Guide to the exceptional importation and sale of certain foods for a special dietary purpose (FSDP) in response to a shortage or risk of a shortage

Disclaimer: This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.

Published January 23, 2026

On this page

• Introduction
• Purpose
• Roles and Responsibilities
• Part 1 of the Order – Shortages and risk of shortages
  • Scope
  • Exceptional importation and/or sale in response to a shortage or risk of a shortage
    • Reporting a shortage or risk of a shortage
    • Assessing a shortage or risk of a shortage
    • Activating the exceptional importation and/or sale of products
    • Information on individual products
    • Ending the exceptional importation and/or sale of products
  • Exemptions under Part 1 of the Order
  • Requirements (Conditions) under Part 1 of the Order
    • Condition 1: Notification of importation (importers)
    • Condition 2: Notification of sale (manufacturers)
    • Condition 3: Preparing a document to support the safe use of foods
    • Condition 4: Providing a copy of the document to the Minister
    • Condition 5: Providing a copy of the document to purchasers and consumers
    • Condition 6: Notification of a risk to health
    • Condition 7: Notification of a change in foreign regulatory status
    • Condition 8: Sale and distribution of human milk fortifiers
• Part 2 of the Order – Transition Strategy products
  • Scope
  • Exceptional importation and/or sale of Transition Strategy products
  • Exemptions under Part 2 of the Order
  • Requirements (Conditions) under Part 2 of the Order
    • Condition 1: Preparing a supplementary label document (if both official languages are not on the label)
    • Condition 2: Providing a copy of the document to purchasers and consumers
    • Condition 3: Notification of a risk to health
    • Condition 4: Notification of a change in foreign regulatory status
    • Condition 5: Sale and distribution of human milk fortifiers
• Contact us
• References and related links

Introduction

Health Canada is responsible for helping people in Canada maintain and improve their health, while respecting individual choices and circumstances. This includes helping to ensure that people in Canada have access to the foods for a special dietary purpose^{Footnote 1} (FSDP) they need when they need them, and that these foods meet safety, quality and nutritional standards.

The Exemption Order in Respect of Foods for a Special Dietary Purpose (the Order) establishes frameworks for the exceptional importation and/or sale of certain FSDP that are authorized for sale in other markets. The Order aims to help prevent and mitigate shortages of these foods. FSDP serve as a critical source of energy and essential nutrients for vulnerable people in Canada and any significant disruption in access can have serious, potentially fatal consequences on the health of the individuals who rely on them.

The Order is separated into two parts:

• Part 1 establishes a framework for the exceptional importation and/or sale of certain FSDP in response to a shortage or risk of a shortage.
• Part 2 establishes a framework for the exceptional importation and sale of the closed list of FSDP that form part of Health Canada's Transition Strategy^{Footnote 2}.

FSDP exceptionally imported and/or sold under Parts 1 and 2 of the Order are produced for a foreign market, but have been manufactured according to either Canadian standards (in the case of domestic products) or foreign food safety and quality standards similar to those upheld in Canada. However, these foods do not fully comply with Canada's Food and Drug Regulations (FDR).

The exceptional importation and sale of certain FSDP began in 2022 in response to widespread shortages of several FSDP caused by the temporary closure of a major production facility in the United States. In the absence of a regulatory framework for FSDP shortages, Health Canada introduced a shortages interim policy^{Footnote 3} to permit the temporary importation and sale of products that did not fully meet Canadian regulatory requirements. As the Canadian market for these FSDP began to stabilize in late 2023, Health Canada published the Transition Strategy to clarify the pathway for products being sold under the interim policy to become fully compliant with the FDR.

On December 17, 2025, the Minister of Health made the Exemption Order in Respect of Foods for a Special Dietary Purpose, which replaced the 2022 shortages interim policy and the associated Transition Strategy.

Purpose

This guidance document aims to help industry stakeholders, including, importers, manufacturers, distributors and retailers involved in the exceptional sale importation and/or sale of FSDP understand how to comply with Parts 1 and 2 of the Order. It outlines:

• the circumstances where a foreign-authorized product may be eligible for exceptional importation and/or sale in Canada.
• the process of exceptional importation and/or sale in response to a shortage or risk of a shortage.
• the regulatory requirements for the exceptional importation and/or sale of foreign-authorized FSDP, including the conditions that must be met.
• the exemptions from certain labelling, compositional and pre-market requirements that apply to products being exceptionally imported and/or sold.

Like the Order, this guidance document is separated into two parts:

• Part 1 of the Order – Shortages and risk of shortages
• Part 2 of the Order – Transition Strategy products

Note on food licensing

All importers and domestic manufacturers of FSDP must hold a valid Safe Food for Canadians licence (SFC licence) to import or manufacture products. This requirement applies regardless of whether FSDP is exceptionally imported and/or sold under Part 1 or Part 2 of the Order. Importers and manufacturers must also comply with all applicable provisions of the Safe Food for Canadians Act (SFCA) and Safe Food for Canadians Regulations (SFCR).

Roles and responsibilities

Health Canada

Health Canada is the federal authority responsible for administering the Exemption Order in Respect of Foods for a Special Dietary Purpose (the Order) and maintaining the List of Human Milk Fortifiers, Infant Formulas and Formulated Liquid Diets for Exceptional Importation and Sale in the Case of a Shortage or Risk of Shortage (the List).

Canadian Food Inspection Agency

The CFIA is the federal authority responsible for verifying or assessing industry's compliance with the Order and other applicable food regulations and taking enforcement action where needed.

Industry stakeholders (FSDP manufacturers, importers, distributors, and retailers)

Industry stakeholders involved in the exceptional importation and/or sale of FSDP must ensure they and their products comply with the Order, as well as other applicable requirements of the FDA/FDR and SFCA/SFCR.

Part 1 of the Order – Shortages and risk of shortages

Scope

Part 1 of the Order applies exclusively to certain categories of FSDP that are either:

• Manufactured outside of Canada and exceptionally imported and sold in Canada, or
• Manufactured in Canada for foreign markets and redirected for exceptional sale in Canada.

These FSDP must be authorized for sale in jurisdictions identified by Health Canada as having and maintaining food safety and quality standards similar to those in Canada.

Inclusions

Part 1 of the Order applies exclusively to foods fitting within the following regulatory categories of FSDP:

• new human milk substitutes, commonly known as infant formulas (IF)^{Footnote 4}, as defined under section B.25.001 of the Food and Drug Regulations.
  • Note: the common name "infant formula" is established under section B.25.045 of the FDR and this is the term used throughout this guidance document.
• human milk fortifiers (HMF)^{Footnote 5}, as defined under section B.25.001 of the Food and Drug Regulations.
• formulated liquid diets (FLD)^{Footnote 6}, as defined under section B.24.001 of the Food and Drug Regulations.

Exclusions

Part 1 of the Order does not apply to the following:

• FSDP captured under Part 2 of the Order. Refer to the Part 2 of the Order – Transition Strategy products for more information.
• food for special dietary use (FSDU) for inherited metabolic disorders (IMD), commonly referred to as 'metabolic products.' Refer to the Interim policy statement on foods for special dietary use for inherited metabolic disorders for more information on the sale of metabolic products in Canada.
• other foods captured under Divisions 24 and 25 of the FDR that do not fall within the three categories listed under the inclusions section above.

Understanding these categories is essential for stakeholders involved in the exceptional importation and sale process, detailed in the following sections of this document.

Exceptional importation and/or sale in response to a shortage or risk of a shortage

Part 1 of the Order establishes the framework that enables Health Canada to activate the exceptional importation and/or sale of certain foreign-authorized FSDP in response to a shortage or risk of a shortage in Canada. Exceptional importation and/or sale refers to the temporary importation and/or sale of FSDP that do not fully comply with certain Canadian regulatory requirements (for example specific labelling, compositional, and premarket provisions of the FDA and FDR), in order to help mitigate the impact of such supply chain disruptions.

• A shortage is a situation where the available supply^{Footnote 7} in Canada of IF, HMF, or FLD is insufficient to meet the demand.
• A risk of a shortage refers to a situation where it is anticipated that the available supply in Canada of IF, HMF, or FLD will be insufficient to meet the demand.

Reporting a shortage or risk of a shortage

While the Order does not require stakeholders to report shortages or risks of shortage, early and voluntary reporting is strongly encouraged. This allows Health Canada to assess the situation and take timely action to mitigate the impact on consumers.

Health Canada will consider evidence of a shortage or risk of shortage from a variety of sources, including:

• Industry and public health stakeholders (e.g., FSDP manufacturers, importers, distributors, retailers, hospitals, health professionals).
• Provincial and territorial governments.
• Foreign regulatory authorities (FRAs).

To report a shortage or a risk of a shortage of IF, HFM, or FLD, stakeholders may contact Health Canada at bns-bsn@hc-sc.gc.ca.

A notification of a shortage or risk of shortage should include:

• the product name(s) and FSDP category(ies).
• evidence supporting the shortage or risk of a shortage.
  • For example, written proof from a reputable source, such as a manufacturer or distributor, industry associations, ingredient suppliers, health professionals, etc., indicating that a shortage exists or the risk of a shortage is imminent or forecasted.
• the estimated start date (and end date, if known) of the shortage or risk of shortage.
• the market share of the implicated product(s) and any other relevant data.

Health Canada may follow up with additional questions to better understand the situation.

Assessing a shortage or risk of a shortage

Health Canada will assess a shortage or risk of shortage at the FSDP category level, not for individual foods. For example, if one brand of a hypoallergenic IF is unavailable in Canada but other hypoallergenic IF brands are still accessible in sufficient amounts, a shortage may not be declared. However, if the supply of suitable alternatives is insufficient to meet demand, a shortage or risk of shortage may be determined for that category of FSDP.

Health Canada will review information voluntarily submitted by stakeholders and gather intelligence from other sources to determine whether the exceptional importation and/or sale of foreign-authorized FSDP should be activated.

Each situation will be assessed on a case-by-case basis. The exceptional importation and/or sale of foreign-authorized FSDP will only be activated when Health Canada determines that:

• there is credible evidence of a shortage or risk of a shortage for a particular category of FSDP, and
• enabling the exceptional importation and/or sale of foreign-authorized foods is necessary to help mitigate the shortage or risk of a shortage.

Activating the exceptional importation and/or sale of products

Where a shortage or risk of a shortage is confirmed, Health Canada will revise the List of Human Milk Fortifiers, Infant Formulas and Formulated Liquid Diets for Exceptional Importation and Sale in the Case of a Shortage or Risk of Shortage (the List). The List is incorporated by reference into the Order and serves as the legislative mechanism by which Health Canada activates the exceptional importation and/or sale of foreign-authorised FSDP.

The List is organized in two parts:

• Part A applies to foods manufactured outside of Canada for exceptional importation and sale.
• Part B applies to foods manufactured in Canada, originally for foreign markets, which are being redirected for exceptional sale in Canada.

Each part of the List includes three columns:

• Column 1 – the category of FSDP that Health Canada has determined is in shortage or at risk of shortage. This is the category of food that is eligible for exceptional importation and/or sale to help mitigate the shortage or risk of shortage.
• Column 2 – the foreign regulatory authorities (FRAs) that Health Canada has identified as having and maintaining food safety and quality standards similar to Canada's. These are the FRAs that must have authorized the food for sale in the corresponding jurisdiction listed in Column 3.
• Column 3 – the jurisdictions (countries or regions) where the food must be authorized for sale by the corresponding FRA listed in Column 2, and from which the food must be imported directly (in the case of product manufactured outside Canada).

More than one category of FSDP may be added to the List at the same time if multiple categories are affected by a shortage or risk of shortage. Each category will be listed as a separate item.

Summary - criteria for foreign-authorized FSDP for exceptional importation and/or sale in Canada

To be eligible for exceptional importation and/or sale under Part 1 of the Order, a food must:

1. be part of a category listed in Column 1 of the List;
2. be authorized by a corresponding FRA set out in Column 2 for sale in the corresponding jurisdiction set out in Column 3; and
3. if manufactured outside of Canada, be imported directly from the jurisdiction set out in Column 3.

Having the List incorporated by reference provides Health Canada with the flexibility to tailor the exceptional importation and/or sale of foods as needed to address the particulars of a shortage or risk of a shortage, both at its outset and as it evolves. Categories of FSDP and/or FRAs and jurisdictions can be easily added or removed as needed through administrative revisions to the List.

Consistent with Health Canada's Incorporation by Reference Policy, updates to the List will be published on the Canada.ca website and shared with stakeholders through Health Canada's Consultation and Stakeholder Information Management System (CSIMS). Register to CSIMS.

Information on individual products

Although the List will not identify individual FSDP being exceptionally imported and sold in response to a shortage or risk of shortage, Health Canada will publish supporting public communications, such as advisories and news releases, to provide additional information.

To further support transparency, Health Canada will maintain a web-based administrative list of individual FSDP being exceptionally imported and sold under Part 1 of the Order. This administrative list:

• will not be part of the List of Human Milk Fortifiers, Infant Formulas and Formulated Liquid Diets for Exceptional Importation and Sale in the Case of a Shortage or Risk of Shortage.
• does not imply that a product has been reviewed or authorized by Health Canada.
• will be compiled based on the mandatory notifications submitted by importers and manufacturers to Health Canada (see Conditions: Notification of importation and Notification of sale).
• is intended to support transparency for the CFIA, health professionals, institutions, and consumers.

Details from this administrative list will be included in the 'Notes' column of the List of Human Milk Fortifiers, Infant Formulas and Formulated Liquid Diets for Exceptional Importation and Sale in the Case of a Shortage or Risk of Shortage to provide contextual information.

Ending the exceptional importation and/or sale of products

The exceptional importation and/or sale of an individual FSDP may continue only as long as its category remains in Column 1 of the List. Once Health Canada has determined that a shortage or risk of shortage has been resolved (i.e., the supply of FDA-compliant products and applicable Transition Strategy products is sufficient to meet demand), the relevant category of FSDP will be removed from the List. At that point, the exceptional importation and/or sale of related foods will no longer be permitted.

To support operational planning and business continuity, Health Canada will notify stakeholders when the process to remove a category of FSDP from the List has begun. Notifications will be shared via CSIMS (Register to CSIMS) and through targeted communications to importers, manufacturers, distributors and retailers.

These notifications will also include information regarding the Government's approach to the sale of any remaining shelf-stock of exceptionally imported and/or sold products.

Exemptions under Part 1 of the Order

Foods that are exceptionally imported and/or sold in Canada pursuant to Part 1 of the Order are exempt from specific labelling, compositional, and premarket provisions of the FDA and FDR. These targeted exemptions enable the exceptional importation and/or sale of foods that meet comparable safety and quality standards but do not fully comply with the applicable Canadian requirements.

The exemptions are as follow:

FDA prohibitions

• Prohibitions under 4(1)(a) and (d) on the sale of food containing poisonous or harmful substances, or food considered adulterated due to the presence of food additives, vitamins, minerals, amino acids or nutritive materials [Subparagraphs 4(a)(i) to (iii) of Part 1 of the Order].

FDR labelling and advertising requirements

• Labelling and advertising requirements under Parts A, B, and D of the FDR [Subparagraph 4(b)(i) of Part 1 of the Order].

FDR compositional requirements

• Specification requirements for food additives under B.16.011 [Subparagraph 4(b)(ii) of Part 1 of the Order].
• Prescribed expressions and nutrient levels, including:
  • Vitamin naming conventions under D.01.002(2)
  • Minimum/maximum levels for added vitamins under D.01.009–D.01.011
  • Minimum levels for added minerals under D.02.009(1)
  • Iron source specifications under D.02.010(2) and D.02.011
  • Limits on added vitamins, minerals, and amino acids in IF, HMF, and FLD under D.03.002 [Subparagraphs 4(b)(xi) to (xvi) of Part 1 of the Order].
• Category specific compositional requirements, including:
  • For FLD:
    • Prohibition under B.24.003(1)(f) unless the product meets B.24.102
    • Requirements under B.24.102 [Subparagraphs 4(b)(iii) to (iv) of Part 1 of the Order].
  • For IF:
    • Requirements under B.25.054 and B.25.056 [Subparagraphs 4(b)(viii) to (ix) of Part 1 of the Order].

FDR premarket authorization and notification requirements

• Notification requirements for novel foods, including novel ingredients under B.28.002 [Subparagraph 4(b)(x) of Part 1 of the Order]
• Authorization and notification requirements for HMF and IF, including:
  • HMF authorization under B.25.010
  • IF notification under B.25.046(1)
  • IF compliance with requirements of Division 25 under B.25.051 [Subparagraphs 4(b)(v) to (vii) of Part 1 of the Order].

Important Note: Other FDA and FDR Provisions still apply

Importers and manufacturers should note that all other applicable FDA and FDR provisions continue to apply. These include, but are not limited to:

• maximum levels for contaminants and other adulterating substances in food set out in Division 15, Part B of the FDR.
• requirements for food packaging materials set out in Division 23, Part B of the FDR.
• microbiological criteria for foods set out in Division 30, Part B of the FDR.

Important Note: food licensing requirements

All importers and domestic manufacturers of FSDP must hold a valid Safe Food for Canadians licence (SFC licence) to import or manufacture products. This requirement applies to FSDP that are exceptionally imported and/or sold under Part 1 of the Order. Importers and manufacturers must also comply with all applicable provisions of the Safe Food for Canadians Act (SFCA) and Safe Food for Canadians Regulations (SFCR).

Requirements (Conditions) under Part 1 of the Order

Importers, manufacturers, distributors and retailers involved in the exceptional importation and/or sale of certain FSDP are subject to the conditions set out in sections 5 to 12 of Part 1 of the Order.

Condition 1: Notification of importation (importers)

Who this applies to:

• Importers of foreign-manufactured HMF, IF, or FLD for exceptional sale in Canada.

What you must do:

• Notify Health Canada at least 5 days before importing each shipment of the food under the Order.

How to notify Health Canada:

• Send an email to bns-bsn@hc-sc.gc.ca with the subject line: "Import notification."

What to include in the notification:

• Brand name and product name of the food(s) being exceptionally imported for sale in Canada.
• Relevant FSDP category(ies) set out in Column 1 of Part A of the List.
• FRA and corresponding jurisdiction set out in Columns 2 and 3 of Part A of the List where the food(s) is authorized for sale and being imported from.
• Name and contact information of the importer. Please include your SFC import licence number.
• Name and contact information of the foreign manufacturer(s).
• Intended port of entry into Canada.
• Estimated date of arrival.
• Estimated quantity of food in the shipment (e.g., "five hundred units of 250 mL bottles").
• If known, the customs identification number for the shipment.

If anything changes:

• Send an e-mail to Health Canada with the revised information.

Condition 2: Notification of sale (manufacturers)

Who this applies to:

• Domestic manufacturers of HMF, IF, or FLD for exceptional sale in Canada.

What you must do:

• Notify Health Canada at least 5 days before the sale of each lot of food under the Order.

How to notify Health Canada:

• Send an email to bns-bsn@hc-sc.gc.ca with the subject line: "Sale notification."

What to include in the notification:

• Brand name and product name of the food(s) for exceptional sale in Canada.
• Relevant FSDP category(ies) set out in Column 1 of Part B of the List.
• FRA and corresponding jurisdiction set out in Columns 2 and 3 of Part B of the List where the food is authorized for sale and was originally intended for export.
• Name and contact information of the domestic manufacturer. Please include your SFC licence number.
• Estimated quantity of the food for exceptional sale (e.g., "five hundred 250 mL bottles").

If anything changes:

• Send an e-mail to Health Canada with the revised information.

Condition 3: Preparing a document to support the safe use of foods

Who this applies to:

• Importers of foreign-manufactured HMF, IF, or FLD for exceptional sale in Canada.
• Domestic manufacturers of HMF, IF, or FLD for exceptional sale in Canada.

What you must do:

• If the food's label does not fully comply with the applicable labelling requirements of the FDR, the importer or manufacturer, as the case may be, must prepare a document that contains the core labelling information described below. This document ensures that consumers, caregivers, and health professionals have access to the information needed to safely prepare, use, and store the food.

  Note: You are not required to seek Health Canada's review and approval of the document.

What to include in the core labelling information document:

A. In English or French:

1. Manufacturer's name and contact information [7(a) of Part 1 of the Order]

Instructions:

• For imported products, provide the contact information of the foreign manufacturer (e.g. website, mailing address, telephone number, and/or email address). The name and contact information of the importer may also be included.
• For domestic products, provide the contact information of the Canadian manufacturer (e.g. website, mailing address, telephone number, and/or email address).

B. In English and French:

2. Brand name and product name [7(b)(iii) of Part 1 of the Order]

Instructions:

• Provide the brand name and product name of the food.
• We recommend using a bold and larger font than that used for the other sections of the document for better visibility.
• An image of the food may be included.

3. Description of the special dietary purpose [7(b)(iv) of Part 1 of the Order]

Instructions:

• Indicate the relevant FSDP category (IF, HMF, or FLD).
• Include its indication for use, for example:
  • "infant formula with iron (milk-based/ready to serve)"
  • "to be added to human milk to increase its nutritional value for premature infants (human milk fortifier)"
  • "nutritionally complete liquid formula (formulated liquid diet) for individuals with renal failure"
• For IF and HMF: refer to section 4.13 of the Guide for the preparation of infant formula and human milk fortifier premarket submissions for guidance on how to present appropriate indications for use.

4. List of ingredients [7(b)(v) of the of Part 1 of the Order]

Instructions:

• Include a complete list of the food's ingredients.
• We recommend titling this section "Ingredients:" in bold font for better visibility.
• We recommend using commas or bullet points to separate ingredients.

5. Food allergen sources, gluten sources, and added sulphites [7(b)(vi) of the of Part 1 of the Order]

Instructions:

• If applicable, include a statement concerning the presence of food allergen sources, gluten sources and added sulphites in the food. This includes:
  • eggs; milk; mustard; peanuts; crustaceans and molluscs; fish; sesame seeds; soy; sulphites; tree nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts); wheat and triticale; and/or gluten sources (barley; oats; rye; triticale and wheat).
• Include all allergens, even if they are already listed in the ingredients section.
• We recommend using "Contains:" to list all allergen sources, gluten sources, and added sulphites that are intentionally added as ingredients or components of the food.
• Also, if applicable, we recommend using "May contain:" in bold font to indicate any allergens that may be present due to unavoidable cross-contamination.

  Contains: Milk, Soy

  May contain: Fish

• If the food does not contain food allergen sources, gluten sources, and added sulphites, either through intentional addition or through potential cross-contamination, these statements are not required.
• If you've included a heading or section for this information in your document and a statement is not required, we recommend including 'N/A' in the document.

6. Aspartame/phenylalanine statement [7(b)(vii) of Part 1 of the Order]

Instructions:

• If the food contains aspartame, include a statement that indicates the presence of phenylalanine, or that aspartame contains phenylalanine (e.g., "Persons with phenylketonuria: contains phenylalanine"; "Aspartame contains phenylalanine")
• If the food does not contain aspartame, the statement is not required.
• If you've included a heading or section for this information in your document and the statement is not required, we recommend stating 'N/A' in the document.

7. Nutritional information [7(b)(viii) and 7(b)(ix)(A) to (C) of Part 1 of the Order]

Instructions:

• Include the following, expressed in standardized units of measure per the stated quantity of food set out in the directions of use:
  • energy value;
  • quantity of protein, fat, carbohydrate, and, if present, fibre;
  • quantity of vitamins, mineral nutrients, and amino acids; and
  • for IF and HMF specifically, any other nutritive substances in the food.
• We recommend you present the nutrition information in a table format with the standardized units of measure clearly displayed. The following units of measure are recommended: Calories (Cal) for energy value, International Units (IU), grams (g), milligrams (mg) or micrograms (µg) for the nutrients.

8. Directions for preparation, use, and storage [7(b)(x) of Part 1 of the Order]

Instructions:

• Include clear and complete directions for the preparation, use and safe storage of the food.
• We encourage the use of bullet points or numbered steps.
• Diagrams or pictograms are also encouraged to support understanding.
• For IF and HMF: refer to Sections 4.12 and 4.13 of the Guide for the preparation of infant formula and human milk fortifier premarket submissions for guidance on how to present appropriate directions for use.
• FSDP category specific requirements:
  • For HMF: include a statement indicating that it is to be used only under medical supervision [7(b)(i) of Part 1 of the Order].
  • For FLD: include a statement that it is intended for oral or tube feeding [7(b)(ii) of Part 1 of the Order].

9. Expiration Date [7(b)(xi) of Part 1 of the Order]

Instructions:

• Include the expiration date or indicate where it appears on the food's label and its format (e.g., "Expiration date: See bottom of container: DD-MM-YYYY").

10. Lot Number [7(b)(xii) of Part 1 of the Order]

Instructions:

• Include the lot number or indicate where it appears on the food's label (e.g., "Lot number: See bottom of container").

Format of the document

Health Canada has developed a standardized template for the core labelling information document. Use of this template is strongly encouraged.

If you choose not to use this template, the document should be designed to help purchasers and consumers easily locate and understand the information needed to use the food safely.

If you are preparing this document, ensure it:

• is clearly formatted and easy to read.
• uses bolded section headings.
• maintains a consistent font style and size throughout (recommended use: sans serif fonts such as Arial, Aptos, or Helvetica, minimum 8 points).

Condition 4: Providing a copy of the document to the Minister

Who this applies to:

• Importers of foreign-manufactured HMF, IF, or FLD for exceptional sale in Canada.
• Domestic manufacturers of HMF, IF, or FLD for exceptional sale in Canada.

What you must do:

• Provide a copy of the core labelling information document to Health Canada prior to the first sale of the food in Canada. As noted under condition 3, you are not required to seek Health Canada's approval of the document.

How to submit the document to Health Canada:

• Send an email to bns-bsn@hc-sc.gc.ca with the subject line: "Core info document."

What to include in the notification:

• A copy of the core labelling information document.

  Note: You are only required to submit the document before the first sale of the food in Canada. You do not need to resubmit this document for subsequent sales unless the document has been revised.

If anything changes:

• If the document is revised, you must submit the revised version to Health Canada prior to first sale of the food to which the revised document applies.

Condition 5: Providing a copy of the document to purchasers and consumers

Who this applies to:

• Importers of foreign-manufactured HMF, IF, or FLD for exceptional sale in Canada.
• Domestic manufacturers of HMF, IF, or FLD for exceptional sale in Canada.
• Canadian distributors and retailers.

What you must do:

• Any person who sells a food pursuant to Part 1 of the Order must ensure that a paper copy of the core labelling information document (if required) is made available to the purchaser or consumer at the time of sale.

This requirement applies throughout the distribution chain:

• Importers and manufacturers must provide paper copies of the document (at least one per unit to be sold) with shipments to consumers (in the case of direct sales) or to Canadian distributors and retailers.
• Distributors and retailers must then ensure that the paper copy document is provided to the end consumer (i.e., the person using or administering the food, such as a parent, caregiver or health professional).

Making the document available to purchasers and consumers:

Health Canada's primary objective is to ensure that the end consumer receives a paper copy of the document. Acceptable methods of distribution include:

• The document accompanies the food.
  • example: the document is attached or tagged to the food's container.
• The document is provided to the purchaser or consumer at the time of sale.
  • example: a paper copy is provided by the pharmacist or health care provider to the purchaser or consumer.
• For foods sold in open self-selection areas, paper copies are placed adjacent to the food in a way that allows the purchaser or consumer to take one.
  • example: paper copies are made available on the shelf or in a nearby display case.

Condition 6: Notification of a risk to health

Who this applies to:

• Importers of foreign-manufactured HMF, IF, or FLD for exceptional sale in Canada.
• Domestic manufacturers of HMF, IF, or FLD for exceptional sale in Canada.

What you must do:

• Immediately notify Health Canada of any information you receive or become aware of concerning any risk to human health relating to a food that is being exceptionally imported and/or sold pursuant to the Order.

How to notify Health Canada:

• Send an email to bns-bsn@hc-sc.gc.ca with the subject line: "Health risk."

What to include in the notification:

• Refer to the Canadian Food Inspection Agency's (CFIA) notification and recall contact list for details on the type of information that should be provided in your notification.

What happens next:

• Upon receipt of the notification, Health Canada will inform the CFIA and work with them to assess the health risk and determine any resulting compliance and enforcement action.

Condition 7: Notification of a change in foreign regulatory status

Who this applies to:

• Importers of foreign-manufactured HMF, IF, or FLD for exceptional sale in Canada.
• Domestic manufacturers of HMF, IF, or FLD for exceptional sale in Canada.

What you must do:

• Immediately notify Health Canada of a change in the regulatory status of a product that is being exceptionally imported and/or sold pursuant to the Order, i.e., if the product is no longer permitted by the FRA indicated in column 2 of the List for sale within the corresponding jurisdiction set out in Column 3.

How to notify Health Canada:

• Send an email to bns-bsn@hc-sc.gc.ca with the subject line: "FRA Status."

What to include in the notification:

• information about the food(s) in question.
• a description of the nature of the change in regulatory status.
• the date on which the change in status occurred.

Health Canada may follow up with additional questions to better understand the situation.

Important: To remain eligible for exceptional importation and/or sale under Part 1 of the Order, a food must be authorized for sale at all times by the FRA set out in Column 2 of the List, within the corresponding jurisdiction set out in Column 3.

If a food loses its authorization for sale, it will no longer be eligible for exceptional importation and/or sale in Canada.

Condition 8: Sale and distribution of human milk fortifiers

Who this applies to:

• Importers of foreign-manufactured HMF for exceptional sale in Canada.
• Domestic manufacturers of HMF for exceptional sale in Canada.
• Canadian distributors and retailers.

What you must do:

HMF remain subject to the sale and distribution restrictions set out in B.25.019 of the FDR. Per these restrictions, HMF may only be sold through the following channels:

• from a manufacturer to a hospital;
• from a manufacturer to the general public, if:
  • the purchaser has a written order from a physician, nurse practitioner or dietitian, and
  • the manufacturer receives a written request from a hospital
• From a hospital to the general public, if:
  • the purchaser has a written order from a physician, nurse practitioner or dietitian.

Part 2 of the Order – Transition Strategy products

Scope

Part 2 of the Order applies exclusively to the closed list of IF and HMF participating in Health Canada's Transition Strategy^{Footnote 8}. It establishes the framework that permits the exceptional importation and sale of Transition Strategy products while Health Canada completes its evaluation of the premarket submissions for these foods.

Inclusions

Part 2 of the Order applies exclusively to IF and HMF that meet all of the following criteria:

1. Authorized for sale by a foreign regulatory authority (FRA) in the United States, United Kingdom, European Union, or Australia and directly imported for sale from the FRA's jurisdiction.
2. Included in Health Canada's Transition Strategy, meaning that the manufacturer:
   1. submitted a letter of intent by January 17, 2024, and
   2. filed a premarket submission by July 15, 2024.
3. Pending a final decision from Health Canada respecting the premarket submission.

A complete list of the Transition Strategy products is available in the List of Transition Strategy Products.

Exclusions

Part 2 of the Order does not apply to the following:

• Foods that are not part of Health Canada's Transition Strategy.
• Foods that were part of Health Canada's Transition Strategy for which Health Canada has issued a final decision in response to the premarket submission (whether favourable or unfavourable).

Exceptional importation and/or sale of Transition Strategy products

Part 2 of the Order establishes the framework that permits the exceptional importation and sale of the Transition Strategy products while their premarket submissions are under review.

Once Health Canada issues a final decision in response to a premarket submission, the product ceases to be a 'Transition Strategy product' and is no longer within the scope of Part 2 of the Order.

If the decision is favourable, the compliant product may be legally sold in Canada. If the decision is unfavourable, the product cannot be legally sold in Canada. In the case of an unfavourable decision, a new submission that addresses the reasons for the unfavourable decision may be filed. However, it will be treated as a new application and the product will not be eligible under Part 2 of the Order.

Exemptions under Part 2 of the Order

Transition Strategy products exceptionally imported and sold in Canada pursuant to Part 2 of the Order are exempt from specific labelling, compositional and premarket provisions of the FDA and FDR. These targeted exemptions are intended to enable continued access to Transition Strategy products while Health Canada completes its review of the premarket submissions.

The exemptions under Part 2, for the most part, mirror those provided under Part 1. However, because Part 2 of the Order concerns itself with the closed list of Transition Strategy products for which Health Canada has access to labels and composition, certain exemptions were either not required or are more targeted in nature.

These exemptions are as follows:

FDA prohibitions

• Prohibitions under 4(1)(a) and (d) on the sale of food containing poisonous or harmful substances, or food considered adulterated due to the presence of food additives, vitamins, mineral, amino acids or nutritive materials [Subparagraphs 14(a)(i) to (iii) of Part 2 of the Order].

FDR labelling and advertising requirements

• Formatting specifications for lot numbers under A.01.014 [Subparagraph 14(b)(i) of Part 2 of the Order].
• Formatting of titles preceding the list of ingredients under B.01.008.2(1)(a) and (b) [Subparagraph 14(b)(ii) of Part 2 of the Order].
• Formatting of the ingredients set out in the list of ingredients under B.01.008.2(3)(b) [Subparagraph 14(b)(iii) of Part 2 of the Order].
• Formatting of allergen/gluten/sulphite statements under B.01.010.3(1)(a)(i) and (ii) [Subparagraph 14(b)(iv) of Part 2 of the Order].
• Bilingual "may contain" statements under B.01.010.4(1)(b) [Subparagraph 14(b)(v) of Part 2 of the Order].
• Requirement for all mandatory label information to appear in both official languages under B.01.012(2) [Subparagraph 14(b)(vi) of Part 2 of the Order].
• Bilingual health claims under B.01.311(5) [Subparagraph 14(b)(vii) of Part 2 of the Order].
• Bilingual nutrient content claims under B.01.501 [Subparagraph 14(b)(viii) of Part 2 of the Order].
• Prohibition on nutrient content claims for HMF under B.01.503(2.01) [Subparagraph 14(b)(ix) of Part 2 of the Order].

FDR compositional requirements

• Specifications for food additives under B.16.011 [Subparagraph 14(b)(x) of Part 2 of the Order].
• Quantitative declaration for polydextrose under B.16.017 [Subparagraph 14(b)(xi) of Part 2 of the Order].
• Prescribed nutrient levels, including:
  • minimum/maximum levels for added vitamins under D.01.010–D.01.011
  • minimum levels for added minerals under D.02.009(1)
  • limits on added vitamins, minerals, and amino acids in IF and HMF under D.03.002 [Subparagraphs 14(b)(xvii) to (xix) of Part 2 of the Order].
• Compositional requirements for IF under B.25.054 [Subparagraph 14(b)(xv) of Part 2 of the Order].

FDR premarket authorization and notification requirements

• Notification requirements for novel foods, including novel ingredients under B.28.002 [Subparagraph 14(b)(xvi) of Part 2 of the Order].
• Authorization and notification requirements for HMF and IF, including:
  • HMF authorization under B.25.010
  • IF notification under B.25.046(1)
  • IF compliance with the requirements of Division 25 under B.25.051[Subparagraphs 14(b)(xii) to (xiv) of Part 2 of the Order].

Important Note: Other FDA and FDR provisions still apply

Importers of Transition Strategy products should note that all other applicable FDA and FDR provisions continue to apply. These include, but are not limited to:

• maximum levels for contaminants and other adulterating substances in food set out in Division 15, Part B of the FDR.
• requirements for food packaging materials set out in Division 23, Part B of the FDR.
• microbiological criteria for foods set out in Division 30, Part B of the FDR.

Important Note: food licensing requirements

All importers of FSDP must hold a valid Safe Food for Canadians licence to import products. This requirement applies to FSDP exceptionally imported and sold under Part 2 of the Order. Importers must also comply with all applicable provisions of the Safe Food for Canadians Act (SFCA) and Safe Food for Canadians Regulations (SFCR).

Requirements (Conditions) under Part 2 of the Order

Importers, distributors and retailers involved in the exceptional importation and sale of Transition Strategy products are subject to the conditions set out in sections 15 to 19 of Part 2 of the Order.

Condition 1: Preparing a supplementary label document (if both official languages are not on the label)

Who this applies to:

• Importers of Transition Strategy products for exceptional sale in Canada.

What you must do:

• Most Transition Strategy products are currently being sold in Canada with bilingual labels. In cases where a product label is not bilingual, the importer must prepare a supplementary label document that provides the same information as found on the product label, in the absent official language. For example, if the product label is in English only, a document with the label information in French must be prepared.

  Note: You are not required to seek Health Canada's review and approval of the document.

Format of the document

• Health Canada has not developed a standardized template for this purpose. However, it should be designed to help purchasers and consumers easily locate and understand the information needed to use the product safely.

  Ensure the document:

  • is clearly formatted and easy to read.
  • uses bold section headings.
  • maintains a consistent font style and size throughout (recommended use: sans serif fonts such as Arial, Aptos, or Helvetica, minimum 8 points).

Condition 2: Providing a copy of the document to purchasers and consumers

Who this applies to:

• Importers of Transition Strategy products for exceptional sale in Canada.
• Distributors and retailers of Transition Strategy products.

What you must do:

• Any person who sells a food pursuant to Part 2 of the Order must ensure that a paper copy of the supplementary label document, if one is required, is made available to the purchaser or consumer at the time of sale.

This requirement applies throughout the distribution chain:

• Importers must provide paper copies of the document (at least one per unit) with shipments to consumers (in the case of direct sales) or to Canadian distributors and retailers.
• Distributors and retailers must then ensure that the paper copy document is provided to the end consumer (i.e., the person using or administering the food, such as a parent, caregiver, or health professional).

Making the document available to purchasers and consumers:

Health Canada's primary objective is to ensure that the end consumer receives a paper copy of the document. Acceptable methods of distribution include:

• The document accompanies the food.
  • example: the document is attached or tagged to the food's container.
• The document is provided to the purchaser or consumer at the time of sale.
  • example: a paper copy is provided by the pharmacist or health care provider to the purchaser or consumer.
• For foods sold in open self-selection areas, paper copies are placed adjacent to the food in a way that allows the purchaser or consumer to take one.
  • example: paper copies are made available on the shelf or in a nearby display case.

Condition 3: Notification of a risk to health

Who this applies to:

• Importers of Transition Strategy products for exceptional sale in Canada.

What you must do:

• Immediately notify Health Canada of any information you receive or become aware of concerning any risk to human health relating to a Transition Strategy product that is being exceptionally imported and sold pursuant to the Order.

How to notify Health Canada:

• Send an email to bns-bsn@hc-sc.gc.ca with the subject line: "Health risk."

What to include in the notification:

• Refer to the Canadian Food Inspection Agency's (CFIA) notification and recall contact list for details on the type of information that should be provided in your notification.

What happens next:

• Upon receipt of the notification, Health Canada will inform the CFIA and work with them to assess the health risk and determine any resulting compliance and enforcement action.

Condition 4: Notification of a change in foreign regulatory status

Who this applies to:

• Importers of Transition Strategy products for exceptional sale in Canada.

What you must do:

• Immediately notify Health Canada of a change in the regulatory status a Transition Strategy product that is being exceptionally imported and sold pursuant to the Order, i.e., if the product is no longer permitted by the FRA indicated in column 2 of the List for sale within the corresponding jurisdiction set out in Column 3.

How to notify Health Canada:

• Send an email to bns-bsn@hc-sc.gc.ca with the subject line: "FRA Status."

What to include in the notification:

• information about the Transition Strategy product(s) in question.
• a description of the nature of the change in regulatory status.
• the date on which the change in status occurred.

Health Canada may follow up with additional questions to better understand the situation.

Important: To remain eligible for exceptional importation and sale under the Order, a Transition Strategy product must remain authorized for sale at all times by the FRA in the corresponding jurisdiction from which it is being exceptionally imported for sale.

If a food loses its authorization for sale, it will no longer be eligible for exceptional importation and sale in Canada.

Condition 5: Sale and distribution of human milk fortifiers

Who this applies to:

• Importers of HMF Transition Strategy products for exceptional sale in Canada.
• Distributors and retailers of HMF Transition Strategy products for exceptional sale in Canada.

What you must do:

HMF Transition Strategy products remain subject to the sale and distribution restrictions set out in B.25.019 of the FDR. Per these restrictions, HMF may only be sold through the following channels:

• from a manufacturer to a hospital;
• from a manufacturer to the general public, if:
  • the purchaser has a written order from a physician, nurse practitioner or registered dietitian, and
  • the manufacturer receives a written request from a hospital
• From a hospital to the general public, if:
  • the purchaser has a written order from a physician, nurse practitioner or registered dietitian.

Contact us

For questions about FSDP shortages, including the Order and this guidance document, please email us at: bns-bsn@hc-sc.gc.ca.

References and related links

Legislation, regulations and documents incorporated by reference

• Exemption Order in Respect of Foods for a Special Dietary Purpose
  • List of Human Milk Fortifiers, Infant Formulas and Formulated Liquid Diets for Exceptional Importation and Sale in the Case of a Shortage or Risk of Shortage
• Food and Drugs Act
• Food and Drug Regulations

Policies and guides

• List of Transition Strategy Products
• Interim policy on the importation and sale of infant formulas, human milk fortifiers and dietary products for the treatment of inborn errors of metabolism to mitigate shortages [ARCHIVED]
• Transition strategy to prepare for the expiration of Health Canada's interim policy to mitigate infant formula shortages [ARCHIVED]
• Interim policy statement on foods for special dietary use for inherited metabolic disorders

Templates

• Information Document (Standardized Template)