T-4- 109 – Requirements for microbial supplements

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 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:

• the mixture is not further manipulated (including culturing or sub-culturing);
• each microbial supplement is registered for the proposed use of the mixture;
• its directions for use are consistent with those of the registered product (for example, target crop, use pattern, application rate, frequency and method).
• all other active ingredients in the mixture are either registered for the proposed use of the mixture or are exempt from registration (for example, materials on the List of Materials).

Note that:

• if the directions for use of the registered microbial supplement or other active ingredient are not consistent with the registered product, the original registration must be amended accordingly (major amendment) or the final mixture must be registered.
• if the mixture contains an unregistered and non-exempt active ingredient the final product requires registration. Alternately, the unregistered ingredient could be registered for that use, in which case the final mixture would be exempt from registration.
• the product proponent is responsible for ensuring that all ingredients in their products are compliant with the regulations – this includes ensuring that registered ingredients maintain valid registrations. If a product is being sold as an exempt mixture that contains a registered a product, and the registered product's registration lapses or is cancelled, then the previously exempt product would no longer meet all requirements of the mixtures exemption, and would be out of compliance and subject to enforcement action.

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:

• labelled with the registration numbers of each registered product in the mixture and the term of each exempt material in the mixture (as set out in the List of Materials) is indicated on the label together with any other information sufficient to demonstrate that the mixture is exempt.

  Or

• the product is labelled with a statement indicating that the fertilizers and the supplements present in the mixture are either registered or exempt from registration;
• the person who packaged the mixture, caused it to be packaged or the person who imported the mixture, maintains a record of the registration numbers and any information that demonstrates that the mixture is compliant with Fertilizers Regulations with respect to the safety of the product; and
• informs the President of the Agency (designated inspectors) of the place where the record is kept.

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
Email: cfia.paso-bpdpm.acia@inspection.gc.ca