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

DIVISION 27Low-Acid Foods Packaged in Hermetically Sealed Containers

B.27.001 In this Division,

commercially sterile

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

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

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

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

shipping container

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

water activity

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)

• 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 réfrigéré” 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.

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.

• B.27.004 (1) Where, in the opinion of the Minister, the sale of a low-acid food packaged in a hermetically sealed container may contravene section B.27.002 or B.27.003, the Minister 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 Minister is of the opinion that the evidence submitted by a manufacturer or importer pursuant to subsection (1) is not sufficient, the Minister 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 Minister that the further evidence is sufficient.

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.

DIVISION 28Novel Foods

Interpretation

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

genetically modify

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

major change

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

novel food means any of the following substances and foods, other than a supplemental ingredient or supplemented food:

• (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)

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 Minister in writing of their intention to sell or advertise for sale the novel food; and

  • (b) has received a written notice from the Minister 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.

• B.28.003 (1) Within 45 days after receiving a notification referred to in paragraph B.28.002(1)(a), the Minister 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 Minister 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.

DIVISION 29Supplemented Foods

Interpretation

• B.29.001 (1) The following definitions apply in this Division.

  Directory of SFFT Formats

  Directory of SFFT Formats means the document entitled Directory of Supplemented Food Facts Table Formats, published by the Government of Canada on its website, as amended from time to time. (Répertoire des modèles de TRAS)

  Directory of Supplemented Food Caution Identifier Specifications

  Directory of Supplemented Food Caution Identifier Specifications means the document entitled Directory of Supplemented Food Caution Identifier Specifications, published by the Government of Canada on its website, as amended from time to time. (Répertoire des spécifications sur l’identifiant des aliments supplémentés avec mise en garde)

  fat

  fat means all fatty acids expressed as triglycerides. (lipides)

• (2) For the purposes of this Division and subject to subsection (3), the amount of vitamins must be determined in accordance with section D.01.003.

• (3) For the purposes of this Division, the amount in metric units of the following vitamins must be determined in terms of their amount in the supplemented food in accordance with column 5 of the List of Permitted Supplemental Ingredients, as applicable, and expressed in the applicable unit set out in column 3 of the List of Permitted Supplemental Ingredients:

  • (a) beta-carotene as a form of vitamin A or retinol, including its derivatives, as a form of vitamin A, or both, if either is a supplemental ingredient; and

  • (b) niacin, if it is a supplemental ingredient.

Nutrition Labelling

Core Information

• B.29.002 (1) Except as otherwise provided in this section and sections B.29.003 to B.29.005, B.29.018 and B.29.019, the label of a supplemented food must carry a supplemented food facts table that contains only the information set out in column 1 of the table to this section, expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4.

• (2) For the purposes of subsection (1), the serving of stated size set out in the supplemented food facts table, as expressed in a metric unit, must be used as the basis for determining the information appearing in the supplemented food facts table in respect of the energy value of, and the content of nutrients and supplemental ingredients in, the supplemented food.

• (3) Subject to subsection (8), the percentage of the daily value for a vitamin or mineral nutrient shown in the supplemented food facts table in accordance with subsection (1) must be established on the basis of the amount, by weight, of the vitamin or mineral nutrient per serving of stated size of the supplemented food, rounded off in the applicable manner set out in column 4 of the table to this section.

• (4) If the information in respect of six or more of the energy value and nutrients referred to in column 1 of items 2 to 5 and 7 to 15 of the table to this section may be expressed as “0” in the supplemented food facts table in accordance with this section, the supplemented food facts table need only include the following information:

  • (a) the serving of stated size;

  • (b) the energy value;

  • (c) the amount of fat;

  • (d) the amount of carbohydrate;

  • (e) the amount of protein;

  • (f) the amount of any nutrient that is the subject of a representation on the label of the supplemented food, or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food, if the representation expressly or implicitly indicates that the supplemented food has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004;

  • (g) the amount of any added sugar alcohol;

  • (h) the amount of any supplemental ingredient;

  • (i) the amount of any vitamin or mineral nutrient that is declared as a component of an ingredient, other than flour, of the supplemented food;

  • (j) the amount of any nutrient referred to in column 1 of any of items 4, 5, 7, 8, 10, 11 and 13 to 15 of the table to this section that may not be expressed as “0” in the supplemented food facts table;

  • (k) the statement “Not a significant source of (naming each nutrient that is omitted from the supplemented food facts table in accordance with this subsection)” or, if the supplemented food meets the condition specified in subsection B.29.010(3), the statement “Not a significant source of other nutrients”;

  • (l) the % Daily Value interpretative statement; and

  • (m) the “Supplemented with” interpretative statement.

• (5) The supplemented food facts table of a supplemented food that is a single-serving prepackaged product need only include the following information:

  • (a) the serving of stated size;

  • (b) the energy value;

  • (c) the amount of fat;

  • (d) the amount of carbohydrate;

  • (e) the amount of protein;

  • (f) the amount of any nutrient that is the subject of a representation on the label of the supplemented food, or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food, if the representation expressly or implicitly indicates that the supplemented food has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the Table of Permitted Nutrient Content Statements and Claims or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004;

  • (g) the amount of any added sugar alcohol;

  • (h) the amount of any supplemental ingredient;

  • (i) the amounts of saturated fatty acids and trans fatty acids and the sum of saturated fatty acids and trans fatty acids, if any of the amounts or the sum may not be expressed as “0” in the supplemented food facts table;

  • (j) the amount of any nutrient referred to in column 1 of item 8 or 11 of the table to this section that may not be expressed as “0” in the supplemented food facts table;

  • (k) the % Daily Value interpretative statement; and

  • (l) the “Supplemented with” interpretative statement.

• (6) Subsection (1) does not apply to a supplemented food intended solely for use as an ingredient in the manufacture of other supplemented foods intended for sale to a consumer at the retail level.

• (7) If the supplemented food facts table on the label of a supplemented food corresponds to Figure 6.5(B), 6.6(B), 6.5.1(B), 6.6.1(B), 7.3(B), 7.4(B), 7.3.1(B), 7.4.1(B), 17.2(E) and (F) or 17.2.1(E) and (F) of the Directory of SFFT Formats, the supplemented food facts table is not required to show the % Daily Value interpretative statement or the “Supplemented with” interpretative statement.

• (8) Subject to subsection (10), if a substance has been added as a supplemental ingredient, the amount referred to in item 18 of the table to this section includes the total amount of the substance in the supplemented food, unless otherwise provided in column 3 or 5 of the List of Permitted Supplemental Ingredients.

• (9) If any amount of a nutrient referred to in column 1 of the table to this section has been added as a supplemental ingredient, the amount of the nutrient may only be expressed in the supplemented food facts table in accordance with item 18 of the table to this section.

• (10) If a substance other than a nutrient has been added as a supplemental ingredient and the substance has one or more constituents for which a maximum amount is specified in column 3 of the List of Permitted Supplemental Ingredients, the amount of each constituent set out in the supplemented food facts table must include the total amount of the constituent in the supplemented food, unless otherwise provided in column 3 or 5 of the List of Permitted Supplemental Ingredients.

  Item	Column 1	Column 2	Column 3	Column 4
  	Information	Description	Unit	Manner of expression
  1	Serving of stated size	“Serving Size (naming the serving size)”, “Serving (naming the serving size)” or “Per (naming the serving size)”	The size is expressed (a) in the case of a supplemented food that is a single-serving prepackaged product, (i) per package, and (ii) in grams or millilitres, in accordance with subparagraph B.01.002A(2)(a)(i) or (ii); and (b) in the case of a supplemented food that is a multiple-serving prepackaged product, in the following units set out in column 3B of the Table of Reference Amounts: (i) the household measure that applies to the supplemented food, and (ii) the metric measure that applies to the supplemented food.	(1) The size if expressed in a metric unit is rounded off (a) if it is less than 10 g or 10 mL, to the nearest multiple of 0.1 g or 0.1 mL; and (b) if it is 10 g or more or 10 mL or more, to the nearest multiple of 1 g or 1 mL. (2) The size if expressed as a fraction is represented by a numerator and a denominator separated by a line. (3) The size must include the word “assorted” if the information in the supplemented food facts table of a prepackaged product containing an assortment of supplemented foods is set out as a composite value.
  2	Energy value	“Calories”, “Total Calories” or “Calories, Total”	The value is expressed in Calories per serving of stated size.	The value is rounded off (a) if it is less than 5 Calories, (i) if the supplemented food meets the conditions set out in column 2 of item 1 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of energy” set out in column 1, to “0” Calorie, and (ii) in all other cases, to the nearest multiple of 1 Calorie; (b) if it is 5 Calories or more but not more than 50 Calories, to the nearest multiple of 5 Calories; and (c) if it is more than 50 Calories, to the nearest multiple of 10 Calories.
  3	Amount of fat	“Fat”, “Total Fat” or “Fat, Total”	The amount is expressed (a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.5 g, (i) if the supplemented food meets the conditions set out in column 2 of item 11 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of fat” set out in column 1 and the amounts of saturated fatty acids and trans fatty acids are declared as “0 g” in the supplemented food facts table or are omitted from that table in accordance with subsection B.29.002(4) and no other fatty acids are declared in an amount greater than 0 g, to “0 g”, and (ii) in all other cases, to the nearest multiple of 0.1 g; (b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. (2) The percentage is rounded off (a) if the amount is declared as “0 g”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.
  4	Amount of saturated fatty acids	“Saturated Fat”, “Saturated Fatty Acids”, “Saturated” or “Saturates”	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g, (i) if the supplemented food meets the conditions set out in column 2 of item 18 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of saturated fatty acids” set out in column 1, to “0 g”, and (ii) in all other cases, to the nearest multiple of 0.1 g; (b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.
  5	Amount of trans fatty acids	“Trans Fat”, “Trans Fatty Acids” or “Trans”	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g, (i) if the supplemented food meets the conditions set out in column 2 of item 22 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of trans fatty acids” set out in column 1, to “0 g”, and (ii) in all other cases, to the nearest multiple of 0.1 g; (b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.
  6	The sum of saturated fatty acids and trans fatty acids	“Saturated Fat + Trans Fat”, “Saturated Fatty Acids + Trans Fatty Acids”, “Saturated + Trans” or “Saturates + Trans”	The sum is expressed as a percentage of the daily value per serving of stated size.	The percentage is rounded off (a) if the amounts of saturated fatty acids and trans fatty acids are declared as “0 g”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.
  7	Amount of cholesterol	“Cholesterol”	The amount (a) is expressed in milligrams per serving of stated size; and (b) may also be expressed as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if the supplemented food meets the conditions set out in column 2 of item 27 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of cholesterol” set out in column 1, to “0 mg”; and (b) in all other cases, to the nearest multiple of 5 mg. (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.
  8	Amount of sodium	“Sodium”	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 5 mg, (i) if the supplemented food meets the conditions set out in column 2 of item 31 of the Table of Permitted Nutrient Content Statements and Claims for the subject “free of sodium or salt” set out in column 1, to “0 mg”, and (ii) in all other cases, to the nearest multiple of 1 mg; (b) if it is 5 mg or more but not more than 140 mg, to the nearest multiple of 5 mg; and (c) if it is more than 140 mg, to the nearest multiple of 10 mg. (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.
  9	Amount of carbohydrate	“Carbohydrate”, “Total Carbohydrate” or “Carbohydrate, Total”	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g.
  10	Amount of fibre	“Fibre”, “Fiber”, “Dietary Fibre” or “Dietary Fiber”	The amount is expressed (a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (2) The percentage is rounded off (a) if the amount is declared as “0 g”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.
  11	Amount of sugars	“Sugars”	The amount is expressed (a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.5 g, to “0 g”; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (2) The percentage is rounded off (a) if the amount is declared as “0 g”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.
  12	Amount of protein	“Protein”	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g, to the nearest multiple of 0.1 g; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g.
  13	Amount of potassium	“Potassium”	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 5 mg, to “0 mg”; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and (d) if it is 250 mg or more, to the nearest multiple of 50 mg. (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.
  14	Amount of calcium	“Calcium”	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 5 mg, to “0 mg”; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and (d) if it is 250 mg or more, to the nearest multiple of 50 mg. (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.
  15	Amount of iron	“Iron”	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.05 mg, to “0 mg”; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; (c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and (d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg. (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.
  16	% Daily Value interpretative statement	“*5% or less is a little, 15% or more is a lot”	[not applicable]	The “% Daily Value” or “% DV” subheading is followed by an asterisk in order to reference the % Daily Value interpretative statement shown in the supplemented food facts table.
  17	“Supplemented with” interpretative statement	“† Includes naturally occurring and supplemental amounts”	[not applicable]	The “Supplemented with” subheading is followed by a dagger in order to reference the “Supplemented with” interpretative statement shown in the supplemented food facts table.
  18	Amount of supplemental ingredient	The supplemental ingredient is described in accordance with column 1 of the List of Permitted Supplemental Ingredients.	The amount is expressed in (a) the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients, per serving of stated size; and (b) in the case of a nutrient with a daily value, as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off to the nearest whole number and expressed in the manner set out in column 3 and, if applicable, column 5 of the List of Permitted Supplemental Ingredients. (2) Unless otherwise provided in column 5 of the List of Permitted Supplemental Ingredients, the percentage is rounded off (a) if the amount declared in the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients is “0”, to 0%; and (b) in all other cases, to the nearest multiple of 1%.