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Policy on Listeria monocytogenes in ready-to-eat foods (2023): Overview

Health Canada has completed its update of the "Policy on Listeria monocytogenes in Ready-to-Eat Foods". The Listeria policy (2023), which replaces the version dated April 1, 2011, was developed by Health Canada, with input from the Canadian Food Inspection Agency and the Public Health Agency of Canada, and takes into account the roles and responsibilities of industry, government and consumers. The Listeria policy (2023) is intended to assist in the application and verification of activities for Listeria monocytogenes in ready-to-eat foods to protect the health and safety of Canadians. Its implementation should permit the early identification of the persistence of Listeria species in the food processing environment and allows for the assessment of the effectiveness of control measures put in place to address Listeria monocytogenes in ready-to-eat foods.

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The updated Listeria policy (2023) came into effect on October 1, 2023.

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Legislative context

The Food and Drugs Act and Regulations, generally apply to all food sold in Canada, including both imported and domestically produced food traded at the interprovincial/territorial and intraprovincial/territorial level. The Safe Food for Canadians Act and Regulations, mainly apply to food that is imported, or prepared for export or interprovincial/territorial trade for commercial purposes. Together they form the legislative foundation of federal food laws.

Health Canada is responsible for administering provisions of the Food and Drugs Act that relate to public health, safety and nutrition. As such, Health Canada's Listeria policy is intended to support the interpretation and application of the Food and Drugs Act. In particular, the manufacturing, preparation, preservation, packaging or storage of food for sale under unsanitary conditions as well as the sale of a ready-to-eat food containing L. monocytogenes at levels exceeding those specified in Table 1 of the Listeria policy, may be considered to contravene paragraphs 4(1)(a), 4(1)(e) and section 7 of the Food and Drugs Act.

In addition to the administration and enforcement of the Safe Food for Canadians Act and Regulations, the Canadian Food Inspection Agency (CFIA) is responsible for the enforcement of the food-related provisions of the Food and Drugs Act and Regulations, and takes into consideration the standards, guidelines and policies established by Health Canada. As such, the relevant federal regulatory authority referred to in Health Canada's Listeria policy is the CFIA. The Listeria policy is applied in the conduct of federal food inspections. The CFIA also provides guidance to help ready-to-eat food manufacturers and importers comply with the control measure requirements set out in the Safe Food for Canadians Regulations in the following document based on Health Canada's Listeria policy: Control measures for Listeria monocytogenes in ready-to-eat foods (the control measures document). Food businesses that require a licence under the Safe Food for Canadians Regulations should be aware that certain control measures and reporting recommendations described in Health Canada's Listeria policy may be regulatory requirements under the Safe Food for Canadians Regulations and should refer to the control measures document for further details. Risk-based guidelines on sampling and testing frequencies are also in the control measures document.

Furthermore, as provincial/territorial food regulatory authorities may be conducting enforcement of their own food legislation, they may apply similar policy considerations in relation to the application of their laws. Hence, Health Canada's Listeria policy may serve as a resource for this purpose. In these cases, Health Canada's Listeria policy can play a complementary role, but is not intended to provide guidance on legislation that is not within Health Canada's jurisdiction or mandate.

Ultimately, it is industry's responsibility to produce safe food and to comply with all applicable Canadian legislative requirements.

To help facilitate your reading

Appendix A contains definitions of the terminology used in this policy, including relevant definitions from the Food and Drugs Act and Regulations. At the first relevant instance, terminology defined in Appendix A have been hyperlinked to facilitate reading and comprehension. Other hyperlinks direct the reader to specific sections, figures or tables. Some hyperlinks direct readers to complementary resources available on the Government of Canada's website.

Summary

Listeria monocytogenes is unique among foodborne pathogens. It is widespread in nature, can grow at refrigeration temperatures and can survive in the environment of food processing plants for months to years. Although rare, L. monocytogenes infections can result in serious and severe diseases, especially in vulnerable individuals. Foodborne outbreaks of listeriosis have mostly been linked to ready-to-eat (RTE) foods that are not normally further prepared before consumption. As such, this document sets out Health Canada's policy relating to the application, implementation and verification of control measures for L. monocytogenes in RTE foods.

Health Canada’s “Policy on Listeria monocytogenes in ready-to-eat foods” (referred to as the Listeria policy) applies to the manufacturing and importation of RTE foods that are sold in Canada. These foods have been classified into 2 categories (see Principles for controlling L. monocytogenes) based on their potential to support the growth of L. monocytogenes. The Listeria policy takes into account the potential for the growth of L. monocytogenes to occur as well as the presence or levels of L. monocytogenes in RTE foods as factors to determine the health concern that such foods pose to consumers (Table 1). Furthermore, the intended consumers of RTE foods (for example, vulnerable populations) are also considered in determining the health concern.

The Listeria policy uses a risk-based approach and is based on Good Manufacturing Practices (GMPs) and the principles of Hazard Analysis Critical Control Points (HACCP). The implementation of the Listeria policy relies on process review, environmental sampling (includes food contact and non-food contact surfaces) and end-product testing. In an effort to manufacture RTE foods that are safe for consumption, the Listeria policy places an emphasis on environmental sampling in post-process areas where foods are exposed to the environment prior to packaging.

The updated Listeria policy replaces the "Policy on Listeria monocytogenes in Ready-to-Eat Foods" dated April 1, 2011. The update focuses on the following:

Purpose and scope

The Listeria policy is intended to assist in the application and verification of activities for L. monocytogenes in RTE foods to protect the health and safety of Canadians. The implementation of the Listeria policy should permit the early identification of the persistence of Listeria species (Listeria spp., including L. monocytogenes) in the food processing environment and allows for the assessment of the effectiveness of control measures put in place to address L. monocytogenes in RTE foods. In this specific context, the Listeria policy guides industry on ways to comply with federal food legislation and may be used as a resource for the relevant regulatory authority for such enforcement. Details regarding risk-based frequencies of sampling, verification and compliance are left to the discretion of the relevant regulatory authority (CFIA, 2023).

In accordance with the Listeria policy, RTE foods should be produced under conditions that will minimize or prevent the introduction and/or growth of L. monocytogenes. This may be accomplished by:

The Listeria policy does not apply to the following food businesses:

Nevertheless, all businesses that sell food in Canada are subject to all relevant provisions of the Food and Drugs Act, including sections 4 and 7 (Government of Canada, 2023a).

In addition, the Listeria policy does not apply to the following activities:

Moreover, the Listeria policy does not provide information on the conduct of food safety investigations or recall activities by regulatory authorities as they are not within the scope of this document.

Nonetheless, in situations for which the Listeria policy does not apply, a finding of L. monocytogenes should still trigger an assessment by the food business to determine if follow-up actions are needed and if the situation represents a health concern. Risk management actions may be needed.

Note: Health Canada, within its mandate, conducts health risk assessments that can identify risks to human health from foodborne pathogens. Upon request, regulatory authorities can contact the Microbiological Evaluation Division, Bureau of Microbial Hazards, Food Directorate, Health Products and Food Branch for support.

Application of the policy

For the purpose of the Listeria policy, RTE foods are defined as follows:

RTE foods are any foods that are normally eaten in the same condition as that in which they are purchased. They are not normally further prepared before consumption, except perhaps being washed/rinsed, thawed or warmed (that is, a heat treatment achieving less than a 5-log reduction in numbers of L. monocytogenes).

RTE foods subject to the Listeria policy often require refrigeration (that is, labelled ‘Keep Refrigerated’ on the package) or freezing (that is, labelled ‘Keep Frozen’ on the package) for their preservation until the time of consumption. These RTE foods must have been subjected to a process by the manufacturer in order to render them RTE, or another process to extend their shelf-life, including but not restricted to the use of heat, chemicals, reduction of pH, reduction of water activity (aw), modified atmosphere packaging and/or storage conditions.

Raw fresh-cut fruits and vegetables that have been peeled, sliced, chopped or shredded prior to being packaged for sale and are intended to be consumed in the same condition as that in which they are purchased are considered to be RTE and are subject to the Listeria policy. Examples include shredded bagged lettuce, sliced mushrooms, grated cabbage for coleslaw, fresh-cut melons and fruit salad.

Foods excluded from the policy

Nonetheless, from the RTE foods definition above, the following foods are excluded from the Listeria policy:

  1. foods that have received a processing step achieving a minimum 5-log reduction in numbers of L. monocytogenes in a hermetically sealed container by the manufacturer and are not further exposed to the environment prior to consumption (for example, canned foods, refrigerated sous-vide type foods, retort pouches, aseptically processed and packaged foods such as ultra-high temperature (UHT) foods)
  2. hot filled/packed foods that have very limited exposure to the environment after filling (for example, maple syrup, jams, jellies, processed cheese)
  3. dried goods or low-moisture foods that do not require storage under refrigeration or freezing conditions (for example, cereals, bread, dry pasta, nuts and seeds, dried herbs and spices, dried soup mixes)
  4. beverages that do not require storage under refrigeration or freezing conditions (for example, alcoholic beverages, bottled water, carbonated beverages, non-carbonated beverages)
  5. raw whole fresh fruits and raw whole fresh vegetables that have only been trimmed, cleaned, brushed, washed, graded or packaged (for example, fresh herbs, whole or trimmed fruits and vegetables, whole leafy vegetables, microgreens, whole mushrooms, berries) as well as sprouts
  6. raw meat or raw seafood or raw eggs
    1. except those specifically processed for raw consumption (for example, oysters on the half shell sold as RTE, sushi containing raw fish, tubed seafood for tartare or ceviche, certain beef products such as steak tartar and Carpaccio) which are subject to the Listeria policy

    Note: Manufacturers of beef products processed for raw consumption should also consult Health Canada's "Guidance Document on E. coli O157:H7 and E. coli O157:NM in Raw Beef" and take steps to address E. coli O157 as a hazard likely to occur (Health Canada, 2014a).

  7. oyster shellstock (live) intended for raw consumption
  8. refrigerated or frozen processed foods that are solely intended to be cooked before consumption and are clearly labelled on the package as such with a declaration (for example, 'cook thoroughly', 'cook and serve', 'cook and eat') as well as with validated, comprehensive cooking instructions achieving a minimum 5-log reduction in numbers of L. monocytogenes
    1. except those defined as being RTE under the Canadian Standards of Identity in the Safe Food for Canadians Regulations (for example, wieners, frankfurters, hot dogs) (Government of Canada, 2021a; 2023c), which are subject to the Listeria policy

    Note: In the context of cooking instructions specified on the label of the package, 'cooking' refers to a treatment that achieves a minimum 5-log reduction in numbers of L. monocytogenes to be applied by the end-user on a food. Cooking instructions should be validated, comprehensive (that is, time/temperature combinations) and include an internal endpoint temperature (for example, minimum internal temperature of 74°C). Information on a food label must not be false or misleading (including, no deception or erroneous impression regarding its safety) and their labelling must comply with section 5 of the Food and Drugs Act (Government of Canada, 2023a). Furthermore, manufacturers should be consistent with how they communicate these cooking instructions in advertising (for example, information on the manufacturer's website).

If there is uncertainty regarding whether a food is subject to the Listeria policy, the relevant regulatory authority should be contacted.

Requirements and best practices for foods excluded from the policy

While the Listeria policy is not applicable to excluded foods, all relevant provisions of federal food legislation, such as sections 4 and 7 of the Food and Drugs Act, still apply to these foods (Government of Canada, 2023a). Food businesses should remain vigilant regarding the presence of L. monocytogenes if it has been identified as a food safety hazard to be controlled (for example, in a HACCP plan or PCP). In order to mitigate the risk from L. monocytogenes (that is, prevent the introduction and/or growth of L. monocytogenes) in foods excluded from the Listeria policy, manufacturers of such foods are still expected to implement GMPs as well as environmental sampling or end-product testing as appropriate to their operation. Industry-specific best-practice guidelines for the control of L. monocytogenes in foods that are not subject to the Listeria policy may represent a good resource to help identify and apply control measures that are appropriate to their operation. Factors such as the processing steps, labelling, trend analysis information, well-documented link to illnesses (for example, certain frozen vegetables (EFSA BIOHAZ Panel et al., 2020), enoki mushrooms (WHO, 2020)) could also have an impact on the level of priority for the frequency of verification activities and risk communication strategies. Manufacturers should be able to demonstrate that their food safety system will control L. monocytogenes in their foods.

If foods are specifically produced for vulnerable populations, which have an increased susceptibility to infection with L. monocytogenes, a greater frequency of verification activities would be expected as compared to foods produced for consumption by the general population. In particular, environmental sampling and end-product testing as per Figures 2 to 4 are recommended for refrigerated or frozen processed foods which are solely intended to be cooked before consumption that are excluded from the Listeria policy (see the section on Foods excluded from the policy, above), if specifically produced for vulnerable populations. In addition, strict adherence to and monitoring of GMPs, process controls and other control measures are recommended (CAC, 2020).

A finding of L. monocytogenes in a food excluded from the Listeria policy should trigger an assessment by the food business to determine what follow-up actions including risk management are needed, particularly if the situation represents a health concern.

Roles and responsibilities

The Listeria policy was developed by Health Canada, with input from the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC). It takes into account the roles and responsibilities of industry, government and consumers.

Industry

It is the responsibility of food businesses to comply with all applicable Canadian legislative requirements (Government of Canada, 2023a; 2023c; 2023d; 2023e). Food businesses that require a licence under the Safe Food for Canadians Regulations should be aware that certain control measures and reporting recommendations described in the Listeria policy may be regulatory requirements under the Safe Food for Canadians Regulations. For instance, RTE food manufacturers that require a licence under the Safe Food for Canadians Regulations must be able to demonstrate that their food safety system will control L. monocytogenes in RTE foods.

Ready-to-eat food manufacturers

As L. monocytogenes is widespread in nature and may be found in the food processing environment, manufacturers of RTE foods should be able to demonstrate that their food safety system will control L. monocytogenes. Manufacturers should carry out environmental sampling, as described in Figures 2 to 4 (see the section on Environmental sampling and testing), under the principle that the environment of higher-risk foods should be sampled at an increased frequency. This should be performed to verify the effectiveness of their sanitation program (that is, cleaning and sanitizing) and of their process controls. Findings of Listeria spp. may be an indication of the presence of L. monocytogenes and should lead to intensified cleaning and sanitizing. A review of the food safety system may also be needed.

Manufacturers must ensure that their labels are in compliance with section 5 of the Food and Drugs Act which states: No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety (Government of Canada, 2023a). From a food safety perspective, this is especially important with regards to storage and preparation instructions for consumers.

Ready-to-eat food importers

Imported food must be prepared with at least the same level of food safety controls as food prepared in Canada since they are required to meet the same food safety outcomes. Food importers are required to have a Safe Food for Canadians Regulations licence and develop, keep, maintain and implement a written PCP, following Part 4 of the Safe Food for Canadians Regulations. They must also have a traceability system in accordance with Part 5 of the Safe Food for Canadians Regulations. Importers must have this information readily available to the CFIA. Furthermore, they should always practise safe food storage and handling procedures.

Ready-to-eat food exporters

The term RTE food manufacturers referred to in the Listeria policy includes manufacturers of RTE foods for export. Canadian exporters are responsible, at a minimum, for exporting food that meets Canadian food safety requirements (see the section on Industry, above).

Government

Health Canada develops policies, guidelines and food safety standards with the goal of protecting the health and safety of Canadians. This is done in consultation with stakeholders (for example, federal and provincial/territorial partners, the food industry and its associations). Health Canada publications are intended to help industry comply with applicable Canadian legislative requirements and serve as a resource for regulatory authorities.

It is the role of the CFIA to verify compliance with federal food legislation.

The role of the PHAC is to promote and protect the health of Canadians through leadership, partnership, innovation and action in public health (PHAC, 2020).

In accordance with their mandates, Health Canada, the CFIA and the PHAC work together and contribute to the following:

Health Canada, the CFIA and the PHAC also work together with other public health officials and provincial/territorial partners to investigate the source of L. monocytogenes-related illnesses when an outbreak is suspected, as applicable.

The Government of Canada provides information and science-based educational materials to the medical community, public health officials, the food industry and consumers about foodborne illness, and also provides Canadians with reliable and consistent information about food safety.

Consumers, caterers and care providers

In addition to the food industry and government authorities, consumers play an important role in reducing foodborne illness. That role calls for Canadians to learn, adopt as well as follow safe food handling, responsible food selection and safe food preparation practices. The Codex Alimentarius Commission's "Guidelines on the Application of General Principles of Food Hygiene to the Control of Listeria monocytogenes in Foods" provides pertinent information in relation to consumer awareness (CAC, 2009a).

It should be emphasized that caterers and care providers (for example, health care providers, caregivers) to vulnerable individuals (that is, people with weakened immune systems, adults ages 60 and over, as well as pregnant people) have a high level of responsibility in food preparation, as vulnerable individuals have an increased susceptibility to infection with L. monocytogenes. Vulnerable individuals should try to avoid the consumption of specific foods or make safer food choices. Furthermore, knowledge about responsible food selection, safe food handling and preparation practices is particularly important to vulnerable populations and the people who prepare food for them (for example, caterers, care providers) (Government of Canada, 2016; 2021b; 2021c; 2021d; 2023f).

While a lot of information is provided by food manufacturers regarding nutrition, information pertaining to food safety is becoming increasingly common on food packaging. Adherence to the instructions labelled on the package should be followed, as they indicate the manufacturer's specific intentions for proper handling, preparation and usage.

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