RG-1 Regulatory Guidance:
Chapter 4 – Labelling and guarantees
4.5 Vitamin D3 and 25 - Hydroxyvitamin D3 guarantees
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Crystalline 25-Hydroxyvitamin D3 is a single ingredient feed that is approved as a source of vitamin D3 activity in complete feeds and supplements for drinking water for chickens and turkeys and complete feeds for swine in Canada. Crystalline 25-Hydroxyvitamin D3 is listed in Part II of Schedule IV of the Feeds Regulations, which means that only registered sources of this vitamin can be used in feeds in Canada. As there is no standard analytical method to determine the vitamin D3 activity from 25-hydroxyvitamin D3 in mixed feeds, the following policy will apply.
Vitamin D3 guarantees on labels for complete feeds and supplements for drinking water for chickens and turkeys and complete feeds for swine will be considered as the sum total of the Vitamin D3 activity from D-activated animal sterol, Vitamin D3, and crystalline 25-hydroxyvitamin D3. The amount of Vitamin D3 activity supplied by crystalline 25-hydroxyvitamin D3 will depend upon the label guarantee of each registered source. Presently, the only approved source of crystalline 25-hydroxyvitamin D3 supplies the following activity: 1 mg of 25-hydroxyvitamin D3 = 40,000 IU of Vitamin D3 activity.
Mixed feeds containing crystalline 25-hydroxyvitamin D3 may be exempt from registration, as long as there is no reference to this ingredient (other than the ingredient name and registration number, when a list of ingredients is present on the label) either by name, guarantee or claim on the label, and all other criteria for exemption from registration under the Feeds Regulations are met.
If the presence of crystalline 25-hydroxyvitamin D3 is highlighted on the label for a mixed feed, the mixed feed must be registered, and the following additional information (compared to a standard product registration) will be required as part of the application for registration:
- a label with a guarantee for the minimum concentration of 25-hydroxyvitamin D3, in mg/kg;
- the vitamin D3 guarantee on the label will have to specify that it includes all sources of vitamin D3 activity;
- the complete and detailed product formula (i.e., indicating the inclusion rate of each ingredient in the formulation, either on a weight/weight or percent basis), which will be used to verify both the label guarantee and the use of a registered crystalline 25-hydroxyvitamin D3 source;
- either the brand name or the approved single ingredient feed name (i.e., crystalline 25-hydroxyvitamin D3) in addition to the registration number of the source of crystalline 25-hydroxyvitamin D3 are to be indicated on the labels for standard mixed feeds and supplements; and
- the appropriate fees for a category 2 type application, as per Chapter 1 of the Regulatory Guidance.
For registered feeds, any proposed changes to the registration (e.g., product formulation, label guarantee(s), directions for use, intended species, the source of crystalline 25-hydroxyvitamin D3 used in the feed, etc.) must be first approved by the Animal Feed Division, via an application for a significant change to the registration that is accompanied by registration fees for a Category 2 type submission. Also please note that at registration renewal, the product formula must be submitted in support of the previously approved source and inclusion rate of crystalline 25-hydroxyvitamin D3.
Note: Additional information may be requested by the Animal Feed Division.
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