Vol. 139, No. 25 — December 14, 2005

Registration
SOR/2005-395 November 28, 2005

FOOD AND DRUGS ACT

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

P.C. 2005-2220 November 28, 2005

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 (1063 — Carrageenan in Infant Formula).

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 1) in column III is replaced by the following:

Article	Colonne III Limites de tolérance
A.3	(3) 240 p.p.m. prête à consommer

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:

Item No.	Column III Maximum Level of Use
A.5	(2) 0.03% as consumed. If used in combination with carrageenan or guar gum or both, the total not to exceed 0.03%

(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):

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
A.5	(9) Infant formula based on isolated amino acids or protein hydrolysates, or both	(9) 0.1% as consumed. If used in combination with carrageenan or guar gum or both, the total not to exceed 0.1%
	(10) Lactose-free infant formula based on milk protein	(10) 0.05% as consumed. If used in combination with carrageenan or guar gum or both, the total not to exceed 0.05%

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):

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
C.15	(13) Lactose-free infant formula based on milk protein	(13) 0.05% as consumed. If used in combination with algin or guar gum or both, the total not to exceed 0.05%

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):

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
G.3	(10) Infant formula based on isolated amino acids or protein hydrolysates, or both	(10) 0.1% as consumed. If used in combination with algin or carrageenan or both, the total not to exceed 0.1%
	(11) Lactose-free infant formula based on milk protein	(11) 0.05% as consumed. If used in combination with algin or carrageenan or both, the total not to exceed 0.05%

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.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

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 per cent. The second use is listed for infant formula, identified as such in the Regulations, at a maximum level of 0.03 per cent.

A submission has been received 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 per cent. 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 per cent is sufficient to maintain these calcium salts in suspension.

Evaluation of available data supports the safety and effectiveness of this use of carrageenan. This amendment to the Regulations permits the use of carrageenan in lactose-free infant formula based on milk protein at a maximum level of 0.05 per cent.

Provision also exists in the Regulations for the use of algin and guar gum in infant formula at a maximum level of 0.03 per cent whether used singly or in combination. In order to clarify the use of algin, carrageenan and guar gum used singly or in combination, addition to the current listings have been made for algin and guar gum specifying that they 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 per cent and 0.05 per cent, respectively. These amendments will 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 amendments will 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 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 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 is optional.

Consultation

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

The proposed amendments were published in the Canada Gazette, Part I, on May 15, 2004. Interested parties were invited to provide comments on these amendments. No comments were received.

Compliance and Enforcement

Compliance will be monitored by ongoing domestic and import inspection programs conducted by 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

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