Threshold levels for cautionary statements and other conditions of use

Overview

The specifications related to the Threshold levels for cautionary statements and other conditions of use are incorporated by reference in the Food and Drug Regulations.

This document outlines certain conditions for some of the products eligible for a transition period under the supplemented foods regulatory framework. Products that applied for a temporary marketing authorization letter (TMAL) before the coming into force of the regulations and subsequently received a Health Canada notification authorizing the sale of the food are required to adhere to the conditions of use in the document during the transition period.

The document outlines cautionary statements that are required on the label of the supplemented food for each supplemental ingredient and the threshold level above which these statements are required. Other conditions of use related to supplemental ingredients, such as restrictions on the forms of the permitted supplemental ingredient and/or additional requirements related to labelling or representations, are also specified in this document.

Additional information regarding the requirements for the cautionary statements and other conditions of use is provided in the Guidance document for Supplemented foods regulations.

Who this document is for

In this document

Part I: Threshold levels for cautionary statements for vitamins, mineral nutrients, amino acids and certain other ingredients other than caffeine

Substance and unit Supplemented Foods, Excluding Caffeinated Energy Drinks Caffeinated Energy Drinks
Cautionary Statement Maximum Daily Level Cautionary Statement Maximum Daily Level
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6 Column 7 Column 8 Column 9
Not intended for children or For adults onlyFootnote 1 If you take a daily supplement, you may be getting too much vitamins or minerals by consuming this product Do not exceed X servings, per dayFootnote 2 Footnote 3
AND
Do not consume this product with other supplemented foods
Do not exceed X servings, per dayFootnote 2 Footnote 3 If you are pregnant or breastfeeding consult a Health Care Practitioner prior to useFootnote 1   Do not exceed X servings, per dayFootnote 2 Footnote 3  
Threshold level per serving of stated size at which the cautionary statement is required Threshold level per serving of stated size at which the cautionary statement is required
Vitamins
Beta-carotene (µg) > 1400 not required > 700 not applicable not required 3500 not applicable not permitted
Biotin (µg) > 43 > 43 > 43 not applicable not required 219 > 29 143
Choline (mg) >0 not required > 196 not applicable not required 980 > 89 443
Niacinamide (mg) > 48 not required > 67 not applicable not required 338 > 25 126
Pantothenic acid (mg) > 48 > 48 > 48 not applicable not required 244 > 20 100
Riboflavin (mg) > 9 > 9 > 9 not applicable not required 48 > 5 27
Thiamine (mg) > 9 > 9 > 9 not applicable not required 48 > 1 5
Vitamin A (µg retinol) >0 not required > 122 not applicable not required 612 not applicable not permitted
Vitamin B6 (mg) > 7 not required > 8 not applicable not required 38 > 3 14
Vitamin B12 (µg) > 99 > 99 > 99 not applicable not required 495 > 5 25
Vitamin C (mg) > 66 not required > 147 not applicable not required 735 > 55 276
Vitamin D (µg) >5 not required > 5 not applicable not required 25 > 3 15
Vitamin E (mg) not required >26 > 6 not applicable not required 30 > 28 141
Mineral Nutrients
Calcium (mg) > 163 >0 > 50 not applicable not required 251 > 45 225
Chromium (III) (µg) > 50 not required > 25 not applicable not required 125 > 2 12
Copper (µg) > 342 not required > 568 not applicable not required 2840 > 247 1233
Magnesium (mg) > 21 not required > 35 not applicable not required 175 > 5 25
Manganese (µg) >0 >0 > 368 not applicable not required 1840 not applicable not permitted
Molybdenum (µg) > 72 not required > 146 not applicable not required 730 > 68 340
Phosphorus (mg) > 229 not required > 105 not applicable not required 524 > 73 364
Potassium (mg) >300 not required > 150 not applicable not required 750 > 70 350
Selenium (µg) > 6 not required > 17 not applicable not required 85 > 7 34
Zinc (mg) >0 >0 > 1 not applicable not required 5 > 1 3
Amino Acids
L-Histidine (mg) >5 not required not applicable >44 >5 220 >44 220
L-Isoleucine (mg) >7 not required not applicable >213 >7 1065 >213 1065
L-Leucine (mg) >15 not required not applicable >364 >15 1824 >364 1824
L-Valine (mg) >8 not required not applicable >238 >8 1194 >238 1194
L-Methionine (mg) >7 not required not applicable >200 >7 1000 >200 1000
L-Cysteine (includes L-Cystine) (mg) >0 not required not applicable >200 >0 1000 >200 1000
L-Phenylalanine (mg) >12 not required not applicable >67 >12 339 >67 339
L-Tyrosine (mg) >0 not required not applicable >720 >0 3600 >720 3600
L-Lysine (mg) >13 not required not applicable >200 >13 1000 >200 1000
L-Threonine >7 not required not applicable >60 >7 301 >60 301
L-Alanine (mg) >0 not required not applicable >72 >0 363 >72 363
L-Arginine (mg) >0 not required not applicable >83 >0 419 >83 419
L-Aspartic Acid (mg) >0 not required not applicable >200 >0 1000 >200 1000
L-Glutamic Acid (mg) >0 not required not applicable >300 >0 1500 >300 1500
L-Glutamine (mg) >0 not required not applicable >1000 >0 5000 >1000 5000
Glycine (mg) >0 not required not applicable >360 >0 1800 >360 1800
L-Proline (mg) >0 not required not applicable >103 >0 519 >103 519
L-Serine (mg) >0 not required not applicable >70 >0 351 >70 351
Other
Taurine (mg) >0 not required not applicable >600 >0 3000 >600 3000
Footnote 1

If a food carries this cautionary statement, there are no marks, statements, labels or advertisements, including product sampling, that promote the product for consumption by children or pregnant or breastfeeding women, as the case may be.

Return to footnote 1 referrer

Footnote 2

An appropriate number of servings can be up to the highest number of servings that would not exceed the maximum daily level for any substance. For example, a product containing 300 µg vitamin A (retinol) can state: "Do not exceed 2 servings per day" (i.e., 612 µg ÷ 300 µg = 2 servings).

Return to footnote 2 referrer

Footnote 3

Where this cautionary statement is required by more than one ingredient contained in the supplemented food, the number of servings "X" must not be more than the most restrictive number. For example, for a product containing ingredient A requiring a maximum of two servings per day, and ingredient B requiring a maximum of three servings per day, the label can state: "Do not exceed 2 servings per day".

Return to footnote 3 referrer

Part II: Threshold levels for cautionary statements and other conditions of use for caffeine

Food Cautionary Statement Maximum level of caffeine per serving of stated sizeFootnote 1 Footnote 2 Other conditions of use
Column 1 Column 2 Column 3 Column 4 Column 5 Column 6
Not recommended for children, pregnant or breastfeeding women and individuals sensitive to caffeineFootnote 3 Do not mix with alcohol Do not exceed X servings, per dayFootnote 4
Threshold level per serving of stated size at which the cautionary statement is required

Non-alcoholic non-carbonated water-based beverages, including mixes, which as consumed contain up to 200 parts per million (p.p.m.) of caffeine,

OR,

Non-alcoholic carbonated water-based flavoured and sweetened beverages other than cola type beverages, and their mixes, which as consumed contain greater than 150 p.p.m and up to 200 p.p.m. of caffeine.

not required

not required

not required

200 p.p.m.

  1. (i) Products require:
    1. (a) the statement "contains caffeine", or equivalent, on the principal display panel of the label; and
    2. (b) a quantitative declaration of caffeine content, expressed in milligrams (mg) per serving of stated size, on the label.
  2. (ii) Products must not:
    1. (a) contain, singly or in combination, 25% or more juice, purée, pulp or nectar, as consumed;
    2. (b) include the word "juice", "purée", "pulp" or "nectar" on the label other than as required in the list of ingredients;
    3. (c) be represented as flavoured water or flavoured sweetened water;
    4. (d) be represented for physical performance, hydration or electrolyte replacement;
    5. (e) contain, singly or in combination, 50% or more dairy-based, soy-based, rice-based, almond-based and similar plant-based ingredients; and
    6. (f) be marketed towards children.

Caffeinated energy drinks, including mixes, which as consumed contain greater than 200 parts per million (p.p.m.) of caffeine

> 200 p.p.m.

> 200 p.p.m.

>79 mg

The lesser of 400 p.p.m. or 180 mg

  1. (i) Products require:
    1. (a) the stand-alone statement "caffeinated energy drink" or "energy drink" on the principal display panel of the label;
    2. (b) the statement "high caffeine content" or equivalent on the label; and
    3. (c) a quantitative declaration of caffeine content, expressed in milligrams (mg) per serving of stated size, on the label.
  2. (ii) Products must not:
    1. (a) contain, singly or in combination, 25% or more fruit and/or vegetable juice, purée, pulp or nectar, as consumed;
    2. (b) include the word "juice", "purée" "pulp" or "nectar" on the label other than as required in the list of ingredients;
    3. (c) be represented as flavoured water or flavoured sweetened water;
    4. (d) include any claims relating to physical performance (implied or explicit) or health benefit claims (general or specific);
    5. (e) be represented for hydration and/or electrolyte replacement before, during or after physical activity;
    6. (e) contain, singly or in combination, 50% or more dairy-based, soy-based, rice-based, almond-based and similar plant-based ingredients;
    7. (f) be marketed towards children; or
    8. (g) contain alcohol.

Protein-isolate- and cereal-based bars

> 56 mg

not required

not required

70 mg

  1. (i) Products containing up to 56 mg of caffeine per serving require the statement "contains caffeine" on the principal display panel of the label.
  2. (ii) Products containing more than 56 mg of caffeine per serving require the statement "high caffeine content" on the principal display panel of the label.
  3. (iii) Products containing more than 56 mg of caffeine per serving must not include any claims relating to physical performance (implied or explicit) or health benefits (general or specific).
  4. (iv) Products require a quantitative declaration of caffeine content, expressed in milligrams (mg) per serving of stated size, on the label, adjacent to the list of ingredients.
  5. (v) Servings or portions thereof shall be individually wrapped or sealed.

Chocolate confectioneries, sweet chocolate confectioneries, and milk chocolate confectioneries

> 56 mg

not required

> 79 mg

100 mg

  1. (i) Products containing up to 56 mg of caffeine per serving require the statement "contains caffeine" on the principal display panel of the label.
  2. (ii) Products containing more than 56 mg of caffeine per serving require the statement "high caffeine content" on the principal display panel of the label.
  3. (iii) Products containing more than 56 mg of caffeine per serving must not include any claims relating to physical performance (implied or explicit) or health benefits (general or specific).
  4. (iv) Products require a quantitative declaration of caffeine content, expressed in milligrams (mg) per serving of stated size, on the label, adjacent to the list of ingredients.
  5. (v) Servings or portions thereof shall be individually wrapped or sealed.
  6. (vi) The package must not contain more than 400 mg of caffeine.

Chewing gum

> 56 mgFootnote 5

not required

not required

50 mg

  1. (i) Products require the statement "contains caffeine" on the principal display panel of the label.
  2. (ii) Products require a quantitative declaration of caffeine content, expressed in milligrams (mg) per serving of stated size, on the label, adjacent to the list of ingredients.
  3. (iii) Servings or portions thereof shall be individually wrapped or sealed.
  4. (iv) The package must not contain more than 400 mg of caffeine.
Footnote 1

The maximum daily level of caffeine is 400 mg.

Return to footnote 1 referrer

Footnote 2

An appropriate number of servings "X" can be up to the highest number of servings that would not exceed the maximum daily level for any substance. For example, a product containing 100 mg of caffeine can state: "Do not exceed 4 servings per day" (i.e., 400 mg ÷ 100 mg = 4).

Return to footnote 2 referrer

Footnote 3

If a food carries this cautionary statement, there are no marks, statements, labels or advertisements, including product sampling, that promote the product for consumption by children or pregnant or breastfeeding women.

Return to footnote 3 referrer

Footnote 4

Where this cautionary statement is required by more than one ingredient contained in the supplemented food, the number of servings "X" must not be more than the most restrictive number. For example, for a product containing ingredient A requiring a maximum of two servings per day, and ingredient B requiring a maximum of three servings per day, the label can state: "Do not exceed 2 servings per day".

Return to footnote 4 referrer

Footnote 5

For chewing gum, the cautionary statement must be used when the sum of the caffeine content of all pieces of chewing gum in the package is more than 56 mg.

Return to footnote 5 referrer

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