T-4-107 - Registration of Supplements Under the Fertilizers Act

September 2005

Under the authority of the Fertilizers Act, supplements are defined as "substances other than fertilizers, manufactured, sold or represented for use in the improvement of the physical condition of the soil or to aid plant growth or crop yields". Supplements, with the exception of the following:

1. those listed in Section 3.1 (3) of the Fertilizers Regulations including those listed in Schedule II of the Fertilizers Regulations,
2. supplements sold only for the correction of soil acidity or alkalinity,
3. seed to which a registered inoculant is adhered, and
4. fibrous organic matter that is represented for use only in improving the physical condition of soil, must be registered prior to being imported into or sold in Canada.

In order to apply for registration, the following information and documentation must be provided:

1. A completed copy of the application form entitled Fertilizer or Supplement Registration Application. Please note that a complete list of constituent materials as well as minimum guarantees for the active ingredients must be identified on the application.
2. Three copies of the proposed label, clearly defining the benefit claim(s) and carrying the complete Guaranteed Minimum Analysis for all active ingredients.
3. An acceptable method of analysis to identify and quantify the active ingredient(s). Please refer to the document Good Laboratory Practices Protocol for Fertilizer and Supplement Registrations for more information.
4. The appropriate fee. A summary of the appropriate fees for an application made under the Fertilizers Act is outlined in the accompanying Trade Memorandum T-4-117 Fees for Consideration of an Application Made Under the Fertilizers Act.
5. Designation of signing authority as outlined in Trade Memorandum T-4-95 Signing Authority.
6. If the registrant/applicant does not reside in Canada, the applicant must have an authorized Canadian Agent or Representative. The Declaration of Resident Canadian Agent or Representative must be completed and accompany the application for registration.
7. Statistically-significant efficacy data that support the claims being made regarding the benefits of the product. Please note that these data must have been compiled from scientifically acceptable field trials where the product was used in accordance with the directions for use that are stipulated on the label. Although studies from other countries may be used to support efficacy, at least part of the data must have been derived from Canadian field trials. Please refer to Trade Memorandum T-4-108 Guidelines for Field Testing Supplements for more information.
8. Data to demonstrate the safety of the product. The advice of other departments, e.g., Health Canada, may be sought in the determination of product safety. Please refer to Trade Memorandum T-4-113 "Guidelines to Safety Assessments of Fertilizers and Supplements and to Information to be Submitted in Demonstrating Product Safety".

In the event that the required efficacy data does not exist, an exemption from registration for the purpose of carrying out research is provided under Sections 23.1 to 23.4 of the Fertilizers Regulations. Applicants wishing to conduct research trials may  apply for a research exemption. Details regarding  research exemptions are outlined in Trade Memorandum T-4-103 Guidelines for Research Authorizations for Testing of Novel Supplements, which can be obtained from the Fertilizer Section, Plant Production Division.

If you have any questions with regard to supplement registration please contact the Fertilizer Section:

Canadian Food Inspection Agency
Plant Health and Biosecurity Directorate
Crop Inputs Division
Fertilizer Section
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Canada
Telephone: 613-221-7519
Facsimile: 613-228-4552

This version replaces trade memorandum T-4-107 dated September 1997.