On July 3, 2024, Health Canada officially permitted the use of Veterinary Health Products (VHPs) via the in-feed route of administration. This significant regulatory update opens new opportunities for maintaining and promoting the health and wellness of animals. This article will explore the background of VHPs, the requirements for in-feed administration, and key considerations for compliance.

Background:

Veterinary Health Products (VHPs) are low-risk veterinary drugs in dosage form, regulated by Health Canada under the Food and Drug Regulations (FDR). These products are designed to maintain or promote the health and wellness of animals but, like Natural Health Products (NHPs), they cannot claim to treat, prevent, or cure disease.

Previously, VHPs were available in various forms of administration such as in water, top-dress, boluses, or as topicals. In-feed administration was not permitted. In 2022, a pilot project tested a limited group of low-risk VHPs for in-feed use. With the conclusion of this program, a list of VHPs allowed to be mixed into livestock feed has been published.

List of Permitted Substances:

Before using your VHP ingredient via the in-feed route, you must check the List of Permitted Substances. If the ingredient is not on the list, you need to submit a Short Substance Application (SSA). This process includes an incompatibility assessment document that must accompany the in-feed substance application.

Additionally, any ingredient targeting the in-feed route listed in Part 2 of the Canadian Feed Ingredients Table (CFIT) must have a Canadian Food Inspection Agency (CFIA) registration number. Part 2 ingredients are subject to the in-feed notification process, which requires informing the VHP Notification Program of any changes in the ingredient’s registration status. Part 1 ingredients are not subject to this requirement.

Additional Considerations:

• Only for food-producing animals (i.e., no companion animals).
• Homeopathic substances are not permitted for in-feed use.
• Stakeholders must submit an in-feed Notification Form in both official languages. Failure to do so will result in rejection.
• Mandatory quantitative declaration on labels of an in-feed VHP for excipients ≥10% of the National Research Council’s (NRC) minimum nutrient requirement.
• For inclusion rates < 5 kg VHP/tonne feed or 5 g VHP/kg feed, an intermediate mixing step should be included in the Notification Form and label to ensure uniformity of mix and proper use by end users: “To ensure adequate mixing, an intermediate mixing step should be performed.”
• Mixing two or more in-feed VHPs within livestock feed is currently not allowed.
• Proprietary blends are not allowed for in-feed use.
• Once notified, the in-feed VHP must be listed on the Compendium of Non-Feed Products before legal use in Canada.

How Can I Be Prepared?

To ensure compliance with the new in-feed route of administration requirements, industry stakeholders should:

1. Check the List of Permitted Substances: Determine if your ingredient is on the list. If not, complete an SSA.
2. Determine the Classification: Identify whether your ingredient is a Part 1 or Part 2 ingredient to determine its registration status.
3. Reach Out to Experts: Contact dicentra for comprehensive services and support in navigating the new in-feed route of administration requirements.

For any additional questions or concerns about this or any other regulatory affairs matters, don’t hesitate to reach out to the experts at dicentra. Take proactive steps now to ensure your products comply with these new regulations and maintain the health and wellness of the animals you serve.