Vol. 145, No. 26 — December 21, 2011
Registration
SOR/2011-282 December 2, 2011
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (1634 — Food Additive)
P.C. 2011-1390 December 1, 2011
His 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 (1634 — Food Additive).
REGULATIONS AMENDING THE FOOD AND DRUG
REGULATIONS (1634 — FOOD ADDITIVE)
AMENDMENTS
1. Subparagraph B.08.049(b)(iv) of the Food and Drug Regulations (see footnote 1) is replaced by the following:
- (iv) benzoyl peroxide, and calcium phosphate tribasic and calcium sulphate as carriers of the benzoyl peroxide, in the case of liquid whey destined for the manufacture of dried whey products other than those for use in infant formula, and
2. Item C.10 of Table VIII to section B.16.100 of the Regulations is amended by adding the following in columns II to IV after subitem (3):
Item No. |
Column II |
Column III |
Column IV |
|---|---|---|---|
C.10 |
(4) Liquid whey destined for the manufacture of dried whey products, other than those for use in infant formula |
(4) Carrier of benzoyl peroxide |
(4) 0.3% of the dried whey product |
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.)
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 a submission from industry requesting that the Regulations be amended to enable the use of calcium sulphate as a carrier of benzoyl peroxide used in liquid whey destined for the manufacture of dried whey products, other than those for use in infant formula, at a maximum level of use of 0.3% of the dried whey product.
Evaluation of available data supports the safety and effectiveness of this food additive in the above specified use. Therefore, the Regulations are amended to permit the use of calcium sulphate 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 providing another carrier of benzoyl peroxide used in liquid whey.
Description and rationale
These amendments enable the use of calcium sulphate currently listed in the Tables to section B.16.100 of the Regulations, as a carrier of benzoyl peroxide used in liquid whey destined for the manufacture of dried whey products, other than those for use in infant formula, at a maximum level of use of 0.3% of the dried whey product.
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 because the use of food additives is optional.
An Interim Marketing Authorization (“IMA”) has been issued to permit the immediate use of calcium sulphate as proposed in the submission 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
- March 28, 2009, to permit the use of calcium sulphate as a carrier of benzoyl peroxide in liquid whey destined for the manufacture of dried whey products, other than those for use in infant formula, at a maximum level of use of 0.3% of dried whey products.
The IMA expired on March 28, 2011, for calcium sulphate as a carrier of benzoyl peroxide in liquid whey destined for the manufacture of dried whey products, other than those for use in infant formula. Health Canada confirms that the results of the pre-market safety assessment that was conducted prior to the issuance of this IMA remain valid.
The Minister has the option to recommend or not to the Governor in Council that the Regulations be amended to permit the use as described above of this food additive. Based on its safety and efficacy assessment and the history of safe use of calcium sulphate as a carrier of benzoyl peroxide in liquid whey destined for the manufacture of dried whey products, other than those for use in infant formula since the publication of the IMA, the Minister is recommending to amend the Regulations to enable the use of this food additive.
Consultation
These amendments permit the use of this food additive in a food for which there is a standard set out in Division 8 (Dairy Products) of the Regulations. Consequently, input regarding the use of calcium sulphate was sought from the Canadian Food Inspection Agency (CFIA). The CFIA has expressed its support for these amendments to the Regulations.
In addition, Health Canada has announced the publication of the IMA for this food additive through posting on its Web site. Health Canada also notified World Trade Organization members about this IMA and the proposed regulatory amendments at the time of publication of the IMA in the Canada Gazette, Part Ⅰ. The IMA for calcium sulphate as a carrier of benzoyl peroxide in liquid whey destined for the manufacture of dried whey products, other than those for use in infant formula, was published in the Canada Gazette, Part Ⅰ, in 2009. The publication was followed by a 75-day comment period. The Government has received no comments regarding the safety of the use of this food additive.
Implementation, enforcement and service standards
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 and list of ingredients, and perform on-site verification of the manufacture of the product. The frequency of inspection depends on the compliance history in relation to the manufacturing of a particular type of product, the compliance history 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