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

3.28 Registration requirements for Mycotoxin Detoxification Agents (MDAs)

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Mycotoxin Detoxification Agents (MDAs) are substances or mixtures of substances incorporated into a feed matrix to mitigate animal exposure to known mycotoxins. These substances may exert their effects on mycotoxins by reducing gastrointestinal absorption, decreasing bioavailability, promoting excretion or by modifying the structure of the mycotoxin.

MDAs may be regulated as a drug or a feed depending on a number of factors as defined in the guidance document on classification of veterinary drugs and livestock feeds. That document provides guidance and criteria to help clarify the regulatory differences between drugs and feeds, and assists in determining the appropriate regulatory oversight for a product for use in livestock species. Appendix E-1 of the document specifically addresses the classification of MDAs.

MDAs that may be classified for a feed purpose include those that exert their effects either prior to ingestion or within the gastrointestinal tract, and function to:

  1. directly bind to the mycotoxin
  2. degrade the mycotoxin
  3. inactivate the mycotoxin itself (for example, enzymes)

MDAs that aid in reversing or mitigating adverse effects or toxicosis due to mycotoxins by causing changes in physiological functions in the animal may be considered drugs.

Regulatory status

MDAs that are regulated as feed are considered specialty products and must be approved and registered by the Canadian Food Inspection Agency (CFIA) prior to their importation, manufacture or sale in Canada.

MDAs can only be used in feeds that are considered safe for livestock consumption in accordance with the Canadian standards for mycotoxins and are not for use to remediate livestock feeds that do not comply with the Canadian standards for mycotoxins. (RG-8, Section 1: mycotoxins in livestock feed). MDAs may mitigate against additional mycotoxin production by storage mycotoxins (for example, aflatoxin) and may work as a preventative aid against additive or synergistic effects of multiple mycotoxins.

Fit for purpose and efficacy as an MDA

To be classified as an MDA, the active ingredient must have demonstrated an effect corresponding to its purpose, that is, a mode of action consistent with an MDA effect, as stated above, when used or fed as directed. Supporting data must be provided from in-house studies or peer reviewed literature that are reflective of the ingredient fed at similar rates and duration of feeding as per the label. In addition, the market formulation (mixed or a single ingredient product) must have a claim which is supported by efficacy studies.

This document is divided into the following 3 parts:

The data requirements outlined below, including the checklist, must be carefully reviewed and followed prior to submitting an application to the CFIA for feed registration.

After reviewing all documents, if specific questions on requirements remain, please contact the CFIA at

Part 1: Registration requirements for new MDAs

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 MDAs must include the following, in addition to standard labelling requirements listed in RG-1, Chapter 4.1 – Labelling and Guarantees - Labelling of Livestock Feed:

1.3 Product identification and description

The application package must include the following information:

1.3.1 General information

1.3.2 Analytical information

1.4 Requirements in support of product claims and other information

The criteria for acceptable scientific studies are outlined in RG-1, Chapter 2.2 -registration requirements for specialty products.

1.4.1 Studies in support of claims

A battery of in vitro studies should be submitted to provide evidence of the intended effect of the additive.

While in vitro studies may aid in elaborating the mode of action, they do not sufficiently mimic the conditions in the digestive tract and the differences between target animals and their metabolism under practical conditions. Demonstration of the efficacy of most MDAs can only be fully established by in vivo studies that show:

The following specific criteria should be considered in designing appropriate studies in support of MDA claims:

Where the results of these studies have not been published in the peer-reviewed literature, complete copies of the raw data and complete printouts of the statistical analysis are required for review.

1.4.2 Product stability and shelf life

To support product stability and the shelf life as stated on a product label, it will be necessary to:

1.4.3 Product stability in pelleted feeds

Provide evidence to demonstrate that the activity of the MDA is not reduced during feed processing, for example, it is heat stable following pelleting. If the MDA is mixed into feed which is then pelleted original, signed CoAs for the active(s) for 3 pre- and post-pelleting samples of the feed are required in support of the product stability. The data must demonstrate that pelleting does not reduce the detoxifying capacity of the MDA. The pelleting conditions used in the pelleting study must reflect the conditions recommended on the label.

If CoAs are not provided, one or more of the following statements will be required on the label:

1.5 Requirements in support of product safety

In cases where approved ingredients (as listed in Schedule IV and V) are used as MDAs, safety may have already been substantiated for the ingredient during the approval process and may not require the submission of new safety studies. If the MDA product is a new single ingredient, or is used at rates exceeding that for the previously approved purpose, a safety assessment will require the submission of data as outlined in RG-1, Chapter 2 - data requirements for single ingredient approval and feed registration:

The following specific information must be provided for all MDA products.

1.5.1 Production of new metabolites and breakdown products

If the mode of action of the MDA involves the modification of the mycotoxin through its degradation or metabolism, the production of new metabolites or breakdown products may result in chemicals which are more toxic than the parent compound.

1.5.2 Potential for interactions

As the mode of action of many MDAs involves the direct binding of the mycotoxin, there exists the potential for the product to affect other constituents in the feed, such as nutrients and veterinary drugs. A consideration of the MDAs ability to reduce the availability of key nutrients and medications must be included in the submission and scientific data may be required.

Which nutrients and veterinary drugs to consider should be based on the feed matrix and the MDA product. Applicants should be aware of how components of the target feed could interact with their particular product.

Part 2: Amendments to registrations of MDAs

Registrants wishing to make a change to the formula or label of a registered product must submit an application for a Registration Amendment (significant change/re-registration) to the CFIA (Category 2 submission). General administrative information regarding application procedures for amendments to feed registrations can be found in RG-1 - Chapter 1 - administrative requirements for pre-market assessment and product registration of livestock feed.

Significant changes may include, but are not limited to, changes to:

Data requirements for significant changes to MDAs 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 MDAs

General administrative information regarding the application procedures for renewals of feed registrations can be found in RG-1, Chapter 1 "administrative requirements for pre-market assessment and product registration of livestock feed".

Specific information is found in the attached checklist.

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

Changes made to the formulation or to the product label (for example, claims, purpose, directions for use, target livestock species feeds, etc.) are considered to be significant changes to existing registrations. An application for renewal with a significant change would be required.

Submission checklist for Mycotoxin Detoxification Agents (MDAs) feed application:

The completed checklist, for Mycotoxin Detoxification Agents (MDAs) submissions, must be included with each application for feed registration. Submissions received without a completed checklist will not be accepted.

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.

1.1 Administrative requirements for each product

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

1.2 Labelling

1.3 Product identification and description

For products with deficiencies previously identified by the CFIA, 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.

1.4 Requirements in support of product claims and other information

1.5 Data requirements in support of safety

Part 4: Renewals of feed registration

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

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

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