TABLE

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(2) Notwithstanding paragraph (1)(a), a food represented for use in a very low energy diet shall be accompanied by directions for use that when followed would result in the daily intake by a person of at least 1.2 g of protein per kilogram target body weight. SOR/94-35, s. 4.

B.24.304. The label of a food represented for use in a very low energy diet shall carry the following information:

(a) a statement of the energy value of the food, expressed in Calories (Calories or Cal) and kilojoules (kilojoules or kJ) per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

(b) a statement of the content in the food of protein, fat, carbohydrate and, where present, fibre expressed in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

(c) a statement of the content in the food of all those vitamins and mineral nutrients that are listed in the table to subsection B.24.303(1) expressed in milligrams, in the case of vitamin A expressed in retinol equivalents (RE), per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

(d) a statement of the content in the food of any other nutritive substance added to the food in an amount described in paragraph B.24.303(1)(c), expressed in milligrams or in grams per 100 g or 100 mL of the food as offered for sale and per unit of ready-to-serve food;

(e) the statement "USE ONLY UNDER MEDICAL SUPERVISION" prominently displayed on the principal display panel;

(f) directions for use of the food, including

(i) a statement of the rationale for the use of the food,

(ii) criteria to be used for the selection of the persons to whom the food may be prescribed,

(iii) instructions for consultation with and evaluation of the patient and patient follow-up, and

(iv) a statement concerning adequate precautions and contra-indications;

(g) directions for the preparation of the food, and storage instructions for the food before and after the container has been opened; and

(h) the expiration date of the food. SOR/94-35, s. 4.

B.24.305. (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell the food or advertise the food for sale.

(2) The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a low energy diet, the following information:

(a) the name under which the food is to be sold or advertised for sale;

(b) the name and address of the principal place of business of the manufacturer;

(c) the name and address of each establishment in which the food is manufactured;

(d) a list of the ingredients of the food, stated quantitatively;

(e) the specifications for nutrient, microbiological and physical quality for each ingredient and for the food;

(f) details of quality control procedures respecting the testing of the ingredients and of the food;

(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 food;

(i) the evidence relied on to establish that the food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is 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 food; 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 food represented for use in a very low energy diet, if the Director, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2). SOR/94-35, s. 4.

B.24.306. (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet that has undergone a major change, 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 food that has undergone the major change.

(2) The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a very low energy diet that has undergone a major change, the following information:

(a) the name under which the food is to be sold or advertised for sale;

(b) the name and address of the principal place of business of the manufacturer;

(c) a description of the major change;

(d) the evidence relied on to establish that the food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is consumed in accordance with the directions for use;

(e) the evidence relied on to establish that the major change has no adverse effect on the food or its use;

(f) the written text of all labels, including package inserts, to be used in connection with the food; and

(g) 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 food represented for use in a very low energy diet that has undergone a major change, if the Director, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2). SOR/94-35, s. 4.

DIVISION 25

Interpretation

B.25.001. In this Division,

"expiration date" means, in respect of a human milk substitute, 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)

"human milk substitute" means any food that is represented

(a) for use as a partial or total replacement for human milk and intended for consumption by infants, or

(b) for use as an ingredient in a food referred to in paragraph (a); (succédané de lait humain)

"infant" means a person who is under the age of one year; (bébé)

"infant food" means a food that is represented for consumption by infants; (aliment pour bébés)

"junior (naming a food)" means the named food where it contains particles of a size to encourage chewing by infants, but may be readily swallowed by infants without chewing; ((nom d'un aliment) pour enfants en bas âge)

"major change" means, in respect of a human milk substitute, any change of an ingredient, the amount of an ingredient or the processing or packaging of the human milk substitute where the manufacturer's experience or generally accepted theory would predict an adverse effect on the levels or availability of nutrients in, or the microbiological or chemical safety of, the human milk substitute; (changement majeur)

"new human milk substitute" means a human milk substitute that is

(a) manufactured for the first time,

(b) sold in Canada for the first time, or

(c) manufactured by a person who manufactures it for the first time; (succédané de lait humain nouveau)

"strained (naming a food)" means the named food where it is of a generally uniform particle size that does not require and does not encourage chewing by infants before being swallowed. ((nom d'un aliment) en purée ou tamisé) SOR/78-637, s. 5; SOR/83-933, s. 1; SOR/90-174, s. 1.

Infant Foods

B.25.002. No person shall sell or advertise for sale an infant food that is set out in Column I of an item of Table I to this Division and contains more than the amount of sodium set out in Column II of that item. SOR/83-933, s. 1.

B.25.003. (1) Subject to subsection (2), no person shall sell infant food that contains

(a) strained fruit,

(b) fruit juice,

(c) fruit drink, or

(d) cereal,

if sodium chloride has been added to that food.

(2) Subsection (1) does not apply to strained desserts containing any of the foods mentioned in paragraphs (1)(a) to (d). SOR/83-933, s. 1.

Human Milk Substitutes and Food Containing Human Milk Substitutes

B.25.045. The common name of a human milk substitute or a new human milk substitute shall be "infant formula". (préparation pour nourrissons) SOR/90-174, s. 2.

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.

B.25.047. Sections B.25.051 to B.25.059 apply in respect of new human milk substitutes. SOR/90-174, s. 2; SOR/2003-11, s. 25.

B.25.048. (1) No person shall sell or advertise for sale a human milk substitute that has undergone a major change unless the manufacturer of the human milk substitute, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell or advertise for sale the human milk substitute.

(2) The notification referred to in subsection (1) shall be signed and shall include, in respect of the 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) a description of the major change;

(d) the evidence relied on to establish that the human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use;

(e) the evidence relied on to establish that the major change has had no adverse effect on the human milk substitute;

(f) the written text of all labels, including package inserts, to be used in connection with the human milk substitute; and

(g) 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 human milk substitute that has undergone a major change 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.

B.25.050. [Repealed, SOR/90-174, s. 2]

B.25.051. (1) No person shall sell or advertise for sale a human milk substitute unless, when prepared according to directions for use, it complies with the provisions of this Division respecting human milk substitutes.

(2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food complies with the nutritional requirements set out in this Division for human milk substitutes. SOR/83-933, s. 1.

B.25.052. (1) No person shall sell or advertise for sale a human milk substitute unless it meets the nutritional requirements of infants with normal or special dietary needs and it is of such a consistency that, when ready-to-serve, it passes freely through a nursing bottle nipple.

(2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food meets the nutritional requirements of infants with normal or special dietary needs. SOR/78-637, s. 6; SOR/82-768, s. 76; SOR/83-933, s. 1.

B.25.053. (1) No person shall sell or advertise for sale a human milk substitute that requires, when prepared according to directions for use, the addition of a nutritive substance, other than water or a source of carbohydrate or both.

(2) No person shall sell or advertise for sale a food represented as containing a human milk substitute that requires, when prepared according to directions for use, the addition of a nutritive substance other than water. SOR/78-637, s. 7; SOR/83-933, s. 1.

B.25.054. (1) Except as otherwise provided in this Division, no person shall sell or advertise for sale a human milk substitute unless it contains, when prepared according to directions for use,

(a) per 100 available kilocalories

(i) not less than 3.3 and not more than 6.0 grams of fat,

(ii) not less than 500 milligrams of linoleic acid in the form of a glyceride,

(iii) not more than 1 kilocalorie from C₂₂ Monoenoic Fatty Acids,

(iv) not less than 1.8 and not more than 4.0 grams of protein,

(v) not less than 1.8 grams of protein of nutritional quality equivalent to casein, or such an amount and quality of protein, including those proteins to which amino acids are added, that, when the quality of the protein is expressed as a fraction of the quality of casein,

(A) the fraction will not be less than 85/100, and

(B) the product obtained by multiplying the fraction by the gram weight of the protein will not be less than 1.8,

(vi) notwithstanding sections D.01.010, D.01.011 and D.02.009, the vitamin and mineral nutrient set out in Column I of an item of Table II to this Division in an amount not less than the amount set out in Column II of that item and not more than the amount set out in Column III of that item, and

(vii) not less than 12 milligrams of choline; and

(b) a ratio of

(i) alpha-tocopherol to linoleic acid of not less than 0.6 International Units to one gram,

(ii) calcium to phosphorus of not less than 1.2 grams to one gram and not more than 2.0 grams to one gram, and

(iii) vitamin B₆ to protein of not less than 15 micrograms to one gram.

(2) No person shall sell or advertise for sale a food that is represented as containing a human milk substitute unless the human milk substitute portion of the food complies with subsection (1). SOR/78-637, s. 7; SOR/83-933, s. 1.

B.25.055. (1) Subparagraph B.25.054(1)(a)(i) does not apply to a human milk substitute represented as being for a fat-modified diet.

(2) Subparagraph B.25.054(1)(a)(iv), except that portion thereof that prescribes the maximum amount of protein, and subparagraph B.25.054(1)(a)(v) do not apply to a human milk substitute represented as being for a low (naming the amino acid) diet.

(3) All that portion of subparagraph B.25.054(1)(a)(vi) that prescribes the minimum amounts of vitamin D, calcium and phosphorus and subparagraph B.25.054(1)(b)(ii) do not apply to a human milk substitute represented as being for a low (naming the mineral) diet or a low vitamin D diet or both. SOR/83-933, s. 1.

B.25.056. No person shall sell a human milk substitute or a food that is represented as containing a human milk substitute

(a) that contains an added nutritive substance that is

(i) normally contained in human milk, and

(ii) not referred to in paragraph B.25.054(1)(a)

unless the amount of that substance present per 100 available kilocalories of the human milk substitute or human milk substitute portion of the food, when prepared according to directions for use, is equal to the amount thereof present per 100 available kilocalories of human milk; or

(b) that contains added amino acids unless

(i) the amino acids are required to improve the quality of the protein in the human milk substitute or human milk substitute portion of the food and are present in an amount not exceeding the minimum required for that purpose, or

(ii) the protein content of the human milk substitute or human milk substitute portion of the food is supplied by isolated amino acids or by protein hydrolysate, or both

and only the L forms of the amino acids have been added. SOR/78-637, s. 8; SOR/83-933, s. 1.

B.25.057. (1) The label of a human milk substitute shall carry the following information:

(a) a statement of the content of protein, fat, available carbohydrate, ash and, where present, crude fibre in the food

(i) in grams per 100 grams or in grams per 100 millilitres of the human milk substitute as offered for sale, and

(ii) in grams in a stated quantity of the human milk substitute when ready-to-serve;

(b) a statement of the energy value expressed in

(i) calories per 100 grams or calories per 100 millilitres of the human milk substitute as offered for sale, and

(ii) calories in a stated quantity of the human milk substitute when ready-to-serve;

(c) a statement of the quantity of all vitamins and mineral nutrients listed in Table II to this Division

(i) in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the human milk substitute as offered for sale, and

(ii) in International Units or milligrams in a stated quantity of the human milk substitute when ready-to-serve;

(d) a statement of the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a)

(i) in milligrams or grams per 100 grams, or in milligrams or grams per 100 millilitres, of the human milk substitute as offered for sale, and

(ii) in milligrams or grams in a stated quantity of the human milk substitute when ready-to-serve;

(e) adequate directions for the preparation, use and storage of the human milk substitute after the container has been opened; and

(f) the expiration date of the human milk substitute.

(2) The label of a food that is represented as containing human milk substitute shall carry the following information:

(a) a statement on the principal display panel of the proportion of the human milk substitute contained in the food as offered for sale in close proximity to any claim regarding the presence of the human milk substitute and given equal prominence to such a claim;

(b) the common name of the human milk substitute in the list of ingredients to be followed by a statement of all the components contained in the human milk substitute;

(c) a statement of

(i) the content of protein, fat, available carbohydrate, ash and, where present, crude fibre contained in the human milk substitute portion of the food, expressed in grams per 100 grams or per 100 millilitres of the human milk substitute portion of the food as offered for sale,

(ii) the energy value of the human milk substitute portion of the food expressed in calories per 100 grams or in calories per 100 millilitres of the human milk substitute portion of the food as offered for sale,

(iii) the quantity of all the vitamins and mineral nutrients set out in Table II to this Division that are contained in the human milk substitute portion of the food in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the human milk substitute portion of the food as offered for sale, and

(iv) the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a) contained in the human milk substitute portion of the food in milligrams or grams per 100 grams or in milligrams or grams per 100 millilitres of the human milk substitute portion of the food as offered for sale;

(d) a statement of

(i) the content of protein, fat, available carbohydrate, ash and, where present, crude fibre in grams per 100 grams or per 100 millilitres of the food as offered for sale and in grams per stated quantity of ready-to-serve food,

(ii) the energy value expressed in calories per 100 grams or in calories per 100 millilitres of the food as offered for sale and in grams per a stated quantity of the food when ready-to-serve,

(iii) the quantity of all vitamins and mineral nutrients set out in Table II to this Division in International Units or milligrams per 100 grams or in International Units or milligrams per 100 millilitres of the food as offered for sale and in International Units or milligrams in a stated quantity of the food when ready-to-serve, and

(iv) the quantity of choline and of any added nutritive substance normally contained in human milk and not referred to in paragraph B.25.054(1)(a) in milligrams or grams per 100 grams or in milligrams or grams per 100 millilitres of the food as offered for sale and in milligrams or grams in a stated quantity of the food when ready-to-serve;

(e) adequate directions for the preparation, use and storage of the food after the container has been opened; and

(f) the expiration date of the food. SOR/83-933, s. 1; SOR/88-559, s. 30.

B.25.058. Notwithstanding section D.02.005, no person shall make any claim with respect to the iron content of a human milk substitute except as required by paragraph B.25.057(1)(c), unless the human milk substitute contains at least one milligram of iron per 100 available kilocalories. SOR/78-637, s. 9(F); SOR/83-933, s. 1.

B.25.059. No person shall, on the label of or in any advertisement for a human milk substitute or a food represented as containing a human milk substitute, make any statement or claim relating to the content in the food of

(a) the percentage of the daily value of

(i) fat,

(ii) saturated fatty acids and trans fatty acids,

(iii) sodium,

(iv) potassium,

(v) carbohydrate,

(vi) fibre, or

(vii) cholesterol; or

(b) the number of Calories from

(i) fat, or

(ii) saturated fatty acids and trans fatty acids. SOR/2003-11, s. 26.

B.25.060. (1) Where the manufacturer of a human milk substitute or of a food that is represented as containing a human milk substitute is requested in writing by the Director to submit on or before a specified day evidence with respect to the human milk substitute, the manufacturer shall make no further sales of that human milk substitute or food that is represented as containing human milk substitute after that day unless he has submitted the evidence requested.

(2) Where the Director is of the opinion that the evidence submitted by a manufacturer pursuant to subsection (1) is not sufficient, he shall notify the manufacturer in writing that the evidence is not sufficient.

(3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to the human milk substitute is not sufficient, he shall make no further sales of that human milk substitute or of that food that is represented as containing the human milk substitute unless he submits further evidence and is notified in writing by the Director that the further evidence is sufficient.

(4) In this section, "evidence with respect to the human milk substitute" means

(a) evidence that establishes that the human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; and

(b) the results of tests carried out to determine the expiration date of the human milk substitute. SOR/83-933, s. 1; SOR/88-424, s. 2; SOR/90-174, s. 3.

B.25.061. (1) Subject to subsection (2), no person shall include on the label of a food any representation respecting the consumption of the food by an infant who is less than six months of age.

(2) Subsection (1) does not apply in respect of a human milk substitute or a new human milk substitute. SOR/88-933, s. 1; SOR/90-174, s. 4.

B.25.062. (1) Subject to subsection (2), no person shall sell a food that is labelled or advertised for consumption by infants if the food contains a food additive.

(2) Subsection (1) does not apply to

(a) bakery products that are labelled or advertised for consumption by infants;

(b) ascorbic acid used in cereals containing banana and fruit purees that are labelled or advertised for consumption by infants;

(c) soyabean lecithin used in rice cereal labelled or advertised for consumption by infants;

(d) citric acid used in foods that are labelled or advertised for consumption by infants;

(e) infant formula that contains the food additives set out in Tables IV and X to section B.16.100 for use in infant formula; or

(f) infant formula that contains ingredients manufactured with food additives set out in Table V to section B.16.100. SOR/83-933, s. 1; SOR/90-24, s. 4; SOR/91-149, s. 6; SOR/97-559, s. 1.

TABLE I
SODIUM CONTENT IN INFANT FOODS

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SOR/78-637, s. 10; SOR/83-933, s. 1.

TABLE II

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SOR/83-933, s. 1; SOR/98-458, s. 7(F).

DIVISION 26
FOOD IRRADIATION

Interpretation

B.26.001. In this Division,

"ionizing radiation" means

(a) gamma-radiation from a Cobalt-60 or Cesium-137 source,

(b) X-rays generated from a machine source operated at or below an energy level of 5 MeV, and

(c) electrons generated from a machine source operated at or below an energy level of 10 MeV; (rayonnement ionisant)

"irradiation" means treatment with ionizing radiation. (irradiation) SOR/89-175, s. 3.

Application

B.26.002. This Division does not apply to foods exposed to ionizing radiation from a measuring instrument used to determine weight, estimate bulk solids, measure the total solids in liquids or perform other inspection procedures. SOR/89-175, s. 3.

General

B.26.003. (1) Subject to subsection (2), no person shall sell a food that has been irradiated.

(2) A food set out in Column I of an item of the table to this Division that has been irradiated may be sold if

(a) the food was irradiated from a source set out in Column II of that item for the purpose set out in Column III of that item; and

(b) the dose of ionizing radiation absorbed by the food is within the permitted absorbed dose set out in Column IV of that item. SOR/89-175, s. 3.

Records

B.26.004. (1) A manufacturer who sells a food that has been irradiated shall keep on his premises, for at least two years after the date of the irradiation, a record containing the following information:

(a) the food irradiated and the quantity and lot numbers of the food;

(b) the purpose of the irradiation;

(c) the date of the irradiation;

(d) the dose of ionizing radiation absorbed by the food;

(e) the source of the ionizing radiation; and

(f) a statement indicating whether the food was irradiated prior to the irradiation by the manufacturer and, if so, the information referred to in paragraphs (a) to (e) in respect of that prior irradiation.

(2) Every person who imports a food that is intended for sale in Canada that has been irradiated shall keep on his premises a record of the information referred to in subsection (1) for at least two years after the date of importation. SOR/89-175, s. 3.

Changes to the Table

B.26.005. A request that a food be added or a change made to the table to this Division shall be accompanied by a submission to the Director containing the following information:

(a) the purpose and details of the proposed irradiation, including the source of ionizing radiation and the proposed frequency of and minimum and maximum dose of ionizing radiation;

(b) data indicating that the minimum dose of ionizing radiation proposed to be used accomplishes the intended purpose of the irradiation and the maximum dose of ionizing radiation proposed does not exceed the amount required to accomplish the purpose of the irradiation;

(c) information on the nature of the dosimeter used, the frequency of the dosimetry on the food and data pertaining to the dosimetry and phantoms used to assure that the dosimetry readings reflect the dose absorbed by the food during irradiation;

(d) data indicating the effects, if any, on the nutritional quality of the food, raw and ready-to-serve, under the proposed conditions of irradiation and any other processes that are combined with the irradiation;

(e) data establishing that the irradiated food has not been significantly altered in chemical, physical or microbiological characteristics to render the food unfit for human consumption;

(f) where the Director so requests, data establishing that the proposed irradiation is safe under the conditions proposed for the irradiation;

(g) the recommended conditions of storage and shipment of the irradiated food including the time, temperature and packaging and a comparison of the recommended conditions for the same food that has not been irradiated;

(h) details of any other processes to be applied to the food prior to or after the proposed irradiation; and

(i) such other data as the Director may require to establish that consumers and purchasers of the irradiated food will not be deceived or misled as to the character, value, composition, merit or safety of the irradiated food. SOR/89-175, s. 3

TABLE

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SOR/89-175, s. 3; SOR/98-458, s. 7(F).

DIVISION 27
LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS

B.27.001. In this Division,

"commercially sterile" means the condition obtained in a food that has been processed by the application of heat, alone or in combination with other treatments, to render the food free from viable forms of microorganisms, including spores, capable of growing in the food at temperatures at which the food is designed normally to be held during distribution and storage; (stérilité commerciale)

"hermetically sealed container" means a container designed and intended to be secure against the entry of microorganisms, including spores; (récipient hermétiquement fermé)

"low-acid food" means a food, other than an alcoholic beverage, where any component of the food has a pH greater than 4.6 and a water activity greater than 0.85; (aliment peu acide)

"refrigeration" means exposure to a temperature of 4°C or less but does not mean frozen; (réfrigéré)

"shipping container" means a receptacle, package or wrapper in which containers of food are placed for transportation; (contenant d'expédition)

"water activity" means the ratio of the water vapour pressure of a food to the vapour pressure of pure water, at the same temperature and pressure. (activité de l'eau) SOR/89-309, s. 1.

B.27.002. (1) No person shall sell a low-acid food packaged in a hermetically sealed container unless the food is commercially sterile.

(2) Subsection (1) does not apply in respect of a low-acid food packaged in a hermetically sealed container where

(a) the low-acid food is kept under refrigeration and the statement "Keep Refrigerated" and "Garder au froid" is carried on the principal display panel of the label of its container, as well as on the label of its shipping container; or

(b) the low-acid food is kept frozen and the statement "Keep Frozen" and "Garder congelé" is carried on the principal display panel of the label of its container, as well as on the label of its shipping container.

(3) Subsection (1) does not apply in respect of tomatoes or tomato products packaged in hermetically sealed containers where the tomatoes or tomato products have a pH of 4.7 or less after heat processing. SOR/89-309, s. 1; SOR/91-149, s. 7.

B.27.003. No person shall sell a low-acid food packaged in a hermetically sealed container where the container

(a) is swollen;

(b) is not properly sealed; or

(c) has any defect that may adversely affect its hermetic seal. SOR/89-309, s. 1.

B.27.004. (1) Where, in the opinion of the Director, the sale of a low-acid food packaged in a hermetically sealed container may contravene section B.27.002 or B.27.003, the Director may, by notice in writing, request that the manufacturer or importer of the food submit, on or before the date specified in the notice, evidence that establishes that the processes used to manufacture, process and package the food rendered and maintained the food commercially sterile.

(2) Where a manufacturer or an importer receives a notice issued pursuant to subsection (1), the manufacturer or importer shall make no further sales of the food on or after the day specified in the notice until he has submitted the evidence requested in that notice.

(3) Where the Director is of the opinion that the evidence submitted by a manufacturer or importer pursuant to subsection (1) is not sufficient, the Director shall notify the manufacturer or importer in writing that the evidence is not sufficient.

(4) Where, pursuant to subsection (3), a manufacturer or importer is notified that the evidence he has submitted is not sufficient, the manufacturer or importer shall make no further sales of the food until he submits further evidence and is notified in writing by the Director that the further evidence is sufficient. SOR/89-309, s. 1.

B.27.005. No person shall sell a commercially sterile low-acid food packaged in a hermetically sealed container unless

(a) the label or container of the food bears a code or lot number that identifies, in a legible and permanent manner,

(i) the establishment in which the product was rendered commercially sterile, and

(ii) the day, month and year on which the food was rendered commercially sterile; and

(b) the exact meaning of each item in any code or lot number referred to in paragraph (a) is available to an inspector at the establishment or, where the food is imported, from the importer. SOR/89-309, s. 1.

DIVISION 28
NOVEL FOODS

Interpretation

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.

Pre-market notification

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.