Draft: Microbiological guidelines for food

Notice

On June 11, 2026, Health Canada published a Proposal to modify the tables of Microbiological Criteria for Food and Microbiological Reference Methods for Food and publish a new guidance document. This guidance document is included as part of the consultation.

To learn more about the proposal, including instructions on how to provide feedback on this document, please consult the Proposal to modify the tables of Microbiological Criteria for Food and Microbiological Reference Methods for Food and publish a new guidance document.

The consultation opens on June 11, 2026, and closes on August 25, 2026

Purpose
- Standards
- Guidelines
Scope
Key elements and limitations
Microbiological guidelines
- Table 1. Microbiological Guidelines for Food
Analytical methods
Deviation from microbiological guidelines
Additional Health Canada guidance and policy documents
Annex A – Roles and responsibilities
- Regulated party
- Regulatory authority
Annex B - Definitions
References

Purpose

This guidance document is intended to assist both regulated parties and regulatory authorities in assessing the safety and general cleanliness of food according to their roles and responsibilities outlined in Annex A. This document provides microbiological guidelines for the food listed in Table 1.

This guidance supersedes the Health Products and Food Branch (HPFB) Standards and Guidelines for Microbiological Safety of Food – An Interpretive Summary (dated April 2008), and it generally applies to all food sold in Canada, whether domestically produced or imported.

Health Canada establishes two types of microbiological criteria for certain foods outlined either in the Table of Microbiological Criteria for Food or in this guidance document: standards (regulatory) and guidelines (non-regulatory).

Standards
Standards are microbiological safety criteria that are listed in the Table of Microbiological Criteria for Food, which is incorporated by reference in Division 30 of the Food and Drug Regulations. According to provision B.30.002 of these regulations, a food that does not meet the corresponding microbiological criteria in the Table is considered adulterated. Conversely, as per B.30.003 of these regulations, a food that meets the microbiological criteria specified in the Table is exempt from the application of paragraph 4(1)(a) of the Food and Drugs Act.

Standards mostly target foodborne pathogens that pose serious or severe health risks. These standards apply to foods in which the identified microorganisms are not expected to be present if the food has been properly processed and formulated.
Guidelines
Guidelines are microbiological criteria used to inform regulated parties and regulatory authorities of the microbiological level that is expected in a food when good agricultural practices (GAPs), good hygienic practices (GHPs) and good manufacturing practices (GMPs) are applied. They are outlined in this document and detailed in Table 1: Microbiological Guidelines for Food. While not a part of the Food and Drug Regulations, these guidelines support the interpretation and application of relevant sections of the Food and Drugs Act (i.e., sections 4 and 7) concerning food safety and general cleanliness of food.

Microbiological guidelines focus on indicator microorganisms and those associated with moderate health risks. These guidelines apply to foods where certain concentrations (levels) of the identified microorganisms may be present. Such levels are considered achievable under GAP, GHP and GMP. When assessing food against these guidelines, additional factors such as the type of food processing, ingredients used, point of sampling, and labeling information may also be considered.

The decision on whether a microbiological criterion is a standard or a guideline is based on several factors, including whether they are linked to health and safety, the severity of associated hazards, and other relevant considerations.

Scope

The microbiological guidelines apply to the foods listed in Table 1 with respect to the microorganisms and methods set out in the Table. Table 1 should be used in conjunction with the standards outlined in the Table of Microbiological Criteria for Food in assessing the safety and general cleanliness of food.

Provincial/territorial regulatory authorities may be conducting enforcement of their own food legislation and may apply similar or stricter guidelines in relation to the application of their laws. Hence, Health Canada's Microbiological Guidelines for Food may serve as a resource for this purpose. In these cases, this guidance document can play a complementary role, but is not intended to provide guidance on legislation that is not within Health Canada's jurisdiction or mandate.

Regulated parties are responsible for complying with all applicable provisions of federal food legislation, including sections 4 and 7 of the Food and Drugs Act. When establishing its own microbiological criteria, the food industry should consider the applicable requirements under their specific jurisdiction (e.g. federal, provincial, territorial, municipal). The food industry may choose to adhere to the microbiological criterial laid down in this document or choose to adopt more stringent criteria.

This document does not constitute part of the Food and Drugs Act or its regulations. If there is inconsistency or conflict between the Act or regulations and this document, the Act or regulations take precedence. This is an administrative document to help the regulated party comply with the Food and Drugs Act and its regulations.

Manufacturers of food for which microbiological criteria have not been established remain responsible for complying with all applicable provisions of federal food legislation, including sections 4 and 7 of the Food and Drugs Act.

Key elements and limitations

This guidance document on the microbiological guidelines for food in Canada has been developed in accordance with the Codex Alimentarius Principles and Guidelines for the Establishment and Application of Microbiological Criteria Related to Foods (CXG 21-1997 (2013)).

Microbiological safety and general cleanliness of food cannot be achieved through end-product testing alone. This could be due to statistical limitations of sampling plans, as well as other factors such as the analytical methods employed, the nature of food matrix, the sampling techniques used, and the prevalence, concentration and distribution of the target organism within the food product. The compliance and safety of end-products should be maintained by controlling hazards through application of GAPs, GHPs, GMPs, and implementation of a preventive control plan such as Hazard Analysis Critical Control Point (HACCP) plans.

The microbiological guidelines set out in Table 1 are expressed in terms of two-class or three-class sampling plans depending on the severity of hazards involved. In general, two-class sampling plans are used where a specific microorganism should not be detected in food. Three-class sampling plans are used where certain levels of a microorganism should not be exceeded.

Definitions are listed in Annex B. The following are definitions for symbols, abbreviations, acronyms and other terms appearing in Table 1:

n:

The number of sample units selected from a lot.

c:

The maximum allowable number of marginally acceptable sample units. "c" is the acceptance number of a sampling plan. When the number is exceeded, the lot becomes unacceptable.

m:

Represents levels (concentrations) of microorganisms. In a 2-class plan, "m" separates acceptable from unacceptable concentrations; in a 3-class plan, "m" separates acceptable from marginally acceptable concentrations. The "m" values are based on levels achievable under GAPs, GHPs and GMPs.

M:

Represents levels (concentrations) of microorganisms. In a 3-class plan, "M" separates marginally acceptable from unacceptable. A value determined for any one sample unit that is greater than "M" renders the pertaining lot unacceptable.

Lot:

A batch or production unit that can be identified by the same code. If individual lots cannot be distinguished by clear product markings, or if the food business is unable to provide information that allows for such differentiation, then a lot may be considered as one of the following, as applicable:

The quantity of the same food type produced and handled under essentially the same conditions, at the same establishment;
The quantity of the same food type from a single manufacturer, available for sampling at a fixed location;
The entire day's production;
The same food type processed on a given line, between two complete sanitation cycles;
The entire shipment of the same food type.

ACC:

Aerobic colony count; ACC is the total number of bacteria able to grow in the presence of oxygen and capable of forming colonies.

CFU:

Colony forming unit; CFU is a direct measure of bacterial colony counts on agar plates.

MPN:

Most probable number; MPN is a statistical bacterial estimate made from decimal dilutions of samples in liquid media.

Microbiological guidelines

These microbiological guidelines should be used in conjunction with the Table of Microbiological Criteria for Food, which contains the microbiological standards.

The following table lists food for which microbiological guidelines have been established.

Table 1. Microbiological Guidelines for Food

Food	Analytical Method	Microorganism	Sampling parameters
Food	Analytical Method	Microorganism	n	c	m	M
Chocolate products	MFHPB-19	Coliforms	5	2	<1.8 MPN/g^{Table 1 Footnote a}	10² MPN/g
Cocoa products	MFHPB-19	Coliforms	5	2	<1.8 MPN/g^{Table 1 Footnote a}	10 MPN/g
Dairy product powders^{Table 1 Footnote b}	MFHPB-18	ACC^{Table 1 Footnote *}	5	2	10⁴CFU/g	5x10⁴ CFU/g
Dairy product powders^{Table 1 Footnote b}	MFHPB-19	Coliforms	5	2	10 MPN/g	10² MPN/g
Infant cereal	MFHPB-18	ACC	5	2	3x10³ CFU/g	10⁴ CFU/g
Infant cereal	ISO 21528-1	Enterobacteriaceae	5	2	10 MPN/g	10² MPN/g
Nuts and their products, and seeds for consumption and their products	MFHPB-19	Coliforms	5	2	10² MPN/g	10³ MPN/g
Powdered infant formula	MFHPB-18	ACC	5	2	5x10²CFU/g	5x10³CFU/g
Powdered infant formula	ISO 21528-1	Enterobacteriaceae	10	2^{Table 1 Footnote c}	0/10g	n/a
Prepackaged ice	MFHPB-19	Coliforms	5	0	<1.8 MPN/100 mL^{Table 1 Footnote a}	n/a
Prepackaged water	MFHPB-19	Coliforms	5	0	<1.8 MPN/100 mL^{Table 1 Footnote a}	n/a
Prepackaged water	ISO 16266	Pseudomonas aeruginosa^{Table 1 Footnote d}^{Table 1 Footnote e}	5	0	not detected in 250 mL	n/a
Spices and dried aromatic herbs	MFHPB-19	Escherichia coli	5	2	10² MPN/g	10³ MPN/g
	MFHPB-42	Bacillus cereus group	5	2	10⁴ CFU/g	10⁶ CFU/g
	MFHPB-23	Clostridium perfringens	5	2	10⁴ CFU/g	10⁶ CFU/g
Table 1 Footnote * ACC: Aerobic colony count Return to table 1 footnote * referrer Table 1 Footnote a Means less than the lower limit of detection. Return to table 1 footnote a referrer Table 1 Footnote b These microbiological criteria do not apply to products such as protein powder, that contain multiple ingredients such as eggs, sugar and thickeners. Return to table 1 footnote b referrer Table 1 Footnote c Contaminations in up to two sample units are tolerated (c=2). It is assumed that the product is sufficiently homogenous that high-level contamination will fail the microbiological criterion (in case of high-level contamination, it is expected that more than two sample units will test positive for Enterobacteriaceae). Finding one or two sample units positive for Enterobacteriaceae should indicate to the manufacturer a trend toward potential loss of process control. Finding three or more positives should signal to the manufacturer a loss of process control (CXC 66-2008). Return to table 1 footnote c referrer Table 1 Footnote d This criterion applies only to natural mineral and spring waters in sealed containers. Return to table 1 footnote d referrer Table 1 Footnote e Process control indicator. The presence of P. aeruginosa is considered as an indicator of contamination of the water at source or during the packaging process (CXC 33-1985 (2011)). Return to table 1 footnote e referrer

Analytical methods

The detection or level of microorganisms in or on a food is to be determined using:

Methods listed in Table 1; or
Methods from the Compendium of Analytical Methods (Health Canada, 2023a); or
An equivalent method as determined by the Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis.

Deviation from microbiological guidelines

While these guidelines are not regulatory standards, they represent levels of microorganisms that are achievable under GAPs, GHPs and GMPs. In situations of deviation from microbiological guidelines outlined in Table 1, regulated parties and regulatory authorities are encouraged to consider appropriate follow-up actions based on factors, such as the microorganisms of concern, the point in the food chain where the product was tested, the assessed level of health risk to consumers and other relevant information. These guidelines are 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 food containing microorganisms at levels exceeding those outlined in Table 1 of this document, may be considered to contravene paragraphs 4(1)(a), 4(1)(e) and section 7 of the Food and Drugs Act.

For regulated parties, when deviations from the microbiological guidelines outlined in Table 1 occur, appropriate follow-up actions may include:

Consulting with the relevant regulatory authority to determine appropriate risk management actions (e.g., product recall or disposition);
Investigating root causes;
Reviewing corrective measures which may involve modification, improvement, or correction of existing measures, and/or implementing additional preventive measures (e.g., GAPs, GHPs, GMPs and preventive control plans such as HACCP); and
Increasing sampling, inspections, and/or audits.

For regulatory authorities, when deviations from the microbiological guidelines outlined in Table 1 are detected or reported, appropriate follow-up actions may include:

Conducting health risk assessments;
Conducting food safety investigations;
If a product is found to represent a risk to health, taking actions to prevent consumer exposure to the product in question (e.g., product recall);
If a product is found to be non-compliant with the Food and Drugs Act, taking compliance and enforcement actions (e.g., issuing a letter of non-compliance, licence suspension/cancellation or issuance of administrative monetary penalties);
If applicable, verifying the implementation of corrective actions by manufacturers and/or importers of non-compliant food;
Ensuring transparency with the public through timely communication identifying hazardous situations and/or affected food; and
Contributing to the continuous improvement of program design (e.g., guidance, requirements, and monitoring activities).

Additional Health Canada guidance and policy documents

In addition to the microbiological guidelines in Table 1, other Health Canada guidance documents and policies may apply to food sold in Canada. These documents provide guidance on intervention strategies to help reduce the burden of foodborne illness in Canada.

Food offered for sale in Canada for which microbiological criteria have not been established is still required to comply with the applicable sections of the Food and Drugs Act (e.g., sections 4 and 7).

Annex A – Roles and responsibilities

Regulated party

It is the responsibility of regulated parties (e.g., food producers, food importers) to comply with all applicable Canadian and provincial/territorial legislative requirements (Government of Canada, 2026a; 2026b; 2026c; 2026d). In addition, regulated parties are encouraged to become familiar with any policies and guidance documents that may apply to a certain food, including those set by a province/territory.

Regulatory authority

Health Canada is responsible for evaluating microbial contaminants in foods to identify and determine their risk to human health through science-based risk assessments. Health Canada also develops policies, guidance documents and microbiological criteria with the goal of protecting the health and safety of the people of Canada. This is done in consultation with interested parties (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 Canadian Food Inspection Agency (CFIA) to verify compliance with federal food legislation. The CFIA ensures that regulated parties comply with federal food safety regulations by conducting activities that include licensing, inspection, and surveillance. When non-compliance is identified, the CFIA takes appropriate control and enforcement actions.

The role of the Public Health Agency of Canada (PHAC) in food safety is to promote and protect the health of the Canadian population through national surveillance and identification of public health risk factors as well as detection of and response to multi- jurisdictional foodborne illness outbreaks using the authorities of the Public Health Agency of Canada Act. PHAC also acts as the International Health Regulations (IHR) national focal point, which is the national centre designated to communicate with the World Health Organization (WHO) IHR Contact Points under these regulations.

In accordance with their mandates, Health Canada, the CFIA and the PHAC work together to protect the health and safety of the Canadian population, for example by:

providing laboratory services for testing food and clinical samples;
conducting food surveillance and food safety investigations;
conducting health risk assessments; and
initiating recall actions.

Health Canada, the CFIA and the PHAC also work together with other public health officials and local/provincial/territorial partners to investigate the source of foodborne illness outbreaks, 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 the Canadian population with reliable and consistent information about food safety.

Annex B - Definitions

For the purpose of this document, the following definitions apply:

Chocolate product means a product derived from one or more cocoa products and includes chocolate, bittersweet chocolate, semi-sweet chocolate, dark chocolate, sweet chocolate, milk chocolate and white chocolate (Government of Canada, 2025a). 
Cocoa product means a product derived from cocoa beans and includes cocoa nibs, cocoa liquor, cocoa mass, unsweetened chocolate, bitter chocolate, chocolate liquor, cocoa, low fat cocoa, cocoa powder and low-fat cocoa powder (Government of Canada, 2025a). 
Dairy product powders include milk powder, whey powder, buttermilk powder and similar products. Definitions and composition standards are available in Volume 7 of the Canadian Food Compositional Standards (Government of Canada, 2025b) and in the National Dairy Code – Part III (AAFC, 2005).
Food includes any article manufactured, sold or represented for use as food or drink for human beings, including chewing gum, and any ingredient that may be mixed with food for any purpose whatever (Government of Canada, 2026a).
Infant means an individual who is under the age of one year (Government of Canada, 2026b).
Infant cereal can be made using either a single type or a mix of cereals (e.g., barley, buckwheat, millet, oat, rice, rye, wheat). Additional ingredients can also be added such as dairy products (e.g., skim milk, yogurt), fruit (e.g., banana, blueberry, apple), vegetables (e.g., carrot, spinach), vitamins (e.g., niacin, riboflavin, thiamine), mineral nutrients (e.g., calcium, iodine, iron, phosphorus) and probiotics.
Microbiological criterion means a risk management metric which indicates the acceptability of a food, or the performance of either a process or a food safety control system following the outcome of sampling and testing for microorganisms, their toxins/metabolites or markers associated with pathogenicity or other traits at a specified point of the food chain (CXG 21-1997 (2013)).
Nuts include for example, almonds, cashews, hazelnuts, pecans, pistachios, walnuts, peanuts, which can be raw, roasted, pasteurized, cut, dried, etc.
Nut/seed products include butters, powders, and pastes (e.g., tahini) made of nut or see; and exclude, nut-based dairy alternatives (e.g., cheeses, milks) that are not low- moisture, hummus (even if it specifies tahini as an ingredient), and multi-ingredient confectionary products (e.g., halva, granola bars).
Powdered infant formula is the common name of a human milk substitute or a new human milk substitute and means any food in a powdered form that is labelled or advertised (a) for use as a partial or total replacement for human milk and as intended for consumption by infants, or (b) for use as an ingredient in a food referred to in paragraph (a) (Government of Canada, 2026b).
Prepackaged ice means ice that has been packaged.
Prepackaged water is water which has been packaged in sealed containers for human consumption. The water can come from a variety of sources including springs, aquifers, or municipal supplies and may be treated to make it fit for human consumption (Health Canada, 2023b). It includes spring and mineral water, but it does not include items with added flavoring/essence or other supplements.
Spices and dried aromatic herbs include spices (e.g., cumin, paprika), dried aromatic herbs (e.g., rosemary, thyme, basil, oregano), and dried powdered vegetables used as seasonings (e.g., onion powder, garlic powder, celery powder).
Seeds for consumption include for example chia seeds, poppy seeds, sesame seeds, sunflower seeds, etc.

References

AAFC (Agriculture and Agri-Food Canada), 2005. National Dairy Code - PART III - Dairy Product Composition Standards [online]. Available from: https://agriculture.canada.ca/en/sector/animal-industry/canadian-dairy-information-centre/acts-regulations-codes-and-standards/national-dairy-code-part-ii-and-iii [accessed 6 March 2026].
CAC (Codex Alimentarius Commission), 2009. Code of Hygienic Practice for Powdered Formulae for Infants and Young Children (CXC 66-2008) [online]. Available from: https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXC%2B66-2008%252FCXC_066e.pdf [accessed 6 March 2026].
CAC (Codex Alimentarius Commission), 2011. Code of Hygienic Practice for Collecting, Processing and Marketing of Natural Mineral Waters (CXC 33-1985) [online]. Available from: https://www.fao.org/fao-who-codexalimentarius/sh-proxy/zh/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org %252Fsites%252Fcodex%252FStandards %252FCXC%2B33-1985%252FCXC_033e.pdf [accessed 6 March 2026].
CAC (Codex Alimentarius Commission), 2013. Principles and guidelines for the establishment and application of microbiological criteria related to foods (CXG 21- 1997) [online]. Available from: https://www.fao.org/fao-who-codexalimentarius/sh- proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex %252FStandards%252FCXG%2B21-1997%252FCXG_021e.pdf [accessed on 6 March 2026].
Government of Canada, 2025a. Canadian Food Compositional Standards. Volume 4 – Cocoa and Chocolate Products [online]. Available from: https://inspection.canada.ca/en/about-cfia/acts-and-regulations/list-acts-and- regulations/documents-incorporated-reference/canadian-food-compositional-standards- 0#a4 [accessed 6 March 2026].
Government of Canada, 2025b. Canadian Food Compositional Standards. Volume 7 – Dairy Products [online]. Available from: https://inspection.canada.ca/en/about-cfia/acts-and-regulations/list-acts-and-regulations/documents-incorporated-reference/canadian-food-compositional-standards-0#a7 [accessed 6 March 2026].
Government of Canada, 2026a. Food and Drugs Act [online]. Available from: http://laws-lois.justice.gc.ca/eng/acts/F-27/ [accessed 6 March 2026].
Government of Canada, 2026b. Food and Drug Regulations [online]. Available from: https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/index.html [accessed 6 March 2026].
Government of Canada, 2026c. Safe Food for Canadians Regulations [online]. Available from: https://laws.justice.gc.ca/eng/regulations/SOR-2018-108/ [accessed 6 March 2026].
Government of Canada, 2026d. Safe Food for Canadians Act [online]. Available from : https://laws-lois.justice.gc.ca/eng/acts/s-1.1/index.html [accessed 6 March 2026].
Health Canada, 2023a. The Compendium of Analytical Methods [online]. Available from https://www.canada.ca/en/health-canada/services/food-nutrition/research-programs-analytical-methods/analytical-methods/compendium-methods.html [accessed 6 March 2026].
Health Canada, 2023b. Frequently Asked Questions about Bottled Water [online]. Available from: https://www.canada.ca/en/health-canada/services/food-nutrition/food-safety/information-product/frequently-asked-questions-about-bottled-water.html [accessed 6 March 2026].

Page details

2026-06-11