Marketing Authorization Amending Certain Marketing Authorizations Issued Under the Food and Drugs Act: SOR/2019-210

Canada Gazette, Part II, Volume 153, Number 13

Registration

SOR/2019-210 June 14, 2019

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.

Ottawa, June 12, 2019

Ginette Petitpas Taylor
Minister of Health

Marketing Authorization Amending Certain Marketing Authorizations Issued Under the Food and Drugs Act

Marketing Authorization for Food Additives with Other Accepted Uses

1 Subsection 1(1) of the Marketing Authorization for Food Additives with Other Accepted Uses footnote 1 is replaced by the following:

Definitions

1 (1) The following definitions apply in this Marketing Authorization.

infant food has the same meaning as in section B.25.001 of the Food and Drug Regulations (aliment pour bébés)

List means the List of Permitted Food Additives with Other Accepted Uses published by the Department of Health on its website, as amended from time to time. (Liste)

2 (1) The portion of subsection 2(1) of the Marketing Authorization before paragraph (a) is replaced by the following:

Food — general

2 (1) When a food additive that is set out in column 1 of the List is added to a food that is set out in column 2, other than an infant food, for a use whose purpose 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 additive only, if

(2) Section 2 of the Marketing Authorization is amended by adding the following after subsection (1):

Infant food

(1.01) When a food additive that is set out in column 1 of the List is added to an infant food that is set out in column 2 for a use whose purpose is set out in column 3, the 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 additive only, if the conditions set out in paragraphs (1)(b) and (c) and, if applicable, paragraph (1)(d) are met.

3 The Schedule to the Marketing Authorization is amended by adding the following after item 1:

Item

Column 1

Additive

Column 2

Purpose of Use

2

L-lysine monohydrochloride

To inhibit acrylamide formation

Marketing Authorization for Food Additives That May Be Used as Preservatives

4 Subsection 2(1) of the Marketing Authorization for Food Additives That May Be Used as Preservatives footnote 2 is replaced by the following:

Food

2 (1) When a preservative that is set out in column 1 of the List is added to a 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.

Marketing Authorization for Food Additives That May Be Used as Sequestering Agents

5 Subsection 1(1) of the Marketing Authorization for Food Additives That May Be Used as Sequestering Agents footnote 3 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)

6 Subsection 2(1) of the Marketing Authorization is replaced by the following:

Food — general

2 (1) When a sequestering agent that is set out in column 1 of the List is added to a food that is set out in column 2, other than an infant food, 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 agent only, if the amount of the agent 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 sequestering agent that is set out in column 1 of the List is added to an infant food that is set out in column 2, the 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 agent only, if the amount of the agent 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.

Coming into Force

7 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 Authorization.)

Issues

Health Canada has approved five new food additive uses based on rigorous safety assessments. However, these food additive uses cannot be enabled without first amending certain Marketing Authorizations (MAs).

Background

MAs are regulatory tools which enable the Minister of Health to implement certain food safety decisions by exempting certain foods from specific prohibitions in the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDR). MAs can also incorporate documents by reference.

In Canada, the use of food additives is subject to the FDA and FDR, and is also subject to food additive MAs issued by the Minister of Health under subsection 30.3(1) of the FDA. The FDR outline a number of prohibitions on the sale of certain foods containing food additives as well as their levels of use, whereas the MAs create exemptions to some of these prohibitions. The MAs also incorporate by reference the Lists of Permitted Food Additives (the Lists), which set out the permitted levels and conditions of use of food additives. These Lists are maintained through an administrative process by Health Canada and are published on the Government of Canada website. Together, the MAs and the Lists allow foods containing approved food additives to be sold in Canada.

Prior to them being permitted to be sold, food additives undergo a comprehensive pre-market evaluation by Health Canada with respect to their quality, effectiveness for intended purpose and safety. If the scientific evidence supports these considerations and the proposed use, then Health Canada initiates the process to enable the use of food additives. In most cases, existing exemptions in MAs are sufficient to permit new food additive uses through modification of the Lists. Where these exemptions are not sufficient (where the use of a food additive would continue to be contrary to one or more provisions of the FDR), as is the case for the subject matter of this regulation, amendments to one or more MAs are necessary before the associated Lists can be administratively modified.

Objective

The objective of this Marketing Authorization is to allow Health Canada to enable five new food additive uses deemed to be safe and to permit the sale of certain foods containing certain food additives in Canada.

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 three existing MAs for food additives:

Amending these MAs is necessary to enable certain new food additive uses, as follows:

(1) Three new food additive uses in certain infant foods

The Marketing Authorization for Food Additives with Other Accepted Uses and the Marketing Authorization for Food Additives That May Be Used as Sequestering Agents are amended to add an exemption from the application of subsection B.25.062(1) of the FDR, which prohibits the sale of an infant food containing a food additive.

The corresponding lists to the MAs (the List of Permitted Food Additives with Other Accepted Uses and the List of Permitted Sequestering Agents) will subsequently be administratively amended to permit the use of three food additives (polysorbate 80, potassium phosphate, dibasic and sodium potassium hexametaphosphate) in certain infant foods, or in an ingredient used in certain infant foods, under specified conditions. Any food additive not specifically permitted by these Lists or the FDR to be present in infant food will continue to be prohibited.

(2) Use of preservatives in certain fish products

The Marketing Authorization for Food Additives That May Be Used as Preservatives is amended to add an exemption from the general prohibition set out in paragraph B.21.005(b) of the FDR, which provides that fish or meat products and preparations thereof are adulterated if they contain preservatives other than those specified in Division 21 of the FDR.

The corresponding list to this MA (List of Permitted Preservatives) will subsequently be administratively amended to permit the use of one specific food additive (tocopherols) as a preservative in certain types of dehydrated seafood broth, under specified conditions. Any food additive not specifically permitted by the List to be present in fish and meat products or preparations thereof will continue to be prohibited.

(3) New food additive and a new purpose of use

Finally, the Schedule to the Marketing Authorization for Food Additives with Other Accepted Uses is amended to include a new food additive (L-lysine monohydrochloride) with a new purpose of use (inhibiting acrylamide formation). Pursuant to paragraph 2(1)(d) of this MA, such an amendment to the Schedule is necessary for the existing exemptions to apply.

The corresponding list to this MA (List of Permitted Food Additives with Other Accepted Uses) will subsequently be administratively amended to permit the use of this food additive for this specific purpose of use in certain processed snack foods.

Regulatory development

Consultation

A Notice of Intent (NOI) detailing the proposed Marketing Authorization was published on the Government of Canada’s website on April 8, 2019, for a 30-day consultation period. Health Canada had previously informed each stakeholder that had submitted a food additive submission which required an MA amendment, that the Lists would not be amended to permit their requested food additive use until the relevant MAs were amended.

Health Canada received eight written comments during the consultation period: five from the public, one from the food industry, one from academia, and one from a child-care facility. None of the comments received directly addressed the proposed amendments to the MAs and no new scientific or regulatory information was submitted to change the proposal. In their responses, stakeholders shared concerns about the use of food additives, asked questions pertaining to the safety assessment of food additives, or requested further clarification on the food additives that are expected to be enabled. Health Canada addressed the general comments on food additive uses and safety by providing information on the pre-market safety requirements that must be met before permitting the use of food additives in infant foods or other foods.

Following the publication of the NOI, Health Canada published on its website a separate Notice of Proposal (NOP/AVP-0032), on May 13, 2019, informing stakeholders of its intent to enable the use of the food additive L-lysine monohydrochloride to inhibit acrylamide formation. A 75-day comment period was provided, which will end on July 26, 2019.

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 relevant MAs are aligned with the Government of Canada’s commitment outlined in the Agri-food and Aquaculture Sector Regulatory Review Roadmap of 2019, to create a more flexible and agile regulatory framework. This will allow industry to bring safe, innovative food products to the Canadian market in a timely manner, while continuing to protect the health and safety of Canadians. Without these amendments, certain food additives that have been assessed as safe for use would continue to be prohibited in certain foods.

These amendments meet the original policy intent regarding the use of MAs with respect to food additives in order to streamline and gain efficiencies in the regulatory process, without changing the nature or rigour of Health Canada’s scientific evaluations.

Regulatory analysis

Costs and benefits

The amendments to the MAs will create new market opportunities for industry by allowing them to use certain food additives in certain infant foods, snack foods, and seafood broths, in order to enhance the quality or extend the shelf life of their products.

Additionally, the amendments will increase access to new, safe and innovative food products (e.g. by reducing acrylamide footnote 4 formation in certain snack foods) for Canadians.

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 simply expand the use of food additives, with no new or 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

International regulators such as the United States Food and Drug Administration (USFDA) and the European Union Food Safety Authority already authorize some of these food additive uses in the same foods at similar maximum levels of use. For example, the USFDA has given L-lysine monohydrochloride a GRAS (Generally Recognized as Safe) status in the United States. In addition, international organizations such as the Codex Alimentarius Commission has also included some of these food additive uses in the Codex General Standards for Food Additives. footnote 5

This Marketing Authorization is the first step to permitting these new food additive uses in Canada and achieving alignment with our key trading partners.

Strategic environmental assessment

In accordance with The Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a SEA preliminary scan was completed and concluded that a detailed analysis was not required because these amendments have no environmental impact.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been identified for these amendments as they do not have a direct focus on men, women and/or diverse individuals. As such, there are no sex, gender and/or diversity implications to 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.

Once the MAs are modified, Health Canada will proceed to the second step, which is to update the corresponding Lists of Permitted Food Additives via Notice of Modification (NOM) announcements published on the Government of Canada’s website. The changes to the Lists will be effective the day on which they are published.

For the new food additive (L-lysine monohydrochloride) with a new purpose of use (inhibiting acrylamide formation), a Notice of Proposal (NOP) has been published on May 13, 2019, followed by a 75-day consultation period. Should the consultation not yield any new information, a NOM will be published indicating the appropriate List is modified accordingly.

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 associated Marketing Authorizations.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
11 Holland Avenue
Holland Cross, Suite 14
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca