RG-1 Regulatory Guidance:
Chapter 2 - Data Requirements for Single Ingredient Approval and Feed Registration
2.2 Registration Requirements for Specialty Products
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The types of mixed feeds for which a submission for a specialty product registration is required include, but are not limited to, the following:
- Anion/Cation Balance Feeds
- Buffer Feeds
- Rumen Bypass Feeds
- Forage Additives (bacterial silage inoculants, nutritive additives, mould inhibitors)
- Odour Control Agents
- Pellet Binders
- Viable Microbial and Yeasts
- Enzyme Products
- Any mixed feed or single ingredient feed making nutritional and/or animal production claims
1. Standard registration requirements as indicated in Chapter 1.
2. Proposed labels must reflect the purpose of the product and the standards, packaging and labelling requirements of the Feeds Act and Regulations. Guarantees for nutrients and/or active ingredients must appear on the product label. Five copies of the proposed label and a copy of the product formulation (e.g., percentage composition) are required for submission.
Product Description and Supporting Information
3. A complete list of ingredients identified by generic name is required, as listed in Schedule IV or V of the Feeds Regulations. Registration numbers for Part II ingredients, mixed feeds, and other registered products must also be included.
Mixed feeds may contain ingredients that are not listed in either Schedule IV or V of the Feeds Regulations. If the applicant wishes to use a currently unapproved feed ingredient as part of the product formulation in question, it is also necessary to submit an application for registration to have the ingredient approved for use in livestock feeds in Canada prior to submitting the application package for the specialty product in question. Information concerning the application process for new feed ingredients can be found in section 2.3. "Single Ingredient Feed Evaluation Requirements". Note that the application for registration for the specialty product cannot be approved unless all of the ingredients used in the product formulation are approved and listed in either Schedule IV or V of the Feeds Regulations (i.e. the application will be placed on hold).
4. The intended purpose of the feed (to assist in designating the name of the feed, e.g., anion/cation balance feed, flavouring agent, antioxidant, forage additive) is also required.
5. Scientific studies must be presented in support of each label claim. These investigations must meet the following criteria:
- they are carried out by qualified research personnel;
- they are performed using the target livestock species;
- they are carried out using suitable/recognized scientific methods and protocols;
- they are designed to facilitate statistical analysis (i.e., using a suitable statistical model, proper sampling protocol and sufficient sample size);
- scientific data are analysed using appropriate statistical methods;
- they consist of at least one control group and one treatment group;
- they show a significant difference (P<0.05) between the control and treatment groups;
- they indicate that the product, when used as directed, results in a significant improvement in one or more nutritional/animal production claims for the product;
- where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate the lowest inclusion rate;
- they are conducted under conditions (i.e., climate, management and feed practices) similar to those that may be expected to occur in Canada; and
- where the results of these studies have not been published in a peer-reviewed journal, copies of the raw data and printouts of statistical analysis are supplied for review by the Feed Program.
6. Certificates of analysis are required from three different and recent lots of product, in addition to an accompanying analytical methodology to substantiate the guarantee(s) that appear on the product label.
7. Quality control procedures demonstrating product consistency are required, if applicable.
8. Product sample(s) (for products such as for forage additives, direct-fed microbials and enzyme supplements) may be requested by the evaluation officer or Feed Laboratory to verify analytical methodologies and/or label guarantees.
9. Stability (i.e., shelf life) information must be submitted, if applicable. To support product stability, it will be necessary to submit certificates of analysis substantiating the guaranteed shelf life on the label (i.e., at the date of manufacture and at the expiry date) for a minimum of three different lots of the product. The certificates of analysis for the level/concentration of the active ingredient(s) at the date of manufacture and at the expiry date must be for the same lot of product. The storage conditions used in the shelf life study should reflect the recommended storage conditions as stated on the product label.
10. As outlined in sections 2.3 and 2.4 scientific investigations supporting product safety may include, but are not limited to: chemical analyses and/or harmful residues and/or toxicological evaluation and/or animal feeding studies and/or tissue residue analysis. The scientific studies presented in support of product safety must be:
- carried out by qualified research personnel;
- carried out using suitable/recognized scientific methods and protocols;
- designed to facilitate statistical analysis (i.e., using a suitable statistical model, proper sampling protocol and sufficient sample size); and
- analysed using appropriate statistical methods.
11. Suitable methodologies for the detection of significant amounts of any ingredient, nutrient, compound, substance, or organism intentionally incorporated into the feed or occurring as a contaminant must also be provided.
Requirements for Amendments (Significant Change) to Specialty Product Registrations
Applications for significant change will be evaluated on a case by case basis. Changes including, but not limited to, the following product characteristics require the submission of efficacy and/or safety data (which meet the criteria previously outlined), as part of the application for registration amendment:
- changes to the label guarantees for nutrients and/or active ingredient(s);
- changes to the product formulation that effect the efficacy and/or nutritional content of the product (e.g., addition/removal of a bacterial culture, changes to ingredients that are a main source of nutrients, or addition/removal of a pellet binder);
- changes to the manufacturing process that may change the nature of the product or contribute to the introduction of chemicals (either as contaminants or additives), or changes to starting materials, processing aids, etc. used in the manufacturing process;
- changes to, or the addition of, label claims;
- the addition of livestock species to the product label (i.e., in cases where a product is only approved for use in certain species);
- modifications to the directions for use; or
- changes to the duration of the shelf life of the product.
Please refer to Chapter 1 for additional information regarding significant changes to product registrations. The application fees for these types of changes are the same as those for a new application for registration for a Category 2 product.
Formulation changes involving ingredients that are not considered to be active ingredients or a significant source of nutrients (e.g., flavours, carriers), will be evaluated on a case-by-case basis and may or may not require the submission of efficacy and/or safety data. However, it is recommended that the Feed Program be contacted ahead of time in order to determine what type of information and documentation will be required for submission with the proposed application for registration amendment.
Registration Requirements for Private Labelled Products
The private label registration process has been put in place to allow companies to commercialize a product that is already registered by another company under a different brand name. Such applications are considered standard feeds and do not require any additional safety or efficacy evaluations. Applications for registration of private labels must include a completed and signed application for Application for Feed Registration or Renewal form (CFIA/ACIA 0009), the application fee for a standard mixed feed, five copies of the proposed product label (including the name and address of the private label registrant), an accompanying cover letter, and a letter from the company holding the original registration, signed by a person having signing authority for this company, allowing the private label applicant to use the information on file to register their product as a private label.
As the formulation of the private label product must correspond exactly to the formulation originally approved for the parent product, any mandatory information present on the original label (e.g., list of ingredients, guaranteed analysis, directions for use, caution statements) must be present on the private label. If the private labelling company also manufactures the feed, the formulation is required and certificates of analysis may be requested.
Applications for amendments to private label registrations will be evaluated on a case-by-case basis according to the following criteria:
- Mandatory amendments
For mandatory registration amendments (i.e., amendments initiated by the Feed Program), the Feed Program will inform all holders of a registration for the type of product affected by the amendment, including private label registrants. Mandatory amendments must be made to both private labels and parent product labels. There will be no charge for such amendments.
In cases where an application is made for a private label for which the status of the original product registration would not satisfy new mandatory requirements (due to concerns with efficacy and/or safety data), the private label application will be refused until the original product meets all registration requirements. The holder of the original registration will be notified of the situation.
Minor mandatory amendments required by the Feed Program will be made to a private label product immediately upon registration or registration renewal, even though the label for the parent product may not yet comply with the new amendment. In these cases, the private label will be corrected before the original product label. Minor mandatory amendments to the original label will be made at the time of renewal or when an application for significant change is submitted to the Animal Feed Division.
- Voluntary amendments
When the original registrant is granted an amendment (e.g., revised guarantee, addition of a claim, changes in the formulation), the original registrant is responsible for notifying the private label registrant(s) of these amendments. In such cases, private label registrants are not obliged to update their registration to reflect the change(s) made to the original registration as long as the private label continues to comply with the Feeds Regulations. However, should the private labelling company chose to include the new information, an application package for a significant change must be submitted.
- Registration renewal
A copy of the product formulation (including registration numbers for Part II ingredients, flavours, registered mixed feeds, etc.), and a letter from the company holding the registration of the parent product allowing the private label company to continue to use the information on file to renew the private label product, must be submitted with each application for registration renewal.
Note: If a parent product is issued a temporary registration, the private label product will only be granted temporary registration status. The expiry date for the private label product will be the same as that for the parent product. The granting of permanent registration status to a private label product that was previously given a temporary registration is contingent upon the parent product receiving permanent registration status. If the application for permanent registration is submitted at the time of renewal, the registration fee will be in addition to the renewal fee. If the application is submitted prior to the expiration of the temporary registration, the registration fee is the same as that for the consideration of a new application for registration.
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