Incorporation by Reference

"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.

Pursuant to sections 30.5 and 30.6 of the Food and Drugs Act, the Minister of Health or Governor in Council may, with respect to retail foods, incorporate any document by reference into the Food and Drug Regulations or a Marketing Authorization (MA). This includes documents generated and managed by Health Canada, other government agencies and departments, or third parties.

The incorporation may be "static" (e.g. incorporating a specific version of a document at a defined date, for instance, Method MFO-15 - November 30, 1981) or may be "ambulatory" (e.g. incorporating a document that will be amended from time to time, for instance, the List of Permitted Anticaking Agents).

Documents incorporated by reference have the force of law.

On this page:

• How are Documents Incorporated by Reference?
• How are Incorporated Documents Modified?
• Documents Currently Incorporated by Reference

Related Information

• Question and Answers - Incorporation by Reference
• Marketing Authorizations

How are Documents Incorporated by Reference?

A document may be incorporated by reference pursuant to a Governor in Council (GIC) Regulation (i.e. incorporated into the Food and Drug Regulations) or a Ministerial Regulation ("Marketing Authorization" or "MA"). As with any regulatory proposal, the Department of Justice will first review the proposal to ensure that the proposed document is appropriate for incorporation by reference. Additionally, the public and stakeholders will be notified of the proposal and given the opportunity to share their comments or concerns. In the case of a GIC Regulation, notification and consultation would occur via the Canada Gazette process. For MAs, the notification/consultation process would be managed by Health Canada via its website.

How are Incorporated Documents Modified?

From time to time, incorporated documents may need to be revised, for instance, in response to a pre-market submission from an industry stakeholder, new science or an emerging health risk.

Changes to third party documents that have been incorporated by reference are managed by the authors of the document. For example, if the Minister of Health decides to incorporate an international  Codex Alimentarius standard into an MA, subsequent changes to that standard will be made by the Codex Alimentarius Commission. As such, it is imperative that the process behind the maintenance of 3rd party documents receive close scrutiny prior to the incorporation of these documents. A number of principles and factors will be taken into careful consideration when determining whether or not to incorporate by reference a 3rd party document. These include, but are not limited to: the scientific rigour with which the 3rd party document was developed; the relevance of the 3rd party document to the Canadian context; how often the document may be revised; the process by which the document is revised; the extent of Health Canada's participation and involvement in revisions to the document.

Regarding Health Canada documents that have been incorporated by reference (such as the Lists of Permitted Food Additives), subsequent changes to such documents are managed administratively by Health Canada. Modifications will only be made following a thorough scientific safety assessment. Domestic and international stakeholders will be notified of all modifications to incorporated documents and provided with an opportunity to comment.

In the case of "static" incorporated documents, a regulatory amendment would be required to change the entry found in the regulations. For "ambulatory" incorporated documents, no regulatory amendment is required as it is understood that the incorporated document changes from time to time.

Documents Currently Incorporated by Reference

Health Canada has incorporated the following documents by reference into food regulation:

• Lists of Permitted Food Additives (incorporated into Market Authorizations)