Proposal to modify the tables of Microbiological Criteria for Food and Microbiological Reference Methods for Food and publish a new guidance document

Notice of Proposal – Table of Microbiological Criteria for Food; Table of Microbiological Reference Methods for Food
Reference Number: PMIC-2604
June 11, 2026

Summary

Health Canada conducted a comprehensive review of microbiological criteria for food. As a result of the review, Health Canada is proposing to:

update the regulatory microbiological criteria (i.e., microbiological standards) in the Table of Microbiological Criteria for Food and the Table of Microbiological Reference Methods for Food
publish a new guidance document containing some of the updated non-regulatory microbiological criteria (i.e., microbiological guidelines) currently outlined in the 2008 Health Products and Food Branch (HPFB) Standards and Guidelines for Microbiological Safety of Food – An Interpretive Summary

You can submit comments, regarding the proposed modifications in the tables and the new guidance document, on this proposal until August 25, 2026 (see the section "Consultation" for instructions).

Background

Since December 2024, when the Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food were published in the Canada Gazette, Part II, the microbiological criteria and their associated methods of analysis have been set out in the Table of Microbiological Criteria for Food, the Table of Microbiological Reference Methods for Food, and the Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis. These documents should be used together and are incorporated by reference into the Food and Drug Regulations (FDR).

New scientific developments, evolving technology, and emerging public health risks may prompt Health Canada to review microbiological criteria.

Issue

As a follow-up to the modernization of Part B of the FDR, Health Canada committed to reviewing and updating both regulatory and non-regulatory microbiological criteria. The existing criteria had not been revised for many years, and many were scientifically outdated or no longer aligned with current safety risk profiles.

Health Canada establishes two types of microbiological criteria:

regulatory standards, mostly for microorganisms posing serious or severe health risks, included in the incorporated by reference Table of Microbiological Criteria for Food
non-regulatory guidelines, for indicator organisms and microorganisms associated with moderate risks, which are outlined in the guidance document entitled Microbiological Guidelines for Food.

Rationale

Health Canada reviewed regulatory and non-regulatory microbiological criteria. The review considered current scientific evidence, surveillance and epidemiological data, risk assessments, results of previous targeted consultations, comments received during the modernization of Part B, and international comparisons. The proposed criteria are considered achievable by industry and realistic to implement.

Both regulatory and non-regulatory criteria support the same objective: protecting public health by limiting or restricting certain microorganisms in food. Because many of the proposed criteria already exist as standards or guidelines, and newly added criteria relate to well recognized microorganisms, Health Canada does not expect the proposed modifications to impose significant additional burden on regulated parties.

The revisions will be implemented in two phases:

Phase 1 covers criteria for:
- chocolate products
- cocoa products
- dairy product powders
- infant cereal
- nuts and their products, and seeds for consumption and their products
- powdered infant formula
- prepackaged ice
- prepackaged water
- spices and dried aromatic herbs
Phase 2 will address:
- dairy products
- fish, shellfish, and their products
- fruits and vegetables
- meat and meat products
- processed egg products.

Each phase includes corresponding updates to the Table of Microbiological Reference Methods for Food to ensure that each microbiological criterion is linked to an appropriate reference method.

The current notice of proposal and consultation pertains only to the Phase 1 criteria and includes the proposed modifications in the tables and in the guidance document.

The outcome of Health Canada's review supports the proposed modifications as set out in Table 1, 2 and 3.

Proposed modifications to the tables

The proposed modifications include updates to food types and names, microorganisms, sampling parameters, and the placement of microbiological criteria within the incorporated by reference table versus the guidance document. An addition of a new reference method is also proposed for the Table of Microbiological Reference for Food.

Health Canada proposes the following updates to the microbiological criteria for Phase 1:

Table 1 is an excerpt from the Table of Microbiological Criteria for Food and presents the proposed modifications to this table;
Table 2 is an excerpt from the Table of Microbiological Reference for Food and presents the added reference method to this table and;
Table 3 provides an excerpt from the guidance document Microbiological Guidelines for Food, which lists food for which microbiological guidelines have been established. The consultation is not limited to Table 3, but rather applies to the entire guidance document.

Table 1. Proposed modifications to the Table of Microbiological Criteria for Food
Column 1	Column 2	Column 3	Column 4	Column 5	Column 6
Food	Microorganism	n	c	m	M
Dairy product powders	Salmonella spp.	20	0	not detected in 25g	n/a
Cocoa products	Salmonella spp.	10	0	not detected in 25g	n/a
Chocolate products	Salmonella spp.	10	0	not detected in 25g	n/a
Powdered infant formula	Salmonella spp.	60	0	not detected in 25g	n/a
Powdered infant formula	Cronobacter spp.	30	0	not detected in 10g	n/a
Infant cereal	Salmonella spp.	20	0	not detected in 25g	n/a
Nuts and their products, and seeds for consumption and their products	Salmonella spp.	10	0	not detected in 25g	n/a
Spices and dried aromatic herbs	Salmonella spp.	10	0	not detected in 25g	n/a
Prepackaged water	Escherichia coli	5	0	<1.8 MPN/100 mL	n/a
Prepackaged ice	Escherichia coli	5	0	<1.8 MPN/100 mL	n/a

Table 2. Proposed modification to the Table of Microbiological Reference Methods for Food
Column 1	Column 2
Microorganism	Reference Methods
Cronobacter spp.	ISO 22964 - Microbiology of the food chain — Horizontal method for the detection of Cronobacter spp.

Table 3. Proposed 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 3 Footnote a}	10² MPN/g
Cocoa products	MFHPB-19	Coliforms	5	2	<1.8 MPN/g^{Table 3 Footnote a}	10 MPN/g
Dairy product powders^{Table 3 Footnote b}	MFHPB-18	ACC^{Table 3 Footnote *}	5	2	10⁴CFU/g	5x10⁴ CFU/g
Dairy product powders^{Table 3 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 3 Footnote c}	0/10g	n/a
Prepackaged ice	MFHPB-19	Coliforms	5	0	<1.8 MPN/100 mL^{Table 3 Footnote a}	n/a
Prepackaged water	MFHPB-19	Coliforms	5	0	<1.8 MPN/100 mL^{Table 3 Footnote a}	n/a
Prepackaged water	ISO 16266	Pseudomonas aeruginosa^{Table 3 Footnote d}^{Table 3 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 3 Footnote * ACC: Aerobic colony count Return to table 3 footnote * referrer Table 3 Footnote a Means less than the lower limit of detection. Return to table 3 footnote a referrer Table 3 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 3 footnote b referrer Table 3 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 3 footnote c referrer Table 3 Footnote d This criterion applies only to natural mineral and spring waters in sealed containers. Return to table 3 footnote d referrer Table 3 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 3 footnote e referrer

Other relevant information

Engagement with interested parties

Prior to the Part B Regulatory Modernization initiative, targeted consultations were conducted with representatives from industry, academia, and federal, provincial, and territorial governments, focusing on the microbiological criteria outlined in both the FDR and a draft version of the guidance document. These consultations provided important insights into the feasibility, effectiveness, and potential challenges of the proposed criteria, and this feedback has been carefully considered in the current review.

Comments received during the 2023–2024 consultation process through Canada Gazette, Part I, regarding the proposed amendments to microbiological criteria and methods of analysis were also taken into account during the drafting of the updates.

International

To ensure consistency and facilitate international trade, it is important that both regulatory and non-regulatory microbiological criteria are aligned as closely as possible with the key trade partners and are based on robust scientific evidence. As part of this review, comparisons were made with standards and guidelines established by the Codex Alimentarius Commission, the United States Food and Drug Administration (U.S. FDA), the European Commission (EC) and the Food Standards Australia New Zealand (FSANZ). This approach supports the Government of Canada's priorities to eliminate trade barriers and reduce regulatory burden on industry.

The reference method being added to the table is an ISO (International Organization for Standardization) standard reference method internationally recognized and already adopted by the industry. Therefore, its inclusion is not expected to result in any additional burden.

Implementation and enforcement

Modifications to the Table of Microbiological Criteria for Food and the Table of Microbiological Reference Methods for Food come into force on the day they are published on Health Canada's website. However, Health Canada is proposing a delayed implementation of these modifications (the revised and the newly added microbiological criteria); the tables will be modified three months after the publication of the Notice of Modification.

The new guidance document, titled Microbiological Guidelines for Food, will remain in draft form until the end of phase 2.

You can consult the Notices of Proposal and Notices of Modification web page to stay informed of these modifications, or you can register for Health Canada's Consultation and Stakeholder Information Management System to be automatically notified when they are issued.

The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.

Consultation

The consultation on the proposed modifications to the Table of Microbiological Criteria for Food, the Table of Microbiological Reference Methods for Food (shown in Tables 1 and 2 respectively), and on the new guidance document titled Draft: Microbiological Guidelines for Food is open for 75 days from the date of publication of this notice.

You can submit your comments on this proposal by email until August 25, 2026 at food.ibr-ipr.aliments@hc-sc.gc.ca. Please use the words "microbiological criteria for foods (PMIC-2604)" in the subject line of your email.

The results of the consultation pertaining to the incorporated by reference tables will be communicated in a notice of modification should the proposal move forward. The results of the consultation related to new guidance document Microbiological Guidelines for Food will be published at the end of phase 2.

Notice of exception

Health Canada's Food and Nutrition Directorate normally publishes Notices of proposal (NOP) to consult on proposed modifications to documents incorporated by reference into regulations. NOPs are normally not used to consult on modifications to guidance documents. However, because the project at hand involves the transfer of criteria from the regulatory Tables to the non-regulatory guidance, and vice-versa, including the guidance portion of this project in this NOP consultation was deemed appropriate to facilitate stakeholder understanding and streamline consultation feedback. This approach should not be interpreted as setting a precedent for any future consultation on Health Canada guidance documents.

Useful links

Health Canada

Canadian Food Inspection agency

Food safety standards and guidelines

Page details

2026-06-11

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