Food and Drug Regulations (C.R.C., c. 870)

B.16.001. A quantitative statement of the amount of each additive present or directions for use that, if followed, will produce a food that will not contain such additives in excess of the maximum levels of use prescribed by these Regulations shall be shown, grouped together with the list of ingredients, of any substance or mixture of substances for use as a food additive.

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 Director, 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.

B.16.003. The Minister shall, within 90 days after the filing of a submission in accordance with section B.16.002, notify the person filing the submission whether or not it is his intention to recommend to the Governor-in-Council that the said food additive be so listed and the detail of any listing to be recommended.

B.16.004. [Repealed, SOR/97-148, s. 6]

B.16.006. Paragraph B.01.042(c) and paragraph B.01.043(a) do not apply to spices, seasonings, flavouring preparations, essential oils, oleoresins and natural extractives.

B.16.007. No person shall sell a food containing a food additive other than a food additive provided for in sections B.01.042, B.01.043 and B.25.062.

B.16.008. [Repealed, SOR/88-418, s. 5]