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• C.01.001 (1) In this Part

  acetaminophen product

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

  adult standard dosage unit

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

  antibiotic

  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)

  children’s standard dosage unit

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

  expiration date

  expiration date  means

  • (a) in the case of a drug in dosage form, the earlier of the following dates, expressed at minimum as a year and month:

    [...]

  • (b) in the case of an active ingredient, whichever of the following dates is applicable, expressed at minimum as a year and month:

    [...]

  List A

  List A  means the document, entitled List of Certain Antimicrobial Active Pharmaceutical Ingredients, that is published by the Government of Canada on its website, as amended from time to time; (Liste A)

  List B

  List B  means the document, entitled List of Certain Veterinary Drugs Which May Be Imported But Not Sold, that is published by the Government of Canada on its website, as amended from time to time; (Liste B)

  List C

  List C  means the document, entitled List of Veterinary Health Products, that is published by the Government of Canada on its website, as amended from time to time; (Liste C)

  List D

  List D  means the document entitled List of Certain Non-prescription Drugs for Distribution as Samples that is published by the Government of Canada on its website, as amended from time to time; (Liste D)

  pharmacy technician

  pharmacy technician  means a person who

  • (a) is registered or otherwise entitled under the laws of a province to practise as a pharmacy technician; and

  • (b) is practising as a pharmacy technician in that province; (technicien en pharmacie)

  salicylate product

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

  withdrawal period

  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 risk to human health. (délai d’attente)

• (1.1) For the purposes of the Act, serious adverse drug reaction has the same meaning as in subsection (1).

• (2) A child resistant package is a package that

  • [...]

  • (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.

• [...]

• (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.

[...]

• B.29.005 (1) Subject to subsections (2) to (5), the information in the supplemented food facts table must be set out only on the basis of the supplemented food as offered for sale.

• [...]

• (3) If a prepackaged product contains an assortment of supplemented foods of the same type and the typical serving consists of more than one of those supplemented foods, the information in the supplemented food facts table must be set out for each of the supplemented foods contained in the prepackaged product or as a composite value.

• (4) If a supplemented food is to be prepared in accordance with directions provided in or on the package or is commonly combined with other ingredients or another food or cooked before being consumed, the supplemented food facts table may also set out information for the supplemented food as prepared, in which case

  • (a) the supplemented food facts table must set out the following information for the supplemented food as prepared, namely,

    • (i) except in the case described in subparagraph (ii), the amount of the supplemented food expressed using the unit referred to in column 3 of subparagraph 1(b)(i) of the table to section B.29.002 as “about (naming the serving size)” or “about (naming the serving size) prepared” and, if applicable, in the manner specified in column 4 of subitems 1(1) and (2),

    • [...]

    • (iv) the information set out in column 1 of items 3, 6 to 8, 10, 11 and 13 to 15 of the table to section B.29.002 and in column 1 of items 11 to 34 of the table to section B.29.003 that is declared as a percentage of the daily value in the supplemented food facts table for the supplemented food as sold, expressed using a description set out in column 2 of those tables, as a percentage of the daily value per serving of stated size and in the manner specified in column 4 of those tables, and

  • (b) the supplemented food facts table may also set out the following information for the added ingredients or the other food, if it is declared in the supplemented food facts table for the supplemented food as sold, namely,

    • [...]

    • (iii) the information set out in column 1 of item 2 of the table to section B.29.002, expressed using a description set out in column 2, in the unit set out in column 3 per serving of stated size of the supplemented food as prepared, and in the manner specified in column 4.

• (5) The information in the supplemented food facts table may also be set out on the basis of other amounts of the supplemented food that reflect different uses or different units of measurement of the supplemented food, in which case

  • (a) the supplemented food facts table must set out the following information for each of the other amounts of the supplemented food, namely,

    • [...]

    • (iii) the information set out in column 1 of items 3, 6 to 8, 10, 11 and 13 to 15 of the table to section B.29.002 and in column 1 of items 11 to 34 of the table to section B.29.003 that is declared as a percentage of the daily value in the supplemented food facts table for the first amount of the supplemented food for which information is declared, expressed using a description set out in column 2 of those tables, as a percentage of the daily value per serving of stated size and in the manner specified in column 4 of those tables, and

[...]

• [...]

• (2) This section does not apply in respect of a vitamin or mineral nutrient that is set out in the supplemented food facts table in accordance with subsection B.29.002(1) if any amount of that vitamin or mineral nutrient has been added as a supplemental ingredient.

• [...]

• (4) For the purposes of subsection (3), 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 and nutrient content of the supplemented food.

• [...]

• (9) The supplemented food facts table must show the amount of any vitamin or mineral nutrient that is declared as a component of an ingredient, other than flour.

• (10) If information set out in column 1 of the table to this section is included in the supplemented food facts table, it must be shown

  • [...]

  • (b) in one of those languages, if, in accordance with subsection B.01.012(3), the information that is required by these Regulations to be shown on the label may be shown in that language only and is shown on the label in that language.

    Item	Column 1	Column 2	Column 3	Column 4
    Information	Description	Unit	Manner of expression
    1	Servings per package	“Servings per Container”, “(number of units) per Container”, “Servings per Package”, “(number of units) per Package”, “Servings per (naming the package type)”, or “(number of units) per (naming the package type)”	The quantity is expressed in number of servings.	[...] (3) If the product is of a random weight, the quantity may be declared as “varied”.
    7	Amount of soluble fibre	“Soluble Fibre” or “Soluble Fiber”	The amount is expressed as grams per serving of stated size.	[...]
    8	Amount of insoluble fibre	“Insoluble Fibre” or “Insoluble Fiber”	The amount is expressed as grams per serving of stated size.	[...]
    9	Amount of sugar alcohol	[...]	The amount is expressed as grams per serving of stated size.	[...]
    10	Amount of starch	“Starch”	The amount is expressed as grams per serving of stated size.	[...]
    11	Amount of vitamin A	“Vitamin A” or “Vit A”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and
    12	Amount of vitamin C	“Vitamin C” or “Vit C”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    13	Amount of vitamin D	“Vitamin D” or “Vit D”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and
    14	Amount of vitamin E	“Vitamin E” or “Vit E”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    15	Amount of vitamin K	“Vitamin K” or “Vit K”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and
    16	Amount of thiamine	“Thiamine”, “Thiamin”, “Thiamine (Vitamin B1)”, “Thiamine (Vit B1)”, “Thiamin (Vitamin B1)” or “Thiamin (Vit B1)”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    17	Amount of riboflavin	“Riboflavin”, “Riboflavin (Vitamin B2)” or “Riboflavin (Vit B2)”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    18	Amount of niacin	“Niacin”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    19	Amount of vitamin B6	“Vitamin B6” or “Vit B6”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    20	Amount of folate	“Folate”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 µg DFE”, to 0%; and
    21	Amount of vitamin B12	“Vitamin B12” or “Vit B12”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and
    22	Amount of biotin	“Biotin”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and
    23	Amount of pantothenic acid	“Pantothenic Acid” or “Pantothenate”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    24	Amount of choline	“Choline”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    25	Amount of phosphorous	“Phosphorus”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    26	Amount of iodide	“Iodide” or “Iodine”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and
    27	Amount of magnesium	“Magnesium”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    28	Amount of zinc	“Zinc”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    29	Amount of selenium	“Selenium”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and
    30	Amount of copper	“Copper”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    31	Amount of manganese	“Manganese”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
    32	Amount of chromium	“Chromium”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and
    33	Amount of molybdenum	“Molybdenum”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 µg”, to 0%; and
    34	Amount of chloride	“Chloride”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and

[...]

• 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.

• [...]

• (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:

  • [...]

  • (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;

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

  • [...]

  • (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;

• (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.

• [...]

• (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)”	[...]	[...] (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.
  3	Amount of fat	“Fat”, “Total Fat” or “Fat, Total”	The amount is expressed [...] (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 (2) The percentage is rounded off (a) if the amount is declared as “0 g”, to 0%; and
  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
  7	Amount of cholesterol	“Cholesterol”	The amount [...] (b) may also be expressed as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
  8	Amount of sodium	“Sodium”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
  10	Amount of fibre	“Fibre”, “Fiber”, “Dietary Fibre” or “Dietary Fiber”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 g”, to 0%; and
  11	Amount of sugars	“Sugars”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 g”, to 0%; and
  13	Amount of potassium	“Potassium”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
  14	Amount of calcium	“Calcium”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
  15	Amount of iron	“Iron”	The amount is expressed [...] (b) as a percentage of the daily value per serving of stated size.	[...] (2) The percentage is rounded off (a) if the amount is declared as “0 mg”, to 0%; and
  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 [...] (b) in the case of a nutrient with a daily value, as a percentage of the daily value per serving of stated size.	[...]

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• D.01.001 (1) In this Part,

  human milk fortifier

  human milk fortifier  has the same meaning as in section B.25.001; (fortifiant pour lait humain)

  human milk substitute

  human milk substitute  has the same meaning as in section B.25.001; (succédané de lait humain)

  supplemental ingredient

  supplemental ingredient  has the same meaning as in section B.01.001; (ingrédient supplémentaire)

  supplemented food

  supplemented food  has the same meaning as in section B.01.001; (aliment supplémenté)

  supplemented food facts table

  supplemented food facts table  has the same meaning as in subsection B.01.001(1); (tableau des renseignements sur les aliments supplémentés)

  Table of Daily Values

  Table of Daily Values  has the same meaning as in subsection B.01.001(1); (Tableau des valeurs quotidiennes)

  Table of Reference Amounts

  Table of Reference Amounts  has the same meaning as in subsection B.01.001(1); (Tableau des quantités de référence)

  testimonial

  testimonial , with respect to a food or drug that is represented as containing a vitamin, mineral nutrient or mineral, means any dramatized or undramatized pictorial, written or oral representation as to the result that is, has been or may be produced by the addition to a person’s diet of that vitamin, mineral nutrient or mineral, as the case may be; (témoignage)

• (2) For the purposes of this Part, a serving of stated size of a food shall be

  • (a) based on the food as offered for sale;

• (3) A serving of stated size of a food shall be expressed as follows:

  [...]

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