Documents incorporated by reference into food regulations

The following page provides information on documents that have been incorporated by reference into food regulations, as well as the process by which Health Canada's Food and Nutrition Directorate manages modifications to such documents.

On this page:

• Health Canada's incorporation by reference policy
• Incorporating by reference documents into food regulations
• How incorporated documents are modified
• Health Canada documents currently incorporated by reference into food regulations
• Related information

Health Canada's Incorporation by Reference Policy

Incorporation by reference is a term used to describe a mechanism, which allows a document or list that is not in the text of the regulations to be made a part of the regulations. Health Canada uses incorporation by reference to achieve policy and regulatory objectives.

The Health Canada Incorporation by Reference Policy sets out the Department's framework for the identification, development and management of documents incorporated by reference into the regulations that Health Canada administers. Its aim is to ensure the responsible, transparent and consistent use of incorporation by reference by Health Canada, including the Food and Nutrition Directorate.

Incorporating by reference documents into food regulations

Chapter 4 of the Health Canada Incorporation by Reference Policy describes the legislative authorities that enable the government to incorporate by reference documents into federal regulations.

With respect to food, sections 30.5 and 30.6 of the Food and Drugs Act provide the explicit authority to the Governor in Council or Minister of Health to incorporate by reference any document into the Food and Drug Regulations or a Marketing Authorization.

This may include documents generated and managed by Health Canada, other government agencies and departments, or third parties. The incorporation may be 'static', for example, incorporating by reference a specific version of a document as it exists on a particular date, or it may be 'ambulatory', such as, incorporating by reference a document that will be amended from time to time.

How incorporated documents are modified

Documents incorporated by reference into food regulations may need to be revised from time to time, for instance, in response to a pre-market submission from an industry stakeholder or to address new science or an emerging health risk.

Chapter 8 of the Health Canada Incorporation by Reference Policy establishes the principles and practices that must be followed when modifying documents that have been incorporated by reference into regulations. The principles and procedures detailed in the sections below align with that policy.

Modifying third party documents

Modifications to a third party document that has been incorporated by reference into food regulations are managed by the third party author of the document. For example, if the Minister of Health were to incorporate by reference an international Codex Alimentarius standard into food regulations, subsequent changes to that standard would be made by the Codex Alimentarius Commission.

Chapter 8.1 of the Health Canada Incorporation by Reference Policy provides information on Health Canada's involvement in managing consultations and revisions to third party documents.

Modifying Health Canada documents

Ambulatory documents

Modifications to a Health Canada document that has been incorporated by reference into food regulations on an ambulatory basis (such as the Lists of Permitted Food Additives) are managed administratively by Health Canada's Food and Nutrition Directorate. No regulatory amendments are required as it is understood that ambulatory documents change from time to time.

Modifications to an incorporated by reference document are proposed following a thorough scientific safety assessment by the Food and Nutrition Directorate. Upon completion of the assessment and internal review and approval, stakeholders are informed of the proposed modifications by means of a Notice of Proposal published on Health Canada's Notices of Proposal and Notices of Modification webpage. Interested stakeholders are provided a 60-75 day period from the day on which the notice is published to provide comments.

At the close of the comment period, all feedback received is taken into consideration. If no new evidence is provided that would demonstrate the need for significant revisions to the proposal, the Food and Nutrition Directorate will then proceed with formally modifying the incorporated by reference document. Stakeholders are informed by means of a Notice of Modification also published on Health Canada's Notices of Proposal and Notices of Modification webpage. The notice will specify the modifications made to the document and the date on which they come into effect (usually the day on which the notice is published).

Health Canada notifies international stakeholders of proposed and final modifications to a document via the World Trade Organization.

Static documents

In the case of a document incorporated by reference on a 'static' basis, a regulatory amendment is always required to change the reference found in the regulations. In such cases, Health Canada follows the regulatory amendment process to incorporate the "new" reference.

Health Canada documents currently incorporated by reference into food regulations

Below is a list of Health Canada documents that have been incorporated by reference into food regulations since 2012. This list does not include documents incorporated by reference prior to 2012, Canadian Food Inspection Agency documents, or third party documents, such as the Food Chemicals Codex, that are also incorporated by reference into food regulations.

A complete inventory of all documents incorporated by reference into regulations administered by Health Canada, including those listed below, is available in the Health Canada's incorporation by reference inventory.

Food additives

• Lists of Permitted Food Additives
• Table of Food Additive Specifications

Contaminants

• List of Contaminants and Other Adulterating Substances in Foods

Nutrition labelling

• Directory of Nutrition Facts Table Formats
• Table of Daily Values
• Table of Reference Amounts for Food
• Directory of Nutrition Symbol Specifications
• Table of Permitted Nutrient Content Statements and Claims

Supplemented foods

• Directory of Supplemented Food Caution Identifier Specifications
• Directory of Supplemented Food Facts Table Formats
• List of Permitted Supplemented Food Categories
• List of Permitted Supplemental Ingredients
• Lists of Temporary Marketing Authorization Letters (TMAL Lists)
• Threshold Levels for Cautionary Statements and Other Conditions of Use

Microbiological criteria and associated microbiological methods

• Table of Microbiological Criteria for Food
• Table of Microbiological Reference Methods for Food
• Canadian Requirements for Determining the Equivalence of Food Microbiological Methods of Analysis

Other

• Table of Chemical, Physical and Nutritional Characteristics of Food
• Determination of the Protein Rating Using the Protein Digestibility Corrected Amino Acid Score
• List of Human Milk Fortifiers Sold in Canada

Related information

• Food and nutrition legislation and guidelines