Vol. 138, No. 25 — December 15, 2004

Registration
SOR/2004-261 23 November, 2004

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1242 — Erythritol)

P.C. 2004-1388 23 November, 2004

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 (1242 — Erythritol).

REGULATIONS AMENDING THE FOOD AND DRUG
REGULATIONS (1242 — ERYTHRITOL)

AMENDMENTS

1. The Food and Drug Regulations (see footnote 1) are amended by adding the following after section B.01.020:

B.01.021. (1) The label of a food that contains erythritol shall carry a statement indicating the amount of erythritol expressed in grams per serving of stated size unless the label carries a nutrition facts table.

(2) The statement of the amount of erythritol shall be grouped together with the statement of the amount of any other sugar alcohols and the amount of polydextrose.

2. Table IX to section B.16.100 of the Regulations is amended by adding the following after item A.2:

Item No.	Column I Additive	Column II Permitted in or on	Column III Maximum Level of Use
E.1	Erythritol	(1) Table-top sweeteners	(1) Good Manufacturing Practice
		(2) Dietetic beverages	(2) 3.5%
		(3) Fat-based cream fillings and toppings	(3) 60%
		(4) Dietetic cookies and wafers	(4) 7%
		(5) Soft candies	(5) 40%
		(6) Hard candies	(6) 50%
		(7) Chewing gum	(7) 60%

COMING INTO FORCE

3. 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

Sugar alcohols (polyols) are food additives that are used as sweeteners and bodying and texturizing agents in foods. The limited absorption and metabolism of sugar alcohols are important factors in their use in dietetic foods. The Food and Drug Regulations currently allow specific sugar alcohols to be used in a variety of foods. The permitted sugar alcohols are: hydrogenated starch hydrolysates, isomalt, lactitol, maltitol, maltitol syrup, mannitol, sorbitol, sorbitol syrup, and xylitol.

Health Canada has received a submission to permit the use of a new sugar alcohol, erythritol, as a carrier for intense sweeteners in table-top sweeteners and as a sweetener in dietetic beverages, fat-based cream fillings and toppings, dietetic cookies and wafers, soft and hard candies, and chewing gum at various maximum levels of use specified in the amendments. Evaluation of available data supports the safety and effectiveness of these uses of erythritol. Similar applications of this food additive are already permitted in the United States, Japan and Australia.

Under the current Regulations, all food products containing permitted sugar alcohols and/or polydextrose must provide information on the label to indicate the total content of these substances in the food expressed in grams per serving of stated size. The new section B.01.021 describes the labelling requirement for erythritol that applies to products whose label does not carry a Nutrition Facts table. It should be noted that in this case, as required by the current regulations, the statement of the amount of polydextrose added to the product must be grouped together with the statement for sugar alcohols.

In the case of products whose label carries a Nutrition Facts table, subsection B.01.402(6) and item 12 of the table to section B.01.402 of the Regulations require that the Nutrition Facts table show the amount of sugar alcohols, including erythritol, added to the product. The declaration of polydextrose is not included in the Nutrition Facts table and must be made separately in accordance with the regulatory requirements for nutrition labelling.

Therefore, this amendment to the Regulations permits the use of erythritol in the above named foods at the specified maximum levels of use and requires that the label of a food product containing erythritol indicate the amount of erythritol added to the product expressed in grams per serving of stated size.

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 shown to be both safe and effective.

Benefits and Costs

This amendment provides the consumer and the industry with an alternative to currently available sweeteners. The uses of erythritol allow a greater availability of quality dietetic food products for the consumer.

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

Consultation

The proposed amendment was pre-published in the Canada Gazette, Part I, on March 13, 2004. Interested parties were invited to provide comments on this amendment. No comments were received as a result of this pre-publication.

Compliance and Enforcement

Compliance 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
A.L. 0702C1
Ottawa, Ontario
K1A 0L2
Telephone: (613) 957-1828
FAX: (613) 941-3537
E-mail: sche-ann@hc-sc.gc.ca

Footnote a

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

Footnote 1

C.R.C., c. 870

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with extensible hypertext markup language (XHTML 1.0 Strict).