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
- Food industry
- Other interested stakeholders
In this document
- Part I: Threshold levels for cautionary statements for vitamins, mineral nutrients, amino acids and certain other ingredients other than caffeine
- Part II: Threshold levels for cautionary statements and other conditions of use for caffeine
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 |
|
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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. |
|
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 |
|
Protein-isolate- and cereal-based bars |
> 56 mg |
not required |
not required |
70 mg |
|
Chocolate confectioneries, sweet chocolate confectioneries, and milk chocolate confectioneries |
> 56 mg |
not required |
> 79 mg |
100 mg |
|
Chewing gum |
> 56 mgFootnote 5 |
not required |
not required |
50 mg |
|
|
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Related information
- About supplemented foods and their labels
- Supplemented foods: Regulations and compliance
- Guidance document for Supplemented foods regulations
- Information on the use of certain ingredients in foods including supplemented foods
Related acts and regulations
Page details
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