Interim policy statement on rounding rules
Rounding rules: Item 18 of the table to B.29.002 of the Food and Drug Regulations related to manner of expression of certain supplemental ingredients
Introduction
Health Canada is responsible for establishing standards and regulations regarding the safety and nutritional quality of food sold in Canada, including supplemented foods. Supplemented foods are subject to the Food and Drugs Act and the Food and Drug Regulations (FDR), as well as the Safe Food for Canadians Act and the Safe Food for Canadians Regulations. The current rounding rules for certain supplemental ingredients declared in the Supplemented Food Facts table have the potential to result in inconsistent label declarations for nutrients that can be declared in the Nutrition Facts table compared to when the same nutrient is added as a supplemental ingredient.
Background
Division 29 in Part B of the FDR sets out specific requirements for supplemented foods. These provisions and the four documents that are incorporated by reference into the FDR establish the regulatory framework for the sale of these products in Canada, including their specific compositional and labelling requirements.
Following the coming into force of the supplemented foods regulations in July 2022, stakeholders have noted that there are several nutrients that can be declared to a greater specificity in the Nutrition Facts table compared to when the same nutrient is added as a supplemental ingredient in the Supplemented Foods Facts table. Stakeholders have requested that accommodations be made for these nutrients, citing the potential for label declarations that are inaccurate and that may mislead consumers.
There are 14 permitted supplemental ingredients, found in Appendix A that have rounding rules which are more specific in the Nutrition Facts table. This could result in declarations in the Supplemented Food Facts table that are significantly different than declarations in the Nutrition Facts table, when a similar amount of a nutrient is present in a food.
For example:
Thiamine: DV = 1.2 mg
- Amount present in food = 0.52 mg (43% DV)
- Declared amount using Nutrition Facts table rounding rules = 0.50 mg (42% DV) mg amount rounded to the nearest 0.05 mg
- Declared amount using supplemental ingredient rounding rules = 1 mg (83% DV) mg amount rounded to the nearest whole number
Thiamine: DV = 1.2 mg
- Amount present in food = 0.48 mg (40% DV)
- Declared amount using Nutrition Facts table rounding rules = 0.50 mg (42% DV) mg amount rounded to the nearest 0.05 mg
- Declared amount using supplemental ingredient rounding rules = 0 mg (0% DV) mg amount rounded to the nearest whole number
Interim policy statement
Health Canada recognizes that the declarations of certain supplemental ingredients in the Supplemented Food Facts table has the potential to result in inconsistent label declarations between supplemented foods and foods that do not contain supplemental ingredients when rounding significantly impacts the percentage of the daily value (DV) that must be declared.
This is of concern at lower values (i.e., those under 100% DV) for consumers who are using the %DV to help determine if they are meeting their daily requirements for a certain nutrient. In addition, different declarations in the Supplemented Foods Facts table and the Nutrition Facts table when the same amount of a nutrient is present does not allow for an accurate comparison between a supplemented food and conventional food.
In light of this situation, Health Canada has determined that it would be appropriate to permit manufacturers to apply similar rounding rules used for the Nutrition Facts table for the nutrients listed in Appendix A instead of the current supplemental ingredient rounding rules.
Industry can use either the manner of expression found at item 18 in the table following B.29.002 of the Food and Drug Regulations (FDR) or the alternate manner of expression described in Appendix A of this statement for the nutrients listed in the appendix, when used as supplemental ingredients. This interim policy will apply until such a time as the FDR are amended.
Scope
This interim policy statement applies to supplemented foods sold in Canada that contain one or more of the 14 nutrients found in Appendix A that has been added as a supplemental ingredient.
Enforcement
The Canadian Food Inspection Agency has published its implementation plan for amendments to the Food and Drug Regulations (Supplemented Foods).
Contact Us
Food and Nutrition Directorate
Health Products and Food Branch
Health Canada
251 Sir Frederick Banting Driveway
Postal Locator 2203E
Tunney's Pasture
Ottawa, Ontario K1A 0K9
E-mail: supplementedfoods-alimentssupplementes@hc-sc.gc.ca
Appendix A: Alternative manner of expression for listed nutrients
| Condition | Rounding absolute amount | Rounding % daily value |
|---|---|---|
| <0.1 µg | 0 µg | 0% |
| ≥0.1 µg to <1 µg | Nearest multiple of 0.2 µg | Nearest multiple of 1% |
| ≥1 µg to <5 µg | Nearest multiple of 0.5 µg | Nearest multiple of 1% |
| ≥5 µg | Nearest multiple of 1 µg | Nearest multiple of 1% |
| Condition | Rounding absolute amount | Rounding % daily value |
|---|---|---|
| <0.1 mg | 0 mg | 0% |
| ≥0.1 mg to <1 mg | Nearest multiple of 0.2 mg | Nearest multiple of 1% |
| ≥1 mg to <5 mg | Nearest multiple of 0.5 mg | Nearest multiple of 1% |
| ≥5 mg | Nearest multiple of 1 mg | Nearest multiple of 1% |
| Condition | Rounding absolute amount | Rounding % daily value |
|---|---|---|
| <0.05 µg | 0 µg | 0% |
| ≥0.05 µg to <0.5 µg | Nearest multiple of 0.1 µg | Nearest multiple of 1% |
| ≥0.5 µg to <2.5 µg | Nearest multiple of 0.25 µg | Nearest multiple of 1% |
| ≥2.5 µg to < 5 µg | Nearest multiple of 0.5 µg | Nearest multiple of 1% |
| ≥ 5 µg | Nearest multiple of 1 µg | Nearest multiple of 1% |
| Condition | Rounding absolute amount | Rounding % daily value |
|---|---|---|
| <0.05 mg | 0 mg | 0% |
| ≥0.05 mg to <0.5 mg | Nearest multiple of 0.1 mg | Nearest multiple of 1% |
| ≥0.5 mg to <2.5 mg | Nearest multiple of 0.25 mg | Nearest multiple of 1% |
| ≥2.5 mg to < 5 mg | Nearest multiple of 0.5 mg | Nearest multiple of 1% |
| ≥ 5 mg | Nearest multiple of 1 mg | Nearest multiple of 1% |
| Condition | Rounding absolute amount | Rounding % daily value |
|---|---|---|
| <0.01 mg | 0 mg | 0% |
| ≥0.01 mg to <0.1 mg | Nearest multiple of 0.02 mg | Nearest multiple of 1% |
| ≥0.1 mg to <0.5 mg | Nearest multiple of 0.05 mg | Nearest multiple of 1% |
| ≥0.5 mg to 5 mg | Nearest multiple of 0.1 mg | Nearest multiple of 1% |
| ≥ 5 mg | Nearest multiple of 1 mg | Nearest multiple of 1% |
| Condition | Rounding absolute amount | Rounding % daily value |
|---|---|---|
| <0.005 µg | 0 mg | 0% |
| ≥0.005 µg to <0.05 µg | Nearest multiple of 0.01 µg | Nearest multiple of 1% |
| ≥0.05 µg to <0.25 µg | Nearest multiple of 0.025 µg | Nearest multiple of 1% |
| ≥0.25 µg to 2.5 µg | Nearest multiple of 0.05 µg | Nearest multiple of 1% |
| ≥2.5 µg to 5 µg | Nearest multiple of 0.5 µg | Nearest multiple of 1% |
| ≥5 µg | Nearest multiple of 1 µg | Nearest multiple of 1% |
| Condition | Rounding absolute amount | Rounding % daily value |
|---|---|---|
| <0.005 mg | 0 mg | 0% |
| ≥0.005 mg to <0.05 mg | Nearest multiple of 0.01 mg | Nearest multiple of 1% |
| ≥0.05 mg to <0.25 mg | Nearest multiple of 0.025 mg | Nearest multiple of 1% |
| ≥0.25 mg to 2.5 mg | Nearest multiple of 0.05 mg | Nearest multiple of 1% |
| ≥2.5 mg to 5 mg | Nearest multiple of 0.5 mg | Nearest multiple of 1% |
| ≥5 mg | Nearest multiple of 1 mg | Nearest multiple of 1% |