RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.10 Hemp products
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Regulation of Hemp Products for use in Livestock Feeds
In Canada, livestock feeds are regulated, as per the federal Feeds Act and Regulations, by the CFIA. All single ingredient feeds manufactured, sold or imported into Canada must be approved and listed in either Schedule IV or Schedule V of the Feeds Regulations. At the present time, hemp products are not approved as livestock feed ingredients in Canada. Each hemp product intended to be used as a livestock single ingredient feed (e.g., hemp meal, hemp oil, seeds) will require separate approval.
For an application to be accepted, an applicant needs to first establish signing authority, provided they have never submitted an application to the Animal Feed Division before. Please refer to Chapter 1 for additional information regarding signing authority.
If a company or an individual wishes to apply for approval of hemp or a hemp by-product as a new single ingredient feed, then the following information needs to be submitted for each ingredient:
1. Application form, covering letter, and the applicable fee.
2. Proposed labels reflecting the purpose of the ingredient, intended species, and suggested and maximum use rates are required, including the standards, packaging, and labelling requirements, as per the Feeds Act and Regulations.
3. A precise description of the hemp product or by-product ingredient is required to assist in accurately describing the ingredient in Schedule IV, including impurities present (i.e., the maximum levels present).
4. Specify the composition of the hemp by-product being evaluated for use in livestock feed, including impurities or chemical contaminants. State whether this particular hemp by-product ingredient is recognized as a food ingredient in Canada.
5. Complete details of the manufacturing process for the specific ingredient are required, including: the identity of the starting materials; chemical and physical treatment processes (e.g., processing temperatures, solvents and reagents used); and quality control procedures.
Note: If the required information cannot be obtained because it is proprietary to the manufacturer, request that the manufacturer submit the details to the Animal Feed Division, accompanied by a signed letter stating that the Animal Feed Division may use this or additional proprietary information on hemp manufacturing deemed necessary for the evaluation.
Safety Data Requirements
6. Identify the pesticides used or applied in the cultivation and production of the hemp crop that is the source of the hemp product or by-product. Please account for all residual chemical concentrations, including those remaining on the portion destined for livestock feed.
7. Certificates of Analysis (signed) are required for 3 different lots of each hemp by-product ingredient being evaluated, including analysis for any known contaminants, such as tetrahydrocannabinol (THC) and heavy metals (aluminum, arsenic, cadmium, chromium and lead, as a minimum). State the maximum allowable concentrations for each of the above compounds present in the hemp product or by-product, as per the company's quality control procedures. Provide the limit of detection for the method of analysis used to measure each contaminant.
8. Provide a discussion of the known toxicants associated with the source of the hemp or its by-product (i.e., the hemp plant), including the maximum level of THC that may be present in the hemp product or by-product. If impurities or contaminants are present, then additional toxicity data is required for each one in order to support the levels that may be present in livestock feed.
Note: The toxicity data may be obtained from complete articles in peer-reviewed journals, information from toxicity databases or actual toxicity studies with all the data provided. Toxicity studies must focus on acute and longer term (such as 28-day or 90-day study) exposure via the oral route and mutagenicity studies (with and without metabolic activation), as a minimum.
9. Evidence of safe feeding to livestock and/or laboratory animals (e.g., rodent toxicity data) is required. As a minimum, the data must include oral feeding studies representative of the pattern of use for the hemp product; that is, the study must be done using the livestock species of interest, and one of the feeding rates must be equal to the proposed maximum inclusion rate. Studies may come from articles from refereed journals or actual studies with all the data provided (including statistical analysis, etc.)
10. Supportive information relevant to the use of the particular hemp product or by-product in other publications may be submitted (e.g., the Canadian Food & Drugs Act, Association of American Feed Control Officials, National Feed Ingredients Association, Red Book, United States (US) Code of Federal Regulations, Council of Europe).
Efficacy Data Requirements
11. A description of each product or by-product is required including the nutritional content, physical form, and the manufacturing processes involved in the production of the ingredient. If these ingredients are intended to be fed to all life stages of the target livestock species, then acceptable studies must cover the appropriate growth phases (e.g., from day one to market for broilers). These studies should show that when fed for the target period, the performance of treated animals is not compromised (i.e., test livestock fed the new ingredient should fare equally well or better than those fed a conventional ration for the targeted feeding period).
12. Certificates of Analysis for proximate analysis and for any additional nutrients that will be guaranteed on the label are required for 3 different lots of each hemp by-product ingredient being evaluated.
13. Labels must state directions for use as supported by efficacy studies (refer to item #14). These labels should also show the guaranteed analysis for the main nutrients supplied by the product (e.g., guarantees for minimum crude protein, minimum fat, maximum crude fibre and maximum moisture). In order to guarantee nutrients not listed in Schedule I, Table 3 of the Feeds Regulations, efficacy data needs to be included supporting the necessity of such "nutrients" (e.g., a guarantee for omega-3 fatty acids is not allowed unless data is included that indicates the nutritional necessity of these fatty acids in the target species).
14. The label should indicate the purpose for incorporating this ingredient in livestock diets (e.g., for maintaining weight gain in broilers, or for use as a source of supplemental crude protein in swine diets). Each claim must be supported by data as requested in item #15.
15. A minimum of 3 efficacy studies evaluating production/performance data are required to support the effectiveness of this product in each target species (e.g., cattle, layers, broilers, or swine, when used as directed in #10 above).
Note: Efficacy studies may be used to support the safety of the hemp product or by-product as long as one of the feeding rates is equal to the proposed maximum inclusion rate to be fed to the target species.
16. To be acceptable, data to support the use of hemp products in livestock diets should be scientifically derived as per Section 2.2 "Specialty Product Registration Requirements". Briefly, scientific studies presented in support of the claim(s) must be:
- carried out by qualified research personnel;
- performed using suitable methods;
- designed to facilitate statistical analysis;
- analyzed using appropriate statistical methods;
- conducted under conditions similar to those that may be expected to occur in Canada; and
- determined using a significant statistical difference (P<0.05) between the control and treatment groups.
When designing studies to evaluate the efficacy of a product where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate the lowest inclusion rate. In addition, when the results of these studies are not published in peer reviewed journals, copies of the raw data and printouts of statistical analysis are required for review by the Animal Feed Division.
Note: Further information may be deemed necessary after the review of the preliminary submission by the Animal Feed Division.
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