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T-3-158 - REGULATION OF MINERAL COMPLEXES

April 3, 2000

This Trade Memorandum is intended as a guide to the regulation by the Canadian Food Inspection Agency (CFIA) of specialty mineral ingredients, including chelates, amino acid complexes, proteinates, etc., hereafter referred to as mineral complexes.

1a) Regulation of mineral complexes

These types of feed ingredients are required to be registered, and must be labelled with a guarantee for minimum percent (or mg/kg) complexed mineral, in addition to an actual percent (or mg/kg) mineral. Companies wishing to market these minerals must submit suitable laboratory method(s) to be used to quantify the complexed mineral.

1b) Regulation of mixed feeds containing mineral complexes

Persons wishing to manufacture, sell, or import complete feeds, supplements, specialty mineral premixes, etc., containing mineral complexes are required to use only registered sources of mineral complexes.

Unless other registration conditions apply, mixed feeds containing mineral complexes are exempt from registration, as long as there is no reference to the products (other than the ingredient name and/or registration number when a list of ingredients is present on the label) and all other criteria for exemption from registration under the Feeds Regulations are met. A reminder: all imported mixed feeds still require registration.

If the complexed mineral ingredients are highlighted on the label for a mixed feed, the feed must be registered. Guarantees for the minerals (actual, mg/kg) and a list of ingredients (including the registration numbers and/or registered name of each registered mineral complex) are required.

2a) Registration requirements - single ingredient mineral complexes

Along with the standard requirements for registration, including, application form, fee of $302.10, and covering letter, applicants should submit:

A. Proposed label, to include a guarantee for the mineral (actual) as well as a guarantee for minimum complexed mineral (express either as a percent of the actual mineral guarantee, or in absolute terms.

Example: The following draft labels show acceptable labelling format:

B. Complete laboratory method description and supporting data used to verify the guarantee for the % bound (complexed) mineral must also be submitted. Laboratory method submissions should address all of the requirements outlined in Trade Memorandum T-3-151, Good Laboratory Practices Protocol for Feed Ingredient Approvals.

For the present time, applicants are required to submit product-specific analytical methods, i.e., the method that would be used in their own quality control procedures to verify product guarantees. This means that the submitted and approved method will be used by the CFIA for post market surveillance of registered products.

The Feed Section and the Ottawa Laboratory (Carling) - Feed and Fertilizer Laboratory of the CFIA will, however, be working toward the utilization of a standard method(s) for verification of guarantees for binding in complexed minerals. In 1997, the Feed Section undertook a survey of the manufacturers of mineral complex products, and advised these manufacturers of the implementation of the new requirement to guarantee and provide laboratory methods for "percent bound" or "percent complexed" in addition to guaranteeing the actual mineral. We plan to consult with these same companies on any developments in establishing a single method. Input on this process from other interested parties is welcome.

2b) Registration requirements - mixed products containing and highlighting mineral complexes

Along with the standard requirements for registration, including, application form, fee of $302.10, and covering letter, applicants should submit:

1. Product formulation

2. Proposed label - to include a complete list of ingredients, including the registered name or registration number of each registered mineral complex ingredient.

Questions regarding this memorandum, and comments on the proposed method standardization should be directed to:

Feed Section
Animal Health and Production Division
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario (Canada)
K1A 0Y9

Phone: 613-225-2342
Fax: 613-228-6614