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Overview of engagement process
Appendix E-3: Acid-based products (ABPs), 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 classifying products containing acids for livestock species and their associated claims.
A joint consultation was held on the proposed Appendix E-3 by Health Canada's Veterinary Drugs Directorate (VDD) and the Canadian Food Inspection Agency (CFIA)'s Animal Feed and Veterinary Biologics Division (AFVBD). Feedback was received from:
- National feed association
- Livestock producer associations
- Livestock feed manufacturers
What we heard
There was overall support for the new categories and added flexibilities for this category of products, especially as feeds, and for including Veterinary Health Products (VHPs) in livestock feeds in the future. These will provide access to more products and thereby allow for increased competitiveness for Canadian livestock producers. The ability for industry to incorporate VHPs in feed was strongly noted. Further clarity on the overlap of claims acceptable for drugs, VHPs and feed was requested, as were clearer details on the relevant classification criteria. Many comments focussed on the need for direction once products are classified as feed, such as how to register products and what studies could support claims. Finally, the respondents expressed interest in having pathogen control options as either feeds or VHPs. At this time, products related to a reduction in pathogens in the animal are classified as veterinary drugs, whereas the reduction of pathogens in feed material may be considered as feed. Further discussion around the classification of pathogen reduction claims is out of the scope of this Appendix.
How the feedback was considered
- The appendix has been updated to include relevant examples for veterinary drug and feed uses
- The appendix has been updated to improve the clarity in the relevant classification criteria section. Examples have been provided in each of the sub-sections
- The scope of this Annex is to facilitate the classification of ABPs as veterinary drugs or livestock feeds. It does not lay out the requirements necessary to complete a submission for any of the 3 classifications. Additional guidance on the contents of a submission can be provided for the appropriate regulatory pathway once a classification has been completed
- Questions and comments on how to complete a feed registration package are noted and will be incorporated into a regulatory guidance document outlining the requirements for ABPs as feeds. A guidance document on the requirements for Gut Modifiers is also being finalized
- Note that the feed categories have been revised as Acid Based Products with subcategories of pH adjuster, preservatives and mould inhibitors, and gut modifiers. The term Acidifiers is being phased out
- Currently, the Feeds Regulations do not allow VHPs to be incorporated into livestock feed. The CFIA has proposed amendments to the Feeds Regulations that would put in place new conditions under which VHPs may be incorporated into feed for food-producing animals. Since the publication of this draft annex, HC and the CFIA initiated a pilot process to explore the incorporation of VHPs into feed prior to these amendments. The pilot is a temporary measure to inform future regulatory amendments and implementation. ABPs were included in the pilot
Next steps
We have considered the feedback and included changes in the Guidance document on classification of veterinary drugs and livestock feeds. HC and the CFIA continue to work together to find ways to facilitate the availability of products that are part of a health management approach promoting livestock's overall health and welfare.