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Standard Registration Requirements
___ Completed application package per T-3-20 (Application for Feed Registration and
Ingredient Approval)
Proposed Label
___ Brand name (optional)
___ Product name reflecting purpose of the product and the intended
species
___ Product claim statement
___ Guaranteed analysis (active ingredient(s))
___ 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 the feed
___ Caution and/or warning statements (if applicable)
___ Name and address of registrant
___ Net amount (metric measure)
___ Registration number (to be added)
Product Composition
___ Formulation / percentage composition listing amount of each ingredient by
generic name as listed in Schedule IV or V of Feed Regulations including
registration numbers for Part II ingredients or mixed feeds
___ Formulation / Ingredients - verify level of ingredients does not exceed
maximums per Schedules IV and V.
Scientific Studies
___ Scientific studies are required to support the intended purpose of the
product and must be provided for our review
___ Efficacy data must be collected under conditions which reflect practical
conditions, e.g., data collected on 25 kg. bags (1 bag = one replicate) stored
for the required period of time
___ 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
___ In general, studies should be for a minimum duration of 120 days and have
a minimum of three replicates per treatment. (Replicates must be treated
individually with the test product as subsamples of one treated batch are
considered duplicates, not replicates)
___ Scientific testing must be performed on feeds for all species which the
mould inhibitor is intended, e.g. swine, poultry, etc.
___ Where the directions for use indicate a range of inclusion rates, the
testing protocol must evaluate the lowest inclusion rate
___ Studies show a significant reduction (P<0.05)
in a
total mould count between the control and treated product
___ The laboratory method used to count the moulds must be submitted,
including references for the method
___ 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
___ Original signed Certificates of Analysis for a minimum of three different
lots of the product supporting label guarantee(s) for the active ingredient(s)
are provided
___ Copies and information on the AOAC or other official
methodologies used to analyse the acid level(s). In the event that these
methods have not been peer-reviewed, additional information is required to
validate the laboratory method as outlined in T-3-151 (Good Laboratory Practices Protocol for Feed
Ingredient Approvals.)
____ Copies and information on any new or unique analytical methods or
guarantees are provided for the Ottawa Laboratory (Carling) Feed and
Fertilizer
Sample
___ Provided (if necessary to validate lab methodology)
Promotional Claims (including Internet and Advertising)
___ Consistent with stated purpose of product
NOTE: Further information may be required after a review of the
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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