Microbial Supplements

Products Regulated

Microorganisms, either naturally occurring or genetically modified that improve the physical condition of soil, aid plant growth or increase crop yield. These may include rhizobia, such as R.meliloti, B.japonicum; free living nitrogen fixing bacteria, such as Bacillus, Pseudomonas; or fungi, such as Penicillium, Glomus spp.

Relevant Legislation/Memoranda

Section 3(a) of the Fertilizers Act requires microbial supplements (also referred to as biofertilizers) be registered before sale in Canada; and applies to imported or domestic products. Standards and labelling requirements are specified in Sections 3(b) and 3(c).

The Plant Protection Act and Regulations indicate that import permits are required before a microbial supplement may be imported into Canada for experimental or commercial purposes. As well, Trade Memoranda T-4-107 explains registration requirements; T-4-103 explains research exemption requirements; and T-4-108 explains the requirements for field testing supplements.

Draft guidelines for the identification and safety evaluation of microbial products intended for field application or registration under the Fertilizers Act are available. These guidelines detail the information requirements to be submitted for safety assessment of microbial supplements.

Key Requirements

Imported microbial supplements for research require an import permit. Application forms and information can be obtained from the addresses listed below. Permits are required to import a micro-organism for laboratory or greenhouse uses. If the product is imported for experimental release, a research exemption must also be obtained.

Research trials - Exemptions may be obtained by submitting an application package based on the information detailed in the guidelines for Identification and Safety Evaluation. An exemption from the Act and Regulations may be granted to researchers who are conducting experimental releases to generate data for registration. This exemption requires that the product be reviewed for safety and that the release is designed to generate statistically significant efficacy data. Information providing guidance for field releases is contained in T- 4-108, while T-4-103 provides information for obtaining a research exemption. Copies of these memoranda are available through the Fertilizer Section.

Registration of supplements for sale - require that applications be submitted for review to the Fertilizer Section. Both domestic and imported product applications are reviewed to assure that products are safe, effective and in compliance with labelling and other standards (eg., quality and safety). Efficacy claims must be supported by data. Human health, environmental, plant and animal safety reviews are conducted by the Canadian Food Inspection Agency. Environment Canada and Health Canada may be consulted during the evaluation process. See Trade Memorandum T-4-107.

Post registration surveillance - is conducted by regional inspectors to ensure that registered products continue to meet quality and safety standards after registration. This involves random sampling of the product with subsequent laboratory testing by the Canadian Food Inspection Agency laboratories and research stations. The results of tests for rhizobial inoculants and pre-inoculated seed are published and distributed annually. Post-registration surveys are administered by the Fertilizer Section.

Responsible Office

Registration or Research Exemption

Fertilizer Section
Plant Health and Production Division
Tel: 613-225-2342

Import information

Plant Health and Production Division
Permit Office
Tel: 613-225-2342

General inquiries may also be directed to the regional office of the Canadian Food Inspection Agency, Plant Health and Production Division in your local area. Please consult the blue pages of your telephone directory for the office nearest you.