Vol. 141, No. 17 — August 22, 2007

Registration
SOR/2007-176 July 31, 2007

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1433 — Neotame)

P.C. 2007-1161 July 31, 2007

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, hereby makes the annexed Regulations Amending the Food and Drug Regulations (1433 — Neotame).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1433 — NEOTAME)

AMENDMENTS

1. Subsection B.01.015(2) of the Food and Drug Regulations (see footnote 1) is repealed.

2. Subsection B.01.017(2) of the Regulations is repealed.

3. Subsection B.01.020(2) of the Regulations is repealed.

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

B.01.022. The label of a food, other than a table-top sweetener, that contains neotame shall carry the following information:

(a) subject to paragraph (b), a statement on the principal display panel to the effect that the food contains neotame or is sweetened with neotame, in letters of at least the same size and prominence as the letters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;

(b) in the case where other sweeteners or sweetening agents are used in conjunction with neotame, a statement on the principal display panel, in letters of at least the same size and prominence as the letters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations, to the effect that the food

(c) if the label of the food carries a nutrition facts table, a statement setting out the neotame content expressed in milligrams per serving of stated size; and

(d) if the label of the food does not carry a nutrition facts table, a statement setting out the following energy value and contents of the food, per serving of stated size, grouped together and given equal prominence on any part of the label:

B.01.023. The label of a food that is a table-top sweetener that contains neotame shall carry the following information:

(a) a statement on the principal display panel to the effect that the food contains neotame or is sweetened with neotame, in letters of at least the same size and prominence as the letters used for showing the numerical quantity in the declaration of net quantity as required under section 14 of the Consumer Packaging and Labelling Regulations;

(b) a statement on any part of the label of the sweetness per serving expressed in terms of the amount of sugar required to produce an equivalent degree of sweetness;

(c) if the label of the food carries a nutrition facts table, a statement setting out the neotame content expressed in milligrams per serving of stated size; and

(d) if the label of the food does not carry a nutrition facts table, a statement setting out the following energy value and contents of the food, per serving of stated size, grouped together and given equal prominence on any part of the label:

5. Paragraph B.01.401(3)(c) of the Regulations is replaced by the following:

(c) the product contains added acesulfame-potassium, aspartame, neotame or sucralose;

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

Item	Column 2 Conditions — Food
2.	(a) 40 Calories or 167 kilojoules or less per reference amount and serving of stated size and, in the case of a food other than a table-top sweetener, if the reference amount is 30 g or 30 mL or less, per 50 g; or

7. Table IX to section B.16.100 of the Regulations is amended by adding the following after item M.3:

Item No.	Column I Additive	Column II Permitted in or on	Column III Maximum Level of Use
N.1	Neotame	(1) Table-top sweeteners	(1) Good Manufacturing Practice
		(2) Breakfast cereals	(2) 0.016%
		(3) Beverage mixes; Unstandardized beverages; Unstandardized beverage concentrates	(3) 0.003% in beverages as consumed
		(4) Dessert mixes; Fillings; Filling mixes; Toppings; Topping mixes; Unstandardized desserts; Yogurt	(4) 0.01% in products as consumed
		(5) Breath freshener products; Chewing gum	(5) 0.032%
		(6) Unstandardized fruit spreads; Unstandardized purées and sauces; Unstandardized table syrups	(6) 0.007%
		(7) Peanut and other nut spreads; Unstandardized salad dressings	(7) 0.002%
		(8) Unstandardized condiments	(8) 0.007%
		(9) Confectionary glazes for snack foods; Sweetened seasonings or coating mixes for snack foods	(9) 0.0032%
		(10) Unstandardized confections and their coatings	(10) 0.01%
		(11) Unstandardized bakery products and baking mixes	(11) 0.013% in products as consumed

COMING INTO FORCE

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

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

High intensity sweeteners used in the manufacture of foods are considered, under the Food and Drug Regulations, to be food additives. The high intensity sweeteners permitted under the Food and Drug Regulations are: aspartame, sucralose and acesulfame-potassium. The use of a new high intensity sweetener can only be accommodated by amendment of the Regulations following a thorough evaluation of its safety.

Health Canada has received a submission to amend the Food and Drug Regulations to permit the use of neotame, a substance that is 7,000 to 13,000 times sweeter than sugar. Neotame can be used as a high intensity sweetener in carbonated soft drinks, beverage concentrates, beverage mixes (powdered soft drinks, pre-sweetened cocoa, or coffee mixes), unstandardized dairy beverages, unstandardized fruit juices, breakfast cereals, dessert mixes, toppings, topping mixes, fillings, filling mixes, unstandardized desserts, yogurt, confectionery glazes for snack foods, sweetened seasonings or coating mixes for snack foods, confections, including candies and their coatings, chewing gum, breath freshener products, unstandardized fruit spreads, purées, sauces, unstandardized table syrups, unstandardized salad dressings, peanut and other nut spreads, condiments, unstandardized baked goods, baking mixes, and as a table-top sweetener at maximum levels of use specified in the amendments.

Evaluation of available data supports the safety and effectiveness of these uses of neotame. Similar applications of this food additive are already permitted in the United States, Australia, New Zealand and Europe.

Under the current Regulations, all foods (including those that are table-top sweeteners) that contain aspartame, acesulfame-potassium or sucralose must carry a statement on the principal display panel to the effect that the food contains or is sweetened with the sweetener. For foods carrying a nutrition facts table, the sweetener content expressed in milligrams per serving of stated size must be declared on their labels. In the case where the label of the food does not carry a nutrition facts table, information on the energy value expressed in calories or kilojoules, the protein, fat, and carbohydrate content, expressed in grams per serving of stated size, and the sweetener content expressed in milligrams per serving of stated size, must be provided on any part of the label, grouped with the list of ingredients. The same requirements apply to foods containing neotame.

The regulatory amendments also consolidate the conditions for the use of the claim "low Calorie" in English on labels of sweeteners within the table of nutrient content claims following section B.01.513 of the Regulations. Health Canada is revoking subsections B.01.015(2), B.01.017(2) and B.01.020(2) and amending paragraph (a) in column 2 to item 2 of the table following section B.01.513 to exclude table top sweeteners from the requirement that applies to foods with a reference amount of 30 g or 30 mL or less.

The revocation of the subsections mentioned above deletes the claim "faible teneur en calories" in French that is currently permitted for use on the label of these products. However, the amendments provide industry with more options under item 2 of the table following section B.01.513 to make other "low in energy" claims on their products. These options include the use of the claim "hypocalorique".

Therefore, these amendments to the Food and Drug Regulations permit the use of neotame in the above-named foods at the specified maximum levels of use and require that the label of a food containing neotame carries the information indicated above.

Alternatives

Under the Food and Drug Regulations, additional provisions for the use of new or already permitted food additives in foods can only be accommodated by regulatory amendment. Maintaining the status quo was rejected as this would preclude the use of a food additive which has been demonstrated to be both safe and effective.

Benefits and costs

These amendments provide consumers and the industry with an alternative to currently available sweeteners.

There is no anticipated increase in cost to government from the administration of the amendments to the Regulations. Furthermore, compliance costs incurred by manufacturers are not considered to be a factor as the use of neotame is optional.

Consultation

The proposed amendments were published in the Canada Gazette, Part I, on December 16, 2006. Interested parties were invited to provide comments on these amendments. Eight stakeholders from industry submitted comments and all were generally supportive of the amendments.

However, two respondents did not support the labelling provision which requires a statement on the principal display panel to the effect that the food contains or is sweetened with neotame. One respondent recommended deleting the proposed quantitative declaration requirement for neotame.

The principal display panel statement and the quantitative declaration requirements apply to all high intensity sweeteners. The Health Products and Food Branch is re-evaluating the necessity for the disclosure statement on the principal display panel and will consider the request regarding the quantitative declaration in the context of all the high intensity sweeteners. In the interest of the petitioner and of potential users of neotame, it was decided to promulgate the labelling provision as proposed and undertake any revisions to the labelling requirements for all high intensity sweeteners in a separate initiative.

One respondent recommended a change to paragraph (a) in column 2 to item 2 of the table following section B.01.513 which sets out conditions for the use of the "low Calorie" claim on labels of sweeteners without requiring the addition of the proposed paragraph (c). Health Canada concurs that amending paragraph (a) to exclude table-top sweeteners from the requirement that applies to foods with a reference amount of 30 g or 30 mL or less, will enable the use of the "low Calorie" claim for table-top sweeteners. The final amendment to paragraph (a) in column 2 to item 2 of the table following section B.01.513 reflects this recommendation.

Six respondents requested that the provisions be amended to permit higher levels of use of neotame in some of the foods listed.

The maximum levels of use of neotame being permitted in the above-named food products were requested in the original submission to Health Canada. The safety assessment supporting neotame's use in these foods is based on the maximum levels of use set out in these amendments. Any request to increase the permitted maximum levels of use of neotame in certain foods is considered a separate submission, requiring a review of the safety assessment and will be addressed in a separate initiative.

Compliance and enforcement

Compliance with the Regulations will be monitored by ongoing domestic and import inspection programs of the Canadian Food Inspection Agency.

Contact

Ronald Burke
Director
Bureau of Food Regulatory,
International and Interagency Affairs
Health Canada
200 Tunney's Pasture Driveway
A.L. 0702C1
Ottawa, Ontario
K1A 0L2
Telephone: 613-957-1828
Fax: 613-941-3537
Email: sche-ann@hc-sc.gc.ca

Footnote a

S.C. 1999, c. 33, s. 347

Footnote 1

C.R.C., c. 870

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