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

B.23.005. Di(n-octyl)tin maleate polymer shall be the octyltin chemical made from di(n-octyl)tin dichloride and shall have the formula ((C₈H₁₇)₂ SnC₄H₂O₄)n (where n is between 2 and 4 inclusive), and a saponification number of 225 to 255, and shall contain 25.2 to 26.6 per cent of tin.

• B.23.006. (1) (n-octyl)tin S,S′,S″-tris (isooctylmercaptoacetate), being an octyltin chemical having the formula n-C₈H₁₇Sn(SCH₂CO₂C₈H₁₇)₃, shall be made from (n-octyl)tin trichloride and shall contain 13.4 to 14.8 per cent of tin and 10.9 to 11.9 per cent of mercapto sulfur.

• (2) For the purposes of this Division, (n-octyl)tin trichloride shall be the chemical having an organotin composition of not less than 95 per cent (n-octyl)tin trichloride and shall contain not more than

  • (a) five per cent total of di(n-octyl)tin dichloride, tri(n-octyl)tin chloride or the higher (more than eight (8) carbons) alkyltin chlorides or any combination of the foregoing;

  • (b) 0.2 per cent total of alkyltin derivatives; and

  • (c) 0.1 per cent of the lower (less than eight carbons) homologous alkyltin derivatives.

B.23.007. No person shall sell a food in a package than may yield to its contents any amount of vinyl chloride, as determined by official method, FO-40, Determination of Vinyl Chloride in Food, October 15, 1981, in respect of that food.

B.23.008. No person shall sell a food in a package that may yield to its contents any amount of acrylonitrile as determined by official method FO-41, Determination of Acrylonitrile in Food, February 16, 1982, in respect of that food.

B.24.001. In this Division,

“expiration date”

“expiration date” means, in respect of a formulated liquid diet, a food represented for use in a very low-energy diet, a meal replacement or a nutritional supplement, the date

• (a) after which the manufacturer does not recommend that it be consumed, and

• (b) up to which it maintains its microbiological and physical stability and the nutrient content declared on the label; (date limite d’utilisation)

“food for special dietary use”

“food for special dietary use” means food that has been specially processed or formulated to meet the particular requirements of a person

• (a) in whom a physical or physiological condition exists as a result of a disease, disorder or injury, or

• (b) for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods; (aliment à usage diététique spécial)

“formulated liquid diet”

“formulated liquid diet” means a food that

• (a) is sold for consumption in liquid form, and

• (b) is sold or represented as a nutritionally complete diet for oral or tube feeding of a person described in paragraph (a) of the definition “food for special dietary use”; (préparation pour régime liquide)

“hospital”

“hospital” means a facility

• (a) that is licensed, approved or designated as a hospital by a province, in accordance with the laws of the province, to provide care or treatment to persons suffering from any form of disease or illness, or

• (b) that is owned or operated by the government of Canada or of a province and that provides health services; (hôpital)

“major change”

“major change” means, in respect of a food that is represented for use in a very low energy diet, any change in any of the following, where the manufacturer’s experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, the microbiological or chemical safety of or the safe use of the food:

• (a) an ingredient or the amount of an ingredient in the food,

• (b) the manufacturing process or the packaging of the food, or

• (c) the directions for the preparation and use of the food; (changement majeur)

“meal replacement”

“meal replacement”[Repealed, SOR/95-474, s. 3]

“pharmacist”

“pharmacist” means a person who is registered and entitled under the laws of a province to practise pharmacy and who is practising pharmacy under those laws in that province; (pharmacien)

“physician”

“physician” means a person who is registered and entitled under the laws of a province to practise medicine and who is practicing medicine under those laws in that province; (médecin)

“prepackaged meal”

“prepackaged meal”[Repealed, SOR/95-474, s. 3]

“target body weight”

“target body weight” means the anticipated body weight at the end of the weight reduction diet, as determined by the physician before the weight reduction diet begins; (poids corporel cible)

“very low energy diet”

“very low energy diet” means a diet for weight reduction that provides less than 900 kilocalories per day when followed as directed. (régime à très faible teneur en énergie)