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Standard Registration Requirements
___ Completed application package per T-3-20 (Application for Feed Registration and
Ingredient Approval)
Proposed Label (see label
provided)
___ Brand name (optional)
___ Product name reflecting purpose of the product and the intended
species
___ Product claim statement (if applicable)
___ Guaranteed analysis for active ingredients, i.e., enzyme activity
___ Details of enzyme assay conditions
___ Complete list of ingredients by generic name as listed in Schedule IV or V
of Feed 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.
For more information, please contact:
Feed Section
Animal Health & Production Division
Canadian Food Inspection Agency
59 Camelot Drive
Nepean, Ontario, Canada K1A 0Y9
Telephone: (613) 225-2342
Facsimile: (613) 228-6614
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