Notice to industry: Update on the pilot project to allow veterinary health products in livestock feed
Further to a January 11, 2021 notice to industry on the pilot project to allow livestock feeds to include veterinary health products (VHPs), information on which veterinary health products (VHPs) may be added to livestock feeds as well as implementation details, are provided below. The pilot project is a collaboration between the Canadian Food Inspection Agency (CFIA) and Health Canada (HC).
This pilot will consider VHPs that contain only the following ingredients (active and non-medicinal ingredients):
|#||Active ingredient||Feed ingredient #||VHP ingredient #||Maximum level in feed (mg/kg feed or ppm Table Note 1)|
|1||Acetic acid||Sch IV, 8.1||3|
|2||Butyric acid||Sch IV, 8.151||8198||1000 ppm|
|3||Citric acid||Sch IV, 8.15||207|
|4||Formic acid||Sch IV, 8.20||6968|
|5||Lactic acid||Sch IV, 8.27||6969|
|6||Propionic acid||Sch IV, 8.41||7696|
|7||Sorbic acid||Sch IV, 8.58||7691|
|8||Fumaric acid||Sch IV, 8.83||5129||20,000 ppm|
|9||Malic acid||Sch IV, 8.124||8201||6,600 ppm|
|10||Cinnamaldehyde||Sch V, 3.8||7602||17.5 ppm, from all sources|
|11||Cinnamomum verum (ceylon) bark, essential oil||Sch V, 3.11||205||17.5 ppm cinnamaldehyde, from all sources|
|12||Cinnamomum verum (zeylanicum) leaf, essential oil||Sch V, 3.1||206||17.5 ppm, cinnamaldehyde, from all sources|
|13||Curcuma longa (turmeric) root , oleoresin||Sch V, 20.17||761||100 ppm|
|14||Eucalyptus globulus leaf, essential oil||Sch V, 5.37||5577||1 ppm|
|15||Allium sativum (garlic) bulb, dried||Sch V, 7.1||333||100 ppm|
|16||Allium sativum (garlic) bulb, essential oil||Sch V, 7.2||333||100 ppm|
|17||Glycyrrhiza glabra (licorice) root, stolon, dried||Sch V, 7.12||447||100 ppm|
|18||Glycyrrhiza glabra (licorice) root, stolon, extract||Sch V, 7.13||447||100 ppm|
|19||Illicium verum (anise) fruit, seed, essential oil||Sch V, 1.12||721||62.5 ppm anethole, from all sources|
|20||Origanum vulgare (oregano) aerial parts, essential oil||Sch V, 15.1||5436||110 ppm|
|21||Mentha piperita (peppermint) leaf or twigs, essential oil||Sch V, 16.20||567||100 ppm|
|22||Rosmarinus officinalis (rosemary) aerial parts, essential oil||Sch V, 18.4||635||100 ppm|
|23||Thymol, isolate||Sch V, 20.11||750||25 ppm|
|24||Thymus vulgaris (thyme) aerial parts, dried||Sch V, 20.4||749||40 ppm|
|25||Thymus vulgaris (thyme) aerial parts, essential oil||Sch V, 20.5||749||40 ppm|
|26||Syzygium aromaticum (Eugenia caryophyllus, clove) flower buds, dried||Sch V, 3.25||213||62.5 ppm eugenol, from all sources|
|27||Syzygium aromaticum (Eugenia caryophyllus, clove) flower buds, essential oil||Sch V, 3.17||213||62.5 ppm eugenol, from all sources|
|28||Eugenol, isolate||Sch V, 5.28||5649||62.5 ppm, from all sources|
|29||Carum carvi (caraway) seed, dried||Sch V, 3.4||151||100 ppm|
|30||Carum carvi (caraway) seed, essential oil||Sch V, 3.3||151||100 ppm|
|31||Trigonella foenum-graecum (fenugreek) seed, dried||Sch V, 6.3||854||62.5 ppm anethole, from all sources|
|32||Trigonella foenum-graecum (fenugreek) seed, extract||Sch V, 6.4||854||62.5 ppm anethole, from all sources|
|33||Trigonella foenum-graecum (fenugreek) seed, oleoresin||Sch V, 6.2||854||62.5 ppm anethole, from all sources|
|34||Capsicum annuum fruit, dried||Sch V, 3.1||149||100 ppm|
|35||Capsicum annuum fruit, oleoresin||Sch V, 3.29||149||100 ppm|
|36||Piper nigrum fruit, extract||Sch V, 16.16||5506||100 ppm|
|37||Piper nigrum fruit, oleoresin||Sch V, 16.17||5506||100 ppm|
- Table Note 1
ppm = parts per million, 10−6 (1 milligram / 1 kilogram)
|#||Inactive (non-medicinal) ingredient||Feed Schedule IV ingredient #||VHP LPS Table Note 2 ingredient #||Maximum level in feed (mg/kg feed or ppm Table Note 3)|
|3||Butylated hydroxyanisole (BHA)||8.9||121||200 ppm of the fat or oil content (BHA plus BHT)|
|4||Butylated hydroxytoluene (HTB)||8.10||4927||200 ppm of the fat or oil content (BHA plus BHT)|
|9||Water (or purified water (RO); reversed osmosis purified water)||N/A||5307|
|10||Water (or aqua; distilled water; purified water; sterile water)||N/A||5360|
|12||Hydrogenated vegetable oil||4.5.19||383|
|14||Mineral oil||8.33||524||600 ppm|
|16||Beet sugar molasses||4.4.1||79|
|21||Sodium carboxymethyl cellulose||8.53||687||20,000 ppm (2%)|
|23||Sunflower seed oil||4.5.8||731|
|25||Xanthan gum||8.67||795||Not to exceed 0.1% in calf milk replacer and 0.25% in liquid feed supplements for ruminant animals.|
|28||Distilled acetylated monoglycerides||8.125||4920|
|29||Sodium salts of fatty acids||8.101||7091|
|34||Glycerin||4.6.44 or 8.21||5238|
|35||Sucrose||4.6.14 or 4.6.17||5329|
|42||Silicon dioxide||8.49||5320||20,000 ppm (2%)|
|45||Glyceryl polyethyleneglycol ricinoleate||8.145||5480||500 ppm|
|46||Brilliant blue FCF dye||8.72||5554|
All products considered under this pilot must continue to follow existing requirements for VHPs. Claims on marketed VHPs are limited to general health claims and must not include anti-parasitic, antimicrobial replacement or therapeutic claims.
How to participate in the pilot project
To participate in the pilot, interested companies with eligible products should:
- Request a pre-screen template from Health Canada's VHP at firstname.lastname@example.org.
- Submit a completed template for each product to be considered to Health Canada's VHP email account between March 15, 2021 to April 2, 2021.
Because this is a pilot project, the number of products accepted will be limited. Companies may submit up to 2 products, on separate templates, for consideration. To allow for fair participation, 1 product per company will be considered before accepting a second product from a company.
Submissions will be considered on a "first come, first served" basis. As a result, companies are encouraged to submit fully completed pre-screen templates to HC as soon as possible.
Submission of a pre-screen template does not guarantee that the product will be "notified" or included in the pilot project.
HC and the CFIA will jointly review submissions to determine eligibility. Applicants will be informed of the outcome of the pre-screening process.
HC will inform successful applicants of products that are eligible for the pilot.
Companies will be asked to complete and submit a notification form for the product via the VHP web application. Companies should only submit this notification once they have received confirmation from HC that the product is eligible for the pilot project.
Information on guidelines, processing and fees for VHPs is available on the page About the VHP notification program. Failure to provide all requested information may result in delays or rejection of the application.
Manufacturers of VHPs are required to follow Part 3 - Good Manufacturing Practices (GMPs) of the Natural Health Products Regulations. Although companies are not required to submit manufacturing information as part of the notification process, companies are responsible for having all of the data available should HC request it.
Applications that meet all the requirements after verification will be accepted for notification, listed in the public list of Notified Products on Health Canada's website and assigned a notification number.
Publication of compendium
The CFIA will prepare and publish on its website the VHP in feed compendium (Compendium) containing all products that have been successfully notified through this pilot project for use in feed.
Once products are listed in the Compendium, they may be used in the manufacture of livestock feeds. The Compendium will include information that is required on the label of livestock feeds that contain a VHP.
The publication of the Compendium is expected by July 2021.
Under the VHP notification program, the principal contact for the notifier (such as the chief executive officer or a director of the company) will be required to attest that there is:
- objective and credible evidence demonstrating that the product is safe; and,
- a reasonable expectation of effectiveness when used as intended.
Because these VHPs are intended for use in feeds, it must be considered whether normal feed manufacturing practices such as pelleting or extrusion would affect the availability or stability of the active ingredients and efficacy of the VHP.
The recommended dose for the VHP should also indicate the types of feeds it is suitable for use in (for example, pellet, mash, etc.). If manufacturers indicate that their product is suitable for use in pelleted feeds, the notifier should be able to demonstrate this suitability if requested by HC.
Products that are already registered as feeds or have been previously notified as a VHP (for example, for use in drinking water) may be submitted for this pilot if they meet all the eligibility requirements. These products will need to be re-notified with the specific in-feed instructions and dosage form, as applicable.
The label of a livestock feed that includes a notified VHP will contain information from the Compendium, including the notification number of the VHP.
For the purposes of this pilot, feeds may only contain VHPs at the level and for the duration of use listed in the Compendium. Feeds may not contain mixtures of different VHPs, or a VHP and a conventional medicating ingredient (with a drug identification number), in the same feed.
The proposed timeline for this pilot is as follows:
- February 2021 – Launch of the in-feed VHP pilot
- March 15, 2021 to April 2, 2021 – Companies submit completed pre-screen templates to HC
- April 2021 – HC and the CFIA notify participating companies of the outcome of their pre-screening submission
- May 2021 - Successfully pre-screened companies submit notification form
- June 2021 - HC issues notification number to accepted VHPs and includes these on the public notified products list
- July 2021 – VHP in feed compendium published, notified products can be used in feeds as of this date
- August 2021 – Pilot project evaluation
If you have any questions, contact HC's Veterinary Drugs Directorate by email at email@example.com with "VHP in feed pilot" in the subject line.
- Notice to industry
- Feeds Regulations, 1983
- Health Canada's Veterinary Health Products program
- Proposed amendments to the Feeds Regulations (Feeds Regulations, 2022)
- Date modified: