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Animals > Livestock Feeds > Trade Memoranda

T-3-122 - REGISTRATION OF FORAGE ADDITIVE PRODUCTS

April 1, 1997

Forage additive products have been registered by the Feed Section for a number of years. Considerable knowledge has been accumulated from members of the scientific community, product users and product manufacturers. This Trade Memorandum describes the present regulatory status and evaluation requirements for forage additive type products.

Forage additives are considered specialty products under the Feeds Regulations and are classified into three categories:

Category 1.	Nutritive additives such as molasses, grains, whey, urea, etc.,
Category 2.	Preservatives, such as organic acids (and derivatives), mineral acids, antioxidants, etc., and
Category 3.	Non-nutritive additives, such as enzymes, yeast and bacterial cultures, etc.

General Registration Requirements

The product formulation must be submitted.

Category 1.	For products considered as nutritive additives, a scientific study is not required to demonstrate their efficacy, since the guaranteed nutrient analysis stated on the product label substantiates the nutritional purpose.
Category 2.	For products marketed as mold inhibitors (preservatives), the registration application must be accompanied by a submission containing satisfactory evidence demonstrating the efficacy of the product to reduce or inhibit mold growth in forage. The studies must show a significant difference (P<0.05) between the control and the treated forage. A claim for mold control at specific moisture levels will have to appear on the label.
Category 3.	For products considered as non-nutritive additives, the registration application must be accompanied by a submission containing satisfactory evidence demonstrating the efficacy of the product, to substantiate at least one nutritional claim (i.e. statistically significant differences when compared to the control at P<0.05). Nutritional claims must relate to the conservation, retention or preservation of recognized nutritional elements such as dry matter, protein, fibre bound protein, vitamins, etc., or to the improvement of animal performance such as daily gain, feed/gain ratio, milk production, etc. Claims relating to chemical or physical attributes of the forage, e.g. pH, temperature, mold count (except for mold inhibitors), etc. are not acceptable as primary nutritional claims but may be accepted as secondary claims on the label, provided at least one nutritional claim has been substantiated.

Nutritional claims are not required but can also be used for Category 2 additives. The satisfactory evidence must be demonstrated according to the procedures outlined for the Category 3 additives.

Testing of forage additive products for efficacy must be performed under conditions similar to Canadian conditions. The experiments must be performed on a "farm scale" under the supervision of qualified research personnel. The research design must include at least 3 replicates of each treatment involved, including the control. The design must facilitate statistical analysis and results thereof must be analyzed by appropriate statistical methods, all of which is submitted for evaluation. The raw data (results) used to perform the statistics must be submitted.

The type of guarantees which must be shown on the product label depends on the type of product, but can be summarized as:

Nutritive additives: nutrient guarantees reflecting significant nutrient additions to the forage

Preservatives:guarantee for the preservative agent (e.g. propionic acid, etc.)

Non-nutritive additives: guarantee for the active ingredient (e.g. enzyme activity, viable lactic acid producing bacteria, etc.).

For additives where label guarantees are made for the enzymatic activity, the applicant should refer to the Trade Memorandum T-3-148 (Regulatory status of enzyme bearing products) and Trade Memorandum T-3-148 supplement (Guidelines for the evaluation of methods to determine the activity of enzyme ingredients used in animal feeds).

Specific requirements for non-nutritive additives

For non-nutritive additives (Category 3) based on microbial activity, original certificates of analysis showing the microbial activity for three different lots of the commercial product have to be supplied to support the guarantees on the label(s).

Also, because live organisms may lose their activity over time, an expiry date must appear on the product(s) label(s). Certificates of analysis substantiating the activity guaranteed on the label through to the end of the expiry period must also be supplied (generally 12 months from the date of manufacture). Companies with registered viable microbial products were informed of the requirement for an expiration date on June 15, 1994 in the revised Trade Memorandum T-3-143 (Regulation of viable microbial products for oral administration to livestock). In order to renew their registration, companies with registered forage additives containing microbial cultures will have to submit revised labels indicating expiry date and supporting documentation upon expiry of the product's registration, as per the dates outlined in the Feeds Regulations amendment SOR/DORS/96-422.

The analytical methods used to measure the activity of the microorganisms must be submitted for evaluation. Applicants must provide the Feed Section with samples of the exact same lots used for the certificates of analysis supporting the label guarantees. Each method will be individually reviewed and tested by the Ottawa Laboratory (Carling) - Feed and Fertilizer Laboratory of the CFIA according to the Trade Memorandum T-3-151 Supplement (Guidelines for the evaluation of methods to determine the viability of direct fed microbials and forage additives containing viable micro-organisms).

Registration of individual microbial strains

Live microbial (bacterial and yeast) cultures which are approved for use in livestock feed are listed in Part II of Schedule IV of the Feeds Regulations. Ingredients listed in Part II require registration prior to being fed to livestock. In the past, our office has not required registration of these individual sources of cultures because they were used in products, such as forage additives and viable microbial products, which themselves required registration. With the introduction of new technologies used to produce microbial strains, our office will now require that all microbial cultures be registered. Since August 1995, the Feed Section has been requiring that new applicants register their individual microbial cultures. All applicants registering products containing viable microbials after August 31, 1995 have complied with this new policy. For registered forage additives and viable microbial products that contain unregistered microbial cultures, the registration holder or the microbial culture manufacturer will have to submit a registration package for the individual cultures upon expiry of the product's registration.

The company must clearly describe the species of bacteria used and submit an analytical report with procedures for the isolation, quantification and identification (e.g. biotyping key, biochemical profile), of each bacterial strain. A description of the confirmational methods used must also be submitted. Submissions must include information demonstrating that the purity and origin of the bacterial strain(s) are acceptable under the Health of Animals Act and Regulations. In order to register the individual strains of microbials, submissions for registration must include:

1.	The standard registration requirements which include an application form, proposed label(s), and the registration fee for each individual strain. The proposed labels must include the exact name of the species and strain, an internal identification number (used by the registrant), a guarantee for the activity, an expiration date and the name and address of the registrant. These labels are intended for the Feed Section use only.
2.	Identification of the strain, its purity, and the origin of the culture used, including details of any genetic modification of the organism.
3.	The original certificate of analysis, in support of label guarantees, showing the test results of three lots of each strain. The certificates should state the actual colony forming units (CFUs) for microbial cultures, or viable cells per gram for yeast and must be signed by the laboratory technician carrying out the test.
4.	Complete composition (i.e. ingredient list, nutritional specifications) of the media on which the culture has been produced.
5.	Quality control specifications to include screenings for pathogens and other contaminants.
6.	If the information provided raises safety concerns (i.e. an unusual organism and/or genetic modifications), the submission of additional information substantiating species and strain safety may be required. The safety assessments for novel microbials will be conducted according to guidelines that are now available. Evaluations will be conducted on a case-by-case basis.
7.	Certificates of analysis supporting guaranteed shelf-life for at least six months from the date of manufacture (i.e. on the date of manufacture and at the expiry date).

Safe Handling of Viable Microbial Products

In developing the 1996 "Guidelines for the Safety Assessment of Novel Feeds: Microbial Products", the expert advisory committee recognized the potential of microbial products to cause dermal and respiratory irritation and/or sensitization. Registrants are therefore required to:

- conduct dermal/respiratory sensitization/irritation studies;

- include the following label statement on all microbial product labels (i.e, forage additives, direct fed microbial products, and individual cultures):

"This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling."; or

- provide scientific rationale as to why the above are not necessary.

Formulation modifications

Companies who wish to market a modified formulation of a registered forage additive will not be required to submit additional scientific evidence for an increase in the level of active ingredients (e.g. acids, nutrients, bacteria, enzymes). The registrant will however have to substantiate that:

- the other ingredients in the product have not been modified;

- the final concentration of active ingredient(s) applied to the forage is the same or higher than what has already been approved;

- the stability of the product under specified storage conditions has not changed.

The submission of new certificates of analysis for active ingredient(s) will be required. The claim(s) approved for the original formulation will be transferred to the new formulation.

Carrier substitutions or carrier additions are considered new formulations and will be evaluated on a case-by-case basis to determine the need for new scientific evidence to justify claims or safety (for which all documentation necessary to complete an evaluation will be required).

Temporary Registration

A temporary registration may be granted only for forage additive products for which all the basic registration requirements (registration of individual strains, safety, etc.) have been provided, and for which:

- the substantiating information (efficacy data) submitted could not support a nutritional claim (i.e. the data cannot quite show a statistical difference when compared with the control, at P>0.05), but showed a tendency (0.05<P<0.10). In the case of a mold inhibitor (category 2), the substantiating information could not support a claim for the control of mold growth; or

- the substantiating information was performed on a small scale (for example lab silos) and showed a significant difference when compared with the control (P<0.05, Categories 2 or 3).

The issuance of temporary registrations is considered an interim measure which allows companies to adequately comply with the policy of demonstrating the efficacy of their products (claim(s)). Only one temporary registration will be granted per product or formulation for a maximum three-year period. If the benefit of the product has not been substantiated by the end of this period, the registration will not be renewed. Products bearing a temporary registration number on the label will be further identified with the letter "T" beside the number.

Director
Animal Health and Production Division

Questions should be directed to:

Feed Section
Animal Health and Production Division
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9
Tel: 613-225-2342
Fax: 613-228-6614

Note: This replaces Trade Memorandum T-3-122 dated December 1, 1996.

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