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T-4- 109 – Requirements for microbial supplements

The 3 year regulatory transition period (October 26, 2020 to October 26, 2023) has now ended. As a result, regulated parties, including all manufacturers, importers, distributors and sellers of fertilizers and supplements must adhere to the amended Fertilizers Regulations. There are few notable exceptions for some product categories. Learn more about the implementation of the amended Fertilizers Regulations.

1. Purpose

The purpose of this document is to outline registration and labelling requirements for microbial supplements regulated under the Fertilizers Act.

2. Registration requirement

Microbial consortium – means a complex community of microorganisms that is taken from a single natural environment and whose composition is maintained without further manipulation.

Microbial supplements, products represented to contain microorganisms as active ingredients require registration under the Fertilizers Act prior to importation and sale in Canada. This applies to pure cultures of bacteria or fungi, microbial consortia and genetically modified microorganisms (including microorganisms generated through gene editing or synthetic biology techniques).

Mixtures containing microbial supplements are exempt from registration if:

Note that:

3. Standards

All microbial supplements must adhere to the prescribed standards as outlined in Trade memorandum T-4-93 with respect to the product's composition and contaminant levels.

4. Registration application and labelling requirements

For guidance on registration requirements (information and data requirements, safety data package, submission content and layout and associated fees) please consults the Guide to Submitting Applications for Registration under the Fertilizers Act. Labelling requirements which also apply to microbial inoculants are outlined in Trade Memorandum T-4-130 – Labeling requirements for fertilizers and supplements.

Specific labelling requirements apply to microbial supplement mixtures and combination products. These products must either be:

For additional information on the record keeping requirements applicable to mixtures of registered or exempt fertilizer and supplement products please consult Trade Memorandum T-4-131 – Record keeping requirements under the Fertilizers Act and Regulations.

5. Research on novel supplements

Research Authorizations must be obtained prior to the environmental release of all novel supplements, that is, supplements that are not registered and not exempt from registration. This includes all products represented to contain microorganisms as active ingredients. For information on how to obtain a research authorization please consult Trade memorandum T-4-103.

6. Contact Information

Fertilizer Safety Section
Canadian Food Inspection Agency
Phone: 1-855-212-7695

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