Chapter 3 - Specific Registration Information by Feed Type
3.6 Enzyme Products

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Regulatory Status of Enzyme Bearing Products

Since specialized products designed only to be sources of enzymes in feeds were introduced into the marketplace, the Feed Program of the CFIA has clarified the status of these products under the Feeds Regulations. Enzyme sources are currently approved and listed in Schedule IV of the Feeds Regulations.

Presently, most enzymes added to feeds are in the form of non-viable fermentation by-products. There are three basic fermentation products containing enzyme activity. These are:

  1. The complete or crude microbial fermentation product. The enzymes as well as the entire medium are recovered, complete with other metabolites and fermentation substances. This includes the solids and solubles associated with the fermentation (e.g. Aspergillus niger fermentation product).
  2. A more purified enzyme source consists of only the soluble portion of the fermentation product, from which the solids have been separated (e.g. Aspergillus niger fermentation solubles).
  3. Relatively pure enzyme product results from extracting and purifying the solubles (e.g. Bacillus subtilis fermentation extract).

The fermentation products listed above that contain enzyme activity are currently described in Schedule IV of the Feeds Regulations. As the enzyme products used in the feed industry are covered by these descriptions in the regulations and as, to date, there is no "pure" enzyme product available, there has been no reason to include a description for purified enzymes.

The following policy has been agreed upon after consultation with the stakeholders:

When an ingredient list is shown on any product label, the enzyme bearing ingredient(s) (i.e. fermentation product, as for example Aspergillus niger fermentation solubles, from which the enzyme activity is derived) rather than the enzyme derived (e.g. cellulase) will be listed.

When a product is marketed for its enzyme content, guarantees for the enzyme activity(ies) will have to be made on the label. Such products will be registered as "enzyme supplements".

It should be noted that products bearing enzyme guarantees on the label are not exempted from registration, as no nutrient ranges have been set forth for them in Table 4 of the Feeds Regulations (Section 5(2) (iii) and (iv)).

Prior to applying for registration at the Animal Feed Division, companies must submit the following information:

  • A sample of each enzyme bearing product submitted for registration;
  • The product formulation;
  • The description of the analytical methods for determination of the enzyme activity (ies) guaranteed (including supporting data). The proposed methods will be reviewed and tested individually, according to the protocol described in section 6.3, "Guidelines for the Evaluation of Methods to Determine the Activity of Enzyme Ingredients Used in Animal Feed";
  • Certificates of analysis for three different lots of the product showing that, using the analytical methodology(ies) submitted, the product meets the guarantees shown on the labels.

The above required information should be submitted directly to this address:

Ottawa Laboratory (Carling)
Building # 22
960 Carling Avenue
Ottawa, Ontario
K1A 0C6

Once the method has been validated by CFIA laboratories, companies will then have to apply for registration under the Feeds Act and Regulations at the Animal Feed Division. To support registration, companies will only be required to submit the standard registration documents (i.e. Application for Feed Registration or Renewal (CFIA/ACIA 0009) form, application fees, proposed label and accompanying letter).

As always, registration is subject to the submission of acceptable information on the safety and efficacy of the product. In developing the 1996 Guidelines for the Safety Assessment of Novel Feeds: Microbial Products, the expert advisory committee recognized the potential of microbial products (including fermentation 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 enzyme bearing product labels:

    "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.

Registration Checklist for Enzyme Supplements

Administrative Registration Requirements

  • Completed application package per Chapter 1

Proposed Label

  • Brand name (optional)
  • Product name reflecting purpose of the product and the intended species
  • Product claim statement (if applicable)
  • Guaranteed analysis for active ingredient(s), i.e., enzyme activity
  • Details of enzyme assay conditions
  • Complete list of ingredients by generic name as listed in Schedule IV or V of the Feeds Regulations including registration numbers for Part II ingredients or mixed feeds as required
  • Directions for use to permit safe and effective use of feed including pelleting statement
  • Caution and/or warning statements (if applicable)
  • Name and address of registrant
  • Net amount (metric measure)
  • Lot Number
  • Expiry date with storage conditions
  • Registration number (to be added)

Product Composition

  • Formulation / percentage composition listing amount of each ingredient

Scientific Studies (products with claims only)

  • Scientific studies are required to support the intended purpose of these products
  • Studies carried out by qualified personnel
  • Suitable methods used in studies
  • Studies designed to facilitate statistical analysis
  • Data analysed by appropriate statistical methods
  • Studies conducted under conditions similar to those that may be expected to occur in Canada
  • Scientific investigations show that the products when used as directed, results in a significant improvement in one or more nutritional feed claims for the product
  • Studies show a significant difference (P<0.05) between the control and treated groups. Where the directions for use indicate a range of inclusion rates, the testing protocol must evaluate the lowest inclusion rate.
  • Where results of these studies have not been published in a refereed journal, copies of the raw data and printouts of statistical analysis are required for our review.

Lab Methods

  • Certificate of Analysis for a minimum of three lots supporting label guarantees for the active ingredients, i.e., enzyme activity
  • Information on the methodologies used to analyse the enzyme activity
  • Certificates of Analysis substantiating the guaranteed shelf life on the label

Safety Review

  • Conduct dermal/respiratory sensitization/irritation studies or provide scientific rationale as to why the above is not necessary or
  • Include required statement on the label "This product may cause dermal and respiratory irritation and/or sensitivity. Appropriate protective equipment must be worn during handling"

Sample

  • Provided (if necessary for laboratory methodology verification)

Promotional Claims (including Internet and Advertising)

  • Consistent with stated purpose of product

Note: Further information may be required after a review of the preliminary submission.

Sample Label: Enzyme Supplement

Brand Name (optional)
Enzyme Supplement for (name species) Feed

When used as directed, (list claims, e.g., reduces requirement for inorganic phosphorus) in (name species and class of livestock)

Guaranteed Analysis

Enzyme Activity
(details of assay conditions must be provided)

X units/g (minimum)

Ingredients

(list all ingredients fermentation products and carriers by generic name as listed in Schedule IV or V of the Feed Regulations including registration numbers for Part II ingredients or mixed feeds as required)

Directions for Use

Mix in feed at x kg/tonne

Pelleting statement

Caution

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

Storage

Keep in a dry cool area. Stability of the product is ensured for 15 months at room temperature and under appropriate storage conditions.

Lot No.

Expiry Date

Registrant's Name and Address

Net Weight (metric measure)

Registration Number (to be added)

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