Test marketing and other authorizations

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Exemptions for test marketing of food – Test market authorizations

Overview

Under limited circumstances, foods may be eligible for an exemption from certain regulatory requirements for the purposes of test marketing a product. Companies may request an exemption to test market a product that is not in compliance with:

  • bilingual labelling requirements of the Food and Drug Regulations (FDR) and the Safe Food for Canadians Regulations (SFCR), and
  • certain provisions in the SFCR (e.g., standard container size requirements)

In this guidance, an exemption granted for the purpose of test marketing a food will be referred to as a test market authorization (TMA).

Note that a new process has been put into place for test market authorizations.

A test market food is only exempt from certain regulatory provisions and must comply with applicable legislation in all other respects.

Background

Former test market authorization processes

In the former test market authorization (TMA) processes prior to the coming into force of the Safe Food for Canadians Regulations (SFCR), certain foods were eligible for an exemption from certain regulatory requirements for the purpose of test marketing a product. TMA provisions previously existed in the regulations for:

  • bilingual labelling requirements of the Food and Drug Regulations (FDR), the now repealed food-related provisions of the Consumer Packaging and Labelling Regulations (CPLR) and the now repealed Meat Inspection Regulations, 1990
  • standard container size requirements of the now repealed food-related provisions of the CPLR, and
  • certain provisions of the now repealed Processed Products Regulations, Honey Regulations, Fresh Fruit and Vegetable Regulations and Fish Inspection Regulations

The guidelines and processes were different depending on the regulation under which the TMA was being requested.

Changes under the Safe Food for Canadians Regulations

With the coming into force of the SFCR, test market provisions have expanded to apply to all foods. A new process has been implemented to streamline the many TMA processes that existed previously under different regulations. This new process will focus on testing the viability on the Canadian market of a product that has not previously been sold in Canada in that form and differs substantially from any other food sold in Canada with respect to its composition, function, state or packaging form.

Under the SFCR, standards of identity and grades have been moved into incorporated by reference documents and some have been updated based on successful test markets. As such, certain foods that were previously only permitted to be sold through a TMA would no longer require one to be marketed. For example, the repealed Processed Products Regulations did not permit the use of concentrated apple juice as an ingredient in apple sauce. As this use was accepted through consultations to be common industry practice, TMAs were being granted for the use of this ingredient in apple sauce, prior to the coming into force of the SFCR. The standard of identity for apple sauce in the Canadian Standards of Identity, Volume 4 – Processed Fruit or Vegetable Products now permits the use of concentrated apple juice to reflect current industry practices.

It is important to become familiar with current requirements before considering applying for a TMA.

Existing test market authorizations

Test market authorizations that were granted prior to the coming into force date of the Safe Food for Canadians Regulations (SFCR) on January 15, 2019 continue to be valid for the period for which they were issued, as indicated in the authorization letters [375(2), SFCR].

For information on the status of previously issued test markets for fresh fruits or vegetables, please consult the summary page Test markets issued under the now repealed Fresh Fruit and Vegetable Regulations, which has been updated with pertinent data.

New test market authorization process

A Ministerial Exemption for the purpose of test marketing a food on the Canadian market, as described in subsection 174(1) of the Safe Food for Canadians Regulations (SFCR), may be requested for an exemption from certain regulatory requirements for a given food product. This type of Ministerial Exemption is referred to as a Test Market Authorization (TMA).

An approved TMA is only valid for the person who submitted the application and the specific product included in the application.

Criteria for test market authorizations under the SFCR

Under the SFCR, all foods are eligible for a test market authorization. In order for an exemption for test marketing a food to be granted, applicants must demonstrate that all of the following criteria are met:

  • the request is for the purpose of test marketing a food, i.e., it has not been sold previously in Canada in that form and differs substantially from any other food sold in Canada with respect to its composition, function, state or packaging form
  • the information in the application is complete, truthful and not misleading
  • the food is edible, not contaminated, and is processed under sanitary conditions
  • there is no risk of injury to human health in granting the exemption
  • the exemption will not confuse or mislead the public
    • for example, will not impact the ability of consumers to make informed and accurate choices and will not lead to misrepresentation or marketplace deception. Examples of exemptions that would not be eligible under this criteria include those from: mandatory labelling requirements (common name, net quantity, etc.), compositional requirements, etc.
  • the exemption will not disrupt the normal trading patterns of the industry or the normal food pricing patterns [174(2)(a)-(d), SFCR]

The product for which a TMA is issued must comply with all other applicable federal legislation (other than the SFCR provision(s) for which it receives an exemption), including the Food and Drugs Act and the Food and Drug Regulations. In all cases, food safety requirements must be met.

In order to meet the criteria for test marketing, the applicant must confirm and be prepared to substantiate that the above criteria are met. Please note that the above criteria do not apply to an exemption from bilingual labelling requirements of the FDR and SFCR, as different criteria must be satisfied. Refer to section below entitled Exemption from bilingual labelling for a test market food for more information.

Marketing a food without the use of a test market authorization

In most cases, requesting a test market authorization is not the appropriate means to market a food in Canada when it is not in compliance with certain provisions of the regulations. Alternate options are outlined below.

Request for regulatory amendment

Regulated parties seeking a permanent change to the regulatory framework, for example, for provisions related to grades, standards of identity, labelling and container sizes could seek an amendment to the incorporated by reference documents under the Safe Food for Canadians Regulations (SFCR) or the regulations themselves. Such a process will allow a product to be marketed in Canada on a permanent basis once the regulatory amendment is brought into force. For more information, refer to the Incorporation by reference policy.

Modified standardized common names

An application for a TMA may not be needed in cases where a product resembles a standardized food but differs with respect to its ingredients or other characteristics, provided an appropriate common name, such as a modified standardized common name, is used. An example of an acceptable modified standardized common name is "tomato paste with basil", as the standard for tomato paste does not include basil. The common name indicates that the product complies with the standard for tomato paste in all respects except for the addition of basil, and is therefore acceptable and would not require a TMA to be sold.

Food additives

If a company would like to add a non-permitted food additive to a standardized food, a modified standardized common name would not enable this; a food additive submission must be made to Health Canada to enable the use of that food additive in food sold in Canada. For more information, refer to Health Canada's Lists of Permitted Food Additives.

The table below outlines examples of cases where seeking a TMA is not the appropriate method to market a non-compliant food in Canada.

Table 1: How to market a food that does not meet the criteria for a TMA
Type of product Ways to Market the food without a TMA
Note: If the food is in compliance with all applicable Canadian regulatory requirements, there is no need for a Test Market Authorization.
Food with a standard of identity containing non-permitted additives
Food with a standard of identity containing non-permitted ingredients
Processed fruit or vegetable product not meeting a requirement for minimum drained weight
Food for which a grade is prescribed not meeting a grade requirement
  • Market ungraded product intraprovincially only provided this is permitted by the applicable provincial regulations
  • Request to amend Canadian Grade Compendium incorporated by reference document

Interim process

In conjunction with this new TMA process, an interim process has temporarily been put into place for TMAs related to standard container sizes that have been granted in the past. The purpose of this interim process is to alleviate the gap created between the publication of the Safe Food for Canadians Regulations (SFCR) and the implementation of proposals under the Food Labelling Modernization (FLM) initiative. The FLM initiative had proposed in Phase III engagement to move standard container sizes into an incorporated by reference (IbR) document, with the inclusion of additional sizes based on previously granted TMAs and feedback received from stakeholder consultations. TMAs issued for certain standard container sizes in the past will continue to be granted through the interim process while the FLM initiative is in progress. Once the proposed FLM regulatory amendments are finalized and if standard container sizes are incorporated by reference, the interim process will be discontinued.

Food Labelling Modernization proposed amendments were pre-published in Canada Gazette, Part I in June 2019. A public comment period is available for Canadians and other interested parties to provide feedback on the regulatory proposal.

Applying for a test market authorization

Step 1

Eight to twelve weeks prior to conducting the test market, a person may apply for an authorization to test market a food product that does not meet certain provisions of the Safe Food for Canadians Regulations (SFCR) via the online form entitled Application for an exemption for the purpose of test marketing a food – Test market authorization (CFIA/ACIA 5868) available in the CFIA's Forms catalogue. Once completed, the application is submitted to the CFIA's Centre of Administration under the National Service Centre, the first point of contact for TMA applications. The online form includes contact information for submissions via email, mail or fax.

The application form includes:

  • legal name of business as registered
  • SFCR licence number, if applicable
  • place of business
  • contact information
  • product information
    • common name
    • brand name
    • ingredients
    • type and size of container
  • whether the product has been sold previously in Canada
  • whether the product differs substantially from any other food sold in Canada with respect to its composition, function, state or packaging form
  • non-compliant elements and reason for seeking the exemption
  • country of origin
  • import information, if applicable
  • quantity of product to be test marketed
  • geographic area of distribution of test market
  • period of time requested to test market (including explanation)

The information submitted in the application must be complete, truthful and not misleading. An applicant who is seeking an exemption to test market a food must demonstrate that the product has not been sold previously on the Canadian market and that it differs substantially from any other food sold in Canada with respect to its composition, function, state or packaging form. The applicant must confirm and be prepared to substantiate that the exemption will not confuse or mislead the public and not disrupt the normal trading or pricing patterns of the industry. In addition, the applicant must confirm that the product meets the requirements set out in paragraphs 8(1)(a) to (d) of the SFCR, will not result in a risk of injury to human health and, with the exception of the non-compliant element(s) listed, the product meets all the requirements established under the SFCR and other applicable federal legislation.

Step 2

An acknowledgement of receipt of the application will be sent to the applicant upon receiving the application. The Centre of Administration will assess the application, including whether the application meets the criteria and whether the interim process applies.

Step 3

A test marketing authorization may be granted if the information provided substantiates that the test marketing of the food product meets all the applicable criteria.

Following assessment of the TMA submission, the final decision and other pertinent information will be communicated.

If the submission for a TMA is deemed complete and satisfactory, an authorization letter will be sent indicating the duration of the TMA and any other applicable conditions. Under the SFCR, the TMA is granted for two years unless otherwise specified [177, SFCR].

If the submission is deemed unsatisfactory, a written notification of the final decision will be sent. The response will indicate the reason for declining the issuance of a TMA. If applicable, the notification may include information on marketing a food without the use of a test market authorization that would provide alternate options for the applicant.

Exemption from bilingual labelling for a test market food

In specific circumstances, a company may request to test market a food that complies with current legislation in all respects, except for the bilingual labelling requirements of the Food and Drug Regulations (FDR) and the Safe Food for Canadians Regulations (SFCR) [205(2), 206(1) & (2), 207(b), SFCR; B.01.012(3), FDR].

According to the FDR, a test market food is defined as a food that was not previously sold in Canada in that form and that differs substantially from any other food sold in Canada with respect to its composition, function, state or packaging form [B.01.012(1), FDR].

A test market food includes food for which a manufacturer or distributor has been issued a Temporary marketing authorization letter under FDR.

Six weeks prior to conducting a test market, a person must apply via the online form entitled Application for an exemption for the purpose of test marketing a food – Test market authorization (CFIA/ACIA 5868) available in the CFIA's Forms catalogue. Once completed, the application is submitted to the CFIA's Centre of Administration under the National Service Centre, the first point of contact for TMA applications. The online form includes contact information for submissions via email, mail or fax.

The application form includes:

  • legal name of business as registered
  • SFCR licence number, if applicable
  • place of business
  • contact information
  • product information
    • common name
    • brand name
    • ingredients
    • type and size of container
  • whether the product has been sold previously in Canada
  • whether the product differs substantially from any other food sold in Canada with respect to its composition, function, state or packaging form
  • non-compliant element (bilingual labelling only)
  • country of origin
  • import information, if applicable
  • quantity of product to be test marketed
  • period of time requested to test market (maximum period is 12 months)
  • geographic area of distribution of test market
    • an entire province is considered too large an area for a bilingual labelling exemption for test market purposes
    • cities are generally accepted, provided they include a local government unit where either French or English is the mother tongue of less than 10% of the population and provided the mandatory label information is shown in the other official language
    • census information regarding potentially-restricted areas may be obtained from the Statistics Canada Language Highlight Tables or by contacting:

    Statistics Canada
    General Enquiries
    R.H. Coates Building
    Tunney's Pasture
    Ottawa, Ontario K1A 0T6
    Telephone 613-951-8116

Notes
  • Test market foods are not exempt from bilingual labelling requirements when both official languages are the mother tongue of less than 10 % of the population residing in a local government unit. For example, if the mother tongue of a local government unit consists of only 9% French and 9 % English, along with several different languages totalling 82% of the population, the food would be required to be labelled in both official languages, i.e., French and English [B.01.012(4), FDR; 6(4), CPLR].
  • The exemption also does not apply where each official language is the mother tongue for more than 10% of its residents. For example, both Ottawa (Ontario) and Montreal (Quebec) have a population of more than 10% of both anglophones and francophones and therefore are not locations where a test market food would be exempt from bilingual labelling requirements.

The applicant must also include information, with supporting data, to substantiate that the test market product was not previously sold in Canada in that form and to establish that it differs substantially from any other product sold in Canada with respect to its composition, function, state or packaging form.

Temporary marketing authorization letters

There is a distinction between a test market food and a food that has received Temporary marketing authorization under the Food and Drug Regulations.

A Temporary marketing authorization letter (TMAL), issued by the Assistant Deputy Minister of the Health Products and Food Branch, Health Canada, authorizes the sale of a food that does not meet one or more of the compositional, packaging, labelling or advertising requirements under the Food and Drugs Act and Food and Drug Regulations. The authorization is granted for a specified period of time, within a designated area and in a specified quantity for a specific manufacturer or distributor. A TMAL does not exempt foods from the requirements under the Safe Food for Canadians Act and Regulations, or other food legislation.

The purpose of a Temporary marketing authorization is to generate information in support of a proposed amendment to the Food and Drug Regulations.

For example, as a condition for obtaining a TMAL for the use of non-permitted labelling on a food, the companies involved agree:

  • to use only those non-permitted labelling statements approved by the Health Products and Food Branch
  • to use these to carry out studies to determine consumer attitudes to the labelling and advertising material, and
  • to submit the results of these studies to the Health Products and Food Branch

Further information on TMALs is available in Health Canada's General guidance document for temporary marketing authorization for foods. Applications for a Temporary marketing authorization letter and questions regarding any procedural details in applying for the TMAL should be addressed to:

Submission Management and Information Unit
Food Directorate, Health Products and Food Branch
Health Canada
251 Sir Frederick Banting Driveway
Postal Locator 2202E
Ottawa, Ontario K1A 0K9

Phone: 613-960-0552
Fax: 613-946-4590

Email address: smiu-ugdi@hc-sc.gc.ca

Marketing authorizations

The Marketing authorization (MA) authority is a regulatory tool that the Minister of Health may choose to use to implement certain food decisions. These are administered by Health Canada. 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. For example, MA's may be used to authorize a specific food additive use in foods sold in Canada.

For more information, refer to Health Canada's Marketing Authorization. The list of valid Marketing Authorizations can also be accessed from this page.

The MA authority has replaced, at the level of the Food and Drugs Act, the ability to issue an Interim marketing authorization (IMA). As such, Health Canada will no longer be issuing IMAs.

Definitions

Local government unit

Local government unit means a city, metropolitan government area, town, village, municipality or other area of local government but does not include any local government unit situated within a bilingual district established under the Officials Languages Act [B.01.012(1), FDR].

Official languages

Official languages means the English language and the French language [B.01.012(1), FDR].

Person

Person means an individual or an organization as defined in section 2 of the Criminal Code [2, FDA; 2, SFCA].

Test market food

A test market food means a food that, prior to the date of application, was not sold in Canada in that form and that differs substantially from any other food sold in Canada with respect to its composition, function, state or packaging form. It includes food for which a manufacturer or distributor has been issued a Temporary marketing authorization letter.

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