Food and Drug Regulations

B.16.002 A request that a food additive be added to or a change made in the Tables following section B.16.100 shall be accompanied by a submission to the Minister in a form, manner and content satisfactory to him and shall include

• (a) a description of the food additive, including its chemical name and the name under which it is proposed to be sold, its method of manufacture, its chemical and physical properties, its composition and its specifications and, where that information is not available, a detailed explanation;

• (b) a statement of the amount of the food additive proposed for use, and the purpose for which it is proposed, together with all directions, recommendations and suggestions for use;

• (c) where necessary, in the opinion of the Minister, an acceptable method of analysis suitable for regulatory purposes that will determine the amount of the food additive and of any substance resulting from the use of the food additive in the finished food;

• (d) data establishing that the food additive will have the intended physical or other technical effect;

• (e) detailed reports of tests made to establish the safety of the food additive under the conditions of use recommended;

• (f) data to indicate the residues that may remain in or upon the finished food when the food additive is used in accordance with good manufacturing practice;

• (g) a proposed maximum limit for residues of the food additive in or upon the finished food;

• (h) specimens of the labelling proposed for the food additive; and

• (i) a sample of the food additive in the form in which it is proposed to be used in foods, a sample of the active ingredient, and, on request a sample of food containing the food additive.