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Proposed Regulations Amending the Food and Drug Regulations

Health Canada finalized its proposed regulatory modifications to Canadian food labelling regulations in Canada Gazette Part I, on June 13, 2015. Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice, i.e. no later than August 27, 2015.

Objectives

The overall objectives of the regulatory amendments are to make the information on labels:

  1. more useful and easier to read and understand; and
  2. based on the latest science (e.g. updates to the Daily Values (DV) for nutrients to be based on the most recent dietary recommendations)

so as to enable Canadians to make informed choices about their food in order to maintain or improve their health.

What’s new with respect to the declaration of ingredients and allergens?

The proposed regulations maintain most of the features described in the initial preliminary proposal, which were discussed in the spring issue of the ACC Reporter, now available on ACC Label’s blog. However, there are some differences, which are summarized in the table 1 below.

Table 1 – Evolution of Regulatory Proposals with Respect to
                    Ingredient and Allergen Declarations

Features from the
Preliminary Proposal

Official Proposal
(Canada Gazette Part I)
and Rationale

Headings in
bold characters

Ingredients

Contains

May contain

Retained. The proposed regulations further specify that the heading shall be shown in a type size that is 2 points larger than the type size used to show ingredients in the list, except that if the available display surface of the prepackaged product is less than 100 cm2, the title may be shown in type that is at least the same size as the type size used to show ingredients in the list.
Heading
on a separate line
Retained only for the heading “May contain”.

For the headings “Ingredients” and “Contains” (where applicable), the proposed rule only requires that they be shown without any intervening printed, written or graphic material appearing between the title and the first ingredient/allergen shown in the list.

Black print on white or neutral background

and

Outline rule to create a box

The proposed regulations require that the ingredient list and allergen statements appear in:

  1. a single colour of type that is a visual equivalent of 100% solid black type and that is shown on a white background or a uniform neutral background having a maximum 5% tint of colour; and
  2. a manner that clearly differentiates it on the label, by means of one or both of:

(a) graphics in the form of a solid-line border around the list, or one or more solid lines appearing immediately above, below or at the sides of the list; and;

(b) a background colour that creates a contrast between the background colour of the list and the background colour used on the adjacent area of the label, other than the area used to display an allergen statement and a Nutrition Facts table.

Specifications for maximum
box width

Not retained.
Bullets
to separate each main ingredient

The preliminary proposal was retained as it was supported by consumers and stakeholders (such as provincial and territorial governments, health organizations, health professionals, and consumer advocacy groups).

However, the requirement to use bullets in the ingredient list would not apply to prepackaged products with labels applied at retail establishments, as the existing machines (scale printers) are incapable of printing a bulleted list of ingredients. This sector, which consists of a significant number of small businesses, would be allowed to continue to use commas, as per current practice.

Font type and size consistent with those required for the Nutrition Facts table Retained. More specifically, the proposed regulatory mofications would require that the lists of ingredients and allergens be shown in:

  1. a single standard sans serif font that is not decorative;
  2. such a manner that the characters never touch each other or any differentiating feature, i.e.:
    • the lines above, below, or on the sides of the ingredients list; or
    • the edge of the background colour (between the background colour of the list and the background colour used on the adjacent area of the label).
  3. a type having normal or condensed width, except that if a nutrition facts table appears on the label the width of type must be the same as that required for nutrients that appear in the nutrition facts table;
  4. regular type, except that allergens may be shown entirely in bold type;
  5. a type size of at least 6 points with leading of at least 7 points, except that if a nutrition facts table appears on the label, the type size and leading must be at least the same as those required for nutrients that appear in the nutrition facts table.

Characters may be displayed in larger type size if all characters are enlarged in a uniform manner.

Use of a capital for the first letter of each main ingredient

 Retained.
Grouping of all sugar-based ingredients

Retained.

The feedback from the latest round of consultation revealed that:

  • most consumers and health stakeholders believed that the grouping of sources of sugars in the list of ingredients would be useful for consumers;
  • industry was concerned that it would disrupt the conventional practice of listing the ingredients in decreasing order of their weight.

Health Canada’s objective is to provide greater transparency regarding the sugar that is added to foods. Ingredients with common names such as fancy molasses, malted barley, isomaltose and pear juice concentrate may not be recognized by most Canadians as sugars-based ingredients. The grouping requirement would, in cases where a product contains a large proportion of sugar, move the sugars-based ingredients closer to the beginning of the ingredient list, indicating more clearly the relative proportion of sugars-based ingredients in the product. Thus, the proposed approach would help consumers identify unfamiliar sources of sugar in their foods.

Overall, the goal is to support the reduction in sugar intake, as excess sugar intake may lead to overconsumption of calories, and thus to obesity and associated chronic diseases.

Food colours to be declared by their common name (as specified in the Regulations) within the list of ingredients on the food label

Food colours are unique among food additives in that current labelling regulations provide food manufacturers with the choice of declaring added food colours by either their common name (e.g. Citrus Red No. 2) or simply as “colours.”

The proposed amendments aim to:

  • enable consumers who have sensitivities to specific food colours to avoid those ingredients when shopping for food; and 
  • align food colour labelling requirements with those of other food additives by mandating that food colours be identified using their common names in the ingredient list.

The requirement to name each specific colour added to food would be consistent with the requirement in USA and European countries, except that in USA and Europe, the food colours are coded with numbers. For example, Allura red (common name specified in the Canadian Food And Drug Regulations), would be declared as:

  • Allura red in Canada
  • FD&C Red #40 in USA
  • E129 in Europe

Health Canada is also proposing to eliminate the requirement for lot-by-lot certification of synthetic food colours. The certification requirements for synthetic food colours were established more than 30 years ago and are no longer considered necessary from a food safety perspective. The requirement for lot-by-lot certification of synthetic food colours is more burdensome than the requirements for other food additives.

What’s new with respect to nutritional labelling?

Proposed regulations with respect to the Canadian Nutrition Facts table differ significantly from the preliminary proposed modifications, which were discussed in the spring issue of the ACC Reporter, and now available on ACC Label’s blog. Nevertheless, the general idea remains the same.

In table 2 below, the various proposed features are discussed.

Table 2  –  Evolution of Regulatory Proposals with Respect to
                    the Nutrition Facts Table (NFT)

Features from the
Preliminary Proposal

Official Proposal
(Canada Gazette Part I)

Health Canada Objective
and Potential Impact

Serving of Stated Size (SSS)

a)  aligned with the regulated reference amounts  (i.e. the amount that is typically consumed in one sitting), and would allow consumers to compare various products more easily at the point of purchase;

and

b) justified to the right of the Nutrition Facts table
(just above the % Daily Values).

 

 

 

 

 

a)  Retained

 

 

 

 

 

 

b)  Not retained

Serving size shall be stated on the left side of the NFT, as on the current NFT.

 

 

To allow consumers to compare various products more easily at the point of purchase. For example, foods such as crackers, which come in pieces, would have to use an SSS as close to 20 g as possible; the serving size on the label would be shown in units (number of crackers) along with the corresponding weight (in grams).

This is consistent with the current US requirements.

Potential Impact

An adjustment to the recommended serving size would require industry to complete new analyses of the nutrient content. In some instances, these changes could mean that health and nutrient-content claims made on the front of the package no longer apply. Conversely, these adjustments could also increase the amount of specific nutrients per serving, such as fibre, which would enable claims. Costing figures were not provided for adjustments being made to serving sizes; however, it was assumed that these costs would be included in the cost of label printing and nutrient analysis.

Deletion of Sub-Heading « Amount/Teneur »

Retained

 

Increased prominence of Calories

Retained

Health Canada is proposing an increased font size and bolding for Calories, but not to the extent proposed in the U.S. The Department and Canadian health stakeholders are concerned that too great a focus on calories could detract from other important factors in choosing healthy foods.

Grouping of nutrients of public health concern for which Canadians should:

  • limit their consumption, at the top of the NFT

and

  • get enough, at the bottom of the NFT

The two groups of nutrients would be separated by a thick line

The proposal was not maintained, nor was the status quo.

 

Health Canada is now proposing to adjust the order in which nutrients are listed in the NFT in order to group energy-providing nutrients together, followed by cholesterol and sodium. This format supports Health Canada’s messaging in its public education campaigns on nutrition.

The new proposed order of declaration of nutrients is very similar to the order of declaration in the current NFT. The main difference is the order of declaration of cholesterol, sodium and potassium which would be, if the proposal becomes regulation, grouped between protein and calcium.

Declaration of dietary fibre near other carbohydrates, but separated from them with a thick line.

  • Fibre grouped at the bottom of the NFT with nutrients which a higher consumption is recommended  
  • Other carbohydrates grouped at the top of the NFT with nutrients which consumption should be limited
Not retained  

% Daily Value for carbohydrates no longer required

Retained

 

Inclusion of % Daily Value (DV) for total sugars
based on a proposed daily value of 100 g (which represents 20% of the daily energy intake for a 2,000 Cal diet).

(Added sugar content
not declared)

or

Declaration of added sugars below the total sugars

(% DV for total sugars
not declared)

It was decided to use a Daily Value approach for sugars instead of added sugars, as this would significantly lower the costs.

The proposal to declare the amount of added sugars in the NFT was popular among consumers and health stakeholders. However, industry stakeholders questioned the scientific basis of requiring the declaration of added sugars in the NFT given that the body metabolizes naturally occurring and added sugars in the same way. Similarly, the inability of analytical methods to distinguish between naturally occurring and added sugars would contribute to significant compliance and enforcement challenges. In addition, industry indicated that research done in the U.S. concluded that consumers have a limited understanding of the “added sugar” declaration in the NFT.

To provide information and educate consumers on the content of sugar in the foods they consume, with the intention of supporting the reduction in sugar intake in a manner consistent with the recommendations of Canada’s Food Guide.

A diet plan based on Canada’s Food Guide would include approximately 85 g of naturally-occurring sugars from fruits, vegetables and milk products. Using a DV of 100 g for total sugars would leave a leeway of about 15 g (1 tablespoon) of added sugars per day.

In USA, a different approach for the declaration of sugars is being proposed. In July 2015, the US Food and Drug Administration supplemented their initial proposal with respect to sugars in the Nutrition Facts table. They are now proposing to declare a % DV for added sugars (as opposed to “total sugars” as in Canada). The % DV would be based on the recommendation that the daily intake of Calories from added sugars not exceed 10 percent of total Calories. This would represent a daily value for “added sugars” of 50 g in a daily diet of 2,000 Calories.

The proposed US daily value for “added sugars” appears quite high compared to the proposed Canadian daily value of 100 g for “total sugars” (which would leave about only 15 g for “added sugars”, if Canada’s Food Guide is followed).

Deletion of the thin lines between:

  • total fat and
    saturated fat
  • total carbohydrate
    and sugars
Retained

The deletion of these lines improves the legibility of the information.

However, the proposed Nutrition Facts table models no longer show the following nutrients indented:

  • saturated and trans fatty acids
  • fibre et sugars

The reasoning behind this typographical feature is not clear. Indentation improves both the legibility and the comprehension: it becomes clearer that the indented nutrients are components of the total fats and total carbohydrates.

Declaration of 
vitamins A and C
eplaced by
vitamine D and potassium

Retained, except that the declaration of vitamin D content will not be mandatory.

There was general support to include potassium and remove vitamin A and vitamin C from the list, although consumers questioned the reason behind removing these two vitamins.

There was less support for the proposal to declare vitamin D, specifically among some health professionals and academic experts, mainly because this vitamin occurs naturally in very few foods, such as fatty fish, and that a “0” declaration may give the impression that a food is not nutritious. Consequently, as a result of stakeholder feedback, the requirement to declare vitamin D has been removed from this proposal. However, if vitamin D is added to a product, it must be included in the Canadian NFT (e.g. milk, fortified plant-based beverages, margarine).

This will limit costs to industry (laboratory analysis for vitamin D can be very complicated and costly), except for food manufacturers who also sell their products on the US market.

In USA, it is proposed to require the inclusion of vitamin D in the Nutrition Facts table, because it is a new “nutrient of public health significance”.

Vitamin and mineral contents
shown by weight
 Retained

Consistent with the declaration of other nutrients.

May be useful for the management of dietary intake, especially for those who consume vitamin and mineral supplements.

In line with proposed modifications to the US Nutrition Facts.

% Daily Values (DV)

  1. The % DV would be indicated only for:
    • macronutrients which consumption should be limited (no more % DV for fibre); and
    • vitamins and minerals.
  2. The DV for fat would be increased to 75 g (up 10 g from the current 65 g DV).
  3. Distinct % DV for saturated and trans fat;
  4. The % DV takes into account the differences in nutritional needs of:
    • infants (six to 12 months); and
    • toddlers (1 to 3 y.o.)

1.  Retained

 

 

  2. Retained

 

 3.  Not retained. The % DV for the saturated fat and trans fat would remain combined as in the current NFT.

4. Health Canada retained the preliminary proposed regulatory modifications, but adjusted the age groups for children under 4 years of age as follows:

  • infants (seven months or older but less than one year); and;
  • children (one year or older but less than four years).

To base DVs on the most recent scientific knowledge.

The increased DV for fat is based on the upper level of the Acceptable Macronutrient Distribution Ranges (AMDR), which is 35% Calories from fat.  This is consistent with the Codex Alimentarius’ General Principles for Establishing Nutrient Reference Values for the General Population.

Footnote explaining % DV benchmark levels

“5% DV or less is a little,
15% DV or more is a lot

This proposal was retained as it was well received by consumers and health stakeholders

* The percent daily value (%DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

To explain the % DVs.
Voluntary declaration of bioactive compounds in a separate box Not retained  

 

 

Nouvelles caractéristiques présentées dans la
Gazette du Canada Partie I
du 13 juin 2015
Objectif de Santé Canada

Expand the use of health claims on fruits and vegetables to allow a disease reduction health claim linking their consumption to a reduction in heart disease.

Allow for approved nutrient content and health claims to be made on prepackaged fresh fruits and vegetables without additional labelling requirements.

To allow Canadians to be informed of the health benefits of eating fresh fruits and vegetables.

Disposition pour les petits emballages ayant une surface exposée disponible de moins de :

– 100 cm2 (e.g. size of a spice jar)

  1. the label need not carry a NFT if the outer side of the label contains an indication of how to obtain the nutrition information.
  2. the Nutrition Facts table, if displayed, need only include the:
  • serving of stated size;
  • energy value;
  • amount of each of the core nutrients (i.e. those generally required to be shown in the NFT) if the amount shown in the NFT is not “0”;
  • the amount of any nutrient that is the subject of a claim (express or implied);  and
    • amount of any sugar alcohol, vitamin or mineral nutrient added to the prepackaged product, if any.

– 15 cm2 (e.g. a very small package of gum containing two to four small pieces) need not carry an NFT, even if sugar alcohol, vitamin or mineral nutrients are added to the product, or if nutrient-content claims are made on the label or in advertising.

To address concerns raised by industry about the challenges associated with printing the NFT on smaller packages.

Currently, in most cases, no NFT is required when the product has less than 100 cm2 of available display surface on the label, but the use of certain sweeteners (namely acesulfame-potassium, aspartame, neotame, and sucralose), the addition of vitamins and/or minerals and/or nutrient content claims (e.g. sugar-free claims) triggers the requirement for an NFT.

If vitamin A is declared, it should be  calculated on the basis of micrograms of retinol activity equivalents (RAE) and expressed in micrograms on the basis of the following relationships:

  • 1 RAE = 1 µg de rétinol
  • 1 RAE = 12 µg of beta-carotene
Based on the most recent scientific knowledge.

Coming into force

The coming-into-force period of 5 years was chosen to minimize the cost of complying with new labelling requirements and allowing time to deplete current label stocks, and plan and gather capital for the label change. This would reduce product and label waste.

Exemptions for micro firms processing and selling food products

Products that are sold by the same person(s) that produced them and are sold at places such as farmers’ markets, craft shows, roadside stands, sugar bushes, and flea markets are exempt from the Regulations.

Benefits of regulatory modifications

Health Canada estimated the benefits of the modifications to the Nutrition Facts table to be worth $2.753 billion over 10 years, assuming a 1% reduction (compounded annually) in direct and indirect health costs in five chronic diseases (i.e. cardiovascular disease, malignant neoplasm, diabetes mellitus, musculoskeletal disease and nutritional deficiency). It is assumed that consumers, when given the necessary information to make healthy food choices, would experience reductions in negative health outcomes.

How to comment?

Interested persons may make representations concerning the proposed Regulations within 75 days after the date of publication of this notice, i.e. no before August 27, 2015. All such representations must:

  • cite the Canada Gazette, Part I, and the date of publication (June 13, 2015), and
  • be addressed to:

Dino Covone, Senior Policy Analyst
Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate
Health Canada
Holland Cross 1600 Scott Street, Tower B, 5th Floor, Address Locator: 3105A
Ottawa, Ontario  K1A 0K9

Fax:       613-941-7104

email:    LRM_ MLR_consultations@hc-sc.gc.ca

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