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Notice to industry: Update on the pilot project to allow veterinary health products in livestock feed

2021-03-02

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).

Product eligibility

This pilot will consider VHPs that contain only the following ingredients (active and non-medicinal ingredients):

Table 1: List of active 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 CinnamaldehydeSch V, 3.87602 17.5 ppm, from all sources
11 Cinnamomum verum (ceylon) bark, essential oilSch 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 , oleoresinSch V, 20.17 761 100 ppm
14 Eucalyptus globulus leaf, essential oilSch V, 5.37 5577 1 ppm
15 Allium sativum (garlic) bulb, dried Sch V, 7.1333 100 ppm
16 Allium sativum (garlic) bulb, essential oilSch V, 7.2333 100 ppm
17 Glycyrrhiza glabra (licorice) root, stolon, driedSch V, 7.12 447 100 ppm
18 Glycyrrhiza glabra (licorice) root, stolon, extractSch V, 7.13 447 100 ppm
19 Illicium verum (anise) fruit, seed, essential oilSch V, 1.12 721 62.5 ppm anethole, from all sources
20 Origanum vulgare (oregano) aerial parts, essential oilSch V, 15.1 5436 110 ppm
21 Mentha piperita (peppermint) leaf or twigs, essential oilSch V, 16.20 567 100 ppm
22 Rosmarinus officinalis (rosemary) aerial parts, essential oilSch 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, driedSch 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

Table Note 1

ppm = parts per million, 10−6 (1 milligram / 1 kilogram)

Return to table note 1  referrer

Table 2: List of inactive ingredients
# 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)
1 Ethanol 8.79 10  
2 Beeswax 8.84 77  
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)
5 Calcium stearate 8.14 142 
6 Coconut oil 4.5.4 225 
7 Corn syrup 4.6.11 251  
8 Deionized water N/A 274 
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 
11 Vegetable oil 4.5.8 383 
12 Hydrogenated vegetable oil 4.5.19 383 
13 Methylparaben 8.32 519 1000 ppm
14 Mineral oil 8.33 524 600 ppm
15 Polysorbate 80 8.38 4928  
16 Beet sugar molasses 4.4.1 79  
17 Sugarcane molasses 4.4.6 145 
18 Povidone (polyvinylpyrrolidone) 8.39 584 
19 Propylene glycol 8.43 607 
20 Silica gel 8.48 678  
21 Sodium carboxymethyl cellulose 8.53 687 20,000 ppm (2%)
22 Sorbitol 8.60 711  
23 Sunflower seed oil 4.5.8 731 
24 Canola oil 4.5.3 5179 
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.
26 Magnesium stearate 8.31 4902 
27 Mono-and diglycerides 8.34 531  
28 Distilled acetylated monoglycerides 8.125 4920 
29 Sodium salts of fatty acids 8.101 7091 
30 Mixed tocopherols 8.133 5142 
31 Vitamin C 7.1.2 5151 
32 Cellulose 1.7 5188 
33 Dextrose 4.6.15 5212 
34 Glycerin 4.6.44 or 8.21 5238 
35 Sucrose 4.6.14 or 4.6.17 5329 
36 Honey 4.6.16 5248 
37 Guar gum 8.24 5244 
38 Maltodextrin 4.6.10 5273 
39 Potassium sorbate 8.40 5301 
40 Potassium carbonate 6.122 7546 
41 Potato starch 4.6.39 5303 
42 Silicon dioxide 8.49 5320 20,000 ppm (2%)
43 Soybean oil 4.5.6 5327 
44 Wheat grain 4.1.17 5340 
45 Glyceryl polyethyleneglycol ricinoleate 8.145 5480 500 ppm
46 Brilliant blue FCF dye 8.72 5554 

Table Notes

Table Note 2

LPS – List of Permitted Substances

Return to table note 2  referrer

Table Note 3

ppm = parts per million, 10−6 (1 milligram / 1 kilogram)

Return to table note 3  referrer

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

Pre-screening process

To participate in the pilot, interested companies with eligible products should:

  1. Request a pre-screen template from Health Canada's VHP at hc.vhp-psa.sc@canada.ca.
  2. 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.

Notification 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.

Additional details

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:

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.

Timeline

The proposed timeline for this pilot is as follows:

Questions

If you have any questions, contact HC's Veterinary Drugs Directorate by email at hc.vhp-psa.sc@canada.ca with "VHP in feed pilot" in the subject line.

Additional information

Date modified: