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.
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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, documents incorporated by reference 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.
Modifying Third Party Documents
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 regulations, 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, and the extent of Health Canada's participation and involvement in revisions to the document.
Modifying Health Canada Documents
Changes to Health Canada documents that have been incorporated by reference on an ambulatory basis into food regulations (such as the Lists of Permitted Food Additives or the List of Contaminants and Other Adulterating Substances in Foods) are managed administratively by Health Canada's Food Directorate. No regulatory amendments are required as it is understood that ambulatory incorporated documents change from time to time.
Modifications are only proposed following a thorough scientific safety assessment. Upon completion of the assessment and internal review and approval, domestic and international stakeholders are notified of the proposed modifications by means of a Notice of Proposal (NOP) published on Health Canada's website. Interested stakeholders are provided a 60-75 day period from the day on which the NOP is posted to provide comments.
At the close of the comment period, all feedback received is taken into consideration. If no new scientific information is provided that would require revisions to the proposal, the Food Directorate will then proceed with formally modifying the incorporated document. Notification is provided by means of a Notice of Modification (NOM) posted on Health Canada's website. The NOM will specify the changes made and the date on which they come into effect (usually the day on which the NOM is published).
In the case of "static" incorporated documents, a regulatory amendment would be required to change the entry found in the regulations.
Health Canada Documents Currently Incorporated by Reference into Food Regulations
Note: This is not an exhaustive list of all documents incorporated by reference into food regulations. In addition to the Health Canada-generated documents listed below, other third party documents, such as the Food Chemicals Codex, are also incorporated by reference into the Food and Drug Regulations.
- Lists of Permitted Food Additives (incorporated by reference into the Marketing Authorizations for Food Additives)
- List of Maximum Residue Limits (MRLs) for Veterinary Drugs in Foods (incorporated by reference into the Marketing Authorization for Maximum Residue Limits for Veterinary Drugs in Foods)
- List of Contaminants and Other Adulterating Substances in Foods (incorporated by reference into the Food and Drug Regulations)
- Nutrition Labelling - Directory of Nutrition Facts Table Labelling Formats (incorporated by reference into the Food and Drug Regulations)
- Nutrition Labelling - Table of Daily Values (incorporated by reference into the Food and Drug Regulations)
- Nutrition Labelling - Table of Reference Amounts for Food (incorporated by reference into the Food and Drug Regulations)
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