The power to make Marketing Authorizations (MA) is an authority provided to the Minister of Health pursuant to sections 30.2 to 30.4 of the Food and Drugs Act. MAs are ministerial regulations which enable the Minister to implement certain food safety decisions by exempting from prohibitions found in either the Food and Drugs Act or the Food and Drug Regulations. Additionally, MAs can be used to define classes, set conditions and incorporate documents by reference.
As regulations, MAs have the force of law and are enforceable as are any documents that are incorporated by reference into the MAs.
Scope and Limitations
The MA authority is a regulatory tool that the Minister of Health may choose to use to implement certain food decisions. Food industry stakeholders may put forward a submission to change some aspect of food regulation, which in turn may result in the amendment of an existing MA or the creation of a new MA.
MAs cannot be used to establish new prohibitions at the level of the Act or Regulations. They can only exempt specifically from paragraphs 4(1)(a), 4(1)(d), sections 6, 6.1 of the Food and Drugs Act and/or any other provision of the Food and Drug Regulations. Furthermore, MAs are rules of general application, meaning that they apply to the entire food industry, as opposed to a single individual or company.
Even though they refer to sections of the Food and Drug Regulations, MAs are not part of or housed under the Food and Drug Regulations. They are their own separate regulations made under the Food and Drugs Act. Links to the current food MAs are available in the Table of Food Marketing Authorizations
The Marketing Authorization Process
As regulations, MAs are subject to the requirements of the Statutory Instruments Act (SIA) and the Cabinet Directive on Regulatory Management (CDRM). When creating a new MA or amending an existing MA, Health Canada must follow a formal regulatory process which includes review of the proposed MA by Justice Canada, public consultations on the proposed MA and final publication of the MA in the Canada Gazette, Part II.
Since MAs are ministerial regulations, the entire regulatory development process, including review of the proposal against the CDRM, is managed by Health Canada (as opposed to the Treasury Board Secretariat), providing greater control over prioritization, approval timelines, consultation management and regulatory drafting. Additionally, final decisions are subject to Ministerial approval (as opposed to the Governor in Council).
Consultations on Food Marketing Authorizations
Consultations pertaining to Food Marketing Authorizations are available under the Food and Nutrition "Public engagement and partnerships" page of the Health Canada website.
Interim Marketing Authorizations
In July 1997, the Food and Drug Regulations were amended to give the authority to the Assistant Deputy Minister of the Health Products and Food Branch, Health Canada to issue Notices of Interim Marketing Authorization (IMA). The purpose of the IMA was to provide a mechanism to bridge the time between the completion of the scientific evaluation of certain enabling amendments and publication of the approved amendments in the Canada Gazette, Part II.
Between 1997 and 2012, 60 IMAs pertaining to food additives or to vitamin and mineral fortification of foods were issued. These IMAs were published in the Canada Gazette, Part I, and are accessible in the Archives of the Canada Gazette website.
On October 25, 2012, Health Canada's authority to issue IMAs was replaced in the Food and Drugs Act with the Marketing Authorization (MA) authority. IMAs issued prior to this date remained in effect until: a) the IMA was cancelled, b) the IMA was adopted into regulation, or c) two years after the day on which the IMA came into effect.
Although the majority of the 60 IMAs issued by Health Canada have been adopted into regulation, ten of these which relate to the fortification of certain food categories have yet to be adopted into regulation and have long expired.
Health Canada's intent is to adopt these ten expired IMAs into regulation. However, until these regulatory amendments are made, Health Canada, in consultation with the Canadian Food Inspection Agency (CFIA), has developed an Interim Policy on the use of expired IMAs related to food fortification.
Temporary Marketing Authorizations
The MA authority does not change Health Canada's ability to issue Temporary Marketing Authorization Letters (TMAL) where appropriate. Further information on TMALs is available in the document General Guidance Document for Temporary Marketing Authorization for Foods.
Table of Food Marketing Authorizations
The table below provides links to Health Canada's current food-related MAs and any documents that are incorporated by reference into each MA.
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