Vol. 144, No. 14 — July 7, 2010

Registration

SOR/2010-141 June 17, 2010

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1514 — Food Additives)

P.C. 2010-766 June 17, 2010

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 (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1514 — Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS
(1514 — FOOD ADDITIVES)

AMENDMENTS

1. Item A.2 of Part IV of Table XI to section B.16.100 of the Food and Drug Regulations (see footnote 1) is amended by adding the following after subitem (3) in columns II and III:

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
A.2	(4) Infant formula	(4) 0.001% as consumed

2. Item T.2 of Part IV of Table XI to section B.16.100 of the Regulations is amended by adding the following after subitem (2) in columns II and III:

Item No.	Column II Permitted in or Upon	Column III Maximum Level of Use
T.2	(3) Infant formula	(3) 0.001% as consumed

3. Subsection B.25.062(2) of the Regulations is amended by striking out “or” at the end of paragraph (g) and by adding the following after paragraph (h):

(i) infant formula that contains ascorbyl palmitate or tocopherols; or

(j) infant formula that contains oils to which ascorbyl palmitate or tocopherols have been added.

COMING INTO FORCE

4. 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.)

Issue and objectives

The Food and Drug Regulations (the Regulations) regulate the sale and use of food additives in Canada, listing the permitted food additives and how they may be used. Health Canada has received submissions from industry requesting that the Regulations be amended to permit the following uses for these food additives:

• ascorbyl palmitate and tocopherols as Class IV preservatives in infant formula, at a maximum level of use of 0.001% as consumed; and
• ascorbyl palmitate and tocopherols as Class IV preservatives in oils used in infant formula, at levels consistent with good manufacturing practice.

Evaluation of available data supports the safety and effectiveness of these food additives in the above specified uses. Therefore, the Regulations are amended to permit the use of the above noted food additives as described.

These amendments benefit consumers by allowing greater availability of food products, while continuing to help protect their health and safety. In addition, these amendments benefit industry by facilitating the manufacture of food products.

Description and rationale

These amendments enable the use of ascorbyl palmitate and tocopherols as described above.

There is no anticipated increase in the 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 because the use of food additives is optional.

The only regulatory options available to address these submissions are for the Minister to recommend or not to the Governor in Council that the Regulations be amended to permit the uses described above for these food additives. Based on its safety and efficacy assessment, Health Canada recommends that the use for these food additives be enabled.

An Interim Marketing Authorization (IMA) was issued to permit the immediate use of these food additives as requested in the submissions while the regulatory process was undertaken to amend the Regulations. It was published in the Government Notices section of the Canada Gazette, Part I, on December 23, 2006, as follows:

• ascorbyl palmitate and tocopherols as antioxidants in infant formula and in the oils used as ingredients in infant formula. The individual maximum level of use for each of these food additives is 1 mg/100 mL in formulas ready to consume, and at levels consistent with good manufacturing practice in the oils used as ingredients in infant formula.

Consultation

These amendments permit the use of these food additives in infant formula for which there are health and safety requirements set out in Division 25 of the Regulations. Since these food additives have a long history of safe use as permitted food additives in Canada in various standardized and unstandardized food products, no input regarding the use of these food additives was needed or sought.

Health Canada has announced, through posting on its Web site, the publication in the Canada Gazette, Part I, of the IMA and the proposed regulatory amendments. Since the publication of the IMA in the Canada Gazette, Part I, in 2006, the Government has received no objections or safety concerns regarding the use of these food additives.

Implementation, enforcement and service standards

The Canadian Food Inspection Agency (the CFIA) is responsible for the enforcement of the Food and Drugs Act and the Regulations with respect to foods. The CFIA uses a science-based risk management approach to set its food safety priorities. Using this approach as its foundation, the CFIA plans its inspection and testing programs for foods, taking into account the degree of risk associated with a particular sector, and concentrates its resources where risk is the greatest. Each CFIA commodity inspection program performs ingredient verifications at which time inspectors compare formulation, list of ingredients and perform on-site verification of the manufacture of the product. The frequency of inspection depends on the history of compliance of a particular product, the history of compliance of the manufacturer and the food safety risk.

Contact

Barbara Lee
Director
Bureau of Chemical Safety
Health Canada
251 Sir Frederick Banting Driveway
Tunney’s Pasture
Address Locator: 2203B
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-0973
Fax: 613-954-4674
Email: sche-ann@hc-sc.gc.ca

Footnote a
S.C. 2005, c. 42, s. 2

Footnote b
R.S., c. F-27

Footnote 1
C.R.C., c. 870

NOTICE:
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