Notice of modification: Incorporating by reference the "Nutrition labelling – Table of permitted nutrient content statements and claims"

Reference number: [NOM/ADM-NCC-2022-1]

July 20, 2022

Table of contents

• Summary
  • Description of the amendments to the Table
• Background and rationale
  • 1) Incorporating by reference the Table of permitted nutrient content statements and claims
  • 2) Modifying the conditions of use of the "no added sugars" claim
  • 3) Modifying the energy-related condition for foods making a "free of sugars" claim
  • 4) Adding synonyms to the "free of saturated fatty acids", "free of trans fatty acids", and "free of sugars" claims
  • 5) Adding a new "low in sugars" claim
  • 6) Moving the "unsweetened" claim from section B.01.509 of the FDR to the Table
• Consultations
  • 1) Incorporating by reference the Table of permitted nutrient content statements and claims
  • 2) Modifying the conditions of use of the "no added sugars" claim
  • 3) Modifying the energy-related condition for foods making a "free of sugars" claim
  • 4) Adding synonyms to the "free of saturated fatty acids", "free of trans fatty acids", and "free of sugars" claims
  • 5) Adding a new "low in sugars" claim
  • 6) Moving the "unsweetened" claim from section B.01.509 of the FDR to the Table
• International considerations
• Implementation and enforcement
• Contact information

Summary

Description of the amendments to the Table

This section provides a brief description of the amendments. Please refer to the Table for the amendments in detail.

1) Incorporating by reference the Table of permitted nutrient content statements and claims

The table of nutrient content claims following section B.01.513 of the FDR is repealed. It is incorporated by reference (IbR) into the FDR as the new "Nutrition labelling - Table of permitted nutrient content statements and claims". This change is accompanied by consequential amendments to several provisions in the FDR where the reference to "the table following section B.01.513" is made.

2) Modifying the conditions of use of the "no added sugars" claim (item 40 in the Table)

The changes include: alignment of the meaning of "added sugars" with the new definition of "sugars-based ingredients" as amended in the FDR in December 2016 for the food carrying the claim and for the similar reference food; and the similar reference food not being "low in sugars".

3) Modifying the energy-related condition for foods making a "free of sugars" claim (item 37 in the Table)

The condition for the food has changed from "free of energy" to "low in energy".

4) Adding synonyms to the "free of saturated fatty acids", "free of trans fatty acids", and "free of sugars" claims (items 18, 22, and 37 in the Table)

These synonyms have been added to the "free of" claims for the respective nutrients: "0 g (naming the nutrient)", "zero g (naming the nutrient)", "0 gram (naming the nutrient)", and "zero gram (naming the nutrient)".

5) Adding a new "low in sugars" claim (item 37.1 in the Table)

A new "low in sugars" claim has been added to the list of permitted statements and claims. This claim can be made on a food that contains not more than 5 g of sugars per reference amount and per serving of stated size, and per 50 g if the reference amount is 30 g or 30 mL or less; or not more than 5 g of sugars per 100 g for prepackaged meals. There are also provisions for synonyms for this claim.

Background and rationale

On February 10, 2018, Health Canada pre-published the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamins D) in Part I of the Canada Gazette. Health Canada proposed, among other things, to repeal the table following section B.01.513 and replace it with an IbR document entitled Nutrition labelling - Table of permitted nutrient content statements and claims, as well as to update certain provisions related to nutrient content claims in the FDR. On the same date, proposed amendments to several nutrient content claims were published in the document Notice of Proposal – Incorporating by Reference the "Nutrition labelling – Table of permitted nutrient content statements and claims", which provided detailed background information on the changes.

1) Incorporating by reference the Table of permitted nutrient content statements and claims

Amending nutrient content claims and/or their associated conditions of use currently requires regulatory amendments to the FDR. In order to enable the Minister of Health to administratively update nutrient content claims in response to new scientific evidence, the Table following section B.01.513 in the FDR was repealed and the Table of permitted nutrient content statements and claims was incorporated by reference. The content in the original table following B.01.513 was copied into the Table of permitted nutrient content statements and claims. The proposed changes to this new table are detailed below.

2) Modifying the conditions of use of the "no added sugars" claim

The "no added sugars" claim is intended to be used on foods which do not contain added sugars, ingredients containing added sugars, or ingredients that contain sugars that functionally substitute for "added sugars". In practice, however, this claim has been commonly used on products containing added ingredients that are functional substitutes for a sweetening agent, such as fruit juice concentrates and purées. For example, fruit juice and fruit spread products that are sweetened with concentrated apple, grape, or pear juice instead of sugars, often carry the "no added sugars" claim. In many cases, the replacement of sugars with functional substitutes for sugars results in products containing similar, if not higher, sugars content than the comparable product with added sugars. The claim has also appeared on foods that are not major sources of sugars (e.g. bread) whether that food contains added sugars or not. The use of the "no added sugars" claim on these two types of products is potentially misleading.

In December 2016, amendments to the FDR were made introducing a definition of "sugars-based ingredients" as well as how these sugars-based ingredients must be grouped in the list of ingredients. To align with these amendments and to address the issues described above, the conditions for the claim in Column 2 have changed to refer to "sugars-based ingredients" in both conditions (1) and (3). Furthermore, the similar reference food cannot meet the "low in sugars" conditions, so that meaningful comparisons are made.

Moreover, Health Canada had proposed a new condition for the use of the "no added sugars" claim stipulating that the claim cannot be made for products that meet or exceed the thresholds for high in sugars for a front-of-package nutrition symbol. This proposed condition was not retained in the Table; instead, the FDR were amended to prohibit the use of certain claims related to saturated fat, sugars, or sodium on the principal display panel, when the product label is required to display a nutrition symbol related to the same nutrient. In the case of "reduced in" claims for these nutrients, their prominence will be restricted (please refer to subsection B.01.503(1.1) of the amended regulations in Part II of the Canada Gazette).

The changes to the "no added sugars" claim will in turn affect the "unsweetened" claim for which the requirements for "no added sugars" are a condition of its use, in addition to the absence of permitted sweeteners regulated in the FDR (e.g. sugar alcohols and high-intensity sweeteners).

3) Modifying the energy-related condition for foods making a "free of sugars" claim

The "free of sugars" claim was originally a claim that was reserved for foods for special dietary use, specifically to help people with diabetes identify foods that did not contain sugars or contribute energy (Calories). In the 2003 amendments, the "sugar-free" claim was removed from Division 24 to be allowed to be used more generally on foods that met the same conditions, but Health Canada maintained the condition that the food also had to meet the conditions for "energy-free". This has become a trade irritant with the approval of additional high intensity sweeteners that contribute small amounts of energy, and Canada was the only country amongst major trading partners to have this restriction.

The change to allow foods carrying the "free of sugars" claim to be "low in energy" recognizes that high intensity sweeteners and sugar alcohols used in these foods contribute small amounts of Calories. The "free of energy" requirement was considered unnecessarily restrictive and would provide minimal additional health benefit compared to the "low in energy" requirement.

4) Adding synonyms to the "free of saturated fatty acids", "free of trans fatty acids", and "free of sugars" claims

The purpose of adding declarations such as "0 g (naming the nutrient)" and their equivalents as synonyms to the "free of (naming the nutrient)" claim is to prevent the misleading use of quantitative declarations of these nutrients outside of the Nutrition Facts table or Supplemented Food Facts table when the food does not meet all conditions of use for this claim. However, the proposed amendment would not impede the use of these quantitative statements or the "free of" claim for sugars, saturated fat and trans fat when the required conditions for the respective claims are met.

5) Adding a new "low in sugars" claim

The establishment of a Daily Value for sugars for labelling purposes in the Table of Daily Values has enabled the development of criteria for a new "low in sugars" claim.

The intent of this provision is to encourage the availability of more foods that would help people living in Canada limit their intake of sugars.

6) Moving the "unsweetened" claim from section B.01.509 of the FDR to the Table

Health Canada proposed to repeal section B.01.509 of the FDR and include the "unsweetened" claim in the Table to be incorporated by reference because this claim is largely grounded in nutrient compositional criteria linked with the "no added sugars" claim. However, after reviewing the comments provided in response to the Notice of Proposal, Health Canada decided not to move forward with the proposal.

Consultations

Twenty-nine sets of comments were provided on the proposed amendments in the Notice of Proposal between February 10 and April 26, 2018. The comments were received from consumers, researchers, individual health professionals and organizations, government representatives, non-governmental organizations, and industry representatives and associations. Industry provided the majority of the comments (18, including 14 from associations).

1) Incorporating by reference the Table of permitted nutrient content statements and claims

Stakeholders' views: There was broad support from respondents who commented on this proposal. Industry stakeholders agreed with the need for an efficient regulatory process and the need for timely response to scientific developments in amending regulations. Some industry stakeholders asked about the transparency of the IbR process. One health stakeholder expressed concern about the lack of cabinet oversight in the IbR process.

Health Canada's response: The IbR process includes elements intended to address the concerns raised by industry, such as notification of the public and stakeholders of a proposal to amend the documents incorporated by reference; provision of a 60-75 day comment period; publication of final changes in a Notice of Modification; and archival of records of past amendments on Health Canada's website.

2) Modifying the conditions of use of the "no added sugars" claim

Stakeholders' views: Among the few respondents that commented on the proposed replacement of the term "added sugars" with "sugars-based ingredients" in conditions (1) and (3) for the claim, there was general support, with the exception of industry associations representing the juice sector. Some members of this group asked for retention of the current term "added sugars". No comment was received on the requirement that the similar reference food not be low in sugars.

On the proposal to prohibit the use of the claim on products meeting or exceeding the threshold for high in sugars, there was strong opposition from industry while the responses from health professionals, representatives from health organizations and governments as well as consumers were supportive. Industry's general objection was related to inconsistency with international standards for "non-addition" claims for which there is no limit on the levels of the nutrient in question. Industry stakeholders also noted consumers' interest in identifying natural vs. added sources of sugars in foods. Industry's specific objection was related to 100% juice products that do not contain sugars-based ingredients but meet or exceed the "high in" threshold for sugars.

Health stakeholders expressed concerns and submitted research showing that concurrent competing claims could confuse consumers or diminish the meaning or understanding of the front-of-package symbol.

Health Canada's response: Given the general support for the use of the term "sugars-based ingredients" and the absence of issues with the similar reference food not being low in sugars, Health Canada will move forward with these proposed conditions.

With respect to the proposal to prohibit the "no added sugars" claim on foods that are high in sugars, a review of stakeholder feedback and consumer studies informed a wider review of all claims related to the three nutrients of concern that might be highlighted in the front-of-package nutrition symbol. Health Canada has decided to prohibit the use of certain claims related to saturated fat, sugars, and sodium on the principal display panel of a product label that is required to display a nutrition symbol related to the same nutrient. For details on Health Canada's responses to stakeholders' comments, please refer to the Regulatory Impact Assessment Statement in the Canada Gazette, Part II.

3) Modifying the energy-related condition for foods making a "free of sugars" claim

Stakeholders' views: There was general support from industry while two industry and health stakeholders provided contrary views. Objections were related to the lack of evidence to support the proposed change and to consumers' association between the absence of sugars and "energy free".

Health Canada's response: The respondents did not provide any data to support their concerns. In proposing the change, Health Canada recognizes that certain sweeteners contribute small amounts of Calories and requires that foods carrying the "sugar-free" claim to be low in energy. The change is consistent with requirements for the claim among major trading partners.

4) Adding synonyms to the "free of saturated fatty acids", "free of trans fatty acids", and "free of sugars" claims

Stakeholders' views: There was no objection from industry respondents who commented on the proposed changes. No other stakeholders provided comments on this proposed change.

Health Canada's response: Health Canada decided to move forward with the change as proposed.

5) Adding a new "low in sugars" claim

Stakeholders' views: Some health stakeholders commented that there is not sufficient evidence to support that such a claim would encourage the availability of more foods that would help people living in Canada limit their sugar intake. There was both support and objection from industry. Objection included expression of doubt from one industry association about public health benefits when reduction of sugar is not accompanied by reduction in Calories. This stakeholder also noted that such a claim would not reduce consumers' preference for sweet taste with the continued use of high-intensity sweeteners and that allowing such a claim is not aligned with the U.S. Other industry stakeholders not supportive of this new claim were concerned with products with small reference amounts. For these products, an adjustment to a higher basis of 50 g is required in determining claim eligibility. There was also disagreement that the claim cannot be made unless the product meets dual requirement on the basis of both per serving of stated size and per reference amount.

Health Canada's response: A preliminary review of the types of food that carry this claim in Australia-New Zealand does not support stakeholder concerns. For non-comparative claims such as "low in", it is not typical to link the claim to another nutrient or energy content. This claim is adapted from that authorized in the European Union (E.U.) and Australia-New Zealand. The criteria are consistent with that used in these jurisdictions and with how Canada applies international standards for nutrient content claims in the Canadian context.

Adjustment for small reference amount and the dual requirement per reference amount and per serving of stated size are consistent with how other nutrient content claims, such as "low in sodium", are regulated.

6) Moving the "unsweetened" claim from section B.01.509 of the FDR to the Table

Stakeholders' views: Industry stakeholders were not supportive of the proposal. In their view, the claim is a sensory claim intended to communicate to consumers that the product carrying the claim has no added ingredients that impart additional sweetness, a property that is not related only to the absence of sugars.

Health Canada's response: Health Canada proposed to include the "unsweetened" claim in the table because this claim is largely grounded in nutrient composition criteria for the "no added sugars" claim. Stakeholders' opposition to the proposal prompted Health Canada to retain the provision in the FDR.

International considerations

With respect to the claims that are amended in the Table, as discussed in the previous sections, by modifying the food eligibility criterion from "free of energy" to "low in energy", the Canadian requirement for the "free of sugars" claim is now consistent with Canada's major trading partners.

As already been noted, Canada adapted the "low in sugars" claim from that authorized in the E.U. and Australia-New Zealand. The criteria are consistent with that used in these jurisdictions and with how international standards for nutrient content claims are taken into consideration in the Canadian context.

Implementation and enforcement

The Canadian Food Inspection Agency (CFIA) is responsible for enforcement of the Food and Drugs Act and its associated regulations with respect to foods. The CFIA will verify that the industry has implemented appropriate measures to meet regulatory requirements through oversight activities such as inspections, audits and/or sampling. Guidance material, such as the Online Industry Labelling Tool, will be updated to reflect these changes.

Contact information

For additional information or to submit comments or information related to this notice, please contact:

Bureau of Nutritional Sciences, Food Directorate
Health Products and Food Branch, Health Canada
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2203E
Ottawa, ON K1A 0K9
Email: nut.labelling-etiquetage@hc-sc.gc.ca