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

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