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

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