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

Regulations are current to 2017-05-11 and last amended on 2017-05-05. Previous Versions

DIVISION 23Food Packaging Materials

 No person shall sell any food in a package that may yield to its contents any substance that may be injurious to the health of a consumer of the food.

 Subject to section B.23.003 no person shall sell any food in a package that has been manufactured from a polyvinyl chloride formulation containing an octyltin chemical.

 A person may sell food, other than milk, skim milk, partly skimmed milk, sterilized milk, malt beverages and carbonated non-alcoholic beverage products, in a package that has been manufactured from a polyvinyl chloride formulation containing any or all of the octyltin chemicals, namely, di(n-octyl)tin S,S′-bis(isooctylmercaptoacetate), di(n-octyl)tin maleate polymer and (n-octyl)tin S,S′,S″-tris(isooctylmercaptoacetate) if the proportion of such chemicals, either singly or in combination, does not exceed a total of three per cent of the resin, and the food in contact with the package contains not more than one part per million total octyltin.

  • SOR/81-60, s. 13;
  • SOR/86-1125, s. 4.
  •  (1) Di (n-octyl)tin S,S′-bis (isooctylmercaptoacetate) shall be the octyltin chemical made from di (n-octyl)tin dichloride and shall contain 15.1 to 16.4 per cent of tin and 8.1 to 8.9 per cent of mercapto sulfur.

  • (2) For the purposes of this Division, di (n-octyl)tin dichloride shall be the chemical having an organotin composition of not less than 95 per cent di (n-octyl)tin dichloride and shall contain no more than

    • (a) five per cent total of n-octyltin trichloride or tri(n-octyl)tin chloride or both;

    • (b) 0.2 per cent total of other eight (8) carbon isomeric alkyltin derivatives; and

    • (c) 0.1 per cent total of the higher and lower homologous alkyltin derivatives.

  • SOR/86-1125, s. 5.

 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.

  • SOR/86-1125, s. 6(F).
  •  (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.

  • SOR/86-1125, s. 7.

 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.

  • SOR/82-768, s. 74.

 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.

  • SOR/82-541, s. 1.

DIVISION 24

Foods for Special Dietary Use

 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)

  • SOR/78-64, s. 1;
  • SOR/78-698, s. 4;
  • SOR/94-35, s. 1;
  • SOR/95-474, s. 3.
  •  (1) No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is a food for special dietary use unless the food is

    • (a) to (e) [Repealed, SOR/2003-11, s. 21]

    • (f) a formulated liquid diet that meets the requirements contained in sections B.24.101 and B.24.102;

    • (f.1) a meal replacement for special dietary use that meets the requirements contained in section B.24.200;

    • (f.2) a nutritional supplement that meets the requirements contained in section B.24.201;

    • (g) a gluten-free food that meets the requirements contained in section B.24.018;

    • (h) represented for protein-restricted diets;

    • (i) represented for low (naming the amino acid) diets; or

    • (j) a food represented for use in a very low energy diet, where the food meets the requirements contained in section B.24.303.

  • (1.1) Despite subsection (1), a person may label, package, sell or advertise a food in a manner likely to create an impression that it is a food for special dietary use if its label carries a statement or claim set out in column 4 of the table following section B.01.513, in accordance with section B.01.503, in respect of any of the following subjects set out in column 1:

    • (a) “free of energy”, set out in item 1;

    • (b) “low in energy”, set out in item 2;

    • (c) “free of sodium or salt”, set out in item 31;

    • (d) “low in sodium or salt”, set out in item 32; or

    • (e) “free of sugars”, set out in item 37.

  • (2) Subsection (1) does not apply to infant formulas.

  • (3) No person shall label, package, sell or advertise a food in a manner likely to create an impression that it is for use in a weight reduction diet unless that food is

    • (a) a meal replacement that meets the compositional requirements contained in section B.24.200;

    • (b) a prepackaged meal;

    • (c) a food sold by a weight reduction clinic to clients of the clinic for use in a weight reduction program supervised by the staff of the clinic; or

    • (d) a food represented for use in a very low-energy diet that meets the compositional requirements contained in section B.24.303.

  • (4) Except as otherwise permitted by these Regulations, no person shall label, package, sell or advertise a food as “dietetic” or “diet”, or use those words as part of the brand name of the food, unless its label carries a statement or claim set out in column 4 of the table following section B.01.513, in accordance with section B.01.503, in respect of any of the following subjects set out in column 1:

    • (a) “free of energy”, set out in item 1;

    • (b) “low in energy”, set out in item 2;

    • (c) “reduced in energy”, set out in item 3;

    • (d) “lower in energy”, set out in item 4; or

    • (e) “free of sugars”, set out in item 37.

  • SOR/78-64, s. 2;
  • SOR/78-698, s. 5;
  • SOR/84-334, s. 1;
  • SOR/86-178, s. 8(E);
  • SOR/94-35, s. 2;
  • SOR/95-444, s. 1;
  • SOR/95-474, s. 4;
  • SOR/2003-11, s. 21.
 
Date modified: