RG-1 Regulatory guidance:
Chapter 2 - Data requirements for single ingredient approval and feed registration
2.8 Guidance on bridging an application to data from publicly available literature and previously approved feed applications

Data to support the efficacy or safety of a feed can be provided by the applicant from in-house studies, peer-reviewed scientific literature, or in some cases, by reference to previous applications to the Canadian Food Inspection Agency (CFIA). When applicants refer to data other than from complete in-house studies, a "bridge" is required to demonstrate the studies' relevance to the product in the current application.

Bridging, when appropriate, is carried out to support the efficacy and/or safety requirements for the approval and registration of a single ingredient feed (SIF) or registration of mixed feeds. The guidance on information requirements to support the registration/approval of feeds is found in "RG-1 Regulatory Guidance: Feed registration procedures and labelling standards".

The CFIA can consider data from peer-reviewed scientific literature or previous applications only if the bridging requirements below are met:

• Requirements for bridging publicly available data
• Requirements for bridging to data in previous applications
• Requirements for bridging to data belonging to a third party company

A. Requirements for bridging publicly available data

Only peer-reviewed scientific literature will be considered acceptable as a source of publicly available data. All information, data and results in the research article will be assessed and considered during the evaluation. The research article does not need to be published by the applicant. However, the study's relevance in the context of the feed under review must be explained in the application, as described below.

For each scientific paper used for bridging data, the applicant must provide a copy of the paper and a summary that includes an explanation of all the relevant information and results. This summary must include substantiation or a rationale:

• to demonstrate the equivalence of the ingredient or product used in the study to the product under review. For example, the ingredient form (physical, chemical, or biological) and processing method applied to the product used in the study must be equivalent to that of the ingredient or product under review. If the ingredient or product is not identical, the bridging rationale must be sufficient to still allow conclusions on the feed under application to be made.
• that the use rate of the ingredient or product in the published study when compared to the ingredient or product under review must be:
  • equivalent when used to support the efficacy
  • equivalent or higher when used to support the safety
• to demonstrate the equivalence of the animals used in the study to those intended to be fed the ingredient or product under review. This must include a discussion of the species, type and phase of production of the animals in the published study and the relevance to the intended livestock species. A scientific rationale supporting inter- or intra-species extrapolation is required. Consideration will be given to:
  • the physiological similarity between species (for example, digestive physiology and metabolism), and
  • their production purpose (for example, meat vs reproduction (that is, milk and egg production)

For example, a beef cattle study may be used to support feed applications for other meat- producing ruminants. However, it may not be relevant to support feed applications for lactating or reproducing ruminants and typically cannot be used to support a feed application for monogastric livestock.

The source of the data from the peer-reviewed scientific literature must be cited in the application (author/source, year), and a list of the complete references must be provided. Each reference must include authors, document title, source, date and page numbers.

B. Requirements for bridging to data in previous applications

Applicants can also bridge data from previously approved applications by referencing their own data that were previously submitted and accepted for approval or registration.

1. The applicant must include a summary of the data and a scientific rationale explaining why the data from a previous application applies to the ingredient or product under review.
2. Bridging of data from a previous application will be considered acceptable when the experiments were designed and performed for the same purpose as in the new application or, if not, would still allow conclusions on the feed under application to be made.
3. The applicant must provide evidence to demonstrate that the previously assessed ingredient or product is equivalent to the ingredient or product under review. For example, the ingredient form (physical and chemical), manufacturing processes and the feed previously assessed use rate must be relevant to the feed being assessed. If not identical, the bridging rationale must be sufficient to still allow conclusions on the feed under application to be made.
4. For the CFIA to consider applicable data from other applications, the applicant may either:
   • Provide all of the bridged information that would apply to the new application in the current application package as an appendix, or
   • Provide the reference number or feed registration number and original registration date corresponding to the application for which the original data were supplied so the CFIA may efficiently locate it

C. Requirements for bridging to data belonging to a third party company

Where appropriate, an application for a feed ingredient or product may be bridged to data submitted by a third party company that previously received approval or registration for a comparable ingredient or product; or, under certain conditions, for the same ingredient or product included in the new application. Along with the information in Section B, the applicant must:

• provide an attestation from an individual with signing authority from the company that holds the registration/approval
  • The attestation from the third party company must indicate that they do not object to having their file and data being used by the CFIA to support data requirements for feed ingredient/product approval/registration for the current application
• When another company's data is being used to bridge and is considered confidential business information:
  • the data may be provided directly to the CFIA by the third party company, or
  • the third party company can provide the original application reference number or feed registration number and original registration date corresponding to the application for which the original data were supplied so the CFIA may efficiently locate it

Checklists

• Checklist for bridging to peer-reviewed scientific literature
• Checklist for bridging to data in previous application or third party information

Checklist for bridging to peer-reviewed scientific literature

The checklist below can be used to verify that all aspects of bridging are included in a submission whenever peer-reviewed scientific literature is used to provide information relevant to submission requirements

Checklist for bridging to data in previous application or third party information

The checklist below can be used to verify that all aspects of bridging are included in a submission whenever an applicant is referencing data previously submitted and accepted for approval or registration to provide information relevant to submission requirements.

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