Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods): SOR/2022-169

Canada Gazette, Part II, Volume 156, Number 15

Registration
SOR/2022-169 June 28, 2022

FOOD AND DRUGS ACT

P.C. 2022-845 June 28, 2022

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) under

• (a) subsection 30(1)^{footnote a} of the Food and Drugs Act^{footnote b}; and
• (b) subsection 139(1) of the Cannabis Act^{footnote c}.

Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods)

Food and Drugs Act

Food and Drug Regulations

1 (1) The definition agricultural chemical in subsection B.01.001(1) of the Food and Drug Regulations ^{footnote 1} is amended by adding the following after paragraph (c):

• (c.1) supplemental ingredient,

(2) The definition food additive in subsection B.01.001(1) of the Regulations is amended by adding the following after paragraph (b):

• (b.1) supplemental ingredients;

(3) Subsection B.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

list of cautionary statements

means the list shown on the label of a supplemented food in accordance with subsection B.29.020(1); (liste des mises en garde)

List of Permitted Supplemental Ingredients

means the document entitled List of Permitted Supplemental Ingredients, published by the Government of Canada on its website, as amended from time to time; (Liste des ingrédients supplémentaires autorisés)

List of Permitted Supplemented Food Categories

means the document entitled List of Permitted Supplemented Food Categories, published by the Government of Canada on its website, as amended from time to time; (Liste des catégories autorisées d’aliments supplémentés)

supplemental ingredient

means a nutrient — including a vitamin, mineral nutrient or amino acid — or any other substance listed in column 1 of the List of Permitted Supplemental Ingredients and added as an ingredient to a food in accordance with the applicable conditions of use set out in columns 2 to 5; (ingrédient supplémentaire)

supplemented food

means a prepackaged product that belongs to a food category set out in column 1 of the List of Permitted Supplemented Food Categories and to which a supplemental ingredient has been added, but does not include

• (a) a food for special dietary use as defined in section B.24.001 and referred to in any of paragraphs B.24.003(1) f) to (f.2) and (h) to (j), even if the food for special dietary use is also a gluten-free food referred to in paragraph B.24.003(1)(g);
• (b) a food that is labelled or advertised for consumption by
  • (i) infants as defined in section B.25.001,
  • (ii) children one year of age or older but less than four years of age, or
  • (iii) women who are pregnant or breastfeeding;
• (c) any of the following foods set out in column I of the Table to section D.03.002:
  • (i) a food referred to in any of items 1, 2.1, 2.2, 4, 5, 7, 8, 9.1, 10 to 13, 15, 17 to 19, 21 to 25 and 27, and
  • (ii) prepackaged ice;
• (d) a food that has not been processed or that has been minimally processed; or
• (e) a beverage with an alcohol content of more than 0.5%; (aliment supplémenté)

supplemented food caution identifier

means the identifier carried on the principal display panel of a supplemented food under subsection B.29.021(1); (identifiant des aliments supplémentés avec mise en garde)

supplemented food facts table

means the supplemented food facts table required by subsection B.29.002(1) to be carried on the label of a supplemented food; (tableau des renseignements sur les aliments supplémentés)

(4) Section B.01.001 of the Regulations is amended by adding the following after subsection (3):

(4) For the purposes of the definitions supplemental ingredient and supplemented food in subsection (1), if a supplemented food is used as an ingredient in the manufacture of a second supplemented food, a supplemental ingredient in the first supplemented food is deemed to also have been added as a supplemental ingredient to — and not to be a component of an ingredient of — the second supplemented food if it is contained in the second supplemented food in accordance with the applicable conditions of use set out in columns 2 to 5 of the List of Permitted Supplemental Ingredients.

2 Subsection B.01.005(5) of the Regulations is replaced by the following:

(5) Despite subsection (2), the nutrition facts table, supplemented food facts table and list of cautionary statements may be shown on that part of the label that is applied to the bottom of the food or container if the available display surface includes the bottom.

3 Paragraph B.01.008(1)(a) of the Regulations is replaced by the following:

• (a) any information required by these Regulations, other than
  • (i) the information required to appear on the principal display panel, nutrition facts table or supplemented food facts table,
  • (ii) the information required by subsection B.01.005(4), sections B.01.007, B.01.301, B.01.305, B.01.311, B.01.503, B.01.513 and B.01.601, paragraphs B.24.103(g), B.24.202(d), B.24.304(h), B.25.020(1)(e), (f) and (h), B.25.057(1)(f) and (2)(f), B.27.005(a) and sections B.29.020 and B.29.026, and
  • (iii) any statement required to be shown on the label of a supplemented food in accordance with column 5 of the List of Permitted Supplemental Ingredients; and

4 (1) The portion of subsection B.01.008.1(1) of the Regulations before paragraph (a) is replaced by the following:

B.01.008.1 (1) Information appearing on the label of a prepackaged product according to sections B.01.008.2 to B.01.010.4, B.01.014 and B.29.020 shall be shown

(2) Paragraph B.01.008.1(1)(c) of the Regulations is replaced by the following:

• (c) in type of normal or condensed width that is not scaled down so that the characters take up less space horizontally and, if a nutrition facts table or supplemented food facts table appears on the label, the width of type must be the same as that required for the type used to show the nutrients that appear in the nutrition facts table or the supplemental ingredients that appear in the supplemented food facts table, as the case may be;

(3) Subsections B.01.008.1(3) and (4) of the Regulations are replaced by the following:

(3) Except as otherwise provided in subsection (4) and sections B.01.008.2 to B.01.010.4, if a nutrition facts table or supplemented food facts table appears on the label of a prepackaged product and the type size of the nutrients shown in the nutrition facts table or the supplemental ingredients shown in the supplemented food facts table is not less than 8 points, the information referred to in subsection (1) must be shown in type that is

• (a) the same height as the type in which the nutrients are shown in the nutrition facts table or the supplemental ingredients are shown in the supplemented food facts table, as the case may be; and
• (b) of a height that is not less than 1.4 mm with identical leading of not less than 3.2 mm.

(4) A title that introduces a list of ingredients, a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1), a declaration referred to in subsection B.01.010.4(1) or a list of cautionary statements may be shown in type that is of a greater height than the type used to show the information in either of the lists, the statement or the declaration, as the case may be.

5 (1) Paragraph B.01.008.2(2)(b) of the Regulations is replaced by the following:

• (b) a background colour that creates a contrast between the background colour of the list and the background colour used on the adjacent surface of the label, other than the surface used to display
  • (i) a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1),
  • (ii) a declaration referred to in sub-section B.01.010.4(1),
  • (iii) any statement referred to in subsection B.01.014(1),
  • (iv) a nutrition facts table,
  • (v) a supplemented food facts table, or
  • (vi) a list of cautionary statements.

(2) Subparagraphs B.01.008.2(3)(b)(i) and (ii) of the Regulations are replaced by the following:

• (i) the first letter of each ingredient or, in the case of a food additive or supplemental ingredient shown in whole or in part by an acronym, the entire acronym, and
• (ii) the alpha-descriptor that forms a part of the common name for a food additive, vitamin, supplemental ingredient or microorganism; and

(3) Subsection B.01.008.2(4) of the Regulations is amended by striking out “and” at the end of paragraph (g), by adding “and” at the end of paragraph (h) and by adding the following after paragraph (h):

• (i) supplemental ingredients.

(4) Subparagraphs B.01.008.2(5)(c)(i) and (ii) of the Regulations are replaced by the following:

• (i) in the case of a food additive or supplemental ingredient shown in whole or in part by an acronym, the entire acronym, and
• (ii) the alpha-descriptor that forms a part of the common name for a food additive, vitamin, supplemental ingredient or microorganism; and

6 Subsection B.01.009(3) of the Regulations is amended by striking out “and” at the end of paragraph (e), by adding “and” at the end of paragraph (f) and by adding the following after paragraph (f):

• (g) any supplemental ingredient.

7 The portion of the definition specialty food in subsection B.01.012(1) of the Regulations before paragraph (a) is replaced by the following:

specialty food means a food — other than a human milk fortifier or supplemented food — that

8 Subsection B.01.021(1) of the Regulations is replaced by the following:

B.01.021 (1) The label of a food that contains erythritol shall carry a statement indicating the amount of erythritol expressed in grams per serving of stated size unless the label carries a nutrition facts table or supplemented food facts table.

9 (1) The portion of subsection B.01.301(1) of the Regulations before paragraph (a) is replaced by the following:

B.01.301 (1) No person shall, on the label of or in any advertisement for a food, other than in the nutrition facts table or supplemented food facts table, if any, include a declaration of the food’s energy value or the amount of a nutrient or supplemental ingredient contained in the food unless it is declared in the following manner, per serving of stated size:

(2) Paragraph B.01.301(1)(b) of the Regulations is replaced by the following:

• (b) in the case of a vitamin referred to in subsection D.01.002(1) that is not one of the following vitamins, in the applicable unit set out in subsection D.01.003(1):
  • (i) 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
  • (ii) niacin, if it is a supplemental ingredient;
• (b.01) in the case of the following vitamins, in the applicable unit set out in column 3 of the List of Permitted Supplemental Ingredients:
  • (i) 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
  • (ii) niacin, if it is a supplemental ingredient;

(3) Subsection B.01.301(1) of the Regulations is amended by striking out “and” at the end of paragraph (d) and by adding the following after that paragraph:

• (d.1) in the case of a supplemental ingredient other than a vitamin or mineral nutrient referred to in this subsection, in the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients; and

(4) Section B.01.301 of the Regulations is amended by adding the following after subsection (1):

(1.1) Despite subsection D.01.003(1) and for the purposes of this section, the amount in metric units of the vitamins referred to in paragraph (1)(b.01) 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.

(5) The portion of subsection B.01.301(2) of the Regulations before paragraph (c) is replaced by the following:

(2) Despite subsection (1), a person may, on the label of or in any advertisement for a food, other than in the nutrition facts table or supplemented food facts table, if any, include a declaration of the percentage of the daily value of a nutrient contained in the food if

• (a) in the case of a food that is not a supplemented food, the nutrient is listed in column 1 of the table to section B.01.401 or the table to section B.01.402 and the percentage of the daily value of the nutrient is required or permitted to be declared in the nutrition facts table;
• (b) in the case of a supplemented food, the nutrient is listed in column 1 of the table to section B.29.002 or the table to section B.29.003, or referred to in column 2 of item 18 of the table to section B.29.002, and the percentage of the daily value of the nutrient is required or permitted to be declared in the supplemented food facts table; and

10 Section B.01.302 of the Regulations is replaced by the following:

B.01.302 If the label of a multiple-serving prepackaged product indicates that the product contains or, if prepared as directed in or on the package, provides a specified number of servings or portions, that information must be based on the serving of stated size set out in the nutrition facts table or supplemented food facts table, as the case may be.

11 (1) The portion of subsection B.01.305(2) of the Regulations before paragraph (a) is replaced by the following:

(2) No person shall, on the label of or in any advertisement for a food, other than a supplemented food, make a representation, express or implied, respecting an amino acid unless

(2) Paragraph B.01.305(3)(i) of the Regulations is replaced by the following:

• (i) a declaration of the amount of protein in the nutrition facts table or supplemented food facts table, as the case may be;

12 Subsection B.01.311(4) of the Regulations is replaced by the following:

(4) If a statement or claim described in subsection (3) concerns a nutrient not listed in column 1 of the tables to sections B.01.401 and B.01.402 — or, as the case may be, not listed in column 1 of the tables to sections B.29.002 and B.29.003 and not referred to in column 2 of item 18 of the table to section B.29.002 — the amount of the nutrient contained in the food must be expressed on any part of the label in grams per serving of stated size.

13 Subsection B.01.350(14) of the Regulations is replaced by the following:

(13.1) Subject to subsection (13.2), subsection (1) does not apply to a supplemented food that has an available display surface of less than 100 cm² other than a supplemented food that is referred to in paragraph B.29.018(2)(b).

(13.2) Subsection (1) does not apply to a supplemented food that has an available display surface of less than 100 cm², whether or not the supplemented food is referred to in paragraph B.29.018(2)(b), if the supplemented food carries a supplemented food caution identifier.

(14) If, as a result of the application of any provision in subsections (5) to (13.2), subsection (1) does not apply to a prepackaged product or does not apply to a prepackaged product in respect of a particular nutrient, that provision prevails over any other provision in subsections (5) to (13.2) that indicates otherwise.

14 Section B.01.358 of these Regulations is renumbered as subsection B.01.358(1) and is amended by adding the following:

(2) For the purposes of subsection (1), a representation does not include a supplemented food caution identifier.

15 Subsections B.01.401(4) and (5) of the Regulations are replaced by the following:

(4) Subsection (1) does not apply to a formulated liquid diet, human milk fortifier, human milk substitute, food represented as containing a human milk substitute, meal replacement, nutritional supplement, food represented for use in a very low energy diet or supplemented food.

(5) The label of, or an advertisement for, a formulated liquid diet, human milk fortifier, human milk substitute, food represented as containing a human milk substitute, meal replacement, nutritional supplement, food represented for use in a very low energy diet or supplemented food shall not contain a nutrition facts table or the phrase “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.

16 Subsection B.01.404(1) of the Regulations is replaced by the following:

B.01.404 (1) Subject to section B.29.004, this section applies to a prepackaged product intended solely for use as an ingredient in the manufacture of other prepackaged products intended for sale to a consumer at the retail level or as an ingredient in the preparation of food by a commercial or industrial enterprise or an institution.

17 Subsection B.01.405(1) of the Regulations is replaced by the following:

B.01.405 (1) This section applies to a prepackaged product, other than a supplemented food, that is a ready-to-serve multiple-serving prepackaged product intended solely to be served in a commercial or industrial enterprise or an institution.

18 (1) The portion of subitem 2(1) of the table to section B.01.603 of the Regulations in column 3 is replaced by the following:

Item

Column 3 Conditions — Label or Advertisement

2

(1) If the statement or claim is made on the label of a prepackaged product, or in any advertisement for the prepackaged product that is made or placed by or on the direction of the manufacturer of the product, the amount of vitamin D and phosphorus shall be included in, as the case may be, (a) the nutrition facts table in accordance with subsection B.01.402(2); or (b) the supplemented food facts table in accordance with subsection B.29.002(1), in respect of the description referred to in column 2, the unit referred to in column 3 and the manner of expression referred to in column 4 of the table to section B.29.002, or with subsection B.29.003(3), or with both, as the case may be.

(2) The portion of item 5 of the table to section B.01.603 of the Regulations in column 3 is replaced by the following:

Item

Column 3 Conditions — Label or Advertisement

5

If the statement or claim is made on the label of a prepackaged product, or in any advertisement for the prepackaged product that is made or placed by or on the direction of the manufacturer of the product, the amount of sugar alcohols, if present, shall be included in, as the case may be, (a) the nutrition facts table, in accordance with subsection B.01.402(2); or (b) the supplemented food facts table, in accordance with subsection B.29.003(3).

19 Subsection B.15.001(4) of the Regulations is amended by adding the following after paragraph (a):

• (a.1) a supplemental ingredient;

20 The portion of the definition novel food in section B.28.001 of the Regulations before paragraph (a) is replaced by the following:

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

21 The Regulations are amended by adding the following after section B.28.003:

DIVISION 29

Supplemented Foods

Interpretation

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

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

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

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.

TABLE
Core Information

Item	Column 1 Information	Column 2 Description	Column 3 Unit	Column 4 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 subpara-graph 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 i 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%.

Additional Information

B.29.003 (1) Subject to subsection (2), the supplemented food facts table may also contain information set out in column 1 of the table to this section.

(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.

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

(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.

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

(6) The amount of omega-6 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids and monounsaturated fatty acids must be shown in the supplemented food facts table if

• (a) the amount of any of those groups of fatty acids or the amount of polyunsaturated fatty acids is shown in the supplemented food facts table or 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; or
• (b) the amount of any specific fatty acid is shown 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.

(7) If the label of the supplemented food, or any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer, contains a representation, express or implied, that includes information that is set out in column 1 of the table to this section, that information must also be shown in the supplemented food facts table.

(8) The supplemented food facts table must show the amount of any added sugar alcohol.

(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

• (a) in English and French; or
• (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.

TABLE
Additional Information

Item	Column 1 Information	Column 2 Description	Column 3 Unit	Column 4 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.	(1) The quantity is rounded off (a) if it is less than 2, to the nearest multiple of 1; (b) if it is between 2 and 5, to the nearest multiple of 0.5; and (c) if it is more than 5, to the nearest multiple of 1. (2) If a quantity is rounded off, it must be preceded by the word "about". (3) If the product is of a random weight, the quantity may be declared as "varied".
2	Energy value	"kilojoules" or "kJ"	The value is expressed in kilojoules per serving of stated size.	The value is rounded off to the nearest multiple of 10 kilojoules.
3	Amount of polyunsaturated fatty acids	"Polyunsaturated Fat", "Polyunsaturated Fatty Acids", "Polyunsaturated" or "Polyunsaturates"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 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.
4	Amount of omega-6 polyunsaturated fatty acids	(1) If the supplemented food facts table includes the amount of polyunsaturated fatty acids: "Omega-6", "Omega-6 Polyunsaturated Fat", "Omega-6 Polyunsaturated Fatty Acids", "Omega-6 Polyunsaturates" or "Omega-6 Polyunsaturated" (2) In all other cases: "Omega-6 Polyunsaturated Fat", "Omega-6 Polyunsaturated Fatty Acids", "Omega-6 Polyunsaturates" or "Omega-6 Polyunsaturated"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 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 omega-3 polyunsaturated fatty acids	(1) If the supplemented food facts table includes the amount of polyunsaturated fatty acids: "Omega-3", "Omega-3 Polyunsaturated Fat", "Omega-3 Polyunsaturated Fatty Acids", "Omega-3 Polyunsaturates" or "Omega-3 Polyunsaturated" (2) In all other cases: "Omega-3 Polyunsaturated Fat", "Omega-3 Polyunsaturated Fatty Acids", "Omega-3 Polyunsaturates" or "Omega-3 Polyunsaturated"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 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	Amount of monounsaturated fatty acids	"Monounsaturated Fat", "Monounsaturated Fatty Acids", "Monounsaturates" or "Monounsaturated"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 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.
7	Amount of soluble fibre	"Soluble Fibre" or "Soluble Fiber"	The amount is expressed as 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.
8	Amount of insoluble fibre	"Insoluble Fibre" or "Insoluble Fiber"	The amount is expressed as 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.
9	Amount of sugar alcohol	(1) If the supplemented food contains only one type of sugar alcohol: "Sugar Alcohol", "Polyol" or "(naming the sugar alcohol)" (2) In all other cases: "Sugar Alcohols" or "Polyols"	The amount is expressed as 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 starch	"Starch"	The amount is expressed as 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.
11	Amount of vitamin A	"Vitamin A" or "Vit A"	The amount is expressed (a) in micrograms 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 µg, to "0 µg"; (b) if it is 5 µg or more but less than 50 µg, to the nearest multiple of 10 µg; (c) if it is 50 µg or more but less than 250 µg, to the nearest multiple of 50 µg; and (d) if it is 250 µg or more, to the nearest multiple of 100 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
12	Amount of vitamin C	"Vitamin C" or "Vit C"	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 0.1 mg, to "0 mg"; (b) if it is 0.1 mg or more but less than 1 mg, to the nearest multiple of 0.2 mg; (c) if it is 1 mg or more but less than 5 mg, to the nearest multiple of 0.5 mg; and (d) if it is 5 mg or more, to the nearest multiple of 1 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%.
13	Amount of vitamin D	"Vitamin D" or "Vit D"	The amount is expressed (a) in micrograms 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 0.1 µg, to "0 µg"; (b) if it is 0.1 µg or more but less than 1 µg, to the nearest multiple of 0.2 µg; (c) if it is 1 µg or more but less than 5 µg, to the nearest multiple of 0.5 µg; and (d) if it is 5 µg or more, to the nearest multiple of 1 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
14	Amount of vitamin E	"Vitamin E" or "Vit E"	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%.
15	Amount of vitamin K	"Vitamin K" or "Vit K"	The amount is expressed (a) in micrograms 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 µg, to "0 µg"; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
16	Amount of thiamine	"Thiamine", "Thiamin", "Thiamine (Vitamin B1)", "Thiamine (Vit B1)", "Thiamin (Vitamin B1)" or "Thiamin (Vit B1)"	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 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 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%.
17	Amount of riboflavin	"Riboflavin", "Riboflavin (Vitamin B2)" or "Riboflavin (Vit B2)"	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 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 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%.
18	Amount of niacin	"Niacin"	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%.
19	Amount of vitamin B6	"Vitamin B6" or "Vit B6"	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 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 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%.
20	Amount of folate	"Folate"	The amount is expressed (a) in micrograms of dietary folate equivalents (DFE) 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 1 µg DFE, to "0 µg DFE"; (b) if it is 1 µg DFE or more but less than 10 µg DFE, to the nearest multiple of 2 µg DFE; (c) if it is 10 µg DFE or more but less than 50 µg DFE, to the nearest multiple of 5 µg DFE; and (d) if it is 50 µg DFE or more, to the nearest multiple of 10 µg DFE. (2) The percentage is rounded off (a) if the amount is declared as "0 µg DFE", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
21	Amount of vitamin B12	"Vitamin B12" or "Vit B12"	The amount is expressed (a) in micrograms 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 0.005 µg, to "0 µg"; (b) if it is 0.005 µg or more but less than 0.05 µg, to the nearest multiple of 0.01 µg; (c) if it is 0.05 µg or more but less than 0.25 µg, to the nearest multiple of 0.025 µg; and (d) if it is 0.25 µg or more, to the nearest multiple of 0.05 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
22	Amount of biotin	"Biotin"	The amount is expressed (a) in micrograms 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 µg, to "0 µg"; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
23	Amount of pantothenic acid	"Pantothenic Acid" or "Pantothenate"	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 0.01 mg, to "0 mg"; (b) if it is 0.01 mg or more but less than 0.1 mg, to the nearest multiple of 0.02 mg; (c) if it is 0.1 mg or more but less than 0.5 mg, to the nearest multiple of 0.05 mg; and (d) if it is 0.5 mg or more, to the nearest multiple of 0.1 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%.
24	Amount of choline	"Choline"	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 1 mg, to "0 mg"; (b) if it is 1 mg or more but less than 10 mg, to the nearest multiple of 2 mg; (c) if it is 10 mg or more but less than 50 mg, to the nearest multiple of 5 mg; and (d) if it is 50 mg or more, 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%.
25	Amount of phosphorous	"Phosphorus"	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%.
26	Amount of iodide	"Iodide" or "Iodine"	The amount is expressed (a) in micrograms 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 1 µg, to "0 µg"; (b) if it is 1 µg or more but less than 10 µg, to the nearest multiple of 2 µg; (c) if it is 10 µg or more but less than 50 µg, to the nearest multiple of 5 µg; and (d) if it is 50 µg or more, to the nearest multiple of 10 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
27	Amount of magnesium	"Magnesium"	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 1 mg, to "0 mg"; (b) if it is 1 mg or more but less than 10 mg, to the nearest multiple of 2 mg; (c) if it is 10 mg or more but less than 50 mg, to the nearest multiple of 5 mg; and (d) if it is 50 mg or more, 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%.
28	Amount of zinc	"Zinc"	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%.
29	Amount of selenium	"Selenium"	The amount is expressed (a) in micrograms 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 0.1 µg, to "0 µg"; (b) if it is 0.1 µg or more but less than 1 µg, to the nearest multiple of 0.2 µg; (c) if it is 1 µg or more but less than 5 µg, to the nearest multiple of 0.5 µg; and (d) if it is 5 µg or more, to the nearest multiple of 1 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
30	Amount of copper	"Copper"	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 0.0015 mg, to "0 mg"; (b) if it is 0.0015 mg or more but less than 0.025 mg, to the nearest multiple of 0.002 mg; (c) if it is 0.025 mg or more but less than 0.05 mg, to the nearest multiple of 0.005 mg; and (d) if it is 0.05 mg or more, to the nearest multiple of 0.01 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%.
31	Amount of manganese	"Manganese"	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 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 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%.
32	Amount of chromium	"Chromium"	The amount is expressed (a) in micrograms 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 µg, to "0 µg"; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
33	Amount of molybdenum	"Molybdenum"	The amount is expressed (a) in micrograms 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 µg, to "0 µg"; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
34	Amount of chloride	"Chloride"	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%.

Supplemented Foods for Use in Manufacturing Other Supplemented Foods

B.29.004 (1) This section applies 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.

(2) It is prohibited to sell the supplemented food unless the information referred to in subsection (3) in respect of the supplemented food is provided in writing and accompanies the supplemented food when it is delivered to the purchaser.

(3) The information

• (a) must include the information that would, but for subsection B.29.002(6), be required by sections B.29.002 and B.29.003 to be included in a supplemented food facts table;
• (b) may include other information that is permitted by section B.29.003 to be included in that supplemented food facts table; and
• (c) must be expressed in accordance with sections B.29.002 and B.29.003, subject to the following modifications, namely,
  • (i) information in respect of supplemental ingredients must be expressed according to the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients,
    • (A) per gram or 100 g of the supplemented food, if the net quantity of the supplemented food is declared on the label by weight or by count, or
    • (B) per millilitre or 100 mL of the supplemented food, if the net quantity of the supplemented food is declared on the label by volume,
  • (ii) information — other than in respect of supplemental ingredients — for vitamins referred to in subsection D.01.002(1) must be expressed in the applicable unit referred to in subsection D.01.003(1) and for mineral nutrients referred to in paragraphs D.02.001(1)(a) to (j), (l) to (n) and (p) must be expressed in milligrams for sodium, potassium, calcium, phosphorus, magnesium, iron, zinc, chloride, copper and manganese and in micrograms for iodide, chromium, selenium and molybdenum,
    • (A) per gram or 100 g of the supplemented food, if the net quantity of the supplemented food is declared on the label by weight or by count, or
    • (B) per millilitre or 100 mL of the supplemented food, if the net quantity of the supplemented food is declared on the label by volume,
  • (iii) information for other nutrients and the energy value set out in column 1 of the table to section B.29.002 or the table to section B.29.003 must be expressed in the units referred to in column 3,
    • (A) per gram or 100 g of the supplemented food, if the net quantity of the supplemented food is declared on the label by weight or by count, or
    • (B) per millilitre or 100 mL of the supplemented food, if the net quantity of the supplemented food is declared on the label by volume,
  • (iv) percentages of daily values and information on servings of stated size may be omitted, and
  • (v) the information must be stated with a degree of precision that corresponds to the accuracy of the analytical methodology used to produce the information.

Basis of Information

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.

(2) If a prepackaged product contains an assortment of supplemented foods of the same type and the typical serving consists of only one of those supplemented foods, the information in the supplemented food facts table must be set out

• (a) on the basis of each of the supplemented foods contained in the prepackaged product, if the information set out in column 1 of the table to section B.29.002 for each of those supplemented foods is different; or
• (b) on the basis of one of the supplemented foods contained in the prepackaged product, if the information set out in column 1 of the table to section B.29.002 for each of those supplemented foods is the same.

(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),
  • (ii) if the supplemented food is commonly served combined with another food, the amount of the other food expressed using the unit referred to in column 3 of subparagraph 1(b)(i) of the table to section B.29.002,
  • (iii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.29.002, in the unit set out in column 3 and in the manner set out in column 4,
  • (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
  • (v) the information referred to in column 1 of item 18 of the table to section B.29.002, expressed using the description referred to in column 2, in the unit referred to in column 3 and in the manner referred to in column 4; 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,
  • (i) the information set out in column 1 of items 3 to 5 and 7 to 12 of the table to section B.29.002, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7 and 8 and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12 and in the manner specified in column 4,
  • (ii) the information set out in column 1 of items 3 to 10 of the table to section B.29.003, expressed using a description set out in column 2, in grams and in the manner specified in column 4, and
  • (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,
  • (i) the amount of the supplemented food expressed in a household measure and a metric measure and in the manner specified in column 4 of subitems 1(1) and (2) of the table to section B.29.002,
  • (ii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.29.002, in the unit set out in column 3 and in the manner set out in column 4,
  • (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
  • (iv) the information referred to in column 1 of item 18 of the table to section B.29.002, expressed using the description referred to in column 2, the unit referred to in column 3 and in the manner referred to in column 4; and
• (b) if the supplemented food facts table is set out in a version of the aggregate format specified in sec-tion B.29.015, it must also set out the following information for each of the other amounts of the supplemented food, if that information is declared in the supplemented food facts table for the first amount of the supplemented food for which information is declared, namely,
  • (i) the information set out in column 1 of items 3 to 5 and 7 to 15 of the table to section B.29.002, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7, 8 and 13 to 15, and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12 and in the manner specified in column 4, and
  • (ii) the information set out in column 1 of items 3 to 34 of the table to section B.29.003, expressed using a description set out in column 2, in micrograms for the information set out in column 1 of items 11, 13, 15, 21, 22, 26, 29, 32 and 33, in micrograms of dietary folate equivalents for the information set out in column 1 of item 20, in milligrams for the information set out in column 1 of items 12, 14, 16 to 19, 23 to 25, 27, 28, 30, 31 and 34, and in grams for the information set out in column 1 of items 3 to 10 and in the manner specified in column 4.

Presentation of Supplemented Food Facts Table

B.29.006 (1) Subject to subsections (2) to (7), the supplemented food facts table must be presented in accordance with the format specified in the applicable figure in the Directory of SFFT Formats, having regard to matters such as order of presentation, dimensions, spacing and the use of upper and lower case letters and bold type.

(2) The characters and rules in the supplemented food facts table must be displayed in a single colour that is a visual equivalent of 100% solid black type on a white background or on a uniform neutral background with a maximum 5% tint of colour.

(3) The characters in the supplemented food facts table

• (a) must be displayed in a single standard sans serif font that is not decorative and in such a manner that the characters never touch each other or the rules; and
• (b) may be displayed with larger dimensions than those specified in the applicable figure in the Directory of SFFT Formats if all the characters in the table are enlarged in a uniform manner.

(4) The type size shown in parentheses for a version referred to in a table to sections B.29.009 to B.29.015 is the minimum type size that may be used in a supplemented food facts table to show nutrients and supplemental ingredients set out in the tables to sections B.29.002 and B.29.003 in accordance with that version.

(5) A rule that is specified in the applicable figure in the Directory of SFFT Formats as being a 1 point rule or a 2 point rule may be displayed with larger dimensions in the supplemented food facts table.

(6) The information in the supplemented food facts table must be in accordance with subsections B.29.001(2) and (3) and sections B.29.002, B.29.003 and B.29.005.

(7) In a supplemented food facts table consisting of a table in both English and French, the order of languages may be reversed from the order shown in the applicable figure in the Directory of SFFT Formats.

Location of Supplemented Food Facts Table

B.29.007 (1) Subject to subsection (2), the supplemented food facts table must be displayed

• (a) in a table in English and a table in French on the same continuous surface of the available display surface;
• (b) in a table in both English and French on a continuous surface of the available display surface; or
• (c) in a table in English on a continuous surface of the available display surface and a table in French on another continuous surface of the available display surface that is of the same size and prominence as the first surface.

(2) If, in accordance with subsection B.01.012(3), the information required by these Regulations may be shown on the label of a supplemented food in English only or in French only and is shown in that language, the supplemented food facts table may be displayed on the label in a table in that language only on a continuous surface of the available display surface.

Orientation of Supplemented Food Facts Table

B.29.008 (1) Subject to subsection (2), the supplemented food facts table must be oriented in the same manner as other information appearing on the label of a supplemented food.

(2) If a version of a supplemented food facts table cannot be oriented in the same manner as other information appearing on the label, it must be oriented in another manner if there is sufficient space to do so and the food contained in the package does not leak out and is not damaged when the package is turned over.

(3) Subsection (1) does not apply in respect of a supplemented food facts table that is set out on the top or bottom of a package.

Standard and Horizontal Formats

B.29.009 (1) This section applies to a supplemented food unless any of sections B.29.010 to B.29.015 applies to it.

(2) Subject to subsection (3), the supplemented food facts table must be set out in a version listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out in

• (a) the bilingual standard format in accordance with Figure 3.5(B), 3.6(B) or 3.7(B) of the Directory of SFFT Formats;
• (b) the bilingual horizontal format in accordance with Figure 4.3(B), 4.4(B) or 4.5(B) of the Directory of SFFT Formats;
• (c) the linear format in accordance with Figures 16.1(E) and (F) or 16.2(E) and (F) of the Directory of SFFT Formats;
• (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table; or
• (e) a manner described in section B.29.017.

(4) For the purposes of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table must include only the information that is required by these Regulations to be included in that table.

(5) Despite subsections (2) and (3), if the supplemented food facts table is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

PART 1

Standard Format

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	1.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	1.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	1.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	1.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	1.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	1.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Narrow Standard Format

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	2.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	2.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	2.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	2.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 3

Bilingual Standard Format

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	3.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	3.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	3.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	3.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 4

Bilingual Horizontal Format

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	4.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in Parts 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
2	4.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in Parts 1 to 3 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Simplified Formats

B.29.010 (1) This section applies to a supplemented food if it satisfies the condition set out in subsection B.29.002(4) and its supplemented food facts table includes only the information referred to in paragraphs B.29.002(4)(a) to (m).

(2) Subject to subsection (3), the supplemented food facts table must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table containing only the information referred to in paragraphs B.29.002(4)(a) to (m) in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out in

• (a) the bilingual simplified standard format in accordance with Figure 6.5(B) or 6.6(B) of the Directory of SFFT Formats;
• (b) the bilingual simplified horizontal format in accordance with Figure 7.3(B) or 7.4(B) of the Directory of SFFT Formats;
• (c) the simplified linear format in accordance with Figures 17.1(E) and (F) or 17.2(E) and (F) of the Directory of SFFT Formats;
• (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table; or
• (e) a manner described in section B.29.017.

(4) Despite subsections (2) and (3), if the supplemented food facts table is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

PART 1

Simplified Standard Format

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	5.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	5.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	5.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	5.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	5.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	5.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Bilingual Simplified Standard Format

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	6.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	6.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	6.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	6.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 3

Bilingual Simplified Horizontal Format

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	7.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in Parts 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
2	7.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in Parts 1 and 2 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Simplified Formats — Supplemented Foods that are Single-serving Prepackaged Products

B.29.011 (1) This section applies to a supplemented food that is a single-serving prepackaged product, whose supplemented food facts table includes only the information referred to in paragraphs B.29.002(5)(a) to (l).

(2) Subject to subsection (3), the supplemented food facts table of the supplemented food that is a single-serving prepackaged product must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food that is a single-serving prepackaged product, a supplemented food facts table containing only the information referred to in paragraphs B.29.002(5)(a) to (l) in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out in

• (a) the bilingual simplified standard format in accordance with Figure 6.5.1(B) or 6.6.1(B) of the Directory of SFFT Formats;
• (b) the bilingual simplified horizontal format in accordance with Figure 7.3.1(B) or 7.4.1(B) of the Directory of SFFT Formats;
• (c) the simplified linear format in accordance with Figures 17.1.1(E) and (F) or 17.2.1(E) and (F) of the Directory of SFFT Formats;
• (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table; or
• (e) a manner described in section B.29.017.

(4) Despite subsections (2) and (3), if the supplemented food facts table of the supplemented food that is a single-serving prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

PART 1

Bilingual Simplified Standard Format — Supplemented Foods that are Single-serving Prepackaged Products

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	6.1.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	6.2.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	6.3.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	6.4.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Bilingual Simplified Horizontal Format — Supplemented Foods that are Single-serving Prepackaged Products

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	7.1.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in Part 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
2	7.2.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in Part 1 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Dual Format — Supplemented Foods Requiring Preparation

B.29.012 (1) Subject to subsection (2), if the supplemented food facts table includes information referred to in subsection B.29.005(4), the supplemented food facts table must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out in

• (a) the bilingual dual format in accordance with Figure 9.5(B) or 9.6(B) of the Directory of SFFT Formats; or
• (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

(3) For the purposes of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table must include only the information that is required by these Regulations to be included in the table, together with the information referred to in subsection B.29.005(4).

(4) Despite subsections (1) and (2), if the supplemented food facts table is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

PART 1

Dual Format — Supplemented Foods Requiring Preparation

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	8.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	8.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	8.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	8.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	8.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	8.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Bilingual Dual Format — Supplemented Foods Requiring Preparation

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	9.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	9.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	9.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	9.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Aggregate Format — Different Kinds of Supplemented Foods

B.29.013 (1) Subject to subsection (2), if the supplemented food facts table of a prepackaged product containing an assortment of supplemented foods includes separate information for each supplemented food as provided in paragraph B.29.005(2)(a) or subsection B.29.005(3), the supplemented food facts table must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out

• (a) in the case of a prepackaged product described in paragraph B.29.005(2)(a), in
  • (i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of the Directory of SFFT Formats,
  • (ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table, or
  • (iii) a manner described in section B.29.017; or
• (b) in the case of a prepackaged product described in subsection B.29.005(3), in
  • (i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of the Directory of SFFT Formats, or
  • (ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

(3) For the purposes of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the supplemented food facts table must include only the information that is required by these Regulations to be included for each supplemented food for which separate information is set out in the table.

(4) Despite subsections (1) and (2), if the supplemented food facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in subparagraph (2)(b)(i) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

PART 1

Aggregate Format — Different Kinds of Supplemented Foods

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	10.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	10.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	10.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	10.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	10.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	10.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Bilingual Aggregate Format — Different Kinds of Supplemented Foods

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	11.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	11.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	11.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	11.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Dual Format — Different Amounts of Supplemented Food

B.29.014 (1) Subject to subsection (2), if the supplemented food facts table includes separate information for different amounts of the supplemented food as provided in paragraph B.29.005(5)(a) without including the information referred to in paragraph B.29.005(5)(b), the supplemented food facts table must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out in

• (a) the bilingual dual format in accordance with Figure 13.5(B) or 13.6(B) of the Directory of SFFT Formats; or
• (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

(3) For the purposes of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table must include only the information that is required by these Regulations to be included for each amount of the supplemented food for which separate information is set out in the table.

(4) Despite subsections (1) and (2), if the supplemented food facts table is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

PART 1

Dual Format — Different Amounts of Supplemented Food

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	12.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	12.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	12.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	12.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	12.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	12.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Bilingual Dual Format — Different Amounts of Supplemented Food

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	13.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	13.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	13.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	13.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Aggregate Format — Different Amounts of Supplemented Food

B.29.015 (1) Subject to subsection (2), if the supplemented food facts table includes separate information for different amounts of the supplemented food as provided in paragraphs B.29.005(5)(a) and (b), the supplemented food facts table must be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table must be set out in

• (a) the bilingual aggregate format in accordance with Figure 15.5(B) or 15.6(B) of the Directory of SFFT Formats; or
• (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

(3) For the purposes of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table must include only the information that is required by these Regulations to be included for each amount of the supplemented food for which separate information is set out in the table.

(4) Despite subsections (1) and (2), if the supplemented food facts table of the supplemented food is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it must be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

PART 1

Aggregate Format — Different Amounts of Supplemented Food

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	14.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	14.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	14.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	14.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	14.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	14.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Bilingual Aggregate Format — Different Amounts of Supplemented Food

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	15.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	15.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	15.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	15.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Presentation of Additional Information

B.29.016 (1) If information referred to in column 1 of the table to section B.29.003 is included in a supplemented food facts table that is set out in a version consisting of a table in English and a table in French or a table in English or French, that information must be displayed

• (a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figures 18.1(E) and (F) of the Directory of SFFT Formats; and
• (b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in the Directory of SFFT Formats.

(2) If information referred to in column 1 of the table to section B.29.003 is included in a supplemented food facts table that is set out in a version consisting of a table in both English and French, that information must be displayed

• (a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figure 19.1(B) of the Directory of SFFT Formats; and
• (b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in the Directory of SFFT Formats.

(3) Despite paragraph (1)(a), the use of indents illustrated in Figures 18.1(E) and (F) of the Directory of SFFT Formats is not applicable if information referred to in column 1 of the table to section B.29.003 is set out in the linear format referred to in paragraph B.29.009(3)(c) or the simplified linear format referred to in paragraph B.29.010(3)(c).

Alternative Methods of Presentation

B.29.017 (1) Despite section A.01.016 and subject to subsection (2), a supplemented food facts table that meets the conditions specified in subsection B.29.009(3), B.29.010(3) or B.29.011(3) or paragraph B.29.013(2)(a) may be set out on

• (a) a tag attached to the package;
• (b) a package insert;
• (c) the inner side of a label;
• (d) a fold-out label; or
• (e) an outer sleeve, overwrap or collar.

(2) The supplemented food facts table must not be set out in a manner described in paragraph (1)(b) or (c) if the label of the supplemented food is required to show a list of cautionary statements.

(3) If the supplemented food facts table is set out in a manner described in paragraph (1)(b) or (c), the outer side of the label of the package must indicate in a type size of not less than 8 points where the supplemented food facts table is located.

(4) If the supplemented food facts table is set out in a manner described in subsection (1), it must be set out

• (a) in the case of a supplemented food described in subsection B.29.009(3), in a version that is described in paragraph B.29.009(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.29.009;
• (b) in the case of a supplemented food described in subsection B.29.010(3), in a version that is described in paragraph B.29.010(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.29.010;
• (c) in the case of a supplemented food described in subsection B.29.011(3), in a version that is described in paragraph B.29.011(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.29.011; and
• (d) in the case of a prepackaged product containing an assortment of supplemented foods described in paragraph B.29.013(2)(a), in a version that is described in subparagraph B.29.013(2)(a)(i) or that is listed in column 1 of the table to section B.29.013.

Small Packages

B.29.018 (1) Despite section A.01.016 and subject to subsection (2), if the available display surface of a supplemented food is less than 100 cm², the label of the supplemented food need not carry a supplemented food facts table if the outer side of the label contains an indication of how a purchaser or consumer may obtain the information that would otherwise be required to be set out in a supplemented food facts table on the label of the supplemented food.

(2) Subsection (1) does not apply to a supplemented food

• (a) if the label of the supplemented food is required to show a list of cautionary statements; or
• (b) that is the subject of any of the following representations 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:
  • (i) any declaration of the supplemented food’s energy value or the amount of a nutrient or supplemental ingredient contained in the supplemented food,
  • (ii) any representation that expressly or implicitly indicates that the supplemented food or any substance it contains 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, and
  • (iii) any health-related statement, name, logo, symbol, seal of approval or mark.

(3) Despite paragraph (2)(b), subsection (1) applies to a supplemented food that meets the conditions set out in column 2 of item 37 of the Table of Permitted Nutrient Content Statements and Claims for the subject “Free of sugars” set out in column 1 if

• (a) the supplemented food is not the subject of any representation referred to in paragraph (2)(b) other than
  • (i) a statement or claim set out in column 4 of item 37 of the Table of Permitted Nutrient Content Statements and Claims for the subject “Free of sugars” set out in column 1,
  • (ii) the energy value of the supplemented food expressed in Calories per serving of stated size, and
  • (iii) the amount of sugar alcohols expressed in grams per serving of stated size;
• (b) the statement or claim set out in column 4 of item 37 of the Table of Permitted Nutrient Content Statements and Claims for the subject “Free of sugars” set out in column 1 and that appears on the label is
  • (i) legibly set out on the principal display panel,
  • (ii) in lower case letters except for the first letter of each word of the statement or claim, which may be an upper case letter,
  • (iii) of at least the same size and prominence as the letters used in the numerical portion of the declaration of net quantity as required under paragraph 229(1)(a) and subsections 229(2) and (3) of the Safe Food for Canadians Regulations, and
  • (iv) displayed in a colour contrasting with the background of the label;
• (c) the energy value of the supplemented food expressed in Calories per serving of stated size and the amount of sugar alcohols expressed in grams per serving of stated size are shown immediately after whichever of the following elements appears last on the label:
  • (i) the list of ingredients,
  • (ii) a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1),
  • (iii) a declaration referred to in subsection B.01.010.4(1), or
  • (iv) any statement referred to in subsection B.01.014(1);
• (d) the label of the supplemented food is not required to show a list of cautionary statements.

(4) An indication referred to in subsection (1)

• (a) must be set out in a type size of not less than 8 points;
• (b) must include a postal address, website address or toll-free telephone number; and
• (c) must be
  • (i) in English and French, or
  • (ii) 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 of the supplemented food may be shown in that language only and is shown on the label in that language.

(5) The manufacturer of the supplemented food must provide the information referred to in subsection (1) to a purchaser or consumer on request

• (a) without charge;
• (b) in the following manner, namely,
  • (i) in the official language in which the information is requested or, if specified by the purchaser or consumer, in both official languages, or
  • (ii) in one of the official languages, if, in accordance with subsection B.01.012(3), the information that is required by these Regulations to be shown on the label of the supplemented food may be shown in that language only and is shown on the label in that language; and
• (c) in the form of a supplemented food facts table that is set out
  • (i) in a format, other than a horizontal format, that is specified in any of sections B.29.009 to B.29.015 and that would otherwise be carried on the label of the supplemented food in accordance with these Regulations, and
  • (ii) in a version of that format that is listed in column 1 of item 1 of any Part of the table to the applicable section referred to in subparagraph (i).

B.29.019 If a supplemented food has an available display surface of less than 100 cm² and has a supplemented food facts table on its label, the supplemented food facts table need only include

• (a) the serving of stated size;
• (b) the information referred to in column 1 of the table to section B.29.002 or the table to section B.29.003 in respect of the energy value of the supplemented food and the amount of any nutrient or supplemental ingredient 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;
• (c) the amount of any added sugar alcohol;
• (d) the amount of any saturated fat, sugars or sodium if the amount meets or exceeds the applicable threshold set out in columns 2, 3, 5 or 6 of the table to section B.01.350; and
• (e) the amount of any supplemental ingredient for which a cautionary statement set out in the list of cautionary statements is applicable.

Cautionary Statements

B.29.020 (1) Every applicable cautionary statement set out in column 4 of the List of Permitted Supplemental Ingredients in respect of the supplemental ingredients contained in a supplemented food must be shown

• (a) in a list on the label of the supplemented food;
• (b) grouped together and introduced by the title, in bold type,
  • (i) “Caution”, “Caution:” or “Caution :” in the English version, and
  • (ii) “Attention”, “Attention :” or “Attention:” in the French version;
• (c) without any intervening printed, written or graphic material appearing between the title and the first cautionary statement;
• (d) in regular or bold type;
• (e) in lower case letters, except that upper case letters must be used to show the first letter of each cautionary statement; and
• (f) separated by a bullet point or comma.

(2) The list of cautionary statements must be shown in a manner that clearly differentiates it on the label by means of one or both of

• (a) graphics in the form of a solid-line border around the list or one or more solid lines appearing immediately above, below or at the sides of the list that are the same colour as that of the type used to show the information referred to in subsection B.01.008.1(1); and
• (b) a background colour that creates a contrast between the background colour of the list and the background colour used on the adjacent surface of the label, other than the surface used to display
  • (i) a list of ingredients,
  • (ii) a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1),
  • (iii) a declaration referred to in subsection B.01.010.4(1),
  • (iv) any statement referred to in subsection B.01.014(1),
  • (v) a nutrition facts table, or
  • (vi) a supplemented food facts table.

(3) The list of cautionary statements must be shown on the label without any intervening printed, written or graphic material,

• (a) in English and French, adjacent to each linguistic version of the supplemented food facts table appearing in the same language, if there are separate English and French versions of the table;
• (b) in English and French, adjacent to a bilingual version of the supplemented food facts table, with one linguistic version of the list following the other linguistic version; or
• (c) in English or French, adjacent to the supplemented food facts table in the same language, if, in accordance with subsection B.01.012(3), the information 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.

(4) If the English and French versions of a list of cautionary statements appear on the label, they must be displayed on a continuous surface of the label’s available display surface, but need not be on the same continuous surface of the label’s available display surface.

(5) If the English and French versions of a list of cautionary statements appear on the same continuous surface of the label, the version that follows the other version must not begin on the same line as that on which the other version ends, unless the available display surface is less than 100 cm².

Supplemented Food Caution Identifier

Presentation

B.29.021 (1) The principal display panel of a supplemented food must carry the supplemented food caution identifier that is set out in Schedule K.2 if a list of cautionary statements is shown on the label of the supplemented food.

(2) The supplemented food caution identifier must be displayed in black and white and must be in accordance with the identifier set out in Schedule K.2.

(3) Subject to subsection (4), the supplemented food caution identifier must be presented in one of the following formats:

• (a) the unilingual standard format, where two separate versions of the identifier are shown, one in English (ES) and one in French (FS); or
• (b) the bilingual standard format (BS), where the identifier is shown in both official languages.

(4) If the principal display surface is less than or equal to 450 cm² and the width of each of the versions of the supplemented food caution identifier in the unilingual standard format or the width of the identifier in the bilingual standard format exceeds the width of the principal display panel, the identifier must be presented in the bilingual compact format (BC) in which the identifier is shown in both official languages.

(5) The supplemented food caution identifier must be displayed in accordance with the applicable specifications set out in the Directory of Supplemented Food Caution Identifier Specifications.

(6) Despite subsection (5), the supplemented food caution identifier may be displayed with larger dimensions than those set out in column 3 of the applicable table in the Directory of Supplemented Food Caution Identifier Specifications if the identifier is enlarged in a proportional manner vertically and horizontally.

(7) If, in accordance with subsection B.01.012(3), the information required by these Regulations may be shown on the label of a supplemented food in English only or in French only and is shown in that language, the supplemented food caution identifier may be displayed on the principal display panel of the supplemented food in that language only on a continuous surface of the available display surface.

(8) If the supplemented food caution identifier is presented in a bilingual format, the order in which the languages appear may be reversed from the order shown in the applicable identifier set out in Schedule K.2.

(9) The characters and other elements of the supplemented food caution identifier must not touch each other.

Placement

B.29.022 (1) The supplemented food caution identifier must be displayed

• (a) in the case of a supplemented food with a principal display panel whose height is less than its width, on the right half of the principal display panel; and
• (b) in the case of any other supplemented food, on the upper half of the principal display panel.

(2) The supplemented food caution identifier must be surrounded by a buffer that

• (a) has a width that is equal to or greater than that set out in column 4 of the applicable table in the Directory of Supplemented Food Caution Identifier Specifications, and
• (b) does not contain any text or other graphic material.

(3) If a supplemented food is cylindrical in shape, the outer edge of the buffer must be a minimum distance of 10% of the width of the principal display surface from the edge of the left or right side of that surface.

(4) If it is impossible to comply with both paragraph (1)(a) and subsection (3), the supplemented food caution identifier may be displayed partially in the left half of the principal display panel but only to the extent necessary to comply with that subsection.

Orientation

B.29.023 The supplemented food caution identifier must be oriented in the same manner as most of the other information that appears on the principal display panel unless the panel is displayed in the vertical plane and most of the other information is not displayed parallel with the base of the package, in which case the identifier must be oriented in such a manner that the words appearing in it are parallel with the base.

Prohibitions

B.29.024 It is prohibited to label a prepackaged product with a supplemented food caution identifier or sell a product that is so labelled, unless a list of cautionary statements is shown on the label.

B.29.025 (1) It is prohibited to label a prepackaged product with any representation, including a word, phrase, illustration, sign, mark, symbol or design, that is likely to be mistaken for a supplemented food caution identifier, or sell a prepackaged product that is so labelled.

(2) For the purposes of subsection (1), a representation does not include a nutrition symbol.

Representations

B.29.026 (1) Despite anything in these Regulations, it is prohibited, on the label of or in any advertisement for a supplemented food, to make a statement or claim to the effect that a supplemental ingredient that is a nutrient contained in the supplemented food is generally recognized as an aid in maintaining the functions of the body necessary to the maintenance of good health, if the supplemental ingredient is one for which a cautionary statement set out in the list of cautionary statements is applicable.

(2) However, the label of or advertisement for a supplemented food may carry such a statement or claim if it is accompanied by a statement or claim about the specific action or effect of the supplemental ingredient in maintaining the functions of the body necessary to the maintenance of good health.

(3) If the label of or any advertisement for the supplemented food carries a statement or claim referred to in subsection (1), that statement or claim and the statement or claim referred to in subsection (2) must,

• (a) if made on the label of or in an advertisement, other than a radio or television advertisement, for the supplemented food,
  • (i) be adjacent to one another without any intervening printed, written or graphic material, and
  • (ii) be shown in letters of the same size and prominence;
• (b) if made in a radio advertisement or in the audio portion of a television advertisement for the supplemented food, immediately follow one another; or
• (c) if made in the visual portion of a television advertisement for the supplemented food,
  • (i) appear concurrently and for the same amount of time,
  • (ii) be adjacent to one another without any intervening printed, written or graphic material, and
  • (iii) be shown in letters of the same size and prominence.

B.29.027 Despite anything in these Regulations, if a supplemented food is required to show a cautionary statement that is set out in the list of cautionary statements and recommends against consumption by any individual less than 18 years of age that is part of a group identified in the cautionary statement, it is prohibited, on the label of or in any advertisement for the supplemented food, to make a statement or claim to the effect that a nutrient contained in the supplemented food is generally recognized as an aid in maintaining the functions of the body necessary to normal growth and development.

B.29.028 (1) Despite anything in these Regulations, if the label of a supplemented food is required to carry the statement “high caffeine content” in accordance with column 5 of the List of Permitted Supplemental Ingredients, it is prohibited to make a representation, express or implied, on the label of or in any advertisement for the supplemented food with respect to any vitamin or mineral nutrient contained in the supplemented food.

(2) Subsection (1) does not apply in respect of a declaration of a vitamin in a list of ingredients or supplemented food facts table, or in respect of a declaration of a mineral nutrient in a list of ingredients, nutrition symbol or supplemented food facts table.

B.29.029 (1) If a list of cautionary statements is shown on the label of a supplemented food, the representations set out in subsection (2) must meet the following requirements:

• (a) if the representation is displayed on the principal display panel,
  • (i) the height of the upper case letters in the representation must not exceed two times the height of the upper case letters, excluding any accents, in the supplemented food caution identifier, other than in the words “Health Canada” and “Santé Canada”, and
  • (ii) the height of the tallest ascender of the lower case letters in the representation must not exceed two times the height of the tallest ascender of the lower case letters in the supplemented food caution identifier, other than in the words “Health Canada” and “Santé Canada”; and
• (b) if the representation is displayed on any continuous surface, other than on the principal display panel,
  • (i) the height of the upper case letters in the representation must not exceed two times the height of the upper case letters, excluding any accents, in the cautionary statements, and
  • (ii) the height of the tallest ascender of the lower case letters in the representation must not exceed two times the height of the tallest ascender of the lower case letters in the cautionary statements.

(2) For the purposes of subsection (1), the representations are the following:

• (a) a declaration referred to in subsection B.01.301(1) or (2);
• (b) any representation that expressly or implicitly indicates that the supplemented food or any substance it contains 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; and
• (c) any health-related statement, logo, symbol, seal of approval or mark.

(3) This section does not apply to the brand name or product name of a supplemented food.

Adulteration and Exemptions

B.29.030 A prepackaged product, other than a supplemented food, is adulterated if it contains a supplemented food as an ingredient.

B.29.031 A prepackaged product, other than a supplemented food, is adulterated if a substance listed in column 1 of the List of Permitted Supplemental Ingredients has been added to it other than in accordance with these Regulations.

B.29.032 A supplemented food does not have a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the Act — or is not adulterated for the purposes of paragraph 4(1)(d) of the Act — by reason only that a supplemental ingredient has been added to it.

22 Subsection D.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

supplemental ingredient

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

supplemented food

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

supplemented food facts table

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

23 Subsection D.01.004(4) of the Regulations is replaced by the following:

(4) Paragraph (1)(b) does not apply in respect of a declaration of the vitamin content in a nutrition facts table or supplemented food facts table.

24 Section D.01.008 of the Regulations is renumbered as subsection D.01.008(1) and is amended by adding the following:

(2) Sections D.01.009 and D.01.011 do not apply to a supplemented food.

25 Subsection D.02.002(6) of the Regulations is replaced by the following:

(6) Paragraph (1)(b) does not apply in respect of a declaration of the mineral nutrient content in a nutrition facts table or supplemented food facts table.

26 Subsection D.02.009(2) of the Regulations is replaced by the following:

(2) Subsection (1) does not apply to a human milk fortifier or a supplemented food.

27 Subsection D.03.002(1) of the Regulations is replaced by the following:

D.03.002 (1) Subject to section D.03.003, no person shall sell a food, other than a supplemented food, to which a vitamin, mineral nutrient or amino acid has been added unless the food is listed in Column I of the Table to this section and the vitamin, mineral nutrient or amino acid, as the case may be, is listed opposite that food in Column II.

28 The portion of section D.03.003 of the Regulations before paragraph (a) is replaced by the following:

D.03.003 Section D.03.002 does not apply to a food, other than a supplemented food, if all of the following conditions are met:

29 The Regulations are amended by adding, after Schedule K.1, the Schedule K.2 set out in the schedule to these Regulations.

Cannabis Act

Cannabis Regulations

30 Subsection 102(2) of the Cannabis Regulations ^{footnote 2} is replaced by the following:

Temporarily marketed foods and supplemented foods

(2) The following foods must not be used as an ingredient to produce edible cannabis referred to in subsection (1) and must not be a constituent of such an ingredient:

• (a) a food that is described in a Temporary Marketing Authorization Letter issued under subsection B.01.054(1) of the Food and Drug Regulations;
• (b) a supplemented food within the meaning of section B.01.001 of those Regulations; or
• (c) a food in respect of which the manufacturer, as defined in section A.01.010 of the Food and Drug Regulations, is exempt from the application of those Regulations in accordance with section 32 or 33 of the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods), as the case may be.

Transitional Provisions

31 (1) The following definitions apply in this section and sections 32 to 36.

Threshold Levels for Cautionary Statements and Other Conditions of Use

means the document entitled Threshold Levels for Cautionary Statements and Other Conditions of Use, published by the Government of Canada on its website, as it reads on the day on which these Regulations come into force. (Seuils maximaux relatifs aux mises en garde et autres conditions d’utilisation)

TMAL Lists

means one or more of the following lists, published by the Government of Canada on its website, as they read on the day on which these Regulations come into force:

• (a) the List of beverages, beverage mixes and concentrates;
• (b) the List of caffeinated energy drinks; and
• (c) the List of conventional foods. (Listes LAMT)

(2) Unless the context requires otherwise, words and expressions used in this section and sections 32 to 36 have the same meaning as in the Food and Drugs Act and the Food and Drug Regulations.

32 (1) Subject to section 35, the manufacturer of a food for which a Temporary Marketing Authorization Letter was issued under subsection B.01.054(1) of the Food and Drug Regulations and for which a Temporary Marketing Authorization number is set out in the TMAL Lists is exempt from the application of the Food and Drug Regulations in respect of the food if the following conditions are met:

• (a) when the Letter expired, the food was not the subject of an outstanding request that it be withdrawn from the market; and
• (b) since the expiration of the Letter,
  • (i) subject to subsection (2), the manufacturer has complied with the Food and Drug Regulations, as they read immediately before the day on which these Regulations come into force, except any provision set out in Appendix 1 to the Letter with which the food does not need to comply,
  • (ii) the manufacturer has complied with the following conditions set out in Appendix 1 to the Letter, as applicable:
    • (A) there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women,
    • (B) the food contains the substances referred to in Appendix 2 to the Letter in the amounts set out in that Appendix,
    • (C) the statements set out in Appendix 1 to the Letter, or statements with equivalent meaning, are shown on the label of the food,
    • (D) no claims are made on the label of the food relating to physical performance or health benefits of the food, and
    • (E) the conditions set out in Appendix 3 to the Letter are complied with, and
  • (iii) no substance set out in column 1 of the List of Permitted Supplemental Ingredients has been added to the food, with the exception of a substance
    • (A) set out in Appendix 2 to the Letter, or
    • (B) used as a food additive to which a marketing authorization applies.

(2) The manufacturer may, in respect of the food referred to in subsection (1), comply with the provisions of the Food and Drug Regulations that were amended by sections 1 to 11, 13 to 48, and 57 to 75 of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours), as they read on December 13, 2016.

33 (1) Subject to section 35, if a manufacturer of a food has submitted a request for a Temporary Marketing Authorization Letter for the food before the day on which these Regulations come into force and a Temporary Marketing Authorization Letter has not been issued under subsection B.01.054(1) of the Food and Drug Regulations before that day, the manufacturer is exempt from the application of the Food and Drug Regulations in respect of the food if the following conditions are met:

• (a) the Minister notifies the manufacturer, in accordance with subsection (2), that the sale of the food is authorized;
• (b) subject to subsections (3) and (4), the manufacturer complies with the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force;
• (c) no substance set out in column 1 of the List of Permitted Supplemental Ingredients has been added to the food, with the exception of a substance
  • (i) contained in the food in the amount specified in the request in response to which the Minister has issued a notice referred to in paragraph (a), or
  • (ii) used as a food additive to which a marketing authorization applies;
• (d) with respect to a food, other than a food referred to in paragraphs (f) and (g), if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a food additive to which a marketing authorization applies — and the total amount of that substance contained in the food is equal to or above the thresholds set out in columns 2 to 6 of the table for that substance, the label of the food carries the applicable cautionary statements set out in the headings to columns 2 to 6 of that table or statements with equivalent meaning;
• (e) if the cautionary statement “Not intended for children”, “For adults only” or “If you are pregnant or breastfeeding consult a Health Care Practitioner prior to use”, or a statement with equivalent meaning, appears on the label of the food, there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women, as the case may be;
• (f) with respect to a food that is a beverage that contains added caffeine and has a total amount of caffeine of more than 200 parts per million, the label of the food carries the following cautionary statements or statements with equivalent meaning:
  • (i) if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a food additive to which a marketing authorization applies — and the total amount of that substance contained in the food is equal to or above the threshold level set out in column 8 for that substance, the applicable cautionary statement set out in the heading to column 8 of that table or a statement with equivalent meaning, and
  • (ii) the cautionary statements set out in the headings to columns 2 to 4 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use or statements with equivalent meaning;
• (g) with respect to a food that contains added caffeine, other than a food referred to in paragraph (f), the label of that food carries the following cautionary statements or statements with equivalent meaning:
  • (i) if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a food additive to which a marketing authorization applies — and the total amount of that substance contained in the food is equal to or above the thresholds set out in columns 2 to 6 for that substance, the applicable cautionary statements set out in the headings to columns 2 to 6 of that table or statements with equivalent meaning, and
  • (ii) if the total amount of caffeine contained in the food is equal to or above the thresholds set out in columns 2 to 4 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the food belongs, the applicable cautionary statements set out in the headings to columns 2 to 4 of the table to Part II or statements with equivalent meaning;
• (h) with respect to a food referred to in paragraph (f) or (g), the manufacturer complies with the conditions of use set out in column 6 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the food belongs; and
• (i) if the cautionary statement “Not recommended for children, pregnant or breastfeeding women and individuals sensitive to caffeine”, or a statement with equivalent meaning, appears on the label of the food, there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women.

(2) The Minister must provide written notification to the manufacturer that the sale of the food is authorized if

• (a) the manufacturer submits to the Minister
  • (i) the information referred to in subparagraphs B.01.054(1)(a)(i) to (vii) of the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force, and
  • (ii) any other information requested by the Minister to assess the information referred to in subparagraph (i); and
• (b) the food belongs to a food category set out in column 1 of the List of Permitted Supplemented Food Categories;
• (c) in the case where a substance set out in column 1 of the table to Part I to the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food, the total amount of that substance contained in the food does not exceed the maximum daily level set out in column 7 or 9 of Part I of the table for that substance; and
• (d) in the case where caffeine has been added to the food, the total amount of caffeine contained in the food does not exceed the maximum level per serving set out in column 5 of the table to Part II to the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category to which the food belongs.

(3) The manufacturer need not, in respect of the food referred to in subsection (1), comply with the following provisions of the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force:

• (a) section B.01.043,
  • (i) in respect of caffeine that has been added to the food for a use other than a use set out in columns 2 to 4 of item C.1 of the List of Permitted Food Additives with Other Accepted Uses, published by the Government of Canada on its website, as amended from time to time, or
  • (ii) in respect of an extraction solvent that has been used in the manufacturing of an extract that has been added to the food other than as a flavouring;
• (b) section B.01.045, in respect of caffeine that has been added to the food and that does not meet the specifications set out in the Food Chemicals Codex, tenth edition, 2016, published by the United States Pharmacopeial Convention, Rockville, MD, United States of America, as that or any subsequent edition, including their supplements, may be amended from time to time;
• (c) section D.01.009;
• (d) section D.01.011;
• (e) section D.02.009; or
• (f) section D.03.002.

(4) The manufacturer may, in respect of the food referred to in subsection (1), comply with the provisions of the Food and Drug Regulations that were amended by sections 1 to 11, 13 to 48 and 57 to 75 of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours), as they read on December 13, 2016.

(5) For greater certainty, the notification referred to in paragraph (1)(a) cannot be a Temporary Marketing Authorization Letter issued under subsection B.01.054(1) of the Food and Drug Regulations.

34 A manufacturer that is exempted under section 32(1) or subsection 33(1) is also exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act in respect only of a substance set out in column 1 of the List of Permitted Supplemental Ingredients that has been added to the food.

35 A manufacturer is not exempted under subsection 32(1) or subsection 33(1) in respect of the food referred to in subsection 32(1) or subsection 33(1), as the case may be, if the Minister notifies the manufacturer, in writing, that the Minister has reasonable grounds to believe that the use of the food is detrimental to the health of the consumer.

36 Sections 32 to 35 cease to have effect on December 31, 2025.

Coming into Force

37 These Regulations come into force on the day following the day on which they are published in the Canada Gazette, Part II.

SCHEDULE

(Section 29)

SCHEDULE K.2

(Subsections B.29.021(1), (2) and (8))

Supplemented Food Caution Identifier Formats

Unilingual Standard Format

ES

FS

Bilingual Standard Format

BS

Bilingual Compact Format

BC

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues

Unlike conventional foods, supplemented foods contain added supplemental ingredients that can pose a risk to health if they are consumed in excess by the general population or if consumed by vulnerable populations such as children and pregnant women. The FDR do not have provisions that permit the sale of supplemented foods in Canada. However, as an interim measure, Health Canada has issued TMAs to allow select supplemented foods on the market on a case-by-case basis.

Under the TMA framework, Health Canada reviews applications for supplemented foods submitted by industry to determine if the supplemental ingredients they contain are safe for consumers. If the safety of the supplemented food can be sufficiently demonstrated, Health Canada issues a TMA letter which includes certain conditions that the manufacturer or distributor must meet in order to sell the product.

As part of the conditions of their TMA, industry has been required to provide research, sales data, and incident reports on their supplemented foods to Health Canada in order to support the development of a regulatory framework. Multiple industry stakeholders have raised concerns that the process to obtain a TMA is unpredictable and time-consuming and that the requirement to regularly provide information to Health Canada on their product is resource-intensive.

Under the TMA framework, Health Canada has permitted only certain categories of food to be eligible as supplemented foods. With a growing interest among industry to introduce different types of supplemented foods to the market, these stakeholders have voiced that the lack of flexibility in the types of foods that can be supplemented as well as the lack of a clear path to market for supplemented foods have been a barrier to innovation.

A new framework in the FDR is needed to provide a flexible and predictable regulatory environment for supplemented foods that continues to protect the health and safety of Canadians, while also allowing industry to bring new and innovative products to market.

Background

Supplemented foods are prepackaged foods containing one or more added supplemental ingredients, which are vitamins, minerals, amino acids, or other ingredients (e.g., caffeine, herbal extracts), which have historically been marketed for the purpose of providing specific physiological or health effects. This includes beverages with added minerals marketed for hydration, caffeinated energy drinks (CEDs) marketed for temporarily restoring mental alertness, and snack bars with added vitamins marketed for the maintenance of good health.

While there are generally no safety concerns with consuming conventional foods as much or as often as desired, consuming supplemented foods may pose a risk because of the supplemental ingredients they contain. Namely, there can be health and safety concerns if the general population overconsumes supplemental ingredients or if vulnerable populations are exposed to them. For example, excess calcium intake has been associated with kidney stones. Because of their potential risks, the addition of supplemental ingredients to food must be carried out according to specific safety requirements.

Supplemented foods differ from fortified foods in that fortification involves adding vitamins and minerals for an established public health purpose (for example, the mandatory addition of vitamin D to milk to help address bone diseases such as rickets in children). Supplemental ingredients also differ from food additives that are typically used to achieve a technical effect on the food (such as guar gum which is used as a thickening agent). Health Canada has assessed the use of food additives and the addition of nutrients for public health purposes and has set out conditions in the FDR under which these ingredients may be safely used in food. However, in the case of foods containing supplemental ingredients, conditions for reducing the risks associated with permitting these foods on the market are yet to be established in the FDR. As a result, the sale of supplemented foods is currently prohibited in Canada except in the cases where Health Canada has issued a TMA.

Supplemented foods were not permitted to be sold as foods under the FDR prior to 2012, leading manufacturers to market their supplemented foods as natural health products. In late 2011, the Minister of Health announced the intent to regulate CEDs and certain other natural health products as foods based on their product format, history of use, representation to consumers and public perception as foods. Subsequently, Health Canada transitioned hundreds of natural health products to the food regulatory framework. Those products containing ingredients at levels considered safe for consumption were allowed to be sold temporarily as foods under a TMA. Since then, manufacturers have also been able to apply for TMAs to allow new supplemented foods to access the market.

A TMA is a regulatory tool that Health Canada may use to authorize a manufacturer to sell, for a specified period of time, a food that could not otherwise be sold because it does not comply with specific requirements of the FDR. As a condition of the TMA, the manufacturer must generate information related to the product while it is on the market and must provide this information to Health Canada to support future regulatory amendments. In the case of supplemented foods, the research and data obtained from the TMAs since 2012 includes public opinion research, consumption patterns, sales data, and consumption incident reports. This has allowed Health Canada to learn more about these products and their related risks and has helped inform the development of the regulations.

Industry stakeholders have raised concerns that marketing supplemented foods under the TMA requirements imposes a significant amount of administrative burden and have identified the lack of a predictable framework for these products as a regulatory impediment to bringing products to market. Accordingly, the initiative to establish a new framework for supplemented foods was put forward in the Government of Canada’s June 2019 Agri-food and Aquaculture Regulatory Review Roadmap.

Objective

The regulations will establish a risk-based regulatory framework for supplemented foods in Canada that will help protect the health and safety of Canadians, while providing a clear and predictable regulatory environment for supplemented foods. Specifically, the regulations will:

• Reduce the risks of overconsumption within the general population, as a well as risks of exposure for certain vulnerable groups within it (e.g., children, pregnant women);
• Support consumers’ ability to distinguish supplemented foods from conventional foods, understand the health risks associated with these products, and make more informed choices related to their consumption; and
• Provide flexibility to adapt to new evidence related to supplemented foods and supplemental ingredients, thus supporting innovation in the food industry.

Description

The regulations will amend the FDR to create a new Division 29 in Part B that sets out a regulatory framework for supplemented foods. Numerous related amendments in existing Divisions of Part B and Part D (Vitamins, Minerals and Amino Acids) will also be made.

Definitions

In Division 1, Part B of the FDR, the regulations will amend the existing definitions of “agricultural chemical” and “food additive” to exclude supplemental ingredients and the existing definition of “specialty food” to exclude supplemented foods. The regulations will also introduce and define the following terms to support the new supplemented foods framework:

• “Supplemental ingredient” will be defined as a nutrient, including a vitamin, mineral nutrient, amino acid, or any other substance listed in the List of Permitted Supplemental Ingredients and added as an ingredient to a food according to the corresponding conditions set out in that list. A new provision will also clarify that when a supplemented food is used as an ingredient in the manufacturing of another supplemented food, the supplemental ingredient in the first food is also a supplemental ingredient in the second food and subject to the same conditions of use in the List of Permitted Supplemental Ingredients.
• “Supplemented food” will be defined as a prepackaged product belonging to a food category specified in the List of Permitted Supplemented Food Categories to which a supplemental ingredient has been added. The definition will also exclude the following food categories due to a higher level of risk for consumers if they were supplemented, or because they are subject to other regulatory provisions in the FDR:
  • Foods that are fortified for public health purposes (except prepackaged water);
  • Foods labelled and advertised for consumption by infants, children one year of age or older but less than four years of age, or women who are breastfeeding or pregnant;
  • Foods for special dietary use (except gluten-free foods);
  • Foods that have not been processed or have been minimally processed; and
  • Beverages with an alcohol content of more than 0.5%.
• The “List of Permitted Supplemented Food Categories” will be defined and incorporated by reference in the FDR through the definition of “supplemented food”. This list will capture the specific categories of food to which supplemental ingredients may be added.
• The “List of Permitted Supplemental Ingredients” will also be defined and incorporated by reference in the FDR through the definition of “supplemental ingredient”. This list will capture all of the substances that may be added to a specified food as a supplemental ingredient grouped by vitamins, mineral nutrients, amino acids, and other supplemental ingredients (including caffeine). The list will also set out the detailed conditions of use for each supplemental ingredient. The conditions include:
  • The food categories in which the supplemental ingredient may be added (with reference to the List of Permitted Supplemented Food Categories);
  • The maximum level of the supplemental ingredient allowed in the product;
  • Cautionary statements that are required on the label of the product, if applicable; and
  • Other conditions of use specific to a supplemental ingredient, such as additional labelling requirements, if applicable.
• “List of cautionary statements” will be defined as the list on the label of a supplemented food showing the cautionary statements associated with the food, as set out in the List of Permitted Supplemental Ingredients.
• “Supplemented food caution identifier” will be defined as the identifier that is shown on the principal display panel of a supplemented food that carries cautionary statements.
• “Supplemented food facts table” will be defined as a facts table that supplemented foods must carry on their label. It will be required in place of the Nutrition Facts table (NFt) that is shown on the label of conventional foods.
• The existing definition of “novel food” in Division 28, Part B will be amended to exclude both supplemental ingredients and supplemented foods.

In addition, the regulations will introduce and define the following elements in Division 29, Part B of the FDR:

• The “Directory of SFFT Formats” will be defined and incorporated by reference and prescribe the acceptable formats in which a SFFt may be displayed on a supplemented food (e.g., standard, horizontal, linear, simplified, aggregate, and dual formats).
• The “Directory of Supplemented Food Caution Identifier Specifications” will be defined and incorporated by reference and will provide dimensions and spacing for displaying the SFCI. The SFCI is a visual identifier that will be required on the principal display panel of supplemented foods that carry a list of cautionary statements.

Changes to the lists

Health Canada will continue to monitor scientific data as it becomes available and will consider updates to the List of Permitted Supplemented Food Categories and the List of Permitted Supplemental Ingredients as needed. Through guidance material, Health Canada will also set out a submission process for stakeholders to request changes to the lists, including additions, removals or modifications, when supporting information can be provided to demonstrate that they would be safe for Canadians. This will provide a path to market for new and innovative uses of food categories or ingredients for supplementation.

Prohibitions and exemptions

Paragraphs 4(1)(a) and (d) of the Food and Drugs Act prohibit the sale of food that contains poisonous or harmful substances or that is adulterated. A new provision in Division 29 will declare a prepackaged product, other than a supplemented food, to be adulterated if a substance from The List of Permitted Supplemental Ingredients has been added to it other than in accordance with the FDR. Division 29 will further indicate that the addition of a supplemental ingredient to a food will not be considered adding a poisonous or harmful substance or adulterating the food if the ingredient is added according to the conditions set out in the List of Permitted Supplemental Ingredients.

To prevent supplemental ingredients from being added indirectly to prepackaged products without respecting the conditions set out in the List of Permitted Supplemental Ingredients, a new provision will indicate that if a supplemented food is used as an ingredient in manufacturing a prepackaged product that is not a supplemented food, the prepackaged product is considered adulterated.

The regulations will also exempt supplemented foods from certain requirements and prohibitions in Part D of the FDR related to the addition of vitamins, mineral nutrients and amino acids to food for public health purposes. The addition of supplemental ingredients, including those which are vitamins, mineral nutrients and amino acids, in food will be subject to the conditions established in the List of Permitted Supplemental Ingredients instead.

Labelling

The new framework intends to leverage existing labelling provisions in the FDR for prepackaged products. As all supplemented foods are prepackaged products, general labelling requirements for prepackaged products in Division 1 will continue to apply to supplemented foods as well. These requirements include: bilingual labelling, common name, country of origin, date markings and storage instructions, name and principal place of business, list of ingredients, allergen labelling, lot numbers, net quantity and the legibility and location of this information. For existing labelling provisions that apply to prepackaged products in Division 1, Health Canada will amend or expand them, or exempt supplemented foods from them, as needed.

In some cases, different or additional labelling requirements will be required for supplemented foods as part of the new framework to help consumers distinguish these products from conventional foods, better understand their associated risks, and make more informed decisions related to consuming them. A supplemental ingredient will always be required to be declared in the list of ingredients, even when it is added as a component of an ingredient that is not otherwise required to be shown on the label.

The following new labelling elements will also be set out in Division 29, Part B:

Supplemented Food Facts table

With the exception of some supplemented foods sold in small packages, supplemented foods will be required to carry a standardized SFFt on their labels, which will take the place of the NFt required on most prepackaged products. The SFFt will require the name and absolute amount of each supplemental ingredient to be declared under a mandatory “Supplemented with” heading. In addition, the % daily value of vitamins and mineral nutrients added as supplemental ingredients must also be declared.

When vitamins and mineral nutrients that are added as supplemental ingredients and naturally occurring amounts of the same vitamin or mineral nutrient are present, the amount will be declared as a total under the “Supplemented with” heading. Therefore, their placement and manner of declaration in the SFFt is dependent on whether any amount of the vitamin or mineral nutrient has been added as a supplemental ingredient. An interpretative statement following the “Supplemented with” heading will be mandatory on supplemented foods to explain that the amounts of supplemental ingredients declared in the SFFt include both naturally occurring and supplemental amounts.

While many of the provisions in the FDR associated with the NFt are relevant to the SFFt, a new set of provisions for the SFFt will be prescribed in Division 29. This involves replicating and modifying a majority of the provisions associated with the NFt in Division 1 while also creating new provisions to account for differences with the NFt. The new provisions in Division 29 will also include requirements on: the presentation, location and orientation of the SFFt on the label; options on various formats of the SFFt (e.g., when a supplemented food is to be prepared according to directions provided on the package or combined with other ingredients, or sold as an assortment of similar kinds of supplemented foods); alternative methods of presentation; and an exception for some small packages.

A hierarchy of SFFt formats and sizes will be set out in the regulations, with the choice of format based on the same rule as the NFt: if it is not possible to display the SFFt on 15% or less of the available display surface of the package, the regulations will permit alternative methods of presentation of the SFFt (i.e., on a tag, package insert, the inner side of a label, a fold-out label or an outer sleeve, overwrap or collar). However, in the case of supplemented foods that carry cautionary statements the SFFt will not be permitted on a package insert or on the inner side of a label.

With respect to small packages, supplemented foods which have less than 100 cm² of available display surface will not be required to display a SFFt, except when the label is required to carry a list of cautionary statements or when the label carries certain representations. However, an indication of how purchasers or consumers may obtain the information will need to be provided on the label.

Cautionary statements

As part of the conditions that will be prescribed in the List of Permitted Supplemental Ingredients, the addition of certain supplemental ingredients (e.g., zinc) or certain levels of supplemental ingredients (e.g., more than 58 mg of calcium per serving) will require the supplemented food to carry cautionary statements on the label. A new provision in Division 29 will require these cautionary statements to be grouped together in a list under a standardized “Caution” heading adjacent to the SFFt. Other provisions related to the appearance of the cautionary statements will be based on the existing requirements for the list of ingredients and allergen statements on the labels of prepackaged products. In particular, the cautionary statements must be listed in both English and French, appear clearly separated from other information on the label, and be shown according to font and type size requirements to ensure legibility of the information.

Supplemented food caution identifier

When a supplemented food is required to be labelled with a list of cautionary statements, the regulations will require the product to carry a SFCI on the label. Prepackaged products will be prohibited from carrying a SFCI, or any representation that may be mistaken for a SFCI, unless they are a supplemented food that is required to carry a list of cautionary statements.

The regulations will require that the SFCI be black and white, include an exclamation mark, the text “Supplemented”, and an attribution to Health Canada, and be placed in a prominent, clutter-free space on the upper half of the principal display panel of the label of the supplemented food, or on the right half of the principal display panel if its height is less than its width. The SFCI will be a visual cue for consumers to examine the cautionary statements for warnings and guidance about consuming the product. New provisions will be prescribed in Division 29 related to the description, appearance/format, legibility and placement of the SFCI. The permitted SFCI format designs will be set out in the FDR in a new Schedule (Schedule K.2). The size of the SFCI will be proportional to the area of the principal display surface of the package, with the SFCI size decreasing as the area of the principal display surface decreases. The hierarchy of formats and sizes will be set out in the Directory of Supplemented Food Caution Identifier Specifications.

Representations

The new framework intends to leverage existing provisions in the FDR with respect to representations such as health claims or statements made on the label of, or in an advertisement for, a food. As with labelling, general requirements in Division 1 of the FDR for making representations about a food will generally apply to supplemented foods as well.

In addition, to prevent representations that may overshadow or contradict any cautionary labelling and reduce their effectiveness, Health Canada will introduce new provisions in Division 29 that will impose the following restrictions:

• When a supplemental ingredient that is a nutrient triggers a cautionary statement, any claim about that ingredient contributing to the maintenance of good health must be accompanied by a claim about the specific action or effect of that ingredient in maintaining the functions of the body necessary to the maintenance of good health;
• When a supplemented food carries a cautionary statement indicating that it is not recommended for any age group under the age of 18 (e.g., not recommended for those under 14 years old), claims about any nutrient in the product contributing to growth and development will not be permitted;
• In the case of supplemented foods that carry the statement “high caffeine content”, representations related to a vitamin or a mineral nutrient in the food will not be permitted; and
• When a supplemented food is required to carry a cautionary statement, certain types of representations used on the label, including nutrition and health-related claims and statements, will be subject to size restrictions.

Transition

On the date of coming into force of the regulations, TMAs for existing supplemented foods on the market will expire. Under the transitional provisions, the regulations will provide manufacturers a transition period for products with expired TMAs to come into compliance with the requirements of the new framework. The products will be allowed to remain on the market as long as the conditions of the transitional provisions are met.

The end of the transition period will be on January 1, 2026, in order to coincide with the first compliance date under the Food Labelling Coordination Policy,^{footnote 3} which was jointly established by Health Canada and Canadian Food Inspection Agency (CFIA) on August 5, 2021. This policy sets out predictable compliance dates on a two-year cycle by which food labelling changes required by new regulations must be implemented.

Health Canada will continue to accept TMA applications up until the coming into force of the regulations and will process these applications following that date. In the case of applications approved after this date, Health Canada will provide written notification to the applicant that their product is authorized to be sold under specific conditions set out in the transitional provisions. These products will also have until January 1, 2026, to transition to the new framework.

As for new supplemented foods coming to market, they will be required to comply immediately with the new regulations. The Food Labelling Coordination Policy does not apply to these products because they require a new label rather than a label change.

Cannabis Regulations

The Cannabis Regulations currently prohibit foods that are described in TMAs from being used as an ingredient to produce edible cannabis or as a constituent of such an ingredient. As supplemented foods will no longer be regulated under a TMA framework, consequential amendments to the Cannabis Regulations are necessary to address the changes introduced by the amendments to the FDR relating to supplemented foods and to continue to prohibit the use of these foods as ingredients to produce edible cannabis.

The consequential amendments would maintain consistency with the public health approach of the cannabis regulatory framework. As such, the regulations will amend subsection 102(2) of the Cannabis Regulations to add supplemented foods (and the foods that would otherwise be exempted due to the transitional provisions of the regulations) among the types of foods that must not be used as an ingredient or as a constituent of such an ingredient to produce edible cannabis referred to in subsection 102(1) of the Cannabis Regulations.

Regulatory development

Consultation

Health Canada has conducted research and consultations to obtain feedback from consumers and impacted stakeholders on the policy elements of the proposal. Health Canada took into account the combined findings as it developed and refined the regulatory proposal in preparation for pre-publication in the Canada Gazette, Part I.

Consumer research

Health Canada conducted food environment and consumer research to develop labelling requirements for supplemented foods. After testing different labelling options with over 4,000 Canadian participants, the consumer research found that:

• A text-based identifier on its own or with an accompanying symbol placed in a prominent, clutter-free space on the front of the package beside the common name of the food is useful for identifying a supplemented food;
• Replacement of the NFt with a SFFt designed with a similar look and feel to the NFt responds to consumer feedback concerning trust and credibility;
• Quantitative listing of all supplemental ingredients in the SFFt in combination with listing of each supplemental ingredient in the list of ingredients helps consumers access information about the detailed contents of the supplemented food;
• A distinct and consistent “Caution” heading that stands out from other information on a label makes the cautionary information more noticeable to consumers; and
• Placement of cautionary statements in proximity to the list of supplemental ingredients helps consumers link the cautionary labelling to specific ingredients in the product.

Consumer research published in August 2021^{footnote 4} also found that a SFCI on the front of a package can act as an effective visual cue for consumers to look for cautionary statements on the back of the label.

Pre-consultations

In fall 2020, Health Canada held targeted pre-consultation meetings with stakeholders to provide an overview of the proposed approach to regulating supplemented foods. The purpose was to obtain initial feedback on key policy elements and to inform the development of the regulatory proposal. Three separate sessions were held with industry associations, key health stakeholders, and small businesses. Health Canada also held several follow-up meetings with industry associations to receive feedback and to answer additional questions related to the proposal.

During the pre-consultation meetings, health and industry stakeholders asked questions to obtain a better understanding of the proposal and its implications. Health stakeholders were in favour of the restrictions to representations on supplemented foods and expressed that they would like Health Canada to consider measures to inform consumers about the higher sugar content in many of the supplemented foods, especially beverages.

Overall, industry stakeholders viewed the proposed framework for supplemented foods as a positive change from the current challenges under the TMAs. In particular, industry was supportive of no longer having to submit annual reports to Health Canada as they consider this TMA requirement to be a significant administrative burden. They also took the opportunity to raise some initial concerns based on the preliminary information shared:

• Industry associations expressed concerns about the restriction related to the use of representations about a supplemental ingredient that triggers a cautionary statement. Industry indicated this would have a negative impact on their business as these representations are used to help market their products by emphasizing their benefits. Health Canada’s response was that it is to avoid conflicting messaging about the safety of the products for consumers and helping them make informed decisions related to their health.
• Industry associations also questioned the need for a SFCI, particularly for CEDs, indicating that consumers are familiar with CEDs and can easily distinguish them from other beverages. In response, Health Canada noted that for health and safety reasons, it is important to have consistent labelling across all supplemented foods to help consumers identify supplemented foods with cautionary statements.
• Small businesses raised some concerns that supplemented foods containing added caffeine would be subject to additional labelling requirements and would be disadvantaged compared to foods containing caffeine that is naturally present and not added (e.g., coffee, tea). Health Canada explained that the scope of the proposed framework is limited to foods with added supplemental ingredients but noted that a broader strategy to regulate caffeine is currently being considered.
• Industry stakeholders requested a reasonable transition period to help minimize costs related to label changes and reformulation for existing products on the market. They also indicated that it would be important for their business planning for Health Canada to continue reviewing TMA applications submitted up until the final publication of a new framework. Health Canada confirmed that it would consider these concerns as it develops its transition approach. Subsequently, Health Canada committed to continue accepting TMA applications until the coming into force of the new regulations and to provide a transition period for as many products as possible.

In spring 2021, Health Canada held engagement sessions with the same stakeholders and provided updates and additional details related to the proposed regulations. Industry and health stakeholders used the sessions to request clarification on certain elements of the proposal. Health Canada invited participants to submit their written comments during the Canada Gazette, Part I consultation process.

Cost-benefit analysis survey

In the fall of 2020, Health Canada sent industry stakeholders a cost-benefit analysis (CBA) survey requesting feedback on the proposed framework. The survey was sent to 60 members of industry, including four associations, which currently have a supplemented food TMA. Although the response rate for the survey was roughly 12%, responses were received from two associations representing approximately 70% of the supplemented food industry in addition to responses from one larger business and four small businesses.

Overall, the survey responses indicated that industry was generally in support of the implementation of the new framework, as it would eliminate the existing TMA process for all supplemented foods, which is cumbersome and complex.

Many of the same concerns that were heard during the pre-consultations were reiterated in the responses to the CBA survey and some additional concerns were also raised. These concerns included:

• The potential for fewer innovative products if certain supplemental ingredients or certain levels of supplemental ingredients which are currently allowed on the market would no longer be permitted;
• The potential to not be able to introduce new kinds of products if the products were limited to certain product categories;
• The potential incremental cost resulting from new labelling requirements;
• The potential impacts of a transition period that may be too short; and
• The potential impact on small businesses, especially if the product affected is core to the business.

Survey responses highlighted specific concerns around the proposed labelling requirements, some of which were also raised during the pre-consultation:

• The proposed SFFt could be costly for existing products and could potentially require a complete redesign of the physical product package if a label-only redesign is not possible;
• The proposed restriction on making representations about a supplemental ingredient that triggers a cautionary statement could challenge industries’ ability to convey to consumers the benefit of adding these ingredients;
• The proposal to use only absolute amounts instead of % daily value for supplemental ingredients in the new SFFt may confuse consumers; and
• The proposed requirement to display a SFCI when other classes of foods could have similar or even higher levels of similar ingredients would be inconsistent.

Health Canada acknowledged these concerns, and made changes to the policy where supported by evidence and appropriate to maintain the objectives of the regulations. Research conducted by Health Canada supports a labelling approach requiring multiple components on the label of a supplemented food to help consumers distinguish them from conventional foods and make informed decisions about consuming them.

In some cases, the survey respondents suggested that Canada should consider the labelling requirements for supplemented foods used in New Zealand, which requires supplemented food products^{footnote 5} to include the text “supplemented food” prominently displayed on the label and all advertising materials, and “a name or description of the food sufficient to indicate the true nature of the food”.^{footnote 6} Health Canada has taken a similar approach to New Zealand, but in consideration of the difference in intent, will require an identifier with the word “Supplemented” and an exclamation mark on the front of the package of supplemented foods with cautionary statements.

The respondents had concerns on how existing supplemented foods will be transitioned to the new framework. In addition to what was already heard during the pre-consultation, respondents indicated a strong preference for Health Canada to provide a minimum transition period of four years for existing supplemented foods to comply with the new requirements and to align the transition compliance date with that of new food labelling requirements resulting from other regulatory proposals. Health Canada will provide an adequate transition period of at least three years after the coming into force until January 1, 2026 to help alleviate burden on all businesses.

Survey respondents also highlighted concerns for impacts on small businesses, indicating a higher cost to small businesses to comply with the proposed regulations. Respondents indicated that updating product labels as a result of the new requirements could be more expensive for small businesses as they lack economies of scale, and that small businesses could be disproportionately impacted with requiring certain existing products to be reformulated. As small businesses are likely to have fewer products on the market, they could be more significantly impacted if one of their products is affected. Health Canada considered the concerns of small businesses and concluded that a transition period of three years will help alleviate some of the burden for both large and small/medium size enterprises.

Pre-publication in the Canada Gazette, Part I

Comments received on the proposal through the Canada Gazette, Part I consultation process and through the World Trade Organization Technical Barriers to Trade notification process are summarized below. In response to comments and concerns raised by stakeholders, a number of adjustments to the regulations have been made where supported by evidence.

Comments on definitions and categorization of supplemental foods

Health stakeholders commented that it was important for consumers to understand that supplemented foods are different from foods that are fortified with nutrients for an established public health purpose. They noted that the term “supplemented” could potentially lead consumers to believe that supplemented foods are a healthy option when, on the contrary, many are highly processed and do not align with Canada’s Dietary Guidelines. They also indicated that increased consumption of these products stemming from the perception that they are healthy could lead to adverse health effects, particularly in vulnerable populations.

As a result of these concerns, many stakeholders emphasized the need for proper messaging and education to ensure all Canadians have the information needed to understand supplemented foods and the way in which they are different from other food. A few stakeholders suggested youth targeted tools and classroom tools will be needed to support an education campaign. A few stakeholders also suggested that Canada’s Dietary Guidelines should be updated to include warnings and recommendations for safe use of these products.

Some stakeholders proposed modifications for certain terms, such as replacing “supplemented food” with “modified food product” and “supplemental ingredient” with “ingredients used in modified foods”. Some stakeholders also suggested that additional measures are required to mitigate negative health impacts from supplemented foods such as restricting the scope of supplemented foods to those foods for which there is evidence that supplementation provides a health benefit for the consumer.

On the other hand, some industry stakeholders commented that the scope was too narrow and would limit innovation. They also expressed a desire to regulate CEDs outside of the supplemented foods framework, asserting that CEDs are a well-understood category of foods and responsibly consumed by Canadians. Industry stakeholders and some international governments further commented that globally, CEDs have a long history of safe consumption and are regulated as conventional foods in major markets such as the United States, the European Union, the United Kingdom, and Switzerland; whereas in Australia and New Zealand CED’s are considered a distinct category with specific requirements applicable to them.

Health Canada’s response:

The objective of the regulations is to regulate the addition of vitamins, minerals, amino acids, caffeine and other ingredients to food to mitigate potential risks to health for consumers. As CEDs are prepackaged products to which caffeine, and generally, vitamins, minerals and amino acids are added, it is appropriate to classify them as supplemented foods. In addition, the design of the supplemented foods regulations was based in large part on the TMA requirements for CEDs.

Foods that are fortified for public health purposes have been excluded from the definition of “supplemented food”. A factor that Health Canada will consider prior to approving a new supplemented food category is whether the food category may be suitable for fortification for public health purposes. In such a case, food supplementation for that category would not be permitted. Health Canada will also require additional labelling elements to help consumers distinguish supplemented foods from conventional foods.

Health Canada will collaborate with a variety of health and governmental stakeholders to develop and inform awareness campaigns and educational material. Audience-appropriate resources and materials for consumers, industry and health professionals will be developed. Health Canada will also review Canada’s Dietary Guidelines to determine whether any sections should be updated to take into account the new supplemented foods framework.

With regard to the comments received on the scope of permitted food categories, the new framework will limit supplemented foods to the food categories that were transitioned from the natural health products framework and permitted under the TMA framework for over a decade. In addition, Health Canada notes that data from the Canadian Community Health Survey 2015 indicates that supplementation of the permitted food categories are not likely to have a negative impact on Canadians. Data shows that their consumption does not result in excessive intakes of vitamins and minerals at the population level.

Stakeholders did not provide any evidence to support the addition of new food categories. To enable innovation, Health Canada’s submission process for requesting changes to the List of Permitted Supplemented Food Categories will offer a path to market for new food categories, granted that supporting information is provided to demonstrate that they will be safe for Canadians.

Outcome:

Health Canada will maintain the pre-publication proposal with respect to the scope of food categories that will be permitted. However, as a result of the comments received, some of the food categories in the List of Permitted Supplemented Food Categories have been renamed or combined for greater clarity and accuracy.

Comments on the indirect addition of supplemental ingredients

One industry stakeholder requested clarification regarding the proposed provision that indicates that a food, other than a supplemented food is considered adulterated if it contains a supplemented food as an ingredient. The stakeholder suggested that this requirement is too broad in scope, since the term “food” in the Food and Drugs Act is not limited to prepackaged products and that such a broad scope could create uncertainty, particularly for foods sold by restaurants or food services. Further, the stakeholder indicated that the proposal did not provide sufficient rationale for this requirement.

Health Canada’s response:

Health Canada’s intent is to prevent supplemental ingredients from being indirectly added to a food and circumventing the safety and labelling rules required for supplemented foods. Health Canada recognizes that the proposed provision would have a broader effect than intended, particularly for prepared food, and agrees that the scope of this provision should be limited to only prepackaged products instead.

Outcome:

For consistency with the new regulations and the new definition for supplemented food, Health Canada will amend the provision to consider a prepackaged product, rather than any food, to be adulterated if it is not a supplemented food but contains a supplemented food as an ingredient.

Comments on Supplemental Ingredients

Several industry stakeholders commented that the List of Permitted Supplemental Ingredients does not provide details about the forms or quality standards under which a supplemental ingredient may be used. They also commented that acceptable overage and tolerance ranges for supplemental ingredients should be provided.

In addition, industry stakeholders raised concerns about discrepancies between the permitted levels of certain supplemental ingredients when used in CEDs compared to when used in other supplemented foods, as well as discrepancies between the levels permitted in supplemented foods and fortified foods. They further suggested that certain other substances should be allowed as supplemental ingredients.

On the other hand, some health stakeholders expressed concerns about the maximum levels of certain supplemental ingredients were set too high, leading to possible overconsumption of nutrients. Their suggestions included lowering maximum levels, requiring additional warning statements, and prohibiting certain nutrients altogether (e.g., amino acids) in order to protect the health of consumers. Health stakeholders further commented that herbal ingredients should not be permitted as supplemental ingredients because they often have pharmacological effects that could interact with medication taken by consumers.

Health Canada’s response:

Sources of vitamins, minerals and amino acids added as supplemental ingredients must be food grade and must have a history of safe use in foods, such as those set out in internationally recognized quality standards (e.g., the Food Chemicals Codex, Codex Alimentarius, United States Pharmacopeia or European Pharmacopoeia). For vitamins, minerals and amino acids, manufacturers will be responsible for ensuring that the overages added for supplemental ingredients are in accordance with good manufacturing practice, do not present a risk to health and are not misleading, as with conventional foods. The tolerance approach for all supplemental ingredients will be set out through guidance material.

The maximum levels set for all vitamins and minerals have been calculated using a risk-based approach to ensure that total intakes from all sources do not exceed the safe daily maximums identified for each nutrient. For most vitamins and minerals, the safe daily amounts reflect the Tolerable Upper Intake Levels established by the National Academy of Medicine, which are internationally accepted amounts that represent the highest average daily nutrient intake level likely to pose no risk of adverse health effects to almost all individuals in a given life-stage and gender group.

In CEDs specifically, the maximum levels of vitamins and minerals permitted as supplemental ingredients have been set lower to take into account the amount of nutrients that a consumer may also be getting from other sources, such as dietary supplements or additional servings of CEDs. CEDs will not be required to carry certain cautionary statements designed to mitigate the risk of overconsumption that are required for other supplemented foods, such as “Do not eat on the same day as any other supplemented food or supplements with the same supplemental ingredients” to avoid giving the impression that their use could be a substitute for other sources of vitamins and minerals. This approach also reduces the number of cautionary statements required on the labels of CEDs.

Health Canada acknowledges that maximum levels for certain supplemental ingredients, such as vitamin D, have been set higher than the levels permitted through fortification. This is because maximum levels for fortified foods are generally more conservative because of the public health purpose to improve the nutritional quality of food sold in Canada and to help prevent nutritional deficiencies.

With respect to using amino acids, their maximum levels were set out such that supplementation with a single essential amino acid would not significantly change the ratios of essential amino acids in the consumer’s background diet. This approach is conservative compared to other jurisdictions such as New Zealand, which has not established maximum levels for amino acids used as supplemental ingredients.

Health Canada acknowledges that some suggested substances, such as iodine, could be added to the List of Permitted Supplemental Ingredients following a public consultation. However, other substances suggested were found to be unsuitable as supplemental ingredients due to risks of overconsumption and adverse health effects. Health Canada will continue to monitor new scientific data as it becomes available, carry out health risk assessments, and consider updates the List of Permitted Supplemental Ingredients as needed.

Concerning herbal ingredients and other supplemental ingredients, Health Canada notes that only those in the pre-publication proposal (i.e., caffeine and taurine) will be included in the List of Permitted Supplemental Ingredients when the regulations are published. New supplemental ingredients will only be added following a thorough safety assessment. Stakeholders will also have the opportunity to review and provide comments on any future changes to the list, including the addition of new supplemental ingredients, before they are made.

Outcome:

Health Canada will maintain the pre-publication proposal concerning the maximum levels established for supplemental ingredients. Health Canada will also consider conditions for iodine to be used as a supplemental ingredient.

Comments on the process to request changes to the lists

Several stakeholders noted that there was a lack of information available with regard to review timelines and suggested that information on service standards should be provided. Others had concerns that a long review process would be a significant barrier to bringing products to the market compared to other jurisdictions, and that these negative impacts would be felt especially by small businesses. One stakeholder suggested that small businesses required additional support, such as benefiting from shorter review timelines.

Several stakeholders also requested clarity on whether a submission for a new supplemental ingredient would need to undergo two separate regulatory approval processes: one for supplemental ingredients and one for novel foods. It was noted that the lack of coordination between these two processes would lead to long review timelines. Another industry stakeholder suggested that allowing manufacturers to choose which process to use, instead of requiring them to prepare submissions for both processes, would be beneficial for innovation.

Health stakeholders were in favour of a more fulsome pre-market process due to potential safety concerns associated with certain products and suggestions included instituting a notification or even a consultation process when modifying the Lists.

Health Canada’s response:

The regulations reflect a risk-based approach whereby a wide range of different supplemented foods that meet the criteria in the List of Permitted Supplemented Food Categories and the List of Permitted Supplemental Ingredients would be allowed to be sold without a pre-market review. For products that do not meet the criteria, Health Canada will undertake a review process and update the lists if evidence is provided to show that a new supplemented food category or a new supplemental ingredient would be safe for Canadians. Health Canada considers this to be a balanced approach which protects consumers while allowing for innovation of supplemented foods.

The pre-publication proposal prescribed the general submission requirements for modifications to the lists of permitted food categories and supplemental ingredients. However, it was not possible to establish detailed requirements or service standards in the regulations due to the extent to which requests may vary.

Following pre-publication, Health Canada determined that the process and requirements for submitting a request to modify the lists will be addressed through guidance material published on the Canada.ca website. In this way, Health Canada will be able to provide a single point of reference with comprehensive and detailed information on the submission requirements.

A new ingredient will only be required to go through the submission processes that corresponds to its intended use. A new ingredient that meets the definition of a novel food in Division 28 of the FDR but is only intended to be added to a food as a supplemental ingredient will not be required to be assessed as novel ingredient. Manufacturers unsure about which submission process to use can request a pre-submission meeting with Health Canada to determine the appropriate course of action.

Outcome:

Guidance material will be developed to further clarify the requirements for requesting a change to the lists and for determining whether a new ingredient should be evaluated as a supplemental ingredient or a novel food.

Comments on the Supplemented Food Caution Identifier

Industry stakeholders were generally opposed to the SFCI requirement, citing the potential for trade implications and providing evidence that it did not align with international jurisdictions. Some stakeholders described the SFCI as being alarmist and similar to warning symbols that mark a product as dangerous. Others were concerned that requiring an identifier was not consistent with other products containing similar levels of vitamins and minerals (e.g., foods fortified for public health purposes), caffeine (e.g., coffee) or other products that carry cautionary labelling (e.g., foods containing allergens, drugs, natural health products).

International governments requested the evidence in support of the SFCI and asked if Health Canada had considered less trade-restrictive alternatives.

A few stakeholders were concerned that the attribution to Health Canada in the SFCI could be viewed as the product being promoted or approved by Health Canada.

Health and academic stakeholders recommended that the SFCI was not restrictive enough and raised concerns about it being perceived positively and providing the impression that the product is healthy. Suggestions included using a larger format, stronger language or colour to bolster the identifier’s appearance.

Health Canada’s response:

Recent Health Canada consumer research found that front-of-package labelling on foods high in nutrients of public health concern can help consumers, especially those with low health literacy, make healthier food choices. An identifier incorporating an exclamation mark was designed to assist consumers in identifying supplemented foods with cautionary statements. The use of the exclamation mark mitigates the perception that the word “supplemented” conveys a positive message. Recent consumer research showed that the SFCI acts as an effective visual cue for consumers to look for cautionary statements on the back of the label.^{footnote 4}

There is no consistent approach internationally for identifiers on supplemented foods. While a front-of-package caution identifier is not required in other jurisdictions, New Zealand requires the text “Supplemented Food” in a prominent position on the product label. The SFCI requirement is not expected to create any trade barriers.

Outcome:

Health Canada will maintain the pre-publication proposal of requiring the SFCI on supplemented foods with cautionary statements.

Comments on the Supplemented Foods Facts table

Health, academic and consumer stakeholders generally supported the use of the SFFt.

A number of industry stakeholders were opposed to having a unique SFFt for supplemented foods and requested that a modified NFt be used instead. They commented that the SFFt could cause confusion for consumers who are accustomed to the NFt, and that there would be trade implications given that the SFFt does not align with international jurisdictions.

These stakeholders also suggested allowing additional flexibility in the case of small packages, for example allowing information to be contained in QR codes whereas several health stakeholders maintained that small packages may be used to avoid many of the labelling requirements and indicated all information should be provided for consumers either as an insert or via another format.

Stakeholders from all sectors recommended that the % daily value be included for supplemental ingredients on the SFFt. Many suggested that this would reduce confusion and help consumers gain a better understanding of the amount of nutrients they are consuming. Others indicated the importance of being consistent with the way in which nutrients were declared in the NFt on other food products.

Health Canada’s response:

Research has demonstrated that consumers are not always able to distinguish supplemented foods from conventional foods. Consumers have also expressed a need for details about the supplemental ingredients in a product. Given that the NFt is a trusted and credible source of information for foods, the SFFt was modeled after the NFt. Additional elements have been included that are unique to supplemented foods, such as the title “Supplemented Food Facts” and the “Supplemented with” section for information on the supplemental ingredients. In this way, Canadians would be better able to identify supplemented foods as well as make informed choices related to their consumption.

Although the use of the SFFt and the SFCI will not be aligned with international jurisdictions, the intent to improve awareness of supplemental ingredients is consistent with the World Trade Organization Agreement on Technical Barriers to Trade, which allows countries to implement regulations based on scientific evidence for the protection of human health.

Health Canada used a risk-based approach when developing the labelling requirements for small packages. Recognizing the need for consumers to have access to important information when purchasing a supplemented food as well as the challenges with displaying all of the required information on a small surface, small packages that are less than 100 cm² are exempted from carrying a SFFt when they do not carry any cautionary statements or nutrition or health-related representations. When such packages are required to carry a SFFt, only a subset of information will be required. For example, information on supplemental ingredients that have associated cautionary statements will be required as this information is important for consumers at the point of purchase. While some alternative methods of providing the information to consumers will be acceptable, including tags, fold-out labels and outer sleeves, the use of QR codes will not be permitted because the information may not be accessible for all consumers.

Health Canada’s proposal related to the restrictions of the % daily value was intended to help avoid consumer confusion, particularly since not all supplemental ingredients have an established daily value. However, Health Canada is supportive of including the % daily value for supplemental ingredients that have an established daily value.

The inclusion of the % daily value for supplemental ingredients will be supported by the current outreach and education activities being conducted to address potential gaps in consumer understanding.

Outcome:

Health Canada will maintain the pre-publication proposal with respect to small packages. However, to maintain consistency with conventional foods, an exception was added whereby a sugar-free supplemented food in a small package will still be allowed to use the modified SFFt format that provides less information than would normally be required, provided that certain conditions are met.

In addition, Health Canada modified its rules for the SFFt, in correspondence to stakeholders’ interests, to require the declaration of the % daily value of supplemental ingredients with an established daily value.

Comments on cautionary statements

A few stakeholders raised concerns that the proposed wording of certain cautionary statements, and the presence of new cautionary statements that were not required under the TMA framework, could cause unintended consumer confusion.

In particular, some stakeholders commented that the cautionary statement “do not consume this product with other supplemented foods or supplements that have the same supplemental ingredients”, may not be understood by consumers to be referring to natural health products.

Industry stakeholders commented that the cautionary statement “not recommended for those under 14 years old” should be replaced with “not recommended for children”, which is the wording that was required under the TMA framework. They argued that the supplemented foods regulations should be consistent with the guidance material published in 2013 for CEDs with TMAs, as well as with regulations for natural health products, which define children as those 12 years old or younger. Industry stakeholders also referenced their own research that indicated that the majority of caffeine intake among teenagers came from products other than CEDs, such as coffee, tea and soft drinks.

In contrast, health researchers and stakeholders commented that the age in the cautionary statement should be increased to under 18 years old. To support their input, they referenced statements made by medical professional organizations, including the Canadian Medical Association and the Canadian Pediatric Society, as well as some from other countries, including the American Academy of Family Physicians and the Australian Medical Association, that CEDs are not recommended for those under 18 years of age. They also raised specific concerns about the overconsumption of caffeine among youth and commented that the cautionary statements for CEDs were lacking, such as on the subject of consuming high doses of caffeine while playing sports. In particular, they recommended additional cautioning about negative health effects due to consumption of CEDs in large quantities or when consumed before, during and after exercise.

Health Canada’s response:

The new framework will require the use of similar cautionary statements that were already being used under the TMA framework. However, in many cases, these cautionary statements were reworded to improve their clarity and better convey their meaning under the new supplemented foods framework. Health Canada will also conduct an education and awareness campaign to further help consumers understand cautionary statements.

For the cautionary statement “not recommended for those under 14 years old”, research supported Health Canada’s proposal to include an age in the statement as consumers did not understand what age group the word “children” referred to when used alone. For example: focus group testing with CEDs found that participants between the ages of 13 and 15 considered “children” as those 10 years old and younger; and in focus groups testing with supplemented foods, most participants thought the “not intended for children” statement meant that the product was not intended for those under the age of 10 or 12.

Setting the cautionary statement to recommend against consumption for those under 14 aligns with an updated health risk assessment on CEDs conducted by Health Canada. The scientific assessment found that the consumption of two servings of a typical CED was safe for healthy adolescents 14 years of age and older, and that there would not be expected to be significant health risks in older adolescents up to the maximum daily limit of 400 mg.

In comparison with other regulatory frameworks, children under the natural health product framework are considered to be those under 18 years of age rather than 12.

Internationally, there is no consistent labelling of age restrictions on supplemented foods, including CEDs. Some jurisdictions require a warning statement on CEDs to indicate that the product is not recommended for children. In New Zealand, supplemented foods containing vitamins or minerals above certain levels require an advisory statement to indicate that the product is only intended for consumption by those 14 years of age or over.

With regard to requiring additional cautionary statements for CEDs and other supplemented food that are high in caffeine, Health Canada found limited evidence to support the need for the additional statement suggested. However, products with a high caffeine content will not be permitted to carry representations about their use in the context of physical performance, hydration or electrolyte replacement.

Outcome:

Health Canada will maintain the pre-publication proposal.

Health Canada has reviewed the wording of the proposed cautionary labelling, in conjunction with scientific and literacy experts, and has made minor changes to the wording of certain cautionary statements to improve clarity and to ensure the intended meaning of cautionary labelling is conveyed. Health Canada has also added a new requirement to group “not recommended” cautionary statements together when more than one is called for on the label of a supplemented food.

An education campaign will also be conducted to inform consumers of the potential risks associated with not following the cautionary labelling on a supplemented food.

Comments on representations

Several stakeholders raised questions about the intended meaning of the term “representation” and expressed concerns that it could be interpreted broadly to include event sponsorships or other marketing.

Almost all industry stakeholders, including several international industry associations, opposed the proposed restrictions on representations for CEDs and other products with cautionary statements. Their reasoning included that the prohibitions were not supported by scientific evidence or consumer research, they would prevent the communication of functional benefits of supplemental ingredients, they would not be aligned internationally and would create trade barriers, and they would put other supplemented foods at a competitive disadvantage compared to other products with similar or higher levels of the same ingredients.

One industry stakeholder provided a legal opinion that described the proposed restrictions as unconstitutional citing that they resulted in a complete ban on providing information about the ingredients added to CEDs. In addition, stakeholders were concerned that the regulations would prevent factual claims about the contents of the food and those about the benefits of supplemental ingredients. Stakeholders provided evidence, including from the International Society of Sports and Nutrition and the European Food Safety Authority, on the benefits of caffeine in sport and suggested to remove the proposed restriction for this type of claim on supplemented foods with high levels of caffeine. Several stakeholders also raised concerns about the potential negative impact of the restrictions on sponsorships for sporting events and research programs.

On the other hand, most health stakeholders and academics supported Health Canada’s approach and recommended to expand the restrictions related to representations. Academic experts provided evidence and rationales in favour of the restrictions including findings that the labelling and marketing of health claims created misperceptions about the healthiness of a product containing supplemental ingredients. Stakeholders noted that claims about the benefits of supplemented foods can be used to promote them as nutritionally superior to conventional foods, putting Canadians who consume them at greater risk of health issues if overconsumed.

Some health and academic stakeholders raised concerns on the marketing of CEDs to children and youth, and called for such practices to be prohibited. Their recommendations included restricting the advertising and sampling of CEDs to those under the age of 18. Stakeholders noted that marketing of CEDs predominantly caters to youth, a vulnerable population group that may not fully grasp the risks associated with these products in order to make informed decisions about consuming them.

Health Canada’s response:

Health Canada notes that the term “representation” is used in the FDR as a broad term that encompasses declarations, claims, statements, symbols or any other element that provides information about a product on its label or in an advertisement.

Research found that consumers had a more favourable perception of supplemented foods with higher levels of vitamins and minerals and did not always notice cautionary statements. Research also found that some children would consume supplemented foods despite a cautionary statement indicating that the food is not for children. Other consumer research conducted by Health Canada showed that consumers used claims on the label of supplemented foods to guide their food choices.^{footnote 4}

With respect to supplemented foods with a high caffeine content, such as CEDs, evidence provided as part of the consultation did not provide an adequate rationale for easing the proposed restrictions. For these higher-risk products, the restrictions on claims related to vitamins and minerals are appropriate to prevent them from being promoted as sources of nutrients or for the maintenance of good health. This approach is consistent with Australia and New Zealand’s prohibitions on nutrient content claims and nutrient function claims for CEDs.

Concerning sponsorships, these will be outside of the scope of the restrictions which specifically target representations made about a specific product. As a result, the regulations will not negatively affect manufacturers in their broader ability to sponsor events and advertise their products.

As foods, CEDs will not be subject to the extensive cautionary labelling and conditions of use (e.g., frequency of use and duration of use) similar to those required for workout supplements containing caffeine, which are regulated as natural health products. Further, there is limited evidence that consumption of more than 200 mg of caffeine, which is less than the daily maximum that can be provided from CEDs, is safe for the general population in the context of physical activity.^{footnote 7} For these reasons, the restrictions on claims related to physical performance were implemented for CEDs under the TMA framework and were maintained to help ensure that these products will not be promoted for use in the context of sports.

Restricting hydration and electrolyte replacement claims on supplemented foods with high levels of caffeine is designed to reduce the misuse of CEDs as sports drinks, which is inconsistent with how CEDs are intended to be consumed. There is not sufficient evidence to support that the consumption of CEDs in accordance with the conditions of use in the List of Permitted Supplemental Ingredients would be safe and suitable for the general population in the context of use for hydration or electrolyte replacement.

Nevertheless, Health Canada acknowledges that the evidence related to the use of CEDs for sports performance may change as this is an area of active research. In order to remain adaptable to potential new evidence, the restrictions on making representations related to physical performance, hydration and electrolyte replacement will be addressed in the List of Permitted Supplemental Ingredients instead of Division 29 of the FDR.

Regarding the concerns related to the marketing of CEDs to youth, Health Canada notes that the new regulations take a risk-based approach to include some restrictions on making representations in advertisements about supplemented foods that are not recommended for consumption by those under 14, such as CEDs. In addition, there is existing legislation in the Food and Drugs Act and the Safe Foods for Canadians Act that requires food advertising to be truthful and accurate and that may be leveraged to address situations where the advertising of supplemented foods is misleading or deceptive.

Outcome:

Health Canada has removed the prohibition on making representations about supplemental ingredients that trigger a cautionary statement and has replaced it with a more narrow prohibition. For any nutrient that is a supplemental ingredient and that triggers a cautionary statement, claims about its general role for the maintenance of good health will be prohibited unless accompanied by a claim about the specific action or effect of the same nutrient in maintaining the functions of the body.

In addition, consistent with the TMA conditions, Health Canada has introduced new restrictions specifically for supplemented foods that will be required to carry a cautionary statement indicating that the product is not suitable for any group of individuals under 18 (e.g., not recommended for those under 14 years old). For these foods, the regulations will prohibit any claims referring to the role of nutrients contained in the supplemented food in maintaining the functions of body necessary for growth and development in order to prevent conflicting information and protect vulnerable population groups.

With respect to supplemented foods that will be required to carry the “high caffeine content” statement, Health Canada will maintain the pre-publication proposal and prohibit any representations about the vitamins and minerals contained in these products. The restriction on representations related to physical performance, hydration and electrolyte replacement will also be maintained, but in place of a prohibition in Division 29 of the FDR, products that carry such representations will not be permitted to be supplemented foods according to the conditions set out in the List of Permitted Supplemental Ingredients.

In all three cases, the restrictions will apply to claims and representations made on the label of, or in an advertisement for, a supplemented food.

Health Canada will also maintain the pre-publication proposal of imposing size restrictions on any nutrition or health-related claims made on the label of a supplemented food that is required to carry any cautionary statements.

Comments on prohibitions related to assortments

A few industry stakeholders raised concerns about the proposed prohibition against selling an assortment of foods of the same type containing both supplemented foods and conventional foods. These stakeholders were concerned that such a prohibition would limit industry’s ability to sell a variety of prepackaged products containing an assortment of foods without a valid justification. They recommended allowing the sale of supplemented foods and conventional foods in an assortment provided that the product is properly labelled. Industry stakeholders expressed support for providing labelling information for all products contained within the assortment, whether supplemented foods or conventional foods.

Health Canada’s response:

The pre-publication proposal prohibited the sale of assortments containing both supplemented foods and conventional foods of the same type to help prevent consumers from mistaking one for the other. However, Health Canada recognizes that clear information provided for the supplemented foods in the package would support consumers in making an informed choice.

Outcome:

As a result of the concerns raised by stakeholders, Health Canada has removed the proposed prohibition and will allow assortments containing a mix of supplemented foods and conventional foods.

Comments on caffeine requirements

Most industry responses, including those from several international industry associations and international jurisdictions, were opposed to the requirement for the “high caffeine content” statement on the principal display panel of CEDs. They claimed that the requirement would be discriminatory towards CEDs as there are non-CED products with similar or higher caffeine levels, such as coffee, that would not require the statement. These comments were supported by references to international studies. Industry stakeholders also highlighted that the proposed labelling approach was not aligned internationally.

Academic and health stakeholders supported the “high caffeine content” statement on the front of the package of supplemented foods and noted that it was important for helping consumers to be aware of the amount of caffeine they are consuming.

With respect to the cautionary statement “do not mix with alcohol” required on CEDs, industry associations provided evidence indicating that the co-consumption of alcohol and CEDs does not present an elevated risk to health and requested that the requirement be removed. The European Union backed this position and referenced a scientific opinion from the European Food Safety Authority^{footnote 8} that also did not find any clear risks to health when CEDs are mixed with alcohol.

Responses from academics and consumers supported the “do not mix with alcohol” cautionary statement” and raised concerns that there is a correlation between consumers (particularly young adolescents) mixing CEDs with alcohol and engaging in risky behaviours.

While industry did not have any comments on the maximum level of caffeine permitted in CEDs, certain academic and health-protection groups were not supportive of the proposed maximum level of 180 mg per serving. They commented that this amount was too high and should be reduced to 80 mg per serving to be more protective of young adolescents.

A few health stakeholders raised concerns about the statement “energy drink” or “caffeinated energy drink” that would be required on the label of CEDs. As the term “energy” in these statements may be perceived as a claim for a physiological benefit, it could be misleading for consumers. They also indicated that the consumption of caffeine does not technically provide energy and the statement fails to communicate the risks associated with CEDs. Instead, they suggested changing the statement to “modified caffeine drink” or “caffeine-modified product”.

Health Canada’s response:

The intent of the “high caffeine content” statement was to alert consumers that the product contains high levels of added caffeine. However, Health Canada acknowledges that there have not been specific studies undertaken that demonstrate that the placement of the statement “high caffeine content” on the principal display panel provided greater consumer awareness or protection compared to its placement elsewhere on the label. Under the TMA framework, Health Canada has allowed the statement to be placed anywhere on the label of CEDs.

Allowing flexibility to place the statement elsewhere on the label is supported by the SFCI on the front of the package, which is designed to alert consumers to review the information elsewhere on the label. In this regard, consumers will be alerted to review other labelling information to determine if the product is right for them, including information about the caffeine content.

Because the supplemented foods framework applies to foods that contain added caffeine, other foods such as prepackaged coffee or tea beverages are excluded. Health Canada will explore options to apply a consistent approach to labelling for all prepackaged foods based on their caffeine content.

There is no consistent international approach, with some countries not requiring any warning about the product containing caffeine, while other countries require a statement that the product contains caffeine or is high in caffeine. In the latter case, some countries require the statement on the front of the package while others do not specify placement.

Health Canada acknowledges that there is currently limited evidence supporting a direct risk to health resulting from the co-consumption of CEDs and alcohol. As well, there is limited evidence that CED consumption causes risky behaviours or masks signs of alcohol-induced inebriation that could promote risky behaviour.

With respect to the amount of caffeine permitted in CEDs, Health Canada did not find sufficient evidence that would justify the need to lower the maximum level to 80 mg per serving.

Regarding the statements “energy drink” and “caffeinated energy drink”, Health Canada agrees that they could be misleading as caffeine is not a source of caloric energy. For this reason, “energy drink” and “caffeinated energy drink” will not be required statements on the label of CEDs, nor will they be formal descriptors of CEDs.

Outcome:

Health Canada will modify its requirements for the “high caffeine content” statement and allow it to be placed anywhere on the label instead of the principal display panel.

Health Canada will also remove the requirement that CEDs include the cautionary statement “Do not mix with alcohol” and the statement “energy drink” or “caffeinated “energy drink” on their label.

Comments on transition period

Health stakeholders commented that they would prefer a shorter transition period (i.e., 1-2 years) for Health Canada to achieve the intended objective of protecting the health and safety of consumers.

Meanwhile, industry stakeholders commented that a longer transition period (i.e., 4-5 years) would help to reduce the cost impacts to them. Some industry stakeholders confirmed the assumption that costs for a five-year transition period would be half the costs attributed to a three-year transition period and, if applied, could reduce their costs per stock keeping unit (SKU). One industry stakeholder also called for more clarity on certain details of the transition period.

Health Canada’s response:

A range of potential costs were provided by industry in response to the CBA survey, but they were not dependent on a specific transition period; however, estimates were accompanied by a timeline of product development, which noted that a total product development cycle could take roughly 28-34 months to complete. Health Canada applied the range of cost estimates to a three-year transition period, which is slightly longer than the product development cycle, assuming that industry based these costs on their current practice. Health Canada will now also be aligning the compliance date for supplemented foods to January 1, 2026, as outlined in the food labelling coordination policy, extending the originally proposed transition period to approximately three and a half years. This will further help minimize costs to industry while balancing health and safety considerations.

Outcome:

Health Canada will maintain its position that, for supplemented foods that will be eligible, a suitable transition period for complying with the new regulations is three years. However, Health Canada and CFIA implemented a joint policy on food labelling coordination in August 2021, which establishes compliance dates for changes to labelling regulations every two years starting on January 1, 2026. By aligning the transition period with this first compliance date of this policy, and based on a publication date in July 2022, the regulations will provide a transition period of approximately three and half years.

Health Canada will work with CFIA to provide additional clarity on the transition period through guidance material.

Comments on post-market monitoring

Various stakeholder groups commented on the post-market monitoring approach for supplemented foods. Generally, they were in favour of strong penalties for non-compliance and emphasized the need for: ongoing monitoring and proactive compliance and enforcement; a comprehensive and user-friendly adverse event reporting system; full transparency and access to information on consumption incidents and safety data; and a notification system for new supplemented foods entering the market.

Health Canada’s response:

Health Canada is working with health partners to enhance the existing food safety surveillance framework to take into account supplemented foods. This includes providing a single window for consumers, health professionals and industry to report consumption incidents related to supplemented foods; and leveraging Health Canada’s Toxicovigilance Canada program which will provide aggregated poison control centre data in real-time. CFIA will explore improvements to its internal systems, including the Issues Management System and the Digital Service Delivery Platform, to expand information collection and analysis capacity for supplemented foods.

CFIA will use a risk-based approach for compliance and enforcement of supplemented foods. This may include proactive activities as needed based on a high level of risk or non-compliance.

In addition, as part of Health Canada’s comprehensive awareness and education strategy, consumers, health stakeholders and provincial/territorial governments will be provided with tools and resources including information on reporting consumption incidents related to supplemented foods.

Outcome:

Health Canada will maintain the pre-publication proposal to not require mandatory reporting to Health Canada of consumption incidents.

Comments on costs and benefits

The majority of industry stakeholders provided comments on the negative impacts of the proposed restrictions on representations, including claims and advertising. A number of stakeholders, including sports associations, were concerned that the restrictions could limit sponsorships and other opportunities for product promotion and developing brand awareness, which are primary avenues for funding.

These stakeholders also noted that certain supplemented foods, including CEDs in particular, would be less competitive in the market and less profitable if the benefits of the supplemental ingredients they contain could not be communicated to consumers.

Industry stakeholders also commented that the length of the transition period would have an impact on the costs associated with adopting new labels and product reformulation, and that a longer transition period would help alleviate some of those costs. Some industry stakeholders confirmed the assumption that costs for a five-year transition period would be half the costs attributed to a three-year transition period and, if applied, could therefore reduce the cost per SKU.

Health Canada’s response:

Some stakeholders provided estimates of additional costs that would stem from the proposed restrictions on representations and the use of claims. However, the estimates were based on a complete prohibition on the use of claims and advertising and did not take into account that some representations and some forms of advertising, including sponsorships and brand promotion, will still be permitted. The restrictions on representations and the use of claims have since been revised and are now less restrictive than what was originally proposed for the Canada Gazette, Part I. However, potential impacts on competitiveness are addressed qualitatively in the CBA.

As per the discussion above regarding comments received on the transition period and the application of cost estimates, Health Canada will now be aligning the end of the transition period with the next appropriate compliance date, as outlined in the food labelling coordination policy, extending the originally proposed transition period to approximately three and a half years and will provide an additional six months to help alleviate costs to industry.

Outcome:

Health Canada has updated the restrictions related to making representations about supplemented foods that carry cautionary statements but will maintain the transition period set out in the pre-publication proposal.

Stakeholder engagement

In March 2022, Health Canada held a targeted engagement session with key industry and health stakeholders. Health Canada presented a summary of the comments received from pre-publication in the Canada Gazette, Part I, and provided an overview of the key changes to the regulatory framework that were made as a result. In addition, Health Canada provided explanations for certain requirements in the pre-publication proposal that were maintained following the consultation.

Stakeholders were provided with the opportunity to ask clarification questions to ensure a common understanding. In particular, stakeholders were interested in the SFCI, the updated claims restrictions, additions to the lists of permitted supplemental ingredients, the cost-benefit analysis, and the education and awareness campaign. Health Canada provided responses to address all of the questions that were asked, including speaking to the breadth of evidence in support of the updated policy.

Modern treaty obligations and Indigenous engagement and consultation

No impacts on the Government’s modern treaty obligations have been identified for this proposal.

Instrument choice

Option 1: Temporary Marketing Authorizations (Status Quo)

There are no provisions in the FDR that specifically permit the sale of supplemented foods in Canada. As a temporary measure, Health Canada has been issuing TMAs following case-by-case safety assessments to allow supplemented foods on the market as Health Canada gathers information from manufacturers to support amendments to the FDR. The absence of a regulatory framework for supplemented foods has been an ongoing burden and impediment for industry stakeholders looking to bring new supplemented foods to market. In addition, the review of TMA applications and their associated post-market reports likewise presents an administrative burden to Health Canada.

Option 2: Non-regulatory approach

The sale of supplemented foods is not permitted by the FDR unless a TMA has been issued. Any non-regulatory approach aimed at permitting their sale would not be viable because it would be inconsistent with the FDR.

Option 3: Regulatory approach (chosen option)

In order to provide transparency for stakeholders and a predictable regulatory environment for supplemented foods to be sold in Canada, amendments to the FDR are needed. A new regulatory framework for supplemented foods will provide predictability for manufacturers to introduce new and innovative supplemented foods to the market. The regulatory amendments were identified as a Health Canada commitment in the Government of Canada’s Agri-food and Aquaculture Regulatory Review Roadmap of June 2019 within the theme of developing clear, agile and responsive regulations. At the same time, the new framework will establish consistent requirements for the sale of supplemented foods to help protect the health and safety of consumers, particularly those belonging to vulnerable groups.

Internationally, there is no consistent regulatory approach to managing supplemented foods. New Zealand is the only country identified that has a specific framework for regulating supplemented foods; its approach was considered by Health Canada.

In view of the principles of outcome-based regulations, Health Canada will use a risk-based approach to allow supplemented foods to access the market. Health Canada will identify supplemental ingredients that may be considered safe when used under specific conditions and in certain food categories and will capture these in a List of Permitted Supplemental Ingredients and a List of Permitted Supplemented Food Categories. Industry will then have the flexibility to create new products in accordance with the lists and their respective conditions.

At the same time, the framework itself will be responsive and adaptable to requests from individuals, and industry. As Health Canada will manage the lists administratively, it could consider changes to the lists following a safety assessment. This will provide a streamlined path to market for innovative uses of food categories or supplemental ingredients that have not previously been reviewed and assessed to be safe by Health Canada.

Regulatory analysis

Benefits and costs

The full CBA report is available upon request. The CBA aims to quantify the benefits and costs of making amendments to the FDR with the introduction of a new framework for the regulation of supplemented foods. The analysis describes and quantifies the potential cost savings to both industry and the Government of Canada by comparing the costs incurred under the current TMA process with the incremental impacts resulting from the regulatory framework. Since publication of the proposal in Canada Gazette, Part I, the total number of supplemented foods on the market and the total number of firms manufacturing these products have increased resulting in changes to the number of products requiring new labels/reformulation, the number of small businesses potentially impacted, and an increase in the average annual growth rate applied. Internal cost estimates to the Government of Canada have also been updated to better reflect the post-market monitoring approach that will be undertaken by both Health Canada and CFIA. The analysis also quantifies the costs for supplemented foods to transition over to the new regulatory framework by updating labels and product formulations. All calculations for the costs and benefits are projected over a 10-year period, and the net present value is discounted by 7% as required by the Treasury Board Secretariat.

Baseline versus Regulatory Scenario

TMAs are an interim measure that Health Canada uses to allow select supplemented foods, including CEDs, on the market on a case-by-case basis and under certain conditions. Under the TMA framework, manufacturers are required to submit an application for a TMA and once approved, to provide research, sales data, and incident reports to Health Canada on their supplemented food throughout their time on the market. TMAs have allowed Health Canada to collect market data while permitting industry to sell supplemented foods in the marketplace. However, with the use of TMAs as a temporary tool, this arrangement creates a burden for both manufacturers to maintain the post-market requirements (i.e., annual consumption incident (CI) reports, annual market sales data and conducting market research) and have Health Canada review this information.

A new, risk-based approach for regulating supplemented foods will allow products with certain ingredients at levels established as safe to access the market without having to submit a TMA application for review. This approach will be consistent with what is already in place for conventional foods where generally applicable rules are established. At the same time, there is an opportunity for Health Canada to establish a framework that is flexible and can be updated on an ongoing basis to help facilitate innovation. This will allow Health Canada to remain responsive to new evidence related to supplemented foods and to be agile in accepting new food categories or new supplemental ingredients when they become established as safe. The regulatory framework for supplemented foods will establish new requirements such as labelling and reformulation to help address certain limitations of the TMA framework.

Key Assumptions

• i. All costs and benefits are presented in 2020 dollars.
• ii. A discount rate of 7% is used in the analysis.
• iii. The analysis evaluates the costs and benefits over a 10-year period, thus the study period is presented from 2022 to 2031.
• iv. The supplemented foods framework will replace the existing TMA process to permit the sale of supplemented foods on the Canadian market with a risk-based approach.
• v. For the Canada Gazette, Part I pre-publication, there were 611 authorized supplemented foods (equivalent to 611 SKU) permitted on the Canadian market through the use of TMAs manufactured by 90 different firms.^{footnote 9} Since Canada Gazette, Part I, the number of supplemented foods has increased to 753 and are manufactured by 95 different firms based on data collected as of November 2021. It is unclear how many of these firms hold operations in Canada; therefore, it is assumed that all 95 firms are within scope.
• vi. The average annual growth rate in the number of firms with supplemented foods and average annual growth rate for the number of supplemented foods on the market are based on Health Canada’s internal TMA database. It was assumed within the baseline for the Canada Gazette, Part I pre-publication, that an average annual growth rate of 10% in the number of firms and an average annual growth rate of 6% in the number of supplemented foods on the market would apply. This assumption has been updated to reflect Health Canada’s latest data (as of November 2021), resulting in an average annual growth rate of 10% in the number of firms with supplemented foods and an average annual growth rate of 10% in the number of supplemented foods on the market.
• vii. With the framework in place, it is unclear how these growth rates for the number of firms and supplemented foods on the market will be impacted. Therefore, Health Canada assumes they will remain unchanged from the baseline and will continue to apply going forward.
• viii. CFIA will begin conducting ongoing compliance and enforcement activities in year one, since it is assumed that new supplemented foods entering the market during the transition period are expected to be in compliance with the new framework. A risk-based approach to compliance and enforcement will be taken.
• ix. Manufacturers of supplemented foods currently on the market will be provided with a transition period until January 1, 2026, aligning with the next appropriate compliance date as outlined in the food labelling coordination policy. As such, this will be slightly longer than the three-year transition period originally proposed for the Canada Gazette, Part I pre-publication. However, for the purposes of the CBA, it is assumed that industry will be provided with three years to transition with the understanding that there will be some flexibility.
• ix. Manufacturers of supplemented foods will most likely opt to wait until year three of the transition period to reformulate products and update labels in order to exhaust their current stock of labels and products. This will allow them to reduce product and label waste and have more time to plan and design their new labels.

Costs

The total direct cost to industry for updating labels and reformulating products and to the Government of Canada for implementing compliance and enforcement activities is estimated to be $4.0 million annualized or $27.9 million PV over a 10-year time period.

Costs to Industry

The total direct cost to industry with the supplemented food framework includes the one-time cost of updating labels and product reformulation, which are estimated to be $23.8 million or $19.4 million PV over a 10-year time period, based on a transition period of three-years using a 7% discount rate. These costs are strictly borne by existing supplemented foods that are currently on the Canadian market to effectively transition from the TMA framework to the supplemented foods regulatory framework. It is expected that new products are assumed to incorporate these new requirements in their product design and development, thus they are excluded from the incremental costs to industry in the CBA.

i. Labelling Costs to Industry

Under the TMA approach, supplemented foods are subject to most of the same food labelling requirements as other prepackaged foods. This includes displaying an NFt as well as a list of ingredients on the label. In addition, the name of the supplemented food on the label must indicate how it is different from a conventional foods (e.g., “nutrient enhanced water beverage”) and cautionary statements must be shown when certain supplemental ingredients are used or when higher quantities of certain supplemental ingredients are used.

As mentioned above, as of November 2021, there were 753 supplemented foods permitted on the market through the use of TMAs. The labelling requirements under the supplemented foods framework will include the introduction of a new SFFt for all supplemented foods, which will replace the current NFt. The SFFt will be similar to the NFt but will clearly specify the name and amount of each supplemental ingredient added to the product. A list of ingredients will continue to be required on the label of a supplemented food, including any supplemental ingredient(s). In addition to the SFFt, the use of certain supplemental ingredients or certain levels of supplemental ingredients must be accompanied with cautionary statements adjacent to the SFFt, along with a black and white SFCI on the principal display panel. These two additional labelling requirements will only be required for those products that pose any potential risk in connection to the individual supplemental ingredient. For the Canada Gazette, Part I pre-publication, it was estimated that 88% of products on the market would require these additional labelling requirements. Upon further review, this has been revised to 81% of supplemented foods based on Health Canada’s latest data as of November 2021; the remaining 19% of products will only be required to carry the SFFt.^{footnote 10}

Industry stakeholders will be provided a transition period of approximately three years to be able to exhaust their existing product and label stocks in order to eliminate product waste, all while updating their labels to include the appropriate labelling requirements.

Industry provided cost estimates in response to the CBA survey in the fall of 2020, which were presented for low, medium, and high-cost scenarios reflecting the varying level of complexity of the label change (e.g., printing on a paper box versus on an aluminum can and the inclusion of various labelling components) and can range from $19,200-$26,000 per SKU. This range of cost estimates were not provided on the basis of a proposed transition period but were accompanied by information regarding the timeline for a typical product development cycle, which noted that a total product development cycle could take roughly 28-34 months (under three years) to complete. Health Canada applied the range of cost estimates to a three-year transition period, which is slightly longer than the product development cycle, assuming that industry based these costs on their current practice. Health Canada will now be aligning the compliance date for supplemented foods to January 1, 2026, as outlined in the food labelling coordination policy, extending the originally proposed transition period to approximately three and a half years. Although the CBA assumes the cost estimates provided can be applied to a three-year transition period, it is unclear how much these cost estimates would be reduced given the additional six months; it is assumed that the additional time and flexibility would reduce the estimated costs. A sensitivity analysis has been conducted to illustrate how a longer transition period is expected to impact labelling costs and is included in the full CBA report.

For the purposes of the CBA, Health Canada also assumes that the higher-bound cost estimate of $26,000 per SKU captures the complexity of including the SFFt, the SFCI, and the list of cautionary statements. Since 19% of supplemented foods will be required to include the SFFt but not the additional labelling requirements (i.e., SFCI and cautionary statements), label changes for these products may cost less. Applying the higher-bound cost estimate of $26,000 per SKU to all products, also takes into account the potential for higher costs due to market pressures (supply chain issues, labour shortages, etc.).

Health Canada estimates that it will cost approximately $26,000 per SKU to incorporate the new labelling requirements. With approximately 753 supplemented foods on the market required to implement these changes, Health Canada assumes it will cost industry stakeholders a one-time cost of $19.6 million. However, these costs are assumed to be incurred within year three of the transition period, resulting in a total one-time cost of approximately $16.0 million PV using a 7% discount rate. Some industry stakeholders indicated that the lifecycle for supplemented foods and their labels are typically every four to five years unless otherwise required by regulations, indicating that some industry members may be able to incorporate the required label changes into their lifecycle, if the timing aligns appropriately. Although the typical lifecycle raised by industry is considered longer than the transition period, the CBA assumes the full label costs as incremental.

ii. Reformulation Costs to Industry

To reduce the potential risks associated with supplemented foods and to inform consumers of their differentiation from conventional foods, Health Canada consulted with stakeholders between 2012-2016 in order to develop guidance documents outlining requirements on composition, labelling and marketing, and CI reporting under the TMA framework. The Department has been monitoring these compositional requirements on a case-by-case basis for supplemented foods and has generally permitted up to the maximum levels of supplemental ingredients in order to help ensure the supplemented food is safe for consumption. Health Canada has published these maximum levels for most vitamins and minerals in a guidance document. However, by requiring manufacturers to submit research, evidence and CI reports under the TMAs, Health Canada has gathered further information as supporting evidence to update these maximum levels, where warranted, and established new ones for amino acids and other supplemental ingredients.

Under the supplemented food framework, these maximum levels will be prescribed in the List of Permitted Supplemental Ingredients and incorporated by reference in the FDR. This approach will provide Health Canada with flexibility to update levels on an administrative basis as new evidence becomes available and/or is presented by stakeholders seeking changes. Based on data collected from the TMAs and the number of products considered to be within scope, it was estimated for the Canada Gazette, Part I pre-publication, that approximately 40 (6.5%) of supplemented foods would need to be reformulated. However, based on Health Canada’s latest data as of November 2021, it is estimated that 48 (6.4%) of all supplemented foods will need to reformulated in order to comply with the updated maximum levels.^{footnote 11}

Industry stakeholders provided cost estimates for reformulating on a per SKU basis. These costs were estimated to potentially range from $75,000-$100,000 per SKU with an average of $87,500 per SKU. With approximately 48 supplemented foods requiring reformulation, it will cost industry stakeholders $4.2 million to meet the new maximum levels proposed. However, these costs are assumed to be incurred within year three of the transition period, resulting in a total one-time cost of $3.4 million PV using a 7% discount rate.

Cost to the Government of Canada

Under the new framework, CFIA will incur an annualized average cost of $1.2 million annualized or $8.5 million PV over a 10-year time period, based on a transition period of approximately three years using a 7% discount rate. These incremental costs reflect one-time implementation activities and the ongoing compliance and enforcement activities required once the framework is in place. CFIA will be responsible for the enforcement of the provisions of the Food and Drugs Act and the FDR as they relate to supplemented foods. These are considered to be low-risk products and will be subject to CFIA’s existing risk-based compliance and enforcement activities. Supplemented food inspections will only be conducted in response to complaints. The costs presented are based on the current number of firms in the market and anticipated resource requirements for reactive investigation activities.

At the time of Canada Gazette, Part I pre-publication of the proposal, CFIA had indicated that it would require 2.5 full-time equivalents (FTEs) in ongoing additional resources to manage the implementation of new regulations through reallocation. For the duration of the originally proposed three-year transition period, Health Canada had committed to reallocate two FTEs, using existing resources that were expected to become available for other initiatives once the regulations were in place and would no longer be required to manage TMAs. Since then, CFIA has reassessed their resource requirements. CFIA now indicates that it will require between 5 to 10 FTEs each year to address resource requirements for implementation as well as the ongoing compliance and enforcement activities, which includes Health Canada’s new commitment to offer in-kind resources of up to 5.5 FTEs for each year of the transition period to help support CFIA. This includes responding to enquiries from industry, developing guidance material for stakeholders, developing training material and operational tools for CFIA inspectors, supporting the development of laboratory methods for food safety investigations, and undertaking surveillance activities.

Qualitative Costs

i. Limits the type of information that can be communicated to consumers (e.g., the intended benefit or purpose of the supplemental ingredients)

The restrictions on representations could potentially limit industry’s ability to communicate certain intended benefits of the supplemental ingredient being added to a product. Imposing certain restrictions could negatively impact competitiveness with like-products regulated outside of the supplemented foods framework. As a result of limiting industry’s ability to communicate such information, the regulations may negatively impact the profitability of certain supplemented foods if certain claims are prohibited and restrictions are placed on representations in combination with other new labelling requirements, especially when the consumer is specifically seeking supplementation.

Benefits

The total direct benefit to both industry and Health Canada from the removal of the TMA application process and eliminating annual post-market reporting requirements is estimated to be an $8.8 million annualized or $61.5 million PV over a 10-year time period. The benefits calculated in the CBA will be recognized immediately after the new regulatory framework comes into force.

Cost Savings to Industry

The regulatory framework for supplemented foods is estimated to result in a significant reduction in burden on industry with the removal of requiring industry to submit a TMA application on a case-by-case basis for supplemented foods and the elimination of post-market requirements to submit data to Health Canada. Industry stakeholders will save approximately $6.8 million annualized or $48.1 million PV over a 10-year time period using a 7% discount rate.

Pre-market Cost-Savings

Under the TMA framework, supplemented foods are required to submit a TMA application to Health Canada on a product-by-product basis, with specific conditions set out for each approved product. Based on industry stakeholder feedback, it costs TMA holders an average of $7,961 to submit a TMA application. It is unclear how this cost estimate varies depending on the level of complexity associated with the supplemented food in question, therefore, this cost estimate is assumed to apply to all submission types. Industry submits an average of 242 TMA applications for supplemented foods, with a 70% issuance rate for receiving TMAs. This indicates that industry stakeholders are spending approximately $1,926,539 a year on average attempting to obtain TMAs for their products. This is anticipated to increase each year within the baseline based on Health Canada’s internal database on supplemented foods. For the Canada Gazette, Part I pre-publication, a 6% average annual growth rate for the number of supplemented foods on the market was applied; however, this has since been revised to 10% based on Health Canada’s latest data as of November 2021.

Eliminating the use of TMAs for supplemented foods under the framework, specifically removing the requirement for manufacturers to submit a TMA application for their product, will significantly reduce this burden for new industry stakeholders entering the market or existing stakeholders introducing new products. Industry will only be able to sell their supplemented food if all the conditions set out in the List of Permitted Supplemental Ingredients and List of Permitted Supplemented Food Categories are met. Health Canada has also created a submission process outlined in guidance for, but is not limited to, industry to request a change to either list. Other stakeholders may also seek to request a change to either list if they choose to; however, it is unclear which stakeholders outside of industry, will choose to seek changes. Requesting changes to the lists will involve a similar review process to a review conducted for a new food additive use. It will be the requestor’s responsibility to gather the data and supporting evidence to support a change. Guidance will be provided to industry, and others, outlining data and information requirements. This may lead to additional costs prior to filing the request for a change, however these costs cannot be estimated by Health Canada. Based on industry as part of the Canada Gazette, Part I, consultation, industry confirmed that they will incur additional costs in response to the new submission process seeking to request a change to either list but were not able to monetize the potential costs. It is assumed that the cost of requesting to amend the lists will remain a minimum of $7,961 per submission. It is anticipated that industry will continue to submit 2.6 requests on average for supplemented foods that are considered complex (i.e., new use of a supplemental ingredient or new food category) each year under the supplemented foods framework. The costs to industry to request a change to the lists will be approximately $20,689 a year. Overall, industry is expected to save $1,905,841 annually. However, these potential savings are assumed to be overstated as the pre-market costs associated with gathering evidence to support such a change is expected to be greater than that applied. It is assumed that the number of complex supplemented foods will continue to increase by 10% each year, based on Health Canada’s internal database on supplemented foods. Assuming the number of supplemented foods on the market continues to apply for complex supplemented foods under the new framework, this will result in an average annualized cost savings of $2.9 million or $20.2 million PV over a 10-year period using a 7% discount rate.

Post-Market Cost-Savings

As a condition of the TMA framework, TMA holders of supplemented foods are currently required to submit three post-market data requirements: (i) annual CI reports, (ii) annual sales reporting data, and (iii) additional in-market research as a one-time requirement following TMA approval.

i. Submitting Annual CI Reports

One condition of the TMA framework includes an obligation for some TMA holders (i.e., those with TMAs for supplemented foods that are required to carry cautionary statements) to provide Health Canada with annual CI reports. These reports are related to suspected or established relationships between the consumption of a supplemented food and the occurrence of an adverse health effect. Based on industry stakeholder feedback, TMA holders are spending an average of $22,606 each year per firm compiling information to draft and submit CI reports. For the Canada Gazette, Part I pre-publication, it was estimated that 79 out of 90 firms with supplemented foods that were required to provide Health Canada with annual CI reports as they hold TMAs for supplemented foods that carry cautionary statements. However, based on Health Canada’s latest data as of November 2021, this has since been revised upwards to 82 out of 95 firms currently providing annual CI reports to Health Canada. Therefore, industry stakeholders are spending an average of $1.9 million a year to provide CI reports to Health Canada. This is anticipated to increase each year within the baseline based on Health Canada’s internal database on supplemented foods, which illustrates a 10% average annual growth rate for the number of firms with supplemented foods on the market.

Under the regulatory framework, TMA holders for supplemented foods will no longer be required to submit annual CI reports, resulting in a cost savings to industry. This is estimated to result in an annualized cost savings of $2.8 million or $19.7 million PV over a 10-year period.

ii. Submitting Sales Data Reports

Another condition of TMAs for all supplemented foods includes an obligation to submit an annual sales report to Health Canada. Based on industry stakeholder feedback, TMA holders are spending an average of $5,595 per firm compiling annual sales data, drafting the required report and submitting the information to Health Canada. With 95 firms on the Canadian market with TMAs for supplemented foods, industry is spending approximately $531,564 a year to provide Health Canada with sales data reporting in order to be compliant with the TMA requirements set out by the TMA process. This is anticipated to increase each year within the baseline based on Health Canada’s internal database on supplemented foods, which illustrates a 10% average annual growth rate for the number of firms with supplemented foods on the market.

Under the new regulatory framework, this requirement to provide an annual sales report will no longer apply, resulting in an estimated annualized cost savings to industry stakeholders of $803,567 or $5.6 million PV over a 10-year period.

iii. Submitting In-Market Research

A third reporting condition of TMAs for all supplemented foods includes a one-time obligation for TMA holders to submit in-market research to Health Canada on their supplemented food, which is typically conducted within its first six months on the market. Health Canada works with the firm to refine their initial proposal to address if any additional market research is required.

Based on industry stakeholder feedback, TMA holders are spending $1,400 per TMA to submit the necessary information to Heath Canada; however, more complex files can be significantly higher. Since firms are being issued an average of 169 TMAs a year for supplemented foods to enter the market, industry stakeholders are spending $236,600 a year on average. However, this is anticipated to increase each year within the baseline based on Health Canada’s internal database on supplemented foods. For the Canada Gazette, Part I pre-publication, it was assumed that a 6% average annual growth rate for the number of supplemented foods on the market would apply; however, this has since been revised upward to 10% based on Health Canada’s latest data as of November 2021.

Under the new framework, TMA holders will no longer be required to submit in-market research, resulting in an estimated annualized cost savings to industry stakeholders of $357,669 or $2.5 million PV over a 10-year period.

Cost Savings to the Government of Canada

Implementing the regulatory framework will eliminate the need to review TMA applications for supplemented foods and their associated post-market reporting requirements and will introduce a new submission process for requests to change the List of Permitted Supplemented Food Categories or the List of Permitted Supplemental Ingredients. It is estimated that Health Canada will save an annualized average of approximately $1.9 million or $13.4 million PV over a 10-year time period using a 7% discount rate.

i. Reduction in Pre-Market Review for Supplemented Foods

Since certain supplemented foods were transferred to the food regulatory framework in 2012, Health Canada has received over 2,174 applications for supplemented foods from both domestic and international firms, with an average of 242 applications per year, each requiring some level of review. After conducting a full review on each submission, Health Canada has issued a TMA to an average of 169 products each year, generating a 70% issue rate. However, the total number of supplemented foods on the market is anticipated to increase each year within the baseline. For the Canada Gazette, Part I pre-publication, it was assumed that a 6% average annual growth rate for the number of supplemented foods on the market would apply; however, this has since been revised upward to 10% based on Health Canada’s latest data as of November 2021.

A complete review of a TMA application submitted to Health Canada resulting in the issuance of a TMA requires an average of 60 hours to complete per application. Applying the appropriate rate of pay for the public service employees involved in reviewing each application,^{footnote 12} it is estimated that it cost the Department approximately $3,150 to review and approve each application submitted for supplemented foods that are deemed safe. With an average of 169 applications receiving a TMA annually, this process is estimated to cost Health Canada $532,424 a year.^{footnote 13} Not having to review these applications will be a cost savings to Health Canada under the supplemented foods framework.

For the remaining 73 TMA applications (average) that Health Canada reviews each year but does not issue a TMA, these applications still involve some level of effort by the Department. Reasons for applicants not receiving a TMA include providing insufficient data, the product not being deemed safe, or the application was withdrawn. Of the 73 TMA applications that do not receive approval, approximately 70.4 are considered less complex typically involving less review time and 2.6 that are considered more complex involving more resources. Less complex applications that do not receive approval take an average of 53 hours in comparison to the average of 60 for a successful application. Applying the appropriate rate of pay for the public service employees that process these applications,^{footnote 12} it is estimated that it costs Health Canada approximately $2,747 to review one of these applications despite not issuing a TMA. For an average of 70.4 applications not receiving a TMA each year, this process is estimated to cost Health Canada approximately $193,399 a year.^{footnote 14} Not having to review these applications will be a cost savings to Health Canada under the supplemented foods framework.

Of the 73 non-authorized TMA applications received by Health Canada annually, 2.6 represent more complex products that include innovative uses of supplemental ingredients or new food categories. These applications have been put on hold or denied because Health Canada required additional safety evidence to approve them. These applications take an average of 960 hours of review based on six months of full-time work and have not resulted in the issuance of a TMA. The approximate resources are considered an underestimate, as other bureaus and evaluators are likely consulted in addition to the standard review process. Applying the appropriate rate of pay for public service employees involved with reviewing each application,^{footnote 12} it is estimated that it costs Health Canada approximately $58,305 to review each application for a more complex product. With an average of 2.6 applications being submitted for complex supplemented foods not receiving a TMA each year, this process is estimated to cost Health Canada approximately $151,592 a year.^{footnote 15} Therefore, the estimated total cost for Health Canada to review all 242 applications received within a given year, is $877,415.

Under the supplemented foods framework, Health Canada will no longer be required to receive and review TMA applications for supplemented foods. However, Health Canada will allow industry, as well as other stakeholders, to submit a request to change the List of Permitted Supplemented Food Categories or the List of Permitted Supplemental Ingredients. These requests will need to be accompanied by supporting evidence to demonstrate that the change would be safe for Canadians and that the change is warranted. This will provide a path to market for products involving innovative uses of ingredients or food categories for supplementation that will otherwise not be permitted under the supplemented foods framework. These new submissions are expected to be similar in nature to the 2.6 complex applications Health Canada currently receives annually under the TMA framework. Assessing these requests will require approximately 170 hours of review time at a cost of $14,000 per submission. If the request is endorsed, the list(s) would then follow an administrative process using a Notice of Proposal to allow for comments before they could be officially amended through a Notice of Modification; however, this will not be considered incremental as it is an already established process used by Health Canada. Assuming Health Canada continues to receive 2.6 complex applications each year, the total cost to the Department would be $36,400 a year, resulting in a reduced cost savings of $841,015.

In sum, with Health Canada no longer required to review TMA applications and with the introduction of a new process outlined in guidance to amend either the List of Permitted Supplemented Food Categories or the List of Permitted Supplemental Ingredients, the supplemented foods framework will result in a total direct cost savings to Health Canada. It is unclear whether the framework will result in a higher or lower growth rate for the number of complex supplemented foods seeking to request a change to the lists; therefore, it is assumed that an average annual growth rate of 10% will continue to apply under the new framework, resulting in an expected annualized cost savings of $1.3 million or $8.9 million PV over a 10-year period.

ii. Reduction in Post-Market Review of Industry Data

As part of the TMA requirements for supplemented foods, TMA holders are required to submit post-market data and information to Health Canada for review, including a one-time review of market research, annual sales data, and annual CI reports for some products.

Internal data indicates that Health Canada spends 137 hours annually to review all CI reporting information collected for certain supplemented foods on the market. By applying the appropriate rate of pay for public service employees involved by their time requirement, reviewing these reports costs approximately $5,900 a year on average. Annual CI reports are collected and reviewed on a per-firm bases; therefore, it is assumed that the cost to review all CI reports submitted by industry will increase within the baseline since the number of firms with supplemented foods on the market is expected to grow by 10% each year. Health Canada also reviews the submission of sales data provided by industry annually. The Department spends approximately 56 hours annually to review all annual sales data for supplemented foods on the market, costing approximately $2,016 based on the appropriate rate of pay for public service employees involved by their time requirement. Annual sales data for supplemented foods is also collected and reviewed on a per-firm basis; therefore, it is assumed that the cost to review this information will increase within the baseline as the number of firms with supplemented foods on the market is expected to grow by 10% each year.

In addition, Health Canada reviews the one-time submission of market research, which is typically conducted within the first year of being on the market. Based on internal data, reviewing and analyzing the one-time submission of market research for supplemented foods is estimated to take 40 hours per new TMA. Health Canada spends approximately $2,452 per supplemented food based the appropriate rate of pay for public service employees. Since there are approximately 169 supplemented foods receiving a TMA each year, completing this step alone is estimated to cost Health Canada approximately $414,303.^{footnote 16} For the Canada Gazette, Part I pre-publication, it was demonstrated that a 6% average annual growth rate for the number of supplemented foods on the market would apply; however, this has since been revised upward to 10% based on Health Canada’s latest data as of November 2021. The costs to review the one-time submission of market research is anticipated to increase annually within the baseline.

Under the supplemented foods regulatory framework, Health Canada will no longer review post-market data from industry, resulting in an expected annualized cost savings of $638,270 or $4.5 million PV over a 10-year period using a 7% discount rate.

Overall, when accounting for all monetized costs and benefits, an annualized net benefit of $4.8 million or $33.6 million PV is anticipated over the next 10 years applying a 7% discount rate.

Qualitative Benefits

i. Reduces the potential risk associated with overconsumption by the general population and consumption by vulnerable groups within it (e.g., children, pregnant women)

With the SFCI located on the front of the package, as well as the SFFt and cautionary statements displayed elsewhere on the label, consumers will be able to inform themselves more easily of the supplemental ingredients added to a supplemented food. This will in turn help in reducing potential risks related to the overconsumption of these products as certain supplemental ingredients, such as caffeine, can have different effects on different segments of the population. For example, consuming amounts above 300 mg of caffeine per day may adversely affect pregnant and breastfeeding women.

ii. Improves consumer ability to access information, distinguish supplemented foods from conventional foods, and identify products of higher risk thereby allowing consumers to make more informed choices

With the new labelling requirements, consumers can make more informed decisions, due to the inclusion of cautionary statements and the SFCI in connection to any risks with certain supplemental ingredients, and the SFFt detailing the certain supplemental ingredients being added. Consumers can access information about whether the product is a risk if overconsumed and the amount of the supplemental ingredient they are consuming.

iii. Facilitates innovation, thus enabling industry to take advantage of new evidence related to supplemented foods and supplemental ingredients

With the new framework, industry as well as other stakeholders will have the flexibility in creating new products that will fit set compositional requirements and allow for the experimentation of different combinations of new food categories and supplemental ingredients. Industry will be provided with the opportunity to request a change related to either the category, supplemental ingredient, and/or any of the conditions of use of the supplemental ingredients, if sufficient health and safety data is provided.

Cost-Benefit Statement

• Number of years: 10 years (2022-2031)
• Base year for costing: 2020
• Present value base year: 2022
• Discount rate: 7%

Monetized costs^{footnote 18}

Impacted stakeholder	Description of cost	Base year (Year 1)	Other relevant years (Year 3)	Final year (Year 10)	Total (present value)	Annualized valuefootnote 17
Industry	Labelling Costs	$0	$19,578,000	$0	$15,981,480	$2,275,403
	Reformulation Costs	$0	$4,200,500	$0	$3,428,451	$488,134
Government	Compliance and Enforcement Costs	$801,582	$1,581,394	$1,032,261	$8,472,229	$1,206,255
All stakeholders	Total costs	$801,582	$25,359,394	$1,032,261	$27,882,160	$3,969,792

Monetized benefits

Impacted stakeholder	Description of benefit	Base year (Year 1)	Other relevant years (Year 3)	Final year (Year 10)	Total (present value)	Annualized value
Industry	Cost Savings – Removing TMA application requirements	$1,905,841	$2,306,067	$4,493,873	$20,235,399	$2,881,066
	Cost Savings – Removing post-market requirements	$2,621,856	$3,172,445	$6,182,199	$27,837,741	$3,963,468
Government	Cost Savings – Removing TMA application review requirements	$841,015	$1,017,628	$1,983,069	$8,929,534	$1,271,365
	Cost Savings – Removing post-market review requirements	$422,219	$510,885	$995,570	$4,482,939	$638,270
All stakeholders	Total benefits	$5,790,930	$7,007,025	$13,654,720	$61,485,613	$8,754,168

Summary of monetized costs and benefits

Impacts	Base year (2022)	Other relevant years (Year 1)	Final year (Year 3)	Total (Year 10)	Annualized value
Total costs	$801,582	$25,359,394	$1,032,261	$27,882,160	$3,969,792
Total benefits	$5,790,930	$7,007,025	$13,654,720	$61,485,613	$8,754,168
NET IMPACT	$4,989,348	-$18,352,369	$12,622,449	$33,603,453	$4,784,376

Quantified (non-$) and qualitative impacts

Positive impacts:

• Reduces the potential risk of overconsumption by the general population, and consumption by vulnerable groups within it (e.g., children, pregnant women);
• Improves consumer access to information, distinguishes supplemented foods from conventional foods, identifying products of higher risk and making more informed choices;
• Significantly reduces administrative burden for new entrants as well as existing stakeholders who wish to bring new products to market; and
• Facilitates innovation, thus enabling industry to adapt to new evidence related to supplemented foods and supplemental ingredients.

Negative impacts:

• Limits the type of information that can be communicated to consumers (e.g., the intended benefit or purpose of the supplemental ingredients).

Small business lens

The Policy on Limiting Regulatory Burden on Business defines a small business as any business, including its affiliates that has fewer than 100 employees or less than $5 million in annual gross revenues. For the Canada Gazette, Part I pre-publication, it was estimated that approximately 67 of all businesses in Canada with supplemented foods met the definition of small businesses and could be affected by the new regulatory framework. However, based on updated data collected through Health Canada’s internal database, this has been revised upward to 70 small businesses out of a total of 95. This includes one that manufactures products in the bars or confectioneries category, 39 that manufacture in the CEDs category and 32 that manufacture in the beverages category.^{footnote 19} Supplemented foods sold by small businesses in Canada represent approximately 36% of all supplemented foods on the market, totaling 271 products.

Industry, including small businesses, will be given the flexibility to request a change related to either the category, supplemental ingredient, and/or any of the conditions of use of the supplemental ingredients, if sufficient health and safety data is provided. Providing small businesses with the flexibility to adapt to new evidence related to supplemented foods and supplemental ingredients will support innovation in the food industry. Responses provided by small businesses through the survey supporting the CBA indicated that the costs with complying with the current TMA requirements can be disproportionately higher for small businesses with a much larger variation in costs to conduct pre-market activities in particular.

In removing the burden of seeking a TMA for supplemented foods and providing a more efficient process for requesting a change to the lists, small businesses are assumed to benefit significantly from the new framework. In addition to the removal of seeking approvals for a TMA, small businesses will also benefit from the removal of post-market requirements of holding TMAs for supplemented foods as these on-going costs likely represent a higher percentage of their revenue streams. It is estimated that small businesses will save an annualized average of approximately $3.8 million or $26.9 million PV over a 10-year period, which represents a significant percentage of the market. These cost savings to industry are outlined in further detail below under the one-for-one rule.

This regulatory framework is expected to have a disproportional impact on small businesses when it comes to updating labels and reformulating their supplemented foods. Small businesses currently manufacture approximately 36% of total SKUs or 271 of the supplemented foods on the market. Since all existing supplemented foods will require a label change, all 271 products manufactured by small businesses will incur these one-time labelling costs. However, the requirement to reformulate affects a percentage of existing supplemented foods.

At the time of Canada Gazette, Part I, the assumption that 6.5% of all products on the market would require reformulation was also applied to the number of products manufactured by small businesses. Industry feedback suggested that further analysis be done to confirm how many products requiring reformulation were attributed to small businesses. Health Canada has carefully assessed the information available through the Department’s own database on supplemented foods and product formulations; it is now estimated that 26 out of the 48 supplemented foods expected to reformulate are manufactured by small businesses. Health Canada considered the concerns of small businesses and concluded that a transition period of approximately three years will help alleviate some of the burden for both large and small/medium size enterprises.

Small business lens summary

• Number of small businesses impacted: 70
• Number of years: 10 (2022-2031)
• Base year for costing: 2020
• Present value base year: 2022
• Discount rate: 7%

Compliance costs

Activity	Annualized valuefootnote 20	Present value
Updating Labels	$818,903	$5,751,635
Reformulating Products (new max levels)	$264,406	$1,857,078
Total compliance cost	$1,083,309	$7,608,713

Cost savings

Activity	Annualized value	Present value
Cost Savings – Removing TMA application requirements	$1,037,184	$7,284,744
Cost Savings – Removing post-market requirements	$2,797,052	$19,645,324
Total cost savings	$3,834,236	$26,930,067

Total compliance costs and administrative cost savings

Totals	Annualized value	Present value
Total cost (all impacted small businesses)	$1,083,309	$7,608,713
Cost per impacted small businessfootnote 21	$15,476	$108,696
Total savings (all impacted small businesses)footnote 22	$3,834,236	$26,930,067
Savings per impacted small business	$54,775	$384,715
Net impact per impacted small business	$39,299	$276,019

One-for-one rule

The one-for-one rule applies since there is an incremental decrease in administrative burden on businesses, and the proposal is considered a burden out under the rule. The supplemented foods framework is expected to significantly decrease administrative burden on industry as it introduces a more efficient risk-based approach. Manufacturers of certain supplemented foods will no longer be required to submit annual consumption incident reports, annual sales data as well as conduct and submit any research (e.g., market studies, consumer research, etc.) on their products post-market as a one-time administrative cost. Removing these requirements under the new framework will result in a reduction in administrative burden for businesses once the regulations come into force, after which there will not be any ongoing administrative costs.

One-for-one rule using The Regulatory Costing Calculator

	One-for-One Rule Results
Annualized administrative cost savings (constant $2012)	$1,924,365
Annualized administrative cost savings Per Business ($2012)	$10,128

Constant 2012 dollars, Present Value Base Year 2012; discounted using a 7% discount rate.

These cost savings are estimated based on responses provided by some industry stakeholders through the CBA survey for the removal of the following post-market elements required to be submitted by industry.^{footnote 23}

i. Annual CI Reporting

Industry is spending an average of $22,606 ($19,725 in 2012 CAD) annually per firm to compile and submit their CI reports. Out of the 95 firms with supplemented foods in Canada, 82 of those firms are required to provide these reports for supplemented foods that carry cautionary statements costing industry a total of $1.9 million annually. With the new framework, these firms will no longer be required to submit CI reports for their supplemented foods, resulting in a cost savings. This is anticipated to increase each year based on Health Canada’s internal database on supplemented foods, which illustrates a 10% average annual growth rate for the number of firms with supplemented foods on the market.

ii. Annual Sales Data

Industry is also spending an average of $5,595 ($4,882 in 2012 CAD) per firm compiling annual sales data to submit to Health Canada for review. With 95 firms with supplemented foods on the Canadian market, industry is spending approximately $531,564 a year to provide Health Canada with sales reporting data in order to be compliant. With the new framework in place, these firms will no longer be required to submit annual sales data for their supplemented foods, resulting in a cost savings. This is anticipated to increase each year based on Health Canada’s internal database on supplemented foods, which illustrates a 10% average annual growth rate for the number of firms with supplemented foods on the market.

iii. One-time Market Research

In addition, industry is currently required to submit in-market research to Health Canada on their supplemented food, typically within the first six months on the market. TMA holders are spending $1,400 ($1,222 in 2012 CAD) per TMA to submit the necessary information to Health Canada. Since 169 TMAs are issued on average each year, industry is currently spending $236,600 a year. With the new framework in place, industry will no longer be required to submit in-market research, which will indicate a cost savings. This is anticipated to increase each year based on 10% average annual growth rate for the number of supplemented foods on the market based on Health Canada’s latest data as of November 2021 and is anticipated to increase each year.

Regulatory cooperation and alignment

In developing a new regulatory framework, Canada considered models from various international regulatory authorities including those in Australia and New Zealand, the European Union, Japan, and the United States. Based on this analysis, it was determined that there is no global standard for the regulation of supplemented foods.

With regard to Canada’s key trading partners, Europe and the United States consider the addition of substances to food more broadly and do not have separate requirements for supplemented foods. In Europe, there is some oversight in terms of the specific vitamins, minerals and amino acids that are approved to be added to foods. However, the use of these ingredients is mostly discretionary where the majority of countries have not set maximum levels. Canada is seeking to permit the discretionary use of supplemental ingredients within specific levels and conditions based on what evidence has shown to be safe.

In the United States, substances added to a food which have been established as safe are categorized as generally recognized as safe (GRAS) substances. Within the category of GRAS substances, a specific framework for supplemental ingredients does not exist. Due to the added risk associated with products containing supplemental ingredients, Canada does not intend to regulate supplemental ingredients using GRAS principles. Instead, it intends to differentiate supplemental ingredients from other substances that may be safely added to foods by providing specific requirements and conditions for the use of the former including maximum levels and cautionary statements.

New Zealand is the only country that was identified as having a specific regulatory framework for supplemented foods. Labels on these products must carry the words “supplemented food”. Cautionary statements are also required under identified conditions including when there is a risk of overconsumption, in the presence of certain ingredients, or when caffeine amounts are above a certain level. As New Zealand categorizes supplemented foods separately and establishes specific requirements for these products, it was found to have the most similar approach to Canada and was considered for the new framework.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus (GBA+)

Gender, age and socio-economic factors were taken into account during the development of these amendments to the FDR.

Women

Compared to the general population, pregnant and breastfeeding women are more vulnerable to health risks related to excessive nutrient intake. Many herbal ingredients have also never been assessed or do not have data available to support their safety as food ingredients in foods targeted to pregnant or breastfeeding women. To help mitigate these additional risks for pregnant or breastfeeding women, Health Canada will not be permitting foods intended solely for these groups to be supplemented foods.

As pregnant or breastfeeding women may be particularly vulnerable to supplementation with amino acids,^{footnote 24} cautionary labelling will be required to indicate that supplemented foods containing amino acids are not recommended for pregnant or breastfeeding women.

Caffeine consumption may present additional risks to pregnant or breastfeeding women, as well as women trying to get pregnant. Research has shown that overconsumption of caffeine may increase the risk of miscarriage and may interfere with fetal growth.^{footnote 25,footnote 26,footnote 27} As a specific mitigation to these risks, Health Canada will require a cautionary statement directed at pregnant or breastfeeding women to be included on supplemented foods that contain high caffeine levels.

Children and youth

Young children are more vulnerable to risks related to nutrient imbalances compared to older children and adults. For this reason, Health Canada will not be permitting foods intended solely for infants or children under the age of four to be supplemented foods.

Recognizing that children are more at risk of adverse outcomes from consumption of supplemented foods compared to adults, two different sets of maximum levels have been prescribed for vitamins and minerals—one for the population four years and older, and one for the population 14 years and older. If using supplemental ingredients up to the maximum levels considered safe for the population 14 years of age and older, risk mitigation measures will require the product to carry cautionary statements. In contrast, if using the maximum levels considered safe for the population four years and older, which have been set more conservatively, age specific cautionary statements may not be required.

When a supplemented food contains ingredients that may pose a risk to health, it will be required to carry cautionary statements regarding the maximum amount that should be consumed (e.g., “Do not consume more than X servings”). As children under 14 will not be expected to interpret this type of caution effectively, products containing higher-risk ingredients will be required to indicate instead that they are not recommended for those under 14 years old. For supplemented foods that carry this cautionary statement, claims referring to the benefit of a nutrient they contain on growth and development will be prohibited.

Research has indicated that male children and young adults (12-30 years) represent the largest proportion of CED users.^{footnote 28,footnote 29} It has also been noted that CEDs may affect children and adolescents more than adults because they weigh less and thus experience greater exposure to stimulant ingredients such as caffeine per kilogram of body weight.^{footnote 30}

Health Canada will require that high caffeine containing supplemented foods and all CEDs carry cautionary statements indicating that these products are not recommended for those under 14 years of age. In addition, all caffeine containing supplemented foods will be required to include a statement indicating that the product contains caffeine. This will help adolescents 14 years of age and over to understand and manage their caffeine consumption within the recommended limits.

Individuals with low literacy

Canadians with lower health literacy levels may be disadvantaged in their ability to identify and distinguish supplemented foods from conventional foods, identify the type and amount of supplemental ingredients a product contains, and most importantly, identify any cautions associated with the use of a particular product.

To support the development of these regulatory amendments, Health Canada implemented a consumer research protocol to test the efficacy of the proposed labelling requirements for supplemented foods and assess their usefulness for all Canadians, including those with limited health literacy.

Health Canada subsequently developed the risk-based approach for labelling of supplemented foods as set out in these amendments to help ensure that Canadians at varying literacy levels will have access to the labelling tools that they will need to safely and appropriately use these products.

Implementation, compliance and enforcement, and service standards

Implementation

The regulations will come into force on the day following publication in the Canada Gazette, Part II.

Under certain conditions, existing supplemented foods on the market with a TMA, will have until January 1, 2026, to become compliant with the new framework. The transition period may also apply to products for which a TMA application is submitted prior to the coming into force of the regulations and that are subsequently authorized for sale by Health Canada.

Information on the implementation of this regulatory proposal will be posted on the Government of Canada website. In addition, Health Canada will carry out education and awareness campaigns to help consumers identify supplemented foods and understand their labels.

Compliance and enforcement

CFIA is responsible for the enforcement of the provisions of the Food and Drugs Act and the FDR as they relate to food. Supplemented foods will be subject to CFIA’s existing risk-based and complaint-based compliance and enforcement activities. This will include undertaking investigations, recalls, and other compliance activities as required. If needed, CFIA will also use proactive measures including planned preventive control inspections, targeted surveys, and third-party contract testing services.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite P2108
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address Locator: 3000A
Email:  lrm.consultations-mlr@hc-sc.gc.ca