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

3.18 Ruminant and horse supplements

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Regulation of ruminant and horse supplement feeds

Over the past several years, confusion has arisen regarding the regulatory status of ruminant and horse feeds manufactured in Canada termed "supplements" to the point where it is generally believed that the majority of these products are exempt from mandatory registration. This section will clarify the regulatory status of "supplement" feeds and identify which products require registration.

Background

The definition of a livestock "supplement" feed in section 2 of the Feeds Regulations is a broad one that allows this category of product to be fed in 3 different ways:

(a) fed undiluted as a supplement to other feeds,
(b) offered free choice with other parts of the ration separately available, or
(c) further diluted and mixed to produce a complete feed that is acceptable for registration.

"complete feed" means a feed that, when used for the kind of livestock and for the purposes stated on the label, will provide all of the nutritional requirements necessary for the maintenance of life or for promoting production except

(a) water, in the case of monogastric animals other than horses, and
(b) water or roughage, in the case of ruminant animals and horses (aliment complet)

For the purposes of the regulations, the complete feed for a ruminant animal or a horse is not the same as its total diet.

Although subsection 5(1) requires that all feeds be registered, subsection 5(2) contains a long list of specific exemption criteria for products defined within the scope of the regulations. With respect to "supplements", paragraphs 5(2)(d) and (e) outline the exemption criteria:

"(d) any complete feed, supplement or macro-premix manufactured in Canada that is designed to be fed to beef cattle, dairy cattle, sheep, swine, chickens, turkeys, horses, goats, ducks, geese, salmonid fish, mink or rabbits where...
(iv) in the case of a supplement or macro-premix, the nutrient level guaranteed for those nutrients listed in Table 4 of Schedule I is such that when the supplement or macro-premix is used according to the directions for use it will not supply the complete feed with any nutrient at a level higher than the maximum listed in that Table for that nutrient but will supply the complete feed, in conjunction with the other ingredients, with a level of nutrient that meets or exceeds the minimum listed in that Table for that nutrient, ..."

"(e) any consultant formula feed manufactured in Canada if ...
(iii) in the case of a supplement, macro-premix or micro-premix, the nutrient level guaranteed for those nutrients listed in Table 4 of Schedule I is such that when the supplement, macro-premix or micro-premix is used according to the directions for use it will not supply the complete feed with any nutrient at a level higher than the maximum listed in that Table for that nutrient but will supply the complete feed, in conjunction with that supplied by the other ingredients, with a level of nutrient that meets or exceeds the minimum listed in that Table for that nutrient, ..."

The criteria mentioned above indicates that supplements are considered exempt from mandatory registration if the nutrient level guaranteed is such that when the supplement is used as directed, it will :

Interpretation

Given the above definitions and exemption criteria, "supplement" feeds to be offered undiluted or free choice to ruminants or horses, with no further mixing directions on the label are not exempt from mandatory registration as they would not meet the specific exemption criteria described above.

Example products required to be registered include:

Considering all other applicable regulatory requirements are met, supplement labels that include sufficient mixing directions to ensure that the Table 4 maximum and minimum level standards are met would be deemed exempt from registration. This could include:

If the nutrients in the supplement alone are sufficient to meet the minimum Table 4 nutrient levels, without exceeding the maximum Table 4 nutrient levels, simple mixing directions may be sufficient to meet the exemption from registration criteria.

For example:

In cases where the nutrients in the supplement alone are not sufficient to meet Table 4 minimum levels, the directions for use on the label must include additional information on the type and amount of the other ingredients to be used, as their nutrient levels must also be considered to determine if the resulting complete feed or total diet meets the Table 4 minimum values.

For example:

Note that in the case of medicated supplements, the directions for use indicated on the label must also be sufficient to confirm that the feed contains the correct amount of medicating ingredient as per the Compendium of Medicating Ingredient Brochures (CMIB) or the veterinary prescription, as applicable.

Therefore, to be considered exempt from registration, all ruminant and horse supplement feeds, including consultant formula feed supplements, require sufficient directions for use to demonstrate that the Table 4 standards are being met.

Product registration

Supplements requiring registration will be accepted and processed per the procedures and application fees for registration outlined in Chapter 1.

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