RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.30 Guidelines for incidental feed additive (IFA) data review applications

1. Purpose

These guidelines have been prepared to assist manufacturers in preparing data review applications for incidental feed additive (IFA) products intended for use in establishments where livestock feeds are manufactured.

2. Introduction

While not defined under the Feeds Act or regulations, IFAs are any substance, not including apparatus or utensils, and not consumed as a feed ingredient by itself, intentionally used in the processing of materials, feed or feed ingredient, to fulfil a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the feed ingredient or its ingredient market formulation, provided that these residues and derivatives do not have an adverse effect on animal health, human health or the environment.  IFAs have no nutritional or technical function in single ingredient feeds (SIFs) or mixed feeds. 

Some examples of IFAs include:

• boiler chemicals where the steam comes in contact with livestock feeds, including steam used in pelleting
• substances used in the production of SIFs.  For example, the antimicrobial agents, enzymes, yeasts and chemicals used in industrial ethanol production where the distillers' grains by-products from the production process are then used as SIFs. (see RG-6 Regulatory Guidance: ethanol distillers' grains for livestock feed)
• water treatment chemicals used in feed manufacturing and food processing plants to recover solids, when the recovered solids are then used as raw materials to produce SIFs
• denaturants and dyes used for marking inedible and prohibited materials in meat processing and rendering

This guidance covers all establishments manufacturing livestock feeds, including feed mills manufacturing mixed feeds, single ingredient feed manufacturers, and where SIFs are manufactured as a secondary product, coproduct or by-product. During compliance verification, feed manufacturers are responsible for demonstrating to CFIA inspectors that substances used in their establishments are safe. This is an essential part of good manufacturing practices to prevent the contamination of livestock feeds.

There are no sections of the Feeds Act and regulations, which specifically require the approval of IFAs for use during feed manufacturing. However, their misuse could result in the contamination of livestock feeds, thereby creating a potential animal or human health risk.  Such an action would be considered to be in violation of:

• Section 3(3) of the Feeds Act, which states, "No person shall manufacture, sell, import or export in contravention of the regulations any feed that presents a risk of harm to human or animal health or the environment"
• Sections 19(1)(j) and (k) of the Feeds Regulations which state: "a feed shall not contain:
  • (j) any material in quantities that could, when fed in proportions commonly used or as specified in the feeding directions, result in the production of an article of food that is prohibited from sale by virtue of section 4 of the Food and Drugs Act
  • (k) any material, other than those referred to in paragraphs (a) to (j), in quantities likely to be deleterious to livestock, when fed in proportions commonly used or as specified in the feeding directions"

Under the authority of the provisions of Section 3(3) of the Feeds Act and 19(1)(j) and (k) of the Feeds Regulations, and with the express intent of assisting feed manufacturers in averting violations thereof, the CFIA evaluates, on a case-by-case basis, the acceptability of various IFA products voluntarily submitted by manufacturers wishing to supply their products to feed manufacturers. Requests for such evaluations are called applications for data review, and the letters expressing favourable opinions are called "Letter Of No-Objection (LONO)".  The product manufacturers may then present these to prospective feed manufacturer customers in support of a letter of guarantee to be included in a preventive control plan. There is no fee attached to obtaining a LONO for an IFA.

A LONO does not constitute an approval of the product under the Feeds Act and regulations. It is simply an opinion expressed by the CFIA on the acceptability of the product, based on the information available at the time of its evaluation. Issuance of a LONO does not relieve the product user (that is, feed manufacturer) from their responsibilities relating to Section 3(3) of the Feeds Act or 19(1)(j) and (k) of the Feeds Regulations.

A LONO has no expiry date. It is considered valid as long as the composition, the intended use and the labelling content remain as described in the initial data review application. Applicants are responsible for notifying the CFIA of any changes that may affect the validity of the no objection status. The CFIA reserves the right to withdraw the no objection status of any given product should information come available showing that its use may potentially pose a risk to human health, animal health, or the environment.

3. Information requirements for IFA submissions

In order to evaluate the safety of the use of IFA products in feed manufacturing establishments, the CFIA requires that applicants submit the following information. These are initial requirements only. Evaluation of submitted information will dictate if any clarification or additional information is required. Third-party information or data on a particular ingredient in the IFA that is not made available to the applicant can be forwarded directly by the third-party to the CFIA. All such information is held in confidence and is used for evaluation purposes only.

3.1 Administrative requirements

• Submit the application package for data review - incidental feed additive as per section 1.3.1 My CFIA online livestock feed applications of RG-1 Chapter 1
• Checklist (included in Appendix 1)

3.2 Labelling guide for IFA products used in feed manufacturing establishments

The proposed label should include the following information:

• brand name (optional)
• descriptive name of the product and a statement denoting the function and specific intended use of the product in establishments manufacturing livestock feeds
• a listing of the major ingredients, (active and non-active)
• the physical state of the product (for example, liquid, powder, spray, aerosol)
• directions for the use of the IFA for the intended purpose, including:
  • the use(s) of the product in feed establishments
  • dilution factor(s) (for example,  millilitre (mL) of the product per litre (L) of water)
  • a potable water rinse (if applicable)
  • the amount of contact time with surfaces under treatment
    • Type of surfaces (for example, non-porous, porous, feed contact surfaces, floors, etc.), where applicable
    • A statement such as, (This product is to be used as recommended by a responsible company representative", and any caution or warning statements necessary to avoid contamination of livestock feed as follows: "Avoid contamination of livestock feed during application and storage)
• other caution and warning statements (if applicable)
• name and address of the manufacturer or distributor
• net content - metric units required (other units optional)
• shelf life of the product
• date of manufacture

3.3 IFA product composition

Full disclosure of the product's formulation, including chemical and microbial (if applicable) ingredients, is required. The formulations are held in strict confidence. This information should be in the form of a complete quantitative list of all ingredients used in its manufacture (pre-reaction formula) and in the final product's formulation (post-reaction formula, where applicable), taking into account that the percentage of components of the full formulation should add up to 100%.

• each chemical ingredient should be clearly identified by its proper chemical name, the Chemical Abstracts Service (CAS) registry number, trade or brand name and supplier
• if the IFA contains a polymer, the residual monomer concentration must be determined and the specification provided
• for microbiologically derived IFAs (for example, viable or non-viable microbes and enzymes)
  • Each microorganism and microorganism source must be identified by the scientific name of organism or production organism )that is, Genus species), source or origin, and designation of the strain
  • Characterization of the microbial product should be as per Section 2 of RG-1 Chapter 2.7 – Guidelines for the assessment of novel feeds: microbial sources

3.4 Use of the IFA and processing conditions resulting in incidental contact with livestock feeds

Provide details of the intended end-use and technical function of the IFA product, indicating that there is incidental contact in the manufacture of livestock feeds. Identify the SIFS or mixed feed into which the IFA may result in a residue from its use.  Describe the use of the IFA, including:

• A detailed flow chart and written description of the feed manufacturing process indicating where and the quantities of the IFA that are applied in the process
• Information on the stability of the IFA during the process, including considerations of thermal stability, etc.
• For microbial or enzyme-based IFAs, a definitive kill or inactivation step(s) must be included since IFAs must not contribute viable microorganisms, active enzymes, antimicrobial activity or resistance determinants to livestock feeds.

Given the product formulation, its use in livestock feed manufacturing, and where applicable, the stability of the IFA, provide estimates of the concentration of the IFA, its components, impurities and breakdown products in livestock feed. Where appropriate, calculations must incorporate a mass balance with concentrations and/or dilution factors.  Any reductions in exposure related to the stability or partitioning of an IFA or the killing or inactivation of a microbial or enzymatic IFA should be accompanied by a clear description and empirical data.

3.5 Livestock exposure estimates to IFA residuals

Provide estimates of livestock intake of IFA residuals in livestock feeds resulting from the use of the product. This information should be in the form of actual analytical data or theoretical estimates based on the proposed use of the IFA product and resulting livestock feeds.

3.6 Data for safety review

Data must be sufficient to demonstrate the safety of the IFA under the proposed conditions of use related to the safety of the livestock feed. Safety must be considered for all livestock species of the intended use of the livestock feed. The submission for new formulations or uses that significantly increase potential exposures should include all unpublished and published studies relevant to the safety assessment of the IFA when used under the same conditions or, if not, would still allow conclusions on the IFA under application to be made.

• In the case of unpublished studies, full reports complete with the primary data should be included with the submission, when available
• Sufficient details should also be provided to ascertain that study protocols conform with published testing guidelines such as those by the Organization for Economic Co-operation and Development (OECD). Studies conducted according to good laboratory practices are preferred

Toxicological data: In the case of chemical IFAs, the toxicity of the IFA and/or its components must be characterized. For an IFA with a fundamentally toxic mode of action such as sanitizers and disinfectants, a complete set of toxicological studies would normally be required, unless the formulation in question has been previously assessed by Health Canada.

• This could include acute, repeated-dose and chronic oral toxicity/carcinogenicity studies, reproductive and developmental toxicity studies, and genotoxicity studies. Additional studies on metabolism and pharmacokinetics  or to examine specific types of toxic effects may also be required to complete the safety assessment

Microbiological data: In the case of IFAs composed of or derived from microorganisms, data are required to characterize the components and support safety.  Since IFAs cannot have an effect on or in the livestock feed, they must not contribute viable microorganisms, active enzymes, or antimicrobial activity to livestock feeds.

While IFAs are not considered livestock feed, applicants of formulations containing microbiologically derived ingredients must characterize the animal and human safety components in Section 4 of RG-1 Chapter 2.7 - Guidelines for the assessment of novel feeds: microbial sources

3.7 Approvals in other jurisdictions or other additional information

The regulatory references of compliance with other government departments or other certification bodies may be useful but in of themselves are not sufficient for assessment purposes.

Health Canada's Bureau of Chemical Safety, the Pest Management Regulatory Agency (PMRA), Veterinary Drugs Directorate, Environment and Climate Change Canada, U.S. Code of Federal Regulations (Title 21 CFR), the European Union (EU) Regulations on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Domestic Substances List (DSL), Food Contact Premarket Notification (FCN), or Material Safety Data Sheets (SDS).

Some examples of references to chemical and microbial listings that may be relevant to a submission include:

Chemical:

1. Approved as a SIF listed in the Feeds Regulations (Schedule IV or V), which is available upon request from the CFIA;
2. In compliance with the Food and Drug Regulations
   • listed in the Food and Drug Regulations, Division 16
   • the subject of a "letter of no objection" from Health Canada for contact with food, or
   • the subject of an Interim Marketing Authorization from Health Canada for use in food
3. Listed in the "Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products Database" with approval that includes food contact;
4. Listed in the U.S. Code of Federal Regulations, Title 21, by the U.S. Food and Drug Administration (FDA), specifically:
   • those listed in Part 573 of Title 21, for the same purpose indicated in the CFR
   • those listed in other parts of Title 21, where the Center for Veterinary Medicine (CVM) has given a letter permitting their use in feed
   • those listed in Part 584 of Title 21, whose Generally Recognized As Safe (GRAS) status has been affirmed in writing by the FDA
   • those listed in Part 582 of Title 21, which the FDA has listed as GRAS based on the history of safe use in food or feed

Microbial:

1. Registered sources of SIFs listed in the Feeds Regulations (Schedule IV, Part II), which is available upon request from the CFIA
2. In compliance with the Food and Drug Regulations
   • considered to be a food additive and listed in the Food and Drug Regulations, Division 16
   • considered to be a food, but not considered to be a novel food (as per Division 28 of the Food and Drug Regulations)
3. Considered to be a novel food as per Division 28, and have received a "no objection letter/opinion" for use in food
4. Considered to be a food additive and the subject of an Interim Marketing Authorization from Health Canada for use in food
5. An enzyme that is considered to be a processing aid, and that is the subject of a "letter of opinion" issued by Health Canada
6. In compliance with the New Substance Notification Regulations (Chemicals and Polymers, and Organisms)
   •  enzymes and Saccharomyces cerevisiae strains listed in the Domestic Substances List (DSL) of the Canadian Environmental Protection Act
7. Listed in the U.S. Code of Federal Regulations, Title 21, by the U.S. Food and Drug Administration (FDA) and used for the same purpose indicated, specifically:
   • those listed in Part 573 of Title 21
   • those listed in other parts of Title 21, where the Center for Veterinary Medicine (CVM) has given a letter permitting their use in feed
   • those listed in Part 584 of Title 21, whose Generally Recognized As Safe (GRAS) status has been affirmed in writing by the FDA
   • those listed in Part 582 of Title 21, which the FDA has listed as GRAS based on the history of safe use in food or feed

The CFIA does not consider those additives whose GRAS status has been determined based on self-affirmation and has not been formally evaluated or confirmed by the FDA as being acceptable.

Note: Further information may be required after review of the preliminary submission. Valid scientific rationale may be provided in place of data requirements.

Appendix 1: Incidental Feed Additive (IFA) application checklist:

3.1 Administrative requirements

3.2 Labelling guide for IFA products used in feed establishments

3.3 IFA product composition

3.4 Use of the IFA and processing conditions resulting in Incidental contact with livestock feeds

3.5 Livestock exposure estimates to IFA residuals

3.6 Data for safety review

3.7 Approvals in other jurisdictions or other additional information

• Previous
• Table of Contents
• Next