Registration requirements for insect-derived livestock feed ingredients

This document is in draft and is part of the current consultation on Registration requirements for insect-derived livestock feed ingredients, which will be open until August 17, 2019. Visit the main consultation page to find out how you can share your thoughts.

Background

Feed ingredients derived from insects can be suitable sources of nutrients for feeding to various livestock species. In some cases, insects have the potential to be used for the production of feed ingredients from a biomass that contains 40-45 percent protein and up to 35 percent fat. However, these products can vary significantly depending on several factors including insect species, rearing method, growth substrate, the insect product isolated, etc. all of which can impact on the safety and efficacy for feeding to livestock.

Safety and efficacy of insect-derived livestock feed ingredients

Given the possible variation of insect-derived products, each source is required to undergo a comprehensive safety and/or efficacy assessment for use in the diets of the intended livestock species. The assessment approach considers the safety of:

  • the insect itself
  • the manufacturing process; including a complete evaluation of the rearing of the insect
  • final feed ingredient produced

Physical, chemical and biological hazards in insect-derived feed ingredients must be identified for each product and are dependent on the insect species, the specific product, the growth substrate, manufacturing process, packaging and storage conditions.

  • Physical hazards – packaging materials, metal, glass, etc. possibly introduced into the process through the growth substrate when recycled food or feed products are used
  • Chemical hazards – may include toxins or allergens from the insect itself, heavy metals, pesticides, anti-nutritional factors, mycotoxins, and environmental contaminants such as dioxins, furans and polychlorinated biphenyls (PCBs)
  • Biological hazards – microbial pathogens, disease vectors and other bacterial contaminants introduced from the growth substrate, present in product storage and the final product

The purpose of the feed assessment is to ensure that the feed ingredient is safe in terms of animal health, human health (safety of foods derived from livestock consuming the ingredient and worker/by-stander exposure), and the environment. The nutritional purpose of the ingredient is assessed to determine its effect on the growth and production performance of the intended livestock species.

Exposure assessment is a key component of the safety and nutrition evaluation. Particular consideration is required of the ability of chemical hazards to bioaccumulate in the insects themselves which can result in elevated residues in the insect-derived feed ingredient. The evaluation also ensures that the feed is accurately defined in the Feeds Regulations and is labelled appropriately for its safe, effective use and for consumer protection.

Regulatory status

Insect-derived feed ingredients intended to be used as sources of macro-nutrients in livestock diets are listed in Schedule IV, Part II and do not meet the exemption from registration criteria as outlined in Section 5(2) of the Feeds Regulations. A pre-market assessment is required for each new ingredient as there may be inherent source related safety and/or efficacy variations associated with different insect species, growth substrates, and/or manufacturing processes. Each source of these ingredients must be approved and registered prior to their importation, manufacture or sale in Canada

This document is divided into the following three parts:

Part 1 – Registration requirements for insect-derived feed ingredients
Part 2 – Amendments to registrations of insect-derived feed ingredients
Part 3 – Renewal of registrations of insect-derived feed ingredients

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

After reviewing all documents, if specific questions on requirements remain, please contact the AFD at: cfia.afd-daa.acia@canada.ca.

Part 1: Registration requirements for insect-derived feed ingredients

1.1 Administrative requirements

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

Specific information is found in the attached checklist.

1.2 Labelling

Proposed labels for insect-derived feed ingredients must include the following in addition to standard labeling requirements listed in RG-1, Chapter 4.1 – Labelling and Guarantees – Labelling of Livestock Feed.

  • name and purpose of the insect-derived feed ingredient
  • list of ingredients, if applicable
  • intended livestock species
  • directions for use for each target species
  • guaranteed analysis for the following components, as applicable to the ingredient:
    • crude fat (minimum)
    • crude protein (minimum)
    • ash (maximum)
    • moisture (maximum)
    • crude fiber (maximum)
  • other guarantees to describe the usefulness of the insect-derived feed ingredient
  • date of manufacture
  • shelf life (for example, 12 months from the date of manufacture when stored under appropriate conditions)
  • recommended storage conditions
  • any caution and/or warning statements, if applicable

1.3 Product identification and description

1.3.1 General information

  • cover letter explaining the purpose of the product for approval and registration
  • summary of documentation/information included with the application
  • precise description of the ingredient to assist in verifying and accurately defining the ingredient in Schedule IV of the Feeds Regulations
  • background supportive information pertaining to approvals in other jurisdictions
  • directions for use
  • target livestock feeds
  • proposed product claim(s)
  • proposed shelf-life

1.3.2 Analytical information

  • certificates of analysis from 3 different and recent lots of product for the guaranteed analysis and other guarantees which describe the usefulness of the insect-derived feed ingredient
  • description of analytical methodology used to substantiate the required guarantees as above: for example, crude fat, moisture, crude protein, ash, crude fibre, minerals, and any other content guarantees made on the proposed label
  • product sample or samples may be requested on a case-by-case basis to verify analytical methodologies and/or label guarantees

1.4 Requirements in support of product claims and other information

Minimum data requirements to support the efficacy of single ingredient feeds are outlined in RG-1, Chapter 2 – Data Requirements for Single Ingredient Approval and Feed Registration.

1.4.1 Studies in support of claims

The intended purpose or nutritive usefulness of the insect-derived feed ingredient for the intended livestock species must be demonstrated. The criteria for acceptable scientific studies are outlined in item 5 in RG-1, Chapter 2.2 -Registration Requirements for Specialty Products

One in-house scientific study using the insect-derived feed ingredient or a minimum of 3 studies published in a peer-reviewed scientific journal is required to support the nutritional efficacy of the product as a protein and/or energy source or other uses for the intended livestock species.

The studies should show that the growth, feed utilization and feed intake of the livestock when fed the feed ingredient is similar or better as compared with the control diet or ingredient(s).

Note: If published peer-reviewed journal articles are submitted to support the safety and/or efficacy of the insect-derived feed ingredient, the applicant is required to provide supporting scientific information and rationale relating the relevance of the data therein to the product intended for registration.

1.4.2 Product stability and shelf life

Provide data from a stability study to support the proposed shelf-life of the final product including certificates of analysis for microbial contaminants (see section 1.5.3.1 below) from the start to end of the shelf-life for the same 3 production lots. The conditions used in the study should be similar to the storage conditions of the final product.

1.5 Data requirements in support of product safety

Minimum data requirements to support the safety of single ingredient feeds are outlined in RG-1, Chapter 2 – Data Requirements for Single Ingredient Approval and Feed Registration

The following specific information must be provided for all insect-derived feed products.

1.5.1 Characterization of the insect

A complete characterization of the insect supported with peer-reviewed scientific literature, including a description of

  • biology, species and subspecies and life cycle of the insect
  • the original source of the insect and how it was obtained by the manufacturer
  • its implications as a vector in the transmission of pathogens

1.5.2 Characterization of the production of the insect-derived feed ingredient

Describe how the insects are grown from the parent insect to harvest. Include:

  • the type of growth substrate used, the origin of the feed/food materials used in growth substrate including a detailed list of the sources/suppliers
    • usual inclusion rates of the various materials in the growth substrate
    • storage conditions and frequency of use of the growth substrate
    • for any materials that come from packaged products (for example, pre-consumer waste) provide details on de-packaging and measures in place to ensure removal of non-edible portions
      • these could result in extraneous/foreign materials (for example, plastic, glass, metal, polystyrene, paper) in the final product
    • quality control specifications and measures in place to screen the incoming growth substrate and any chemicals that are used in the manufacturing process.
  • Provide details on how the insects are harvested
  • Final production processes
    • end-processing steps to make final product, including the times and temperatures
    • a listing of any chemicals used

1.5.3 Hazards

Identify any physical, chemical or biological hazards that may be inherent to the insect, introduced via the growth substrate or the production process.

A careful consideration of the entire process should determine potential contaminants that may be inherent to the insects, the growth substrate or introduced via production and processing steps. These will vary dependent on sources of all of the above.

Signed original certificates of analysis for 3 different and recent production lots must be provided for the following contaminants as applicable. The details of any analytical methodology used along with limits of detection/limits of quantification must be provided.

These may include:

1.5.3.1 Biological hazards

These include pathogens and other bacterial contaminants, listed below. In certain cases, additional tests may be required.

  • water activity
  • pH
  • total plate count
  • yeasts and molds (with no Aspergillus flavus or Fusarium species detected)
  • total coliforms
  • total fecal coliforms
  • E. coli
  • Salmonella spp.
  • Listeria monocytogenes
  • Bacillus cereus
  • Clostridium spp.
  • Pseudomonas spp.
  • Staphylococcus aureus
1.5.3.2 Chemical Hazards

As applicable:

  • metal contaminants such as chromium, lead, arsenic, cadmium, and mercury as a minimum
  • pesticides, from residues in the growth substrate
  • mycotoxins such as aflatoxin, deoxynivalenol, fumonisins, ochratoxin A, zearalenone, HT-2 and T-2 toxins
  • dioxin congeners (7), furan congeners (10), dioxin-like PCBs (12) in the final product
    • See Annex 1 (below) for a list of required congeners for the analysis
  • Non-dioxin-like/ indicator PCBs (PCB 28, PCB 52, PCB101, PCB 138, PCB 153, and PCB 180)
  • Processing aids introduced via processing steps
1.5.3.3 Other Hazards
  • physical hazards – extraneous/foreign materials such as plastic, glass, metal, polystyrene, paper, etc.
  • any other inherent toxins, contaminants, or allergens of the organism known from its biology.

1.5.4 Quality Control Measures

Describe the product specifications (including microbial contaminant levels), quality control and monitoring procedures that are in place to maintain consistency of product as well as to prevent introduction of unacceptable levels of contaminants.

  • provide the measures in place to contain the insects at the site
  • clearly describe the composition of the final product

1.5.5 Toxicity and safety studies

  • provide evidence that the addition of the insect-derived feed ingredient in the diets of the intended livestock species at the proposed maximum inclusion rates will not cause adverse effects. Evidence should include scientific studies where the product being considered for registration is fed to the intended livestock species
  • relevant studies with an equivalent product may be submitted in support of this application. Studies must be bridged with consideration of the growth substrate, the manufacturing process, insects at different life stages, etc., and clearly indicate that the differences in the products will not affect the safety of feeding this product to the intended livestock species
  • in some cases, a scientific rationale supported by appropriate data may be used to address dietary safety issues when feeding studies are unavailable
  • if impurities or known contaminants are present in the insect-derived feed ingredient, additional toxicity data is required in order to support their safety
  • the potential for allergenicity or sensitivity reactions from the insect and its by-products (pupal cases, eggs, feces, etc.), should be provided in consideration of livestock and human safety

Supporting data must be peer-reviewed scientific articles or in-house trials with all the data provided.

Part 2 – Amendments to registrations of insect-derived feed ingredients

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 (Category 2 or 3 submissions). General administrative information regarding the procedures for application for feed registration can be found in Regulatory Guidance: RG-1, Chapter 1 – Administrative Requirements for Pre-market Assessment and Product Registration of Livestock Feed

Proposed significant changes may include, but are not limited to, changes to

  • label guarantees
  • manufacturing process (including changes to the growth substrate)
  • label claims
  • directions for use
  • intended livestock species
  • duration of the shelf life of the product
  • ingredient stability (heat or pelleting stability)

Data requirements for significant changes to insect-derived feed ingredients will be dependent on the changes being requested and would be evaluated on a case-by-case basis. For more information on data requirements for amendments to registrations, refer to RG-1, Chapter 2.2 Registration Requirements for Specialty Products.

Part 3 – Renewal of registrations of insect-derived feed ingredients

General administrative information regarding the application procedures for renewals of feed registrations can be found in Section 1.6 of RG-1, Chapter 1 – Administrative Requirements for Pre-market Assessment and Product Registration of Livestock Feed.

Specific information is found in the attached checklist.

Changes made to the formulation and/or to the product label (for example, claims, directions for use, intended livestock species, etc.) are considered to be significant changes to existing registrations. These changes cannot be submitted for review and approval at the time of registration renewal unless substantiating information and scientific data (if applicable) has been submitted with the application for registration renewal. This would no longer be considered a renewal and would be subject to appropriate fees as per Part 2, above.

Please note that additional information may be requested at the time of renewal if safety and/or efficacy questions emerge after the original registration date.

Annex 1: List of required congeners for the analysis of dioxins per section 1.5.3.2

Dioxin congeners Dioxin-like PCB congeners non-ortho substituted PCBs
2,3,7,8-TCDD
1,2,3,7,8-PeCDD
1,2,3,4,7,8-HxCDD
1,2,3,6,7,8-HxCDD
1,2,3,7,8,9-HxCDD
1,2,3,4,6,7,8-HpCDD
OCDD
PCB 77
PCB 81
PCB 126
PCB 169
Furan congeners Dioxin-like PCB congeners mono-ortho substituted PCBs
2,3,7,8-TCDF
1,2,3,7,8-PeCDF
2,3,4,7,8-PeCDF
1,2,3,4,7,8-HxCDF
1,2,3,6,7,8-HxCDF
1,2,3,7,8,9-HxCDF
2,3,4,6,7,8-HxCDF
1,2,3,4,6,7,8-HpCDF
1,2,3,4,7,8,9-HpCDF
OCDF
PCB 105
PCB 114
PCB 118
PCB 123
PCB 156
PCB 157
PCB 167
PCB 189

Printable checklist – PDF (91 kb)

Submission checklist for insect-derived livestock feed ingredients feed application

The completed checklist, for insect-derived livestock feed ingredients submissions, must be included with each application for feed registration.

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

Submissions received without a completed checklist will be returned.

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

1.1 Administrative requirements
Required information Page number in application or Not Applicable (N/A)

RG-1 Chapter 1: Administrative requirements for registration and approval of livestock feeds

Application for Feed Registration and Renewal.

Form Available: 1.3.1 Application for feed Registration and Renewal (CFIA/ACIA 0009)

Total application fees (cheque, money order, Visa, MasterCard, or American Express payable in Canadian Funds)

RG-1 Chapter 1: Appendix A for application fees

For a new company or an existing company requiring changes to the signing authority list, include supporting documentation on Establishing a Company File and Signing Authority

For a new applicant residing outside of Canada or an existing company requiring changes to the Resident Canadian Agent, , include supporting documentation and a Declaration of Resident Canadian Agent, Form II (CFIA/ACIA 1194) – PDF (101 kb)

Cover letter and summary of the documentation included with the application, with the email address of the contact person clearly identified

1.2 Labelling
Required information Page number in application or Not Applicable (N/A)

Proposed Labels including all required information as per section 1.2

1.3 Product identification and description
Required information Page number in application or Not Applicable (N/A)

For products with deficiencies previously identified by the AFD, attach the reference number of the return letter or letter of rejection of the application and explain how you have addressed the rejection points in the new submission.

Complete identification and description of the final product as detailed in Section 1.3.1

Specify target livestock species and proposed directions for use for each species.

Certificates of analysis from 3 different and recent lots of product to support the proposed label guarantees and other guarantees which describe the usefulness of the insect-derived feed ingredient. See section 1.3.2.

Analytical methods used to support the proposed label guarantees, as above.

Product sample or samples, if required. The sample may be used to validate the analytical method by the CFIA laboratory.

Keep a 500 g sample of the final product in stock. When the application is accepted, you will be contacted to send the sample directly to the CFIA laboratory.

1.4 Requirements in support of product claims and other information
Required information Page number in application or Not Applicable (N/A)

Acceptable studies in support of claims. Address all design considerations as listed in section 1.4.1

Certificates of Analysis and analytical methods for studies used to support the proposed label claim

Demonstration in support of product stability and shelf life for the maintenance of the insect-derived livestock feed ingredients as defined in section 1.4.2 including microbial contaminants listed in section 1.5.3.1.

Certificates of analysis (original and signed) for 3 recent and different lots of production of the final product to support the stability and shelf life as above. These must include three (3) certificates of analysis at the beginning of the shelf life period and three (3) from the same three lots of the product at the end of the desired storage period. The 3 sampled lots must be kept in similar storage conditions up to the proposed expiry date.

The analytical methods used for the above analyses must be included on the certificates.

1.5 Data requirements in support of product safety
Required information Page number in application or Not Applicable (N/A)

Description and data demonstrating the safety of the feed as noted in section 1.5. This is required for new source of insect derived feed ingredients or for proposed inclusion rate exceeding the approved level of the intended species. Evidence provided as per section 1.5.5.

Characterization of the biology, species and subspecies and life cycle of the insect, the original source of the insect and how it was obtained by the manufacturer and its implications as a vector in the transmission of pathogens. Evidence provided as per section 1.5.1

Description on how the insects are grown and harvested, the type of substrate used and a detailed manufacturing process of the final product. See section 1.5.2

Identify any physical, chemical or biological hazards that may be inherent to the insect, introduced via the growth substrate or the production process. Evidence provided as per section 1.5.3.

Certificates of analysis (original and signed) from 3 different and recent lots of product to provide contaminant concentrations identified in the sections 1.5.3.1, 1.5.3.2 and 1.5.3.3.

Analytical methods used along with limits of detection/limits of quantification for each contaminant, as above.

Describe the product specifications (including microbial contaminant levels), quality control and monitoring procedures that are in place to maintain consistency of product as well as to prevent introduction of unacceptable levels of contaminants. See section 1.5.4.

Part 3: Renewals of feed registration
Required information Page number in application or Not Applicable (N/A)

If there is a change to the product at renewal, use this checklist to describe the changes as applicable. See section Part 2.

If there is no change to the product, use the checklist for renewals available in the RG1- Chapter 1 at: Appendix B – Checklist for renewals . See section Part 3.

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