RG-1 Regulatory Guidance:
Chapter 3 – Guidance on data requirements for feed approval and registration
3.12 Micro premixes

Regulation of Micro Premixes

In recent years, CFIA inspection personnel have noted an increase in the number of intra-company or "in-house" micro premixes stocked in feed manufacturing plants during routine inspections. As these premixes are generally highly concentrated sources of vitamins and/or trace minerals and/or medicating ingredients, they may pose serious health and safety concerns to both workers and livestock if inadequate labelling results in their inappropriate or incorrect use to manufacture other feeds.

This section outlines the interpretation of what are considered as "in-house", "customer-formula" and "consultant-formula" micro premix feeds for the purpose of their exemption from registration and certain labelling provisions under the federal Feeds Act and Regulations. These exemptions only apply to products manufactured in Canada; all micro premix products manufactured outside Canada are subject to mandatory registration by the Animal Feed Division of the CFIA prior to importation, distribution or sale in Canada.

"In-house" Micro Premixes

Micro premixes are considered to be bona fide "in-house" products only if they are manufactured by and intended for distribution and use within wholly-owned company operations. Such "in-house" premixes cannot be sold by the feed manufacturer, even to other mills manufacturing the same company brands or lines of feeds (e.g. franchise mills, buying groups or other business divisions).

Micro premixes of this description may be distributed between wholly-owned company operations without requiring registration or labelling as per the current Feeds Regulations providing they are labelled with the following:

• the name of the feed including the species and class of species it is intended for (e.g. "Micro Premix for Broiler Finisher");
• the statement "This feed is for internal use only by [Company name] and must not be offered for sale"; and
• Directions for Use stating that:
  (a) "This feed must be further mixed prior to feeding"; and
  (b) Users of the product should consult a company production manual or specific mixing formula for guidance on the proper use of the micro premix.

Where products contain medications, it is also required that the name and actual amount of the medication and all cautions and warnings associated with the use of the medication be on the label of the micro premix to prevent potential misuse, especially in facilities other than the one where the premix has been manufactured.

At any time, CFIA inspectors may request information concerning the specifications and content of an "in-house" micro premix on the premises so that compliance with the Feeds Regulations can be assessed. If information cannot be supplied within a reasonable amount of time (typically the length of time the inspector will be on the premises to conduct an inspection), an "in house" product may be subject to detention until the inspector is satisfied the product is in compliance.

"Customer Formula" Micro Premixes

Micro premixes are considered to be bona fide customer formula products only if the conditions for the manufacture and exemption from registration of such feed as prescribed by the Feeds Regulations are met (i.e. meets the definition, labelling and packaging requirements of the Regulations and a signed customer formula is in place on the premises of the premix manufacturer).

Note: You are reminded that from the definition of "customer formula feed" in section 2 of the Feeds Regulations, customer formula feeds are not to be resold by the purchaser nor are they allowed to be used by the purchaser to manufacture another customer formula feed referred to in paragraphs (b) or (c) of the definition.

"Consultant-Formula" Micro Premixes

Where micro premixes are formulated and manufactured by a seller to meet the requirements of a specific purchaser and are not intended to be resold by the purchaser, such micro premixes are considered "consultant-formula" products. While such products are exempt from registration, they are not exempt from the labelling requirements of section 26(1) of the Feeds Regulations.

All other types of micro premixes must be registered by the CFIA prior to sale in or importation into Canada.

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