B.28.001. The definitions in this section apply in this Division.

“genetically modify” means to change the heritable traits of a plant, animal or microorganism by means of intentional manipulation. (modifier génétiquement)

“major change” means, in respect of a food, a change in the food that, based on the manufacturer’s experience or generally accepted nutritional or food science theory, places the modified food outside the accepted limits of natural variations for that food with regard to

(a) the composition, structure or nutritional quality of the food or its generally recognized physiological effects;

(b) the manner in which the food is metabolized in the body; or

(c) the microbiological safety, the chemical safety or the safe use of the food. (changement majeur)

“novel food” means

(a) a substance, including a microorganism, that does not have a history of safe use as a food;

(b) a food that has been manufactured, prepared, preserved or packaged by a process that

(i) has not been previously applied to that food, and

(ii) causes the food to undergo a major change; and

(c) a food that is derived from a plant, animal or microorganism that has been genetically modified such that

(i) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism,

(ii) the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or

(iii) one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism. (aliment nouveau)

SOR/99-392, s. 1.

B.28.002. (1) No person shall sell or advertise for sale a novel food unless the manufacturer or importer of the novel food

(a) has notified the Director in writing of their intention to sell or advertise for sale the novel food; and

(b) has received a written notice from the Director under paragraph B.28.003(1)(a) or subsection B.28.003(2).

(2) A notification referred to in paragraph (1)(a) shall be signed by the manufacturer or importer, or a person authorized to sign on behalf of the manufacturer or importer, and shall include the following information:

(a) the common name under which the novel food will be sold;

(b) the name and address of the principal place of business of the manufacturer and, if the address is outside Canada, the name and address of the principal place of business of the importer;

(c) a description of the novel food, together with

(i) information respecting its development,

(ii) details of the method by which it is manufactured, prepared, preserved, packaged and stored,

(iii) details of the major change, if any,

(iv) information respecting its intended use and directions for its preparation,

(v) information respecting its history of use as a food in a country other than Canada, if applicable, and

(vi) information relied on to establish that the novel food is safe for consumption;

(d) information respecting the estimated levels of consumption by consumers of the novel food;

(e) the text of all labels to be used in connection with the novel food; and

(f) the name and title of the person who signed the notification and the date of signing.

SOR/99-392, s. 1.

B.28.003. (1) Within 45 days after receiving a notification referred to in paragraph B.28.002(1)(a), the Director shall review the information included in the notification and

(a) if the information establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient; or

(b) if additional information of a scientific nature is necessary in order to assess the safety of the novel food, request in writing that the manufacturer or importer submit that information.

(2) Within 90 days after receiving the additional information requested under paragraph (1)(b) the Director shall assess it and, if it establishes that the novel food is safe for consumption, notify the manufacturer or importer in writing that the information is sufficient.

SOR/99-392, s. 1.

C.01.001. (1) In this Part

“acetaminophen product” has the same meaning as in Division 9; (produit d’acétaminophène)

“adult standard dosage unit” has, with reference to a drug, the same meaning as in Division 9; (dose normale pour adultes)

“adverse drug reaction” means a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function; (réaction indésirable à une drogue)

“antibiotic” means any drug or combination of drugs such as those named in C.01.410 to C.01.592 which is prepared from certain micro-organisms, or which formerly was prepared from micro-organisms but is now made synthetically and which possesses inhibitory action on the growth of other micro-organisms; (antibiotique)

“brand name” means, with reference to a drug, the name, whether or not including the name of any manufacturer, corporation, partnership or individual, in English or French,

(a) that is assigned to the drug by its manufacturer,

(b) under which the drug is sold or advertised, and

(c) that is used to distinguish the drug; (marque nominative)

“case report” means a detailed record of all relevant data associated with the use of a drug in a subject; (fiche d’observation)

“children’s standard dosage unit” has, with reference to a drug, the same meaning as in Division 9; (dose normale pour enfants)

“child resistant package” means a package that meets the requirements of subsection (2); (emballage protège-enfants)

“common name” means, with reference to a drug, the name in English or French by which the drug is

(a) commonly known, and

(b) designated in scientific or technical journals, other than the publications referred to in Schedule B to the Act; (nom usuel)

“expiration date” means the earlier of

(a) the date, expressed at minimum as a year and month, up to and including which a drug maintains its labelled potency, purity and physical characteristics, and

(b) the date, expressed at minimum as a year and month, after which the manufacturer recommends that the drug not be used; (date limite d’utilisation)

“immediate container” means the receptacle that is in direct contact with a drug; (récipient immédiat)

“internal use” means ingestion by mouth or application for systemic effect to any part of the body in which the drug comes into contact with mucous membrane; (usage interne)

“official drug” means any drug

(a) for which a standard is provided in these Regulations, or

(b) for which no standard is provided in these Regulations but for which a standard is provided in any of the publications mentioned in Schedule B to the Act; (drogue officielle)

“parenteral use” means administration of a drug by means of a hypodermic syringe, needle or other instrument through or into the skin or mucous membrane; (usage parentéral)

“per cent” means per cent by weight unless otherwise stated; (pour cent)

“practitioner” means a person authorized by the law of a province of Canada to treat patients with any drug listed or described in Schedule F to the Regulations; (praticien)

“prescription” means an order given by a practitioner directing that a stated amount of any drug or mixture of drugs specified therein be dispensed for the person named in the order; (ordonnance)

“proper name” means, with reference to a drug, the name in English or French

(a) assigned to the drug in section C.01.002,

(b) that appears in bold-face type for the drug in these Regulations and, where the drug is dispensed in a form other than that described in this Part, the name of the dispensing form,

(c) specified in the Canadian licence in the case of drugs included in Schedule C or Schedule D to the Act, or

(d) assigned in any of the publications mentioned in Schedule B to the Act in the case of drugs not included in paragraph (a), (b) or (c); (nom propre)

“salicylate product” has the same meaning as in Division 9; (produit de salicylate)

“serious adverse drug reaction” means a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death; (réaction indésirable grave à une drogue)

“serious unexpected adverse drug reaction” means a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the drug; (réaction indésirable grave et imprévue à une drogue)

“teaspoon” means, for the purpose of calculation of dosage, a volume of 5 cubic centimetres; (cuillerée à thé)

“test group” means a group that meets the requirements of subsection (3); (groupe d’essai)

“withdrawal period” means the length of time between the last administration of a drug to an animal and the time when tissues or products collected from the treated animal for consumption as food contain a level of residue of the drug that would not likely cause injury to human health. (délai d’attente)

(2) A child resistant package is a package that

(a) when tested in accordance with an acceptable method,

(i) in the case of a test group comprising children, cannot be opened

(A) by at least 85 per cent of those children prior to a demonstration to them of the proper means of opening the package, and

(B) by at least 80 per cent of those children after the demonstration, and

(ii) in the case of a test group comprising adults

(A) can be opened by at least 90 per cent of those adults, and

(B) where the package is designed so that, once opened and reclosed, it continues to meet the requirements of subparagraph (i), can be so reclosed by at least 90 per cent of those adults; or

(b) complies with the requirements of one of the following standards, namely,

(i) Canadian Standards Association Standard CAN/CSA-Z76.1-M90, entitled Recloseable Child-Resistant Packages, published January 1990, as amended from time to time,

(ii) European Standard EN 28317:1992, entitled Child-resistant packaging—Requirements and testing procedures for reclosable packages, as adopted by the European Committee for Standardization on October 30, 1992, recognized by the British Standards Institution, and effective February 15, 1993 and by the Association française de normalisation, and effective December 20, 1992, and which reiterates fully the international standard ISO 8317:1989, as amended from time to time, and

(iii) Code of Federal Regulations (United States), Title 16, Section 1700.15, entitled Poison prevention packaging standards, as amended from time to time.

(3) For the purposes of this section, “test group” means

(a) in relation to children, a group of at least 200 children who

(i) are healthy and have no obvious physical or mental disability,

(ii) are between 42 and 51 months of age, and

(iii) represent evenly, within plus or minus 10 per cent, each monthly age between 42 and 51 months calculated to the nearest month; and

(b) in relation to adults, a group of at least 100 adults who

(i) are healthy and have no obvious physical or mental disability,

(ii) are between 18 and 45 years of age, and

(iii) represent evenly, within plus or minus 10 per cent, each yearly age between 18 and 45 years calculated to the nearest year.

(4) For the purpose of this section, an amendment from time to time to a standard referred to in paragraph (2)(b) becomes effective 18 months after the date designated by the competent authority as the effective date for the amendment.

SOR/80-543, s. 1; SOR/85-966, s. 1; SOR/86-93, s. 1; SOR/87-484, s. 1; SOR/92-654, s. 1; SOR/93-202, s. 1; SOR/95-411, s. 1; SOR/95-521, s. 1; SOR/96-399, s. 1; SOR/96-240, s. 1; SOR/97-543, s. 5.

C.01.001A. [Repealed, SOR/98-423, s. 1]