RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.13 Mineral complexes

Regulation of Mineral Complexes

This section is intended as a guide to the regulation by the 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, applicable fee 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:

i)  Super zinc complex for livestock feeds
Ingredients: zinc proteinate, wheat midds

Guaranteed analysis:

ii)  Super zinc complex for livestock feeds
Ingredients: zinc lysine complex, wheat midds

Guaranteed analysis:

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 section 6.2, 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 Animal Feed Division and the Science Branch 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 (now the Animal Feed Division) 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, applicable fee 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.

Registration Checklist for Mineral Complexes

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
• Guaranteed analysis for a minimum percent (or mg/kg) complexed mineral, in addition to an actual percent (or mg/kg) mineral
• 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
• 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 manufacturing & Composition

• Details concerning manufacturing process of product
• Formulation / percentage composition listing amount of each ingredient

Lab Methods

• Complete laboratory method description and supporting data used to verify the guarantee for the % bound (complexed) mineral. Follow section 6.2 for laboratory requirements

Safety Review

• Dioxin analysis for 3 lots for single ingredient minerals

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.

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