Notice of Proposal - Incorporating by Reference the "Nutrition Labelling – Table of Permitted Nutrient Content Statements and Claims"
Notice to the reader:
The online consultation is now closed.
Reference Number: [NOP/ADP-NCC-2018-1]
February 10, 2018
Table of Contents
- Description of the proposal
- Background and rationale
- Other relevant information
- Implementation and enforcement
- Contact Information
- Appendix: Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims
The purpose of this notice is to inform consumers and interested stakeholders of Health Canada's intent to create a new Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims (Table) which will be incorporated by reference into the Food and Drug Regulations (FDR) to replace the table following section B.01.513, which lists the 47 permitted nutrient content claims. The proposed Table also includes a number of updates as described below. A copy of the new Table is appended to this notice.
Note - To facilitate understanding of the Table, it is recommended that the reader review this document in conjunction with the regulatory proposal in Part I of the Canada Gazette as the subject matter is closely linked.
Further information on the Department's rationale for proceeding with this proposal as well as a summary of comments received during the pre-consultation, held from November 14, 2016 to January 26, 2017, is provided in the Background and rationale and Other relevant information sections of this notice.
Description of the proposal
Incorporation by reference - Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims
The Table of Permitted Nutrient Content Statements and Claims is proposed to be the document entitled "Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims" published on the Government of Canada's website, and which will be amended by Health Canada from time to time, following consultation. Unless otherwise noted, the statements and claims and their associated conditions have simply been reproduced in the Table from the current table following section B.01.513 of the FDR, which is included as an appendix to this document.
Updating certain nutrient content claims
1) Modifying the conditions of use of two claims
Free of sugars: The proposal is to change the condition for "free of energy" to the conditions for "low in energy".
No added sugars: The proposed changes include
- Updating the conditions for the food to align with the new definition of "sugars-based ingredients", as amended in section B.01.001 in the FDR in December 2016
- Adding the following two conditions for the food:
- The food does not meet the conditions for "high in sugars", as set out in the proposed amendment to FDR subsection B.01.350(1);
- The similar reference food does not meet the conditions set out in item 37.1 ("low in sugars") in the Table (i.e. the similar reference food is not a food that contains 5 g of sugars or less per reference amount and per serving).
2) Addition of synonyms to the "free of saturated fatty acids", "free of trans fatty acids" and "free of sugars" claims
Health Canada proposes to add the following synonyms 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)".
3) Addition of a new claim "low in sugars"
A "low in sugars" claim may be used for a food that meets the following criteria:
- No more than 5 g per reference amount and per serving, and per 50 g if the reference amount is 30 g or 30 mL or less;
- No more than 5 g per 100 g for prepackaged meals.
The limit of 5 g is equivalent to 5% DV for sugars.
Proposed synonyms for this claim include: "low in sugar", "low sugar", "low source of sugar", "little sugar", "containing only (number) g of sugar per serving", "contains less than (number) g of sugar per serving".
4) Moving the "unsweetened" claim from section B.01.509 of the FDR to the Table
Section B.01.509 regarding the "unsweetened" claim would also be repealed and brought to the Table to be incorporated by reference (item 40.1) and will continue to be affected by the no-added sugars claim.
Incorporating by reference "the Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims" would require consequential amendments to several provisions in the FDR in order to replace reference to "the table following section B.01.513" with "the Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims". The consequential amendments are included in Canada Gazette Part I, published on February 10, 2018.
Background and rationale
On February 10, 2018, Health Canada pre-published the Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) in Part I of the Canada Gazette which propose, among other things, to repeal the table following section B.01.513 and replace it with an incorporated by reference document entitled "Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims", as well as updating certain provisions related to nutrient content claims in the Food and Drug Regulations.
Incorporation by reference
The FDR currently prescribe 47 nutrient content claims and set out the conditions that a food must meet in order to use these claims on food labels and in advertisements. Amending nutrient content claims and/or their associated conditions of use currently requires Governor in Council regulatory amendments to the Food and Drug Regulations. In order to enable more efficient and timely updates to these nutrient content claims in response to new scientific evidence, amendments are needed to the FDR to incorporate by reference the Table of Permitted Nutrient Content Statements and Claims.
Updating certain nutrient content claims
Nutrient content claims are voluntary statements or expressions which describe, directly or indirectly, the level of a nutrient or energy in a food (e.g. "low in sodium"). The Food and Drug Regulations outline 47 permitted nutrient content claims and set out the requirements pertaining to their use on the label or in any advertisement for a food in the table following section B.01.513. The requirements aim to ensure that nutrient content claims for foods are consistent, accurate and non-misleading and are based on recognized health and scientific criteria. Economic and trade considerations are taken into account where possible and when not in conflict with health and safety. Nutrient content claims are intended to help consumers make informed dietary choices.
Health Canada is proposing to update certain nutrient content claims to align with the recent changes to the Nutrition Facts table and list of ingredients regulations and the proposed new front-of-package (FOP) nutrition labelling. The proposed changes to nutrient content claims are summarized below. Please refer to the Table in the appendix for details.
1) Modifying the conditions of use of two claims
Free of sugars (item 37 in the Table)
Foods that do not meet the requirements for the "free of energy" claim as set out in the FDR are prevented from carrying the "free of sugars" claim, even though they meet the requirements for the sugars content. The energy restriction in the current definition has a long history of use in Canada and was intended to provide an easy means of identifying foods that would be acceptable for individuals with diabetes. Health Canada has previously considered the use of disclaimers (e.g. allowing the use of a "free of sugars" claim with the statement "not calorie-free"); however, the use of a disclaimer was not considered an acceptable alternative as prior consultations indicated that disclaimers could confuse consumers.
In addition, the "free of energy" restriction associated with the "free of sugars" claim has been a source of trade irritants as Canada is the only country with this requirement among major trading partners.
The proposed change to the conditions of use for the "free of sugars" claim is expected to allow products that contain sweeteners that contribute small amounts of Calories to use the claim and to remove the trade irritant.
No added sugars (item 40 in the Table)
The current regulations governing the use of "no added sugars" 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 juice concentrates and fruit purées. Standardized fruit juices, other than apple juices, are currently permitted to contain added sweetening agents. The claim "no added sugars" has become popular on fruit juices primarily to differentiate them from juice beverages and fruit-flavoured beverages, even though the addition of sweetening agents is no longer common practice, and has been replaced with blending juices with apple, grape or pear juices. These juices and juice blends often contain similar, if not higher sugars content, than comparable beverages. The claim has also appeared on foods that are not major sources of sugars in the finished food (e.g. bread) whether the food contains added sugars or not. The use of the "no added sugars" claim on these two types of products is potentially misleading.
The proposed changes are expected to limit the use of the "no added sugars" claim on foods marketed in Canada, including those containing sugars-based ingredients as well as foods, including juices, required to display an FOP symbol for "high in" sugars. These changes would align with the recent changes to the labelling of sugars in the list of ingredients and the proposed FOP nutrition labelling initiative. The proposed changes to the "no added sugars" claim would 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).
2) Addition of synonyms to "free of saturated fatty acids", "free of trans fatty acids", and "free of sugars" claims (items 18, 22, and 37 in the Table)
Quantitative declarations of the amount of nutrients per serving of stated size, including sugars, saturated fat and trans fat, are permitted outside the Nutrition Facts table on labels or in advertisements. For consumers, a quantitative declaration of "0 g nutrient X" on a food could be misinterpreted to mean that the food is "free of nutrient X". This is potentially misleading for sugars, saturated fat and trans fat, for which the absence of the nutrient in the food is not the only condition of use of the "free of" claim.
The proposal to add declarations such as "0 g (naming the nutrient)" and their equivalents as synonyms to the "free of (naming the nutrient)" claim is intended to prevent the misleading use of quantitative declarations of these nutrients outside of the Nutrition Facts table if 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.
3) Addition of a new claim "low in sugars" (item 37.1 in the Table)
There is currently no provision for a "low in sugars" claim in the FDR. 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 "low in sugars" claim.
The intent of this provision is to encourage the availability of more foods that would help Canadians limit their intake of sugars, which is consistent with the FOP nutrition labelling initiative.
4) Moving the "unsweetened" claim from section B.01.009 to the Table (item 40.1 in the Table)
The current provision in section B.01.509 of the FDR allows for the use of the "unsweetened" claim to describe a food product that is not sweetened with a sweetener permitted in the FDR (e.g. sugar alcohols and high intensity sweeteners). The food must also meet the condition for the "no added sugars" claim. As such, the "unsweetened" claim was considered to be separate from the "no added sugars" claim in the table pertaining to nutrient content claims following section B.01.513.
With the current proposal to incorporate the Table by reference in the FDR, Health Canada is also proposing to include the "unsweetened" claim in the Table because this claim is largely grounded in nutrient compositional criteria linked with the "no added sugars" claim. Consequently section B.01.509 would be repealed. This proposal would not change the conditions for using the "unsweetened" claim.
Other relevant information
"Free of sugars" claim
No requirement for energy as part of the conditions for the "free of sugars" claim was identified in the other standards or regulations reviewed. In the United States (U.S.), there is an additional requirement that the food contain no ingredient that is a sugar or generally understood to contain sugars, unless the caloric profile is disclosed (e.g. "low Calorie").
"No added sugars" claim
Internationally, the principles underlying the "no added sugars" claim are similar but specific requirements vary. The Codex Alimentarius Commission standards permit the claim on foods where there is no addition of sugars, either directly or indirectly.
In the U.S., a product bearing the "no added sugars" claim is required to state that the food is not "low Calorie" or "Calorie reduced" unless the food meets the requirements for a "low" or "reduced Calorie" food and directs consumers' attention to the Nutrition Facts panel for further information on sugar and Calorie content.
The European Union (E.U.) allows for the claim to be made on foods containing naturally occurring sugars by indicating that the food "contains naturally occurring sugars".
In Australia and New Zealand, the "no added sugars" claim may be made on a food if it does not contain a sugar ingredient as defined in the Australian New Zealand Food Standards Code or if the food contains no added concentrated fruit juice or deionized fruit juice. Certain standardized beverage products, such as standardized fruit juice and vegetable juice, are excluded from the latter condition.
"Low in sugars" claim
A 'low in sugars" claim is included in the Australia New Zealand Food Standards Code and in the European regulations on nutrition and health claims (Regulation (EC) No. 1924/2006). In both of these jurisdictions, the claim may be used in a food that contains no more sugars than (a) 2.5 g per 100 mL for liquid food; or (b) 5 g per 100 g per solid food. There is no provision for a "low in sugars" claim in the U.S.
A pre-consultation on Health Canada's proposal for FOP nutrition labelling, changes to nutrient content claims and sweetener labelling was held between November 14, 2016 and January 26, 2017. Approximately 1600 online and written responses were received from consumers, industry representatives and associations, individual health professionals and organizations, academics, government representatives and non-governmental organizations (NGOs).
During this pre-consultation, consumers and stakeholders were asked the following questions related to the proposed changes to nutrient content claims in the consultation document:
- Do you support the changes proposed to update claims and other nutrition-related statements described in Table 3? Please explain.
- If you do not support one or more of the proposed changes, please identify the subject of the proposed change (e.g., "i. no added sugar" claim) and explain why, along with a rationale and evidence to support your comments.
The following is a summary of the comments received in the pre-consultation.
Comments on the "free of sugars" claim
Amongst the specific comments provided in relation to the proposed changes to this claim, two industry associations suggested alternatives to the proposal that the "free of energy" condition for this claim be changed to "low in energy". One asked that energy not be linked at all to the claim, while the other suggested following the U.S. model where the Calorie profile must be declared in conjunction with the claim (e.g. "Free of sugars, Low in Calories"). One of them also questioned whether the "free of sugars" claim provides meaningful public health benefit.
Health Canada's response
Health Canada is proposing to move forward with the proposed change which would replace the current "free of energy" condition with the condition that the food also meets the "low in energy" limit. As noted earlier in the "Background and rationale" section, stating the Calorie level as a disclaimer could be confusing to consumers. A complete removal of any limit on Calories would risk the likelihood of such a claim being made on a high-Calorie food. Excess Calorie intake is not only a concern for overweight and obesity but for a wide variety of diseases and health conditions (e.g. cardiovascular disease, diabetes).
Comments on the "no added sugars" claim
Many health and industry stakeholders supported the proposed alignment between the meaning of "added sugars" (in the current "no added sugars" claim and by cross reference, the related statement "unsweetened") with the new definition of "sugars-based ingredients" introduced in the 2016 nutrition and ingredient labelling regulations.
However, responses from health professionals and consumers were mixed to the proposal to disallow the use of the "no added sugars" / "unsweetened" claims on foods that would also be identified as "high in sugars" under the proposed FOP approach, including fruit juices. Few industry stakeholders supported this proposal. Among the stakeholders who supported the proposal, the view was that because they considered the "no added sugars" claim on a food deemed high in sugars would be confusing and misleading. Those who did not agree with the proposal considered that the claim and the "high in sugars" designation on the same foods are not contradictory but provide different information important for making informed choices. Standardized or 100% fruit juice was the most contentious food discussed in the comments received because, although sugars are a major component of juice, it is considered by many as a nutritious food recommended in dietary guidance. Industry also considered the claim to be truthful even if the food itself naturally contains a high level of sugars.
Health Canada's response
Health Canada is planning to move forward with the proposed condition that a food carrying the "no added sugars" claim not be high in sugars, including standardized fruit juices. There is a need to exclude the use of a claim that would not be consistent with the intent of the proposed FOP approach (i.e. to help consumers reduce consumption of sugars) and that would not align with recommendations from authoritative health organizations to limit intakes of free sugars, including from fruit juices. This recommendation is also among the proposed guiding principles in Health Canada's consultation on updating Canada's Food Guide held from June 10, 2017 to August 14, 2017.
Comments on the "0 g sugars" and "0 g trans fats" claims
The proposal to prohibit quantitative statements "0 g sugars" and "0 g trans fats" outside the Nutrition Facts table was generally supported by consumers and health stakeholders. There was also a suggestion to examine other similarly misleading quantitative statements. Some industry stakeholders did not support the proposal because the quantitative statements are factual information and do not characterize the nutrient level of a food.
Health Canada's response
Health Canada reviewed additional quantitative statements that could be misleading. It was determined that "0 g saturated fat" could also be misinterpreted to mean "free of saturated fat" when used on a food that does not meet the required limit for trans fat. Therefore, consistent with the rationale for the published proposal, Health Canada is adding saturated fat to the proposal by including "0 g (naming the nutrient)" and equivalents as synonyms to the respective "free of" claims.
Comments on the "low in sugars" claim
Some respondents opposed the introduction of a "low in sugars" claim because it could encourage the marketing of foods that are not necessarily healthier (e.g. products with lowered sugars and increased starch). Some industry stakeholders did not support the new claim for technical reasons, including: the adjustment for foods with small reference amount would prevent the use of this claim for products like mint and gums; the claim is not currently in the Codex Guidelines for Nutrition and Health Claims nor the U.S. Code of Federal Regulations; and the proposed condition is not linked to Calories.
Health Canada's response
The proposed criteria are consistent with how Canada adopts international standards for nutrient content claims. International standards (e.g. claims adopted by Codex or other jurisdictions such as the U.S., E.U. and Australia-New Zealand) are considered in the Canadian context. The "low in sugars" claim is adapted from that authorized in the E.U. and Australia-New Zealand. The technical adjustment for products with small reference amount (30 g or 30 mL or below) is consistent with other nutrient content claims. Countries can permit claims not currently in Codex guidance. Codex guidelines would be referred to in the case of a trade dispute where the condition of use of a claim is contested. As nutrient content claims are voluntary within Canada, there should not be a trade impediment to the use of such claims. While the "low in sugars" claim may not result in healthier versions of all foods carrying the claim, helping people to lower sugars intake in their diet and potentially encouraging a preference of less sweet foods are both consistent with the objective of the proposed FOP nutrition labelling. Health Canada, therefore, is proceeding with the "low in sugars" claim as proposed.
Implementation and enforcement
The "Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims" would be incorporated by reference into the Food and Drug Regulations on the day on which the Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) are published in Part II of the Canada Gazette.
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.
To make representations concerning the proposed regulations pre-published on February 10, 2018 or to submit comments or information specific to the "Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims", please submit your consolidated comments to the same contact information provided in the proposal.
(Attention: Canada Gazette, Part I, February 10, 2018)
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Holland Cross, Tower A, Suite 14, Ground Floor
1600 Scott Street
Address locator: 3000A
Appendix: Nutrition Labelling - Table of Permitted Nutrient Content Statements and Claims
Nutrition Labelling – Table of Permitted Nutrient Content Statements and Claims
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