Chapter 4 - Labelling and Guarantees

---

4.5 Vitamin D and 25-Hydroxyvitamin D₃ Guarantees

25-Hydroxyvitamin D₃ is a single ingredient feed that is approved as a source of vitamin D activity in chicken and turkey feeds in Canada. 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. As there is no analytical method for vitamin D activity from 25-hydroxyvitamin D₃ in mixed feeds, the following policy will apply.

Vitamin D guarantees on chicken and turkey feed labels will be considered as the sum of the Vitamin D activity from D-activated animal sterol, Vitamin D₃, and 25-hydroxyvitamin D₃. The Vitamin D activity supplied by 25-hydroxyvitamin D₃ will depend upon the registered source. Presently, the only approved source of 25-hydroxyvitamin D₃ supplies the following activity: 1 mg of 25-hydroxyvitamin D₃ = 40,000 IU of Vitamin D₃ activity.

Mixed feeds containing 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 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:

1. a label with a guarantee for minimum mg/kg of 25-hydroxyvitamin D₃;
2. the vitamin D₃ guarantee on the label will have to specify that it includes all sources of vitamin D₃ activity;
3. the product formula, to verify both the label guarantee and the use of a registered 25-hydroxyvitamin D₃ source;
4. the name and source of 25-hydroxyvitamin D₃ indicated on the labels for standard mixed feeds and supplements; and
5. the appropriate fees for a category 2 type application, as per Chapter 1 of this document.

Please note that a successful registration will be based on a specified inclusion rate of the embedded source of 25-hydoxyvitamin D₃. Any proposed changes to the inclusion rate or the source of 25-hydroxyvitamin D₃ must be first approved by the Animal Feed Division, via an application for a "Significant Change to the Registration", in addition to the modified formulation and category 2 type fee. Also please note that at registration renewal, the product formula must be submitted in support of the previously approved source and inclusion rate of 25-hydroxyvitamin D₃.

Note: information in addition to that listed above may be requested by the evaluating officer.

Next page: Section 4.6 | Previous page: Section 4.4