Is Your Product a Microbial Consortium or a Mixture of Strains?

Knowing can clarify your path to regulatory compliance

28 July 2022

Did You Know...

...in Canada, microorganisms or microbial strains (e.g., viruses, bacteria, or fungi) are regulated even if they are naturally occurring? For most uses, these microorganisms are regulated under the New Substance Notification Regulations (Organisims) ("the Regulations"). For some uses, such as plant‑growth-promotion (i.e., as fertilizer supplement), the organism(s) is/are exempt from "the Regulations"; however, theseorganisms are still subject to registration on a per-product basis under the Fertilizers Act.

Both notification under "the Regulations" and, if applicable, registration under the Fertilizers Act require you to submit information for an environmental and human health risk assessment. If the product contains multiple microorganisms, each of the strains may have to be notified as a separate substance under "the Regulations". For registration under the Fertilizers Act, a multi-strain product would require completing a risk assessment for each strain. However, this is not the case if the mixture of strains is considered a consortium (2 or more microorganisms living in a natural and stable community). If the substance or product contains a consortium of microorganisms, then the consortium is treated as a single entity for the purposes of risk assessment.

What Is a Consortium of Microorganisms?

A consortium of microorganisms (or microbial consortium) is similarly defined in both the respective Environment and Climate Change Canada (ECCC) and Canadian Food Inspection Agency (CFIA) guidance documents. CFIA guidance T-4-126 defines a microbial consortium as a "[...] complex community of microorganisms taken from a single natural environment whose composition is maintained without further manipulation." The New Substances guidance defines a consortium of microorganisms as a "[] complex unformulated natural combination of microorganisms." The New Substance guidance goes on to explain the additions of pure cultures to a consortium—in such cases, each component (consortium or pure culture) is considered a separate substance. The same logic is applied to mixtures of consortia. Each component consortium (isolated for a single environment) is considered a separate substance.

A product that consists of a mixture of microorganisms isolated from a soil or water sample, cultured as one entity without other additions, would be considered a microbial consortium. However, if the same consortium was subjected to microbiological culturing techniques separating individual strains into pure cultures that were formulated into a mixture, the mixture would not be considered a microbial consortium.

Conclusion

Both the history of strain sourcing/isolation and the specific production process of your microbial product will influence the cost of achieving regulatory compliance. Do you have questions about this topic or a related topic? Contact our experts at Intertek. We can help you understand complex issues surrounding the regulation of microorganisms in Canada, and in jurisdictions worldwide.

To learn more about how we can support your business, visit: https://www.intertek.com/assuris/chemicals/.

References:

CEPA (1999) Canadian Environmental Protection Act, 1999 (justice.gc.ca)

ECCC. Guidelines for the Notification and testing of New Substances: Organisms

New Substance Notification Regulations (Organisms) SOR/2005-248

CFIA. T-4-126- Identification and Taxonomic Classification of Microorganism(s) represented for use as supplements under the Fertilizer Act.

Fertilizers Act (R.S.C., 1985, c. F-10).

 

John Heil Intertek headshot

John Heil,
Regulatory Manager, Chemicals Group
Intertek Assuris

Today's expert blogger, John Heil, is a Regulatory Manager in Intertek's Chemicals Group.  John offers clients assistance with new substances, pesticides, fertilizers, and regulatory review in diverse jurisdictions.  John specializes in organisms and biochemicals.  John holds a Ph.D. in Microbiology from the University of Waterloo.