Marketing Authorization Amending Certain Marketing Authorizations Issued Under the Food and Drugs Act (Food Enzymes and Preservatives): SOR/2021-176
Canada Gazette, Part II, Volume 155, Number 16
Registration
SOR/2021-176 July 20, 2021
FOOD AND DRUGS ACT
The Minister of Health, pursuant to subsection 30.3(1) footnote a and section 30.5 footnote b of the Food and Drugs Act footnote c, issues the annexed Marketing Authorization Amending Certain Marketing Authorizations Issued Under the Food and Drugs Act (Food Enzymes and Preservatives).
Ottawa, July 19, 2021
Patricia Hajdu
Minister of Health
Marketing Authorization Amending Certain Marketing Authorizations Issued Under the Food and Drugs Act (Food Enzymes and Preservatives)
Marketing Authorization for Food Additives That May Be Used as Food Enzymes
1 (1) The definition infant formula in subsection 1(1) of the Marketing Authorization for Food Additives That May Be Used as Food Enzymes footnote 1 is repealed.
(2) Subsection 1(1) of the Marketing Authorization is amended by adding the following in alphabetical order:
- infant food
- has the same meaning as in section B.25.001 of the Food and Drug Regulations. (aliment pour bébés)
2 (1) Subsection 2(1) of the Marketing Authorization is replaced by the following:
Food — general
2 (1) When a food enzyme that is set out in column 1 of the List and that is obtained from a source that is set out in column 2 is added to a food, other than an infant food, that is set out in column 3, the food is exempt from the application of paragraphs 4(1)(a) and (d) and sections 6 and 6.1 of the Food and Drugs Act and sections B.01.042, B.01.043 and B.16.007, as applicable, of the Food and Drug Regulations, in respect of the use or presence of the enzyme only, if the amount of the enzyme does not exceed the maximum level of use for that food that is set out in column 4 and if any other condition that is set out in that column is met.
Infant food
(1.1) When a food enzyme that is set out in column 1 of the List and that is obtained from a source that is set out in column 2 is added to an infant food that is set out in column 3, the infant food is exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act and sections B.01.043 and B.16.007 and subsection B.25.062(1), as applicable, of the Food and Drug Regulations, in respect of the use or presence of the enzyme only, if the amount of the enzyme does not exceed the maximum level of use for that infant food that is set out in column 4 and if any other condition that is set out in that column is met.
(2) Subsections 2(3) and (4) of the Marketing Authorization are repealed.
Marketing Authorization for Food Additives That May Be Used as Preservatives
3 Subsection 1(1) of the Marketing Authorization for Food Additives That May Be Used as Preservatives footnote 2 is amended by adding the following in alphabetical order:
- infant food
- has the same meaning as in section B.25.001 of the Food and Drug Regulations. (aliment pour bébés)
4 Subsection 2(1) of the Marketing Authorization is replaced by the following:
Food — general
2 (1) When a preservative that is set out in column 1 of the List is added to a food, other than an infant food, that is set out in column 2, the food is exempt from the application of paragraphs 4(1)(a) and (d) and sections 6 and 6.1 of the Food and Drugs Act and sections B.01.042, B.01.043 and B.16.007 and paragraph B.21.005(b), as applicable, of the Food and Drug Regulations, in respect of the use or presence of the preservative only, if the amount of the preservative does not exceed the maximum level of use for that food that is set out in column 3 and if any other condition that is set out in that column is met.
Infant food
(1.1) When a preservative that is set out in column 1 of the List is added to an infant food that is set out in column 2, the infant food is exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act and sections B.01.043 and B.16.007 and subsection B.25.062(1), as applicable, of the Food and Drug Regulations, in respect of the use or presence of the preservative only, if the amount of the preservative does not exceed the maximum level of use for that infant food that is set out in column 3 and if any other condition that is set out in that column is met.
Coming into Force
5 This Marketing Authorization comes into force on the day on which it is published in the Canada Gazette, Part II.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Marketing Authorization.)
Issues
Health Canada has implemented a regulatory framework for the sale of human milk fortifiers (HMFs) in Canada. To support this framework, the Department is amending two Marketing Authorizations (MAs) [i.e. the Marketing Authorization for Food Additives That May Be Used as Food Enzymes and the Marketing Authorization for Food Additives That May Be Used as Preservatives] so that Health Canada can more efficiently permit the safe use of certain food additives in HMFs and other infant foods through its administrative process.
Background
HMFs are infant foods which are intended to be added to human milk (i.e. breast milk) to increase its nutritional value and provide necessary nutrients for infants who are born prematurely or for other infants, as medically required (e.g. small for gestational age, high protein needs). Food additives are used in some HMFs and other infant foods to perform certain technical functions.
In Canada, food additives are regulated by both the Food and Drug Regulations (FDR) and MAs issued by the Minister of Health under subsection 30.3(1) of the Food and Drugs Act (FDA). The FDA and FDR prohibit the sale of foods containing food additives, whereas the MAs exempt from these prohibitions for uses of food additives that are shown on Health Canada’s Lists of Permitted Food Additives (the Lists). The Lists are incorporated by reference on an ambulatory basis into the MAs. In addition, the Lists set out which food additives are permitted in Canada, the foods they can be used in, the maximum level of use for those foods, and other conditions of use.
Health Canada maintains the Lists on the Government of Canada’s website. Each MA and its corresponding List relate to one or more classes of food additives (e.g. food enzymes, preservatives), with the exception of one MA and its corresponding List that relate to various purposes of use. By setting out exemptions from certain sections of the FDA and FDR, the MAs allow foods containing food additives that are set out in the Lists to be sold in Canada, provided all applicable requirements are met. Before new food additives or new food additive uses are added on the Lists, they are reviewed by Health Canada for safety. Health Canada notifies the public about all changes to the Lists.
In most cases, Health Canada can permit a safe new food additive use by adding it to the relevant List through an administrative process if the corresponding MA includes the necessary exemptions. If an MA does not include an exemption from the relevant prohibition(s), amendments to one or more MAs are necessary before the associated List(s) can be modified to permit the safe new use of the food additive in the food.
The Marketing Authorization for Food Additives That May Be Used as Food Enzymes and the Marketing Authorization for Food Additives That May Be Used as Preservatives did not provide the exemptions needed to permit food enzymes and preservatives in HMFs, or other infant foods, through the administrative process. Accordingly, as part of the implementation of a regulatory framework for HMFs, the Minister is amending these two MAs to permit certain new, safe uses of these types of food additives in HMFs and other infant foods in the future.
These MA amendments alone will not have the effect of permitting new uses of these food additives in HMFs or other infant foods until the corresponding food additive Lists are amended accordingly. New requested uses would be permitted only after a pre-market safety evaluation, after which they would be added by Health Canada to the corresponding food additive List (the List of Permitted Food Enzymes or the List of Permitted Preservatives). Health Canada will review submissions for new uses of food additives for HMFs or other infant foods through the Department’s pre-market safety evaluation process for food additives.
Objective
The objective of these amendments is to allow Health Canada to enable certain new, safe uses of food enzymes and preservatives in HMFs or other infant foods, through the same administrative modification of the Lists that the Department routinely uses to permit other new uses of food additives.
Description
Pursuant to sections 30.3 and 30.5 of the FDA, the Minister of Health is issuing this Marketing Authorization, which amends the following two existing MAs to enable new food additive uses: the Marketing Authorization for Food Additives That May Be Used as Food Enzymes and the Marketing Authorization for Food Additives That May Be Used as Preservatives.
Definition
The Marketing Authorization for Food Additives That May Be Used as Food Enzymes and the Marketing Authorization for Food Additives That May Be Used as Preservatives are amended to add a definition of “infant food.” The term “infant food” will have the same meaning as in section B.25.001 of the FDR.
Use of food enzymes in infant foods
The Marketing Authorization for Food Additives That May Be Used as Food Enzymes is amended to add an exemption for infant foods from the application of subsection B.25.062(1) of the FDR which, subject to certain exceptions set out in subsection B.25.062(2), prohibits the sale of an infant food containing a food additive. Infant foods that contain food enzymes are also exempted from the application of sections B.01.043 and B.16.007 of the FDR, and paragraphs 4(1)(a) and 4(1)(d) of the FDA, which prohibit the sale of an article of food that has, in or on it, any poisonous or harmful substance or that is adulterated.
In the Marketing Authorization for Food Additives That May Be Used as Food Enzymes, the definition of “infant formula” is repealed. In the same MA, the provisions setting out exemptions related to infant formula and infant cereal products in subsections 2(3) and 2(4) are also repealed. These are replaced by provisions related to infant food, described above.
No administrative changes will be made to the List of Permitted Food Enzymes at this time. Manufacturers will be able to request the use of a food enzyme in the manufacture of an infant food or in an ingredient used in infant foods, including HMFs, through the Department’s established administrative process for food additives.
Use of preservatives in infant foods
Two preservatives were already permitted for use in infant formula and in oils used in infant formula under the provisions set out in paragraphs B.25.062(2)(i) and (j) of the FDR.
The Marketing Authorization for Food Additives That May Be Used as Preservatives is amended to add an exemption for infant foods from the application of subsection B.25.062(1) of the FDR which, subject to certain exceptions set out in subsection B.25.062(2), prohibits the sale of an infant food containing a food additive. Infant foods that contain preservatives are also exempted from the application of sections B.01.043 and B.16.007 of the FDR, and paragraphs 4(1)(a) and 4(1)(d) of the FDA, which prohibit the sale of an article of food that has, in or on it, any poisonous or harmful substance or that is adulterated.
No administrative changes will be made to the List of Permitted Preservatives at this time. Manufacturers will be able to request the use of a preservative in infant foods, including HMFs, through the Department’s established administrative process for food additives.
Regulatory development
Consultation
A Notice of Intent detailing the proposed Marketing Authorization was published on the Government of Canada’s website on April 14, 2021, for a 30-day consultation period.
Health Canada received no comments during the consultation period.
Modern treaty obligations and Indigenous engagement and consultation
No impacts have been identified on modern treaty obligation or Indigenous peoples in these amendments.
Instrument choice
The amendments to the two MAs are aligned with the Government of Canada’s commitment outlined in the Agri-food and Aquaculture Sector Regulatory Review Roadmap of June 2019, to create a more flexible and agile regulatory framework. This will allow industry to bring safe, innovative HMFs or other infant foods to the Canadian market in a timely manner, while continuing to help protect the health and safety of vulnerable infants. Without these amendments, Health Canada would be unable to permit certain safe uses of food additives in HMFs or other infant foods through the Department’s established administrative process for food additives.
These amendments reflect the original policy intent regarding the use of MAs and incorporation by reference with respect to enabling the use of food additives administratively in order to streamline and gain efficiencies in the regulatory process, without changing the nature or rigour of Health Canada’s scientific evaluation of the safety of the food additives.
Regulatory analysis
Benefits and costs
The amendments to the MAs will enable Health Canada to efficiently permit safe uses of food enzymes and preservatives in HMFs and other infant foods, as requested by industry. Once food additives are added to the corresponding Lists, this would enable the creation of new market opportunities for industry and allow Canadians access to new, safe and innovative infant foods, including HMFs, containing food additives.
There are no additional operational costs for the Department with respect to these amendments. There are also no anticipated impacts expected on the Canadian Food Inspection Agency as it relates to compliance and enforcement activities, since these amendments are not creating additional regulatory requirements.
Small business lens
The small business lens does not apply, since no new regulatory requirements are created by these amendments. These amendments will not impose administrative or compliance costs on small businesses.
One-for-one rule
The one-for-one rule does not apply to these amendments, since they are not expected to introduce any administrative burden on businesses, as no new requirement is created.
Regulatory cooperation and alignment
The amendments to the two MAs are necessary for Health Canada to permit new, safe uses of food enzymes and preservatives in infant foods, including HMFs, using the Department’s administrative process and to achieve alignment with trading partners.
Should HMF manufacturers submit information on HMFs that are approved in other jurisdictions, such as the European Union or the United States, Health Canada will consider this information during its pre-market review. This assessment would include a review of the food additives used in the HMF.
Strategic environmental assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment preliminary scan was completed and concluded that a detailed analysis was not required because these amendments have no environmental impact.
Gender-based analysis plus (GBA+)
Consideration of gender and diversity were taken into account during the development of the proposal to establish a regulatory framework for the sale of HMFs. No additional sex, gender and/or diversity implications have been identified for these amendments.
Implementation, compliance and enforcement, and service standards
Implementation
The amendments described above come into force on the day on which they are published in the Canada Gazette, Part II.
Compliance and enforcement
The Canadian Food Inspection Agency is responsible for the enforcement of the food-related aspects of the Food and Drugs Act, the Food and Drug Regulations and the Marketing Authorizations for food additives.
Contact
Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca