What We Heard – Appendix E-2: Viable microbial products (VMPs)
Overview of engagement process
Appendix E-2: Viable microbial products (VMPs), is an addition to the Guidance document on classification of veterinary drugs and livestock feeds. It aims to provide guidance on the proposed criteria for the classification of products containing viable microorganisms for livestock species and their associated claims. A consultation was held from May 7, 2018 to July 7, 2018 on the proposed Appendix E-2. Feedback was received from:
- a veterinary association
- pharmaceutical drug manufacturer association
- producer associations
- livestock feed association and manufacturers
What we heard
There was overall support for the additional flexibility for feed claims and the introduction of the gut modifier category for feed. The need to have VMPs allowed in-feed or in-water as Veterinary Health Products (VHPs) was noted, along with the suggestion to allow feed claims related to pathogen reduction. Also, it was requested that general health claims similar to those for VHPs be considered for feeds. Respondents expressed interest in having the ability to combine registered VMP strains in feeds, rather than requiring that all products be registered as a defined product.
How the feedback was considered
- The appendix has been updated to further clarify the classification of VMPs.
- There was a request to expand the definition of ‘physiological event’ in Table E-2. Several examples of potential physiological events have been added.
- A statement was added to clarify that VHPs are regulated under the Food and Drugs Act and Regulations, as a type of veterinary drug.
- Much of the feedback expressed pertains to the regulation of the products rather than to their classification. As the document itself is intended to clarify the classification of VMPs, regulatory changes cannot be addressed through the appendix.
- Health Canada’s Veterinary Drugs Directorate (VDD) and the Canadian Food Inspection Agency (CFIA)’s Animal Food Division (AFD) continue to discuss the potential to include some VHPs in-feed and to increase regulatory flexibilities.
- Both VDD and AFD consider that products with claims related to the reduction of pathogens will be classified as drugs, and be subject to the relevant requirements of the Food and Drugs Act and Regulations.
We have considered the feedback and included the changes in the Guidance document on classification of veterinary drugs and livestock feeds. Health Canada and the Canadian Food Inspection Agency continue to work together to find ways to facilitate the availability of products that are part of a health management approach to promote the overall health and welfare of livestock.
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