Animals > Livestock Feeds > Trade Memoranda  

T-3-142 - SPECIALTY PRODUCT REGISTRATION REQUIREMENTS

September 1, 1997

Applications for specialty product registrations may include but are not limited to:

Administrative Requirements

1. Standard registration requirements including completed application for registration form (CFIA 0009), application fee, 5 copies of a proposed label, the accompanying letter, signing authority/Canadian agent (if applicable).

Labelling

2. Proposed labels must reflect the purpose of the product and the standards, packaging and labelling requirements of the Feeds Act and Regulations.

Product Description and Supporting Information

3. Complete list of ingredients identified by generic name as listed in Schedule IV or V of the Feeds Regulations (if not so listed, Single Ingredient Feed evaluation requirements must be fulfilled and the ingredient clearance granted prior to registration) and formulation/percentage composition (if judged necessary by the evaluation officer).

4. Intended purpose of the feed (to assist in designating the name of the feed (e.g. milk replacer, flavouring agent, antioxidant, forage additive etc.)).

5. Scientific investigations presented in support of label claims must be:

• carried out by qualified research personnel;
  
• carried out using suitable methods;
  
• designed to facilitate statistical analysis;
  
• analysed by appropriate statistical methods; and
  
• conducted under conditions similar to those that may be expected to occur in Canada.

6.  Certificate of analysis and analytical methodology substantiating the guarantee(s) (e.g. new guarantee or method).

7.  Quality control procedures demonstrating consistency if applicable.

8. Sample (such as for forage additives, direct-fed microbials and enzyme supplements or at the request of the evaluation officer).

9. Stability information if applicable.

Safety Information

10. As outlined in Trade Memoranda T-3-141 and T-3-141 suppl., scientific investigations supporting product safety may include, but are not limited to, chemical analyses and/or harmful residues and/or toxicological evaluation and/or animal feeding study and/or tissue residue analysis etc. presented in support must be:

• carried out by qualified research personnel;
  
• carried out using suitable methods;
  
• designed to facilitate statistical analysis;
  
• analysed by appropriate statistical methods; and
  
• conducted under conditions similar to those that may be expected to occur in Canada.

11. Suitable methodology for the detection of significant amounts of any ingredient, compound, substance, or organism intentionally incorporated into the feed or occurring as a contaminant.

Registration Requirements for Private Labelled Products

The private label registration process has been put in place to allow companies to commercialize a product registered by another company under their own brand name. Such applications are considered standard feeds, not requiring any additional safety or efficacy assessments. Applications for registration of private labels must include the following:

• Application form CFIA 0009.
  
• Application fees for a standard feed.
  
• 5 copies of a proposed label. The proposed label must include the name and address of the private registrant.
  
• The accompanying letter.
  
• A letter from the company holding the original registration, signed by a person having signing authority for this company, allowing the applicant to use the information on file to register their product under a private label.

As the formulation of the private labelled product must correspond exactly to the formulation originally registered, any mandatory information present on the original label (i.e. ingredient list, guaranteed analysis, directions for use and notes), must be present on the private label. If the private labelling company also manufactures the feed, the formulation and certificates of analysis may be required.

Applications for amendments to private labels will be evaluated on a case-by-case basis according to the following criteria:

 a) Mandatory amendments:

For mandatory amendments (i.e. amendments initiated by the Feed Section), the Feed Section will inform all holders of a registration for the type of product affected by the amendment, including private label registrants. Mandatory amendments must be made to both private labels and original labels. There will be no charge for such amendments.

In cases where an application is made for a private label for which the status of the original product registration would not satisfy new mandatory requirements, either for efficacy or safety, the private label application would be refused, until the original product meets all registration requirements. The holder of  the original registration will be notified of the situation.

Minor mandatory amendments required by the Feed Section (e.g. addition of a label statement), would be made to a private label immediately upon registration, even though the original label might not yet comply with the new amendment. In these cases, the private label will be corrected before the original label. Minor mandatory amendments to the original label would be made at the time of renewal.

 b) Voluntary amendments:

When the original registrant is granted an amendment (e.g. upgraded guarantee, addition of a claim), the original registrant is responsible for notifying the private label registrant of these amendments. In such cases, private label registrants are not obliged to update their registration to reflect the change(s) made to the original registration as long as the private label continues to comply with the Feed Regulations. However, should the private labelling company choose to include the new information, an application package for a significant change must be submitted.
 

Questions regarding this memorandum may be directed to :

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