Food and Drug Regulations
B.25.046 (1) No person shall sell or advertise for sale a new human milk substitute unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell or advertise for sale the new human milk substitute.
(2) The notification referred to in subsection (1) shall be signed and shall include, in respect of the new human milk substitute, the following information:
(a) the name under which it will be sold or advertised for sale;
(b) the name and the address of the principal place of business of the manufacturer;
(c) the names and addresses of each establishment in which it is manufactured;
(d) a list of all of its ingredients, stated quantitatively;
(e) the specifications for nutrient, microbiological and physical quality for the ingredients and for the new human milk substitute;
(f) details of quality control procedures respecting the testing of the ingredients and of the new human milk substitute;
(g) details of the manufacturing process and quality control procedures used throughout the process;
(h) the results of tests carried out to determine the expiration date of the new human milk substitute;
(i) the evidence relied on to establish that the new human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use;
(j) a description of the type of packaging to be used;
(k) directions for use;
(l) the written text of all labels, including package inserts, to be used in connection with the new human milk substitute; and
(m) the name and title of the person who signed the notification and the date of signature.
(3) Notwithstanding subsection (1), a person may sell or advertise for sale a new human milk substitute if the manufacturer has notified the Director pursuant to subsection (1) and is informed in writing by the Director that the notification is satisfactory.
- SOR/90-174, s. 2
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