
- the air
- insects and rodents
Chemical hazards may occur naturally or may be introduced during any stage of food processing. For example, allergens may be introduced either by being present in an ingredient or a component of an ingredient, or through cross-contamination during processing.
Examples of chemical hazards include:
- chemicals intentionally used in food processing such as processing aids, food additives
- chemicals that are by-products of processing such as nitrosamines, chloramines
- chemical contamination from equipment such as lead-soldered seams
- industrial chemicals such as cleaning agents, oils, gasoline, lubricants, ammonia
- naturally occurring toxicants such as products of plant, animal or microbial metabolisms, including mycotoxins, histamines, marine biotoxins
- agricultural chemicals such as pesticides, antibiotics, fungicides, rodenticides, algicides, fertilizers
- nutrients such as over-addition of vitamins and/or minerals
- food allergens such as peanuts, tree nuts, sesame seeds, milk, eggs, fish, crustaceans, shellfish, soy, mustard and wheat, sources of gluten and sulphites
Physical hazards in food include many types of unwanted materials that may be introduced anywhere along the food chain, from primary production up to and including the consumer. Unwanted materials can be introduced by anything or anyone coming in contact with the food, such as people who handle the food, or during processing, transportation or storage. The unwanted materials are considered to be hazards if they can result in illness or injury to anyone who consumes the food.
Examples of physical hazards include:
- bone or shell fragments, hair or feathers from animal products
- stones, rocks and dirt (commonly found in fruits, vegetables and other foods that are grown close to the soil)
- metal (commonly associated with processing activities such as cutting, slicing or grinding operations, as well packaging materials or containers such as metal shards, staples and nails)
- jewelry and personal items (resulting from poor food handling practices)
- glass or other contaminants from packaging materials or containers, or from the processing environment, for example, uncovered light fixtures
- wood splinters from broken pallets or packaging material
- flaking paint from overhead structures or equipment
- insect pieces
Step 1. Identify all hazards
To properly identify a hazard, you need to be fully familiar with the food and processing steps, be knowledgeable about food hazards and have a good understanding of how they can be controlled. One approach to identifying potential hazards is to use a multidisciplinary team of people from within or outside the company. In some cases, you may want to hire an outside consultant and/or resource centre for this step.
If you're an importer, your hazard analysis includes the hazards associated with your foreign supplier's manufacturing processes and the hazards associated with the shipping, handling and storage conditions of the imported foods.
Preparing a list of hazards
To identify all potential hazards for a food, prepare a list of biological, chemical and physical hazards that may reasonably be expected or likely to occur from:
- all inputs (for example, the raw materials, ingredients, additives, packaging materials), and the intended end use of the food
- Keep in mind special uses of the food; for instance, infant formula or foods for immune-compromised consumers where the consequences of contamination may be more severe. A Product description template such as the one presented in the Preventive control plan templates – for domestic food businesses can help you with this.
- each step in the production of food as part the operation of the establishment, from receiving to storage and shipping
- To help with this stage, you can refer to other production documents such as a process flow diagram, traffic flow diagram and the blueprint of the building to identify potential cross-contamination points. You can also refer to the Preventive control plan templates – for domestic food businesses for an example of a process flow diagram and of a traffic flow diagram.
Be thorough and methodical
If you miss, at this step, hazards likely to occur, you will not be evaluating them in Step 2, placing the entire food safety control system in jeopardy.
Base your hazard identification on:
- employees' knowledge and experience on practical aspects of the establishment's operations
- documented production issues such as files on production rework, returned products, product complaints and recalls
- external references (see Tell me more! for some links), for example:
- reference texts, for example, food biology, food chemistry, food processing
- scientific publications
- information available from industry associations and governments, such as hazard guides, generic HACCP models and reports
- other sources of hazard information: consumer complaints; notices from a supplier; advisories from a provincial health authority; notices from a distributor, retailer, customer or foreign competent authority
In your list of identified hazards, include the name of the pathogen (for example, Listeria monocytogenes) or the type of physical hazard (for example, glass fragments), the conditions that are associated with it (for example, presence, survival, growth, contamination), and the reason for the hazard. For example:
- presence of metal fragments in dough due to broken mixer paddle
- presence of Salmonella on packaging material due to contamination with faecal material from pests (rodents, birds and insects) during storage
- contamination of allergen-free ingredients with allergens due to inadequate separation from allergen-containing ingredients in bulk storage
- survival of Listeria monocytogenes due to inadequate time and temperature during cooking
Step 2. Evaluate each hazard
Determine whether the hazards identified in Step 1 are reasonably likely to occur and how severely they could affect the health of consumers.
In evaluating the likelihood that a hazard will occur:
- consider existing procedures and controls that you have in place to meet the preventive control requirements of Division 4 "Maintenance and Operation of Establishment" in part 4 of the SFCR.
- use a combination of experience, data from past outbreaks, scientific literature, and corporate historical information on recalls and customer complaints.
Base your evaluation of the severity of a hazard on:
- the impact on public health, including the duration and magnitude of illness or injury that the hazard may cause
- the susceptibility of certain consumers to be affected, based on population groups or age groups, for example, infants, the elderly or individuals with underlying conditions
Determining whether a hazard is significant is important! This helps you identify the critical control points (CCPs). If you miss a significant hazard, it will not be controlled appropriately. On the other hand, if you put unnecessary CCPs in place for hazards that are not significant, you're diverting your business' efforts from activities that have a real impact on food safety.
The Preventive control plan templates – for domestic food businesses provide examples of ways you can document the identification and evaluation of potential hazards.
- Why a hazard is not reasonably likely to occur
- Why a hazard reasonably likely to occur is or is not significant
Step 3. Determine the control measures
After you have identified all potential hazards that are reasonably likely to occur for your specific operation, the next steps are to determine how you would control each of those hazards:
- describe the measures that would control each hazard:
- the tasks required to carry out the control measure
- how the tasks are carried out
- how frequently the tasks are carried out (for example, hourly, weekly, monthly)
- who is responsible for carrying out the task
- the forms you use for the day-to-day collection of information, such as the forms used to record delivery of tasks and controls
Refer to the Preventive control plan templates – for domestic food businesses for an example of a Control measure template that you can use to capture the information.
When there is no control measure for a significant hazard
When you identify a hazard as significant, a control measure is necessary for food safety. If you do not have a control measure for a significant hazard at the step it was identified, or any other step, then you need to modify the product or process, at that step or at an earlier or later stage, to include a control measure.
- Describe the evidence that shows that your control measures are capable of controlling the hazard. More information on how to demonstrate the effectiveness of your control measures can be found in Evidence showing a control measure is effective.
Your hazard analysis should be reviewed and updated periodically to ensure any new hazards are identified and evaluated.
Document your hazard analysis
If your food business is required to document the hazard analysis, you keep on file and have readily available any information used to identify and evaluate the hazards associated with your operations, as well as the results of the hazard analysis.
Tell me more! Further reading
The following references contain information that helps explain food safety controls, demonstrates how to develop them, and provides examples. The CFIA is not responsible for the content of documents that are created by other government agencies or international sources.
- Chemical residue surveillance program
- Determining critical control points and their critical limits
- Food recalls and allergy alerts
- Guide for preparing a preventive control plan for domestic food businesses
- Preventive control plan templates – For domestic food businesses
- National microbiological monitoring program
- Reference database for hazard identification
- Codex Alimentarius Commission, General Principles of Food Hygiene, CXC 1-1969, 2020
- Health Canada, Food allergies
- Health Canada, Food packaging
- Food safety standards and guidelines
- International Commission on Microbiological Specifications for Foods (ICMSF). Microorganisms in Foods 4: Application of the Hazard Analysis Critical Control Point (HACCP) System to Ensure Microbiological Safety and Quality, Oxford: Blackwell Scientific Publications,1988
- Public Health Agency of Canada, Food Safety
- U.S. Food & Drug, Fish and fishery products hazards and controls guidance – fourth edition
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