Chapter 3 - Specific Registration Information by Feed Type

3.25 Carotenoid Pigments

Registration Requirements for Carotenoid-Based Colouring Agents and Mixed Feeds containing Registered Colouring Agents

This section is intended as a guide to the registration of carotenoid-based colouring agents, containing beta-apo-8'-carotenoic acid ethyl ester, astaxanthin, or canthaxanthin as the active compound, that are destined for use in poultry and/or salmonid fish feeds. Each source of a single ingredient feed (SIF) listed in Part II of Schedule IV of the Feeds Regulations (which includes the three pigments named) requires registration prior to import, manufacture or sale in Canada, in support of the safety and/or efficacy of the source in question. This section also applies to mixed feeds containing registered colouring agents. For any new pigment, which is not listed in Schedule IV, a proponent must apply for it to be approved as a feed ingredient. See Chapter 1, "Application for Feed Registration and Ingredient Approval" for more information.

Maximum Allowable Carotenoid Levels in Salmonid Fish Feeds and Poultry Feeds

Health Canada, in conjunction with the CFIA, has determined that the maximum combined level of astaxanthin and canthaxanthin permitted in salmonid fish feeds must be reduced. The Animal Feed Division has revised the maximum allowable levels for canthaxanthin and astaxanthin in salmonid fish feeds based on the health risk information provided by Health Canada, as well as information provided by the feed and aquaculture industries and published data from scientific literature.

Based on all of this information, it has been concluded that the maximum allowable level of 30 grams canthaxanthin per tonne of complete salmonid fish feed could be increased to 50 grams per tonne. However, the maximum allowable level of astaxanthin has been lowered from 200 grams per tonne of complete salmonid fish feed to 80 grams per tonne. Furthermore, when astaxanthin is used in combination with canthaxanthin, the combined concentration of these two carotenoids shall not exceed 80 grams per tonne of complete salmonid fish feed.

For poultry feeds, the maximum allowable level of canthaxanthin has been set at 30 grams per tonne of complete feed, and astaxanthin is not permitted at this time.

The following table summarizes the maximum allowable use rates of canthaxanthin and astaxanthin in feeds in Canada:

Type of Feed	Maximum Level of Canthaxanthin	Maximum Level of Astaxanthin	Maximum Level of Canthaxanthin + Astaxanthin
Poultry Feeds	30 grams/tonne of complete feed	N/A	N/A
Salmonid Fish Feeds	50 grams/tonne of complete feed	80 grams/tonne of complete feed	80 grams/tonne of complete feed

Registration of New Sources of Carotenoid-Based Colouring Agents Listed as Single Ingredient Feeds in Schedule IV, Part II

Administrative Requirements

Standard registration requirements, including a completed and signed application for registration form (CFIA/ACIA 0009); application fee as per Chapter 1, "Application for Feed Registration and Ingredient Approval" (please use the Category 3 application code 3256, Novel Ingredient, as both efficacy and safety reviews are required); three copies of the proposed product label; an accompanying cover letter identifying and explaining the purpose of the feed and listing the enclosed information; and signing authority/Canadian agent (if applicable).

Labelling

1. The product label must reflect the purpose of the product as a colouring agent for use in poultry and/or salmonid fish feeds.
2. The product label must bear all required guarantees and have the necessary labelling statements, as per the regulatory definition(s) listed in Part II, Class 8 of Schedule IV of the Feeds Regulations.
3. Directions for use are to be stated on the product label, and must be consistent with the maximum allowable use rates of the single ingredient feed in question.

Product Description and Supporting Information

1. A complete description of the manufacturing process used to produce the colouring agent must be provided with the application for registration. This should include detailed written descriptions, flow charts, time/temperature specifications for particular steps in the production process, quality control measures, and a list of all starting materials/reagents/chemicals/processing aids, etc., including the amount or concentration of each compound.
2. The complete product formula (formulation/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 Feeds 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 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 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.

3. Original, signed Certificates of Analysis from three different and recent lots of the product, which support the label guarantees for the active compound(s) (e.g., astaxanthin, canthaxanthin) on an as fed basis as well as for any other analytes (e.g., moisture) required by the SIF definition in question (e.g., no.8.11, 8.63).
4. 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 or astaxanthin. These methods will be used to determine the levels of the active compound(s) in the colouring agent that is being submitted for registration.

   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 the technical requirements for analytical methods for livestock feeds and feed ingredients.

5. If an analytical methodology used to determine the concentration of carotenoid pigment 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 the carotenoid (i.e., beta-apo-8'-carotenoic acid ethyl ester, astaxanthin or canthaxanthin) content must accompany the product sample
6. Stability (e.g., shelf life) data must also accompany the application for registration, as an expiry date or shelf life guarantee 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 three 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.

Safety Information

1. Scientific investigations supporting product safety may be required. Applicants should consult Section 2.3, "Single Ingredient Feed Evaluation Requirements" and Section 2.4, "Generic Data Requirements for Safety Evaluations of Single Ingredients", for more information on the Animal Feed Division's requirements as they pertain to product safety. It may also be necessary to submit supporting safety data for any contaminants or toxins present in the carotenoid product. 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, human health, or the environment.

   Depending on the source, these investigations may include, but are not limited to:

   1. a detailed description of any contaminants or toxins inherent to the source or manufacturing process of the carotenoid product; and
   2. chemical analyses of suspected contaminants or toxins (i.e., certificates of analyses):
      i. three signed Certificates of Analysis, which have been completed within the last three years of the date of the application. The certificates of analysis must include arsenic, cadmium, lead, chromium and aluminum, and any residual solvent(s) that may be present in the final carotenoid product. However, other contaminant analyses may be requested by the Animal Feed Division if required (e.g., mercury, triphenylphosphine (TPPO), etc.).

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

2. For new sources of Phaffia rhodozyma yeast or dried Haematococcus algae meal, 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.
3. For strains of Phaffia rhodozyma yeast or dried Haematococcus algae meal containing one or more novel traits, a novel feed assessment is required. Section 2.7, "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 for a 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 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 (if stated on the product label)

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 three (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 marketed, sold, or distributed in Canada.

Requirements for Renewal of Registration for Colouring Agents containing Beta-apo-8'-carotenoic acid ethyl ester, Canthaxanthin or Astaxanthin as the Active Compound

As with all registered feeds, colouring agents containing beta-apo-8'-carotenoic acid ethyl ester, canthaxanthin, or astaxanthin that have been granted permanent registration status are registered for a three-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 three copies of the product label, as per Chapter 1, "Application for Feed Registration and Ingredient Approval".

Furthermore, the complete and detailed manufacturing process for the crystalline pigment, as well as Certificates of Analysis for contaminants from three different and recent lots of product, are also required and must be included with the application for registration renewal. Additional information may be requested if safety and/or efficacy concerns emerge between the time of registration and the renewal due date.

Note that any proposed changes to registered 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). Colouring agents 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 Carotenoid-Based Colouring Agents containing Beta-apo-8'-carotenoic acid ethyl ester, Canthaxanthin or Astaxanthin

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, canthaxanthin, beta-apo-8'-carotenoic acid ethyl ester, moisture content (for Phaffia rhodozyma yeast and dried Haematococcus algae meal), etc.;
• changes to the product formulation that affect the efficacy of pigmentation and/or the beta-apo-8'-carotenoic acid ethyl ester, canthaxanthin, or astaxanthin content of the product (e.g., addition/removal of carrier ingredients, addition/removal of a pellet binder);
• changes to the manufacturing process that may change the nature/chemical form 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 and/or canthaxanthin content in the product in question;
• modifications to the directions for use; or
• 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, or astaxanthin, it would be necessary to submit a minimum of three (3) feeding trials (meeting the criteria outlined in Section 2.2, "Registration Requirements for Specialty Products") demonstrating the safety and efficacy of the increased use rate in feeds for poultry and/or salmonid fish as part of the submission package.

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

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 3 product.

Formulation changes involving ingredients that are not considered to be active ingredients or a significant source of nutrients (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 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.

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Registration of Mixed Feeds containing Carotenoid-Based Colouring Agents that are Registered Sources of Part II Single Ingredient Feeds

Requirements for Registration of Diluted Supplements of Carotenoic Pigments for Use in the Further Manufacturing of Poultry and/or Salmonid Fish Feeds

Mixed feeds (including imported products) considered to be supplements of crystalline beta-apo-8'-carotenoic acid ethyl ester, crystalline astaxanthin, crystalline canthaxanthin, Phaffia rhodozyma yeast, or dried Haematococcus algae meal (i.e., a registered carotenoid pigment source that is being diluted) that 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 to be a diluted source of carotenoid pigments for use as colouring agents 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 a carotenoid pigment must be registered prior to its use in feeds in Canada, the inclusion rate of each pigment 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 the registered colouring agent used in 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, must also be respected.

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
• three 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 and/or astaxanthin derived from the carotenoid-based colouring agent(s) used in the mixed feed's product formulation; and
  - directions for use that are based upon the registered carotenoid pigment 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 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.) 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.

Requirements for Amendments (Significant Change) to Diluted Supplements of Carotenoid pigments 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, canthaxanthin, beta-apo-8'-carotenoic acid ethyl ester, moisture content (for Phaffia rhodozyma yeast and dried Haematococcus algae meal), etc.;
• changes to the product formulation of the mixed feed (e.g., addition/removal of carrier ingredients, addition/removal of a pellet binder, etc.);
• changes to the active ingredients(s) (e.g., embedded registration(s)) used in the mixes feed;
• modifications to the directions for use; or
• changes to the duration of the shelf life of the product.

Please refer to Chapter 1 for additional information regarding significant changes to product registrations. The application fees for these types of changes are the same as those for a new application for registration for a Category 2 product. 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 Renewal of Registration for Mixed Feeds Claiming the Presence of Carotenoid-Based Colouring Agents, Beta-apo-8'-carotenoic acid ethyl ester, Astaxanthin and/or Canthaxanthin

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
• three copies of the product label
• a copy of the current product formula
• any additional information, documentation, scientific data, etc. that is required to be submitted with application for registration renewal which has been previously requested by the Animal Feed Division

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

Below are three checklists, pertaining to carotenoid-based colouring agents for use in poultry and salmonid fish feeds, which detail the information required for a submission 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 Animal Feed Division with each application for livestock feed 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 Animal Feed Division and submitted materials will be destroyed.

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A) Single Ingredient Feeds

• For applications for registration for new sources of carotenoid-based colouring agents found 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.

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)
Payment for a Category 3 (requiring safety and efficacy) feed – cheque, money order, Visa, MasterCard, or American Express
If a review of your ingredient has been performed previously by the Animal Feed Division 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 (Form 1194) (requirement for foreign companies only)

Source of colouring agent meets a definition listed in Schedule IV
If derived from an organism, a statement indicating whether the source of 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"

Brand name (optional)
Product name reflecting the purpose of the product and the intended livestock species
Guaranteed analysis for the carotenoid 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)
Expiration date
Date of manufacture (if linked to expiration date)
Required labelling statements, as specified by RG-1, Section 3.25

Formulation/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

Complete and detailed laboratory methods to determine carotenoid pigment content

For applications for significant changes to registered colouring agents:
Signed statement that the analytical method used to determine carotenoid content has not changed from that submitted for review and approved by the Animal Feed Division (not required for diluted supplements and mixed nutional feeds)
- OR -
If method has changed, the revised method has been provided

Original, signed copies of certificates of analysis for a minimum of three different and recent lots of product supporting the label guarantees for carotenoid pigment(s) 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 at the expiry date) for a minimum of three different and recent lots of product
Three original, signed Certificates of Analysis for each of:
analysis of heavy metals (arsenic, cadmium, lead, chromium and aluminum) in
the pigment
analysis of residual solvents in the pigment and final product originating from
the manufacturing process
analysis of any other chemical compounds that may be considered to be
contaminants in the pigment
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 pigment

Sample Provided to Support Verification of Enzyme-Based Methods

For enzyme-based analytical methods that are used to determine the concentration of carotenoid pigment, 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 pigment(s) present is not enzyme-based; therefore, a 500 g sample is not required

Complete and detailed description of the manufacturing process (including raw materials, processing aids, flow charts, written descriptions, times and temperatures, etc.) for both the crystalline pigment (if applicable) as well as the finished product (as added to feeds)

For applications for significant changes to registered colouring agents:
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 process has been provided

Three 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

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

Note: Further information may be required after the initial review of the submission by the Animal Feed Division.

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

• For applications for registration for diluted pigment 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 pigment in the guaranteed analysis portion of the label).

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)
Payment for Category 2 (requiring safety or efficacy) feed – 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
For new companies:
Signing authority and/or corporate documents (requirement for all new companies)
"Declaration of Resident Canadian Agent" form (Form 1194) (requirement for foreign companies only)

Brand name (optional)
Product name reflecting the purpose of the product and the intended livestock species
Guaranteed analysis for the carotenoid(s) 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 pigments) 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)
Expiration date
Date of manufacture (if linked to expiration date)
Required labelling statements as specified by RG-1, Section 3.25 (not required for mixed nutritional feeds that claim the presence of carotenoid-based colouring agents)

Formulation/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 Animal Feed Division.

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C) Applications for Renewal of Registration

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)
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 require, in addition to the renewal application, an application to the Animal Feed Division for significant change or administrative amendment (these two 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 supplements and mixed nutritional feeds).

Note: Any proposed changes made to the approved product formulation will require, in addition to the renewal application, an application to the Animal Feed Division for significant change (these two 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 formula/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

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 process has been provided

Signed statement that the analytical method used to determine carotenoid content has not changed from that submitted for review and approved by the Animal Feed Division (not required for diluted supplements and mixed nutritional feeds)
- OR -
If method has changed, the revised method has been provided

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