Vol. 138, No. 20 — May 15, 2004

Regulations Amending the Food and Drug Regulations (1063 — Carrageenan in Infant Formula)

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

Description

Provision currently exists in the Food and Drug Regulations for the use of carrageenan in different infant formula products. The first use is permitted in infant formula based on isolated amino acids or protein hydrolysates, or both, at a maximum level of 0.1 percent. The second use is listed for infant formula, identified as such in the Regulations, at a maximum level of 0.03 percent.

A submission has been received by Health Canada to permit the use of carrageenan as a suspension agent for calcium salts in lactose-free infant formula based on milk protein at a maximum level of 0.05 percent. The calcium salts used in the formulation of lactose-free infant formula based on milk protein are insoluble and settle out with time. Studies have shown that the addition of carrageenan at a level of 0.05 percent is sufficient to maintain these calcium salts in suspension.

Evaluation of available data supports the safety and effectiveness of this use of carrageenan. Therefore, it is proposed to amend the Regulations to permit the use of carrageenan in lactosefree infant formula based on milk protein at a maximum level of 0.05 percent.

Provision also exists in the Regulations for the use of algin and guar gum in infant formula at a maximum level of 0.03 percent, whether used singly or in combination. In order to clarify the use of algin, carrageenan and guar gum used singly or in combination, it is proposed to add to the current listings for algin and guar gum that these can be used singly or in combination with carrageenan in infant formula based on isolated amino acids or protein hydrolysates, or both, and in lactose-free infant formula based on milk protein at maximum levels of 0.1 percent and 0.05 percent respectively. These proposed amendments would provide consistency between the listings for algin, carrageenan and guar gum.

Alternatives

Under the Food and Drug Regulations, provision for an extension of use of a permitted food additive can only be accommodated by regulatory amendment. Maintaining the status quo was rejected, as this would preclude the use of food additives which have been shown to be both safe and effective.

Benefits and costs

These proposed amendments would benefit infants through the availability of a lactose-free infant formula based on milk protein which would provide a more consistent delivery of calcium. They will also benefit industry by allowing the production of these infant formula with improved mineral suspension.

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

Consultation

Because of the proprietary nature of submissions, consultation is not carried out prior to the prepublication of these proposed amendments in the Canada Gazette, Part I.

Compliance and enforcement

If these proposed amendments are adopted, compliance will be monitored by ongoing domestic and import inspection programs conducted by the Canadian Food Inspection Agency.

Contact

Mr. 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).

PROPOSED REGULATORY TEXT

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 (1063 — Carrageenan in Infant Formula).

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, Building No. 7, Room 2395, 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.

Ottawa, May 10, 2004

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1063 — CARRAGEENAN
IN INFANT FORMULA)

AMENDMENTS

1. The portion of subitem A.3(3) of Table IV to section B.16.100 of the French version of the Food and Drug Regulations (see footnote b) in column III is replaced by the following:

2. (1) The portion of subitem A.5(2) of Table IV to section B.16.100 of the Regulations in column III is replaced by the following:

(2) Item A.5 of Table IV to section B.16.100 of the Regulations is amended by adding, in columns II and III, the following after subitem (8):

3. Item C.15 of Table IV to section B.16.100 of the Regulations is amended by adding, in columns II and III, the following after subitem (12):

4. Item G.3 of Table IV to section B.16.100 of the Regulations is amended by adding, in columns II and III, the following after subitem (9):

5. Table IV to section B.16.100 of the French version of the Regulations is amended by replacing the expression " prête à être consommée " with the expression " prête à consommer " wherever it occurs in column III of the following subitems:

(a) C.15(6) and (7);

(b) G.3(3);

(c) L.2(3);

(d) M.4(5);

(e) M.5(5);

(f) P.3(12) and (14);

(g) S.9(3); and

(h) S.18(6).

COMING INTO FORCE

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

[20-1-o]

Footnote a

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

Footnote b

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 hypertext language (HTML). Its content is very similar except for the footnotes, the symbols and the tables.

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