CHAPTER 13
13.1
TEST MARKET AUTHORIZATIONS
OBJECTIVES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
13.1.1 Objectives of this Chapter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
13.1.2 Objectives of a Test Market Authorization [Section 9.1, PPR]. . . . . . . . . . . . . . . . . . . . . . . 13-1
13.2
SCOPE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
13.3
REQUIRED FORMS and REFERENCES.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
13.3.1 Forms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
13.3.2 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
13.4
LIST OF EXISTING TEST MARKET AUTHORIZATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
13.5
TERMS AND CONDITIONS FOR TEST MARKET AUTHORIZATIONS. . . . . . . . . . . . . . . . . . 13-2
13.6
APPLICATION PROCEDURES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
13.7
PRODUCTS NOT MEETING THE FOOD AND DRUG REGULATIONS. . . . . . . . . . . . . . . . . . 13-3
13.7.1 Interim Marketing Authorization under the FDR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-4
13.7.2 Temporary Marketing Authorization Letter under the FDR. . . . . . . . . . . . . . . . . . . . . . . . . 13-5
APPENDIX 13A:
Template Letter: Test Market Authorization Application. . . . . . . . . . . . . . . . . . . . . 13-7
APPENDIX 13B:
Example Letter: Test Market Authorization (TMA). . . . . . . . . . . . . . . . . . . . . . . . . 13-8
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CHAPTER 13
13.1
TEST MARKET AUTHORIZATIONS
OBJECTIVES
Return to Index
13.1.1 Objectives of this Chapter
•
To outline the conditions and procedures involved in the Test Market Authorization (TMA)
application and approval process;
•
To outline the procedures for inspectors to confirm the existence of a TMA; and
•
To advise inspection staff of their role when a TMA is granted in their District.
13.1.2 Objectives of a Test Market Authorization [Section 9.1, PPR]
13.2
Return to Index
•
To allow for the legal marketing of a product which does not meet the current Processed
Products Regulations (PPR) but meets the requirements of the Food and Drug Regulations
(FDR) and other applicable regulations;
•
To analyze the consumer perception and acceptance of the product; and
•
To gather data to justify and support an amendment to the PPR.
SCOPE
Return to Index
Processed products that do not comply with one or more of the requirements of the PPR, but
comply with all other applicable federal, provincial and/or municipal legislation.
13.3
REQUIRED FORMS and REFERENCES
13.3.1 Forms
•
Return to Index
Template Letter for a Test Market Authorization Application (Appendix 13A)
13.3.2 References
•
•
•
•
•
•
13.4
Return to Index
Canada Agricultural Products Act (CAPA)
Processed Products Regulations (PPR)
Food and Drugs Act (FDA)
Food and Drug Regulations (FDR)
Test Market Authorizations / Interim Marketing Authorizations Procedure
List of Approved Interim Marketing Authorizations
LIST OF EXISTING TEST MARKET AUTHORIZATIONS
Return to Index
The list of Test Market Authorizations (TMA) is continuously updated. The TMAs are listed in order
by which they are signed by the Director.
When a TMA is granted, CFIA sends an approval letter to the applicant, similar to the one shown
in Appendix 13B. To confirm that a TMA has been granted, an inspector may view the list of TMAs
or request to see the applicant’s approval letter during an inspection.
Note:
When a TMA is refused, CFIA advises the applicant in writing.
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CHAPTER 13
13.5
TEST MARKET AUTHORIZATIONS
TERMS AND CONDITIONS FOR TEST MARKET AUTHORIZATIONS
Return to Index
A written application for a TMA (see 13.6 below) must be submitted by the operator of a
registered establishment, a Canadian first dealer or a Canadian importer.
The food product must :
i)
contravene at least one PPR requirement, such as container size or dimensions, ingredients
or additives, and/or style of preparation;
ii)
meet all other requirements of the PPR;
iii) meet all provisions of the FDR or be exempted from certain provisions by an Interim
Marketing Authorization (IMA) or a Temporary Marketing Authorization Letter (TMAL) (see
13.7 below);
iv) not disrupt the normal or usual trading patterns of the industry;
v)
not confuse or mislead the public; and
vi) not have an adverse affect on public health or safety or on product pricing.
A TMA is granted to a specific company for a specific product, quantity and geographical area of
distribution. Therefore, the product covered by a certain TMA can only be sold by the company
that received the TMA. If another company also wishes to import this same product, or pack a
similar product, they must apply for and receive a TMA for themselves.
Once granted, the TMA is valid for two (2) years. The authorization is subject to cancellation at
any time, if conditions set out in Section 9.1 of the PPR are not met during the test market period.
When the test market period ends, a request for a new test market can be submitted in writing. If
the new test market is approved, a new number will be given.
If changes are made to the product formulation or to the label after a TMA has been granted, the
applicant must notify the Director. After evaluation, the TMA letter will be amended accordingly.
Examples of TMAs issued under the PPR:
•
Apple Juice Packed in a 473 mL Container:
473 mL is not a container size prescribed for apple juice in Schedule III of the PPR, but it is a
proposed new container size under the PPR re-write. The FDR does not prescribe container
sizes, so the product meets the FDR.
•
Citric Acid in Canned Fruit Cocktail:
Citric acid is currently not permitted in fruit cocktail under the PPR, but it is a proposed
change in the PPR re-write. Fruit cocktail is an unstandardized food under the FDR. The FDR
allows the use of citric acid in unstandardized foods, so the product meets the FDR.
•
Citric Acid in Canned Peaches
Citric acid is currently not permitted in canned peaches under the PPR, but it is a proposed
change in the PPR re-write. Canned peaches are standardized under the FDR. The FDR
does not allow the use of citric acid in canned peaches, but an IMA has been issued by
Health Canada to allow it.
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CHAPTER 13
13.6
TEST MARKET AUTHORIZATIONS
APPLICATION PROCEDURES
Return to Index
a)
The company should first consult their local inspector to make sure their product meets the
conditions for a TMA. As needed, inspectors can consult their Processed Products Program
Specialist for assistance.
b)
In order to process TMA applications and questions more efficiently, applications and/or
questions should be emailed to PPRTMA-RPTEMM@inspection.gc.ca.
c)
The company must mail the following application package to CFIA (Ottawa):
i) a written application, preferably using the template in Appendix 13A ;
ii) a sample of the product; and
iii) three labels (electronic PDF files are also accepted, if they can be printed in actual size).
Address:
d)
13.7
Director, Consumer Protection Division
Canadian Food Inspection Agency
1400 Merivale Road
T2-6-150
Ottawa, Ontario
K1A 0Y9
Once the application is received, CFIA will send an email acknowledging receipt of the
request. Depending on the complexity of the submission, a letter of approval or refusal should
be sent within 2 to 4 weeks.
PRODUCTS NOT MEETING THE FOOD AND DRUG REGULATIONS
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When a food product does not comply with the FDR, the manufacturer or distributor of the food
may submit a written request to Health Canada for:
a)
an exemption for the product from the application, in whole or in part, of the requirements of
the FDR relating to that product;
b)
a Notice of IMA concerning the food that confirms the exemption (see 13.7.1);
c)
an amendment to the FDR; or
d)
a TMAL (see 13.7.2).
For food products that do not comply with the FDR, a TMA cannot be granted under the PPR
unless an IMA or a TMAL has been granted under the FDR by Health Canada. Table 13-1
highlights the major differences between the 3 types of authorizations.
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TEST MARKET AUTHORIZATIONS
Table 13-1: Comparison of Marketing Authorization Mechanisms
Test Market
Authorization
(TMA)
Interim Marketing
Authorization
(IMA)
Temporary Marketing
Authorization Letter
(TMAL)
Granted by
CFIA
Health Canada
Health Canada
Reason
The product does not
meet the requirements
for the PPR but meets
the FDR (or has an
IMA or TMAL).
The product does not meet
the requirements of the
FDR.
The product does not meet
the requirements of the
FDR.
- product specific
- product specific
- company specific
Terms and
Conditions
- granted for an
approximate quantity
of product
- specific area of
distribution
Examples
- any company
(i.e., once an IMA is
granted, any company can
use it)
- any quantity of product
- any area of distribution
- product specific
- company specific
- granted for a specific
quantity of product
- specific area of
distribution
- pre-determined period of
time (contract between
Health Canada and the
company)
- 2 year period
- valid until the FDR is
amended, unless the
authorization is cancelled
by Health Canada
Apple juice packed in
a non-prescribed
container size
(Company A)
Citric acid in canned
peaches (any company)
None are currently in effect
for Processed Products.
If the product is subject to
the PPR, any company can
apply to CFIA for a TMA.
If the product is subject to
the PPR, the company to
which the TMAL was
granted can then apply to
CFIA for a TMA.
* TMALs are not very
common.
Other
-
13.7.1 Interim Marketing Authorization under the FDR [B.01.056]
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An IMA is not the first step in amending the FDR and can only be considered after Health
Canada has:
a)
received, in the case of food additives, a fully documented submission pursuant to
Section B.16.002 of the FDR requesting the amendment of the appropriate portions of
the FDR and the issuance of an IMA;
b)
completed a safety assessment on the proposed use of the substance in question in the
food supply and concluded that it will not pose a health hazard to consumers;
c)
verified 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
d)
had the proposed amendment of the FDR reviewed by the appropriate senior
management committee at Health Canada and received recommendations from that
committee to proceed with the development of an amendment of the FDR and the
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TEST MARKET AUTHORIZATIONS
issuance of an IMA.
An IMA allows the sale of foods not in compliance with the FDR while an amendment to
permit their ongoing legal sale is being processed. IMAs are limited to a food which:
a)
contains a veterinary drug or an agricultural chemical or any of their derivatives in excess
of the maximum residue limit established in Division 15, or for which a maximum residue
limit has not been established;
b)
contains a food additive in excess of the maximum level of use listed in Division 16, FDR,
or for which there are no provisions in Division 16, FDR (see B.16.002, FDR);
c)
contains an ingredient in a form not listed in the standard for that food in the FDR; or
d)
contains an added vitamin or mineral nutrient for which no provision is found in the Table
to Division 3, Part D, FDR, or which is present at a level other than the prescribed level.
An IMA is granted for a specific product and can be used by any company. An IMA is valid
from the date it is published in the Canada Gazette Part I, until the FDR is amended
accordingly, unless it is revoked by Health Canada. The List of Approved IMAs is available on
the Health Canada website.
For more information on applying for an IMA, see Section B.01.056 of the FDR or contact:
For Food Additives:
Director, Bureau of Chemical Safety
A.L. 2203G2
Health Canada
Ottawa, Ontario K1A 0L2
Tel.: (613) 957-0973 or Fax: (613) 954-4674
For Vitamins and Mineral Nutrients:
Director, Bureau of Nutritional Sciences
A.L. 2203C
Health Canada
Ottawa, Ontario K1A 0L2
Tel.: (613) 948-8476 or Fax: (613) 948-8470
For Other Information:
Director, Bureau of Food Regulatory, International and Interagency Affairs
A.L. 0702C
Health Canada
Ottawa, Ontario K1A 0L2
Tel.: (613) 957-1828 or Fax (613) 941-3537
13.7.2 Temporary Marketing Authorization Letter under the FDR [B.01.054, B.01.055]
Return to Index
A TMAL authorizes the sale of a food that does not meet one or more of the compositional,
packaging, labelling or advertising requirements of the Food and Drugs Act and Regulations.
A TMAL is granted to a specific company for a specific product and quantity sold in a specific
area for a specified period of time.
Applications for TMALs should be addressed to:
Assistant Deputy Minister
Health Products and Food Branch
Health Canada
Ottawa, Ontario K1A 0L2
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Questions regarding any procedural details for applying for a TMAL may be addressed to:
Chief, Nutrition Evaluation Division
Bureau of Nutritional Sciences, Food Directorate
Health Products and Food Branch
Health Canada
Ottawa, Ontario K1A 0L2
Tel.: (613) 957-0352
Fax: (613) 941-6636
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Appendix 13A
Return to Index
TEMPLATE LETTER: TEST MARKET AUTHORIZATION APPLICATION
Date:
Director, Consumer Protection Division
Canadian Food Inspection Agency
1400 Merivale Road
T2-6-150
Ottawa, Ontario
K1A 0Y9
The XXX Company requests a Test Market Authorization under Section 9.1 of the Processed Products
Regulations to market the following product:
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.
TOTAL QUANTITY OF PRODUCT TO BE TEST MARKETED
10. GEOGRAPHIC AREA OF DISTRIBUTION
11. PORT OF IMPORTATION
12. 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 Drug 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. Besides the non-compliant elements listed in 3. above, the
product also meets all the requirements as established under the Processed Products Regulations.
Enclosed is a sample of the product and 3 copies of the label planned to be used.
Signature
(Name in block letters)
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Appendix 13B
Return to Index
EXAMPLE LETTER: TEST MARKET AUTHORIZATION (TMA)
Consumer Protection Division
Canadian Food Inspection Agency
1400 Merivale Road
Ottawa, Ontario
K1A 0Y9
November 24, 2009
PPRTM ### -MMYY
Mr. I. M. Foodguy
Program Manager - Quality and Regulatory Affairs
Processed Products Company of Canada
123 Any Street
Someville, Ontario
M8V 2B8
Dear Mr. Foodguy:
This is in response to your application of November 18, 2009 for a Test Market Authorization (TMA), for readyto-serve tomato soup, packed in a non-standard container size.
Pursuant to Section 9.1 of the Processed Products Regulations, the Canadian Food Inspection Agency (CFIA)
authorizes Processed Products Company of Canada to test market the product described below, subject to
the following terms and conditions:
1.
APPLICANT
Processed Products Company of Canada
123 Any Street
Someville, Ontario
M8V 2B8
Tel.: (123) 456-7890
Fax: (123) 456-7891
e-mail: imfoodguy@processedproducts.com
2.
NON-COMPLIANT ELEMENT UNDER THE PPR
Container size
3.
COMMON NAME
Tomato Soup
4.
BRAND NAME
Souper Douper
5.
INGREDIENTS
Tomato Soup: - Water, tomato paste, glucose-fructose, enriched wheat flour, cream, salt, canola or
soybean oil, whey powder, calcium caseinate, soy protein isolate, spices and citric acid.
6.
SIZE AND TYPE OF CONTAINER
Format:
212 ml
Type: 211 x 300 can, easy open pop top
7.
MANUFACTURED BY
Processed Products Company of Canada, Someville, Ontario
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Appendix 13B
8.
TOTAL QUANTITY OF PRODUCT TO BE TEST MARKETED
Approximately 94, 000 cases of 24 cans
10. GEOGRAPHIC AREA
Canada
11. DURATION OF THE TEST MARKET
24 months: November 24, 2009 to November 24, 2011
Your file contains a copy of the label to be used on the product. Please note that the current and final label
must be submitted to this office within 90 days, as prescribed in Sub-section 9.1 (4) of the PPR.
This authorization is subject to cancellation should any condition set out in Section 9.1 of the PPR, or in this
letter, not be met during the test market period. Your product will need to comply with all applicable Canadian
regulatory requirements in order to be marketed beyond the test market period.
If you have any questions regarding this TMA, please contact Ms. Test Market (PPRTMARPTEMM@inspection.gc.ca, (xxx) xxx-xxxx, Fax: (xxx) xxx-xxxx).
Yours sincerely,
Director
Consumer Protection Division
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