RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration

3.1 Guidance on data requirements to complete Sections 9, 10, 11 and 12 of the feed approval or registration application

Existing regulatory guidance documents are found on the Canadian Food Inspection Agency (CFIA) website for the approval or registration of various feed types. These outline the data requirements needed to complete Sections 9, 10, 11 and 12 of your feed approval or registration application.

• Section 9 Guidance on data requirements to establish the identification, the characterization and conditions of use of the feed, and methods of analysis of the feed
• Section 10 Guidance on data requirements to establish the safety of the livestock feed
• Section 11 Guidance on data requirements to establish the efficacy of the livestock feed
• Section 12 Novel Feed from animal or plant sources with a novel trait

Other references may offer additional support in completing these sections and can be found on external websites such as:

• International Cooperation for Convergence of Technical Requirements for the Assessment of Feed Ingredients (ICCF)
• Organisation for Economic Co-operation and Development (OECD)

Section 9 Guidance on data requirements to establish the identification, the characterization and conditions of use of the feed, and methods of analysis of the feed

• CFIA – Chapter 2.3 Single Ingredient Feed Evaluation Requirements
• ICCF – Guidance Document #04 Manufacturing Process and Specification – PDF (788 kb)
• CFIA – Chapter 2.7 Guidelines for the assessment of novel feeds: microbial sources
• CFIA – Chapter 6 – Sampling and Laboratory Requirements
• ICCF – Guidance Document #01 Stability Testing of Feed ingredients – PDF (471 kb)
• ICCF – Guidance Document #03 Homogeneity Testing of Feed Ingredients – PDF (535 kb)

Section 10 Guidance on data requirements to establish the safety of the livestock feed

• CFIA – Chapter 2.3 Single Ingredient Feed Evaluation Requirements
• CFIA – Chapter 2.4 Generic Data Requirements for Safety Evaluations of Single Ingredients
• CFIA – Chapter 2.7 Guidelines for the assessment of novel feeds: microbial sources
• CFIA – Chapter 2.8 Guidance on bridging an application to data from publicly available literature and previously approved feed applications
• ICCF – Guidance Document #05 Genotoxicity Testing – PDF (600 kb)
• ICCF – Guidance Document #02 – Sub-Chronic Oral Toxicity Testing in Laboratory Animals – PDF (608 kb)

Section 11 Guidance on data requirements to establish the efficacy of the livestock feed

• CFIA – Chapter 2 item 5 2.2 Registration Requirements for Specialty Products
• CFIA – Chapter 2.8 Guidance on bridging an application to data from publicly available literature and previously approved feed applications
• CFIA – Chapter 2.9 Data flexibility for production performance endpoints and associated claims
• EFSA – EFSA Guidance on the assessment of the efficacy of feed additives. Note: the CFIA is in the process of developing guidance for the efficacy data requirements of livestock feeds. In the interim, EFSA guidance can offer support to assist applicants in their application process.

Section 12 Novel Feed from animal or plant sources with a novel trait

• CFIA – Chapter 2.6 Guidelines for the assessment of novel feeds: Plant sources
• OECD – Organisation for Economic Co-operation and Development – consensus documents

3.2 Anion/cation balance feeds

Registration Checklist for Anion/Cation Balance Feeds

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended species
• Product claim statement
• Guaranteed analysis
• Guarantees for actual % chlorine and actual cation/anion balance expressed in mEq/kg
• Formula used to determine DCAB (Dietary Cation/Anion Balance)
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds as required
• Directions for use to permit safe and effective use of feed
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Net amount (metric measure)
• Registration number (to be added)

Product Composition

• Formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds
• Formulation / Ingredients - verify level of ingredients does not exceed maximums per Schedules IV and V

Scientific Studies

• A minimum of 2 studies supporting the efficacy of the product to significantly reduce DCAB of the total diet (forage + concentrates) for typical dairy dry cow nutritional regimes must be submitted for evaluation.
• Calculations used to determine Dietary Cation/Anion Balance (DCAB)

Promotional Claims (including Internet and Advertising)

• Consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

3.3 Antioxidants

Registration Checklist for Antioxidants

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended species
• Product claim statement
• Guaranteed analysis (active ingredients)
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds as required
• Directions for use to permit safe and effective use of the product
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Shelf life of product
• Net amount (metric measure)
• Registration number (to be added)

Product Composition

• Formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds
• Formulation / Ingredients - verify level of ingredients does not exceed maximums per Schedules IV and V.

Scientific Studies

• Scientific studies are required to support the intended purpose of these products
• Studies carried out by qualified personnel
• Suitable methods used in studies
• Studies designed to facilitate statistical analysis
• Data analysed by appropriate statistical methods
• Studies conducted under conditions similar to those that may be expected to occur in Canada
• Scientific investigations show that the products when used as directed, significantly reduce the rancidity or improve the preservation of nutrients susceptible to oxidation of the feed. Where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate the lowest inclusion rate.
• Studies show a significant difference (P<0.05) between the control and treated groups
• Where results of these studies have not been published in a refereed journal, copies of the raw data and printouts of statistical analysis are required for our review.

Lab Methods

• Original signed copies of Certificate of Analysis for a minimum of 3 lots of these products supporting label guarantees for the active antioxidant ingredients
• Information on the methodologies used to analyse the acid levels e.g. a copy of the AOAC International or other official method is required. In the event that these methods have not been peer-reviewed, additional information is required to validate the laboratory method as outlined in section 6.2
• Analytical methodology substantiating the guarantee(s) (e.g. novel guarantee or method) - provided for Ottawa Laboratory (Carling)
• Original signed copies of Certificates of Analysis for a minimum of 3 lots of product to support product stability or shelf life.

Sample

• Provided (if necessary to validate lab methodology)

Promotional Claims (including Internet and Advertising)

• Consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

3.4 Buffer feeds

Registration of Buffer Feeds for Ruminant Animals

Feeds containing buffering ingredients have been acceptable for registration and have been labelled with the terms "Buffer" or "Buffered" in the brand or feed name providing the directions for use indicated that such feeds were only to be used for ruminants receiving high grain or concentrate rations.

Claims

Previously, claims were not permitted on the label of buffer feeds. As scientific evidence has been submitted to support the nutritional claim "to improve butter fat test in dairy cows" such a claim, for a specific combination of buffer ingredients (see Registration Checklist for Buffer Feeds), has been accepted on a buffer feed label. Other nutritional claims may be accepted provided satisfactory evidence to support the claim is presented with the application for registration.

Ingredient Listing

The name and amount of each ingredient used in a Buffer Feed shall be attached to the application for registration pursuant to sections 8(1) and (2)(b) of the Feeds Regulations. A complete list of ingredients must appear on the label.

Permitted Guarantees

Feeds containing both buffer ingredients and other nutrient sources shall guarantee only the nutrients normally shown for a similar feed not containing buffer ingredients. Labels may also show the actual level of the buffer ingredient(s).

Feeds consisting of a mixture of buffer ingredients shall be registered under the provisions of Feed Article 7 of Table 3 of Schedule 1 of the Feeds Regulations. The actual level of the buffer ingredient(s) may be shown on the label. No other guarantee will be permitted.

Registration Checklist for Buffer Feeds

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended ruminant species
• Product claim statement
• Guaranteed analysis:

1. Feeds consisting of a mixture of buffer ingredients:
   • No nutrient guarantees permitted;
   • The actual level of buffer ingredient(s) may be shown on the label.
2. Feeds containing both buffer ingredients and other nutrient source
   • Guarantees for nutrients normally shown for a similar feed not containing buffer ingredients (e.g. sodium from sodium bicarbonate cannot be included in the guaranteed analysis);
   • The actual level of buffer ingredient(s) may be shown on the label.

• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds as required
• Directions for use to permit safe and effective use of feed and must indicate that the feed is to be used for the intended ruminant species receiving high grain or concentrate diets.
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Net amount (metric measure)
• Registration number (to be added)

Product Composition

• Formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds
• Formulation / Ingredients - verify level of ingredients does not exceed maximums per Schedules IV and V.

Scientific Studies

• Scientific studies are not required if the product supplies one of the following: either the recommended levels of Sodium Bicarbonate, or the recommended level of MgO, or the recommended levels for a combination of these 2 mineral salts, pursuant to the "Nutrient Requirements of Dairy Cattle" published by the National Research Council in 1989 (NRC 1989), as follows:
  • Sodium Bicarbonate at 1.2 - 1.6 % of the dairy ration, or 0.6 - 0.8 % of the total diet dry matter
  • MgO at 0.4 - 0.6 % of the dairy ration, or 0.2 - 0.4 % of the total diet dry matter
  • 2 to 3 parts Sodium Bicarbonate mixed with one part MgO at 1.6 - 2.2 % of the dairy ration or 0.8 - 1.2 % of the total diet dry matter.
• If the product supplies less than these recommended amounts or uses other buffer ingredients, scientific studies are required to support the rumen buffering claim for the product when used as directed.
• Studies carried out by qualified personnel
• Suitable methods used in studies
• Studies designed to facilitate statistical analysis
• Data analysed by appropriate statistical methods
• Studies conducted under conditions similar to those that may be expected to occur in Canada
• Studies show a significant difference (P<0.05) between the control and treated groups
• Where results of these studies have not been published in a refereed journal, copies of the raw data and printouts of statistical analysis are required for our review.

Promotional Claims (including Internet and Advertising)

• Consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

3.5 Dilute drug premixes

This section is currently being developed and will be added when finalized. For more information please contact the Animal Feed Division.

3.6 Enzyme supplements and mixed feeds containing registered enzyme supplements

Background

An enzyme is a substance that acts as a catalyst in living organisms that regulates the rate at which chemical reactions proceed without being altered in the process. Every enzyme has a specific function, and in many cases an array of enzymes is required to complete a reaction for different nutrients. The most commonly used feed enzymes are the hydrolases which include for example, amylase, cellulose, lipase, mannanase, pectinase, phytase, protease, and xylanase.

Enzyme supplements may be added to livestock feeds to catalyse feed degradability thereby improving digestibility. They can be added to a feed immediately before consumption, or added during processing (for example, as a forage or grain treatment) to enhance the stability and digestibility of the stored/ensiled feed.

Enzyme supplements may be regulated as a drug or a feed depending on a number of factors as per the Guidance Document on Classification of Veterinary Drugs and Livestock Feeds. That document provides guidance and criteria to help clarify the regulatory differences between drugs and feeds, and assists in determining the appropriate regulatory oversight for a product destined for use in livestock species.

There are 3 types of fermentation products which can have enzyme activity, as described below:

• Fermentation product, complete or crude
  The enzymes as well as the entire medium are recovered, complete with other metabolites and fermentation substances. There is no separation step in the processing. This includes the solids and solubles associated with the fermentation (for example, Aspergillus niger fermentation product).
• Fermentation solubles product
  This consists of only the soluble portion of the fermentation product, from which the solids have been separated (for example, Aspergillus niger fermentation solubles).
• Fermentation extract
  This is a purified enzyme source resulting from further extracting and purifying the solubles (for example, Aspergillus niger fermentation extract).

Regulatory status

Products marketed for their enzyme activity in livestock feeds are considered to be enzyme supplements, and are subject to registration by the Animal Feed Division (AFD) of the Canadian Food Inspection Agency (CFIA) prior to importation, manufacture or sale in Canada. Ingredients currently approved as sources of enzyme activity in livestock feeds are listed in the "Fermentation Products" category (5.4) of Class 5, Protein Feeds in Schedule IV of the Feeds Regulations. Enzymes added to feeds must be in the form of non-viable fermentation by-products. Further information on viable microbial products is available in the RG1-Chapter 3 Section 3.22.

Before submitting an application to register an enzyme supplement, all ingredients, including the fermentation products making up the enzyme supplement, must be approved and listed in Schedule IV of the Feeds Regulations. If any ingredient of an enzyme supplement, including a fermentation product, is not found in Schedule IV, an application for that ingredient is required. The application for the enzyme supplement should only be submitted once all ingredients in the enzyme supplement are approved.

When the enzyme source is derived from a novel microorganism, a safety assessment will be conducted according to the document entitled Guidelines for the Safety Assessment of Novel Feeds: Microbial Products (RG-1, Section 2.7). The data requirements for submitting an application can be found in Section 2.7.

This document is divided into 3 parts as follows:

• Part 1 - Registration requirements for enzyme supplements, mixed feeds containing enzyme supplements or dilutions of enzyme supplements
• Part 2 - Amendments to registrations of enzyme supplements, diluted enzyme supplements and mixed feeds claiming the presence of enzyme supplements
• Part 3 - Renewal of registrations for enzyme supplements, diluted enzyme supplements and mixed feeds claiming the presence of enzyme supplements

It is recommended that the data requirements outlined below be carefully reviewed and followed prior to submitting an application for feed registration to the AFD.

After reviewing all documents, if specific questions on requirements remain, please contact the AFD at: cfia.afp-paa.acia@inspection.gc.ca.

Part 1: Registration requirements for enzyme supplements, mixed feeds containing enzyme supplements or dilutions of enzyme supplements

1.1 Administrative requirements

General administrative information regarding the procedures for application for feed registration can be found in Regulatory Guidance: RG-1, Chapter 1 - Administrative Requirements for Pre-market Assessment and Product Registration of Livestock Feed.

Specific information is found in the attached checklist.

Registration requirements for enzyme supplements

1.2 Labelling

Proposed labels for enzyme supplements must include the following, in addition to standard labelling requirements listed in RG-1, Chapter 4.1 – Labelling of Livestock Feed:

• the product name, that reflects the purpose of the product and the intended species
• a complete list of ingredients
• a nutritional claim statement (if applicable)
• a guarantee for the enzyme activity or activities, and the enzyme unit definition^Footnote 1, with details of the enzyme assay conditions^Footnote 2
• directions for use to permit safe and effective use of the feed
• recommended storage conditions in order to maintain activity until the expiration date
• expiry date (stated as the number of months from date of manufacture)
• a cautionary and/or warning statement, if applicable

1.2.1 Safe handling of enzyme feeds

Microbial products (including fermentation products) have the potential to cause dermal and respiratory irritation and/or sensitization. Applicants are therefore required to include the following statement on all enzyme supplement labels:

• "This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling."

Alternatively, applicants may choose to provide scientific rationale as to why this statement does not apply to their product and is therefore not necessary. For example, the applicant may provide the results of dermal/respiratory sensitization/irritation studies in support of the product.

1.3 Product identification and description

1.3.1 General Information

• cover letter explaining the purpose of the product for registration
• summary of documentation/information included with the application
• background supportive information pertaining to approvals in other jurisdictions
• directions for use
• target livestock feeds.
• proposed product claim(s)
• proposed shelf-life
• detailed product formulation and complete list of ingredients identified by generic name as listed in Schedule IV or V of the Feeds Regulations, and registration number for ingredients listed in Schedule IV, Part II, or mixed feeds.
• brief manufacturing process of the enzyme supplement to demonstrate that the product meets the description of the approved ingredient definition as listed in Schedule IV.
• if the product is an unapproved single ingredient, additional information as per RG-1, Chapter 2 - 2.3 Single Ingredient Feed Evaluation Requirements

1.3.2 Analytical method

A laboratory method is required. The methodology must be effective in verifying the enzyme activity guarantees for both enzyme supplements, and finished feeds or complete feeds, as per the Feeds Regulations (Section 2(1)).

The proposed label guarantees must be supported by certificates of analysis from 3 different and recent lots of product which describe the usefulness of the enzyme supplements.

Where an AOAC method is being used, the applicant need only reference the AOAC method on the certificate of analysis of each guarantee.

Where a proprietary method of analysis is used, the applicant must submit a copy of their method for assessment with the feed application. The proposed method(s) will be reviewed and tested individually, according to the protocol described in Chapter 6 section 6.3 Guidelines for the Evaluation of Methods to Determine the Activity of Enzyme Ingredients Used in Animal Feed. Product sample or samples may be requested by the AFD on a case–by-case basis to verify analytical methodologies and/or label guarantees. The sample must come from a recent lot (within the last 12 months) and the amount supplied must be sufficient for the enzyme activity to be determined 20 times using the method (minimum 50 grams).

The AFD will contact the applicant directly if a product sample must be sent to the CFIA lab. The applicant will be provided with a reference number used to complete Appendix I "Laboratory Sample Submission Form - PDF (864 kb)" in order to submit their samples to the CFIA lab.

Only the sample(s) along with the completed Appendix I "Laboratory Sample Submission Form - PDF (864 kb)" are to be submitted directly to the CFIA Laboratory, at the following address:

Ottawa Laboratory (Carling)
Feed Bioanalysis and Microscopy Section
Building 22, Central Experimental Farm
960 Carling Ave.
Ottawa ON
K1A 0C6

All other documentation must be submitted to the AFD, which will forward the appropriate copies to the CFIA Laboratory.

1.4 Requirements in support of product claims and other information

The criteria for acceptable scientific studies are outlined in RG-1, Chapter 2.2 -Registration Requirements for Specialty Products

1.4.1 Studies in support of claims

1.4.1.1 Nutritional claim(s)

Applicants may have nutritional claims for enzyme supplements; these may appear on labels. However, nutritional claims are not mandatory for any enzyme supplements, including any source of approved phytase.

Scientific data in support of a nutritional purpose is not required for enzymes recognized in peer-reviewed publications to enhance feed digestibility or nutrient availability (for example, β-mannanase, β-glucanase, xylanase, galactomannanase , ɑ-amylase, cellulase, phytase, carbohydrase).

When performance claims (for example, improvement of feed efficiency, improvement of daily weight gain, improvement in milk, meat, egg or wool production) are made, valid scientific studies must be presented in support of each label claim, as described in RG-1, Chapter 2.2 - Registration Requirements for Specialty Products.

1.4.1.2 Phytase claims

The claim:

• "Phytase improves the availability of phytin-bound phosphorus in cereal and oil-seeds based diets for swine and poultry"

is acceptable for all approved sources of phytase, and may appear on the label. This does not require efficacy data, as long as the minimum inclusion rate is equivalent to 500 U/kg (units of phytase per kg of complete swine or poultry feed). This rate of use is based on the industry history of use, and is acceptable for products for which AOAC method #2000.12 9(4.10.06) has been used to measure the enzyme activity. The unit definition for the AOAC method is "One phytase unit is defined as that quantity of enzyme that will liberate 1 micromole of inorganic ortho-phosphate per minute under conditions of the assay".

1.4.2 Product Stability and Shelf Life

To support product stability and the shelf life as stated on a product label, it will be necessary to:

• demonstrate maintenance of the enzyme activity over the specified shelf life
• submit certificates of analysis for the active ingredient(s) or substance(s) to substantiate the guaranteed shelf life (In other words, at the date of manufacture and the expiry date)
  • a minimum of 3 different lots of the product.
  • certificates of analysis for the level/concentration of the active ingredient(s) or substance at the date of manufacture and at the expiry date must be for the same lot of product
  • storage conditions used in the shelf life study must reflect the recommended storage conditions as stated on the product label

1.4.3 Product stability in pelleted feeds

If the directions for use indicate that the enzyme supplement can be used in feeds undergoing commercial feed processing (for example, premix, supplement, mineral), analysis will be required to support that the enzyme(s) retains an effective level of activity during processing, and stability under typical storage conditions. The data to support the addition of the enzyme supplement to the various feed types could be provided by the original applicant, or by subsequent applicants choosing to add the enzyme supplement to their product.

Where data showing the stability of an enzyme supplement to pelleting conditions is not provided, one of the following statements must be added to the label:

• "Do not pellet" or
• "Apply post-pelleting" or
• "Pelleting this product may significantly reduce enzyme activity".

1.5 Registration requirements for mixed feeds containing enzyme supplements or dilutions of enzyme supplements considered mixed feed.

Mixed feeds containing registered enzyme supplements are exempt from registration, if the following conditions are met:

• the mixed feed is manufactured in Canada and;
• the presence of the enzyme products is not highlighted on the label, other than the brand name and registration number in the list of ingredients;
• the feed meets all other criteria for exemption from registration under the Feeds Regulations

Mixed feeds with labels that highlight the presence of registered enzyme supplements or enzyme activity must also be registered. In addition to the administrative requirements as per the RG 1 Chapter 1 and applications fees for an efficacy review Category 2 (new feed), the following information will be required with the feed application:

• the product formulation, to verify the guarantee for enzyme activity, and verify that the amount of enzyme supplement supplied is not less than that approved (per the embedded registered enzyme supplement label)
• 3 copies of the proposed label, with:
  • the complete list of ingredients, including the name and registration number for the approved enzyme supplement or
  • the name and registration number of the approved enzyme supplement, in conjunction with the standard ingredient statement "The list of ingredients used in this feed may be obtained from the registrant or manufacturer of the feed."
  • guarantee(s) for enzyme activity expressed as per the parent product, as well as nutrient guarantees applicable for the type of mixed feed in question. (Note: enzyme unit definition is required on the label for mixed feeds)
  • the approved nutritional claim for the registered enzyme supplement (if applicable)
  • feed processing claims, on supplement and premix labels only, as per the registered enzyme supplement label
  • expiry dates and storage conditions, on supplement and premix labels only, as per the registered enzyme supplement label if applicable (for example, pelleting statements)

Mixed feeds, as private label products, that highlight the presence of enzyme supplements or enzyme activity must be registered. For more information about registration of private label products, consult Chapter 2 Section 2.2 of RG-1. For this type of feed application, provide administrative requirements as per the RG 1 Chapter 1 and application fees for Category 1 Standard Feeds; submission Code 3254.

1.5.1 Product Stability

If the registered enzyme supplement is diluted using a different carrier (from granular to liquid form) than the parent product, supporting data (for example, method of analysis, stability data, certificates of analysis) as described in the document may be required.

1.5.2 Studies in support of claims

If label claims are being made for mixed feeds containing enzymes for which no claims have been previously approved, the registrant must submit efficacy data in support of those claims.

Part 2: Amendments to registrations of enzyme supplements, diluted enzyme supplements and mixed feeds claiming the presence of enzyme supplements

Registrants wishing to make a change to the formula or label of a registered product must submit an amendment for a (significant change/re-registration) to the AFD (Category 2 submission). General administrative information regarding application procedures for amendments to feed registrations can be found in RG-1 - Chapter 1 - Administrative Requirements for Pre-market Assessment and Product Registration of Livestock Feed.

Proposed significant changes may include, but are not limited to, changes to any of the following:

• brand or product name
• product claim statement(s)
• enzyme guarantee(s)
• shelf life
• heat stability/pelleting statement
• directions for use including addition of new target species
• formulation and list of ingredients on the label
• manufacturing process (not applicable to diluted enzyme supplements)
• methodology (not applicable to diluted enzyme supplements)

Data requirements for significant changes to enzyme supplements will be dependent on the changes being requested and would be evaluated on a case-by-case basis. In general, any proposed change that will affect product efficacy will also require supplemental or new efficacy data. Examples include: a proposed change or revision of the laboratory method; a change in the directions for use; or a change in heat stability (pelleting) conditions. For more information on data requirements for amendments to registrations, refer to RG-1, Chapter 2.2 Registration Requirements for Specialty Products.

Part 3: Renewal of registrations for enzyme supplements, diluted enzyme supplements and mixed feeds claiming the presence of enzyme supplements

General administrative information regarding the application procedures for renewals of feed registrations can be found in RG-1, Chapter 1 "Administrative Requirements for Pre-market Assessment and Product Registration of Livestock Feed".

Specific information is found in the attached checklist.

In addition to typical renewal requirements, a signed statement from the registrant is required confirming that no changes have been made to the manufacturing process for the product since the last registration. A signed cover letter from the registrant should confirm that the laboratory method approved by the CFIA, and used to verify the label guarantees for enzyme activity, has not changed nor been revised by the company since the last registration of the product.

Printable checklist - PDF (241 kb)

Submission checklist for enzyme supplements and mixed feeds containing registered enzyme supplements

The completed checklist, for enzyme supplements and mixed feeds containing registered enzyme supplements submissions, must be included with each application for feed registration.

Indicate the submission page number corresponding to each item in the checklist; if the item does not apply, a written justification must still be provided.

Submissions received without a completed checklist will be returned.

With your submission package, you must include with the following information (mandatory)

3.7 Fox feeds

Registration of Complete Dry Fox Feeds

All fox feeds require registration prior to marketing in Canada.

Complete dry fox feeds conforming to the evaluation standards set out below will be accepted for registration without the necessity to submit evidence of animal trials.

*NRS = No Requirement Specified

A statement of the typical percentage of animal protein-bearing ingredients is required to be shown on the label.

In order to help companies wishing to register feeds designed for foxes, the following table containing adequate nutrient contents of complete feeds is presented. It should be noted that this table has been extrapolated from the limited information available and cannot be considered to represent the animal's minimum and maximum tolerances; it represents only levels that support animal performance. This table is presented for information purposes only.

Recommended Fox Nutrition Levels

*NRS = No Requirement Specified

Please note that products meeting the above standards are not exempt from registration. Complete feeds that do not meet these standards may may also be registered, provided the acceptability of the feed for registration is demonstrated.

Registrants are reminded of the regulatory amendments to the Feeds Regulations, effective July 12, 2007, which require that dry fox feeds containing prohibited materials must carry the following warning statement: "Feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act."

3.8 Flavouring agents

Registration requirements of flavouring agents

Flavouring ingredients

Single flavouring ingredients must be approved by the CFIA prior to their importation, manufacture, or sale, for use in livestock feeds. The approval process consists of an evaluation of each flavouring ingredient, and single flavouring ingredients that are approved and listed in Schedule V, Part I or II, of the Feeds Regulations. If possible, the maximum concentration of the ingredient to be used in feeds is established during the review.

Flavouring ingredients can be found listed in Schedule V of the Feeds Regulations, available on the Feed Program's web page on the CFIA web site. A number of flavouring ingredients are also listed in Schedule IV. Any feed ingredient that does not appear on these lists requires approval, as per Chapter 2.3 and 2.4 (Single Ingredient Feed Evaluation Requirements). Information to conduct a complete safety evaluation must be supplied as part of the new flavouring ingredient submission.

Flavouring agents

All flavouring agents require registration. Flavouring agents are generally made up of flavouring ingredients and facilitating agents, and they are present in feed at very low levels. Both flavouring and facilitating agents must be listed in either Schedule IV or V of the Feeds Regulations. Typical inclusion rates for flavouring agents are 100-1,000 g/tonne (ppm) of complete feed, with maximum levels of 3,000 g/tonne. Common flavouring ingredient levels range from 10 to 50 ppm in complete feed, while maximum use levels seen are approximately 100 ppm. When formulating a flavouring agent product, please ensure that a maximum inclusion rate for the product is selected such that none of the individual flavouring ingredients exceed their specified maximums in complete feed as per Schedule V of the Feeds Regulations, and no individual flavouring ingredient exceeds 100 ppm in complete feed.

Recognized facilitating agents (commonly called "carriers") for flavouring agents include, but are not limited to, corn, wheat, silicon dioxide, sodium carbonate, propylene glycol, and ethyl alcohol. Please note that fermentation products, and other feed ingredients such as sodium bentonite, calcium bentonite, montmorillonite clay, sepiolite, zeolite ore, or microbial products, are not considered to be acceptable facilitating agents. This is not a complete list, but it identifies the products commonly misused as carriers in flavour formulations.

Administrative requirements

The standard registration requirements include a cover letter, application form, proposed label, product formulation, and the application fee. General administrative information regarding the procedures for application for feed registration can be found in Chapter 1 (Application for Feed Registration and Ingredient Approval).

Labelling

The proposed label must include the product name, reflecting the purpose of the product and the intended species; a complete list of ingredients by generic name, as listed in Schedule IV or V of the Feeds Regulations; registration numbers for any Part II ingredients or mixed feeds included in the formulation; directions for use to permit safe and effective use of the feed; a cautionary or warning statement (if applicable); the net amount (metric measure); and the name and address of the registrant.

Requirements for flavouring agents containing sodium saccharin

• A list of each intended species is required in the product name rather than stating the term "livestock" (e.g., "Flavouring agent for non-lactating dairy cattle, beef, sheep, poultry and swine feeds");
• The following cautionary statement is required on the label: "This product contains sodium saccharin, a non-nutritive sweetener which shall not be used in lactating dairy feeds".

Additional labelling requirements for liquid flavouring agents

• For liquid flavouring agents, the registrant must provide the specific gravity of the product. Please note that specific gravity does not have units and should be measured at 20°C.
• The following statement is required: "The viscosity of this product will vary inversely with temperature".

Product formulation

The product formulation, listing the amount of each ingredient by generic name as per Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds, is required. The amounts of the individual ingredients in the formulation may be presented as percentages totalling 100%, or amounts comprising a total of 1,000 kg (1 tonne) of the product. Ingredient levels must not exceed maximums in complete feed as per Schedules IV and V. The applicant should include calculations verifying that the concentration of each ingredient in the flavouring agent does not exceed their respective maximum tolerance levels when the product is used at the maximum inclusion rate.

Example calculation:

Proportion of ingredient A in flavouring agent product [2%] × maximum inclusion rate of flavouring agent product in complete feed [200 g/tonne] = inclusion rate of ingredient A in complete feed [= 4 g/tonne complete feed (or 4 ppm)]

Notes:

• some maximums are specified as GMP or "Good Manufacturing Practices" in Schedule V of the Feeds Regulations. Ingredients marked with this term must be employed at a level which is appropriate for the purpose, i.e., a typical use level. As mentioned above, they must not exceed the specified 100 ppm maximum in complete feed. The same policy applies to ingredients where the maximum is specified as "". Information on typical levels may be obtained from a recognized flavour reference (e.g., Fenaroli's Handbook of Flavour Ingredients).
• all ingredients present in the flavouring agent must be stated on the formulation statement. No "and/or" statements are permitted.
• all ingredients present at a level of 0.1% or below may be declared as a range between 0% and 0.1%, but must not be 0%.
• the safety evaluation of ingredients for which a formulation range is provided will be performed using the upper limit stated in the formulation range.
• if the formulation lists previously registered products as ingredients, the registrant must ensure that these registrations are valid at the time of registration or renewal.

All formulations are treated as confidential and are protected as outlined under the Canadian Access to Information and Privacy Act.

Renewal and amendment to registered flavouring agent

As with all registered products, flavouring agents are registered for a 3-year period, renewable by March 31 of the third year after the registration date. All application(s) for renewal or amendment to a registered feed must be accompanied by an application form, appropriate fees, labels as per Chapter 1 (Application for Feed Registration and Ingredient Approval), and complete product formulation. Additional information may be requested if safety concerns emerge between the time of registration and renewal.

Changes made to the formulation of approved flavouring agents are considered new registrations and require the applicable fee (see Chapter 1). Flavouring agents submitted at the time of renewal with a change in formulation will necessitate payment of the fee for the registration of the new formulation in addition to the renewal fees.

Product claims

Flavouring ingredients listed in Schedule V of the Feeds Regulations are approved as non-nutritive ingredients for use in livestock feed. Please be aware that products intended to prevent, mitigate or treat disease, or restore, correct or modify organic function in animals, may be considered drugs rather than feeds in Canada and are regulated by the Veterinary Drugs Directorate (VDD) at Health Canada.

For more information please contact VDD at:

Veterinary Drugs Directorate
Health Canada
Tower A
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address Locator - 3000A

Registration checklist for flavouring agents

Administrative registration requirements

• Completed application package per Chapter 1

Proposed label

• brand name (optional)
• product name reflecting purpose of the product and the intended species

Note: Flavouring agents containing sodium saccharin need to list each intended species in the product name instead of stating the term "livestock". Non-lactating dairy may be included as one of the intended species.

• complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations including valid registration numbers for Part II ingredients or mixed feeds as required
• directions for use to permit safe and effective use of feed
• liquid flavouring agents require the following additional information on the label (see section 4.2):
  • - specific gravity - the reference point temperature for specific gravity is measured at 20°C. Please note that specific gravity does not have units.
  • - the statement "The viscosity of this product will vary inversely with temperature."
• caution and/or warning statements (if applicable)

Note: If product contains sodium saccharin then the following cautionary statement is required: "This product contains sodium saccharin, a non-nutritive sweetener which shall not be used in lactating dairy feeds".

• name and address of registrant
• net amount (metric measure)
• registration number (to be added)

Product composition

• formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of Feed Regulations including registration numbers for Part II ingredients or mixed feeds
• verify the level of ingredients when used at the maximum inclusion rate to ensure each ingredient does not exceed maximums per Schedules IV or V.

Note: As per the Registration Requirements of Flavouring Agents (see above), flavouring agents should consist of only flavouring ingredients and facilitating agents. Fermentation and microbial products are not considered to be facilitating agents.

Promotional claims (including internet and advertising)

• consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

Sample label: flavouring agent

Brock's Flavour-Ade
Flavouring Agent for Swine, Beef, Poultry, Horse,
Sheep, Goats and Non-lactating Dairy Feeds

Registration No.: (to be added)

Ingredients

Vanillin, butyric acid, fenugreek seed extract, sodium saccharin, fine ground corn cobs dehydrated

Directions for Use

Use 500 to 1000 ml per tonne of complete feed.

Caution

This product contains sodium saccharin, a non-nutritive sweetener, which
shall not be used in lactating dairy feeds.

The viscosity of this product will vary inversely with temperature.

Lot No.: AA205/01

Net Volume: 20 L

Specific Gravity: 1.10 @ 20°C

Registered by:

Brock's Flavours
24 Cherry Drive
Blueberry, Ontario
N0M 1T0

Sample Label: Flavouring Agent

Confidential Formula

Brock's Flavour-Ade
Flavouring Agent for Swine, Beef, Poultry, Horse,
Sheep, Goats and Non-lactating Dairy Feeds

Registration number: (to be added)

Registered by:

Brock's Flavours
24 Cherry Drive
Blueberry, Ontario
N0M 1T0

1. Conversion to a weight per weight (w/w) maximum inclusion rate, if necessary, from volume per weight (v/w) maximum inclusion rate, using the specific gravity (S.G.) provided.

   S.G.: 1.10 @ 20°C

   S.G. = density offlavouring agents (g/ml) / density of water (1.00 g/ml)

   Maximum inclusion rate of flavouring agent (v/w)
   in the Directions for Use = 1000 ml/tonne

   Since mass = density × volume

   Therefore,

   Maximum inclusion rate of flavouring agent (w/w)
   = (S.G. × water density) × Maximum inclusion rate of flavouring agent (v/w)
   = 1.10 × 1.00 g/ml × 1000 ml/tonne
   = 1100 g/tonne (ppm)

   Note: For liquid flavouring agents whose "Directions for Use" are already expressed as w/w, the conversion using the S.G. is not necessary.

2. Example calculation of the concentration of an ingredient in the complete feed, when the flavouring agent is used at the maximum inclusion rate:

   Flavouringagent inclusion rate per tonne of complete feed × %Concentrationof the ingredient in the flavouring agent = Concentrationof the ingredient in the complete feed

   1100 g/tonne or 1100 ppm × 2% (0.2) vanilline = 22 ppm

3.9 Forage additives

Registration of Forage Additives and Mould Inhibitor Products

This section describes the regulatory status and registration requirements for forage additive and mould inhibitor products. Forage additives and mould inhibitor products are mixed feeds that do not meet exemption from registration criteria as outlined in Section 5(2) of the Feeds Regulations. As such, each forage additive and mould inhibitor must be approved and registered by the Animal Feed Division prior to its importation, manufacture or sale in Canada.

Forage additives and mould inhibitors are considered specialty products as indicated in Section 2.2 "Registration Requirements for Specialty Products", and in Table 3 of the Feeds Regulations (item # 7). They have been separated into the following types:

Type 1. Nutritive supplements applied directly to forage crops and silages, such as mixtures of molasses, urea, vitamins, minerals, flavouring agents, etc. Efficacy data is not required for Type 1 forage additives.

Product claims related to animal nutrition and/or animal production are not required for this type of product, and applications in support of product claims for nutritive forage supplements will be reviewed on a case-by-case basis. However, these products must provide a significant source of nutrients, whose guarantees must fall within Table 4 of the Feeds Regulations.

Type 2. Mould inhibitor products applied to mixed feeds (e.g., complete feeds) and approved feed ingredients, silages and hays, wherein the active ingredients are organic acids and their derivatives. Efficacy data (i.e., scientific studies) must be submitted in support of an application for registration for Type 2 mould inhibitor products.

With the exception of those related to mould growth or mould inhibition, claims are not permitted for this type of specialty product. The claim(s) must make reference to the particular forage crop(s), feedstuff(s) or type of mixed feed(s) the product has been tested on and must state the specific moisture level(s) at which the product is effective in inhibiting or reducing mould growth.

Type 3. Viable bacterial silage inoculants, including products containing registered strains of Lactobacillus buchneri, wherein the purpose of the product is the registration of primary product claims pertaining to animal production (e.g., improved milk yield) and/or animal nutrition (e.g., improved silage dry matter consumption). This type of application for registration requires the submission of efficacy data in support of product registration.

The primary claim(s) must make reference to the particular forage crop(s) the product has been tested on, as well as to the per cent dry matter content of the forage and/or silage in question. Claims relating to the chemical or physical attributes of the forage or silage (e.g., per cent heat damaged protein, ammonia nitrogen levels, NDF content in the silage) are not acceptable as primary nutritional claims for Type 3 bacterial inoculants. They are however, acceptable as secondary product claims for this type of forage additive, provided at least one primary claim (as described above) has been scientifically substantiated for the product in question.

Type 4. Viable bacterial silage inoculants wherein the principal active bacterial culture is a registered strain of Lactobacillus buchneri and whose primary purpose is to reduce or prevent yeast and/or mould growth and improve the aerobic stability of silage at feeding. This type of inoculant also requires the submission of scientific studies in support of an application for registration, wherein the registration of primary product claims pertaining to mould growth and aerobic stability are a requirement.

As with Type 3 silage inoculants, the primary product claims must refer to the specific forage crop(s) the additive has been tested on, in addition to the per cent dry matter content of the forage and/or silage in question. Secondary claims pertaining directly to animal production and/or animal nutrition are permitted, but are not mandatory for Type 4 forage additives.

Administrative Requirements

Standard registration requirements, including a completed and signed Application for Feed Registration or Renewal (CFIA/ACIA 0009) form; application fee as per Chapter 1 "Application for Feed Registration and Ingredient Approval" (Category 2); five copies of the proposed product label; a copy of the product formulation (e.g., percentage composition); an accompanying cover letter; and signing authority/Canadian agent (if applicable).

Labelling

Proposed labels for forage additives and mould inhibitors must include the complete list of ingredients and state a minimum guarantee for each one of the active ingredients in the product (Note - bacterial counts must be expressed in either colony forming units (CFU) per gram of product or CFU per kilogram of product). For Type 3 and Type 4 forage additive products bearing label guarantees for viable bacterial counts, the applicant should consult the "Guidelines for the Evaluation of Methods to Determine the Viability of Direct Fed Microbials and Forage Additives Containing Viable Microorganisms" in Section 6.2, prior to submitting the application for registration for the forage additive product in question. With regards to forage additives bearing label guarantees for enzymatic activity, the applicant should in this case refer to Section 3.6 "Regulatory status of enzyme bearing products" and Section 6.3 "Guidelines for the evaluation of methods to determine the activity of enzyme ingredients used in animal feeds" before submitting an application for registration for these types of forage additive products. Forage additive and mould inhibitor labels must reflect the standards, packaging and labelling requirements of the Feeds Act and Regulations.

Additionally, detailed directions for use must also be provided and are to reflect specific mixing instructions, different application rates, etc. Note that the directions for use, as they appear on a product label, are to be crop- or feedstuff-specific and must be substantiated by the scientific data submitted in support of the application for registration. They must also be indicative of the intended use rate of the product in question.

Also, the following label statement must appear on all forage additive and mould inhibitor product labels:

"This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling."

Alternatively, if an applicant would like to have this labelling statement removed from a product label, it will be necessary to provide a scientific rationale and substantiating scientific documentation as to why the above statement is not necessary.

Requirements for Efficacy Data and Other Supporting Scientific Information

1. A cover letter explaining the purpose of the application for registration, including what type of forage crop(s), feeds, or feed ingredients the product is to be used on, the desired product claims, what type of documentation/information has been included with the application, etc.
2. The detailed product formulation and complete list of ingredients identified by generic name as listed in Schedule IV or V of the Feeds Regulations. Registration numbers for Part II ingredients (including bacterial cultures), mixed feeds, and other registered products (e.g., flavouring agents) must also be included. The registration requirements for individual bacterial cultures are described below, under the heading "Registration of Individual Microbial Strains".

   Mixed feeds, including forage additives and mould inhibitors, may not contain ingredients that are not listed in either Schedules 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 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 particular forage additive or mould inhibitor 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 forage additive or mould inhibitor cannot be reviewed unless all of the ingredients used in the product formulation are approved and listed in either Schedule IV or V of the Feeds Regulations.

3. Certificates of analysis from 3 different and recent lots of product, in addition to an accompanying analytical methodology, to substantiate the guarantee(s) that appear on the product label.
4. To support product stability and the shelf life as stated on a product label, it will be necessary to submit certificates of analysis substantiating the guaranteed shelf life (i.e., the date of manufacture and at the expiry date) for a minimum of 3 different lots of the product. The certificates of analysis for the level/concentration of the active ingredient(s) or viable microbial cells 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.
5. A product sample(s) may be requested by the evaluation officer or Feed Laboratory to verify analytical methodologies and/or label guarantees. Samples will be requested on a case-by-case basis.
6. For new applications for registration, a minimum of 2 complete farm or production-scale studies must be presented in support of each product claim for each forage additive or mould inhibitor (i.e., Type 2, Type 3 or Type 4 products). Once a mould inhibitor or viable bacterial silage inoculant has been granted permanent registration status, a minimum of 1 complete farm or production-scale study will be required for each subsequent claim, which will be submitted as an application for significant change/re-registration. The criteria for acceptable scientific studies have been outlined below, under the heading "Criteria for scientific studies submitted in support of label claims".

Registration of individual microbial strains

With regards to the 2 types of viable bacterial silage inoculants previously described in this section (i.e., Type 3 and Type 4 forage additives), it is important to note that the bacterial cultures already assessed for use in silage inoculants are listed in Part II of Schedule IV of the Feeds Regulations. Single ingredient feeds (including bacterial cultures) located in this part of Schedule IV require registration prior to their use in livestock feeds and forage additives in Canada. Due to this registration requirement, an applicant may choose to: a) use one or more currently registered bacterial cultures, or b) in the event of an unregistered strain or culture, to submit an application to have the culture registered.

In order to register individual microbial strains, applicants should consult the "Requirement for Registration of Viable Microbial Strains" in Section 3.22, as well as the "Guidelines for the Assessment of Novel Feeds: Microbial Sources" in Section 2.7, for information concerning the documentation and information that is required to be submitted with each application for registration for an individual microbial strain.

Criteria for scientific studies submitted in support of label claims

For Type 2 mould inhibitors and Type 3 and 4 viable bacterial silage inoculants, a minimum of 2 farm or production-scale studies must be presented in support of each label claim submitted as a new application for registration. For each subsequent claim requested as part of an application for significant change/re-registration (and after the product in question has already been permanently registered), a minimum of 1 farm or production-scale scientific study is required. These investigations must meet the following criteria:

• carried out by qualified research personnel;
• performed using the target forage crop, feed ingredient and/or mixed feed for (Type 2 mould inhibitors only);
• performed using the target livestock species (in the case of Type 3 and Type 4 bacterial inoculants);
• carried out using suitable/recognized scientific methods and protocols;
• designed using an appropriate experimental design;
• designed to facilitate statistical analysis (i.e., using a suitable and recognized statistical model, proper sampling protocol and sufficient sample size);
• scientific data are analysed using appropriate statistical methods;
• consist of at least one control group and one treatment group;
• the control and experimental treatment groups must be kept in separate experimental units, so as to reduce the risk of cross-contamination (e.g., control and treated forage cannot be stored in the same silo during the ensiling (test) period);
• show a significant difference (P<0.05) between the control and treatment groups;
• indicate that the product, when used as directed, results in a significant reduction or inhibition in mould growth (Type 2 and Type 4 products) or significant improvement in one or more nutritional/animal production claims for the product (Type 3 and Type 4 products);
• where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate each individual application rate;
• conducted under conditions (i.e., climate, management, crop production, feeding practices, etc.) 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, complete copies of the raw data and complete printouts of the statistical analysis are required for our review.

Description of farm- or production-scale studies

In order to clearly describe what is considered to be an acceptable farm- or production-scale study, the following criteria must be met:

• the minimum size/weight of each individual experimental unit will be from 1,500 to 2,000 kg (1.5 to 2.0 metric tonnes) for Type 2, Type 3 and Type 4 products;
• examples of acceptable experimental units include individual silos, large round or large square bales, sealed totes, etc.);
• a control group must be included in each study;
• studies must be conducted in Canada or in climates similar to those expected to occur in Canada. Studies generated from locales that differ significantly from the Canadian climate (i.e., high humidity, extreme temperatures, etc.) will not be accepted;
• data must be generated from forage crops commonly grown in Canada. Experimental results arising from studies using forages that are not typically grown on Canadian farms will not be accepted (due to the fact that claims are crop-specific); and
• for Type 2 mould inhibitors, the mixed feed(s), feed ingredient(s) or forage must be stored for a minimum period of 120 days after treatment with the mould inhibitor product.

With regards to the use of laboratory silos and other experimental-scale ensiling structures in efficacy studies presented in support of an application for registration, these smaller units may produce highly variable experimental results lacking in statistical significance and may not accurately reflect the efficacy and effectiveness of the forage additive or mould inhibitor in question when extrapolated to farm-scale or commercial conditions. Due to the potentially large variations in crop management and ensiling practices, it is felt that the use of experimental-scale ensiling structures does not accurately reflect practical conditions.

Furthermore, scientific data obtained from studies conducted in lab silos and other small-scale structures will not be accepted for new applications for registration, applications for temporary registration, or with applications for re-registration/significant change (i.e., in terms of the addition of new product claims).

The exact number of replicates required per experimental treatment and/or study will be determined by the experimental design and type of statistical analyses used in the study in question. If in doubt, a statistician should be consulted prior to beginning the scientific study in order to establish a statistically valid number of replicates.

In the event an applicant is uncertain as to whether or not their experimental design and/or testing protocol meets the criteria described above, it is recommended that the Feed Program be contacted prior to submitting an application for registration to discuss the suitability of the protocol in question.

Applications for registration for mould inhibitors (Type 2) and viable bacterial silage inoculants (Types 3 and 4) submitted without efficacy data (i.e., scientific studies), or with scientific studies that do not meet the requirements outlined above, will be not be accepted and shall be screened out and returned to the applicant.

Temporary Registrations

A temporary registration may only be granted for mould inhibitors (Type 2 products) and Type 3 and Type 4 forage additives for which all the basic registration requirements (registration of individual strains, safety, etc.) have been met, but for which the substantiating information (i.e., efficacy data) submitted in support of the application for registration did not demonstrate a statistical difference between the control and treatment group(s) (i.e., P>0.05), yet did indicate a trend toward becoming statistically significant (i.e., 0.05<P<0.10). Products bearing a temporary registration number on the label will be identified by the letter "T" in front of the registration number. Note that, as mentioned above, data submitted from laboratory silos and other experimental structures are not acceptable for temporary registration status.

The issuance of temporary registrations is considered an interim measure which allows companies to adequately comply with the conditions of their temporary registration, as outlined in their approval letter. Only one temporary registration will be granted per product and the maximum duration for a temporary registration for a forage additive or mould inhibitor will be 2 years.

1. Temporary registrations for new applications for registration
   • for new registrations given temporary registrations, no claims will be allowed on product labels, as the desired claims have not yet been substantiated by the applicant; and
   • the crop(s)/feed ingredient(s)/mixed feeds for which the mould inhibitor or forage additive has been approved for use on will appear in the product name (i.e., Silage Inoculant for Whole Plant Corn Silage or Mould Inhibitor for Complete Fish Feeds) and in the directions for use on the product label.

   With regards to new applications for registration, if the product has not been proven to be efficacious and the desired product claims have not been supported by acceptable scientific data by the end of the temporary period, and/or if other registration criteria have not been met as outlined in the approval letter granting temporary registration status to the product in question, the temporary registration will not be renewed and the product will not be considered for full registration. Hence, the current temporary registration will expire, thereby making the product in question non-compliant with Section 3 of the Feeds Act.

2. Temporary registrations granted to products that are already permanently registered
   • in the case of a forage additive or mould inhibitor that is already fully registered for use on one or more forage crops, feed ingredients, etc., and for which one or more claims are already approved, a temporary registration may be issued in the case of an application for significant change/re-registration wherein the new efficacy data submitted in support of a new product claim and/or use on a new forage crop, feedstuff, etc. only demonstrates a trend toward statistical significance;
   • in this case, the conditions of the temporary registration will only apply to the claims and the forage crop, feed ingredient, mixed feed, etc. that constitute the application for significant change;
   • a "T" will be placed in front of the existing registration number and the new crop, feed ingredient, etc., will appear in the product name and in the directions for use, but no new claims will be permitted on the product label;
   • if the conditions of the temporary registration pertaining to the new forage crop, feedstuff, mixed feed, etc. are met at the end of the temporary registration period, the product will have its full registration status restored and the new product claims (having been properly substantiated) will be added to the product label; and
   • in the event the conditions of the temporary registration are not met, no new claims will be permitted to appear on the product label and the new crops, feed ingredients, etc., will be removed from the product name and directions for use. Additionally, the label will revert back to the previously approved label (i.e., before the application for significant change was submitted) and the product will be given back its previous full registration status.

Requirements for Registration Renewal for Forage Additive and Mould Inhibitor Products

As with all registered feeds, forage additive and mould inhibitor products that have been granted permanent registration status are registered for a 3-year period, renewable by March 31 of the third year after the registration date. All applications for registration renewal must be accompanied by the following:

• a cover letter explaining the purpose of the application;
• a signed and completed application form, accompanied by the proper renewal fee;
• five copies of the product label;
• a copy of the current product formula; and
• any additional information, documentation, scientific data, etc. that is required to be submitted with application for registration renewal.

Please note that further information may be requested if safety and/or efficacy concerns emerge between the time of registration and the renewal due date.

Note that changes made to the formulation and/or to the label (e.g., claims, directions for use, crop types, etc.) of forage additive and mould inhibitor products are considered to be significant changes to these registrations. These changes cannot be submitted for review and approval at the time of registration renewal unless substantiating information and scientific data (if applicable) has been included with the application for registration renewal and are accompanied by the appropriate fees. Please consult the following section for additional information concerning the requirements for significant change/re-registration to these products.

Requirements for Amendments (Re-registration/Significant Change) to Forage Additives and Mould Inhibitors

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 data (which meets the criteria previously outlined) and/or safety data as part of the application for registration amendment:

• changes to the label guarantees for nutrients 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, etc.);
• changes to the manufacturing process that may alter 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 (i.e., new livestock species, addition of a different stage of production or class of livestock, addition of a new forage crop or feedstuff, etc.);
• modifications and/or additions to the directions for use and/or application rates; and
• changes to the duration of the shelf life of the product.

Please refer to Chapter 1 for additional information regarding significant changes to specialty 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 mixed feed.

Formulation changes involving ingredients that are not considered to be active ingredients or a significant source of nutrients (e.g., flavours, carriers, dyes, etc.) 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 to be submitted with the proposed application for registration amendment.

Registration Requirements for Private Label 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 Feed Registration or Renewal (CFIA/ACIA 0009) form; application fee for a standard mixed feed (see Chapter 1); five (5) 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 registered for the parent product, any mandatory information present on the original label (i.e., list of ingredients, guaranteed analysis, directions for use, caution statements, etc.), 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. Additional information concerning amendments to private label products can be found in Section 2.2 "Registration Requirements for Specialty Products".

Note: The registration checklist for forage additives (formerly RC-007) and the registration checklist for mould inhibitors (section 3.14, formerly RC-008) have been combined into a single Registration Checklist for Forage Additives and Mould Inhibitor Products. This new registration checklist is now located below.

Registration Checklist for Forage Additives and Mould Inhibitor Products

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended use (e.g., Liquid mould inhibitor for complete livestock feeds, Silage inoculant for whole crop barley silage)
• Product claim statement(s)
• Guaranteed analysis
• Type 1 (see "Registration of Forage Additive Products" above for type definitions)
  Minimum nutrient guarantees
• Type 2, 3 and 4
  Minimum guarantees for active ingredients (e.g., active ingredient [Type 2], viable lactic acid producing bacteria (LAB) and/or enzyme activity [Types 3 and 4]). If the product contains bacterial cultures, a parenthetical listing of the genus and species of microorganisms is required in conjunction with the LAB guarantee (e.g., total viable lactic acid producing bacteria: minimum 2.2 × 10⁵ CFU/g (from Lactobacillus acidophilus and Pediococcus pentosaceus spp.))
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for any Part II ingredients or mixed feeds, as required
• Directions for use to permit safe and effective use of the feed
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Net weight in metric units (non-metric units of measurement may be indicated in parentheses)
• Date of Manufacture, if referred to in the expiry date (e.g., expires 12 months from the date of manufacture)
• Expiration date (shelf life in number months from the date of manufacture, or actual expiry date [e.g., June 2010], when stored under appropriate conditions)
• Registration number (to be added)

Product Composition

• Formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for any Part II ingredients or mixed feeds
• The registration of each microbial culture has been provided with the product formulation, as well as the registration number for any mixed feeds or Part II ingredients
• The inclusion level of each ingredient does not exceed the regulatory maximum as specified by the specific single ingredient feed definition outlined in Schedule IV or V of the Feeds Regulations

Scientific Studies

Type 1

• No scientific studies are required to support product efficacy 8

Type 2, 3 and 4

• Scientific studies are required to support the intended purpose of these products, as well as the desired product claims
• Experiments must be performed on a "farm scale" (see "Description of farm- or production-scale studies" subsection "Registration of Forage Additive Products" above for the requirements for farm-scale studies)
• Experiments must meet the criteria for acceptable scientific studies as outlined in the "Criteria for scientific studies submitted in support of label claims" subsection in "Registration of Forage Additive Products" above
• For Type 2 mould inhibitors, studies must be for a minimum duration of 120 days and scientific testing must be performed on feeds for all species which the mould inhibitor is intended

Laboratory Methods

Type 1

• No laboratory methods are required to support nutrient guarantees on labels

Type 2, 3 and 4

• Original signed Certificates of Analysis for a minimum of 3 different lots of product supporting the label guarantee(s) for the active ingredients used in the product formulation (e.g., per cent propionic acid, minimum CFU/g of lactic acid bacteria, etc.)
• Copies and information on the AOAC International or other official methodologies used to determine the level of the active ingredient(s) in the product formulation
• For type 2 mould inhibitors, the laboratory method used to count moulds must be submitted, including references for the method
• Copies and information on the analytical methodologies and relevant technical information substantiating the guarantee for an active ingredient using a novel method, as required by CFIA laboratories
• Copies and information on the analytical methodologies and relevant technical information substantiating any new or different nutrient guarantees or guarantees for new or different active ingredients, as required by CFIA laboratories
• In the event that these methods have not been peer-reviewed, additional information is required to validate the laboratory method as outlined in Section 3.6 "Regulatory status of enzyme bearing products", Section 6.2 "Guidelines for the Evaluation of Methods to Determine the Viability of Direct Fed Microbials and Forage Additives Containing Microorganisms", and Section 6.3 "Guidelines for the Evaluation of Methods to Determine the Activity of Enzyme Ingredients Used in Animal Feeds"

Expiry Date (Shelf life)

Type 1

• An expiry date and shelf life data are not required for Type 1 products

Type 2, 3 and 4

• Expiry date must appear on the label (e.g., X months from the date of manufacture, June 2010, etc.)
• Original signed Certificates of Analysis substantiating the guaranteed shelf life on the label (i.e., on the date of manufacture and at the expiry date) for a minimum of 3 different lots of product. Each Certificate of Analysis must be for the same lot of product that has been analysed at the beginning and at the end of the storage period. The storage conditions used for the shelf life study should reflect storage conditions recommended on the label.

Sample

• A product sample may be requested by the evaluating officer to validate the laboratory methodology for Type 2, 3 and 4 products (to be determined by the officer evaluating the application)

Safety Requirements

• The following statement is indicated on the label "This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling"

Note: Further information may be required after a review of the preliminary submission.

3.10 Hemp products

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:

Administrative Information

1. Application form, covering letter, and the applicable fee.

Labelling

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.

Ingredient Description

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).

Ingredient Composition

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.

Manufacturing Process

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.

3.11 Horse treats

Registration Requirements for Horse Treats

Under the Feeds Act and Regulations, horses are considered a livestock species. As such, their feed is subject to the Act and Regulations.

Because horse treats are intended to be fed occasionally as a treat or reward, they are not considered part of the normal balanced diet, and are not intended to provide a significant source of nutrition (i.e., crude protein, fat, fibre, vitamins or minerals). Horse treats are therefore considered a speciality feed within Section 7 ("A mixed feed not otherwise provided for in this Table") of Table 3 in Schedule I of the Feeds Regulations, and require registration.

The following items are required when submitting an application for registration for a horse treat.

Administrative Requirements

1. The standard registration requirements include a cover letter, application form, five (5) copies of the proposed label, and the application fee (as a Category 2, New Feed, Code 3253). General administrative information regarding the application for feed registration procedures, and the table of fees, can be found in Chapter 1

It is important to note that each type, variety or flavour of horse treat is considered to be a different product, and therefore requires a separate registration. Multiple applications may be submitted in the same envelope, with the same cover letter. However, each product to be registered must have its own separate application form, copies of the proposed label, formulation (as described in 3. below), and fee (multiple fees may be combined and paid with one cheque or money order).

Labelling

2. The proposed label must include:

• The feed name, indicating the physical form (i.e., biscuits, pellets, cookies, muffins, etc.), and clearly stating "treats for horses";
• The complete list of ingredients using approved names as listed in the Feeds Regulations, Schedule IV or V (registration numbers are required for ingredients listed in Part II of Schedule IV or V);
• The guarantee for maximum percent moisture (no other guarantees are permitted);
• The average number of pieces per package;
• Directions for use, specifying how many pieces to feed as a reward;
• The net weight (in grams or kilograms); and
• The name and address of the registrant.

Note: horse treat labels may not make any nutritional or health claims (e.g. through the brand name, directions for use, or symbols on the label).

Formula

3. The product formula is required, listing the amount of each ingredient by generic name as per Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds (e.g. flavouring agents). Flavouring ingredient levels must not exceed maximums set out in Schedule V.

Renewal and Amendment to Registered Horse Treats

As with all registered products, horse treats are registered for a 3 year period, renewable by March 31 of the third year after the registration date. All applications for renewal or amendment to a registered feed must be accompanied by an application form, appropriate fees, labels as per Chapter 1 and complete product formulation. Additional information may be requested if safety concerns emerge between the time of registration and renewal.

Changes made to the formulation of approved Horse Treats are considered new registrations and require the regular registration fee.

Note: Further information may be deemed necessary after the review of the preliminary submission by the Animal Feed Division.

3.12 Micro premixes

Regulation of Micro Premixes

In recent years, CFIA inspection personnel have noted an increase in the number of intra-company or "in-house" micro premixes stocked in feed manufacturing plants during routine inspections. As these premixes are generally highly concentrated sources of vitamins and/or trace minerals and/or medicating ingredients, they may pose serious health and safety concerns to both workers and livestock if inadequate labelling results in their inappropriate or incorrect use to manufacture other feeds.

This section outlines the interpretation of what are considered as "in-house", "customer-formula" and "consultant-formula" micro premix feeds for the purpose of their exemption from registration and certain labelling provisions under the federal Feeds Act and Regulations. These exemptions only apply to products manufactured in Canada; all micro premix products manufactured outside Canada are subject to mandatory registration by the Animal Feed Division of the CFIA prior to importation, distribution or sale in Canada.

"In-house" Micro Premixes

Micro premixes are considered to be bona fide "in-house" products only if they are manufactured by and intended for distribution and use within wholly-owned company operations. Such "in-house" premixes cannot be sold by the feed manufacturer, even to other mills manufacturing the same company brands or lines of feeds (e.g. franchise mills, buying groups or other business divisions).

Micro premixes of this description may be distributed between wholly-owned company operations without requiring registration or labelling as per the current Feeds Regulations providing they are labelled with the following:

• the name of the feed including the species and class of species it is intended for (e.g. "Micro Premix for Broiler Finisher");
• the statement "This feed is for internal use only by [Company name] and must not be offered for sale"; and
• Directions for Use stating that:
  (a) "This feed must be further mixed prior to feeding"; and
  (b) Users of the product should consult a company production manual or specific mixing formula for guidance on the proper use of the micro premix.

Where products contain medications, it is also required that the name and actual amount of the medication and all cautions and warnings associated with the use of the medication be on the label of the micro premix to prevent potential misuse, especially in facilities other than the one where the premix has been manufactured.

At any time, CFIA inspectors may request information concerning the specifications and content of an "in-house" micro premix on the premises so that compliance with the Feeds Regulations can be assessed. If information cannot be supplied within a reasonable amount of time (typically the length of time the inspector will be on the premises to conduct an inspection), an "in house" product may be subject to detention until the inspector is satisfied the product is in compliance.

"Customer Formula" Micro Premixes

Micro premixes are considered to be bona fide customer formula products only if the conditions for the manufacture and exemption from registration of such feed as prescribed by the Feeds Regulations are met (i.e. meets the definition, labelling and packaging requirements of the Regulations and a signed customer formula is in place on the premises of the premix manufacturer).

Note: You are reminded that from the definition of "customer formula feed" in section 2 of the Feeds Regulations, customer formula feeds are not to be resold by the purchaser nor are they allowed to be used by the purchaser to manufacture another customer formula feed referred to in paragraphs (b) or (c) of the definition.

"Consultant-Formula" Micro Premixes

Where micro premixes are formulated and manufactured by a seller to meet the requirements of a specific purchaser and are not intended to be resold by the purchaser, such micro premixes are considered "consultant-formula" products. While such products are exempt from registration, they are not exempt from the labelling requirements of section 26(1) of the Feeds Regulations.

All other types of micro premixes must be registered by the CFIA prior to sale in or importation into Canada.

3.13 Mineral complexes

Regulation of Mineral Complexes

This section is intended as a guide to the regulation by the CFIA of specialty mineral ingredients, including chelates, amino acid complexes, proteinates, etc., hereafter referred to as mineral complexes.

1a) Regulation of mineral complexes

These types of feed ingredients are required to be registered, and must be labelled with a guarantee for minimum percent (or mg/kg) complexed mineral, in addition to an actual percent (or mg/kg) mineral. Companies wishing to market these minerals must submit suitable laboratory method(s) to be used to quantify the complexed mineral.

1b) Regulation of mixed feeds containing mineral complexes

Persons wishing to manufacture, sell, or import complete feeds, supplements, specialty mineral premixes, etc., containing mineral complexes are required to use only registered sources of mineral complexes.

Unless other registration conditions apply, mixed feeds containing mineral complexes are exempt from registration, as long as there is no reference to the products (other than the ingredient name and/or registration number when a list of ingredients is present on the label) and all other criteria for exemption from registration under the Feeds Regulations are met. A reminder: all imported mixed feeds still require registration.

If the complexed mineral ingredients are highlighted on the label for a mixed feed, the feed must be registered. Guarantees for the minerals (actual, mg/kg) and a list of ingredients (including the registration numbers and/or registered name of each registered mineral complex) are required.

2a) Registration requirements - single ingredient mineral complexes

Along with the standard requirements for registration, including application form, applicable fee and covering letter, applicants should submit:

A. Proposed label, to include a guarantee for the mineral (actual) as well as a guarantee for minimum complexed mineral (express either as a percent of the actual mineral guarantee, or in absolute terms).

Example: The following draft labels show acceptable labelling format:

i)  Super zinc complex for livestock feeds
Ingredients: zinc proteinate, wheat midds

Guaranteed analysis:

ii)  Super zinc complex for livestock feeds
Ingredients: zinc lysine complex, wheat midds

Guaranteed analysis:

B. Complete laboratory method description and supporting data used to verify the guarantee for the % bound (complexed) mineral must also be submitted. Laboratory method submissions should address all of the requirements outlined in section 6.2, Good Laboratory Practices Protocol for Feed Ingredient Approvals.

For the present time, applicants are required to submit product-specific analytical methods, i.e., the method that would be used in their own quality control procedures to verify product guarantees. This means that the submitted and approved method will be used by the CFIA for post market surveillance of registered products.

The Animal Feed Division and the Science Branch of the CFIA will, however, be working toward the utilization of a standard method(s) for verification of guarantees for binding in complexed minerals. In 1997, the Feed Section (now the Animal Feed Division) undertook a survey of the manufacturers of mineral complex products, and advised these manufacturers of the implementation of the new requirement to guarantee and provide laboratory methods for "percent bound" or "percent complexed" in addition to guaranteeing the actual mineral. We plan to consult with these same companies on any developments in establishing a single method. Input on this process from other interested parties is welcome.

2b) Registration requirements - mixed products containing and highlighting mineral complexes

Along with the standard requirements for registration, including application form, applicable fee and covering letter, applicants should submit:

1. Product formulation
2. Proposed label - to include a complete list of ingredients, including the registered name or registration number of each registered mineral complex ingredient.

Registration Checklist for Mineral Complexes

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended species
• Guaranteed analysis for a minimum percent (or mg/kg) complexed mineral, in addition to an actual percent (or mg/kg) mineral
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds as required
• Directions for use to permit safe and effective use of feed
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Net amount (metric measure)
• Lot Number
• Expiry date with storage conditions
• Registration number (to be added)

Product manufacturing & Composition

• Details concerning manufacturing process of product
• Formulation / percentage composition listing amount of each ingredient

Lab Methods

• Complete laboratory method description and supporting data used to verify the guarantee for the % bound (complexed) mineral. Follow section 6.2 for laboratory requirements

Safety Review

• Dioxin analysis for 3 lots for single ingredient minerals

Promotional Claims (including Internet and Advertising)

• Consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

3.14 Mould inhibitors

Section 3.14, Registration Checklist for Mould Inhibitors (formerly RC-008) has been merged with the Registration Checklist - Forage Additives (formerly RC-007) in section 3.9. Please consult the "Registration Checklist for Forage Additives and Mould Inhibitor Products" in section 3.9, Forage Additives.

3.15 Odour control agents

Registration Checklist for Odour Control Agents

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended species
• Product claim statement
• Guaranteed analysis (active ingredient(s))
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds as required
• Directions for use to permit safe and effective use of feed
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Net amount (metric measure)
• Registration number (to be added)

Product Composition

• Formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of Feed Regulations including registration numbers for Part II ingredients or mixed feeds
• Formulation / Ingredients - verify level of ingredients does not exceed maximums per Schedules IV and V

Scientific Studies

• Scientific studies are required to support the intended purpose of the product
• Studies carried out by qualified personnel
• Suitable methods used in studies
• Studies designed to facilitate statistical analysis
• Data analysed by appropriate statistical methods
• Studies conducted under conditions similar to those that may be expected to occur in Canada
• Studies show a significant reduction (P<0.05) in barn and/or litter ammonia levels or other indicators of odour control when the product is fed to each species for which the product is intended to be fed
• Where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate the lowest inclusion rate
• Where results of these studies have not been published in a refereed journal, copies of the raw data and printouts of statistical analysis are required for our review

Sample

• Provided (if necessary to validate lab methodology)

Promotional Claims (including Internet and Advertising)

• Consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

3.16 Pellet binders

Registration Checklist for Pellet Binders

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended species
• Product claim statement
• Guaranteed analysis (active ingredient(s))
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds as required
• Directions for use to permit safe and effective use of feed
• Caution and/or warning statements (if applicable)
• Required statement: "Consult the Compendium of Medicating Ingredients Brochures for acceptable drug compatibility with this product"
• Name and address of registrant
• Net amount (metric measure)
• Registration number (to be added)

Product Composition

• Formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of Feed Regulations including registration numbers for Part II ingredients or mixed feeds
• Formulation / Ingredients - verify level of ingredients does not exceed maximums per Schedules IV and V

Scientific Studies

• Scientific studies are required to support the intended purpose of the product and must be provided for our review
• Studies carried out by qualified personnel
• Suitable methods used in studies
• Studies designed to facilitate statistical analysis. The research design must include at least 3 replicates of each treatment involved, including the control.
• Data analysed by appropriate statistical methods
• Studies conducted under conditions similar to those that may be expected to occur in Canada
• Scientific investigations show that the product, when used as directed, significantly (P<0.05) improves pellet durability in a specific feed for a specific class of livestock
• When the pellet binder is intended for use in a variety of feeds and/or for various classes of livestock, scientific investigations must show significant differences (P<0.05) between the control and treated groups, for each of the specific feeds and/or livestock groups where the product is intended for use
• Where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate the lowest inclusion rate
• Where results of these studies have not been published in a refereed journal, copies of the raw data and printouts of statistical analysis are required for our review

Sample

• Provided (if necessary to validate lab methodology)

Promotional Claims (including Internet and Advertising)

• Consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

3.17 Processing aids

Registration Checklist for Processing Aids to be Utilized in Livestock Feed Production

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name
• Product name reflecting purpose of the processing aid
• Directions for use for the processing aid for the intended process
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Net amount (metric measure)
• Date of Manufacture
• Expiration date
• Registration number (to be added)

Product Composition

• The ingredient formulation of the processing aid is required (Please note that such formulations are held in strict confidence)
• If the processing aid contains a polymer, the residual monomer concentration must be determined

Processing Conditions

• A schematic, or flow chart of the process, clearly indicating where the processing aid is to be applied in the process (e.g., rendering, meat processing) and quantities administered
• The stability of the processing aid during the process to include considerations of thermal stability
• The potential concentration of the processing aid, or its ingredients or breakdown products, present in the recovered solids (coagulated fat/protein mixture). Calculations must incorporate appropriate concentration factors
• If the processing aid is used as a flocculant in the treatment of wastewater a discussion on the partitioning of the flocculant should be provided, e.g., does the polymer/monomer constituents partition with the recovered solids or with the waste water?

Feed Ingredient Composition

• A description of how the recovered solids are to be used as a livestock feed ingredient, including types of feeds, inclusion rates, and intended species
• The final composition (list possible degradation products, if any) of the processing aid in the livestock feed ingredient

Quality Control Procedures

• Method of analysis for the processing aid, or its constituents and breakdown products in the feed ingredient
• Certificates of Analysis (for a minimum of 3 separate lots if applicable) of the processing aid, or its constituents and breakdown products, in the feed ingredient or in complete feeds

Safety Review

• Material Safety Data Sheet (MSDS) for the processing aid
• Appropriate toxicological studies for the processing aid and/or its constituents, including but not limited to, acute, sub-acute or chronic bioassays via the appropriate exposure route (oral), and bacterial mutagenicity and in vitro chromosome aberration studies. Toxicity results may be obtained from journals, toxicological data bases or registrant-funded toxicity studies. Results from toxicology studies using similar compounds may also be accepted, provided sufficient bridging data between compounds is established
• Toxicity must be considered for all species of intended use of the final feed ingredient

Note: Further information may be required after a review of the preliminary submission. Valid scientific rationale may be provided in place of data requirements.

3.18 Ruminant and horse supplements

Regulation of ruminant and horse supplement feeds

Over the past several years, confusion has arisen regarding the regulatory status of ruminant and horse feeds manufactured in Canada termed "supplements" to the point where it is generally believed that the majority of these products are exempt from mandatory registration. This section will clarify the regulatory status of "supplement" feeds and identify which products require registration.

Background

The definition of a livestock "supplement" feed in section 2 of the Feeds Regulations is a broad one that allows this category of product to be fed in 3 different ways:

(a) fed undiluted as a supplement to other feeds,
(b) offered free choice with other parts of the ration separately available, or
(c) further diluted and mixed to produce a complete feed that is acceptable for registration.

"complete feed" means a feed that, when used for the kind of livestock and for the purposes stated on the label, will provide all of the nutritional requirements necessary for the maintenance of life or for promoting production except

(a) water, in the case of monogastric animals other than horses, and
(b) water or roughage, in the case of ruminant animals and horses (aliment complet)

For the purposes of the regulations, the complete feed for a ruminant animal or a horse is not the same as its total diet.

Although subsection 5(1) requires that all feeds be registered, subsection 5(2) contains a long list of specific exemption criteria for products defined within the scope of the regulations. With respect to "supplements", paragraphs 5(2)(d) and (e) outline the exemption criteria:

"(d) any complete feed, supplement or macro-premix manufactured in Canada that is designed to be fed to beef cattle, dairy cattle, sheep, swine, chickens, turkeys, horses, goats, ducks, geese, salmonid fish, mink or rabbits where...
(iv) in the case of a supplement or macro-premix, the nutrient level guaranteed for those nutrients listed in Table 4 of Schedule I is such that when the supplement or macro-premix is used according to the directions for use it will not supply the complete feed with any nutrient at a level higher than the maximum listed in that Table for that nutrient but will supply the complete feed, in conjunction with the other ingredients, with a level of nutrient that meets or exceeds the minimum listed in that Table for that nutrient, ..."

"(e) any consultant formula feed manufactured in Canada if ...
(iii) in the case of a supplement, macro-premix or micro-premix, the nutrient level guaranteed for those nutrients listed in Table 4 of Schedule I is such that when the supplement, macro-premix or micro-premix is used according to the directions for use it will not supply the complete feed with any nutrient at a level higher than the maximum listed in that Table for that nutrient but will supply the complete feed, in conjunction with that supplied by the other ingredients, with a level of nutrient that meets or exceeds the minimum listed in that Table for that nutrient, ..."

The criteria mentioned above indicates that supplements are considered exempt from mandatory registration if the nutrient level guaranteed is such that when the supplement is used as directed, it will :

• supply the complete feed with nutrient levels that do not exceed the Table 4 maximum values and
• supply the complete feed, in conjunction with the other ingredients, a nutrient level that meets or exceeds the Table 4 minimum levels

Interpretation

Given the above definitions and exemption criteria, "supplement" feeds to be offered undiluted or free choice to ruminants or horses, with no further mixing directions on the label are not exempt from mandatory registration as they would not meet the specific exemption criteria described above.

Example products required to be registered include:

• molasses-based blocks or liquid suspension feeds
• free choice or blocked "mineral" supplements for cattle, sheep, goats or other species on pasture or range
• any supplement, including a consultant formula feed, where the directions for use indicated do not sufficiently support the exemption from registration criteria, for example, where
  • the nutrients in the supplement alone are not sufficient to meet minimum Table 4 levels, and the feed label does not include the type and amount of the other ingredients to be used, or
  • no mixing directions are provided on the label, such as "feed this supplement at 10 kg/head/day"

Considering all other applicable regulatory requirements are met, supplement labels that include sufficient mixing directions to ensure that the Table 4 maximum and minimum level standards are met would be deemed exempt from registration. This could include:

• directions for use as a complete feed (grain portion only), or
• in the case of ruminant animals or horses, directions for use as a total diet (grain and roughage portion), or
• supplements labelled where both further mixing and feeding undiluted or free choice are indicated in the directions for use

If the nutrients in the supplement alone are sufficient to meet the minimum Table 4 nutrient levels, without exceeding the maximum Table 4 nutrient levels, simple mixing directions may be sufficient to meet the exemption from registration criteria.

For example:

• Complete feed – mix 200 kg of this supplement with grain to make a 1 tonne batch of complete feed
• Total diet – mix this supplement at a rate of 4% of dry matter intake with grains and forage

In cases where the nutrients in the supplement alone are not sufficient to meet Table 4 minimum levels, the directions for use on the label must include additional information on the type and amount of the other ingredients to be used, as their nutrient levels must also be considered to determine if the resulting complete feed or total diet meets the Table 4 minimum values.

For example:

• Complete feed – Mix 200 kg of this supplement with 800 kg of barley
• Total diet – Mix this supplement at a rate of 4% of the total daily diet with 21% barley and 75% timothy hay

Note that in the case of medicated supplements, the directions for use indicated on the label must also be sufficient to confirm that the feed contains the correct amount of medicating ingredient as per the Compendium of Medicating Ingredient Brochures (CMIB) or the veterinary prescription, as applicable.

Therefore, to be considered exempt from registration, all ruminant and horse supplement feeds, including consultant formula feed supplements, require sufficient directions for use to demonstrate that the Table 4 standards are being met.

Product registration

Supplements requiring registration will be accepted and processed per the procedures and application fees for registration outlined in Chapter 1.

3.19 Recycled food products

Recycled food products (RFPs) are materials that remain after, or are produced during, the processing, manufacture, preparation or sale of human food. RFPs may, under certain conditions, be suitable for use as livestock feeds. This section sets out the regulatory requirements for RFPs intended as livestock feeds in Canada. The information contained herein is pertinent to food processing plants, feed mills, RFP manufacturers, distributors, and all other persons involved with the manufacture, importation, sale or distribution of RFPs in Canada.

Although these products are generated as by-products of human food production, it is important to stress that the livestock feed chain is not a means to dispose of degraded or contaminated foodstuffs, and that the product must have a nutritional value to be considered a feed.

RFPs that are currently approved as single ingredients for use in livestock feed are listed in Schedule IV of the Feeds Regulations. Examples include Bakery waste dehydrated (4.6.1), Cereals breakfast process residue (4.6.7), and Wheat distillers grains dehydrated (5.5.21). For a complete and up-to-date listing, please contact the Animal Feed Division of the Canadian Food Inspection Agency (CFIA).

If an RFP meets an existing definition as listed in Schedule IV, Part 1, namely, a substance that has been assessed or evaluated as acceptable for use in feed, and meets the standards, packaging and labelling requirements set out in the Feeds Regulations, it may be manufactured, sold, imported or distributed as a single ingredient feed without registration. If an RFP meets an ingredient definition as set forth under Schedule IV, Part 2, or if it contains 2 or more single ingredient feeds listed in Schedule IV or V, it must be registered with the Animal Feed Division. If an RFP does not meet any approved feed definitions or requires registration, it is not to be manufactured, sold, imported or distributed as a feed without prior approval of the Animal Feed Division. Please refer to Section 1.1, "Application for Feed Registration and Ingredient Approval".

Sale and distribution of RFPs

• If an RFP is manufactured, sold, imported or distributed as a feed by any person, including livestock producers, feed mill operators or food manufacturers, it is subject to the regulatory requirements of the Feeds Act and Regulations, including approval and/or registration by the Animal Feed Division.
• If an RFP is given away to one person it may be exempt from the requirements of the Feeds Act and Regulations, but only if the RFP is for the recipient's own use and it does not contain any drugs or other substances that could adversely affect human health or the environment. Note that the RFP may also be subject to acts and regulations of other jurisdictions (e.g. Health of Animal Regulations). See "Restrictions on Recycled Food Products" below.

Handling and storage of RFPs

RFPs should be handled, transported and stored in a sanitary manner in order to prevent contamination and the growth of pathogenic organisms, or the production of harmful toxins (e.g., mycotoxins). The risk of contamination by microbial or chemical impurities must be minimized for all livestock feeds.

Feed manufacturers and livestock producers are responsible for ensuring that suppliers apply quality control procedures, and that appropriate hygienic practices are followed in the collection, handling, transportation, and storage of the RFPs.

Restrictions on Recycled Food Products

1. Meats and meat products; facilities that handle meat

   Due to the risk of zoonotic and exotic diseases, meat products, meat by-products and products suspected to contain meat are not permitted in RFPs intended for livestock feed unless they:

   1. are in compliance with the Mammalian to Ruminant Feed Ban;
   2. have been processed in a manner which would prevent the introduction of disease (subject to approval by the Animal Health Directorate of the CFIA); and
   3. have been registered as a feed, or are listed in Schedule IV or V of the Feeds Regulations.

   If an RFP contains meat or is sourced from a facility where there is meat present (including sandwich meats, filler, beef patties, plate waste, restaurant preparation waste, etc.), including facilities where products are sorted and separated from products containing meat, it is prohibited from being sold, manufactured, imported or distributed as feed, without prior approval of the Animal Feed Division.

   Note: RFPs that are exempt from the Feeds Act and Regulations are still subject to the Health of Animals Regulations. These RFPs must meet conditions a) and b) above, and RFPs that are to be fed to swine or poultry must also comply with condition c).

2. Spent cooking oils

   Spent cooking oils are fats or oils of animal or vegetable origin that have been used in the manufacture and preparation of human foods. These oils may be considered approved feed ingredients as listed in Schedule IV of the Feeds Regulations, if they meet the prescribed definition, as well as the labelling standards.

3. Imported RFP Ingredients

   RFPs imported into Canada must be approved, and must meet packaging and labelling standards as prescribed in Schedule IV or V of the Feeds Regulations prior to their importation and sale in Canada.

4. Degraded material

   Degraded materials are prohibited from use in livestock feed. Degraded materials consist of:

   • decomposing products - product that is visibly mouldy, rotting or decayed;
   • products that have been stored and have been visibly affected by pests, such as insects or rodents, or animal feces;
   • products that have been kept uncovered outdoors; and
   • products that have been damaged by heat, such as in a fire.
5. Contaminated recycled food sources

   Contaminated materials are prohibited from use in livestock feed. Examples of contaminated materials include:

   • foods that are contaminated on the production line (e.g., by a spill of hydraulic oil);
   • production floor wastes that have been in contact with contaminants, cleaners, or wastes that are not part of the food production line;
   • foods contaminated with foreign material (e.g., paper, wood, glass, plastic, metal or soot); and
   • foods rejected due to microbial contamination.
6. RFPs with high moisture considerations

   Due to the potential for concentrated bacterial growth, high moisture RFPs are not acceptable unless the RFP is further heat treated, has been registered as a feed, or is listed in Schedule IV. A safety evaluation will be required prior to approval of RFPs containing high moisture ingredients, or uncooked materials such as raw dough (for breads, cookies, pastries, etc.), or fillings (e.g., apple pie filling, jams, jellies).

Feed Registration and Ingredient Approval Requirements

The following identifies the registration and approval requirements for RFPs ingredients per the Feeds Act and Regulations. Please note that additional information beyond what is listed in this section may be requested, on a case-by-case basis, after review of the submitted information. In order to facilitate the evaluation process, it is recommended that applicants contact the Animal Feed Division prior to submitting an application for ingredient approval or registration.

A) Registration and Ingredient Approval Information

Information on registration and ingredient approval requirements can be found in Chapter 1.

Please see the "Registration Checklist for Recycled Food Products (RFPs) to be Used as Livestock Feed Sources" below, which summarizes the basic requirements for all RFPs submissions.

B) Composition and Manufacturing Conditions

A detailed description of the manufacturing process for the submitted RFPs must be provided, including the source and description of all individual ingredients that enter into the manufacture of the RFPs. This information includes, but is not limited to:

• A complete list of all food ingredients or products that make up each RFP (e.g., vegetables, crackers, cheese, milk, flavours, chocolate, fruits, nuts, candy, preservatives or specific products).
• The source of each ingredient used to manufacture the RFPs, including the names and contact information of each supplier.
• The product formulation as sold, stating the food ingredients/products percentage composition (note that a range may be used).
• A list of products added to facilitate the manufacture of each RFP, such as antifoaming agents or flocculants, and a list of cleaners, disinfectants, etc., associated with the manufacture and storage of the RFPs. Please note that the database of products approved for use in food production facilities is available on the CFIA web site.
• A detailed explanation of the manufacturing process used to generate the final product, including all processing steps (i.e. blending, crushing, mixing, filtering, dehydration, heating, sorting or separation) at each facility, and the method for removing extraneous materials (e.g., glass, plastic, metal, wood).
• A precise description of the storage of the products before processing, storage and transportation of the finished product, and storage on farm, including the times, temperatures and amounts for each.

If, following approval/registration, there are changes in the composition of the RFPs (e.g., a new ingredient or source), the manufacturing process, or other conditions, the Animal Feed Division must be notified.

C) Quality Control Procedures

Since RFPs are exposed to multiple handling, storage, and transportation conditions, temperature variations, etc., a detailed description of the quality control procedures is required. This includes, but is not limited to:

• Written records (from each supplier) maintained at the manufacturing facility, detailing the origin of the food product ingredients;
• The reasons for rejection. Please note that if a food product has been returned to the supplier or rejected due to contamination it may not be considered acceptable as livestock feed, prior to receiving approval from the Animal Feed Division;
• Written procedures used to screen incoming ingredients for contaminants; and
• Records demonstrating that written procedures were followed.

D) Safety Data

Data demonstrating the safety of the RFPs must be provided, including the following information:

Identification of potential chemical contaminants and sources of contamination

• A detailed description of any contaminants inherent to the RFPs (i.e. chemical agents), or introduced through handling, storage or transportation (e.g., metals, pesticides, dioxins, fungal toxins), or other ingredients that may be of concern to humans, livestock or the environment.
• Signed Certificates of Analysis for relevant contaminants for 3 different production lots of the RFP ingredient.
• A detailed description of the sampling protocols used for obtaining representative samples for analysis.
• A detailed description of the methods of analysis used to assess contaminants, including detection limits and recovery rates.

It may be necessary to submit additional safety data for any contaminants present in the RFPs. Based on the data submitted, a scientific rationale may be required to demonstrate that the levels present in complete feed do not result in adverse effects on the intended species of livestock or to human health. The toxicity data may be obtained from complete scientific articles in refereed journals, information from toxicity databases, or unpublished toxicity studies with all the data provided. Abstracts and testimonials are not acceptable.

Microbial Contamination, Shelf-life, and Stability

• Certificates of Analysis are required to demonstrate the safety and stability of the product for a minimum of 3 representative production lots of the final product prior to sale. RFPs are divided into categories on the basis of their physical characteristics, for example; liquid, dry, or vegetable-based. The minimum recommended microbial parameters and physical criteria required to be analyzed for these categories of RFPs are listed in Table 1 (below). Additional microbial analyses may also be required, depending on the type of RFPs being manufactured and the storage and handling conditions.
• When the product may be stored for a period of time before it is fed to livestock, Certificates of Analysis are required for microbial parameters and physical criteria from each of the production lots at the beginning and end of the proposed shelf-life (i.e. sample from the production lot and store the sample; and then resample same production lot sample at the end of the time period). The product samples should be stored under representative conditions, reflecting the storage conditions used in the field. Please refer to Section 6.1, "Sampling Protocol for Feed Products", for sampling information.
• A typical shelf life encompassing on-farm use for the RFPs should be provided and stated on the proposed label. An expiration date may be required depending on the stability of the product.

These analyses must be provided with the application for approval or registration. In some cases, analyses may be omitted when justified by a scientific rationale, supported by peer-reviewed literature.

It is recommended that applicants contact the Animal Feed Division well in advance of submitting an application for approval or registration to determine the types of analyses that may be required.

E) Efficacy Data

RFPs must have a nutritional purpose to be acceptable as livestock feeds. Product labels and supporting information must indicate the target species, the typical and maximum feeding or usage rate, and nutritional guarantees. Supporting Certificates of Analysis (signed originals) for 3 production lots of the finished RFPs are required to characterize the nutrition of the product and to support the proposed label guarantees. The certificates must include analysis of percent moisture content. The certificates must include analysis of added or inherent sources of nutrients (e.g. protein, fat, fibre, sugars, vitamins, minerals) to determine if these nutrients are present at significant levels. Note that scientific studies may be required to support the usefulness of the ingredient.

Certificates may be required for nutritional analysis at the end of the proposed shelf life period, depending upon the type of product being manufactured. In these cases the laboratory should analyze the same lots over the time period specified (i.e. sample from the production lot and store the sample; and then resample same production lot sample at the end of the time period). The product samples should be stored under conditions representative of the storage conditions used in the field.

F) Facility Inspections

Before approval or registration, an inspection of the facilities that manufacture, collect, or process RFPs destined for livestock feed may be conducted. These facilities, like other feed producing facilities, will be subject to periodic monitoring inspections and random sampling by CFIA inspection staff to verify that the feeds comply with regulatory requirements.

Registration Checklist for Recycled Food Products (RFPs) to be used as Livestock Feed Sources

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended species
• Guaranteed analysis
• Directions for use to permit safe and effective use of feed (including feeding rate)
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Net amount (metric measure)
• Date of Manufacture
• Expiration date
• Registration number (to be added)

Product Composition

• List of all food ingredients/products that may be mixed into each product
• Source of each ingredient, including the name and contact information of each supplier
• The product formulation (note that a range may be used)
• List of products added during the manufacture, processing and storage of the RFPs

Manufacturing Conditions

• Detailed explanation of the manufacturing process used to generate the final product
• Description of the storage of the products

Quality Control Procedures

• Records (from each supplier) detailing the origin of the food product ingredients and the reasons for rejection
• Written procedures used to screen ingredients for contaminants
• Records demonstrating that written procedures were followed

Safety Review

• Identification of potential chemical contaminants and sources of contamination
• Signed Certificates of Analysis for relevant contaminants for 3 different lots of the RFPs ingredient
• Proposed shelf life
• Certificates of Analysis for a minimum 3 different lots of finished product for the specified indicators
• Matching Certificates of Analysis of the same 3 lots from the end of the proposed shelf life. Note: this requirement is dependent upon on the proposed shelf life and the type of product being manufactured

Efficacy Data

• Supporting Certificates of Analysis (signed originals) for 3 production lots for the nutrient content of the finished RFPs, including added nutrients and moisture.
  
• Certificates may be required for the same lots at the end of the proposed shelf life period depending upon the type or product being manufactured.

Facility Inspections

• The RFPs supplier/manufacturer may be subject to a pre-approval plant inspection to verify the information submitted.
• The RFPs supplier/manufacturer may be subject to monitoring inspections to confirm continued compliance.

Note: Further information may be required after a review of the preliminary submission.

3.20 Rumen bypass feeds

Registration Checklist for Rumen Bypass Feeds

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended species
• Product claim statement
• Guaranteed analysis
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds as required
• Directions for use to permit safe and effective use of feed
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Net amount (metric measure)
• Registration number (to be added)

Product Composition

• Formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds
• Formulation / Ingredients - verify level of ingredients does not exceed maximums per Schedules IV and V.

Scientific Studies

• Scientific studies may not be required if the product contains predominantly recognized sources of bypass protein/fat ingredients
• If the product is intended a a source of bypass nutrients other than recognized proteins/fats, scientific studies are required
• Studies carried out by qualified personnel
• Suitable methods used in studies
• Studies designed to facilitate statistical analysis
• Data analysed by appropriate statistical methods
• Studies conducted under conditions similar to those that may be expected to occur in Canada
• Results showing a significant increase in a related parameter in the blood or plasma of treated animals, e.g., significant increase in plasma amino acids for bypass amino acids
• Studies show a significant difference (P<0.05) between the control and treated groups
• Where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate the lowest inclusion rate
• Where results of these studies have not been published in a refereed journal, copies of the raw data and printouts of statistical analysis are required for our review

Promotional Claims (including Internet and Advertising)

• Consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

3.21 Veterinary biologics

Regulation of Veterinary Biologics for use in Livestock Feeds

This section outlines the registration requirements for livestock feeds containing Veterinary Biologics (VB) that are licensed for use in livestock feeds.

Under the authority of the Health of Animals Act and Regulations, the Canadian Centre for Veterinary Biologics (CCVB) of the Canadian Food Inspection Agency (CFIA) is responsible for the licensing of all veterinary biologics, including those intended for use in livestock feed. The licensing process includes the evaluation of the manufacturing process, the efficacy and safety of the veterinary biologic, and the label indications for use. All veterinary biologics must be licensed by the CCVB prior to import, manufacture or sale in Canada. The CCVB works cooperatively with the Animal Feed Division (AFD) to regulate the use of veterinary biologics in livestock feeds (e.g. methodology, mixability, and labelling).

Livestock feeds containing a licensed VB manufactured, sold or imported in Canada are also considered to be veterinary biologics under the Health of Animals Act. The CCVB and AFD have agreed to regulate licensed biologics in livestock feeds as follows.

Registration Requirements for Livestock Feeds Containing a Licensed Veterinary Biologic

Livestock feeds containing a VB must be registered under the Feeds Act and Regulations. The following items are required as part of the submission package.

Administrative Requirements

Standard registration requirements, including a completed and signed Application for Feed Registration or Renewal (CFIA/ACIA 0009) form; application fee as per Chapter 1, "Application for Feed Registration and Ingredient Approval" (Category 2); five copies of the proposed product label; an accompanying cover letter; and signing authority/Canadian agent (if applicable). General administrative information regarding the application for feed registration procedures, and the table of fees, can be found in Chapter 1.

Supplemental Information Requirements

Additionally, the following information and documentation are required with each application for registration:

• detailed product formula in support of the approved level of inclusion; and
• additional labelling information related to the licensed incorporated VB:
  • the product name, reflecting the purpose of the product and the intended species (e.g., "Supplement with veterinary biologic for weaned piglets", "Veterinary biologic product for weaned piglets");
  • label claim statement (as indicated for the licensed incorporated VB);
  • list of ingredients, including the trade name (brand name) for the incorporated VB;
  • guarantee for activity (if applicable);
  • directions for use with regard to the mixing or feeding rate, intended species, or class of livestock, duration of feeding, reflecting the incorporated licensed VB;
  • recommendations with respect to the optimum age for vaccination, repeat dose (booster) instructions, precautions, withdrawal period, and antidote for the incorporated licensed VB (if applicable);
  • storage conditions reflecting those of the incorporated VB;
  • an expiry date, reflecting that of the incorporated VB;
  • a lot number or identification code; and
  • the name and address of the facility that will manufacture the product.

Renewal of Registered Livestock Feeds Containing a Licensed VB

As with all registered products, feeds containing a licensed VB are registered for a 3-year period, renewable by March 31 of the third year after the registration date. All applications for registration renewal must be accompanied by a signed and completed application form; the appropriate fee; the complete product formulation; and five copies of the product label, as per Chapter 1.

The renewal fee applies in cases where no changes have been made to the product formula or the label.

Please note that the 3-year registration period does not supersede the CCVB requirement for annual renewal of licensing of the incorporated VB.

Amendment to a Registered Livestock Feed Containing a Licensed VB

Registrants wishing to make a change to the formula or label of a registered product at any time must first submit an application for an Amendment to Registration with the proposed changes to the AFD for approval. Any proposed changes to the brand or product name, product claim(s), directions for use or formulation and ingredients is considered a significant change to registration.

All applications for a significant change must be accompanied by the appropriate fee, five copies of the proposed label, and the product formulation.

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.

It is recommended that the AFD be contacted ahead of time in order to determine what type of information and documentation will be required to be submitted with the proposed application for registration amendment.

Please note that changes to the VB formulation (including manufacturing, claims, directions for use) will require approval by the CCVB first.

For information purposes, an updated list of approved veterinary biologics (with labelling information) for use in livestock feeds is attached. (See Annex 1).

All applications for the approval of a Veterinary Biologic should be addressed to:

National Manager
Canadian Centre for Veterinary Biologics
Animal Health Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9

Telephone No.: 613-773-7408
Fax No.: 613-773-7570

For further information about the regulation of veterinary biologics, please refer to the Canadian Centre for Veterinary Biologics page on the CFIA web site.

Annex 1

Veterinary Biologics Licenced for Use in Feeds

1. Approved Brand: HYPER-EGG-F-18

Manufactured by: Nutratech, A Division of J.H. Hare Associates Ltd.

Canadian Veterinary Biologics Establishment Licence Number: 58

Assigned Name: Escherichia coli polyclonal antibodies, chicken egg origin.

Approved Claim: For weaned piglets: As an aid in the prevention of diarrhea due to infection with enterotoxigenic Escherichia coli F-18.

Level of Veterinary Biologic: 2 - 4 kg per metric ton of feed.

Directions: To be fed to piglets during the 2-week period following weaning.

Caution: Product should be stored in a closed container in a dry place at 8-25°C (46-77°F).

2. Approved Brand: HYPER-EGG-K-88

Manufactured by: Nutratech, A Division of J.H. Hare Associates Ltd.

Canadian Veterinary Biologics Establishment Licence Number: 58

Assigned Name: Escherichia coli polyclonal antibodies, chicken egg origin

Approved Claim: For weaned piglets: As an aid in the prevention of diarrhea due to infection with enterotoxigenic Escherichia coli K-18.

Level of Veterinary Biologic: 2 - 4 kg per metric ton of feed.

Directions: To be fed to piglets during the 2-week period following weaning.

Caution: Product should be stored in a closed container in a dry place at 8-25°C (46-77°F).

Registration Checklist for Mixed Feeds Containing Veterinary Biologics

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended species
• Product claim statement (the approved claim for the licensed incorporated VB)
• Guarantee for activity (if applicable)
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations (including registration numbers for Part II ingredients or mixed feeds as required), and assigned brand name for the VB components
• Directions for use to permit safe and effective use of the feed; should reflect that of the incorporated licensed VB
• Recommendations with respect to the optimum age for vaccination, repeat dose (booster) instructions, precautions, withdrawal period, and antidote for the incorporated licensed VB (if applicable)
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Name and address of the facility that manufactures the product
• Net amount (metric measure)
• Lot Number or identification code
• Expiry date with storage conditions reflecting that of the incorporated VB (if applicable)
• Registration number (to be added)

Product Composition

• Formulation/percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds
• Assigned name, trade name (brand name) for incorporated VB

Promotional Claims (including Internet and Advertisement)

• Consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

3.22 Viable microbials and yeasts

Regulation of Viable Microbial Strains, Viable Microbial Products, Viable Microbial Supplements (Diluted Viable Microbial Products), and Mixed Feeds containing Viable Microbial Products

This section of the RG-1 sets out the policy of the CFIA regarding viable microbial strains, viable microbial products (VMPs), viable microbial supplements, and mixed feeds containing VMPs that are manufactured or sold in Canada, or imported into Canada, as livestock feed.

This section is divided into 3 parts:

• the introduction to Section 3.22 provides information regarding the CFIA and Health Canada's regulatory oversight of viable microbial products (VMPs) for oral administration to livestock, including an explanation of the regulatory classification of these products;
• subsection 3.22.1 provides information regarding the CFIA's registration requirements for viable microbial strains; and
• subsection 3.22.2 provides information regarding the CFIA's registration requirements for viable microbial products, viable microbial supplements (diluted VMPs) and mixed feeds containing VMPs.

Definitions

Viable microbial strain:

includes strains of viable yeast, viable fungi, and viable bacteria.

Viable microbial product (VMP):

viable microbial strain on a carrier.

Viable microbial supplement (diluted VMP):

dilutions of registered VMPs, e.g., a VMP on a carrier.

Mixed feeds containing VMPs:

nutritional feeds (premixes, supplements and complete feeds) claiming the presence of a VMP.

Embedded:

refers to the presence of a product used in the formulation of another product.

Classification of Viable Microbial Products

VMPs for voluntary oral administration to livestock species include both those mixed into livestock feed, and those delivered via the watering system. All VMPs for direct livestock consumption must be approved prior to their sale in Canada according to their classification as a livestock feed, a veterinary drug, or a veterinary biologic. VMPs are classified, along with other factors, on the basis of their intended purpose and label claims. The onus is on the company producing the product to determine, and support, the appropriate classification of its product in a satisfactory manner. The amount and type of substantiating data required for approval is directly related to the product's regulatory classification.

If applicants are uncertain as to the regulatory classification of their product, they may submit information on the product using the Information Template for Veterinary Product Classification Requests to the Veterinary Drugs Directorate (VDD) of Health Canada.

To obtain an electronic version of the template, please contact VDD. Requests for classification should include a cover letter, the completed template, and the related supporting documentation. All classification requests must be submitted in writing (mail, e-mail or facsimile) to VDD at the coordinates below:

Veterinary Drugs Directorate (VDD)
Health Canada
Holland Cross Complex
11 Holland Avenue, Suite 14
Postal Locator: 3000A
Ottawa ON  K1A 0K9

Telephone: 613-954-5687
Facsimile: 613-957-3861
E-mail: vetdrugs-medsvet@hc-sc.gc.ca

Upon review of this template, VDD will then consult with the Animal Feed Division (AFD) of the CFIA to agree on a classification decision. Drug status decisions will be made by the VDD; feed status decisions will be made by the AFD. The applicant will be notified in writing of the decision concerning the regulatory status of a product. For VMPs classified as veterinary drugs, VDD will provide information on the appropriate regulatory requirements and related guidance documents.

Veterinary Drugs

VMPs intended to be administered via forced oral administration, or in dosage forms consistent with forced oral administration (e.g., boluses, gavages or drenches) will be classified as veterinary drugs.

Products with indications for the following claims (along with other factors) may be considered veterinary drugs:

• claims regarding improvements of production parameters beyond normal ranges (as defined in current National Research Council (NRC) or equivalent published literature, under normal conditions of animal husbandry);
• statements that imply treatment, mitigation (i.e. reduction in incidence and severity) or prevention of a disease, disorder, abnormal physical state, or its symptoms;
• any reference to intestinal flora; or
• claims regarding restoration, correction or modification of organic function. Any stress-related claim will be evaluated on the basis of disease, disorder, abnormal physical state, or their symptoms resulting from stressful conditions.

Registration inquiries regarding drugs should be directed to the Veterinary Drugs Directorate (VDD) (see contact information above).

Veterinary Biologics

Products that imply, directly or indirectly, the diagnosis, treatment, mitigation or prevention of an infectious disease, mediated by an immune response or the modulation of an immune response, will be considered veterinary biologics. (See also Section 3.21, "Regulation of Veterinary Biologics in Livestock Feeds", for more information on veterinary biologics.) Registration inquiries regarding veterinary biologics should be directed to:

Canadian Centre for Veterinary Biologics
Animal Health Directorate
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa ON K1A 0Y9

Telephone: 613-773-7408
Facsimile: 613-773-7570

Livestock Feeds

Acceptable feed claim statements include improved appetite, weight gain, nutrient digestibility, feed efficiency, and other production parameters, to within normal ranges as defined in current National Research Council (NRC) or equivalent published literature, under normal conditions of animal husbandry. In the absence of NRC published values, the inclusion of a positive control group in an efficacy trial as a reference standard would be acceptable. Normal conditions of animal husbandry may include weaning, ration changes, vaccination, debeaking, dehorning, castration, shipping, shearing, etc.

Once a VMP has been determined to be a feed, then an application can be made to the Animal Feed Division of the CFIA for it to be evaluated for registration as a feed.

Products with Multiple Claims

Products with multiple claims will undergo a joint review by the regulatory groups involved, coordinated through the agency or department having authority over the principal claim. Products with multiple claims will be labelled with one approval number. The following hierarchy has been established to cover products with multiple claims: Veterinary biologic or Veterinary drug > Livestock feed (a product's status as a biologic or a drug takes precedence over its status as a feed). In other words, if the label claims for a VMP are such that it could be considered as both a veterinary biologic and a feed product, then it will be approved as a biologic, and a VMP that could be considered as both a veterinary drug and a feed will be approved as a drug. For the registration of veterinary biologics, a product licence is issued by the Terrestrial Animal Health Division of the CFIA, and an Establishment Licence Number must be shown on licensed veterinary biologics. A Drug Identification Number issued by HC must appear on any drug label. A Feed Registration Number must be indicated on feed labels.

List of CFIA Documents referenced in Section 3.22

Feeds Regulations, Schedule IV
Feeds Regulations, Schedule V

RG-1, Regulatory Guidance: Feed Registration Procedures and Labelling Standards

• Chapter 1, "Application for Feed Registration and Ingredient Approval"
• Section 2.2, "Registration Requirements for Specialty Products"
• Section 2.7, "Guidelines for the Safety Assessment of Novel Feeds: Microbial Sources"
• Section 3.9, "Forage additives"
• Section 3.21, "Regulation of veterinary biologics in livestock feeds"
• Subsection 3.22.1, "Registration requirements for Viable Microbial Strains"
• Subsection 3.22.2, "Registration requirements for Viable Microbial Products (VMPs) and mixed feeds containing VMPs"
• Section 6.2, "Good Laboratory Practices Protocol for Feed Ingredient Approvals"

3.22.1 Registration requirements for Viable Microbial Strains

Each viable microbial strain is required to undergo a mandatory pre-market assessment and registration prior to the registration of the Viable Microbial Product (VMP). These strains can fall in one of 2 categories:

1. Novel Microbial Feeds
2. Other Than Novel Microbial Feeds

The CFIA provides guidance to stakeholders on how to meet the requirements for the assessment process for microbial strains. 2 documents (RG-1 Section 2.7, and RG-1 subsection 3.22.1) have been developed that outline the specific data requirements for the safety assessment of viable microbial strains. The following text explains how to determine which document to consult.

How to determine which guidance document applies to your strain (Section 2.7 or subsection 3.22.1)

Feed products vary widely in their individual characteristics, and the prescription of the same set of data requirements for all safety assessments would be impractical and onerous for applicants. Data requirements are tailored, instead, based on the nature of the specific product, including its history, use, and complexity. This allows applicants to concentrate on meeting those data requirements relevant for their particular product.

Novel Microbial Feeds

Any microorganism that is not currently listed in Part II of Schedule IV of the Feeds Regulations, or has a novel trait, is considered to be novel (see Appendix I below for definitions). In these cases, the draft document entitled Guidelines for the Safety Assessment of Novel Feeds: Microbial Sources (RG-1, Section 2.7) is to be used as a guide in preparing an application. The guidelines include criteria that will be considered in the assessment of safety and efficacy of a novel feed from microbial sources. They are not intended to explicitly define all of the data that could be required in the course of the assessment, however the list of requirements is more exhaustive than the requirements outlined in this subsection (3.22.1).

Other Than Novel Microbial Feeds

The present document, subsection 3.22.1, has been developed to guide applicants wishing to register individual microbial strains that do not contain a novel trait (see Appendix I below for definitions), and that belong to a genus already listed in Schedule IV, Part II. It is important to note that, under certain circumstances, a microbial species or strain may be considered novel even though its genus is listed in Schedule IV, Part II. This is usually because of a lack of familiarity with the particular species or strain, or because the species/strain could potentially cause foodborne disease and/or animal health issues. For these species or strains, a safety assessment is required, as per the draft Guidelines for the Assessment of Novel Feeds: Microbial Sources (Section 2.7).

Applicants seeking advice on determining which of the 2 guidance documents to follow in order to prepare a submission package can refer to Appendix II, or consult directly with the Animal Feed Division (AFD). Consultation with the AFD is highly recommended for any applicants experiencing difficulty in determining which approach to follow.

The following subsection outlines the requirements for the registration of viable microbial strains to be used in livestock feeds. For registration requirements for VMPs, please consult Registration of Viable Microbial Products (VMPs) and mixed feeds containing VMPs (subsection 3.22.2), as well as Section 3.9, Forage Additives.

Submissions for registration of individual strains of microorganisms, other than those considered to be novel, must include the following:

Administrative Requirements

Standard registration requirements, including a completed and signed Application for Feed Registration or Renewal (CFIA/ACIA 0009) form; application fee as per Chapter 1, Application for Feed Registration and Ingredient Approval (Category 2); 3 copies of the proposed product label; an accompanying cover letter; and signing authority/Canadian agent (if applicable), for each individual strain.

Labelling

A copy of the proposed label, which must include the following:

• the ingredient name, in accordance with the ingredient definition in Part II of Schedule IV of the Feeds Regulations (e.g., Lactobacillus Culture Dehydrated);
• the name of the organism (i.e., genus and species) including the strain identification number/code or the internal identification number used by the registrant (e.g., Lactococcus lactis LL 123);
• any required statements pursuant to the ingredient description found in Part II of Schedule IV of the Feeds Regulations (e.g., product claim statement: "This product is for use only as a component of a silage additive to aid in the production of lactic acid or to lower the pH of the ensiled plant material or as a source of viable organisms in viable microbial products");
• a guarantee for the activity of the microorganism (e.g., minimum 1 × 10¹² CFU/g);
• lot number;
• date of manufacture;
• expiration date (at least 12 months from the date of manufacture when stored under appropriate conditions);
• recommended storage conditions in order to maintain activity until the expiration date;
• cautionary and/or warning statements, if applicable (e.g., "This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling");
• the name and address of the registrant;
• the name and address of the manufacturer, if different from the registrant; and
• the net amount (metric units).

The label is intended for CFIA use only.

Analytical Method

A sample from a recent lot, and a signed Certificate of Analysis showing the actual colony forming units or viable cells in that sample must be submitted. The assay method used for analysis must be provided, and must also be stated on the Certificate of Analysis. Refer to Section 6.2, Good Laboratory Practices Protocol for Feed Ingredient Approvals, for requirements concerning laboratory methodology.

Submit your sample, signed Certificate of Analysis and the laboratory methodology directly to the CFIA Laboratory at the following address:

Ottawa Laboratory (Carling)
Feed Bioanalysis and Microscopy Section
Canadian Food Inspection Agency
Building 22, Central Experimental Farm
960 Carling Avenue
Ottawa ON K1A 0C6

Please note that, along with submitting the sample, applicants will need to fill out the submission form in Appendix III below.

Scientific Data

1. The purpose of the microbial strain in livestock feed.
2. The history of the microorganism. If applicable, information on previous use in agriculture and/or other industries, as well as the origin or source and isolation method.
3. The taxonomic identity of the strain, including genus, species, subspecies, strain and/or type, the origin of the strain (when, where and from which material it was isolated), and any identifying number or code used by the applicant, as well as any substantiated changes in nomenclature.
4. The certificate from the depositary, if the strain has been deposited in a recognized culture collection, e.g., American Type Culture Collection (ATCC), Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH (DSMZ), National Collection of Food Bacteria (NCFB).
5. An analytical report substantiating the identification and classification of the strain, including procedures for the isolation, quantification and identification (e.g., biotyping key, biochemical profile). Information on the methodologies used to analyse the viable counts of the strain, e.g., a copy of the AOAC International or other official method, is required. In the event that these methods have not been peer reviewed, additional information is required to validate the laboratory method as outlined in Section 6.2, Good Laboratory Practices Protocol for Feed Ingredient Approvals. The information submitted should allow the differentiation of the strain from other strains and closely related microorganisms.
6. Information about any genetic manipulation of the strain. Please note that if the microbe is a novel feed (i.e., is not listed in Part II of Schedule IV, or is a genetically modified organism), the applicant will need to consult the Guidelines for the Assessment of Novel Feeds: Microbial Sources (Section 2.7).
7. The identification data from 3 recent manufacturing lots of the microorganism. (e.g., API strips).
8. A detailed description of the manufacturing process including all downstream processing.
9. The complete composition (ingredient list and levels) of the media on which the culture has been produced, and other processing aids from the initial inoculation to the downstream processing and manufacture, including the proportion or percentage of each ingredient of the downstream processing additives (e.g., cryoprotectants). Consideration for any potential contaminants which may be introduced either through the ingredients or the process should be identified here.

   Meat-derived ingredients (such as peptone, tryptone, beef extract, etc.) may be present in the media used for the production of the strain, either as a component of ready-made media (e.g., MRS), or as an individually added component in the production media. In order to minimize the risk of transmission of Transmissible Spongiform Encephalopathy (TSE) agents, material of ruminant origin must be sourced from a low-TSE-risk country. A signed statement must be submitted by registrants concerning the source of the meat-derived ingredients present in any of the media used, from the initial inoculation to the downstream processing. The country of origin of the animals from which these ingredients are derived must also be identified.

   Since a registrant may change suppliers at any time or the media supplier may change the source of their ingredients, it is the registrant's responsibility to monitor their suppliers to ensure that ingredients of ruminant origin present in the growth media comply with the above animal health requirements.

   Note: Importers of microorganisms used as livestock feeds must comply with all import requirements stipulated in the Health of Animals Act and Regulations. Applicants are advised to contact the Terrestrial Animal Health Division of the CFIA for information related to animal health. For such information, please contact:

   Import/ Export Section
   Terrestrial Animal Health Division
   Canadian Food Inspection Agency
   59 Camelot Drive
   Ottawa ON  K1A 0Y9

   Telephone: 613-773-2342
   Facsimile: 613-773-7571

10. Information on any inherent antimicrobial activity expressed by the strain (if applicable).
11. Information on the susceptibility of the strain to a range of antimicrobials. Susceptibility testing must be done using internationally recognised and standardized methods. Antimicrobial susceptibility testing should be determined for the following antimicrobials:
    

    Chemical class	Antimicrobial
    ß-lactams	Ampicillin
    Aminoglycosides	Streptomycin Kanamycin/neomycin Gentamycin
    Chloramphenicols	Chloramphenicol
    Tetracyclines	Tetracycline
    Macrolides	Erythromycin
    Streptogramins	Quinupristin/dalfopristin
    Polypeptides	Vancomycin Bacitracin
    Sulfonamides	Sulfamethoxazole
    Fluoroquinolones	Ciprofloxacin/enrofloxacin
    Oxazolidinones	Linezolid
    Rifamycins	Rifampicin

    Note 1: Where resistance to a particular antimicrobial is found, comments on the impact of this resistance with respect to human and animal health, as well as the environment, will be required.

    Note 2: Where the resistance profile of a strain to a particular antimicrobial raises concerns about potential transfer of the genetic resistance to other microorganisms, further information may be required from the applicant about the genetic basis and the likelihood of transfer of the resistance determinants.

12. Where species of microorganisms used are taxonomically related to species that are pathogenic to humans or to animals, additional information may be required (e.g., Certificates of Analysis for toxins). For example, the genus Bacillus includes species approved for use in livestock feed, such as B. licheniformis and B. subtilis. The genus, however, contains known pathogenic species such as B. cereus, and other Bacillus species which may produce emetic and/or diarrhoeal toxins. Consequently, for any strain of Bacillus submitted for registration, experimental data must be provided to demonstrate that the strain does not produce any of the toxins associated with pathogenic Bacillus spp. The methods used to demonstrate the absence of toxin production must be scientifically valid and recognized. The data submitted must include the scientific reference to the assays, the experimental protocol and the results.
13. A description of the quality control parameters used to monitor purity and identify of the strain from the master seed culture to the finished ingredient.

Required Certificates of Analysis

For each analytical requirement, please submit 3 original Certificates of Analysis from different lots of product. Only results of recent lots of product should be submitted, and they must be representative of the product submitted for registration.

Note: It is recommended to use the same manufacturing lots for identification, microbial counts and contaminant screening.

All Certificates of Analysis must be signed by the laboratory technician carrying out the test. The analytical methods used to conduct each analysis must be submitted. In the event that these methods have not been peer-reviewed, additional information is required to validate the laboratory method.

1. Certificates of Analysis in support of label guarantees stating the actual colony forming units (CFU/g) or viable cells per gram (depending on the enumeration method).
2. Certificates of Analysis for the screening of pathogens and other bacterial contaminants, including counts for the following:

   Pseudomonas^Footnote 3
   Staphylococcus^Footnote 3
   E. coli, total coliforms^Footnote 3
   Salmonella^Footnote 3
   Total plate count (or APC)^Footnote 4
   Yeast and mold counts (with no Aspergillus flavus or Fusarium species detected)^Footnote 4

3. If metals are purposely supplemented in the media to result in a microbial product with enhanced levels of that metal, provide Certificates of Analysis for the metal in the final product.
4. If heavy metals and/or chemical contaminants, either inherently present or introduced via the process, are anticipated (e.g., heavy metals from the media), Certificates of Analysis are required for these contaminants. Additional information for validating the laboratory method as outlined in Section 6.2, Good Laboratory Practices Protocol for Feed Ingredient Approvals.
5. Certificates of Analysis are required to support the guaranteed shelf life of at least 12 months from the date of manufacture (i.e., a microbial count on the date of manufacture, and another count 12 months after the date of manufacture). The storage conditions used for the shelf life study should reflect the storage conditions recommended on the label.

Promotional Claims

If published literature or promotional material indicate that this strain could be considered a drug or a veterinary biologic as per its mode of action, registration applications will be closed and returned to the applicant. Applicants will then be advised, as applicable, to submit their application to the Veterinary Drug Directorate, Health Canada, or the Canadian Centre for Veterinary Biologics, CFIA (for more information, please refer to "Classification of Viable Microbial Products" at the beginning of section 3.22).

Safe Handling of Viable Microbial Strains and Viable Microbial Products

Microbial strains and products have the potential to cause dermal and respiratory irritation and/or sensitization. Registrants are therefore required to:

• conduct dermal/respiratory sensitization/irritation studies; or
• provide scientific rationale as to why this is not necessary; or
• include the following statement on all microbial strain labels (i.e., individual cultures): "This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling.".

Renewal and/or Amendment of Registrations for Microorganisms

Strain registration certificates are issued for a 3 year period, renewable by March 31 of the third year after the registration date. All applications for renewal of a registered feed must be accompanied by:

• the application fee (refer to Chapter 1 for fee amounts);
• 3 copies of the proposed label;
• complete media formulation and any downstream additives; and
• a signed statement from the registrant to the effect that no modifications were made to the manufacturing process or to the media composition since the strain was last registered or renewed.

Certificates of Analysis for 3 recent lots substantiating identification of the strain, as well as guaranteed analysis, will be required at the time of renewal. Additional information may be requested if safety concerns emerge between the time of registration and renewal.

In the case of an amendment to a registration, applicants must submit a description of the amendment, any relevant supporting data, and administrative requirements.

Registration Checklists for Viable Microbial Strains

Below are 2 checklists, pertaining to viable microbial strains, which detail the information required for a submission for registration. Choose the relevant checklist based on the type of submission (new submission or renewal).

A completed checklist must be submitted to the Animal Feed Division (AFD) with each application for product registration. Please indicate the page number of your submission corresponding to each category in the checklist.

Note: Incomplete submissions will not be accepted by the AFD.

A) Applications for Registration for Viable Microbial Strains

• For applications for registration for new sources of viable microbial strains found in Part II of Schedule IV of the Feeds Regulations.

Regulatory Status

Submission page #

• The strain and the viable microbial product containing the strain meets the criteria for classification as a feed (and not as a drug or veterinary biologic) according to the guidance provided in Section 3.22
• Promotional claims (including internet and advertisement) consistent with stated purpose of the product

Administrative Registration Requirements

Submission page #

• Cover letter (detailing purpose of product, and any requested change(s) if product is already registered; please include the email address of the authorized representative)
• One for Application for Feed Registration or Renewal (CFIA/ACIA 0009) form per product
• Payment for a Category 2 feed (requiring safety or efficacy review) – cheque, money order, Visa, MasterCard or American Express
• If a review of your ingredient has been performed previously by the AFD and the file was closed due to deficiencies identified, please enclose the return letter with the new application and detail in the cover letter how deficiencies were addressed
• Supporting documentation for any changes in signing authority
• If new Canadian Agent, a new Declaration of Resident Canadian Agent form
  For new companies:
• Signing authority and/or corporate documents (requirement for all new companies)
• declaration of Resident Canadian Agent form (CFIA/ACIA 1194) (requirement for foreign companies only)

Proposed Label (3 copies)

Submission page #

• Brand name (optional)
• Ingredient name
• Name of organism including strain identification number/code
• Product claim statement
• Guaranteed analysis (active ingredients)
• Lot number
• Date of manufacture
• Expiration date
• Storage conditions
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Name and address of manufacturer if different from registrant
• Net amount (metric measure)
• Registration number (to be added)

Data Requirements

Submission page #

• Statement indicating that the strain has not been genetically modified
• Purpose of the microbial strain in livestock feed
• History of the microorganism and isolation method
• Taxonomic identity of the strain, including any substantiated changes in nomenclature
• Certificates from the depositary
• Analytical report substantiating the isolation, identification and classification of the strain
• Identification data from 3 recent manufacturing lots of the micro-organism

Sample and Laboratory Method

Submission page #

• Sample from a recent lot with a corresponding Certificate of Analysis
• Laboratory method used for the analysis indicated on the Certificate of Analysis
• Submission form for Viable Microbial Strain samples has been filled out (Appendix III)
• Sample, method and all accompanying documents have been submitted to the CFIA Ottawa Carling Laboratory

Product Manufacturing and Composition

Submission page #

• Description of the manufacturing and downstream processing of the organism, including quality control parameters
• Complete composition of the media

Antimicrobial Susceptibility and Activity

Submission page #

• Information on the strain's susceptibility to antimicrobials
• Information on the strain's antimicrobial activity

Certificates of Analysis

Submission page #

• Original, signed copies of Certificates of Analysis for a minimum of 3 different and recent lots of product supporting the label guarantees for the active ingredient
• Original, signed Certificates of Analysis for screening of pathogens
• Original, signed Certificates of Analysis for any other anticipated contaminants, as well as methods used to analyse for the contaminants
• Original, signed Certificates of Analysis substantiating the guaranteed shelf life as stated on the label (i.e., one certificate on the date of manufacture and another certificate at the expiry date) for a minimum of 3 different and recent lots of product

Taxonomic Relationship with a Pathogenic Species

Submission page #

• If relationship with a pathogenic species has been determined, information provided to demonstrate that the strain does not produce any of the toxins associated with the taxonomically related pathogenic species
• Methods used to demonstrate the absence of toxin production

Note: Further information may be required after the initial review of the submission by the AFD.

For applications for significant changes to registered viable microbial strains that are not brand name changes, please contact the AFD to obtain guidance on information requirements.

B) Applications for Renewal and/or Amendment of Registration

Regulatory Status

Submission page #

• The strain and the viable microbial product containing the strain continues to meet the criteria for classification as a feed (and not as a drug or veterinary biologic) according to the guidance provided in Section 3.22
• Promotional claims (including internet and advertisement) continue to be consistent with stated purpose of the product

Administrative Registration Requirements

Submission page #

• Cover letter, stating any requested changes and including the email address of the authorized representative
• One Application for Feed Registration or Renewal (CFIA/ACIA 0009) form per product
• Payment of renewal fee – cheque, money order, Visa, MasterCard or American Express
• Additional fees if modifications are made to the registration
• Supporting documentation for any changes in signing authority
• If new Canadian Agent, a new Declaration of Resident Canadian Agent form
  
  Note: Any proposed changes made to the approved product label will require an application for significant change or administrative amendment be made to the AFD. If an amendment is requested at the time of renewal, then 2 requests (renewal and amendment) are to be made on the same application form.

Product Label (as previously approved, 3 copies)

Submission page #

• If changes are made to label guarantees, Certificates of Analysis must be provided to support the changes.

Sample and Laboratory Method (if requested)

Submission page #

• Sample from a recent lot with a corresponding Certificate of Analysis
• Laboratory method used for the analysis indicated on the Certificate of Analysis
• Submission form for Viable Microbial Strain samples has been filled out (Appendix III)
• Sample, method and all accompanying documents have been submitted to the CFIA Ottawa Carling Laboratory

Manufacturing process

Submission page #

• Signed statement that the manufacturing process, including processing additives used, has not altered from that submitted and approved by the AFD
  - or -
• If manufacturing process has changed, the new process has been provided

Strain Identification

Submission page #

• Signed statement that the strain identity has not changed from that submitted for review and approved by the AFD
  - or -
• If the strain has been reclassified (e.g., Streptococcus to Enterococcus), a signed statement describing the strain's new taxonomy

Appendix I

Definitions

Novel Feed: means a feed composed of, or derived from, a microorganism, plant or animal source that

1. is not approved as livestock feed in Canada (i.e. is not listed in Schedule IV or V of the Feeds Regulations). These include non-traditional sources, such as Bacillus coagulans; feeds used or approved in other countries; and products approved for other uses in Canada; and/or
2. contains a novel trait (see following definition).

Novel Trait: means a characteristic of the feed that

1. has been intentionally selected, created or introduced into the feed through a specific genetic change, and
2. based on valid scientific rationale, is not substantially equivalent in terms of its specific use and safety both for the environment and for human and animal health, to any characteristic of a similar feed that is set out in Schedule IV or V (Feeds Regulations).

With respect to novel feeds, novelty is the trigger for a mandatory pre-market assessment. Once a novel feed (including those containing a novel trait) has received authorization (i.e., it gets listed in Schedule IV or V or is determined to be substantially equivalent to an ingredient already listed in the Schedules), it is no longer considered to be novel.

Appendix II

Process for Determining Which Guidance Document (RG-1, Section 2.7, or RG-1, subsection 3.22.1) is to be Used in Preparation of a Microbial Submission

Q1: Is the microbial genus^Footnote 5 listed in Schedule IV Part II of the Feeds Regulations?

A1: If no, then follow guidance in Section 2.7.
If yes, then go on to question 2.

Q2: Does the microorganism contain a novel trait (i.e., has been intentionally modified through a specific genetic change, or is not substantially equivalent to a similar strain)?

A2: If yes, then follow guidance in Section 2.7.
If no, then go on to question 3.

Q3: Is there history of use of similar strains in livestock feed (i.e., same genus and species) in Canada?

A3: If yes, then follow subsection 3.22.1 above.
If no then follow guidance in Section 2.7.

Consultation with the Animal Feed Division is highly recommended for any applicants experiencing difficulty in determining which approach to follow.

Appendix III

Submission Form for Viable Microbial Strains Samples

(Completed form must be submitted, with samples, to the CFIA Ottawa Carling Laboratory)

Sample submitted for:

• Registration
• Renewal¹

Date sample submitted:

Submitted by (registrant):

Registrant address:

Sample Information

Product name:

Active Ingredient name:

Sample amount:

Guaranteed analysis:

Shipping condition:

Storage condition:

¹Registration number if renewal

Checklist for submitting a sample to the CFIA:

• Amount shipped (minimum 50g):
• Product label:
• Certificates of Analysis:
• Method used for the analysis:

3.22.2 Registration requirements for Viable Microbial Products (VMPs) and mixed feeds containing VMPs

This sub-section outlines the feed registration requirements for viable microbial products (VMPs) and mixed feeds containing VMPs in Canada. Viable microbials include viable yeast, viable fungi and viable bacteria. All individual microbial cultures (strains) that are to be used in the VMP formulation must be registered prior to being incorporated into the product. For information on registration requirements for individual microbial strains, please refer to subsection 3.22.1 Registration Requirements for Viable Microbial Strains (formerly T-3-159).

All VMPs that are classified as feeds (refer to "Classification of Viable Microbial Products" at the beginning of Section 3.22) are subject to the standards of the Feeds Regulations, and must be registered by the Animal Feed Division (AFD) of the CFIA. The following items are required as part of the submission for registration:

Administrative Requirements

Standard registration requirements, including a completed and signed Application for Feed Registration or Renewal (CFIA/ACIA 0009) form; application fee as per Chapter 1, Application for Feed Registration and Ingredient Approval (Category 2); 3 copies of the proposed product label; an accompanying cover letter; and signing authority/Canadian agent (if applicable).

Labelling

Proposed labels for VMPs must include:

• the product name, reflecting the purpose of the product and the intended species;
• product claim statement(s);
• a guarantee for minimum viable organisms, expressed in colony forming units (CFU) (for bacteria, yeast or fungi) or viable cells (yeasts only) per gram or kilogram;
• a complete list of ingredients by generic name, as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds as needed;
• directions for use to permit safe and effective use of the feed;
• recommended storage conditions;
• caution, warning and/or note statements as applicable (e.g., "Do Not Pellet");
• an expiration date (at least 6 months from the date of manufacture when stored under appropriate conditions);
• the net amount (metric units); and
• the name and address of the registrant.

In order to ensure safe handling of VMPs, registrants are also required to include the following statement on all microbial product labels:

"This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling."

However, products manufactured using strains that have been demonstrated to be free of respiratory/dermal toxicity will not be required to bear this label statement (refer to "Safe Handling of VMPs" in subsection 3.22.1, Registration Requirements for Viable Microbial Strains.

Please note that brand names may be added to labels, even though this is not a regulatory requirement. If a brand name is present, however, the AFD may refuse to register a feed if, after evaluating the application for registration, it is determined that the brand name would tend to mislead a purchaser with respect to its composition or usefulness, or if the brand name would likely be confused with a brand already applied to a registered feed.

Product Description

The complete product formula, detailing each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations, and each concentration. The registration numbers for Part II ingredients (e.g. registered microbial strain) or mixed feeds must also be provided. Ingredient concentrations must not exceed maximums as per Schedules IV and V.

Scientific Data

Laboratory Methodology

As part of the product assessment, a CFIA laboratory will assess the method to be used to verify label guarantees, as provided by the company. The proposed method will be reviewed according to the protocol described in RG-1, Section 6.2, Good Laboratory Practices Protocol for Feed Ingredient Approvals.

The following 3 items must be submitted along with the application for registration:

1. A laboratory method to verify label guarantees in terms of the viability of the microorganism (i.e., enumeration and identification) must be provided. For guarantees expressed in terms of viable cells per unit weight (yeast only), the method must discriminate between live and dead or heat stressed cells.
2. Samples from 3 recent but different lots of the viable microbial product must be provided, which will be used to verify the method. Each sample must have a corresponding Certificate of Analysis signed by the company Quality Control Agent or the analyst that carried out the tests. The method used to analyse the samples must be the verification method provided to the CFIA and must be stated on the Certificate of Analysis. Samples must be accompanied by a completed "Submission Form for Viable Microbial Product Samples" (see Appendix I).
3. A product label stating the minimum guaranteed activity: a guarantee for minimum viable organisms expressed in colony forming units (CFUs) for bacteria, yeast or fungi, or viable cells (yeasts only), per gram or kilogram.

Shelf Life Data

Data for 3 recent and different lots are required to support the guaranteed shelf-life of at least 6 months from the date of manufacture (e.g., on the date of manufacture and at the expiry date). The storage conditions used for the shelf life study must reflect storage conditions recommended on the label.

Heat Stability/Pelleting Data

If the product is to be applied before the pelleting of feed, a complete and detailed description of the pelleting process (temperature, moisture, duration, etc.) is required, including original, signed Certificates of Analysis for 3 pre- and post-pelleting samples of the product which support the label guarantee. The data need to demonstrate that pelleting does not negatively affect the viability of the VMP. The pelleting conditions used in the pelleting study must reflect the conditions recommended on the label.

If Certificates of Analysis are not provided, one or more of the following statements will be required on the label:

"Do not pellet." or
"Apply post-pelleting." or
"Pelleting may negatively affect the effectiveness of this product."

Substantiation of Product Efficacy

All applications for registration of a VMP classified as a feed must be supported by satisfactory evidence to substantiate one or more feed claims for the product.

Scientific investigations presented in support of feed claims must be carried out by qualified research personnel, using suitable methods, designed to facilitate statistical analysis, analysed by appropriate statistical methods, and conducted under conditions similar to those which may be expected to occur in Canada. In cases where results of these studies have not been published in peer reviewed journals, copies of the raw data and printouts of statistical analysis are required for review by the AFD.

Studies to demonstrate efficacy of VMPs are to include at least 2 test groups: (1) Control Group - handled, not treated, and (2) Test Group - handled, and treated with the VMP. Handling refers to normal conditions of animal husbandry for that particular species, which may include weaning, ration changes, vaccination, debeaking, dehorning, castration, shipping, etc.

A minimum of 3 efficacy studies in which the VMP is included in the ration at the recommended inclusion level and under label use conditions is required for each species on the label. These studies must substantiate the efficacy claim(s) that will be on the label for each species.

In cases where the label directions for use indicate a range of inclusion rates, the testing protocol must evaluate each individual inclusion rate.

In addition to the requirements outlined above, the efficacy studies must address the following:

• All products designed for inclusion in broiler and turkey rations must be evaluated in rations which contain an approved coccidiostat at the recommended level.
• Data must be submitted to demonstrate the efficacy of the product in all feed forms (e.g. mash, pellets, and pellets containing a pellet-binding agent) for which approval is required.
• Studies must be conducted for an appropriate period of time consistent with the label claim desired. For claims concerning maintenance of productivity after a specific event, e.g., weaning, castration, etc., short term studies will be acceptable. Where the claim is more general in nature, the length of required studies must be longer, i.e., conducted up to market weight in meat-producing animals, or up to the start of the production phase in replacement animals.
• The information submitted on efficacy trials must be as complete and descriptive as possible (i.e., containing a description of the actual product tested, and the protocol for experimental testing; for unpublished data, the complete set of raw data and computer printouts of statistical analysis).

Temporary Registrations

A temporary registration may be granted for VMPs for which all the basic registration requirements have been met, but for which the substantiating technical and/or scientific information submitted in support of product efficacy is partially lacking or incomplete.

Temporary registrations are issued for a limited period of time, up to a maximum of 3 years, so as to allow companies the opportunity to complete tests and/or studies to determine the efficacy of their product as described above. If the efficacy data is not submitted prior to the expiry date, or if the efficacy data submitted is inadequate, the temporary registration number will not be renewed. Please note that the efficacy data must be submitted via a formal Application for Feed Registration as a "new" feed. The application fees for these types of changes are the same as those for a new application for registration for a Category 2 product (refer to RG-1, Chapter 1 for applicable fee amounts).

Products bearing a temporary registration number on the label will be identified by the letter "T" preceding the registration number. No claims will be allowed on product labels, as the desired claims and/or label guarantees will not yet have been substantiated by the applicant; however, the label will indicate any intended species for which efficacy data has been supplied and accepted.

Requirements for Renewal of Registration for VMPs

As with all registered feeds, VMPs that have been granted permanent registration status are registered for a 3-year period, renewable by March 31 of the third year after the registration date. All applications for renewal of a registered VMP must be accompanied by:

• the application fee (refer to Chapter 1 for fee amounts);
• 3 copies of the proposed label; and
• the product formulation, detailing the generic name as listed in Schedule IV or V of the Feeds Regulations, and the concentration of each. The registration numbers for Part II ingredients (e.g., registered microbial strain) or mixed feeds must also be indicated.

The renewal fee applies only in cases where no changes have been made to the product formula and label.

Requirements for Amendments (Significant Change) to a Registered VMP

Registrants wishing to make a change to the formula or label of a registered VMP at any time must first submit an application for an Amendment to Registration with the proposed changes to the AFD for approval. A significant change to the registration is considered as any proposed changes to any of the following:

• brand or product name;
• product claim statement(s);
• label guarantee(s);
• shelf life;
• heat stability/pelleting statement;
• directions for use including addition of new target species;
• formulation;
• list of ingredients on the label; or
• manufacturing process.

The nature of the proposed changes will dictate the type of supporting information required. In general, any proposed change that will affect product efficacy will also require supplemental or new efficacy data (as outlined above). Examples include a proposed change or addition to the product claim, a change in the directions for use, or a change in the embedded viable microbial strains.

All applications for a significant change to a registered viable microbial product must be accompanied by the following:

• application fee;
• 3 copies of the proposed label;
• the product formulation, detailing the generic name as listed in Schedule IV or V of the Feeds Regulations and the concentration of each. The registration numbers for Part II ingredients (e.g., registered microbial strain) or mixed feeds must also be indicated, and
• scientific data (e.g., lab method, shelf life, product efficacy, i.e. animal performance data (feeding trials), and heat stability/pelleting data for products to be pelleted) if applicable.

Please refer to RG-1, 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 (refer to Chapter 1 for applicable fee amounts).

It is recommended that the AFD be contacted in advance in order to determine what type of information and documentation will be required to be submitted with the proposed application for registration amendment.

Regulation of Diluted VMPs (Viable Microbial Supplements) and Mixed Feeds Containing and Highlighting VMPs

Registered VMPs that have been diluted with a suitable carrier(s) are considered supplements and are subject to registration. The "product name" for diluted VMPs shall be Viable Microbial Supplements for bacteria and fungi products, whereas for yeast products, the product name shall be Viable Yeast Supplements. Thus the term "Microbial Product" shall refer to the mother product, whereas the term "Microbial Supplement" shall refer to diluted formulations of the mother product.

Mixed feeds (i.e., supplements, premixes and complete feeds) containing registered VMPs are only exempt from registration if the following conditions are met:

• there are no references to the presence of the VMP or viable microbial activity on the label, other than the listing of the brand name and registration number of the VMP in the list of ingredients; and
• the mixed feed meets all other criteria for exemption from registration under the Feeds Regulations.

Note: All imported mixed feeds still require registration.

Mixed feeds (i.e., supplements, premixes and complete feeds) claiming or highlighting the presence of a VMP or viable microbial activity must be registered.

Viable microbial supplements, and mixed feeds highlighting the presence of VMPs, will require the following information as part of the submission package:

• the product formulation, in order to verify the label guarantee for live cells/gram or CFU/gram;
• fees for a specialty product, i.e. a Category 2 feed (refer to Chapter 1 for applicable fee amounts);
• 3 copies of the proposed label, in addition to the information required on standard labels (e.g., nutrient guarantees; see "Checklist for Standard Feeds");
• the label claim statement (as indicated on the embedded registered VMP);
• a list of ingredients, including the brand name and registration number for the embedded VMP;
• a guarantee for live cells/gram or CFU/gram or kilogram;
• directions for use, reflecting the inclusion rate on the embedded registered VMP;
• storage conditions, reflecting those on the embedded registered VMP;
• an expiry date, reflecting the date on the embedded registered VMP; and
• any required/appropriate caution/note statements (e.g. "apply post pelleting," or "pelleting may reduce the effectiveness of this product").

Requirements for Renewal of Registration and Amendments (Significant Change) to Registered Viable Microbial Supplements and Mixed Feeds Containing VMPs

The same requirements as described for the renewal and amendments of a VMP apply, with the exception of the scientific data, as this pertains to the embedded VMP only.

Note: If the embedded registered VMP has been subject to a significant change that would require a modification to the mixed feed label (e.g., product claims, viable guarantee, directions for use, or stability information) and/or to the product formulation for the mixed feed (e.g., change in the viable microbial guarantee of the VMP), then the mixed feed containing that VMP will require re-formulation and an application for amendment of the registration for the significant change.

Registration Requirements for Private Label 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. Note that if the private label product is manufactured by a different manufacturer from the original product manufacturer, then a product formula must be submitted by the applicant. For more information, please refer to Section 2.2, Registration Requirements for Specialty Products.

Promotional Claims

If published literature or promotional material describing the intent of a product submitted for registration or registration renewal indicates a drug or a veterinary biologic purpose for the VMP, the application will be closed and returned to the applicant. The applicant will be advised to submit their application to the VDD, Health Canada, or to the Canadian Centre for Veterinary Biologics, CFIA, as appropriate (refer to Classification of Viable Microbial Products at the beginning of Section 3.22 for contact addresses).

Registration Checklists for Viable Microbial Products (VMPs), Viable Microbial Supplements and Mixed Feeds Containing VMPs

Below are 3 checklists, pertaining to VMPs, viable microbial supplements or mixed feed claiming the presence of a VMP, and registration renewal of these products, which detail the information required for a submission for registration.

A completed checklist must be submitted to the Animal Feed Division (AFD) with each application for product registration. Please indicate the page number(s) of your submission corresponding to each category in the checklist.

Note: Incomplete submissions will not be accepted by the AFD.

A) Viable Microbial Products

• For applications for registration of a registered viable microbial strain on carrier.
• For applications for significant changes to registered VMPs that are not brand name changes.
• For applications for significant changes to registered VMPs currently granted a temporary registration seeking permanent registration status.

Regulatory Status

Submission page #

• The VMP meets the criteria for classification as a feed (and not as a drug or veterinary biologic) according to the guidance provided in Section 3.22
• Promotional claims (including internet and advertisement) consistent with stated purpose of the product

Administrative Registration Requirements

Submission page #

• Cover letter (detailing purpose of product, and any requested change(s) if product is already registered; please include the email address of the authorized representative)
• One Application for Feed Registration or Renewal (CFIA/ACIA 0009) form per product
• Payment for a Category 2 feed (requiring safety or efficacy) – cheque, money order, Visa, MasterCard or American Express
• If a review of your VMP has been performed previously by the AFD and the file was closed due to deficiencies identified, please enclose the return letter with the new application and detail in the cover letter how deficiencies were addressed
• Supporting documentation for any changes in signing authority
• If new Canadian Agent, a new Declaration of Resident Canadian Agent form
  For new companies:
• Signing authority and/or corporate documents (requirement for all new companies)
• Declaration of Resident Canadian Agent form (CFIA/ACIA 1194) (requirement for foreign companies only)

Information on the Source of the
Strain(s)

Submission page #

• All viable microbial strains in the product have valid registration numbers

Proposed Label (3 copies)

Submission page #

• Brand name (optional)
• Product name reflecting the purpose of the product and the intended species
• Product claim statement
• Guarantee for minimum viable organisms expressed in colony forming units (CFU) (for bacteria, yeast or fungi), or viable cells (yeasts only) per gram or kilogram
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds as required
• Directions for use to permit safe and effective use of the feed
• Recommended storage conditions
• Caution, warning and/or note statement(s) (if applicable)
• Expiration date (at least 6 months from the date of manufacture when stored under appropriate conditions)
• Name and address of registrant
• Net amount (metric measure)

Formula

Submission page #

• Formulation/percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds
• Formulation/ingredients - level of ingredients not to exceed maximums as per Schedules IV and V
• All microbial cultures (strains) listed in the formula have valid registration number(s)

Sample and Laboratory Method

Submission page #

• Samples from 3 recent lots of product, with corresponding Certificates of Analysis, have been sent directly to the CFIA Ottawa Carling Laboratory
• Laboratory method used for the analyses indicated on the Certificates of Analysis
• Submission Form for Viable Microbial Product Samples has been filled out (Appendix I)
• Method and all accompanying documents have been sent to the Animal Feed Division

Certificates of Analysis

Submission page #

• Original, signed copies of Certificates of Analysis for a minimum of 3 different and recent lots of product supporting the label guarantees for the active ingredients
• Original, signed Certificates of Analysis substantiating the guaranteed shelf life as stated on the label (i.e., the date of manufacture and at the expiry date) for a minimum of 3 different and recent lots of product
• Original, signed Certificates of Analysis to support pelleting application

Feeding Trials

Submission page #

• Minimum of 3 feeding trials per intended livestock species
• Feeding trials conducted as per guidance on Substantiation of Product Efficacy in subsection 3.22.2 above

Dermal and Respiratory Irritation and/or Sensitivity

Submission page #

• Dermal/respiratory sensitization/irritation studies or provide scientific rationale as to why these are not necessary
  - or -
• Required statement included on the label as follows: "This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling."

Note: Further information may be required after the initial review of the submission by the AFD.

B) Diluted VMPs (Viable Microbial Supplements) and Mixed Feeds Containing VMPs

• For applications for registration for viable microbial supplements (i.e., diluted VMPs).
• For applications for registration for mixed feeds (e.g., complete feeds, premixes, supplements) that claim the presence of a VMP on the product label (i.e., either in the brand name, in the product name, or through the addition of a label guarantee for the viable microbial).
• For applications for significant changes to viable microbial supplements and mixed feeds containing VMPs that are not brand name changes.

Regulatory Status

Submission page #

• Promotional claims (including internet and advertisement) continue to be consistent with stated purpose of the product

Administrative Registration Requirements

Submission page #

• Cover letter (detailing purpose of product, and any requested change(s) if product is already registered; please include the email address of the authorized representative)
• One Application for Feed Registration or Renewal (CFIA/ACIA 0009) form per product
• Payment for a Category 3 feed (requiring safety and efficacy) – cheque, money order, Visa, MasterCard or American Express
• If a review of your VMP has been performed previously by the AFD and the file was closed due to deficiencies identified, please enclose the return letter with the new application and detail in the cover letter how deficiencies were addressed
• Supporting documentation for any changes in signing authority
• If new Canadian Agent, a new Declaration of Resident Canadian Agent form
  For new companies:
• Signing authority and/or corporate documents (requirement for all new companies)
• Declaration of Resident Canadian Agent form (CFIA/ACIA 1194) (requirement for foreign companies only)

Information on the Source of the embedded VMPs

Submission page #

• All VMPs in the product have valid registration numbers

Proposed Label (3 copies)

Submission page #

• Brand name (optional)
• Product name reflecting the purpose of the product and the intended species
• Product claim statement
• Guarantee for minimum viable organisms expressed in colony forming units (CFU) (for bacteria, yeast or fungi), or viable cells (yeasts only) per gram or kg
• Nutrient guarantees (if applicable; mixed feeds)
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds as required
• Directions for use to permit safe and effective use of the feed
• Recommended storage conditions
• Caution, warning, and/or note statements (e.g. "Do Not Pellet")
• Expiration date (at least 6 months from the date of manufacture when stored under appropriate conditions)
• Name and address of registrant
• Net amount (metric measure)

Formula

Submission page #

• Formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds
• Formulation / Ingredients – level of ingredients not to exceed maximums as per Schedules IV and V.

Note: Further information may be required after the initial review of the submission by the AFD.

C) Applications for Renewal of Registration

Regulatory Status

Submission page #

• Promotional claims (including internet and advertisement) consistent with stated purpose of the product

Administrative Registration Requirements

Submission page #

• Cover letter, stating any requested changes and including the email address of the authorized representative
• One Application for Feed Registration or Renewal (CFIA/ACIA 0009) form per product
• Payment of renewal fee – cheque, money order, Visa, MasterCard or American Express
• Additional fees if modifications are made to the registration
• Supporting documentation for any changes in signing authority
• If new Canadian Agent, a new Declaration of Resident Canadian Agent form

Product Label (as previously approved, 3 copies)

Submission page #

Note: Any proposed changes made to the approved product label require, in addition to the renewal application, an application for significant change or administrative amendment (these 2 requests are to be made on the same application form). This will necessitate payment of the fee for the evaluation of the revised product label in addition to the renewal fees.

• If changes are made to label guarantees, Certificates of Analysis provided to support the changes (not required for diluted VMPs and mixed feeds)

Formula (as previously approved)

Submission page #

Note: Any proposed changes made to the approved product formulation will require that in addition to the renewal application, an application for significant change (these 2 requests are to be made on the same application form). This will necessitate payment of the fee for the evaluation of the revised product formulation in addition to the renewal fees.

• If changes are requested, the revised formulation/percentage composition listing the amount of each ingredient by generic name as listed in Schedule IV or V of th Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds, provided to support the changes

Laboratory Method

Submission page #

• Signed statement that the analytical method used to verify label guarantees has not changed from that submitted for review and previously approved by the AFD (not required for diluted VMPs and mixed feeds)
  - or -
• If the method has changed, the revised method has been provided, with 3 recent samples and 3 corresponding Certificates of Analysis

Appendix I

Submission Form for Viable Microbial Product Samples

(Completed form must be submitted, with samples, to the CFIA Ottawa Carling Laboratory)

Sample submitted for:

• Registration
• Renewal¹

Date sample submitted:

Submitted by (registrant):

Registrant address:

Sample Information

Product name:

Active Ingredient name(s):

Sample amount:

Guaranteed analysis:

Shipping condition:

Storage condition:

¹Registration number if renewal

Checklist for submitting a sample to the CFIA:

• Amount shipped (minimum 50g/active ingredient):
• Product label:
• Certificates of Analysis:
• Method used for the analysis:

3.23 Yeast cell wall products

The Animal Feed Division has recently established a regulatory definition for the single ingredient feed named "yeast cell wall". This ingredient is intended to be a source of mannan-oligosaccharides (MOS), mannans and/or beta-glucans. It is described as follows:

#8.76 Yeast cell wall - is the product resulting from the extraction and purification of the structural components of the yeast cell wall from a fermentation conducted in accordance with good manufacturing practices. This fermentation is conducted for the production of beta-glucans, mannans and mannan-oligosaccharides using a non-pathogenic strain of the microorganism Saccharomyces cerevisiae, which does not contain a novel trait. It shall be labelled with one or both of the following statements: "This product is free of antimicrobial activity and is not a source of viable microbial cells"; or "Ce produit est exempté d'activité anti-microbienne et n'est pas une source de cellules microbiennes vivantes." It shall also be labelled with guarantees for minimum beta-glucans and mannans and/or mannan oligo-saccharides and maximum moisture.

The placement of this single ingredient feed in Part II of Schedule IV of the Feeds Regulations will require registrants to claim the presence of mannan-oligosaccharides, mannans and/or beta-glucans from the cell wall of the yeast Saccharomyces cerevisiae. As this ingredient is listed in Part II of Schedule IV, each source will have to be registered with one or more feed-related claims (i.e., efficacy in support of a feed-related purpose or claim will be required at the time of registration) prior to import, manufacture or sale in Canada. This approach is consistent with that taken for viable microbial products registered by the Animal Feed Division.

The purpose of this section is to provide applicants with the necessary information and requirements to submit an acceptable application for registration of a yeast cell wall product to the Animal Feed Division. It is strongly recommended that the technical and scientific criteria outlined below are carefully reviewed before an application is submitted.

Administrative Requirements

Standard registration requirements, including a completed and signed Application for Feed Registration or Renewal (CFIA/ACIA 0009) form; application fee as per Chapter 1, "Application for Feed Registration and Ingredient Approval" (please use the Category 2 application code 3255, New Ingredient listed in Part II of Schedule IV); five copies of the proposed product label; a copy of the product formulation (e.g., percentage composition); an accompanying cover letter; signing authority/Canadian agent (if applicable); and additional information as described below. Please note that additional fees may be required at a later date if a full safety assessment is required.

Note that the cover letter should explain the purpose of the application for registration, including what the intended livestock species are, how the yeast cell wall source is to be used (i.e., fed on a gram/head/day basis, inclusion rate in complete feeds, etc.), the desired product claims, what type of documentation/information has been included with the application, etc.

Labelling

1. The proposed label must reflect the purpose of the product (i.e., as a source of yeast cell wall for use in livestock feeds) in addition to meeting the standards, packaging and labelling requirements of the Feeds Act and Regulations.
2. The product label must also be labelled as per the regulatory definition for the ingredient and bear all relevant guarantees and have the necessary labelling statement (i.e., "This product is free of antimicrobial activity and is not a source of viable microbial cells").
3. Additionally, it will be necessary to add feed-related claim statements to the product label. Acceptable feed claims include: improved growth, improved weight gain or feed efficiency, etc.
4. Drug-related claims, or claims that are therapeutic in nature, are not permitted to appear on yeast cell wall product labels that are destined for use in livestock feeds. Examples of unacceptable product claims include: improved immune status or function, reduction in the incidence of disease or diarrhea, improved health status, improved gut health, ability to modify gut microflora.
5. Directions for use are to be stated on the product label, and must be reflective of the inclusion rates of the yeast cell wall product used in the efficacy data/scientific studies submitted with the application for registration.

Product Description and Supporting Information

1. A detailed description of the manufacturing process used to produce the yeast cell wall product is to be provided with the application for registration. Information such as detailed written descriptions, flow charts, time/temperature specifications for particular steps in the production process, quality control measures, a list of all starting materials/reagents/chemicals/processing aids, etc., are to be provided as well.
2. If applicable, the complete product formula (formulation/percentage composition) listing the amount of each ingredient, which must be identified as per the generic names listed in Schedules IV and V of the Feed Regulations, must be provided. Note that registration numbers for Part II ingredients, mixed feeds and other registered products must be included in the formula.

   Note that feeds may not contain ingredients that are not listed in either Schedules IV or V of the Feeds Regulations. If the applicant wishes to use a currently unapproved feed ingredient as part of the product formulation, it is 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 yeast cell wall 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 yeast cell wall product cannot be reviewed unless all of the ingredients used in the product formulation are approved and listed in either Schedules IV or V of the Feeds Regulations.

3. Original, signed Certificates of Analysis from 3 different and recent lots of the yeast cell wall product, which support the label guarantees for the active compound(s) (e.g., beta-glucans, mannans).
4. The complete and detailed description of each analytical methodology used to support the label guarantee(s). These methods will be used to determine the levels of the active compound(s) in the yeast cell wall product. Note that if guarantees for multiple yeast cell wall components (i.e., beta-glucans and/or mannans and/or mannan-oligosaccharides) are made on the label, methodologies must be submitted to support each label guarantee.

   Please consult Section 6.2 "Good Laboratory Practices Protocol for Feed Ingredient Approvals" and Section 6.3 "Guidelines for the Evaluation of Methods to Determine the Activity of Enzyme Ingredients Used in Animal Feeds" for additional information concerning our technical requirements for analytical methods for livestock feeds and feed ingredients.

5. Stability (i.e., shelf life) data must also accompany the application for registration, as an expiry date and lot number must appear on the product label. In order to satisfy this requirement, original, signed Certificates of Analysis substantiating the guaranteed shelf life on the label (i.e., on the date of manufacture and at the expiry date) for a minimum of 3 different lots of the product are required. The certificates of analysis for beta-glucan, mannan and/or mannan-oligosaccharide content at the date of manufacture and at the expiry date must be for the same lot of product. The storage conditions used for the shelf life study should reflect the storage conditions suggested on the label.
6. A 500 g product sample is also required and must be included with the application package. This sample will be used to verify analytical methodologies and label guarantees. A certificate of analysis stating the lot number and date of production for beta-glucan, mannan and/or mannan-oligosaccharide content must accompany the product sample.
7. A minimum of 3 efficacy studies for each target livestock species is required to support the feed-related claim statements as they appear on the product label. Please note that efficacy data is required whenever feed claims are made for a particular product. For additional information concerning our requirements for efficacy data and scientific studies, please refer to Section 2.2 "Registration Requirements for Specialty Products".

   To summarize, acceptable efficacy data will have to meet the following criteria:

   • experiments must be performed using the target livestock species
   • experiments must be conducted using the yeast cell wall product for which the application for registration is being submitted
   • studies must be carried out by qualified personnel
   • suitable experimental methods (e.g., experimental design, sampling protocol(s), endpoint measurement determination, etc.) must be used in the studies
   • studies must be designed to facilitate the statistical analysis and the data must be analysed by appropriate statistical methods
   • studies must be conducted under conditions similar to those that may be expected to occur in Canada
   • scientific investigations show that the product, when used as directed, results in a significant improvement in one or more nutritional or feed-related claims for the yeast cell wall product in question
   • studies show a significant difference (P<0.05) between the control and treatment groups
   • where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate the entire range of inclusion rates
   • where the results of these studies have not been published in a peer-reviewed journal, copies of the complete raw data sets and complete printouts of statistical analysis will be required for our review

   Examples of unacceptable types of efficacy data include, but are not limited to: incomplete or poorly designed scientific studies, studies that produce non-significant treatment results, scientific data generated from studies using a yeast cell wall product other than the product that is being submitted for registration, conference presentations (e.g., PowerPoint presentations), research summaries, abstracts, magazine articles, promotional publications, and testimonials.

Safety Information

1. As outlined in Section 2.3 "Single Ingredient Feed Evaluation Requirements" and Section 2.4 "Generic Data Requirements for Safety Evaluations of Single Ingredients", scientific investigations supporting product safety may be required, and will be requested on a case-by-case basis. These investigations 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:
   1. carried out by qualified research personnel
   2. carried out using suitable/recognized scientific methods and protocols
   3. designed to facilitate statistical analysis (i.e., using a suitable statistical model, proper sampling protocol and sufficient sample size)
   4. analysed using appropriate statistical methods
2. Suitable methodologies for the detection of significant amounts of any ingredient, compound, substance, or organism intentionally incorporated into the feed or occurring as a contaminant must also be provided.
3. If the strain of Saccharomyces cerevisiae used in the production of the yeast cell wall product is considered to be novel (i.e., is derived from a strain that has a novel trait), then a novel feed assessment would be considered. Please consult Section 2.7 "Guidelines for the Assessment of Novel Feeds: Microbial Sources", for additional information.

Temporary Registrations

A temporary registration may be only be granted for yeast cell wall products for which all the basic registration requirements have been met, but for which the substantiating technical and/or scientific information submitted in support of the application for registration is partially lacking or incomplete. Additionally, note that a temporary registration cannot be granted to a product that has not satisfied the regulatory requirements as they pertain to product safety, as stated in Section 9 (5) of the Feeds Regulations.

Examples of why a yeast cell wall product may be granted a temporary registration include, but are not limited to:

• fewer than 3 acceptable scientific studies per livestock species were submitted
• laboratory methods require additional substantiating technical data
• shelf life data is incomplete

Products bearing a temporary registration number on the label will be identified by the letter "T" in front of the registration number. Note that for products given temporary registrations, no claims will be allowed on product labels, as the desired claims and/or label guarantees have not yet been substantiated by the applicant. Products that have no efficacy data or accompanying analytical method are not acceptable for temporary registration status.

With regards to the livestock species that are to be indicated on the labels of yeast cell wall sources that have been granted temporary registrations, note that only the species for which efficacy data has been submitted and that tends to support acceptable feed-related claims will be permitted to appear on product labels.

The issuance of temporary registrations is considered an interim measure which allows companies to adequately comply with the conditions of their temporary registration, as outlined in their approval letter. Only one temporary registration will be granted per product and the maximum duration for a temporary registration will be 3 years.

With regards to the submission of applications for permanent registration status (which must be submitted by the end of the temporary registration period) for yeast cell wall products, be aware that if the product has not been proven to be efficacious and the desired product claims have not been supported by acceptable scientific data by the end of the temporary period, and/or if other registration criteria have not been met as outlined in the approval letter granting temporary registration status to the yeast cell wall product in question, the temporary registration will not be renewed and the product will not be considered for full registration. Hence, the current temporary registration will expire, thereby making the product in question non-compliant with Section 3 of the Feeds Act.

Requirements for Renewal of Registration for Yeast Cell Wall Products

As with all registered feeds, yeast cell wall products that have been granted permanent registration status are registered for a 3-year period, renewable by March 31 of the third year after the registration date. All applications for registration renewal must be accompanied by a signed and completed application form; the appropriate fee; the complete product formulation (if applicable); and five copies of the product label, as per Chapter 1 "Application for Feed Registration and Ingredient Approval". Additional information may be requested if safety and/or efficacy concerns emerge between the time of registration and the renewal due date.

Note that changes made to the formulation of registered yeast cell wall products are considered to be significant changes to the registration, and require the submission of a signed and completed application form, a copy of the updated formula, and revised product labels, as well as the applicable registration fee (see Chapter 1 for details). Yeast cell wall products submitted at the time of renewal with a change in formulation will necessitate payment of the fee for the evaluation of the new formulation in addition to the renewal fees.

Requirements for Amendments (Significant Change) to Yeast Cell Wall 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 beta-glucan, mannan and/or mannan-oligosaccharide content
• changes to the product formulation that affect the efficacy and/or beta-glucan, mannan and/or mannan-oligosaccharide content of the product (e.g., addition/removal of carrier ingredients, addition/removal of a pellet binder, etc.)
• 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 the analytical method(s) used to determine beta-glucan, mannan and/or mannan-oligosaccharide content in the product in question
• changes to, or the addition of, label claims
• the addition of livestock species to the product label (i.e., in cases where a yeast cell wall product is only approved for use in certain species)
• modifications to the directions for use
• 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 Animal Feed Division 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.

Requirements for Registration for Mixed Feeds Claiming the Presence of Yeast Cell Wall, Mannans, Mannan-oligosaccharides and/or Beta-glucans

Mixed feeds (i.e., a feed comprised of 2 or more single ingredient feeds) claiming the presence of the ingredient yeast cell wall and/or mannans, mannan-oligosacchrides and/or beta-glucans on the product label (e.g., in the brand name, product name, guaranteed analysis) are subject to registration under the Feeds Act and Regulations, as they do not meet exemption from registration criteria.

As each yeast cell wall source must be registered with one or more feed-related claims, these claims must also appear on the product labels for mixed feeds indicating they are a source of mannans, MOS and/or beta-glucans. Additionally, as each source of the ingredient yeast cell wall must be registered with one or more species-specific feed-related claims, the inclusion rate of each yeast cell wall source in the mixed feed's product formulation, as well as the directions for use stated on the product label, must reflect the directions for use indicated on the approved label(s) for the yeast cell wall source(s) used in manufacture of the mixed feed.

Applications for registration for this type of mixed feed are considered Category 1 applications for registration (code 3254). The following documentation is to be included with each submission:

• a signed and completed application form
• a cover letter explaining the purpose of the application for registration
• a copy of the list of ingredients and detailed product formulation, including the registration number(s) of the yeast cell wall source(s) used in the formula
• five copies of the proposed product label
• label guarantee(s) for mannans, mannan-oligosaccharides and/or beta-glucans derived from the yeast cell wall sources used in the mixed feed's product formulation
• relevant label claims originating from the yeast cell wall source(s) used in the mixed feed
• directions for use for the mixed feed that are based upon the registered yeast cell wall source(s) used in the product formulation

Standard mixed feeds (i.e., complete feeds, supplements, etc.) using registered yeast cell wall sources in their product formulations that do not make a claim for the presence of this single ingredient feed, mannans, mannan-oligosaccharides and/or beta-glucans do not require registration, provided they meet all other exemption from registration criteria, as outlined in the Feeds Regulations. Please note that all imported mixed feeds must be registered, as per Section 3 of the Feeds Act.

Note that mixed feeds claiming to be a source of mannans, MOS and/or beta-glucans may only use registered yeast cell wall sources in their product formulations. Applications for mixed feeds containing unregistered yeast cell wall sources will not be accepted for registration and will be screened out and returned to the applicant.

Requirements for Renewal of Registration for Mixed Feeds Claiming the Presence of Yeast Cell Wall, Mannans, Mannan-oligosaccharides and/or Beta-glucans

The following information is to be submitted with each application for registration renewal:

• cover letter explaining the purpose of the application
• a signed and completed application form, accompanied by the proper renewal fee
• five copies of the product label
• a copy of the current product formula, if applicable
• any additional information, documentation, scientific data, etc. that is required to be submitted with application for registration renewal

Registration Checklist for Yeast Cell Wall Products

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended species
• Product claim statement (e.g., improves the weight gain in grower pigs)
• Guaranteed analysis for beta-glucan, mannan and/or mannan-oligosaccharide content
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for any Part II ingredients or mixed feeds, as required
• Directions for use to permit safe and effective use of the feed
• Caution and/or warning statements (if applicable)
• Feed processing instructions (e.g., do not pellet) (if applicable)
• Name and address of registrant
• Net weight (metric measure)
• Date of manufacture
• Expiration date
• Registration number (to be added)

Product Composition

• Formulation/percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds
• Formulation/Ingredients - verify that the levels of ingredients do not exceed maximums per Schedules IV and V
• The registration number of each yeast cell wall source used in the mixed feed (if applicable)

Scientific Studies

• A minimum of 3 scientific studies per target species to support the intended purpose(s)
• Experiments performed using the target livestock species
• Efficacy studies conducted using the yeast cell wall product that is being submitted for registration
• Studies carried out by qualified personnel
• Suitable experimental methods used in the studies
• Studies designed to facilitate statistical analysis
• Data analysed by the appropriate statistical methods
• Studies conducted under conditions similar to those that may be expected to occur in Canada
• Scientific investigations show that the product, when used as directed, results in a significant improvement in one or more of the proposed feed-related claims for the product
• Studies show a significant difference (P<0.05) between the control and treatment groups
• Where the directions for use indicate a range of inclusion rates, the testing protocol has evaluated each one of the inclusion rates used in the scientific studies
• Where results of these studies have not been published in a refereed journal, copies of the raw data and printouts of the statistical analysis are required for our review.

Laboratory Methods

• Original, signed copies of Certificates of Analysis for a minimum of 3 different and recent lots of product supporting the label guarantees for beta-glucan, mannan and/or mannan-oligosaccharide levels
• Complete and detailed laboratory methodologies to analyse (determine) beta-glucan, mannan and/or mannan-oligosaccharide content

Expiry Date

• Expiry date appears on the product label
• Original, signed Certificates of Analysis substantiating the guaranteed shelf life as stated on the label (i.e., the date of manufacture and at the expiry date) for a minimum of 3 different and recent lots of product have been included with the application

Safety Review (as required)

• Complete and detailed description of the manufacturing process (including flow charts, written descriptions, etc.) has been provided
• Toxicity data has been included with the application, if applicable or required

Sample

• A 500 g sample and accompanying Certificate of Analysis for beta-glucan, mannan and/or manna-oligosaccharide content, which also states the lot number and date of production, have been included with the application for registration

3.24 Organic label claims

The Canada Organic Regime is a regulated system for organic agricultural products, set up by the Government of Canada in response to requests by the organic sector and consumers. Under the regime, part 13 of the Safe Food for Canadians Regulations (SFCR) define specific requirements for organic products that are labelled as organic, or that bear the approved organic agricultural product legend (logo), and are sold interprovincially or are imported.

The Canadian Food Inspection Agency (CFIA) is responsible for the monitoring and enforcement of the SFCR. Under the Canada Organic Regime, certification bodies will be accredited based on the recommendation of CFIA-designated conformity verification bodies. The certification bodies are responsible for verifying the application of the Canadian Organic Standards (the Canadian General Standards Board's (CGSB) Organic Production Systems – General Principles and Management Standards (CAN/CGSB 32.310)).

Products for which an organic claim is made must be certified by an accredited certification body. The certification body must certify the product to the Canadian Organic Standards. The CFIA is working with designated conformity verification bodies to accredit certification bodies under the Canada Organic Regime. Inquiries regarding the SFCR should be directed to the Canada Organic Office.

Livestock feeds are regulated under the Feeds Act and regulations and the Health of Animals Act and regulations, which are administered by the CFIA. Under the Feeds Regulations, any product with a claim must be assessed and evaluated. Prior to the implementation of the SFCR, feeds with an organic claim required registration to ensure that the product was properly certified in accordance with the voluntary Canadian Organic Standards. The SFCR  provide clear regulatory authority on the certification and assessment of products making organic claims.

It is important to note that organic feeds will always need to meet the requirements of the Feeds Act and regulations. As with other feeds, organic feeds may be exempt from registration, if they meet all regulatory requirements and meet the criteria for exemption from registration.

There are 3 categories (types) of organic claims which are permitted under the SFCR for products in interprovincial and international trade.

Category I claims are for single ingredient products, or multi-ingredient products that are comprised of at least 95% organic ingredients. These products may make the claim as part of the product name (for example, "Organic corn" or "Organic chicken feed") and may use the approved logo.

Category II claims are for multi-ingredient products in which 70 to 95% of the ingredients are organic. These products may indicate the % organic ingredients.

Category I and II claims on feed labels will not require feed registration if SFCR requirements are met, provided that they meet all of the Feeds Regulations registration exemption criteria.

Category III claims for multi-ingredient products that contain less than 70% organic ingredients. These products may indicate organic ingredients in their list of ingredients. This type of claim on a feed will require registration by the Animal Feed Program of the CFIA, as it is not assessed by a certification body under the SFCR.

Organic feeds may only contain ingredients which are approved per Schedules IV and V of the Feeds Regulations, and are on the permitted substances list (CGSB's Organic production systems permitted substances lists (CAN/CGSB 32.311)). The permitted substances list includes both ingredients which may be certified as organic (for example,  grains), and additives and supplements (sometimes called "inputs") such as vitamin and mineral sources, which cannot be certified as organic. Ingredients on the permitted substances list must be used in accordance with the origin and usage restrictions that are listed.

Ingredients from the permitted substances list which are not certifiable as organic (for example, minerals) may not make any label claims indicating that they are organic. They also cannot contain claims such as "approved for use in organic agriculture", or "certified approved for use in organic agriculture". These are not claims that are permitted under the SFCR. There is currently no program in place for certification bodies to certify a product comprised of non-certifiable ingredients from the permitted substances list as approved for use in organic agriculture. Feeds also cannot claim to be listed or approved by the "Organic Materials Review Institute (OMRI)", nor can they claim to be included on any other international permitted substances list, as other countries have organic standards and permitted substance lists that are different from Canada's.

The feed regulatory requirements, including labelling, and restrictions pertaining to organic claims are outlined below:

Domestic organic feeds (interprovincial trade)

Category I claims: Organic

Feeds that are certified organic (that is, more than 95% organic ingredients) in accordance with the SFCR will not require registration of the organic claim by the Animal Feed Program of the CFIA with the following conditions:

Labels must:

• have the term "organic" in association with the common name of the product (for example, XX Mill's Organic Complete Feed for Laying Hens)
• bear the name of a CFIA-accredited certification body^Footnote 6
• bear the words "imported" or "product of [country name]"; for imported products that bear the "Canada Organic" logo
• indicate which ingredients in the list of ingredients (if present) are organic; and
• meet the requirements of the Feeds Regulations

Labels may:

• use the "Canada Organic" logo
• use terms such as organic; organically grown; organically raised; organically produced, or words of similar intent, including diminutives of, symbols for, and phonetic renderings of these words (for example, "organik")
• use the logo of the certification body; and/or
• require registration, if the product does not meet all of the Feeds Regulations registration exemption criteria

Labels can not:

• have label statements such as "certified organic" or "100% organic"; nor
• have statements such as "made with organic x" or "includes organic x"

Category II claims: 70 to 95% organic

In the case of a multi-ingredient product whose contents are more than 70% and less than 95% organic, the % organic may be claimed provided the certifying body has approved this claim. This claim does not require feed registration, with the conditions that:

Labels must:

• bear the statement "% organic ingredients", immediately following the percentage number rounded down to the nearest whole number
• bear the name of a CFIA-accredited certification body^Footnote 6
• indicate which ingredients in the list of ingredients (if present) are organic; and
• meet the requirements of the Feeds Regulations

Labels may:

• use the logo for the certification body; and/or
• require registration, if the product does not meet all Feeds Regulations registration exemption criteria

Labels can not:

• use the "Canada Organic" logo
• have statements such as "certified organic"
• have the term "organic" as a descriptor of the common name of the product; nor
• have statements such as "made with organic x" or "includes organic x"

Category III claims: Contains organic ingredients

Multi-ingredient products which contain less than 70% organic ingredients may indicate the organic ingredients within the list of ingredients. As these claims are not assessed by a certification body, feeds that indicate which ingredients are organic in the list of ingredients must be registered by the Animal Feed Program.

Companies will need to submit the standard feed registration information, as outlined in Chapter 1 - Administrative requirements for pre-market assessment and product registration of livestock feed, as well as copies of the organic certification for the organic ingredients used in the feed. All organic ingredients must be certified organic in accordance with the SFCR. Companies must also submit information such as policies and procedures which detail how adulteration or cross-contamination with non-organic material is prevented.

Labels must:

• be as they are approved by the Animal Feed Program; and
• have a valid feed registration number

Labels may:

• indicate the organic ingredient(s) in the list of ingredients

Labels can not:

• use the term "organic" anywhere other than the list of ingredients
• use the "Canada Organic" logo
• indicate the % organic ingredients
• indicate the name of a certification body; nor
• have statements such as "made with organic x" or "includes organic x"

Please note that organic feeds may still require registration with the Animal Feed Program if they do not meet all exemption from registration criteria as outlined in the Feeds Act and Feeds Regulations.

Domestic organic feeds (intra-provincial)

Products that are manufactured and sold within a single province (that is, intra-provincial) are exempt from the SFCR. An organic claim on a feed that is manufactured and sold within a province, and that is not in accordance with the SFCR, is required to be registered in support of the product being certified, in accordance with the Canadian General Standards Board organic standard or an equivalent standard.

Imported organic feeds

All mixed feeds, and feed ingredients listed in Schedules IV or V, Part II, of the Feeds Regulation, require registration before they are imported into Canada. Feed ingredients listed in Schedules IV or V, Part I, are exempt from registration, provided that they meet the regulatory standards, including the approved definition, and are properly labelled. Imported feeds may make an organic claim subject to the following conditions:

Labels must:

• meet the criteria for the appropriate claim category (I, II or III) as listed above
• declare the country of origin ("imported" or "product of X") in close proximity to the "Canada Organic" logo, if used (Category I only); and
• be certified by a certification body that is accredited by a Competent Authority or certification body that is accredited by the CFIA

Labels may:

• bear the "Canada Organic" logo if the product has a Category I organic claim; and/or
• require feed registration

Enforcement of organic regulations

CFIA inspection staff will verify organic claims during routine inspections. Regulated parties are reminded that the Feeds Act and regulations continue to apply, and that enforcement action may be taken under the Feeds Act and regulations if non-compliant product is found in the marketplace.

All feeds (including organic feeds) that are manufactured, sold, or imported into Canada may only use approved ingredients per Schedules IV and V of the Feeds Regulations. The presence of other (unapproved) ingredients is considered non-compliance requiring corrective and/or enforcement action.

3.25 Registration requirements for carotenoid-based colouring agents and mixed feeds containing carotenoid-based colouring agents

The purpose of this section is to provide applicants with the registration requirements for the submission of an acceptable application for registration to the Animal Feed Division (AFD) for carotenoid-based colouring agents listed in Part II of Schedule IV of the Feeds Regulations containing beta-apo-8'-carotenoic acid ethyl ester, astaxanthin, or canthaxanthin as the active compound and that are destined for use in poultry and/or salmonid fish feeds.

It is to be noted that each source of a single ingredient feed (SIF) listed in Part II of Schedule IV of the Feeds Regulations requires registration prior to import, manufacture, sale or use in Canada, in support of the safety and/or efficacy of the source in question.

This section also applies to mixed feeds containing registered carotenoid-based colouring agents and provides information concerning the AFD's requirements for registration renewal and registration amendment (significant change) for carotenoid-based colouring agents that are already approved for use in poultry and/or salmonid fish feeds in Canada.

Maximum Allowable Carotenoid Concentrations in Poultry and Salmonid Fish Feeds

Health Canada, in conjunction with the Canadian Food Inspection Agency (CFIA), has determined that, based on a human health risk assessment, the maximum allowable level of canthaxanthin in complete feeds for salmonid fish is 50 grams of canthaxanthin per tonne of complete salmonid fish feed, and the maximum allowable level of astaxanthin is 80 grams per tonne of complete salmonid fish feed.

Furthermore, when astaxanthin is used in combination with canthaxanthin, the rate of canthaxanthin used shall not exceed 50 grams per tonne of complete salmonid fish feed. Additionally, the combined level of these 2 carotenoids shall not exceed 80 grams per tonne of complete salmonid fish feed.

For poultry feeds, the level of canthaxanthin used must not exceed 30 grams of canthaxanthin per tonne of complete feed. Astaxanthin is not permitted in poultry feeds at this time.

In addition, the concentration of beta-apo-8'-carotenoic acid ethyl ester in poultry feeds must not exceed 30 grams of beta-apo-8'-carotenoic acid ethyl ester per tonne of complete feed.

The AFD has also reviewed scientific information regarding the presence of the carotenoid, adonirubin, in certain carotenoid-based colouring agents destined for use in salmonid fish feeds. After discussing these findings with Health Canada, the AFD has determined that the presence of adonirubin in salmonid fish feeds, in combination with astaxanthin and canthaxanthin, must not exceed a combined maximum concentration of 80 grams per tonne of complete feed.

It is to be noted that adonirubin itself is not approved as a colouring agent for use in salmonid fish feeds in Canada. However, given its joint presence with canthaxanthin and astaxanthin in certain carotenoid-based colouring agents, its concentration in a given product must be factored into the maximum allowable total carotenoid concentration of 80 grams per tonne of complete feed.

It is important to note that these maximum concentrations set by Health Canada pertain directly to human safety. These revised carotenoid concentrations will also bring Canada more in line with other international jurisdictions.

Part 1: Registration Requirements for Carotenoid-based Colouring Agents

1.1 Administrative Requirements

General administrative information regarding the procedures for application for feed registration can be found in Chapter 1 of RG-1. Specific information is found in the attached checklists.

1.2 Labelling

The proposed label must include:

• the product name, reflecting the purpose of the product as a carotenoid-based colouring agent for use in poultry and/or salmonid fish feeds;
• required guarantees and the necessary labelling statements, as per the relevant single ingredient feed definition(s) listed in Part II of Schedule IV of the Feeds Regulations; and
• directions for use consistent with the maximum allowable use rates of the single ingredient feed in question;

1.3 Product Description and Supporting Information

Specific and more detailed information is found in the attached checklist.

A complete description of the manufacturing process used to produce the carotenoid-based colouring agent must be provided. This should include detailed written descriptions, flow charts, time/temperature specifications for particular steps in the production process, quality control measures, a list of all starting materials/ reagents/ chemicals/ processing aids, etc., including the amount or concentration of each compound.

The complete product formula (formulation on a weight for weight basis or expressed as a percentage composition) for the finished product (i.e., as added to feed) listing the amount of each ingredient, which must be identified as per the generic names listed in Schedules IV and V of the Feed Regulations, must be provided. Note that registration numbers for Part II ingredients, mixed feeds and other registered products must be included in the formula.

Note that feeds may not contain ingredients that are not listed in either Schedules IV or V of the Feeds Regulations. If the applicant wishes to use a currently unapproved feed ingredient as part of the product formulation, it is 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 carotenoid-based colouring agent 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 carotenoid-based colouring agent cannot be reviewed unless all of the ingredients used in the product formulation are approved and listed in either Schedules IV or V of the Feeds Regulations.

Technical information accompanied by supporting references outlining the complete carotenoid content or profile of the carotenoid-based colouring agent in question (e.g., chromatograms, product specification sheet, compositional breakdown, peer-reviewed scientific materials, etc.) are to be provided.

Original, signed certificates of analysis from 3 different and recent lots of product, which support the label guarantees for the active compound(s) (e.g., astaxanthin, canthaxanthin) as well as for any other analytes (e.g., moisture) required by the SIF definition in question must be included.

If adonirubin is present in the colouring agent that is being submitted for registration, original, signed certificates of analysis from 3 different and recent lots of product indicating the concentration of adonirubin must also be provided.

The complete and detailed description of each analytical methodology used to support the label guarantee(s) for beta-apo-8'-carotenoic acid ethyl ester, canthaxanthin, astaxanthin or astaxanthin dimethyldisuccinate is required. These methods will be used to determine the levels of the active compound(s) in the carotenoid-based colouring agent that is being submitted for registration.

If adonirubin is present in the carotenoid-based colouring agent that is being submitted for registration, a complete and detailed analytical methodology used to determine the concentration of adonirubin in the carotenoid-based colouring agent in question must also be provided.

Please consult RG-1, Sections 6.2 (Good Laboratory Practices Protocol for Feed Ingredient Approvals) and 6.3 (Guidelines for the Evaluation of Methods to Determine the Activity of Enzyme Ingredients Used in Animal Feeds) for additional information concerning the technical requirements for analytical methods for livestock feeds and feed ingredients.

If adonirubin is not present in the carotenoid-based colouring agent that is being submitted for registration, the applicant will be required to submit supporting scientific and/or technical information (e.g., certificates of analysis, scientific rationale, published peer-reviewed reports) substantiating the absence of adonirubin in the product in question.

If the analytical methodology used to determine the concentration of a carotenoid in the product is enzyme-based, a 500 g product sample is required to be submitted with the application for registration. This sample will be used by the CFIA's Ottawa Laboratory to verify analytical methodologies and label guarantees. A certificate of analysis stating the lot number and date of production for carotenoid (i.e., beta-apo-8'-carotenoic acid ethyl ester, astaxanthin, astaxanthin dimethyldisuccinate, canthaxanthin and/or adonirubin) content must accompany the product sample.

An expiry date or shelf life guarantee is to appear on the product label. It is necessary for the applicant to submit stability (i.e., shelf life) data with the application for registration. In order to satisfy this requirement, original, signed certificates of analysis substantiating the guaranteed shelf life on the label (i.e., date of manufacture and expiry date) for a minimum of 3 different lots of the product are required. The certificates of analysis for carotenoid content at the date of manufacture and at the expiry date must be for the same lot of product. The storage conditions used for the shelf life study should reflect the storage conditions suggested on the label.

1.4 Supporting Information for Safety Evaluations

Scientific data supporting product safety may be required. Applicants should consult RG-1, Sections 2.3 (Single Ingredient Feed Evaluation Requirements) and 2.4 (Generic Data Requirements for Safety Evaluations of Single Ingredients), for more information on the AFD's requirements as they pertain to product safety. It may be necessary to submit supporting safety data for any contaminants or toxins present in the carotenoid-based colouring agent. Based on the data submitted, a scientific rationale may be required to demonstrate that the level present in complete feed does not result in adverse effects on the intended species of livestock, to human health or to the environment. Depending on the source, these investigations may include, but are not limited to:

1. A detailed description of any contaminants inherent to the source or manufacturing process of the carotenoid-based colouring agent.
2. Signed certificates of analysis from 3 different and recent lots of product for suspected chemical and microbial contaminants, completed within the last 3 years of the date of the application:
   1. 3 signed certificates of analysis, for heavy metals which must include arsenic, cadmium, lead, chromium, mercury and aluminium and for any residual solvent(s) (e.g., methylene chloride) that may be present in the final product. However, other contaminant analyses may be requested by the AFD if required (e.g., triphenylphosphine (TPPO), etc.).
   2. For sources of Phaffia rhodozyma yeast, dried Haematococcus algae meal or Paracoccus carotinifaciens fermentation product, dehydrated only, 3 signed certificates of analysis for microbial contaminants which must include yeasts and moulds (with no Aspergillus flavus or Fusarium spp. detected), Salmonella, E. coli, total coliforms, total plate count or aerobic plate count (APC)).

Note: It is important to include the limit of quantification and/or limit of detection, the proper units of measurement, the date as well as the name and signature of the personnel responsible to carrying out the analyses on each certificate. Acceptable methodologies for the detection of significant amounts of any ingredient, compound, substance or organism intentionally incorporated into the feed or occurring as a contaminant (such as heavy metals or solvents used in the manufacturing process) must also be provided.

For new sources of Phaffia rhodozyma yeast, Dried Haematococcus algae meal or Paracoccus carotinifaciens fermentation product, dehydrated, detailed scientific information on the strain (including identification of the strain, its purity, the origin of the culture used, details of any genetic modifications made to the organism, composition of the culture media, as well as a detailed description of the fermentation and manufacturing processes used) that is being submitted for registration is required.

Further to point #2 above and in the case of applications for registration for strains of Phaffia rhodozyma yeast, Dried Haematococcus algae meal or Paracoccus carotinifaciens fermentation product, dehydrated containing one or more novel traits, a novel feed assessment would be required. Chapter 2.7 of the Regulatory Guidance, "Guidelines for the Assessment of Novel Feeds: Microbial Sources" should be consulted for additional information on this type of review.

Temporary Registrations

A temporary registration may only be granted to a carotenoid-based colouring agent for which all the basic registration requirements pertaining to product efficacy have been met, but for which the substantiating technical and/or scientific information in support of a permanent registration is partially lacking or incomplete. All safety requirements must be met before a temporary registration can be granted, as stated in Section 9 (5) of the Feeds Regulations.

Examples of why a carotenoid-based colouring agent may be granted a temporary registration include, but are not limited to:

• laboratory methods submitted in support of label guarantee(s) require additional substantiating technical data;
• shelf life data is incomplete

Products bearing a temporary registration number on the label will be identified by the letter "T" in front of the registration number. Products that do not have an accompanying analytical method are not acceptable for temporary registration status.

The issuance of temporary registrations is considered an interim measure which allows companies to adequately comply with the conditions of their temporary registration, as outlined in their approval letter. Only one temporary registration will be granted per product and the maximum duration for a temporary registration will be 3 years.

The temporary registration will not be renewed and the product will not be considered for full registration if the conditions have not been fulfilled. Once the registration expires the product may not continue to be imported, sold or used in Canada.

Part 2: Regulation of Mixed Feeds Containing Registered Carotenoid-based Colouring Agents

Requirements for Registration for Diluted Supplements of Beta-apo-8'-carotenoic acid ethyl ester, Canthaxanthin or Astaxanthin for Use in the Further Manufacturing of Poultry and/or Salmonid Fish Feeds

Mixed feeds (including imported mixed feeds) that are considered to be supplements of crystalline beta-apo-8'-carotenoic acid ethyl ester, crystalline astaxanthin, crystalline astaxanthin dimethyldisuccinate, crystalline canthaxanthin, Phaffia rhodozyma yeast, dried Haematococcus algae meal, or Paracoccus carotinifaciens fermentation product, dehydrated (i.e., a registered carotenoid-based colouring agent source that is being diluted) and are destined for use in the further manufacturing of poultry and/or salmonid fish feeds are subject to registration under the Feeds Act and Regulations, as they do not meet exemption from registration criteria. The main intent of such products is that they are a diluted source of carotenoid-based colouring agents for use in poultry and/or salmonid fish feeds. They typically consist of a registered source of one or more carotenoid-based colouring agents that have been further blended with one or more suitable carriers.

As each source of crystalline beta-apo-8'-carotenoic acid ethyl ester, crystalline canthaxanthin, crystalline astaxanthin, crystalline astaxanthin dimethyldisuccinate, Phaffia rhodozyma yeast, dried Haematococcus algae meal or Paracoccus carotinifaciens fermentation product, dehydrated, these products must be registered prior to its use in feeds in Canada, the inclusion rate of each source in the mixed feed's product formulation, as well as the directions for use stated on the product label, must reflect the directions for use indicated on the approved label for each registered carotenoid-based colouring agent used in the manufacture of the supplement. Additionally, the maximum permitted use rate of the carotenoid(s) in feeds, as indicated in the relevant SIF definition(s) found in Part II of Schedule IV of the Feeds Regulations must also be respected in the diluted supplement. Applications for registration for this type of mixed feed are considered Category 2 applications for registration. The following documentation is to be included with each submission:

• a signed and completed application form;
• a cover letter explaining the purpose of the application for registration;
• a copy of the detailed product formulation, including the registration number(s) of the carotenoid-based colouring agent(s) used in the formula;
• 3 copies of the proposed product label including:
  • the list of ingredients;
  • product name reflecting the purpose of the mixed feed in question (e.g., Canthaxanthin supplement for use in salmonid fish feeds);
  • label guarantee(s) for beta-apo-8'-carotenoic acid ethyl ester, canthaxanthin, astaxanthin, astaxanthin dimethyldisuccinate and/or adonirubin derived from the registered carotenoid-based colouring agent(s) used in the mixed feed's product formulation;
  • directions for use that are based upon the registered carotenoid-based colouring agent source(s) used in the product formulation.

Note that mixed feeds claiming to be a source of beta-apo-8'-carotenoic acid ethyl ester, astaxanthin, astaxanthin dimethyldisuccinate and/or canthaxanthin may only use registered sources of carotenoid-based colouring agents in their product formulations. Applications for mixed feeds containing unregistered carotenoid-based colouring agents will not be accepted for registration and will be screened out and returned to the applicant.

Standard mixed feeds (i.e., complete feeds, vitamin/mineral supplements, etc.) that are manufactured and sold in Canada using registered carotenoid-based colouring agents in their product formulations that do not make a claim for the presence of these single ingredient feeds do not require registration, provided they meet all other exemption from registration criteria, as outlined in the Feeds Regulations. However, standard mixed feeds that do claim the presence of one or more carotenoid-based colouring agents are subject to registration, as they no longer meet exemption from registration criteria. The registration requirements for standard mixed feeds claiming the presence of one or more carotenoid-based colouring agents are the same as those outlined above for diluted supplements.

Part 3: Amendments (Significant Change) to Registered Carotenoid-based Colouring Agents and Mixed Feeds Containing Carotenoid-based Colouring Agents

General administrative information regarding application procedures for amendments to feed registrations can be found in Chapter 1 of RG-1. Specific information is found in the attached checklist.

Proposed 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 astaxanthin, astaxanthin dimethyldisuccinate, canthaxanthin, beta-apo-8'-carotenoic acid ethyl ester, adonirubin and moisture content (for Phaffia rhodozyma yeast, dried Haematococcus algae meal and Paracoccus carotinifaciens fermentation product, dehydrated);
• changes to the product formulation that affect the efficacy of pigmentation and/or the beta-apo-8'-carotenoic acid ethyl ester, canthaxanthin, astaxanthin, astaxanthin dimethyldisuccinate or adonirubin content of the product (e.g., addition/removal of carrier ingredients, addition/removal of an antioxidant, etc.);
• changes to the manufacturing process that may change the composition 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 the analytical method(s) used to determine beta-apo-8'-carotenoic acid ethyl ester, astaxanthin, astaxanthin dimethyldisuccinate, canthaxanthin and/or adonirubin content in the product in question;
• modifications to the directions for use; and
• changes to the duration of the shelf life of the product.

Note that with regards to applications for significant change proposing to increase the maximum permitted use rate of Part II single ingredient feeds that are carotenoid-based colouring agents containing beta-apo-8'-carotenoic acid ethyl ester, canthaxanthin, astaxanthin, astaxanthin dimethyldisuccinate and/or adonirubin, it would be necessary to submit a minimum of 3 feeding trials (meeting the criteria outlined in Chapter 2.2 of the Regulatory Guidance, Registration Requirements for Specialty Products) demonstrating the safety and efficaciousness of the increased use rate of beta-apo-8'-carotenoic acid ethyl ester, canthaxanthin, astaxanthin, astaxanthin dimethyldisuccinate and/or adonirubin in feeds for poultry and/or salmonid fish as part of the submission package.

In the event an applicant wishes to have a source of crystalline beta-apo-8'-carotenoic acid ethyl ester, crystalline canthaxanthin, crystalline astaxanthin, crystalline astaxanthin dimethyldisuccinate, Phaffia rhodozyma yeast, dried Haematococcus algae meal or Paracoccus carotinifaciens fermentation product, dehydrated, approved for use in feeds for livestock species other than poultry or salmonid fish, it will be necessary to provide the AFD with the required efficacy and safety data outlined above (i.e., manufacturing information, analytical method, certificates of analysis, etc.), as well as 3 feeding trials per species, with the application for registration. These studies must demonstrate the efficaciousness and safety of the product in question as a carotenoid-based colouring agent for the new livestock species it is being fed to.

Formulation changes involving ingredients that are not considered to be active ingredients (e.g., antioxidants, 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 AFD 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.

Requirements for Amendments (Significant Change) to Diluted Supplements of Beta-apo-8'-carotenoic acid ethyl ester, Canthaxanthin or Astaxanthin for Use in the Further Manufacturing of Poultry and/or Salmonid Fish Feeds

Proposed 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 astaxanthin, astaxanthin dimethyldisuccinate, canthaxanthin, beta-apo-8'-carotenoic acid ethyl ester, adonirubin, and moisture content (for Phaffia rhodozyma yeast, dried Haematococcus algae meal or Paracoccus carotinifaciens fermentation product, dehydrated), etc.;
• changes to the product formulation of the mixed feed (e.g., addition/removal of carrier ingredients, addition/removal of an antioxidant, etc.);
• changes to the active ingredient(s) (i.e., embedded registration(s)) used in the mixed feed;
• modifications to the directions for use;
• changes to the duration of the shelf life of the product.

Please refer to Chapter 1 of the Regulatory Guidance 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. However, it is recommended that the AFD 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.

Part 4: Renewal of Registrations for Carotenoid-based Colouring Agents and Mixed Feeds Containing Carotenoid-based Colouring Agents

General administrative information regarding the application procedures for renewals of feed registrations can be found in Chapter 1 of RG-1. Specific information is found in the attached checklist.

Submission Checklists for Carotenoid-Based Colouring Agents used in Poultry and Salmonid Fish Feeds

Below are 3 checklists, pertaining to carotenoid-based colouring agents for use in poultry and/or salmonid fish feeds, which detail the information required for the submission of an application for registration. Choose the relevant checklist based on the type of submission (single ingredient feed, supplement or mixed feed, or renewal).

A completed checklist must be submitted to the AFD with each application for feed registration. Please indicate the page number of your submission corresponding to each category in the checklist.

Note: Incomplete submissions will not be accepted by the AFD and will be screened out and returned to the applicant.

A) Single Ingredient Feeds

• For applications for registration for new sources of carotenoid-based colouring agents listed in Part II of Schedule IV (i.e., single ingredient feeds)
• For applications for registration seeking approval to use carotenoid-based colouring agents found in Part II of Schedule IV in feeds for species of livestock other than poultry and salmonid fish
• For applications for significant changes to registered carotenoid-based colouring agents that are not brand name changes
• For applications for significant changes to carotenoid-based colouring agents currently granted a temporary registration seeking permanent registration status

Administrative Registration Requirements

Submission page #

• Cover letter (detailing purpose of product, and any requested change(s) if product is already registered; please include the e-mail address of the authorized representative)
• One application form for feed registration or renewal per product (Form 0009), completed and signed
• Payment for a Category 3 (requiring safety and efficacy) feed (code 3256 on the application form) – cheque, money order, Visa, MasterCard, or American Express
• If a review of your submission has been performed previously by the Animal Feed Division and the file was closed due to deficiencies identified, please cite the reference number of the return letter in the cover letter enclosed with the new application and explain how deficiencies were addressed.
• Supporting documentation for any changes in signing authority
• If a new Canadian agent, a new "Declaration of Resident Canadian Agent" form (CFIA/ACIA 1194), completed and signed

For new companies:

• Signing authority and/or corporate documents (requirement for all new companies)
• Declaration of Resident Canadian Agent form (CFIA/ACIA 1194) (requirement for foreign companies only), completed and signed

Source of the Carotenoid-Based Colouring Agent

Submission page #

• Source of carotenoid-based colouring agent meets a definition listed in Schedule IV
• Technical information accompanied by supporting references outlining the complete carotenoid content or profile of the carotenoid-based colouring agent in question
• If derived from an organism, a statement indicating whether the source of the carotenoid-based colouring agent has been modified to contain a novel trait
• If modified, supporting information provided as per RG-1, Section 2.7, "Guidelines for the Assessment of Novel Feeds: Microbial Sources"

Proposed Label (3 copies)

Submission page #

• Brand name (optional)
• Product name reflecting the purpose of the product and the intended livestock species
• Guaranteed analysis for the carotenoids in question, as well as any other guarantees prescribed by the relevant single ingredient feed definition
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for any Part II ingredients or mixed feeds, as required
• Directions for use to permit safe and effective use of the feed
• Name and address of registrant
• Net amount (metric measure)
• Shelf life guarantee or expiration date
• Date of manufacture (if linked to expiration date/shelf life guarantee)
• Required labelling statements, as specified by the relevant single ingredient feed definition

Formula

Submission page #

• Formulation (either on a weight for weight basis or as a percentage composition) listing the amount of each ingredient by the approved generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or registered mixed feeds

Certificates of Analysis

Submission page #

• Original, signed copies of certificates of analysis for a minimum of 3 different and recent lots of product supporting the label guarantees for the carotenoid-based colouring agent as well as for any other analytes required by the relevant single ingredient feed definition(s);
• Original, signed certificates of analysis substantiating the guaranteed shelf life as stated on the label (i.e., the date of manufacture and the expiry date) for a minimum of 3 different and recent lots of product
• 3 original, signed certificates of analysis for each of:
  • analysis of microbial contaminants (i.e., yeasts and moulds (with no Aspergillus flavus or Fusarium spp. detected), Salmonella, E. coli, total coliforms, total plate count or aerobic plate count (APC)) for sources of Phaffia rhodozyma yeast, dried Haematococcus algae meal or Paracoccus carotinifaciens fermentation product, dehydrated only
  • analysis of heavy metals (arsenic, cadmium, lead, chromium, mercury and aluminum) in the carotenoid-based colouring agent
  • analysis of residual solvents in the carotenoid-based colouring agent originating from the manufacturing process
  • analysis of any other chemical compounds that may be considered to be contaminants in the carotenoid-based colouring agent
  • each certificate of analysis indicates the limit of quantification and/or limit of detection, the proper units of measurement, the date as well as the name and signature of the personnel responsible for carrying out the analyses
  • name(s) of the method(s) used to generate certificates of analysis for heavy metals, residual solvents originating from the manufacturing process, or any other chemical compounds that may be considered a contaminant in the carotenoid-based colouring agent

Laboratory Methods

Submission page #

• Complete and detailed laboratory methods to determine the concentration for each carotenoid in the colouring agent

For applications for significant changes to registered carotenoid-based colouring agents:

• Signed statement that the analytical method(s) used to determine the carotenoid concentration(s) have not changed from those submitted for review and approved by the Animal Feed Division (not required for diluted supplements and mixed nutritional feeds)
  - Or -
• If the method(s) have changed, the revised method(s) have been included with the submission

Sample Provided to Support Verification of Enzyme-Based Methods

• For enzyme-based analytical methods that are used to determine the concentration of the carotenoid(s), a 500 g sample, and
• Accompanying certificate of analysis for carotenoid content, stating the lot number and date of production
  - Or -
• Analytical method used to determine the concentration of carotenoid(s) present is not enzyme-based; therefore, a 500 g sample is not required

Manufacturing Process Description

Submission page #

• Complete and detailed description of the manufacturing process (including raw materials, processing aids, flow charts, written descriptions, times and temperatures, etc.)

For applications for significant changes to registered carotenoid-based colouring agents:

• Signed statement that the manufacturing process, starting materials and solvents used have not altered from those submitted and approved by the AFD (not required for diluted supplements and mixed nutritional feeds)
  - Or -
• If the manufacturing process has changed, the new manufacturing process has been provided (complete and detailed description required)

Feeding Trials

Submission page #

• 3 feeding trials per intended livestock species (not required for applications for registration for new or currently registered sources of carotenoid-based colouring agents already listed in Part II of Schedule IV that do not exceed the maximum use levels permitted in feed and that are intended for use in poultry and/or salmonid fish feeds)

SIF Reference Sample Provided

• 500 g sample for new single ingredient feeds (SIFs) that are not listed in Schedule IV of the Feeds Regulations

Registered Products Seeking Permanent Registration Status

Submission page #

• Products that are currently granted a temporary registration - all of the required information and documentation previously requested by the AFD to gain permanent registration status has been provided

Note: Further information may be required after the initial review of the submission by the AFD.

B) Diluted Supplements and Mixed Feeds Claiming the Presence of Carotenoid-Based Colouring Agents on the Label

• For applications for registration for diluted supplements (i.e., mixed feeds that are registered Part II SIFs on carrier ingredients).
• For applications for registration for mixed nutritional feeds (e.g., complete feeds, nutritional supplements) that claim the presence of a carotenoid-based colouring agent on the product label (i.e., either in the brand name, in the product name, or through the addition of a label guarantee for the carotenoid in the guaranteed analysis portion of the label).

Administrative Registration Requirements

Submission page #

• Cover letter (detailing purpose of product, and any requested change(s) if product is already registered; please include the e-mail address of the authorized representative)
• One application form for feed registration or renewal per product (Form 0009), completed and signed
• Payment for Category 2 (requiring safety or efficacy) feed (code 3253 on the application form) – cheque, money order, Visa, MasterCard, or American Express
• Supporting documentation for any changes in signing authority
• If new Canadian Agent, a new "Declaration of Resident Canadian Agent" form (CFIA/ACIA 1194), completed and signed

For new companies:

• Signing authority and/or corporate documents (requirement for all new companies)
• "Declaration of Resident Canadian Agent" form (CFIA/ACIA 1194) (requirement for foreign companies only), completed and signed

Proposed Label (3 copies)

Submission page #

• Brand name (optional)
• Product name reflecting the purpose of the product and the intended livestock species
• Guaranteed analysis for the carotenoids in question, as well as any other guarantees prescribed by the relevant single ingredient feed definitions
• Guaranteed analysis for the required nutrients, as stipulated by Table 3 of the Feeds Regulations (required for mixed nutritional feeds claiming the presence of a carotenoid-based colouring agent on the product label)
• For mixed nutritional feeds, the statement "A list of the ingredients used in this feed may be obtained from the manufacturer or registrant"
  - Or -
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for any Part II ingredients (e.g., carotenoid based colouring agents ) or mixed feeds, as required by Section 26(1)(j.1) of the Feeds Regulations
• Directions for use to permit safe and effective use of the feed
• Name and address of registrant
• Net amount (metric measure)
• Shelf life or expiration date
• Date of manufacture (if linked to expiration date)
• Required labelling statements as indicated on the label of the registered carotenoid-based colouring agent(s) that are being used in the mixed feed

Formula

Submission page #

• Formulation (either on a weight for weight basis or as a percentage composition) listing the amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds
• The registration number of each carotenoid-based colouring agent used in the mixed feed is provided

Note: Further information may be required after the initial review of the submission by the AFD.

C) Applications for Renewal of Registration

Administrative Registration Requirements

Submission page #

• Cover letter, stating any requested changes and including the email address of the authorized representative
• One application form for feed registration or renewal per product (Form 0009), completed and signed
• Payment of renewal fee (code 3259 on the application form) – cheque, money order, Visa, MasterCard, or American Express
• Additional fees if modifications are made to the registration
• Supporting documentation for any changes in signing authority
• If new Canadian Agent, a new "Declaration of Resident Canadian Agent" form (CFIA/ACIA 1194), completed and signed

Product Label (as previously approved, 3 copies)

Submission page #

Note: Any proposed changes made to the approved product label or to the registration per se require, in addition to the renewal application, an application to the AFD for significant change or administrative amendment (these 2 requests are to be made on the same application form). This will necessitate payment of the fee for the evaluation of the revised product label in addition to the renewal fees.

• No label changes made
  - Or -
• If label changes are made, the amended label is provided
• If changes are made to label guarantees, certificates of analysis provided to support the changes (not required for diluted supplements and mixed nutritional feeds)

Formula (as previously approved)

Submission page #

Note: Any proposed changes made to the approved product formulation will require, in addition to the renewal application, an application to the AFD for significant change (these 2 requests are to be made on the same application form).

This will necessitate payment of the fee for the evaluation of the revised product formulation in addition to the renewal fees.

• No changes made to the product formulation
  - Or -
• If changes are requested, the revised formula (either on a weight for weight basis or as a percentage composition) listing the amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations, including registration numbers for Part II ingredients or mixed feeds, provided to support the changes

Manufacturing process

Submission page #

• Signed statement that the manufacturing process, starting materials and solvents used have not altered from those submitted and approved by the Animal Feed Division (not required for diluted supplements and mixed nutritional feeds)
  - Or -
• If the manufacturing process has changed, the new manufacturing process has been provided
• Signed statement that the identity of the strain of Phaffia rhodozyma yeast, dried Haematococcus algae meal or Paracoccus carotinifaciens fermentation product, dehydrated, as well as the purity and the origin of the culture used, in addition to any details regarding any genetic modifications that have been made to the organism, composition of the culture media, etc. have not changed
  - Or -
• If they have changed, the relevant information and documentation has been provided to the Animal Feed Division for review

Analytical method

Submission page #

• Signed statement that the analytical method(s) used to determine the carotenoid content (including the adonirubin concentration, where applicable) have not changed from that submitted for review and approved by the AFD (not required for diluted supplements and mixed nutritional feeds)
  - Or -
• If the method(s) have changed, the revised analytical method(s) have been provided

Certificates of analysis for contaminants

Submission page #

For registered sources of Phaffia rhodozyma yeast, dried Haematococcus algae meal or Paracoccus carotinifaciens fermentation product, dehydrated only:

• Original, signed certificates of analysis from 3 different and recent lots of product for :
  • moisture content and carotenoid pigment concentrations (e.g., adonirubin, astaxanthin) analysis of heavy metals (arsenic, cadmium, lead, chromium, mercury and aluminum) present in each source
  • analysis of residual solvents in each source, if applicable, and analysis of any other chemical compounds that may be considered to be contaminants in the carotenoid-based colouring agent
  • each Certificate of Analysis indicates the limit of quantification and/or limit of detection, the proper units of measurement, the date as well as the name and signature of the personnel responsible for carrying out the analyses
  • name of method(s) used to generate certificates of analysis for heavy metals, residual solvents originating from the manufacturing process, or any other chemical compound that may be considered a contaminant in the carotenoid-based colouring agent

Additional information as requested by AFD

• Any additional required information and documentation previously requested by the AFD to be submitted at the time of registration renewal has been included

3.26 Camelina products

Regulation of Camelina 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. Each camelina product intended to be used as a livestock single ingredient feed (e.g., camelina meal, camelina 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 RG-1, Chapter 1 for additional information regarding signing authority.

If a company or an individual wishes to apply for approval of Camelina sativa or a camelina by-product as a new single ingredient feed, then the following information needs to be submitted for each ingredient:

Administrative Information

1. Application form, covering letter, and the applicable fee.

Labelling

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.

Ingredient Description

3. A precise description of the camelina 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).

Ingredient Composition

4. Specify the composition of the camelina by-product being evaluated for use in livestock feed, including impurities or chemical contaminants. Camelina is known to contain glucosinolates, so Certificates of Analysis for glucosinolates levels will be required for 3 different lots of each camelina by-product being evaluated as a new livestock feed ingredient.

Manufacturing Process

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); any processing aids, enzymes, carriers or dust control agents that are added, and quality control procedures. Information on whether any other by-products (e.g. oil, screenings) are produced as part of the manufacturing process is also required.

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 camelina manufacturing deemed necessary for the evaluation.

Safety Data Requirements

6. Identify the pesticides used or applied in the cultivation and production of the camelina crop that is the source of the camelina product or by-product. Certificates of Analysis (signed) are required for 3 different lots of the source of the camelina by-product for a pesticide screen and need to include all pesticides that may be used and applied in the production and cultivation of camelina in Canada. Please provide the name of the lab method used for the pesticide analyses, as well as the limit of detection for each pesticide analysed.

7. Certificates of Analysis (signed) are required for 3 different lots of each camelina by-product ingredient being evaluated, including analysis for any known contaminants, such as glucosinolates 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 camelina 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 camelina or its by-product, including the maximum level of glucosinolates that may be present in the camelina 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 camelina 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 camelina 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 camelina 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 camelina 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 camelina 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.

3.27 Registration requirements for modified fatty acid single ingredient feeds

Fat supplements are used as energy sources to raise the energy density of livestock diets, however, the partitioning of these nutrients among tissues may vary depending on the chain length of the fatty acids. In particular, calcium salts of fatty acids and fat products with high levels of specific fatty acids, such as palmitic acid (C16:0) and stearic acid (C18:0), are used in feeds for high producing dairy cows. Highly saturated fatty acid products and calcium salts of fatty acids do not degrade rapidly in the rumen and therefore can influence productivity during early lactation as well as change the tissue and milk fatty acid composition/profile. Salts of fatty acids and fat products physically and/or chemically altered to change the composition and/or fatty acid profile and/or to obtain a higher level of a specific fatty acid(s) are referred to as "modified fatty acid single ingredient feeds" in this document.

Modified fatty acid single ingredient feeds may be obtained from the further processing of edible vegetable oils for human consumption and/or their by-products (e.g., fatty acid distillates). Further processing steps may include the formation of salts, filtration, refining, fractionation, distillation, hydrogenation or combinations of these processes during which specific fatty acids (e.g., palmitic acid and stearic acid) are concentrated, enriched and purified. As such, the chemical composition, fatty acid profile and/or physical properties of these modified fatty acid single ingredient feeds are distinct from those of the approved edible vegetable oils listed in Part I of Schedule IV of the Feeds Regulations.

Certain by-products of the vegetable oil manufacturing process such as palm fatty acid distillates (PFAD) may be sources of contaminants (e.g., dioxins and furans) in livestock feeds when used as the starting fatty acid source for producing calcium salts of fatty acids and other modified fatty acid single ingredient feeds. Given these potential safety concerns, all sources of modified fatty acid single ingredient feeds will require registration as feed, prior to their importation, sale, or manufacture in Canada.

This guidance applies to the following ingredients:

• Calcium Salts of Fatty Acids (Schedule IV; Part II #4.2);
• Fractionated Palm Fatty Acid Distillate (Schedule IV; Part II #4.12);
• Hydrogenated Palm Fatty Acid Distillate (Schedule IV; Part II #4.16);
• Palm Palmitic Acid (C16:0) (Schedule IV; Part II #4.17);
• Modified Fatty Acid Single Ingredient Feeds not listed in Schedule IV.

Section 1 - outlines the registration requirements for new sources of existing modified fatty acid single ingredient feeds, as well as new ingredients which do not meet existing definitions in Schedule IV, or those that have a new purpose other than as an energy source.

Section 2 - provides guidance on the registration requirements for mixed feeds, containing registered sources of modified fatty acid single ingredient feeds, including calcium salts of fatty acids, which are used as energy sources for livestock.

Section 3 - provides guidance on registration amendments to registrations of modified fatty acid products (single ingredient feed and mixed feeds).

Section 4 - provides guidance on the renewal of registered modified fatty acid products (single ingredient feed and mixed feeds).

It is recommended that the data requirements outlined below are carefully reviewed and followed prior to submitting an application for feed registration to the Animal Feed Division (AFD). As with all submissions, a preliminary screening is completed in order to determine whether the submission is acceptable for review. Submissions which are missing the required data elements will be returned to the applicant.

Section 1: Registration Requirements for Modified Fatty Acid Single Ingredient Feeds (not listed in Schedule IV) and New Sources of Existing Modified Fatty Acid Single Ingredient Feeds

1.1 Administrative Requirements

General administrative information regarding the application for feed registration procedures can be found in Chapter 1 of RG-1. Specific information is found in the attached checklist.
This section pertains to:

• New ingredients not listed in Schedule IV of the Feeds Regulations - Category 3 application (submission code 3256)
• New sources of existing Part II ingredients – Category 2 application (submission code 3255)

1.2 Labelling

• Brand Name (optional)
• Product Name (including the source of the free fatty acid (e.g. palm, soy, canola etc.)
• Purpose of the product for the intended livestock species
• Guaranteed analysis
• Antioxidant(s) used, where applicable
• Directions for use to permit safe and effective use of the product for the intended purpose
• Caution and/or warning statements (if applicable)
• Net weight (in metric units)
• Name and Address of the Registrant

1.3 Ingredient Identification and Characterization

• A proper characterization of the fatty acid ingredient (i.e., information about the raw materials used in its manufacture as well as specifications (including purity and grade) for the fatty acid source) is to be provided.
• Clear identification of the origin of the fatty acids (i.e., are obtained from edible vegetable oil and/or are a by-product of vegetable oil manufacturing).
• Identification of the plant species (e.g., corn, soy, palm, etc.) that the fatty acid source originated from.
• Indicate the grade of the final product (e.g., food, technical, industrial, cosmetic, or pharmaceutical grade) that is destined for use in livestock feeds.

1.4 Manufacturing Process

• A flowchart/diagram and detailed written description of the manufacturing process of the actual product that is submitted for registration, including the origin/source and specifications (e.g., purity, grade, levels of known contaminants) of each raw material (e.g., fatty acid source), and the specifications of any processing aids, catalysts, carriers, anti-oxidants, etc. used during the manufacturing process are to be provided. For each physical, chemical and/or biological step of the manufacturing process, the time, temperature and pressure parameters must be clearly stated.
• Specific details about how the fatty acid ingredient is manufactured, including all refining, extracting, distilling, fractionating, hydrogenation and purification steps involved (where applicable), must be provided.
• Provide the formulation/composition of the final product as well as the amount or percentage of all raw materials used in the manufacturing of the final product, where applicable.

1.5 Certificate of Analysis and Analytical Methods

• Original and signed certificates of analysis from 3 different and recent production lots of the final product (as added to livestock feeds) in support of the proposed label guarantees and complete fatty acid profile.
• Original and signed certificates of analysis for 3 different and recent production lots of the final product for known contaminants (e.g., pesticide residues, heavy metals including arsenic, aluminium, lead, cadmium, chromium as a minimum, and residual solvents if used in the manufacturing process). The analytical methodology/instrumentation used and limit of detection/limit of quantification must be noted.
• Original and signed certificates of analysis for 3 different and recent production lots of the final product for the 7 dioxin congeners, 10 furan congeners and 12 dioxin-like PCB congeners are to be submitted with the application. The analytical methodology/instrumentation used and limit of detection/limit of quantification must be noted. The following table lists the congeners required for the analysis of the final product.

• Note: All certificates must include the name and address of the testing laboratory, the signature of the person performing the analyses, the testing method used, the lot number, and the date of manufacture of the product being tested. The analytical methodology/instrumentation used for each analyte listed on the certificate of analysis is to be provided. If AOAC methods or other official analytical methods are used, it is necessary to reference each method on the certificates. In the event that the methods have not been peer-reviewed, additional information is required to validate the laboratory method as outlined in Chapter 6.2 of RG-1. A sample may also be requested as part of the validation process.

1.6 Reference Sample

• A reference sample (50 grams) is required for all new modified fatty acid ingredient feeds not listed in Schedule IV of the Feeds Regulations.

1.7 Data in Support of Purpose Assessment of New Modified Fatty Acid Single Ingredient Feeds and/or New Feed–Related Purpose

Studies supplying data in support of the purpose assessment are only required for new modified fatty acid single ingredients not listed in Schedule IV of the Feed Regulations or existing modified fatty acid ingredients with a new feed purpose.

• 3 scientific studies (per target livestock species) are required to support the intended purpose of the new modified fatty acid single ingredient feeds or an existing modified fatty acid single ingredient with a new feed purpose. For example, if a new ingredient is intended to be used as a source of dietary energy in feeds for one or more species of livestock, then the studies that are submitted in support of the application for registration for the product in question should clearly demonstrate the efficaciousness and nutritional suitability of the ingredient as a source of dietary energy in feeds for the target livestock species.
• When the new ingredient is used as directed, the performance of the livestock species should be statistically similar to those on the control fat source(s).
• Note: Published peer-reviewed scientific literature or papers on the new modified fatty acid single ingredient feeds can be used as bridging data in support of the efficacy of the new ingredient that is being submitted for registration. For more information related to the design of livestock efficacy studies in support of the efficacy of single ingredient feeds, please refer to RG-1, Chapter 2.3.

1.8 Data to Support Feed-Related Label Claims

The additional data requirements below apply to the registration of new modified fatty acid single ingredient feeds with feed-related label claims.

Rumen Bypass Claims

• A minimum of one (1) acceptable (in situ or in vivo) scientific study (per target livestock species) is required to support rumen bypass claims. The study must demonstrate statistically improved post-ruminal digestibility and increased bioavailability of the modified fatty acid single ingredient feed when compared to the control group(s). For more information on the design of livestock studies in support of rumen bypass claims, please refer to RG-1, Chapter 3.20.

Production Claims

• 3 scientific studies per target livestock species (e.g., 3 dairy cattle feeding studies) are required to support livestock performance claims associated with the modified fatty acid single ingredient feed in question, when used at the inclusion rates specified on the proposed label. The studies must demonstrate statistically improved livestock performance on diets using the new modified fatty acid single ingredient feed, when compared to the control group(s). For more information related to the design of livestock studies in support of production claims, please refer to RG-1, Chapter 2.2.

Section 2: Registration Requirements for Mixed Feeds Containing Registered Sources of Modified Fatty Acid Single Ingredient Feeds

Applicants wishing to manufacture, sell or import mixed feeds containing modified fatty acid single ingredient feeds are required to use only registered sources of these single ingredient feeds.

All mixed feeds highlighting or claiming the presence of a registered source of a modified fatty acid single ingredient feeds on the label (i.e., either in the brand name, product name, or addition of guarantees of the registered fatty acid ingredient) are subject to registration under the Feeds Act and Regulations as specialty mixed feeds (Category 2 products).

Mixed feeds that are manufactured in Canada containing registered sources of modified fatty acid single ingredient feeds may be exempted from registration as long as there is no claim highlighting the name or presence of the registered modified fatty acid single ingredient feeds (other than in the list of ingredients). The label may not bear any additional guarantees for the modified fatty acid single ingredient feed. All other criteria for exemption from registration under the Feeds Regulations must also be met.

2.1 Administrative Requirements

General administrative information regarding the application for feed registration procedures can be found in Chapter 1 of RG-1. Specifics are found in the checklist.

2.2 Labelling

• As speciality mixed feeds, the proposed label must include a complete list of all ingredients as per Schedule IV and V of the Feeds Regulations, including the registration numbers for Part II ingredients. Mixed feeds may not contain any ingredients that are not approved or listed in Schedule IV and V of the Feed Regulations.
• If the mixed feed contains a registered modified fatty acid single ingredient feed with a feed-related label claim, the mixed feed label may add the approved feed-related label claim with reference only to the modified fatty acid single ingredient feed, without providing supporting data. For example, "This feed contains palm palmitic acid (C16:0) (Reg. #) a high bypass fat" or "This feed contains fractionated palm fatty acid distillates (Reg. #) which increases milk production."
•  If the intent is to make a feed-related label claim for the entire "mixed feed", this mixed feed would have to be assessed for this feed-related label claim, as per the feed-related label claim requirements outlined in Section 1.8 of this document.

2.3 Product Formula

• Product formula listing the amount or inclusion rate of each ingredient in the final product.

Section 3: Amendments to the Registration of Modified Fatty Acid Products (Single Ingredient Feeds and Mixed Feeds)

Registrants wishing to make a change to a registered product must submit an application for a Registration Amendment (significant change/re-registration) to the AFD for approval (Category 2 submission). Proposed significant changes may include (but are not limited to) changes to directions for use, label guarantees, raw materials used, manufacturing process, the supplier(s), manufacturer(s), etc. This may require the submission of efficacy and/or safety data. Please refer to data requirements in Section 1 of this document.

3.1 Administrative Requirements

General administrative information regarding the application for feed registration amendment procedures can be found in Chapter 1 of RG-1. Specifics are found in the checklist.

3.2 Data Requirements for Registration Amendments

Data requirements for significant changes to modified fatty acid single ingredient feeds and mixed feeds containing registered sources of modified fatty acid single ingredient feeds will be dependent on the changes being requested and would be evaluated on a case by case basis. Please see below for examples of the data requirements for different types of amendments.

3.3 Single Ingredient Feeds

Changes to the suppliers of raw materials and/or product composition and/or name of manufacturer/supplier and/or manufacturing process, etc.

• Ingredient identification and characterization
• Manufacturing process and product composition
• Certificate of analysis and analytical methods (label guarantees and fatty acid profile)
• Certificate of analysis and analytical methods for contaminants (e.g., dioxins, furans, dioxin-like PCBs, pesticide residues, heavy metals, residual solvents, etc.)

Changes to directions for use/addition of livestock species/new purpose/addition of feed-related label claims, etc.

• Data supporting the purpose of the new use rates and/or usage for additional livestock species
• Data supporting the new purpose
• Data supporting feed-related label claims

3.4 Mixed Feeds

Changes to product formulation/list of ingredients/new source of registered modified fatty acid single ingredient feeds/directions for use/addition of approved feed-related label claims, etc.

• New product formula (including the registration number of the registered modified fatty acid single ingredient feeds).

Please refer to Section 1 and 2 of this document for more information regarding these registration requirements.

Section 4: Renewal of Registered Modified Fatty Acid Products (Single Ingredient Feeds and Mixed Feeds)

4.1 Administrative Requirements

General administrative information regarding the application for feed registration renewal procedures can be found in Chapter 1 of RG-1. Specifics are found in the checklist.

4.2 Single Ingredient Feeds

Please note that additional information is to be submitted at the time of registration renewal for modified fatty acid single ingredient feeds.

• Original and signed certificates of analysis for 3 different and recent production lots of the final product for the 7 dioxin congeners, 10 furan congeners and 12 dioxin-like PCBs for each final product. The analytical methodology used and limit of detection/limit of quantification must be noted.
• Original and signed certificates of analysis for 3 different and recent production lots of the final product for known contaminants (e.g., heavy metals (including arsenic, lead, aluminium, chromium, mercury and cadmium, and residual solvents if applicable). The analytical methodology used and the limit of detection/limit of quantification must be noted.
• A signed statement that the manufacturing process and all raw materials (source and origin of fatty acid source), processing aids, carriers, catalysts, anti-oxidants, etc., have not changed since the original approval. This would include a statement that no modifications to the times, pressure and temperature parameters used during the manufacturing process have been made.

If the manufacturing process and/or origin and source of the raw materials have changed since the original approval, the registrant must provide:

• detailed written description of the manufacturing process and diagram/flowchart
• signed, original and recent certificates of analysis for 3 production lots of the final product to support the fatty acid profile, label guarantees as well as specifications for the final product.

Note: Appropriate fees for a significant change to the registration in addition to the renewal fees for the registration are required.

4.3 Mixed Feeds

• A copy of the current product formulation.

For questions or clarification, please e-mail the Animal Feed Division.

Submission Checklist for Modified Fatty Acid Single Ingredient Feeds

Printer friendly PDF version (139 kb).

Note: Submissions received without the completed checklists will be returned. Applicants should indicate if each item is included (Y), or not applicable (N/A).

Administrative requirements: (Please refer to Administrative Requirements for Registration and Approval of Livestock Feeds):

New companies must include:

• Signing Authority and/or corporate documents
• Declaration of Resident Canadian Agent (required when the product is being imported)

All submissions must include:

• Cover Letter (detailing purpose of product, any requested change(s) if product is already registered and please include the e-mail address of the authorized representative)
• Completed Application for Feed Registration or Renewal (CFIA/ACIA 0009) form; (One (1) application form per product is required)
• Application fees (cheque, money order, Visa, MasterCard, or American Express payable in Canadian Funds).
  • New Applications:
    • Ingredients not listed in Schedule IV ( Code 3256, Category 3);
    • New sources of existing Part II ingredients (Code 3255, Category 2);
    • Mixed feeds claiming/highlighting registered sources of modified fatty acid single ingredient feeds (Code 3253, Category 2)
  • Significant Changes to an existing registration (requiring efficacy and/or safety):
    • Modified Fatty Acid Single Ingredient Feeds (Code 3255, Category 2)
    • Mixed feed containing registered sources of modified fatty acid single ingredient feeds (Code 3253, Category 2)
  • Renewal of Registration:
    • Modified Fatty Acid Single Ingredient Feed or Mixed feed containing registered sources of Modified Fatty Acid Single Ingredient Feeds (Code 3259)

Note: Any proposed changes made to the original registration require, in addition to the renewal application, an application to the AFD for significant change or administrative amendment. Note these 2 requests are to be made on the same application form, and will necessitate payment of the corresponding fee for the evaluation of the revised product label in addition to the renewal fees.

As applicable:

• Supporting documentation for any changes in signing authority
• New Declaration of Resident Canadian Agent form if any changes to Canadian Agent
• If a review of your product has been performed previously by the AFD and the file was closed due to deficiencies identified, please enclose a copy of the return letter with the new application and detail in the cover letter how deficiencies were addressed

Modified Fatty Acid Single Ingredient Feeds

• Proposed Label (3 copies)
• Ingredient Identification and Characterization
  • A proper characterization of the modified fatty acid single ingredient feeds (specifications of the fatty acid source).
  • Clear identification of the origin of the fatty acids (i.e., are obtained from edible vegetable oil and/or are a by-product of vegetable oil manufacturing).
  • Identification of the plant species (e.g., corn, soy, palm, etc.) that the fatty acids source originated from.
  • Indicate the grade of the final product that is destined for use in livestock feeds.
• Manufacturing Process
  • Flowchart/diagram of the manufacturing process
  • Detailed written description of the manufacturing process including the origin/source and specifications of each raw material, and the specifications of any processing aids, catalysts, carriers, anti-oxidants, etc. Specific details about each biological, chemical or physical processing step are required
  • Product formulation and amount or percentage of all raw materials used in the manufacturing of the final product
• Certificates of Analysis and Analytical Methods
  • Original and signed certificates of analysis from 3 different and recent production lots of the final product in support of the proposed label guarantees and the complete fatty acid profile, and the analytical methodology/instrumentation used for each analyte.
  • Original and signed certificates of analysis for 3 different and recent production lots of the final product for known contaminants (e.g., pesticide residues, heavy metals including arsenic, aluminium, lead, cadmium, chromium, residual solvents if used in the manufacturing process). The analytical methodology/instrumentation used and limit of detection/limit of quantification must be noted.
  • Original and signed certificates of analysis for 3 different and recent production lots of the final product for the 7 dioxin congeners, 10 furan congeners and 12 dioxin-like PCB congeners are to be submitted with the application. The analytical methodology/instrumentation used and limit of detection/limit of quantification must be noted.
• Reference Sample
  • A reference sample (50 grams) is required for all new modified single ingredient feeds not listed in Schedule IV or V of the Feeds Regulations.

• Data Requirements for New Modified Single Ingredient Feeds and/or New Feed-Related Purpose
  • 3 scientific studies (per target livestock species) are required to support the intended purpose of the new modified fatty acid single ingredient feed or an existing modified fatty acid ingredient with a new purpose.
• Data Requirements to Support Feed-Related Label Claims
  • Rumen Bypass Claims
    • A minimum of one (1) acceptable (in situ or in vivo) scientific study (per target livestock species) is required to support rumen bypass claims.
  • Production Claims
    • 3 scientific studies per target livestock species (e.g., 3 dairy cattle feeding studies) are required to support livestock performance claims associated with the modified fatty acid single ingredient feeds in question, when used at the inclusion rates specified on the proposed label.

Mixed Feeds Containing Registered Sources of Modified Fatty Acid single Ingredients

• Proposed Label (3 copies)
  • Label must include a complete list of all ingredients listed in Schedule IV or V of the Feeds Regulations, including the registration number for Part II ingredients.

Note: The source of the modified fatty acid single ingredient must be approved and registered by AFD prior to being used in the mixed feed purpose

• Product Formulation
  • Product formula listing the amount or inclusion rate of each ingredient used

Applications for Feed Registration Renewal

• Single ingredient feeds:
  • Original and signed certificates of analysis for 3 different and recent production lots of the final product for the 7 dioxin congeners, 10 furan congeners and 12 dioxin-like PCBs for each final product. The analytical methodology used and limit of detection/limit of quantification must be noted.
  • Original and signed certificates of analysis for 3 different and recent production lots of the final product known contaminants (e.g., heavy metals (including arsenic, lead, aluminium, chromium, mercury and cadmium, and residual solvents if applicable).The analytical methodology used and limit of detection/limit of quantification must be noted.
  • A signed statement that the manufacturing process has not changed and all raw materials (source and origin of fatty acid source), all processing aids, carriers, catalysts, anti-oxidants, etc. have not changed since the original approval.
• Mixed Feeds:
  • A copy of the current product formulation.

3.28 Registration requirements for Mycotoxin Detoxification Agents (MDAs)

Background

Mycotoxin Detoxification Agents (MDAs) are substances or mixtures of substances incorporated into a feed matrix to mitigate animal exposure to known mycotoxins. These substances may exert their effects on mycotoxins by reducing gastrointestinal absorption, decreasing bioavailability, promoting excretion or by modifying the structure of the mycotoxin.

MDAs may be regulated as a drug or a feed depending on a number of factors as defined in the guidance document on classification of veterinary drugs and livestock feeds. That document provides guidance and criteria to help clarify the regulatory differences between drugs and feeds, and assists in determining the appropriate regulatory oversight for a product for use in livestock species. Appendix E-1 of the document specifically addresses the classification of MDAs.

MDAs that may be classified for a feed purpose include those that exert their effects either prior to ingestion or within the gastrointestinal tract, and function to:

1. directly bind to the mycotoxin
2. degrade the mycotoxin
3. inactivate the mycotoxin itself (for example, enzymes)

MDAs that aid in reversing or mitigating adverse effects or toxicosis due to mycotoxins by causing changes in physiological functions in the animal may be considered drugs.

Regulatory status

MDAs that are regulated as feed are considered specialty products and must be approved and registered by the Canadian Food Inspection Agency (CFIA) prior to their importation, manufacture or sale in Canada.

MDAs can only be used in feeds that are considered safe for livestock consumption in accordance with the Canadian standards for mycotoxins and are not for use to remediate livestock feeds that do not comply with the Canadian standards for mycotoxins. (RG-8, Section 1: mycotoxins in livestock feed). MDAs may mitigate against additional mycotoxin production by storage mycotoxins (for example, aflatoxin) and may work as a preventative aid against additive or synergistic effects of multiple mycotoxins.

Fit for purpose and efficacy as an MDA

To be classified as an MDA, the active ingredient must have demonstrated an effect corresponding to its purpose, that is, a mode of action consistent with an MDA effect, as stated above, when used or fed as directed. Supporting data must be provided from in-house studies or peer reviewed literature that are reflective of the ingredient fed at similar rates and duration of feeding as per the label. In addition, the market formulation (mixed or a single ingredient product) must have a claim which is supported by efficacy studies.

This document is divided into the following 3 parts:

• Part 1 – Registration requirements for new MDAs
• Part 2 – Amendments to registrations of MDAs
• Part 3 – Renewal of registrations of MDAs

The data requirements outlined below, including the checklist, must be carefully reviewed and followed prior to submitting an application to the CFIA for feed registration.

After reviewing all documents, if specific questions on requirements remain, please contact the CFIA at cfia.afp-paa.acia@inspection.gc.ca.

Part 1: Registration requirements for new MDAs

1.1 Administrative requirements

General administrative information regarding the procedures for application for feed registration can be found in Regulatory Guidance: RG-1, Chapter 1 - Administrative Requirements for Pre-market Assessment and Product Registration of Livestock Feed.

Specific information is found in the attached checklist.

1.2 Labelling

Proposed labels for MDAs must include the following, in addition to standard labelling requirements listed in RG-1, Chapter 4.1 – Labelling and Guarantees - Labelling of Livestock Feed:

• Product name
• Complete list of ingredients
• A minimum guarantee for each of the active ingredients in the product
• Each specific mycotoxin targeted by the MDA
• Target livestock species and feed type
• Directions for use and applicable use rates for the MDA
• Date of manufacture
• Shelf life (For example, 12 months from the date of manufacture when stored under appropriate conditions)
• Recommended storage conditions in order to maintain full activity until the expiration date
• Caution and warning statements, if applicable
• Statement on interactions with veterinary drugs, if applicable

1.3 Product identification and description

The application package must include the following information:

1.3.1 General information

• Cover letter explaining the purpose of the product for registration
• Summary of documentation/information included with the application
• Detailed product formulation and complete list of ingredients identified by generic name as listed in Schedule IV or V of the Feeds Regulations, and registration number for ingredients listed in Schedule IV, Part II, or other registered feeds in the formulation
• Complete characterization of the product and active ingredients if a mixed product
  • If the product contains ingredients that are not listed in Schedule IV or V, additional information as per RG-1, Chapter 2 - 2.3 single ingredient feed evaluation requirements and Chapter 2.7 guidelines for the assessment of novel feeds: microbial sources.
  • For products whose active ingredients are clay minerals, elemental and mineralogical characterization and identity of each constituent clay mineral as well as information on the structure is to be provided with verification of physical properties obtained from analysis such as X-Ray Diffraction, Differential Thermal analysis, Infrared Spectroscopy, and atomic absorption spectrophotometry.
• Background supportive information pertaining to approvals in other jurisdictions (if applicable)
• Detailed manufacturing process
• Name(s) of the targeted mycotoxin(s)
• Intended livestock species
• Directions for use
• Target livestock feeds (for example, for use in complete feeds, for use in grains prior to mixing)
• Proposed product claim(s)
• Proposed shelf-life

1.3.2 Analytical information

• Certificates of analysis (CoAs) for the active agent from 3 different and recent lots of product.
• The analytical methodology used to substantiate the proposed label guarantee(s).
• Analytical methodology for the detection of the specific targeted mycotoxin in each target feed matrix (for example, in the premix, complete feed, and ingredients).
  • This must include evidence that the action of the MDA does not interfere with the capability to determine the mycotoxin levels in feed. This is especially important for clays and other substances that act by binding, or otherwise reducing the levels of mycotoxins.
• The method of sample preparation (for example, grinding, etc.) used in the analytical method must reflect the form of feed in the proposed use of the MDA (for example, whole versus ground corn).
• Product samples may be required to verify any analytical methodology provided or label guarantees. Samples will be requested on a case–by-case basis.

1.4 Requirements in support of product claims and other information

The criteria for acceptable scientific studies are outlined in RG-1, Chapter 2.2 -registration requirements for specialty products.

1.4.1 Studies in support of claims

A battery of in vitro studies should be submitted to provide evidence of the intended effect of the additive.

While in vitro studies may aid in elaborating the mode of action, they do not sufficiently mimic the conditions in the digestive tract and the differences between target animals and their metabolism under practical conditions. Demonstration of the efficacy of most MDAs can only be fully established by in vivo studies that show:

• reduction of the absorption of mycotoxins
• increased excretion of mycotoxins
• degradation/transformation of mycotoxins
• reduced concentration of mycotoxins in food of animal origin

The following specific criteria should be considered in designing appropriate studies in support of MDA claims:

• The mode of action should be declared and demonstrated with a minimum of one study for each identified target mycotoxin as per the directions for use specified on the label.
  • May be provided as an in vitro study.
• The target animal species is specified.
• Treatments with mycotoxin concentrations below listed maximum limits are used in the studies. There are described in RG-8, Section 1: mycotoxins in livestock feed.
  • If justified, an additional treatment which includes mycotoxin(s) concentrations in feeds exceeding the maximum limits can be added, however, a rational must be provided^Footnote 7.
  • Positive controls cannot exceed the maximum limits.
• An analysis and method that is reflective of the mode of action with appropriate endpoints in feed and target tissues is provided.
• For MDAs that act by binding (for example, clays), the mycotoxin binding capacity should be provided.
• For MDAs that act in the feed by degrading the mycotoxin into non-toxic compounds, and can demonstrate that this action is not reversible, an in vitro study may be used. The safety of the degradation products must be demonstrated. Studies need to be undertaken in farm-scale commercial feed manufacturing and should meet expected Canadian environmental conditions.
• To fully demonstrate the efficacy of the MDA for modes of action, other than via degradation as described in the previous bullet, in vivo studies most accurately allow for the validation of the intended effect in the animal. For these studies:
  • A minimum of 3 complete in vivo studies per target livestock species must be presented in support of product efficacy for each target mycotoxin.
  • For products intended to be used in feeds for all livestock species, excluding fish, at least one study per each of the 3 representative major digestive systems in livestock production (that is, poultry, non-ruminant mammal (swine) and ruminant species) must be provided.
  • For products intended for use in fish feeds, 3 studies performed in salmonids or relevant species are required.
• If the product is intended for use at various inclusion rates, the in vivo studies showing significant effects at the lowest recommended rate are included.
• All studies are performed with the final product(s) for which registration is sought with consideration of the feed matrix.
• Studies should measure relevant bio-markers as endpoints such as mycotoxin or mycotoxin metabolite excretion in feces or urine, or concentration in peripheral circulation (plasma, blood, and serum), animal products or tissues.
  • While animal performance end-points are not considered acceptable as indicators of MDA efficacy impacts on performance should be measured and reported in the study.
• A significant difference (p≤0.05) in the relevant biomarkers between the control and treatment groups is demonstrated.

Where the results of these studies have not been published in the peer-reviewed literature, complete copies of the raw data and complete printouts of the statistical analysis are required for review.

1.4.2 Product stability and shelf life

To support product stability and the shelf life as stated on a product label, it will be necessary to:

• Demonstrate maintenance/stability of the MDA activity over the specified shelf life of the product.
  • If an active ingredient/substance has been identified, verify the stability of the specific MDA mode of action. For example:
    • for MDAs that act by binding, the stability of the binding capacity.
    • for enzyme based MDAs, the stability of the enzyme activity.
    • for chemical based MDAs, the stability of the chemical.
  • If no specific active ingredient can be measured then the default would be the demonstration of maintained efficacy (that is, another efficacy study after the MDA has been stored).
• If the MDA treated feeds are meant to be stored prior to their use, the applicant must demonstrate that the MDA treated feed remains stable (that is, the bound, degraded, or modified form is stable) throughout the proposed storage time and conditions of the MDA treated feed.
• Submit certificates of analysis for the active ingredient(s) or substance(s) to substantiate the guaranteed shelf life. In other words, at the date of manufacture and the expiry date.
  • A minimum of 3 different lots of the product.
  • CoAs for the level/concentration/activity of the active ingredient(s) or substance(s) or binding capacity at the date of manufacture and at the expiry date must be for the same lot of product.
  • Storage conditions used in the shelf life study must reflect the recommended storage conditions as stated on the product label.

1.4.3 Product stability in pelleted feeds

Provide evidence to demonstrate that the activity of the MDA is not reduced during feed processing, for example, it is heat stable following pelleting. If the MDA is mixed into feed which is then pelleted original, signed CoAs for the active(s) for 3 pre- and post-pelleting samples of the feed are required in support of the product stability. The data must demonstrate that pelleting does not reduce the detoxifying capacity of the MDA. The pelleting conditions used in the pelleting study must reflect the conditions recommended on the label.

If CoAs are not provided, one or more of the following statements will be required on the label:

• "Do not pellet." Or
• "Apply post-pelleting." Or
• "Pelleting may negatively affect the effectiveness of this product."

1.5 Requirements in support of product safety

In cases where approved ingredients (as listed in Schedule IV and V) are used as MDAs, safety may have already been substantiated for the ingredient during the approval process and may not require the submission of new safety studies. If the MDA product is a new single ingredient, or is used at rates exceeding that for the previously approved purpose, a safety assessment will require the submission of data as outlined in RG-1, Chapter 2 - data requirements for single ingredient approval and feed registration:

• 2.4 generic data requirements for safety evaluations of single ingredients
• 2.5 data requirements for product safety evaluations: explanatory notes.

The following specific information must be provided for all MDA products.

1.5.1 Production of new metabolites and breakdown products

If the mode of action of the MDA involves the modification of the mycotoxin through its degradation or metabolism, the production of new metabolites or breakdown products may result in chemicals which are more toxic than the parent compound.

• The presence of any metabolites and breakdown products must be determined, and an assessment of their inherent toxicity to animals, humans and the environment must be evaluated.
  • Combined effects of both the MDA and any metabolites must be considered in this analysis.
• The transfer to resulting foods of animal origin must be considered and discussed; metabolic fate and residue studies may be required.
• If the toxicity of the new metabolite or breakdown product is unknown, toxicity assays may be required to evaluate their safety.

1.5.2 Potential for interactions

As the mode of action of many MDAs involves the direct binding of the mycotoxin, there exists the potential for the product to affect other constituents in the feed, such as nutrients and veterinary drugs. A consideration of the MDAs ability to reduce the availability of key nutrients and medications must be included in the submission and scientific data may be required.

Which nutrients and veterinary drugs to consider should be based on the feed matrix and the MDA product. Applicants should be aware of how components of the target feed could interact with their particular product.

Part 2: Amendments to registrations of MDAs

Registrants wishing to make a change to the formula or label of a registered product must submit an application for a Registration Amendment (significant change/re-registration) to the CFIA (Category 2 submission). General administrative information regarding application procedures for amendments to feed registrations can be found in RG-1 - Chapter 1 - administrative requirements for pre-market assessment and product registration of livestock feed.

Significant changes may include, but are not limited to, changes to:

• label guarantees
• product formulation
• manufacturing process
• label claims
• directions for use and/or application rates
• shelf life of the product
• ingredient stability (heat or pelleting stability)

Data requirements for significant changes to MDAs will be dependent on the changes being requested and would be evaluated on a case-by-case basis. For more information on data requirements for amendments to registrations, refer to RG-1, Chapter 2.2 registration requirements for specialty products.

Part 3: Renewal of registrations of MDAs

General administrative information regarding the application procedures for renewals of feed registrations can be found in RG-1, Chapter 1 "administrative requirements for pre-market assessment and product registration of livestock feed".

Specific information is found in the attached checklist.

Please note that additional information may be requested at the time of renewal if safety or efficacy questions emerge after the original registration.

Changes made to the formulation or to the product label (for example, claims, purpose, directions for use, target livestock species feeds, etc.) are considered to be significant changes to existing registrations. An application for renewal with a significant change would be required.

Submission checklist for Mycotoxin Detoxification Agents (MDAs) feed application:

• Printable checklist - PDF (339 kb)

The completed checklist, for Mycotoxin Detoxification Agents (MDAs) submissions, must be included with each application for feed registration. Submissions received without a completed checklist will not be accepted.

Indicate the submission page number corresponding to each item in the checklist; if the item does not apply, a written justification must still be provided.

1.1 Administrative requirements for each product

Required information: RG-1 Chapter 1: Administrative requirements for registration and approval of livestock feeds

• Application for Feed Registration and Renewal: Form Available – 1.3.1 Application for feed registration and renewal (CFIA/ACIA 0009)
• Total application fees (cheque, money order, Visa, MasterCard, or American Express payable in Canadian Funds): RG-1 Chapter 1: Appendix A for application fees
• For a new company or an existing company requiring changes to the signing authority list, include supporting documentation on establishing a company file and signing authority.
• For a new applicant residing outside of Canada or an existing company requiring changes to the Resident Canadian Agent, include supporting documentation and a declaration of Resident Canadian Agent (CFIA/ACIA 1194).
• Cover letter and summary of the documentation included with the application, with the email address of the contact person clearly identified.

1.2 Labelling

• Proposed Labels including all required information as per Section 1.2.

1.3 Product identification and description

For products with deficiencies previously identified by the CFIA, attach the reference number of the return letter or letter of rejection of the application and explain how you have addressed the rejection points in the new submission.

• Complete product identification and description as per Section 1.3.1.
• Specify target mycotoxins and intended livestock species.
• For an unapproved ingredient, information as per RG-1, Chapter 2.3.
• Detailed product formulation (either on a weight for weight basis or as a percentage composition):
  • list the amount of each ingredient by generic name as per Schedule IV or V of the Feeds Regulations
  • include registration numbers for Part II ingredients or mixed feeds
• Note: The source of all single ingredients listed in Schedule IV Part II must be approved and registered by CFIA prior to being used in the mixed feed.
• For new ingredients, provide a detailed written description of the manufacturing process. A production flow diagram is also recommended.
• Certifications of analysis (original and signed) from 3 different and recent lots of product to support the proposed label guarantees for each active ingredient.
• Analytical methodology used to support the proposed label guarantees for each active ingredient, as above.
• Product samples if required. The sample will be used to validate the analytical method by the CFIA laboratory.
• Keep a 500 g sample of the final product in stock. When the application is accepted, you will be contacted to send the sample directly to the CFIA laboratory.

1.4 Requirements in support of product claims and other information

• Acceptable studies in support of claims. Address all design considerations as listed in section 1.4.1.
• Certificates of analysis and analytical methodology for studies used to support the proposed label claim.
• Demonstration in support of product stability and shelf life for the maintenance of the mycotoxin detoxification effects as defined in section 1.4.2.
• Certificates of analysis (original and signed) for 3 recent and different lots of production of the final product to support the stability and shelf life as above. These must include 3 certificates of analysis at the beginning of the shelf life period and 3 certificates of analysis from the same 3 lots of the product at the end of the desired storage period. The 3 lot samples must be kept in similar storage conditions up to the proposed expiry date.
• The analytical methodology/instrumentation used for the above analyses must be included on the certificates.
• Evidence to demonstrate the activity of the MDAs is not impacted during feed processing as defined in section 1.4.3. This should include certificates of analysis (original and signed) for a minimum of 3 different lots of product.
• If certificates of analysis are not provided, required statements added to label as per section 1.4.3.

1.5 Data requirements in support of safety

• Description and data demonstrating the safety of the feed as noted in section 1.5. This is required for new ingredients or for a new purpose of an existing ingredient.
• If the mode of action results in any new metabolites or breakdown products, the safety of these must be demonstrated. Evidence provided as per section 1.5.1.
• Scientific evidence demonstrating that the MDA does not reduce the availability of key nutrients and medications in the feed. See section 1.5.2.

Part 4: Renewals of feed registration

If there is a change to the product at renewal, use this checklist to describe the changes as applicable.

If there is no change to the product, use the checklist for renewals available in the RG1- Chapter 1 at Appendix B – Checklist for renewals

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3.29 Acid based products

Registration Checklist for Acidifiers

Administrative Registration Requirements

• Completed application package per Chapter 1

Proposed Label

• Brand name (optional)
• Product name reflecting purpose of the product and the intended species
• Product claim statement
• Guaranteed analysis (major active ingredient(s))
  
• Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds as required
• Directions for use to permit safe and effective use of feed
• Caution and/or warning statements (if applicable)
• Name and address of registrant
• Net amount (metric measure)
• Registration number (to be added)

Product Composition

• Formulation / percentage composition listing amount of each ingredient by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds
• Formulation / Ingredients - verify level of ingredients does not exceed maximums per Schedules IV and V.

Scientific Studies

• Scientific studies are required to support the intended purpose of these products
• Studies carried out by qualified personnel
• Suitable methods used in studies
• Studies designed to facilitate statistical analysis
• Data analysed by appropriate statistical methods
• Studies conducted under conditions similar to those that may be expected to occur in Canada
• Scientific investigations show that the products when used as directed, significantly reduced the pH of feeds for each species/class for which they are intended. Where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate the lowest inclusion rate.
• Studies show a significant difference (P<0.05) between the control and treated groups
• Where results of these studies have not been published in a refereed journal, copies of the raw data and printouts of statistical analysis are required for our review.

Lab Methods

• Original signed copies of Certificate of analysis for a minimum of 3 lots of these products supporting label guarantees for the primary acidifying ingredients.
• Information on the methodologies used to analyse the acid levels e.g. a copy of the AOAC International or other official method is required. In the event that these methods have not been peer-reviewed, additional information is required to validate the laboratory method as outlined in section 6.2
• Analytical methodology substantiating the guarantee(s) (e.g. novel guarantee or method) - provided for CFIA Laboratories

Sample

• Provided (if necessary to validate lab methodology)

Promotional Claims (including Internet and Advertising)

• Consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

3.30 Guidelines for incidental feed additive (IFA) data review applications

1. Purpose

These guidelines have been prepared to assist manufacturers in preparing data review applications for incidental feed additive (IFA) products intended for use in establishments where livestock feeds are manufactured.

2. Introduction

While not defined under the Feeds Act or regulations, IFAs are any substance, not including apparatus or utensils, and not consumed as a feed ingredient by itself, intentionally used in the processing of materials, feed or feed ingredient, to fulfil a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the feed ingredient or its ingredient market formulation, provided that these residues and derivatives do not have an adverse effect on animal health, human health or the environment.  IFAs have no nutritional or technical function in single ingredient feeds (SIFs) or mixed feeds. 

Some examples of IFAs include:

• boiler chemicals where the steam comes in contact with livestock feeds, including steam used in pelleting
• substances used in the production of SIFs.  For example, the antimicrobial agents, enzymes, yeasts and chemicals used in industrial ethanol production where the distillers' grains by-products from the production process are then used as SIFs. (see RG-6 Regulatory Guidance: ethanol distillers' grains for livestock feed)
• water treatment chemicals used in feed manufacturing and food processing plants to recover solids, when the recovered solids are then used as raw materials to produce SIFs
• denaturants and dyes used for marking inedible and prohibited materials in meat processing and rendering

This guidance covers all establishments manufacturing livestock feeds, including feed mills manufacturing mixed feeds, single ingredient feed manufacturers, and where SIFs are manufactured as a secondary product, coproduct or by-product. During compliance verification, feed manufacturers are responsible for demonstrating to CFIA inspectors that substances used in their establishments are safe. This is an essential part of good manufacturing practices to prevent the contamination of livestock feeds.

There are no sections of the Feeds Act and regulations, which specifically require the approval of IFAs for use during feed manufacturing. However, their misuse could result in the contamination of livestock feeds, thereby creating a potential animal or human health risk.  Such an action would be considered to be in violation of:

• Section 3(3) of the Feeds Act, which states, "No person shall manufacture, sell, import or export in contravention of the regulations any feed that presents a risk of harm to human or animal health or the environment"
• Sections 19(1)(j) and (k) of the Feeds Regulations which state: "a feed shall not contain:
  • (j) any material in quantities that could, when fed in proportions commonly used or as specified in the feeding directions, result in the production of an article of food that is prohibited from sale by virtue of section 4 of the Food and Drugs Act
  • (k) any material, other than those referred to in paragraphs (a) to (j), in quantities likely to be deleterious to livestock, when fed in proportions commonly used or as specified in the feeding directions"

Under the authority of the provisions of Section 3(3) of the Feeds Act and 19(1)(j) and (k) of the Feeds Regulations, and with the express intent of assisting feed manufacturers in averting violations thereof, the CFIA evaluates, on a case-by-case basis, the acceptability of various IFA products voluntarily submitted by manufacturers wishing to supply their products to feed manufacturers. Requests for such evaluations are called applications for data review, and the letters expressing favourable opinions are called "Letter Of No-Objection (LONO)".  The product manufacturers may then present these to prospective feed manufacturer customers in support of a letter of guarantee to be included in a preventive control plan. There is no fee attached to obtaining a LONO for an IFA.

A LONO does not constitute an approval of the product under the Feeds Act and regulations. It is simply an opinion expressed by the CFIA on the acceptability of the product, based on the information available at the time of its evaluation. Issuance of a LONO does not relieve the product user (that is, feed manufacturer) from their responsibilities relating to Section 3(3) of the Feeds Act or 19(1)(j) and (k) of the Feeds Regulations.

A LONO has no expiry date. It is considered valid as long as the composition, the intended use and the labelling content remain as described in the initial data review application. Applicants are responsible for notifying the CFIA of any changes that may affect the validity of the no objection status. The CFIA reserves the right to withdraw the no objection status of any given product should information come available showing that its use may potentially pose a risk to human health, animal health, or the environment.

3. Information requirements for IFA submissions

In order to evaluate the safety of the use of IFA products in feed manufacturing establishments, the CFIA requires that applicants submit the following information. These are initial requirements only. Evaluation of submitted information will dictate if any clarification or additional information is required. Third-party information or data on a particular ingredient in the IFA that is not made available to the applicant can be forwarded directly by the third-party to the CFIA. All such information is held in confidence and is used for evaluation purposes only.

3.1 Administrative requirements

• Submit the application package for data review - incidental feed additive as per section 1.3.1 My CFIA online livestock feed applications of RG-1 Chapter 1
• Checklist (included in Appendix 1)

3.2 Labelling guide for IFA products used in feed manufacturing establishments

The proposed label should include the following information:

• brand name (optional)
• descriptive name of the product and a statement denoting the function and specific intended use of the product in establishments manufacturing livestock feeds
• a listing of the major ingredients, (active and non-active)
• the physical state of the product (for example, liquid, powder, spray, aerosol)
• directions for the use of the IFA for the intended purpose, including:
  • the use(s) of the product in feed establishments
  • dilution factor(s) (for example,  millilitre (mL) of the product per litre (L) of water)
  • a potable water rinse (if applicable)
  • the amount of contact time with surfaces under treatment
    • Type of surfaces (for example, non-porous, porous, feed contact surfaces, floors, etc.), where applicable
    • A statement such as, (This product is to be used as recommended by a responsible company representative", and any caution or warning statements necessary to avoid contamination of livestock feed as follows: "Avoid contamination of livestock feed during application and storage)
• other caution and warning statements (if applicable)
• name and address of the manufacturer or distributor
• net content - metric units required (other units optional)
• shelf life of the product
• date of manufacture

3.3 IFA product composition

Full disclosure of the product's formulation, including chemical and microbial (if applicable) ingredients, is required. The formulations are held in strict confidence. This information should be in the form of a complete quantitative list of all ingredients used in its manufacture (pre-reaction formula) and in the final product's formulation (post-reaction formula, where applicable), taking into account that the percentage of components of the full formulation should add up to 100%.

• each chemical ingredient should be clearly identified by its proper chemical name, the Chemical Abstracts Service (CAS) registry number, trade or brand name and supplier
• if the IFA contains a polymer, the residual monomer concentration must be determined and the specification provided
• for microbiologically derived IFAs (for example, viable or non-viable microbes and enzymes)
  • Each microorganism and microorganism source must be identified by the scientific name of organism or production organism )that is, Genus species), source or origin, and designation of the strain
  • Characterization of the microbial product should be as per Section 2 of RG-1 Chapter 2.7 – Guidelines for the assessment of novel feeds: microbial sources

3.4 Use of the IFA and processing conditions resulting in incidental contact with livestock feeds

Provide details of the intended end-use and technical function of the IFA product, indicating that there is incidental contact in the manufacture of livestock feeds. Identify the SIFS or mixed feed into which the IFA may result in a residue from its use.  Describe the use of the IFA, including:

• A detailed flow chart and written description of the feed manufacturing process indicating where and the quantities of the IFA that are applied in the process
• Information on the stability of the IFA during the process, including considerations of thermal stability, etc.
• For microbial or enzyme-based IFAs, a definitive kill or inactivation step(s) must be included since IFAs must not contribute viable microorganisms, active enzymes, antimicrobial activity or resistance determinants to livestock feeds.

Given the product formulation, its use in livestock feed manufacturing, and where applicable, the stability of the IFA, provide estimates of the concentration of the IFA, its components, impurities and breakdown products in livestock feed. Where appropriate, calculations must incorporate a mass balance with concentrations and/or dilution factors.  Any reductions in exposure related to the stability or partitioning of an IFA or the killing or inactivation of a microbial or enzymatic IFA should be accompanied by a clear description and empirical data.

3.5 Livestock exposure estimates to IFA residuals

Provide estimates of livestock intake of IFA residuals in livestock feeds resulting from the use of the product. This information should be in the form of actual analytical data or theoretical estimates based on the proposed use of the IFA product and resulting livestock feeds.

3.6 Data for safety review

Data must be sufficient to demonstrate the safety of the IFA under the proposed conditions of use related to the safety of the livestock feed. Safety must be considered for all livestock species of the intended use of the livestock feed. The submission for new formulations or uses that significantly increase potential exposures should include all unpublished and published studies relevant to the safety assessment of the IFA when used under the same conditions or, if not, would still allow conclusions on the IFA under application to be made.

• In the case of unpublished studies, full reports complete with the primary data should be included with the submission, when available
• Sufficient details should also be provided to ascertain that study protocols conform with published testing guidelines such as those by the Organization for Economic Co-operation and Development (OECD). Studies conducted according to good laboratory practices are preferred

Toxicological data: In the case of chemical IFAs, the toxicity of the IFA and/or its components must be characterized. For an IFA with a fundamentally toxic mode of action such as sanitizers and disinfectants, a complete set of toxicological studies would normally be required, unless the formulation in question has been previously assessed by Health Canada.

• This could include acute, repeated-dose and chronic oral toxicity/carcinogenicity studies, reproductive and developmental toxicity studies, and genotoxicity studies. Additional studies on metabolism and pharmacokinetics  or to examine specific types of toxic effects may also be required to complete the safety assessment

Microbiological data: In the case of IFAs composed of or derived from microorganisms, data are required to characterize the components and support safety.  Since IFAs cannot have an effect on or in the livestock feed, they must not contribute viable microorganisms, active enzymes, or antimicrobial activity to livestock feeds.

While IFAs are not considered livestock feed, applicants of formulations containing microbiologically derived ingredients must characterize the animal and human safety components in Section 4 of RG-1 Chapter 2.7 - Guidelines for the assessment of novel feeds: microbial sources

3.7 Approvals in other jurisdictions or other additional information

The regulatory references of compliance with other government departments or other certification bodies may be useful but in of themselves are not sufficient for assessment purposes.

Health Canada's Bureau of Chemical Safety, the Pest Management Regulatory Agency (PMRA), Veterinary Drugs Directorate, Environment and Climate Change Canada, U.S. Code of Federal Regulations (Title 21 CFR), the European Union (EU) Regulations on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Domestic Substances List (DSL), Food Contact Premarket Notification (FCN), or Material Safety Data Sheets (SDS).

Some examples of references to chemical and microbial listings that may be relevant to a submission include:

Chemical:

1. Approved as a SIF listed in the Feeds Regulations (Schedule IV or V), which is available upon request from the CFIA;
2. In compliance with the Food and Drug Regulations
   • listed in the Food and Drug Regulations, Division 16
   • the subject of a "letter of no objection" from Health Canada for contact with food, or
   • the subject of an Interim Marketing Authorization from Health Canada for use in food
3. Listed in the "Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products Database" with approval that includes food contact;
4. Listed in the U.S. Code of Federal Regulations, Title 21, by the U.S. Food and Drug Administration (FDA), specifically:
   • those listed in Part 573 of Title 21, for the same purpose indicated in the CFR
   • those listed in other parts of Title 21, where the Center for Veterinary Medicine (CVM) has given a letter permitting their use in feed
   • those listed in Part 584 of Title 21, whose Generally Recognized As Safe (GRAS) status has been affirmed in writing by the FDA
   • those listed in Part 582 of Title 21, which the FDA has listed as GRAS based on the history of safe use in food or feed

Microbial:

1. Registered sources of SIFs listed in the Feeds Regulations (Schedule IV, Part II), which is available upon request from the CFIA
2. In compliance with the Food and Drug Regulations
   • considered to be a food additive and listed in the Food and Drug Regulations, Division 16
   • considered to be a food, but not considered to be a novel food (as per Division 28 of the Food and Drug Regulations)
3. Considered to be a novel food as per Division 28, and have received a "no objection letter/opinion" for use in food
4. Considered to be a food additive and the subject of an Interim Marketing Authorization from Health Canada for use in food
5. An enzyme that is considered to be a processing aid, and that is the subject of a "letter of opinion" issued by Health Canada
6. In compliance with the New Substance Notification Regulations (Chemicals and Polymers, and Organisms)
   •  enzymes and Saccharomyces cerevisiae strains listed in the Domestic Substances List (DSL) of the Canadian Environmental Protection Act
7. Listed in the U.S. Code of Federal Regulations, Title 21, by the U.S. Food and Drug Administration (FDA) and used for the same purpose indicated, specifically:
   • those listed in Part 573 of Title 21
   • those listed in other parts of Title 21, where the Center for Veterinary Medicine (CVM) has given a letter permitting their use in feed
   • those listed in Part 584 of Title 21, whose Generally Recognized As Safe (GRAS) status has been affirmed in writing by the FDA
   • those listed in Part 582 of Title 21, which the FDA has listed as GRAS based on the history of safe use in food or feed

The CFIA does not consider those additives whose GRAS status has been determined based on self-affirmation and has not been formally evaluated or confirmed by the FDA as being acceptable.

Note: Further information may be required after review of the preliminary submission. Valid scientific rationale may be provided in place of data requirements.

Appendix 1: Incidental Feed Additive (IFA) application checklist:

3.1 Administrative requirements

3.2 Labelling guide for IFA products used in feed establishments

3.3 IFA product composition

3.4 Use of the IFA and processing conditions resulting in Incidental contact with livestock feeds

3.5 Livestock exposure estimates to IFA residuals

3.6 Data for safety review

3.7 Approvals in other jurisdictions or other additional information

3.31 Registration requirements for gut modifier products

• Background
• Regulatory status
• Approval and registration process steps for gut modifier – ingredients versus products
• Identification of the gut modifier ingredient(s)
• Registration of a gut modifier specialty product with claims

Background

Gut modifiers as livestock feed are products that, once fed, have a mode of action in the gastrointestinal (GI) tract of an animal.  They achieve this by acting on the feed itself while in the gut or by modifying the GI environment to provide a benefit to the animal or the environment as may be linked to a nutritional effect.

The gut modifier category can encompass a variety of feed ingredients, including new feed ingredients and new purposes for existing approved ingredients^Footnote 8. These ingredient types (sub-categories) may include, but are not limited to:

• viable microbial strains
• prebiotics
• postbiotics
• enzymes
• organic acids
• essential oils

Note that gut modifier products may be regulated as a veterinary drug or a feed depending on a number of criteria as described in the Guidance document on classification of veterinary drugs and livestock feeds. The document provides guidance, criteria and examples to help clarify the regulatory differences between veterinary drugs and feeds, and assists in determining the appropriate regulatory oversight for a product destined for oral use in livestock species.

Gut modifier products that directly target the reduction of  pathogens or aid in the treatment or mitigation of disease in the animal are considered to be veterinary drugs.

Regulatory status

The gut modifier category can be applied to ingredients (single ingredient feeds) or mixed feeds (specialty feeds). Approved ingredients must be categorized as a gut modifier.  As specialty products do not meet the exemption from registration criteria, as outlined in Section 5(2) of the Feeds Regulations, these must be registered by the Canadian Food Inspection Agency (CFIA) before their manufacture, sale or import in Canada.

The following section clarifies the overall process for approval of an ingredient as a gut modifier ingredient and the registration of a gut modifier specialty product.

Approval and registration process steps for gut modifier – ingredients versus products

Step 1 – Categorization of a gut modifier ingredient

A gut modifier ingredient is an active ingredient (for example, thymol) or source of an active ingredient (Yucca schidigera pulp powder) that, when fed, exhibits a mode of action in or on the gastrointestinal tract. Once an ingredient is approved as a gut modifier, it will be listed in Schedule IV indicating its approval as an ingredient for use as a component in a gut modifier product.

Note: a claim is not needed at the ingredient categorization step; however, an applicant may provide data to support a claim on the ingredient itself, as discussed below.

Step 2 – Registration of a gut modifier product with claims

Gut modifier products may be a single ingredient feed from the gut modifier category or a mixed feed containing 1 or more gut modifying ingredients (that is, as actives) and other non-active ingredients. 

Note that in some situations, an active ingredient from the gut modifier category may also be considered for registration as a single ingredient feed, as described below.

If an ingredient is to be used as a gut modifier product on its own, a company must supply data to support the gut modifier mode of action (as indicated in step 1) with a claim(s) for the ingredient alone. This ingredient could then be added to a mixed feed as a gut modifier on its own merit. In effect, this blends step 1 and step 2. The ingredient must meet the specifications as listed in the ingredient description and be used according to the approved directions for use (for example, rates of incorporation for the species/classes of livestock). This ingredient would receive a registration number.

For either situation,  a gut modifier product must be registered with claims supported by data demonstrating either:

• typical production/performance effects
• gut modifying effects, or
• a mixture of both

Note: 2 distinct applications can be submitted at the same time for step 1 and 2.

Identification of the gut modifier ingredient(s)

A gut modifier product must contain 1 or more identified active ingredient(s) that have been classified as gut modifier ingredients in Schedule IV.

The ingredient(s) that is (are) providing the gut modifier effect in a product must be identified as the active ingredient(s). There are 3 pathways for having an ingredient identified as a gut modifier.

1. If the ingredient is already listed in Schedule IV in the gut modifier sub-class, there is no need to request any further action. The ingredient must meet the specifications as listed in the ingredient description, be used according to any listed directions and meet all labelling requirements.
2. If the ingredient is an approved ingredient but not identified as a gut modifier in Schedule IV, a request to add a gut modifier purpose, with data to support a gut modifier mode of action, is required. If the intended use rate for gut modification exceeds a limit existing for the ingredient or is for a different species, safety data is required to modify the maximum levels and species/classes.
3. If the ingredient is not listed in Schedule IV or V, the ingredient is considered to be an unapproved ingredient, and a request for approval with a separate application is required. A safety assessment will be required along with information to support the gut modifier mode of action. The submission should follow the established route of submitting an application as per RG-1, Chapter 2 - 2.3 Single ingredient feed evaluation requirements.

A minimum of 1 study to demonstrate a gut modification effect must be provided for the ingredient from in-house research or scientific literature. Research should demonstrate that a mode of action is in the gut.

Studies may be either in vitro and/or in vivo. Some endpoints, such as gut integrity and microbiome, may be better supported with in vivo studies. In vitro studies are useful for providing data for mechanistic data with consideration of the species, feeding rates, and duration of feeding.

The studies do not have to be from an applicant's proprietary product; however, each study must clearly link to the ingredient which is the subject of the submission. Where published peer-reviewed studies are provided to support an application, bridging information must be provided to show the relevance of published studies to the application under review. The identity of the active gut modifier ingredient(s) in the studies should be demonstrated as being relevant to the submitted ingredient(s). Guidance may be found in the RG-1 Chapter 2.8 Guidance on bridging an application to data from publicly available literature and previously approved feed applications.

Note that data to support a specific claim is not necessary to have an ingredient approved and classified as a gut modifier in Schedule IV. The ingredient may only be used as a "component of a gut modifier" specialty product that will require registration with supported claims as described below.

Registration of a gut modifier specialty product with claims

This section is divided into the following 3 parts:

• Part 1 – Registration requirements for new gut modifier products
• Part 2 – Amendments to registrations of gut modifiers
• Part 3 – Renewal of registrations of gut modifiers

It is recommended that the data requirements outlined below be carefully reviewed and followed prior to submitting an application for feed registration to the CFIA.

After reviewing all documents, if specific questions on requirements remain, please contact the CFIA by email at: cfia.afp-paa.acia@inspection.gc.ca.

Part 1: Registration requirements for new gut modifiers

1.1 Administrative requirements

• Submit the application package for registration or approval as per section1.3.1 My CFIA online livestock feed applications of RG-1 Chapter 1
• For each application, data must be submitted with your application via My CFIA
  • Upload the following supporting documents in My CFIA at the appropriate section during the application process

If you are unable to sign up for My CFIA, refer to how to apply by mail.

1.2 Labelling

Proposed labels for gut modifiers must include the following, in addition to standard labelling requirements listed in RG-1, Chapter 4.1 – Labelling and guarantees - Labelling of livestock feed:

• product name
• the feed name on the label can include "gut modifier"
• complete list of ingredients
• a minimum guarantee for each of the active ingredients in the gut modifier product
• target livestock species and feed type
• directions for use and applicable use rates in line with the proposed claims on the label of the gut modifier
• proposed claim for the gut modification or effects in the gut and/or for animal performance (for example, may improve growth rate in pigs) when used or fed as directed
• date of manufacture
• shelf life
• recommended storage conditions to maintain activity until the expiration date

1.3 Product identification and description

1.3.1 General information

• short description  explaining the purpose of the product for registration
• identification of the gut modifier active ingredient(s) in the product (see Identification of the gut modifier ingredient(s) above) summary of documentation/information included with the application
• supportive information about approvals in other jurisdictions may be provided
• directions for use
• target livestock feeds
• proposed product claim(s)
• proposed shelf-life
• detailed product formulation and a complete list of ingredients identified by generic name as listed in the Schedules of the Feeds Regulations, and registration number for ingredients listed in Part II of the Schedules, or mixed feeds
• if the product is, or contains, an unapproved ingredient, additional information as per RG-1, Chapter 2 - 2.3 Single ingredient feed evaluation requirements

1.3.2 Analytical information

• certificates of analysis from 3 different and recent lots of the product to support claims, labelled guaranteed analysis and shelf-life stability
• analytical methodology used to substantiate the label guarantee(s) (if an accredited method is used, providing the reference name of the method will be acceptable)
• product sample or samples may be required to verify analytical methodologies and/or label guarantees
  • Samples will be requested on a case-by-case basis

Further guidance may be found in RG 6.4 – Guidance of the acceptability and preparation of certificates of analysis for livestock feed applications  and the International Cooperation for Convergence of Technical Requirements for the Assessment of Feed Ingredients (ICCF) Guidance on Stability testing of Feed Ingredients, Guidance on Stability testing of feed ingredients.

1.4 Requirements in support of product claims and other information

General criteria for acceptable scientific studies are outlined in RG-1, Chapter 2.2 - Registration requirements for specialty products

1.4.1 Studies in support of claims for gut modifier products

Gut modifier products are specialty feeds that must have claims and require registration. They may be a single ingredient feed from the gut modifier category or a mixed feed containing one or more gut modifying ingredients (that is, active and non-active ingredients). Claims are applied in either situation. Data to be submitted must support claims when the product is used or fed as directed on the label. Studies should be based on the final product(s) for which registration is sought.

Where the results of these studies have not been published in a peer-reviewed journal, raw data and statistical analyses must be submitted in their entirety for review.

A minimum of 3 studies are required to demonstrate the product's efficacy for each effect when fed as directed per the target livestock species and may include the production class if the claim necessitates that specification. Due to the potential for very different claims associated with gut modifier products, it is not possible to prescribe one specific set of requirements to support this category.

1.4.1.1 Studies for production and performance based claims

As gut modifier products are known to exhibit variable results in vivo, it will be necessary to submit 3 studies per species and production class. In this case, general production and performance claims may be supported by a combination of more than one endpoint exhibiting beneficial results per study. Beneficial effects can include improved growth, feed intake, weight gain or feed efficiency. More detail on flexibilities to the number and types of production performance studies is outlined in the RG-1 Chapter 2.9 Data flexibility for production performance endpoints and associated claims.

Note that the number of independent in vivo efficacy studies required depends on the number of target species/categories for which the application is made and the claims to be supported. Extrapolation of efficacy data from certain species to other physiologically related species is possible as, in principle, data can be extrapolated between physiologically similar species. The degree to which species are physiologically related is judged predominantly in terms of gastrointestinal function. Similarities in metabolism may also be considered. The interspecies extrapolation, however, can be applied only in case the animals are kept for the same purpose, that is, meat production or reproduction (including milk or egg production), the mode of action can reasonably be presumed to be the same between species and the effects claimed are the same. More detail on flexibilities to the number and types of production performance studies is outlined in the RG-1 Chapter 2.9 Data flexibility for production performance endpoints and associated claims.

1.4.1.2 Studies to support gut modification based claims

A minimum of 3 studies per species and production class are required to support a desired gut modification based claim. Studies must include at least one in vivo study and may also include in vitro studies. If an outcome is strongly correlated, such as, for example, an organic acid response in the microvilli, the number of required studies may be reduced if supported by a scientific rationale.

In some cases, in vitro models with robust data sets that have been repeatedly shown to have validity in vivo could be considered in support of claims.

Some considerations for studies include:

• Validated in vitro models could support the reduction of in vivo requirements
• In vitro models should be published and peer-reviewed
• Meta-analysis studies could be useful for these types of modes of action, but more details will be needed when using them to replace a distinct study

Depending on the mode of action and claim, it is clear that certain extrapolations across species may be made to reduce the number of trials in cases where a supported scientific rationale is provided.

While extrapolations from ruminant to ruminant or monogastric to monogastric animals could be indicated, extrapolations from ruminants to monogastric species may not be. Extrapolation from monogastrics to classes of ruminant livestock during the pre-rumination period may be considered. An example would be a gut modification effect that increases the surface area of microvilli in small intestine models.

In most cases, dosages would need to be species-specific and will depend on body weight, age, feed intake, etc. This is especially true for ruminants when trying to compare feeding rates from g per head per day (g/h/d) to kg/tonne of feed. In other words, this would not be different than for traditional performance/production type claims.

Treatments in vitro should be relevant to feed inclusion rates and species. In vitro studies could be considered; however, it may be difficult to extrapolate an in vitro treatment to an as-fed dosage or inclusion rate as would be indicated on the label.

1.4.2 Product stability and shelf life

For certain gut modifier product types, it will be necessary to support product stability and shelf life as stated on the product label. Typically, products which are protein-based can degrade when exposed to environmental conditions; these include enzymes, microbial strains, fermentation products, extracts and oils, and chelated products. It will be important to identify the active ingredient(s) and determine if one of the ingredient types listed above applies. The stability of these actives should be assessed accordingly.

The ICCF Guidance on stability testing of feed ingredients provides very detailed guidance on studies; however, the following are the minimal requirements to demonstrate maintenance of the claim over the specified shelf life.

Accelerated stability studies may be acceptable. Details are provided in a VICH guidance document as discussed here Stability: Stability testing of new veterinary drug substances (revision) (PDF)

1.4.2.1 Product stability in pelleted feeds

Likewise, a consideration that those actives identified above are not impacted following heat treatment during pelleting should be given. Pelleting studies must reflect the conditions recommended on the label.

1.5 Requirements in support of product safety

In cases where approved ingredients are already listed in the Schedules of the Feed Regulations, safety may have already been substantiated for the ingredient itself during the original approval process and may not require the submission of new safety studies to support the new purpose as a gut modifier.  If, however, the ingredient is a new ingredient, or its use has changed based on inclusion rates, duration of feeding, or species, a safety assessment will be required with the submission of data as outlined in:

• RG-1, Chapter 2 - Data requirements for single ingredient approval and feed registration
  • 2.4 Generic data requirements for safety evaluations of single ingredients
  • 2.5 Data requirements for product safety evaluations: Explanatory notes
  • 2.7 Guidelines for the assessment of novel feeds: microbial sources
• RG-1, Chapter 3.22 – Viable microbials and yeasts

Part 2: Amendments to registrations of gut modifiers

Registrants wishing to make a change to the formula or label of a registered product must submit an application package for an amendment to registration or approval as per section 1.3.1 My CFIA online livestock feed applications of RG-1 Chapter 1.

Data requirements for the changes are dependent on the type of changes being requested. Refer to the data requirements for that type of feed. Submit the documents in support of the changes with your application via My CFIA. Upload the supporting documents in My CFIA at the appropriate section during the application process.

Each change made to an existing registration must be detailed in the box Requested changes on the last application page review and submit.

Part 3: Renewal of registrations of gut modifiers

You must submit an application package before the expiry date for renewal to registration or approval as per section 1.3.1 My CFIA online livestock feed applications of RG-1 Chapter 1.

If your registration has specific requirements for renewal, the CFIA will let you know what information you'll need to submit at the time of renewal.