Feeds Regulations, 2024 — 7
Application for approval or registration 7 (1) An application for approval or registration of a feed must be made to the Minister in a form approved by the President. Elements required (2) Subject to subsections (4) and (5), the application must be accompanied by (a) three copies of a proposed label to be used with the feed if the application is submitted by mail, or one copy of such label if the application is submitted electronically; (b) the name of the feed that complies with sections 50 and 51 , as well as any other name or registration or reference number used to identify the feed; (c) a description of the feed, including a list of ingredients; (d) a description of the intended purpose of the feed; (e) directions for use of the feed; (f) the name and address of each location where the feed is manufactured; (g) specifications, concerning, among other things, (i) the usefulness, purity and quality of the feed and the homogeneity of the mix, and (ii) any component, the amount of which must be guaranteed in the feed; (h) the identification and description of any contaminant in the feed, as well as the methodology and analysis for the detection of the amounts of those contaminants; (i) reports of any analysis conducted on representative samples drawn from three different and recent lots of the feed, to support any information referred to in paragraphs (g) and (h); (j) a description of the production methods, including details of (i) the formulae used in manufacturing the feed, (ii) the steps of the feed manufacturing process and any variation in the process resulting from the source of any ingredient or additive in the feed or the location where it is manufactured, (iii) the type and capacity of the equipment used in manufacturing the feed, and (iv) quality control procedures to assure mix uniformity and to prevent contamination of subsequent lots of feed manufactured in the same place; (k) evidence, including the results of any scientific investigation, (i) demonstrating the safety of the feed for the species of livestock for which it is intended, as well as other species of livestock that may be exposed to it, and for humans and the environment, (ii) demonstrating the efficacy of the feed when used for its intended purposes and according to its directions for use, (iii) demonstrating the stability of the feed under normal storage conditions, (iv) demonstrating that any guarantee shown on the label, other than those set out in the Tables of Nutrient Guarantees and Conditions for Feed Labels , conveys useful information to the purchaser of the feed, and (v) supporting any claim on the label of the feed that is not set out in the Tables of Permissible Claims for Feed Labels ; (l) scientific analysis that shows whether there are significant changes in the chemical, biological or physical composition of livestock products when the feed is used; and (m) a summary of all the elements provided in support of the application. Additional information — novel trait (3) In the case of a feed with a novel trait, an application for approval must be accompanied by the following additional information: (a) the identification and characterization of the novel trait and, if the novel trait is introduced from another species, details of the host and donor organisms and the methods of introduction of the novel trait into the feed; (b) the identification and characterization of the feed with a novel trait resulting from the introduction of the novel trait, including details relating to expression of the novel trait and the stability of the introduction of the novel trait into the feed, as well as a comparison of the characteristics of the feed with those of any comparable feed; (c) any other information, including the results of any scientific investigation and test data in respect of the novel trait that are relevant in identifying whether the feed presents a risk of harm to human or animal health or the environment, that is in the applicant’s p