Canada Gazette

On December 12, 2002, the Government of Canada promulgated regulatory amendments to the Food and Drug Regulations to make nutrition labelling mandatory on most prepackaged foods, update nutrient content claims, and introduce provisions for the use of diet-related health claims. These amendments were published in the Canada Gazette, Part II, on January 1, 2003. A period of three years was provided to manufacturers to comply with the new regulations, with the exception of small businesses which were provided with a period of five years. Small businesses are manufacturers who had gross revenues from sales of food in Canada of less than $1,000,000 for the 12-month period immediately prior to December 12, 2002. Nevertheless, manufacturers who choose to make certain claims or use the expression "nutrition facts," "valeur nutritive" or "valeurs nutritives" can no longer benefit from the transition period of three or five years and must comply with the mandatory nutrition labelling requirements. These claims are

— the nutrient content claims for source of omega-3 polyunsaturated fatty acids and source of omega-6 polyunsaturated fatty acids; and

— the diet-related health claims set out in column 1 of the table following section B.01.603.

Since the promulgation of the December 2002 Regulations, Health Canada and the Canadian Food Inspection Agency (CFIA) have received inquiries from the food industry on the interpretation of the new labelling requirements. Health Canada recognized, through the process of assisting the industry in implementing the December 2002 Regulations, that additional regulatory amendments were required to bring more flexibility to the regulatory framework, clarify the intent of these requirements, correct inconsistencies between labelling provisions, and address items that were not included in the previous amendments. The regulatory amendments now proposed are integral to the Smart Regulation approach to promote effective and efficient processes, thus enhancing responsiveness and cooperation, as well as reducing compliance burden. As industry continues to implement the December 2002 Regulations on nutrition labelling, nutrient content claims and diet-related health claims, additional regulatory amendments may be required, as warranted, to continue to facilitate the conveyance of information about the nutrient content of food in a format which allows for comparison among foods and prevents consumers' confusion in respect of the nutrient value and composition of a food at point of purchase. All necessary changes are aimed at enabling consumers to make appropriate food choices to reduce the risk of developing diet-related chronic diseases, thus preventing injury to health.

The proposed amendments are not expected to have a significant impact on labels that have already been brought into compliance since December 2002 because most amendments would either give more flexibility to the requirements or would not change their intent. Only a few proposed amendments would result in more restrictive requirements than those found under the current nutrition labelling framework.

Amendments are proposed to the sections of the Regulations dealing with exemptions from the mandatory nutrition labelling requirements and format requirements for the Nutrition Facts table.

A number of categories of prepackaged foods are currently exempted from the mandatory nutrition labelling requirements. Based on comments received, three new exemptions are proposed which would add flexibility for the labelling of these categories of prepackaged foods. They would apply to coffee and tea, bottled water, and ground meat and ground poultry.

First, it is proposed to exempt coffee, tea and herbal tea, including the standardized products (e.g. regular and decaffeinated tea and coffee) and unstandardized products that are not sweetened (e.g. instant coffee and flavoured coffee). Since these products as consumed would meet the conditions for an exemption set out under paragraph B.01.401(2)(a), more specifically that all the core nutrient information "may be expressed as '0' in the Nutrition Facts table," these foods would not be required to carry a Nutrition Facts table.

The second proposed new exemption is for bottled water sold in 18-litre refillable plastic containers. This exemption would recognize the current industry practice that returnable bottles are not "product specific" (e.g. containers are not dedicated to spring water or distilled water). Therefore, it is not practical to change the label every time the container is returned for refilling. Furthermore, in most cases, mandatory labelling information is displayed on the cap closure, this being the principal display panel for these products. As with refillable glass containers of milk and cream, which are exempted from mandatory nutrition labelling requirements, as specified in subparagraph B.01.401(2)(c)(iii) of the Regulations, the proposed exemption would still apply if a claim were made on the label of or in any advertisement for these products. In this case, the amount of the nutrient that is the subject of the claim would have to appear on the label or in the advertisement, as described in the proposed amendment to paragraph B.01.503(1)c).

The third proposed exemption is for ground meat and ground poultry packaged at retail and labelled by means of a sticker where the available display surface of the package is less than 200 square centimetres (cm²). The current exemption, in subparagraph B.01.401(2)(b)(viii), pertaining to small packages does not include small packages of ground meat and ground poultry. Therefore, a new exemption is proposed to address this category of food.

The existing subparagraph B.01.401(2)(b)(ii) exempting fresh vegetables and fruits would be amended to clarify that the exemption includes fresh vegetables and fruits coated with mineral oil or other protective coatings. Mineral oil is a permitted coating under Division 16 of the Regulations, and other substances such as cottonseed oil, beeswax, candelilla wax, and carnauba wax have been recognized as acceptable protective coatings on fresh vegetables and fruits.

The English version of the exemption described in subparagraph B.01.401(2)(b)(viii) would be amended to clarify that the available display surface of 200 cm² applies to the package and not to the sticker label attached to the package. Similar changes are proposed in subsections B.01.454(5) and B.01.455(4) to clarify that the available display surface applies to the package and not to the sticker label.

A number of amendments are also proposed to the conditions that trigger the loss of an exemption.

In paragraph B.01.401(3)(a), sugar alcohols would be included in order to be consistent with the approach that has been applied throughout the Regulations for labelling requirements when vitamins, mineral nutrients and sugar alcohols are added to food. When these substances are added to a prepackaged food exempted from mandatory nutrition labelling, the food would lose its exemption and would be required to carry a Nutrition Facts table.

A second amendment in paragraph B.01.401(3)(a) would maintain the exemption for prepackaged water or ice containing insignificant amounts of all the core nutrients in the case where fluoride is added. Fluoride is not one of the core or additional nutrients listed under the tables to sections B.01.401 or B.01.402 that need to appear in the Nutrition Facts table. Therefore, it is considered unnecessary to require the display of the Nutrition Facts table whenever fluoride is added to prepackaged water or ice.

The reference to flour in paragraph B.01.401(3)(b) would be deleted, making it mandatory for a prepackaged food otherwise exempted from mandatory nutrition labelling to carry a Nutrition Facts table when vitamins or mineral nutrients are declared as components of flour used as an ingredient. Since it is optional to declare the components of flour in the list of ingredients, flour would be treated in the same manner as any other ingredient to which vitamins or mineral nutrients have been added.

In the case of foods that are intended solely for use as an ingredient in the manufacture of other foods, subsection B.01.404(2) of the Regulations currently provides that, while a Nutrition Facts table on the package is not required, nutrient information must accompany each shipment of the food. An amendment is proposed to clarify the situation where some prepackaged foods are sold both for use as an ingredient in the manufacture of other foods and directly to consumers at the retail level. It is proposed to remove the term "solely" in subsection B.01.404(1) to extend the requirement to provide nutrition information for prepackaged products used for further manufacturing to prepackaged products sold both for this purpose and to consumers at retail.

However, because a Nutrition Facts table would have to be provided on the label of prepackaged foods sold at the retail level, the information required under subsection B.01.404(2) would be required on a separate sheet accompanying the shipment of the product to cover situations where these products are used for further manufacturing. The information accompanying a shipment would not be permitted to appear on the label of a product sold also at the retail level, as having nutrient information presented in two different ways on the label would be confusing for the consumer. The proposed amendments in section B.01.404 would also clarify that the label could be used to display the information only when the product is solely intended for use as an ingredient in the manufacture of other foods.

Subsection B.01.404(2) requires that written nutrient information be provided with each shipment of all foods destined for use as ingredients in the manufacture of other food products. There are currently no exemptions to this requirement. The following list of foods, currently exempted from carrying a Nutrition Facts table when they are sold at the retail level, would be added to this subsection to apply the exemption when these foods are intended for use as ingredients in the manufacture of other foods:

— a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with paraffin wax, petrolatum, mineral oil or other protective coating;

— a raw single-ingredient meat, meat by-product, poultry meat or poultry meat by-product, except for ground meat and ground poultry; and

Suppliers of ingredient preparations containing vitamins or mineral nutrients, or a mixture of both, would be required to provide nutrition information only on the vitamin or mineral nutrient that is present in the preparation, since these preparations contain insignificant amounts of other nutrients.

Some of the following proposed amendments are required to complement the proposed amendments on exemptions described above.

Under the requirements of the December 2002 Regulations, when vitamins or mineral nutrients are added to a food, the Nutrition Facts table must include a declaration of the added nutrients. While fluoride added to prepackaged water or ice is currently exempted from this requirement, the reference to fluoride is not necessary since fluoride is not a nutrient whose declaration is permitted in the Nutrition Facts table. Therefore, an amendment is proposed to remove the reference to fluoride in subsection B.01.402(6) and in paragraphs B.01.401(6)(g) and B.01.403(5)(g).

It is also proposed that, when vitamins and mineral nutrients are declared as components of flour, they would be required to be declared in the Nutrition Facts table. This provision is needed in recognition that it is optional to declare the components of flour in the list of ingredients and that flour should be treated the same way as other ingredients to which vitamins or mineral nutrients are added. It is therefore proposed to delete the exemption for flour in paragraphs B.01.401(6)(h), B.01.403(5)(h) and subsection B.01.402(7).

In subsection B.01.402(7), it is proposed that sugar alcohols be included so that, when they are declared as a component of an ingredient in a food, the Nutrition Facts table would have to include a declaration of their amount. This would maintain consistency with the regulatory approach that has been applied on labelling requirements for added vitamins, mineral nutrients and sugar alcohols.

In view of providing more options in describing in a meaningful manner the serving size in a measure that is familiar to consumers in the case of a multiple serving of meat (e.g. roast beef), poultry (e.g. whole chicken) or fish that cannot be cut into slices or pieces of similar sizes, or fish fillets, the option of declaring the serving size on the basis of 100 grams would be given for these products. The value of 100 grams is consistent with the requirement before the December 2002 Regulations for the labelling of nutrient information on meats containing added phosphate salts.

It is also proposed that, when the serving size is expressed in grams, it would be described with the words "edible portion" to clarify that the weight of a serving does not include the portion of the food that is not consumed, e.g. the bone of a chicken leg.

Amendments are also proposed to bring clarity to the rounding rules for the declaration of cholesterol in the Nutrition Facts table. This proposed amendment is minor and intends to address an inconsistency introduced inadvertently during the preparation of the final version of the December 2002 Regulations. While the original proposal for this rule, published in the Canada Gazette, Part I, in June 2001, required the rounding to the nearest multiple of 1 milligram (mg), it was recognized that there was no reason to make the rounding rules for cholesterol more stringent than those for saturated fat and trans fat. Thus, it was considered appropriate to allow rounding of cholesterol values to the nearest multiple of 5 mg in the Nutrition Facts table. This decision made it obsolete to link the conditions for rounding to the "free of cholesterol" claim. Removing this condition in column 4, subitem 1(a) of item 7 in the table to section B.01.401 would address this oversight.

A proposed new provision would introduce a footnote to the "manner of expression" column in the tables to sections B.01.401 and B.01.402 to clarify that, when a number is equidistant from two consecutive multiples, it would be rounded off to the higher of the two multiples. For example, "To the nearest multiple of 1 g" means that a value of 1.5 g would be declared as "2 g" in the Nutrition Facts table. This precision would not affect how nutrient values are declared but would simply clarify the applied convention.

It is proposed that subparagraph (a)(ii) of item 14 in column 4 of the table to section B.01.402, for the optional vitamins and mineral nutrients, be amended to read the same as subparagraph (a)(ii) of item 13 of the table to section B.01.401. This would not change the current requirement but would maintain consistency with the wording used to describe the rounding rules for the core vitamins and mineral nutrients in item 13 of the table to section B.01.401.

Based on comments received from companies that have voluntarily implemented the Regulations since December 12, 2002, several amendments, described below, are proposed to the Nutrition Facts table format. The majority of these amendments would bring more flexibility in the way nutrient information may be presented on the label, or would clarify the terminology or the intent of a requirement. Nevertheless, one of the proposed amendments would represent a new requirement where more than one method of preparation is suggested on the package.

The Regulations currently state that, in the case of a product that is an assortment of foods, such as multi-packs of instant oatmeal, granola bars and different varieties of muffins, the Nutrition Facts table must be set out in an Aggregate Format. However, it is recognized that greater flexibility should be given to permit the display of the information in multiple Nutrition Facts tables (i.e. one Standard Format table for each food) rather than in a single Aggregate Format. Therefore, section B.01.457 would be amended to provide for this option. While the hierarchy of formats would not apply in this case, the nutrient information in each of the Standard Formats would need to be presented in 7-point condensed type with 11-point leading as a minimum.

In some cases, a manufacturer may wish to provide information "as prepared" for each food in an assortment. However, the Regulations require that, when information is provided for the food "as prepared," it be presented in the Dual Format. Since the Dual Format only sets out information for a single food, section B.01.457 would be amended to allow for the use of multiple Dual Formats (i.e. one Dual Format for each food in the assortment). Similar to the situation described above where multiple Standard Formats would be used, the nutrient information in each of the Dual Formats would be required in 7-point condensed type with 11-point leading as a minimum.

The same issue has been raised with respect to the use of the Dual or Aggregate Format for different amounts of a food. While these formats set out information for each amount of the food on an "as sold" basis, sometimes a food can be used for two or more types of preparation, each requiring a different amount of the food. Therefore, sections B.01.458 and B.01.459 would be amended to provide for the option of using multiple Dual Formats — Foods Requiring Preparation (i.e. one Dual Format for each amount of the food). Again, a minimum 7-point condensed type with 11-point leading would be required as a minimum for the display of the information within the Nutrition Facts tables.

A new requirement is proposed in the case where the label of a food carries more than one method of preparation on the package, as stated in the new proposed subparagraph B.01.406(5)(a)(vi). Currently, there is no requirement for an indication of which method of preparation has been used as the basis for the information appearing in the Nutrition Facts table for the food as prepared. This situation could be confusing to the consumer who may not necessarily know if the nutrient information is relevant to the product as consumed. Therefore, manufacturers would be required to indicate clearly which method of preparation forms the basis of the information appearing in the Nutrition Facts table for the food as prepared, when more than one method of preparation is suggested. To clarify this intent, it is also proposed that the word "directions" appearing in subsection B.01.406(5) be replaced with "method of preparation."

Section B.01.456 would be amended to remove the requirement for the use of the Dual Format when the serving size is presented for the food "as prepared" in the case where the nutrient information would be the same for the food as sold and "as prepared" (e.g. frozen concentrated juice that requires the addition of water). A change would also be made to Figure 1.1 in Schedule L to show how the serving size for the food "as prepared" would be displayed.

It is proposed to clarify subparagraphs B.01.406(5)(b)(i) and (ii) regarding the presentation of information for a food "as prepared" using a Dual Format. To reflect the information illustrated as such in the appropriate Figures in Schedule L (Figures 8.1, 9.1, 9.5), a new subparagraph would be added in paragraph B.01.406(5)(b) to specify that the information in the footnote pertaining to the added ingredients also include an indication of calories. In addition, it would be clarified that the information is based on a serving of the food as prepared.

A new format is proposed, titled "Simplified Aggregate Format — Different Ingredients or Foods," in the case where each ingredient or food in an assortment would meet the conditions for the use of a Simplified Format. The provisions for the use of this format are proposed under new section B.01.457.1 and mirror those of the Aggregate Format for different ingredients or foods. The proposed new Figures 11.11 to 11.16 and 11.21 to 11.26 are introduced in Schedule L. The provisions set out in section B.01.466 would also be amended to specify when alternative methods of presentation could be applied using this new format.

Subsection B.01.455(1) would be amended to clarify that the Simplified Format may contain additional (optional) information in addition to what is required to be declared in such a format. This proposal corrects an inconsistency in the provisions for the use of a Simplified Format. Subsection B.01.401(6) would also be amended to clarify that the amounts of saturated fat and trans fat, including their sum expressed as a "% Daily Value," would be required to be declared in the Simplified Format when either one of the two nutrients, or both, would not qualify for a "0 g" declaration.

It is proposed that the heading "Aggregate Format — Different Kinds of Foods" be changed to "Aggregate Format — Different Ingredients or Foods" to better reflect its intended purpose. While none of the graphic specifications would be affected in this case, proposed new illustrations would be introduced in Schedule L for Figures 11.1 and 11.5 to reflect accurately the 7-point leading requirement for the second line of the subheadings. An amendment is also proposed in subsections B.01.406(3) and (4) to clarify that the provisions for assortments of foods of the same type apply to all assortments and not just to assortments of foods of the same type.

It is necessary to amend the definition of "point," i.e. the unit of measurement for the size of characters, rules and leading in the Nutrition Facts table, such as 7-point condensed type. It would be defined as 0.3527777778 millimetres (mm) to correct an error introduced in section B.01.400. This definition would be consistent with the norm used in desktop publishing and applied in the development of all of the Nutrition Facts table Figures in Schedule L as well as in the Compendium of Templates for Nutrition Facts tables.

Based on comments received, Figure 1.1 would be amended to include a few additional specifications to clarify intent. It would indicate that the "Nutrition Facts" heading may be full justified and that the box may be printed with a rule that is greater than 0.5 point. This is reflected in the current illustration but a specification would also be added to state explicitly that there must be a minimum of 5 points of spacing between columns.

The words "under the customary conditions of purchase" in paragraphs (b) and (d) of the definition of "available display surface" would be changed to "under normal or customary conditions of sale" to maintain consistency in wording between different regulations. A number of other provisions in the format sections would also be amended to be consistent with this terminology, more specifically subsections B.01.454(6), B.01.455(5), B.01.456(4), B.01.457(4), B.01.458(4), B.01.459(4), and paragraph B.01.467(2)(b).

The Regulations promulgated on December 12, 2002, require a declaration of the amount of sugar alcohols in the Nutrition Facts table. Therefore, section B.01.018 has been amended to repeal the requirement that the label of a food containing isomalt, lactitol, maltitol, maltitol syrup, mannitol, sorbitol, sorbitol syrup or xylitol carry a declaration of the amount of any such substance in the food. Nevertheless, meal replacements, nutritional supplements, formulated liquid diets, and foods represented for use in a very low-energy diet are exempted from carrying a Nutrition Facts table. As a consequence, these foods are not required anymore to carry a declaration of the amount of sugar alcohols present on their labels, which no longer indicate to consumers the presence of these substances in food. This information is essential to consumers and, therefore, a proposed amendment would re-instate the requirement in the case of the aforementioned foods and would require that such a declaration be grouped together with the statement of the amount of polydextrose, when applicable.

Currently, the definition of "infant" appears in Division 25 of Part B of the Regulations because it applies to the provisions for infant foods, human milk substitutes, and foods containing human milk substitutes found in this Division. However, since the new provisions for nutrition labelling and claims also use the term "infant," it is proposed that the definition be moved to Division 1 of Part B and be added to Part D of the Regulations. This would cover the use of the term "infant" throughout these parts of the Regulations.

Amendments are proposed to adjust certain provisions related to the use of claims. Although most changes would add flexibility for manufacturers wishing to include claims on the labels of their products or would simply bring clarity to some of the requirements, other new requirements are proposed. Additional reference amounts are also proposed for different categories of foods.

The current subsection B.01.503(3) requires that all the words, numbers, signs or symbols that are part of a nutrient content claim be of the same size and prominence. It is proposed to extend this requirement to all types of statements or claims regarding a nutrient, whether it is a quantitative declaration, biological role claim or health claim, by amending sections B.01.301, B.01.305, and B.01.311 and by adding section B.01.601.1. This would avoid a situation where undue emphasis is given to any one part of the claim, recognizing that all aspects of a claim are important for consumer understanding in order to achieve prevention of injury to health.

A new provision in section B.01.313 is proposed to allow a representation regarding the presence of a specific fatty acid on the label of or in any advertisement of a human milk substitute or a formulated liquid diet. This was current practice before the promulgation of the December 2002 Regulations which prohibited the use of such statements on foods as a result of the new nutrient content claims rules. It is proposed to continue to allow statements to indicate that a specific fatty acid has been added in human milk substitutes and formulated liquid diets. Therefore, an amendment would be required to permit such statements on these products.

Since reference amounts do not exist for meal replacements and nutritional supplements, most nutrient content claims and health claims would not be acceptable on these foods, as the conditions for their use are linked to the amount of a nutrient in a reference amount of the food. A new provision is proposed in sections B.01.503 and B.01.601 that would base the nutrient criteria for these foods on the serving of stated size to provide more flexibility.

A proposed new requirement would include quantitative declarations for 0 g trans fat, 0 g saturated fat and 0 mg cholesterol that appear outside the Nutrition Facts table under the nutrient content claims provisions. Such statements could be perceived by consumers as being the same as a "free of" nutrient content claim, for which terms like "0 saturates," "0 trans" and "0 cholesterol" are acceptable synonyms. Therefore, to avoid misleading the consumer, it is proposed that such statements be treated in the same manner as nutrient content claims. Amendments are proposed in section B.01.301 and in column 4 of items 18, 22 and 27 of the table following section B.01.513 to address this situation.

A new requirement is also proposed on the use of a "no added fat" claim. It is proposed that the conditions for the use of this claim be expanded to consider added monoglycerides, diglycerides, or oils from marine and fresh water sources (e.g. oils from algae or fungi) as added fats or oils. The addition of any one of these to a food or to an ingredient in a food would disqualify the food from being eligible to carry the "no added fat" claim. The current conditions for the use of the claim were intended to cover all types of fats or oils added to a food. However, it became clear through inquiries received that some of the potential sources used were not explicitly included in the requirements.

The current requirements limit the use of protein claims to those foods for which a reasonable daily intake has been determined. Since the Regulations do not include reasonable daily intakes for all categories of foods, it is proposed that the conditions in column 2 of items 8, 9 and 10 related to protein claims in the table following section B.01.513 be amended to specify that the nutrient criteria relate to the amount of the nutrient in a reference amount of the food, where no reasonable daily intake has been specified.

It is also proposed that the conditions for making a "no added sodium or salt" or "no added sugars" claim be amended, as set out in column 2 of items 35 and 40 of the table following section B.01.513, to exempt foods intended solely for children under two years of age from the condition in subsections (2) and (3), respectively, which relate to the comparison to the similar reference food. This change would recognize that this information is still useful to those individuals buying these foods even in the absence of similar reference foods with added sugars or added salt.

Currently, representations characterizing the amount of alcohol on beverages containing more than 0.5 percent alcohol are exempted from the general prohibition on making claims, as stipulated in section B.01.502. To reflect current practice and the availability of alcoholic beverages containing low levels of alcohol, it is proposed to amend paragraph B.01.502(2)(j) to also allow such representations on a beverage that contains less than 0.5 percent alcohol, e.g. low alcohol wine.

The conditions for making "lower" or "more" nutrient content claims are based on the amount of the nutrient in the food in comparison with the amount of the nutrient in a reference food of the same food group. To help clarify the intent, it is proposed that the definitions for "reference food of the same food group" and for "other foods" be amended to indicate that a food belonging to one of the subcategories listed in the definition for "other foods" can only be compared with another food from that same subcategory. For example, since butter and margarine belong to the same subcategory of "other foods," they may be the subject of a comparison; but butter and jam could not be compared given that they belong to different subcategories of "other foods."

When the claim "light" is used to refer to a sensory characteristic of the food, the Regulations require that the sensory characteristic be identified adjacent to the claim, e.g. light in colour. There are currently two situations where the sensory claim "light" would not trigger this requirement. It is proposed that a third exemption be provided in subsection B.01.513(2) in the case of tuna. The Fish Inspection Regulations require the words "Light tuna" or "Light Meat tuna" to appear on labels of tuna cans to indicate the colour of the fish flesh.

The compositional criteria for nutrient content claims are based on both regulated standardized reference amounts and servings of stated size. The reference amounts are derived from the average quantities of foods consumed at single eating occasions. Their use ensures a uniform basis for claims for any specific category of food. Reference amounts were determined for 153 categories of foods in the December 2002 Regulations, which are described by examples of foods. Since the existing reference amounts failed to capture a number of foods, it is proposed that additional reference amounts be introduced for the following foods:

• Gnocchi — 85 grams (g) dry, 215 g cooked (item 35);

• Streusel topping — 35 g (item 59);

• Yeast — 0.6 g (item 97);

• Flavouring preparation — 1 millilitre (mL) [item 106.1];

• Side dishes, such as beans, pasta or rice — 40 g dry, 125 mL cooked (item 109.1);

• Fresh, canned or frozen vegetables primarily used for garnish or flavouring — 4 g fresh or frozen, 5 mL canned (item 144);

• Sun-dried tomatoes — 15 g (item 149); and

• Foods intended solely for children under two years of age:

- Combination dishes, meat, desserts, fruit and vegetables that are strained — 60 mL (item 154),

- Dry instant cereals — 15 g (item 155),

- Juices, all varieties — 125 mL (item 156),

- Combination dishes represented for toddlers — 170 g (item 157),

- Combination dishes represented for juniors — 110 g (item 158),

- Desserts, fruit and vegetables represented for juniors — 110 mL (item 159),

- Ready-to-eat cereal represented for toddlers — 20 g (item 160), and

- Cookies, teething biscuits and toasts — 7 g (item 161).

It is proposed that the reference amount for canned potatoes, sweet potatoes and yams be changed from 160 g to 150 mL (item 116) to maintain consistency with the units required under the Consumer Packaging and Labelling Act and Regulations for the declaration of the net quantity.

A few changes are also proposed to help clarify which food categories are intended to be covered under a specific reference amount. The descriptions for egg products and for syrups in items 62 and 141, respectively, would be amended to clarify the link between products and the reference amounts that apply. The term "wine coolers" would be deleted from item 23, since it is covered under "carbonated and non-carbonated beverages" in the same category. In the French version, it is proposed that the term "biscuits pour le thé" in item 2 be changed to "gâteaux pour le thé" to better reflect the intent of the term and that "petits pains au lait sucrés" in item 7 be deleted, since "brioches" more appropriately describes the foods falling under this category. The proposed amendment in item 26 would simply correct the misalignment between the two columns of information.

Currently, the Regulations set out two options for the health claim pertaining to the link between saturated and trans fats and reduced risk of heart disease. The first option indicates that the food subject of the claim is "free" of saturated and trans fats, and the second permits the use of the term "low" for these two nutrients. To provide more flexibility, it is proposed that a third option be introduced, in column 1 of item 3 of the table following section B.01.603, to cover the situation where the food is low in saturated fat and free of trans fat. The corresponding condition that the food be "free in trans fat," which also requires that the food be "low in saturated fat," is consequently proposed in column 2.

In light of the introduction of provisions for nutrient content claims, an amendment was made in Division 24 to allow the use of the claims "diet" and "dietetic" on foods for special dietary use. To maintain consistency and provide clarity, the provision in subsection B.24.003(4) would be amended to explicitly state that the product must be a food for special dietary use in order to carry these claims.

It is proposed that the term "ration quotidienne normale," which appears in Part D (D.01.001, D.01.009 to D.01.011, D.02.009) and Schedule K, be changed to "ration quotidienne raisonnable" to correct an inconsistency in the French terminology that currently exists between Part B, Part D and Schedule K of the Regulations. The wording of the definition in section D.01.001 would also be slightly amended to maintain consistency in terminology used throughout the Regulations. The meaning of this term would not change.

Manufacturers will be able to implement changes to their labels when the proposed amendments come into force, i.e. on the day on which the Regulations would be registered. Nevertheless, a transition period ending on December 12, 2006, is proposed to provide time to comply with the additional requirements subject of these proposed amendments. Thus, except in the case explained in the paragraph below, manufacturers who will bring their products into compliance with the December 2002 Regulations on December 12, 2005, would also benefit of the transition period ending on December 12, 2006, to implement the additional requirements detailed in the proposed amendments.

The transition period ending on December 12, 2006, would also apply to small businesses that have already changed their labels to reflect the December 2002 Regulations. However, in the case of small businesses that have not yet implemented the December 2002 Regulations, they would have until December 12, 2007, to comply with the December 2002 Regulations and the additional requirements specified in these proposed amendments.

Manufacturers who would choose to make the proposed health claim set out in subitem 3(3) of the table following section B.01.603 would have to comply immediately with the December 2002 Regulations and the proposed amendments once they come into force.

Under the Food and Drugs Act, provisions for changes to the Regulations can only be accommodated by regulatory amendments. Maintaining the status quo was not an acceptable option as this would prevent introducing changes to the Regulations required to correct inconsistencies and provide more flexibility and clarity to the regulatory requirements to facilitate compliance. Amendments were also warranted to provide the consumers with better nutrition information and to enable them to make informed food choices in order to prevent injury to their health.

The proposed amendments would benefit consumers since the individual's capacity to adopt a healthy pattern of eating is influenced both by the availability and consistency of nutrition information from many sources, including food labels. The proposed amendments to the Regulations would improve the clarity of the nutrition information. These proposed amendments would enhance consumers' ability to make informed dietary choices that contribute to prevent injury to their health.

The proposed amendments would also be beneficial to the food industry as the proposed amendments would facilitate compliance with the Regulations by correcting inconsistencies, bringing clarity to the requirements and providing more flexibility on how to present nutrition information on the labels of food products. These proposals would not affect the level of compatibility, neither would they increase the differences with the nutrition labelling requirements in the United States, Canada's major trading partner.

The proposed amendments to the nutrition labelling framework would not be expected to increase the overall cost of labelling for industry, except for the few additional requirements that would be more restrictive for manufacturers who have already changed their labels, when applicable. To address these challenges to the industry, it is proposed that manufacturers would have until December 12, 2006, to comply with the proposed new requirements. Because food manufacturers can choose to use nutrient content or diet-related health claims, the cost associated with the proposed changes to the claims would be minimal compared to the benefits.

It is anticipated that the proposed amendments to the current regulatory framework would not increase the cost of food products for the consumers. With regard to cost to the Government, no new resources have been identified to support the implementation of these proposed Regulations. Additional costs would be expected to implement these proposed changes to amend the 2003 Guide to Food Labelling and Advertising and adapt CFIA inspection tools and other training and reference materials.

A formal consultation on the proposed amendments to the Regulations was not carried out. However, Health Canada and the CFIA have provided advice to the food industry seeking clarification on the December 2002 Regulations. Based on the incoming questions from the industry, Health Canada deemed it necessary to move forward with proposed amendments to the Regulations to address gaps, clarify requirements where necessary, and provide additional flexibility where warranted.

Requests were received from the Coffee Association of Canada and the Tea Association of Canada to exempt coffee, tea and herbal tea from mandatory nutrition labelling. While the intent of the current Regulations was to exempt such products on the basis that all of the core nutrients could be expressed as "0 g" in the Nutrition Facts table, these Associations pointed out that even though the final prepared product would contain insignificant amounts of all the core nutrients, this could not be confirmed on an "as sold" basis because levels of carbohydrates would be too high to meet the condition for a 0 g declaration. Given that the product as consumed would meet the conditions for the exemption, it is proposed to eliminate this ambiguity by exempting coffee, tea and herbal tea, including standardized products (e.g. regular and decaffeinated tea and coffee) and unstandardized ones that are not sweetened (e.g. instant coffee, flavoured coffee) from carrying a Nutrition Facts table.

The Canadian Bottled Water Association (CBWA) submitted a request for a blanket exemption from the nutrition labelling requirements for all bottled waters that do not carry a nutrient content claim. In the case of the 18-litre refillable containers, the proposed exemption from having to carry a Nutrition Facts table is based on the fact that it is not practical to change the label every time the container is returned for refilling. Furthermore, the cap closure, which is considered the principal display panel for these foods and is most often used for the display of mandatory labelling information, could not accommodate a Nutrition Facts table. Nevertheless, when a claim is made, the amount of the nutrient subject of the claim would have to be declared on the label or in the advertisement. An exemption could not be supported in the case of single use containers of bottled water because some imported products may have elevated sodium levels, an important piece of information for consumers, particularly when high blood pressure is a concern.

Based on questions from the Canadian Meat Council and the Canadian Produce Marketing Association, it was noted that the exemptions provided for certain categories of foods apply only to prepackaged products sold at the retail level and not to those prepackaged foods sold for use as ingredients in the manufacture of other foods. In response to the concerns raised, it is proposed that the exemptions from carrying a Nutrition Facts table currently established for beverages with an alcohol content of more than 0.5 percent; fresh fruit and vegetables; raw single ingredient meat, meat by-products, poultry meat or poultry meat by-products, that are not ground; and raw single ingredient marine and fresh water animal products also apply to food intended for use as ingredients in the manufacture of other foods.

While the intent of the Regulations was to exempt all types of products that are sold only in the retail establishment where they are packaged, if they are labelled by means of stickers and have an available display surface of less than 200 cm², the Beef Information Centre pointed out that the exemption in subparagraph B.01.401(2)(b)(viii) could be lost in the case of ground meats even if the available display surface of packages of ground meats are less than 200 cm². It is, therefore, proposed that an exemption be added in the case of ground meats sold in packages with less than 200 cm² of available display surface.

A number of other requests were received from various stakeholders. Some members from the industry requested that the Regulations provide for the option of using multiple Nutrition Facts tables for an assortment of foods instead of a single Aggregate Format. Also, in the case of foods that are prepared in accordance with a method of preparation suggested on the package, or that are combined with other ingredients, there is currently no regulation that allows for the nutrient information to be declared as "prepared" for each food in an assortment, e.g. multiple pack of cereals prepared with milk, or for each amount of food in the case where more than one type of final product can be prepared, e.g. different amounts of a dry mix used to prepare pizza crust or bread rolls. Based on examples of labels bearing multiple Nutrition Facts tables, it is agreed that this option would be an acceptable alternative for manufacturers. Therefore, it is proposed that the sections pertaining to the different Nutrition Facts table formats be amended to provide more flexibility.

It was also pointed out that while the Regulations provide for the option of using a Simplified Format when a food contains a "0" declaration for at least seven of the core nutrients, this option is not available in the case where each of the foods in an assortment would meet this condition. In recognition that there are assortments where each food would qualify for a simplified declaration, e.g. assortment of candies, it is proposed to permit the use of a new Simplified Aggregate Format for the Nutrition Facts table in this case.

The serving size on which the nutrient information in the Nutrition Facts table is based is always provided for the food as sold. When the Dual Format is used to display information for the food as sold and as "prepared," the serving size is also expressed for both forms of the food, e.g. per 4 tablespoons (60 mL) / (about 250 mL prepared). When nutrient information is the same for both the food as sold and as "prepared," it is unlikely that a manufacturer would apply the Dual Format. However, some manufacturers have asked that they be allowed to provide the serving size for the food as "prepared" in these cases, without having to use the Dual Format, as this information is useful to the consumer. It is proposed that the regulations be amended accordingly.

In light of the difficulties expressed by several industry stakeholders in determining a unit of measure familiar to consumers, in the case of a product that is a multiple serving of meat, poultry or fish that cannot be divided into pieces or slices of similar sizes, or that is a product comprised of multiple fish fillets of different sizes, it is proposed to allow the declaration of the serving size on the basis of 100 grams.

A number of inquiries were made about applicable reference amounts for different types of products. While Schedule M is intended to simply set out examples of products fitting into different categories of foods, there are currently some foods that would not be covered by the existing reference amounts. A number of new proposed reference amounts have been added in Schedule M.

The situation for meal replacements and nutritional supplements was also clarified. It is proposed that the conditions for making claims be based on the serving size rather than on the reference amount in the case of these products.

It is also proposed, based on comments received, that in the case of the health claim for saturated and trans fats and reduced risk of heart disease, manufacturers be given the option of indicating that the particular food is free of trans and low in saturates, based on related conditions. It is proposed to add a third claim option in order to provide for this flexibility.

Health Canada and the CFIA have both received requests from the industry to revoke the requirement that the nutrient information required for foods intended for use as ingredients in the manufacture of other foods be provided on written documentation accompanying each shipment. While the industry has expressed concerns about the paper burden the December 2002 Regulations impose, it would be premature to propose changes to the Regulations at this point without alternative suggestions from the industry. It is important to give enough time to the industry to explore appropriate and efficient ways to deliver the nutrient information to its customers, in this case.

Correspondence from the beverage sector of the food industry suggested that the reference amounts for carbonated and non-carbonated beverages, and bottled water, which were increased from 250 mL to 355 mL and 500 mL, respectively, be reconsidered. The increase in these reference amounts reflects the most common single serving containers sold in Canada and brings about labelling that is more reflective of what is actually consumed. Without more compelling data from the industry that these reference amounts are inappropriate, changing the reference amount back to 250 mL cannot be justified at this time.

Comments were received from the food industry to extend the three-year transitional period for bringing labels into compliance with the December 2002 Regulations. Because of the Government of Canada's strong commitment to consumers to provide nutrient information on labels of most prepackaged foods by December 12, 2005, extending the transition provision is not considered acceptable.

As industry continues to prepare for implementation of the December 2002 Regulations, Health Canada and the CFIA will maintain discussions with specific sectors of the food industry to respond to issues raised and consider the most appropriate solutions to address them. Additional amendments may be required in the years to come to continue to improve the labelling requirements with the view to facilitate compliance and establish the best system of providing the appropriate information to consumers and preventing injury to health from diet-related chronic diseases.

The CFIA is responsible for the enforcement of the Food and Drugs Act as it relates to food. These proposed amendments would be integrated as part of the CFIA compliance activities on nutrition labelling, nutrient content claims and diet-related health claims for foods. The proposed amendments would be integrated into the 2003 Guide to Food Labelling and Advertising, CFIA inspection tools, and other training and reference materials.

Ronald Burke, Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, Address Locator 0702C1, Ottawa, Ontario K1A 0L2, (613) 957-1828 (telephone), (613) 941-3537 (facsimile), sche-ann@hc-sc.gc.ca (electronic mail).

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1416 — Nutrition Labelling, Nutrient Content Claims and Health Claims).

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Ronald Burke, Director, Bureau of Food Regulatory, International and Interagency Affairs, Department of Health, Room 2395, Building No. 7, Address Locator 0702C1, Tunney's Pasture, Ottawa, Ontario K1A 0L2 (tel: (613) 957-1828; fax: (613) 941-3537; e-mail: sche-ann@hc-sc.gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

REGULATIONS AMENDING THE FOOD AND DRUG
REGULATIONS (1416 — NUTRITION LABELLING,
NUTRIENT CONTENT CLAIMS AND
HEALTH CLAIMS)

1. (1) The definition "available display surface" in section B.01.001 of the Food and Drug Regulations (see footnote 1) is replaced by the following:

(a) the bottom of an ornamental container or the total surface area of both sides of a tag attached to the ornamental container, whichever is greater,

(b) the total surface area of both sides of a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under normal or customary conditions of sale, and

(c) the total surface area of any other package, excluding the bottom if the contents of the package leak out or are damaged when the package is turned over,

(d) any area of a package on which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under normal or customary conditions of sale,

(e) any part of a package that is intended to be destroyed when it is opened, other than a package of a food that is intended to be consumed by one person at a single eating occasion, or

(f) the area occupied by the universal product code; (surface exposée disponible)

(2) The definition "ration quotidienne raisonnable" in section B.01.001 of the French version of the Regulations is replaced by the following:

« ration quotidienne raisonnable » S'agissant d'un aliment dont le nom ou la description figure à la colonne I de l'annexe K, la quantité de cet aliment précisée à la colonne II. (reasonable daily intake)

(3) Section B.01.001 of the Regulations is amended by adding the following in alphabetical order:

2. The Regulations are amended by adding the following after section B.01.021:

B.01.022. (1) The label of a meal replacement, a nutritional supplement, a formulated liquid diet or a food represented for use in a very low energy diet that contains hydrogenated starch hydrolysates, isomalt, lactitol, maltitol, maltitol syrup, mannitol, sorbitol, sorbitol syrup or xylitol, either singly or in combination, shall carry a statement indicating the amount of each of these substances that is in the food, grouped together if more than one substance is present in the food, expressed in grams per serving of stated size.

(2) The statement of the amount of the substances referred to in subsection (1) shall be grouped together with the statement of the amount of polydextrose.

3. (1) Section B.01.301 of the Regulations is amended by adding the following after subsection (1):

(1.1) Despite subsection (1), a person may, on the label of or in any advertisement for a food, other than in the nutrition facts table, if any, include a declaration in respect of the amount of saturated fatty acids, trans fatty acids or cholesterol when the amount is declared as "0 g" in the case of saturated fatty acids and trans fatty acids, or as "0 mg" in the case of cholesterol, if the food meets the conditions set out in column 2 of the table following section B.01.513 for the following subjects set out in column 1:

(a) in respect of the amount of saturated fatty acids, the subject "free of saturated fatty acids", set out in item 18;

(b) in respect of the amount of trans fatty acids, the subject "free of trans fatty acids" set out in item 22; or

(2) The portion of subsection B.01.301(3) of the Regulations before paragraph (a) is replaced by the following:

(3) A declaration referred to in subsection (1), (1.1) or (2) that appears on the label of a food shall be

(3) Section B.01.301 of the Regulations is amended by adding the following after subsection (3):

(4) If a declaration referred to in subsection (1), (1.1) or (2) appears on the label of or in any advertisement for a food, other than in the nutrition facts table, all the words, numbers, signs or symbols that constitute the declaration shall be of the same size and prominence.

4. Section B.01.305 of the Regulations is amended by adding the following after subsection (4):

(5) If a representation referred to in subsection (1) or (2) is made on the label of or in any advertisement for a food, other than a declaration of the amount of protein in the nutrition facts table, all the words, numbers, signs or symbols that constitute the representation shall be of the same size and prominence.

5. Section B.01.311 of the Regulations is amended by adding the following after subsection (5):

(6) If a statement or claim referred to in subsection (2) or (3) is made on the label of or in any advertisement for a food, all the words, numbers, signs or symbols that constitute the statement or claim shall be of the same size and prominence.

6. The Regulations are amended by adding the following after section B.01.312:

B.01.313. Subject to section B.24.100, a person may, on the label of or in any advertisement for a formulated liquid diet or a human milk substitute, make a representation regarding the presence of a specific fatty acid.

7. The definition "point" in section B.01.400 of the Regulations is replaced by the following:

"point" means a unit of measurement for type size that is known as an Anglo-American point and is equal to 0.3527777778 mm. (point)

8. (1) Subparagraph B.01.401(2)(b)(ii) of the Regulations is replaced by the following:

(2) Paragraph B.01.401(2)(b) of the Regulations is amended by striking out the word "or" at the end of subparagraph (vii) and by replacing subparagraph (viii) with the following:

(viii) subject to subparagraph (c)(iv), sold only in the retail establishment where the product is packaged, if the product is labelled by means of a sticker and the product has an available display surface of less than 200 cm², or

(ix) coffee or tea products for which a standard is prescribed by these Regulations, or unsweetened, unstandardized coffee, herbal tea or tea; or

(3) Paragraph B.01.401(2)(c) of the Regulations is amended by striking out the word "or" at the end of subparagraph (ii) and by adding the following after subparagraph (iii):

(iv) a meat, meat by-product, poultry meat or poultry meat by-product that is ground, and that is sold only in the retail establishment where the product is packaged, if the product is labelled by means of a sticker and the product has an available display surface of less than 200 cm², or

(v) prepackaged water sold in an 18 L refillable plastic container.

(4) Paragraphs B.01.401(3)(a) and (b) of the Regulations are replaced by the following:

(a) the product contains an added sugar alcohol, or an added vitamin or mineral nutrient, except in the case of fluoride added to prepackaged water or ice;

(b) a vitamin or mineral nutrient is declared as a component of one of the product's ingredients;

(5) Paragraphs B.01.401(6)(g) to (i) of the Regulations are replaced by the following:

(g) the amount of any sugar alcohol, vitamin or mineral nutrient added to the prepackaged product, other than iodide added to salt for table or general household use;

(h) the amount of any vitamin or mineral nutrient that is declared as a component of one of the prepackaged product's ingredients;

(i) the amount of any nutrient referred to in column 1 of item 7, 8, 10, 11 or 13 of the table to this section that may not be expressed as "0" in the nutrition facts table;

(i.1) the amounts and the sum of saturated fatty acids and trans fatty acids if either or both amounts may not be expressed as "0" in the nutrition facts table; and

(6) The heading "Manner of expression" of column 4 of the table to section B.01.401 of the Regulations is replaced by "Manner of expression (see footnote 2)".

(7) The portion of subitem 1(1) of the table to section B.01.401 of the Regulations in column 3 is amended by striking out the word "and" at the end of paragraph (b) and by adding the following after paragraph (b):

(8) The portion of item 1 of the table to section B.01.401 of the Regulations in column 4 is amended by adding the following after subitem (3):

(9) The portion of subitem 7(1) of the table to section B.01.401 of the Regulations in column 4 is replaced by the following:

(10) The table to section B.01.401 of the Regulations is amended by adding the following after item 13:

¹ If the manner of expression requires that a number be rounded off to the nearest multiple specified and that number is equidistant from two consecutive multiples, it shall be rounded off to the higher of those multiples.

9. (1) Subsections B.01.402(6) and (7) of the Regulations are replaced by the following:

(6) The nutrition facts table shall show the amount of any sugar alcohol, vitamin or mineral nutrient added to the prepackaged product, except in the case of iodide added to salt for table or general household use.

(7) The nutrition facts table shall show the amount of any vitamin, mineral nutrient or sugar alcohol that is declared as a component of one of the prepackaged product's ingredients.

(2) The heading "Manner of expression" of column 4 of the table to section B.01.402 of the Regulations is replaced by "Manner of expression (see footnote 5)".

(3) The portion of subparagraph 14(a)(ii) of the table to section B.01.402 of the Regulations in column 4 is replaced by the following:

(4) The table to section B.01.402 of the Regulations is amended by adding the following after item 16:

10. Paragraphs B.01.403(5)(g) and (h) of the Regulations are replaced by the following:

(g) the amount of any sugar alcohol, vitamin or mineral nutrient added to the product;

(h) the amount of any vitamin or mineral nutrient that is declared as a component of one of the product's ingredients;

11. (1) Subsections B.01.404(1) and (2) of the Regulations are replaced by the following:

B.01.404. (1) This section applies to a prepackaged product that is intended for use as an ingredient in the manufacture of other prepackaged products intended for sale to a consumer at the retail level or as an ingredient in the preparation of food by a commercial or industrial enterprise or institution.

(b) a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or other protective coating;

(c) a raw single ingredient meat, meat by-product, poultry meat or poultry meat by-product, except those that are ground; or

(2) No person shall sell the prepackaged product unless written nutrition information concerning the product appears

(a) in the case of a prepackaged product that is intended solely to be used for the purposes of subsection (1), on the label of the product or in a separate document accompanying the product when it is delivered to the purchaser; or

(b) in the case of a prepackaged product that is intended to be sold at the retail level to the consumer and used for the purposes of subsection (1), in a separate document accompanying the product when it is delivered to the purchaser, but not on the label of the product.

(2) Paragraph B.01.404(3)(a) of the Regulations is replaced by the following:

(a) shall include, subject to subsection (4), the information that would, but for subsection B.01.401(7), be required by sections B.01.401 and B.01.402 to be included in a nutrition facts table for the product;

(3) Section B.01.404 of the Regulations is amended by adding the following after subsection (3):

(4) In the case of a preparation that contains one or more vitamins or mineral nutrients, or a mixture of both, and that is sold for use as an ingredient in accordance with subsection (1), only a declaration of the amount of the vitamin or mineral nutrient in the preparation is required.

12. (1) The portion of subsection B.01.406(3) of the Regulations before paragraph (a) is replaced by the following:

(3) If a prepackaged product contains an assortment of foods and the typical serving consists of only one of those foods, the information in the nutrition facts table shall be set out

(4) If a prepackaged product contains an assortment of foods and the typical serving consists of more than one of those foods, the information in the nutrition facts table shall be set out for each of the foods contained in the product or as a composite value.

(3) The portion of subsection B.01.406(5) of the Regulations before paragraph (a) is replaced by the following:

(5) If a prepackaged product contains a food that is to be prepared in accordance with a method of preparation provided in or on the package or that is commonly combined with other ingredients or another food or cooked before being consumed, the nutrition facts table may also set out information for the food as prepared, in which case

(4) Paragraph B.01.406(5)(a) of the Regulations is amended by striking out the word "and" at the end of subparagraph (iv) and by adding the following after subparagraph (v):

(5) Subparagraphs B.01.406(5)(b)(i) and (ii) of the Regulations are replaced by the following:

(i) the information set out in column 1 of items 3 to 5 and 7 to 12 of the table to section B.01.401, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7 and 8, per serving of stated size of the food as prepared, and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12, per serving of stated size of the food as prepared, and in the manner specified in column 4,

(ii) the information set out in column 1 of items 5 to 13 of the table to section B.01.402, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of item 9, per serving of stated size of the food as prepared, and in grams for the information set out in column 1 of items 5 to 8 and 10 to 13, per serving of stated size of the food as prepared, and in the manner specified in column 4, and

(iii) the information set out in column 1 of item 2 of the table to section B.01.401, expressed using a description set out in column 2, in the unit set out in column 3, per serving of stated size of the food as prepared, and in the manner specified in column 4.

13. Subsection B.01.454(5) of the English version of the Regulations is replaced by the following:

(5) Despite subsections (2) and (3), if the prepackaged product is sold only in the retail establishment where the product is packaged, is labelled by means of a sticker and the product has an available display surface of 200 cm² or more, its nutrition facts table shall be set out in a version that is listed in column 1 of items 1 to 3 of Parts 1 to 3 of the table to this section, without regard to any condition specified in column 2.

14. (1) Subsection B.01.455(1) of the Regulations is replaced by the following:

B.01.455. (1) This section applies to a prepackaged product if it satisfies the condition set out in subsection B.01.401(6) and its nutrition facts table includes the information referred to in paragraphs B.01.401(6)(a) to (j).

(2) Subsection B.01.455(4) of the English version of the Regulations is replaced by the following:

(4) Despite subsections (2) and (3), if the prepackaged product is sold only in the retail establishment where the product is packaged, is labelled by means of a sticker and the product has an available display surface of 200 cm² or more, its nutrition facts table shall be set out in a version that is listed in column 1 of items 1 to 3 of Parts 1 and 2 of the table to this section, without regard to any condition specified in column 2.

15. (1) Subsection B.01.456(1) of the Regulations is replaced by the following:

B.01.456. (1) Subject to subsections (2) and (5), if the nutrition facts table of a prepackaged product includes information referred to in subsection B.01.406(5), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) Section B.01.456 of the Regulations is amended by adding the following after subsection (4):

(5) If the nutrition information of a prepackaged product that is set out for the food as prepared, as provided by subsection B.01.406(5), is the same as that of the food as sold, the nutrition facts table may be presented in accordance with section B.01.454 or B.01.455 or subsections B.01.457(1) to (4).

16. The heading before section B.01.457 of the Regulations is replaced by the following:

17. (1) Subsection B.01.457(1) of the Regulations is replaced by the following:

B.01.457. (1) Subject to subsections (2), (5) and (6), if the nutrition facts table of a prepackaged product includes separate information for each food or ingredient as provided in subsection B.01.406(2), paragraph B.01.406(3)(a) or subsection B.01.406(4), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) Section B.01.457 of the Regulations is amended by adding the following after subsection (4):

(5) The nutrition information of a prepackaged product that is set out on the basis of each of the foods contained in the product, as provided in paragraph B.01.406(3)(a), may be presented in multiple nutrition facts tables, such that there is one table for each food, in a version that is listed in column 1 of items 1 to 3 of Parts 1 to 3 of the table to section B.01.454, without regard to any condition specified in column 2.

(6) The nutrition information of a prepackaged product that is set out on the basis of each of the foods contained in the product, as provided in paragraph B.01.406(3)(a), and that includes information for the food as prepared, as provided in subsection B.01.406(5), shall be presented in multiple nutrition facts tables, such that there is one table for each food, in a version that is listed in column 1 of items 1 to 3 of Parts 1 and 2 of the table to section B.01.456, without regard to any condition specified in column 2.

(3) The heading of Part 1 of the table to section B.01.457 of the Regulations is replaced by the following:

(4) The heading of Part 2 of the table to section B.01.457 of the Regulations is replaced by the following:

18. The Regulations are amended by adding the following after section B.01.457:

B.01.457.1 (1) Subject to subsections (2) and (5), if a prepackaged product satisfies the condition set out in subsection B.01.401(6) and its nutrition facts table includes separate information for each food or ingredient as provided in subsection B.01.406(2), paragraph B.01.406(3)(a) or subsection B.01.406(4), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a nutrition facts table in any of the versions that is listed in column 1 of the table to this section, the nutrition facts table shall be set out

(i) the bilingual simplified aggregate format in accordance with Figure 11.25(B) or 11.26(B) of Schedule L,

(ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the nutrition facts table, or

(iii) a manner described in section B.01.466.

(3) For the purpose of this section, in determining whether a version of a nutrition facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the nutrition facts table shall include only the information that is required by these Regulations to be included for each food or ingredient for which separate information is set out in the table.

(4) Despite subsections (1) and (2), if the nutrition facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the normal or customary conditions of sale, it shall be set out in a version that is described in subparagraph (2)(a)(i) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

(5) The nutrition information of a prepackaged product referred to in subsection (1) that is set out on the basis of each of the foods contained in the product, as provided in paragraph B.01.406(3)(a), may be presented in multiple nutrition facts tables, such that there is one table for each food, in a version that is listed in column 1 of items 1 to 3 of Parts 1 and 2 of the table to section B.01.455, without regard to any condition specified in column 2.

19. (1) Subsection B.01.458(1) of the Regulations is replaced by the following:

B.01.458. (1) Subject to subsections (2) and (5), if the nutrition facts table of a prepackaged product includes separate information for different amounts of the food as provided in paragraph B.01.406(7)(a) without including the information referred to in paragraph B.01.406(7)(c), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) Section B.01.458 of the Regulations is amended by adding the following after subsection (4):

(5) The nutrition information of a prepackaged product referred to in subsection (1) that also includes information for the food as prepared in accordance with subsection B.01.406(5) shall be presented in multiple nutrition facts tables, such that there is one table for each amount of the food, in a version set out in column 1 of items 1 to 3 of Parts 1 and 2 of the table to section B.01.456, without regard to any condition specified in column 2.

20. (1) Subsection B.01.459(1) of the Regulations is replaced by the following:

B.01.459. (1) Subject to subsections (2) and (5), if the nutrition facts table of a prepackaged product includes separate information for different amounts of the food as provided in paragraphs B.01.406(7)(a) and (c), the nutrition facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) Section B.01.459 of the Regulations is amended by adding the following after subsection (4):

21. The heading before section B.01.463 of the Regulations is replaced by the following:

Aggregate Format — Different Ingredients or Foods — Children under Two Years of Age

22. (1) The heading of Part 1 of the table to section B.01.463 of the Regulations is replaced by the following:

AGGREGATE FORMAT — DIFFERENT INGREDIENTS OR FOODS — CHILDREN UNDER TWO YEARS OF AGE

(2) The heading of Part 2 of the table to section B.01.463 of the Regulations is replaced by the following:

BILINGUAL AGGREGATE FORMAT — DIFFERENT INGREDIENTS OR FOODS — CHILDREN UNDER TWO YEARS OF AGE

23. (1) The portion of subsection B.01.466(1) of the Regulations before paragraph (a) is replaced by the following:

B.01.466. (1) Despite section A.01.016, the nutrition facts table of a prepackaged product that meets the condition specified in subsection B.01.454(3) or B.01.455(3), paragraph B.01.457(2)(b) or B.01.457.1(2)(b), subsection B.01.461(3) or B.01.462(3) or paragraph B.01.463(2)(b) may be set out on

(2) Subsection B.01.466(3) of the Regulations is amended by adding the following after paragraph (c):

(c.1) in the case of a product described in paragraph B.01.457.1(2)(b), in a version that is described in subparagraph B.01.457.1(2)(b)(i) or that is listed in column 1 of the table to section B.01.457.1;

24. (1) The portion of the definition "other foods" in subsection B.01.500(1) of the Regulations before paragraph (a) is replaced by the following:

"other foods" means the category of food to which belong foods that are not part of any food group and includes the following subcategories of food:

(2) Paragraph (b) of the definition "reference food of the same food group" in subsection B.01.500(1) of the Regulations is replaced by the following:

(b) the category of other foods, if the food to which it is compared belongs to the same subcategory of food set out in paragraphs (a) to (e) of that category, such as pretzels as a reference food for potato chips; or

25. Paragraph B.01.502(2)(j) of the Regulations is replaced by the following:

26. (1) Paragraph B.01.503(1)(a) of the Regulations is replaced by the following:

(a) subject to subsection (1.1), the food meets the applicable conditions set out in column 2;

(2) The portion of paragraph B.01.503(1)(c) of the Regulations before subparagraph (i) is replaced by the following:

(c) in the case of a food that is not a prepackaged product, prepackaged water sold in an 18 L refillable plastic container or a prepackaged product for which an advertisement is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement includes, per serving of stated size, and in accordance with section B.01.505 or B.01.506 if applicable,

(3) Section B.01.503 of the Regulations is amended by adding the following after subsection (1):

(1.1) For the purposes of paragraph (1)(a), in the case of a meal replacement or a nutritional supplement, the reference to "per reference amount" or "per reference amount and serving of stated size" in column 2 of the table following section B.01.513 shall be read as a reference to "per serving of stated size".

27. Paragraph B.01.513(2)(a) of the Regulations is replaced by the following:

(a) the English statement or claim "light" when used in accordance with subsection 12(1) of the Maple Products Regulations or paragraph 49(b) of the Fish Inspection Regulations; or

28. (1) Paragraph 8(a) of the table following section B.01.513 of the Regulations in column 2 is replaced by the following:

(2) Paragraph 9(a) of the table following section B.01.513 of the Regulations in column 2 is replaced by the following:

(3) The portion of item 10 of the table following section B.01.513 of the Regulations in column 2 is replaced by the following:

(4) The portion of item 17 of the table following section B.01.513 of the Regulations in column 2 is replaced by the following:

(5) The portion of item 18 of the table following section B.01.513 of the Regulations in column 4 is replaced by the following:

(6) The portion of item 22 of the table following section B.01.513 of the Regulations in column 4 is replaced by the following:

(7) The portion of item 27 of the table following section B.01.513 of the Regulations in column 4 is replaced by the following:

(8) Subitem 35(2) of the table following section B.01.513 of the Regulations in column 2 is replaced by the following:

(9) Subitem 40(3) of the table following section B.01.513 of the Regulations in column 2 is replaced by the following:

29. (1) Paragraph B.01.601(1)(a) of the Regulations is replaced by the following:

(a) subject to subsection (1.1), the food meets the applicable conditions set out in column 2;

(2) Section B.01.601 of the Regulations is amended by adding the following after subsection (1):

(1.1) For the purposes of paragraph (1)(a), in the case of a meal replacement or a nutritional supplement, the reference to "per reference amount and per serving of stated size" in column 2 of the table following section B.01.603 shall be read as a reference to "per serving of stated size".

30. The Regulations are amended by adding the following after section B.01.601:

B.01.601.1 If a statement or claim set out in column 1 of the table following section B.01.603 is made on the label of or in any advertisement for a food, all the words, numbers, signs or symbols that constitute the statement or claim shall be of the same size and prominence.

31. (1) The portion of item 3 of the table following section B.01.603 of the Regulations in column 1 is amended by adding the following after subitem (2):

(2) The portion of item 3 of the table following section B.01.603 of the Regulations in column 2 is amended by striking out the word "and" at the end of paragraph (g), by adding the word "and" at the end of paragraph (h) and by adding the following after paragraph (h):

32. The portion of subsection B.24.003(4) of the Regulations before paragraph (a) is replaced by the following:

(4) Except as otherwise permitted by these Regulations, no person shall label, package, sell or advertise a food as "dietetic" or "diet", or use those words as part of the brand name of the food, unless it is a food for special dietary use, and unless its label carries a statement or claim set out in column 4 of the table following section B.01.513, in accordance with section B.01.503, in respect of any of the following subjects set out in column 1:

33. The definition "infant" in section B.25.001 of the Regulations is repealed.

34. (1) The definition "ration quotidienne normale" in subsection D.01.001(1) of the French version of the Regulations is repealed.

(2) The definition "reasonable daily intake" in subsection D.01.001(1) of the English version of the Regulations is replaced by the following:

"reasonable daily intake", in respect of a food set out in column I of an item of Schedule K, means the amount of that food set out in column II of that item; (ration quotidienne raisonnable)

(3) Subsection D.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

(4) Subsection D.01.001(1) of the French version of the Regulations is amended by adding the following in alphabetical order:

35. The heading of Schedule K to the French version of the Regulations is replaced by the following:

36. The heading "R.Q.N." of column II of Schedule K to the French version of the Regulations is replaced by "R.Q.R.".

37. Figures 1.1(E) and 1.1(F) of Schedule L to the Regulations are replaced by the following:

38. The heading before Figure 10.1(E) and Figures 10.1(E) and 10.1(F) of Schedule L to the Regulations are replaced by the following:

39. Figure 11.1(B) of Schedule L to the Regulations and the heading before it are replaced by the following:

40. Figure 11.5(B) of Schedule L to the Regulations is replaced by the following:

41. Schedule L to the Regulations is amended by adding the following after Figure 11.6(B):

42. The heading before Figure 27.1(E) of Schedule L to the Regulations is replaced by the following:

43. The heading before Figure 28.1(B) of Schedule L to the Regulations is replaced by the following:

44. The portion of item 2 of Schedule M to the French version of the Regulations in column 1 is replaced by the following:

45. The portion of item 7 of Schedule M to the French version of the Regulations in column 1 is replaced by the following:

46. The portion of item 23 of Schedule M to the Regulations in column 1 is replaced by the following:

47. Item 26 of Schedule M to the English version of the Regulations is replaced by the following:

48. The portion of item 35 of Schedule M to the Regulations in column 1 is replaced by the following:

49. The portion of item 59 of Schedule M to the Regulations in column 1 is replaced by the following:

50. The portion of item 62 of Schedule M to the Regulations in column 1 is replaced by the following:

51. The portion of item 97 of Schedule M to the Regulations in column 1 is replaced by the following:

52. Schedule M to the Regulations is amended by adding the following after item 106:

53. Schedule M to the Regulations is amended by adding the following after item 109:

54. The portion of item 116 of Schedule M to the Regulations in column 2 is replaced by the following:

56. The portion of item 144 of Schedule M to the Regulations in column 2 is replaced by the following:

57. The portion of item 149 of Schedule M to the Regulations in column 1 is replaced by the following:

58. Schedule M to the Regulations is amended by adding the following after item 153:

59. The Regulations are amended by replacing the expression "customary conditions of purchase" with the expression "normal or customary conditions of sale" wherever it occurs in the following provisions:

60. The French version of the Regulations is amended by replacing the expression "ration quotidienne normale" with the expression "ration quotidienne raisonnable" wherever it occurs in the following provisions:

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (NUTRITION LABELLING, NUTRIENT CONTENT CLAIMS AND HEALTH CLAIMS)

61. The definition "former Regulations" in subsection 38(1) of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Nutrient Content Claims and Health Claims) (see footnote 14) is replaced by the following:

"former Regulations" means the Food and Drug Regulations as they read on December 11, 2002. (règlement antérieur)

"former Regulations" means the Food and Drug Regulations as they read immediately before the day on which these Regulations come into force, without regard to section 38 of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Nutrient Content Claims and Health Claims), as enacted by Order in Council P.C. 2002-2200 dated December 12, 2002 and registered as SOR/2003-11. (règlement antérieur)

"manufacturer" has the same meaning as in section A.01.010 of the Food and Drug Regulations. (fabricant)

"prepackaged product" has the same meaning as in section B.01.001 of the Food and Drug Regulations. (produit préemballé)

(2) Despite sections 1 to 60, the former Regulations continue to apply to a prepackaged product that is labelled in accordance with the former Regulations until December 12, 2006, unless the label of the product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product contains the statement or claim set out in column 1 of subitem 3(3) of the table following section B.01.603 of the Food and Drug Regulations, as enacted by subsection 31(1) of these Regulations.

(3) Despite sections 1 to 60 and subject to subsection (4), the Food and Drug Regulations as they read on December 11, 2002 continue to apply to a prepackaged product that is labelled in accordance with those Regulations until December 12, 2005, unless the label of the product, or any advertisement for the product that is made or placed by or on the direction of the manufacturer of the product, contains

(a) a statement or claim set out in column 4 of any of items 15, 16 and 22 to 26 of the table following section B.01.513 of the Food and Drug Regulations;

(b) a statement or claim set out in column 1 of the table following section B.01.603 of the Food and Drug Regulations; or

(4) In applying subsection (3) to a prepackaged product that is sold by a manufacturer who had gross revenues from sales in Canada of food of less than $1,000,000 for the 12-month period immediately prior to December 12, 2002, the reference to December 12, 2005 in that subsection shall be read as a reference to December 12, 2007.

(5) For greater certainty, subsection (4) does not apply to a prepackaged product that is sold by a manufacturer referred to in that subsection if the prepackaged product is labelled in accordance with the former Regulations.

63. These Regulations come into force on the day on which they are registered.

If the manner of expression requires that a number be rounded off to the nearest multiple specified and that number is equidistant from two consecutive multiples, it shall be rounded off to the higher of those multiples.