Test Market Authorizations / Interim Marketing Authorizations

Guide for food manufacturers / importers on how to apply for:

• A Test Market Authorization (TMA) as per the Processed Products Regulations (PPR)
• An Interim Marketing Authorization (IMA) as per the Food and Drug Regulations (FDR)

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Overview

The operator of a registered establishment or an importer of food products in Canada may apply in writing to the Director for an authorization to test market a food product that does not meet the requirements of the PPR. Part 1.2, Section 9.1 of the PPR provides for the test marketing of regulated processed fruit and vegetable products that are in compliance with the food safety requirements prescribed in the FDR, but are not compliant with the requirements prescribed in the PPR. Examples of such products include, but are not limited to, products packed in different container sizes, products containing new ingredients, etc.

If a food product is not compliant with the FDR, and the manufacturer/importer wishes to proceed with the marketing of this product, then an amendment to the FDR should be requested. The issuance of an IMA by Health Canada prior to requesting a TMA from the Canadian Food Inspection Agency (CFIA) is necessary.

The following two procedures (A and B) describe in greater detail the various steps required when applying for a TMA and IMA.

Procedure A - Food Products Not in Compliance with the PPR

The operator of a registered establishment or an importer of food products in Canada may apply in writing to the Director for an authorization to test market a food product that does not meet the requirements of the PPR.

Step 1

Please send:

• A letter requesting a TMA
• A sample of the product
• If the product is certified organic, a copy of the certificate
• Three labels to the following address: (A reasonable facsimile of the label can be submitted with the application if the final label is submitted to the Director within 90 days after the date issue of the authorization)
  
  Director, Agrifood Division
  Canadian Food Inspection Agency
  1400 Merivale Road
  T1-4-334
  Ottawa, Ontario
  K1A 0Y9

Note: You will find at the end of this document a Template of a Letter to help complete your request.

Step 2

A facsimile transmittal and/or an E-mail acknowledging receipt of your application will be sent to you within a week of receiving your application.

Step 3

Following assessment of the TMA submission, the Director's office will communicate to you the final decision and other pertinent information.

If the submission for a TMA is deemed complete and satisfactory, you will receive an Authorization Letter indicating the duration of the TMA and other applicable conditions, if any. Please be advised that depending on the complexity of a submission, processing of applications and subsequent issuance of authorizations may vary from 2 to 4 weeks.

If the submission is deemed unsatisfactory, the Director's office will also notify you in writing of the final decision. The response will indicate to you the reason for declining the issuance of a TMA as it pertains to applicable sections of the Regulations.

For more information on applying for a TMA, please contact your local CFIA office.

Procedure B - Food Products Not in Compliance with the FDR

Where a food does not comply with the requirements of these regulations, the manufacturer or distributor of the food may request in writing to Health Canada:

1. For the exemption of the food from the application, (in whole or in part), of the requirements relating to it under these Regulations;
2. For a Notice of IMA concerning the food that confirms the exemption; and
3. That these Regulations (FDR) be amended.

It must be recognized that the issuance of an IMA is not the first step in the amendment of the Regulations but can be considered only after:

• receipt of a fully documented submission requesting the amendment of the appropriate portions of the FDR and the issuance of an IMA;
• completion of a safety assessment on the proposed use of the substance in question in the food supply and the conclusion that the proposed use will not result in a health hazard to the consumer;
• verification that the request for an IMA meets the eligibility criteria for the issuance of an IMA as described in section B.01.056 of the FDR; and
• review of the proposed amendment of the Regulations by the appropriate senior management committee at Health Canada and recommendations by that committee to proceed with the development of an amendment of the Regulations and the issuance of an IMA.

A request that a food additive be added to or a change made in the Tables following section B.16.100 of the FDR shall be accompanied by a submission to the Minister in a form, manner and content satisfactory to him and shall include all the elements required in B.16.002.

It is noteworthy that the issued IMA must be published in the Canada Gazette Part I and has effect beginning on the date of publication. A Notice of IMA issued under of the FDR in relation to a food loses its effect on the coming into force of any amendment to these regulations resulting from the Director's recommendation referred to in that subsection.

Note:  View the list of the IMAs that are currently in effect.

For more information on applying for an IMA, please visit the Health Canada website or contact:

For Food Additives:

Director
Bureau of Chemical Safety
A.L. 2203G2
Health Canada
Ottawa, Ontario
K1A 0L2
Telephone 613-957-0973
Facsimile 613-954-4674

For Vitamins and Minerals:

Director
Bureau of Nutritional Sciences
A.L. 2203C
Health Canada
Ottawa, Ontario
K1A 0L2
Telephone 613-948-8476
Facsimile 613-948-8470

Applicable to Procedure B only:

When a request for an IMA has been issued and published by Health Canada for a product subject to the PPR, the manufacturer/Importer must subsequently apply for a TMA with the CFIA prior to the marketing of their products.

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Template Letter

Date:
Director, Agrifood Division
Canadian Food Inspection Agency
1400 Merivale Road
T1-4-334
Ottawa, Ontario   K1A 0Y9

The XXX Company requests a Test Market Authorization (TMA) under section 9.1 of the Processed Products Regulations (PPR) to market the following product(s):

1. COMMON NAME
2. BRAND NAME
3. NON-COMPLIANT ELEMENT(S) UNDER THE PPR/PURPOSE OF TEST MARKETING
4. INGREDIENTS
5. TYPE AND SIZE OF CONTAINER
6. FORMULATION/METHOD OF MANUFACTURE
7. COUNTRY OF ORIGIN
8. MANUFACTURED BY:  Name and Address
9. IMPORTED BY (if applicable)
10. TOTAL QUANTITY OF PRODUCTS TO BE TEST MARKETED
11. GEOGRAPHIC AREA OF DISTRIBUTION
12. PORT OF IMPORTATION (if applicable)
13. APPLICANT:
    • Name
    • Address
    • Telephone and facsimile
    • email
    • Establishment registration number (if applicable)

The container used meets the requirements of Division 23 of Part B of the Food and Drugs Regulations. The label of the container is not misleading as to the nature, quantity, quality, composition, character, safety, value, variety or origin of the food product, and meets the requirements of the Consumer Packaging and Labelling Act and Regulations. With the exception of the non-compliant element(s) listed in 3 above, the product meets all the requirements as established under the PPR. Enclosed is a sample of the product and 3 copies of the label planned to be used.

Signature
(Name in block letters)