Vol. 145, No. 26 — December 21, 2011
SOR/2011-281 December 2, 2011
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (1618 — Food Additive)
P.C. 2011-1389 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 (1618 — Food Additive).
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS
(1618 — FOOD ADDITIVE)
1. Subparagraph B.08.039(1)(b)(iv) of the Food and Drug Regulations (see footnote 1) is amended by striking out “and” at the end of clause (A), by adding “and” at the end of clause (B) and by adding the following after clause (B):
- (C) in an amount not exceeding 1.5%, caramel,
2. Item 2 of Table III to section B.16.100 of the Regulations is amended by adding the following in columns II and III after subitem (4):
(5) Cream cheese spread with (naming the added ingredients)
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 the food additive caramel as a colouring agent in chocolate-flavoured cream cheese spread at a maximum level of use of 1.5%.
Evaluation of available data supports the safety and effectiveness of this food additive in the above specified use. Since there are no safety concerns regarding the use of this food additive in cream cheese spread with (naming the added ingredients), the amendments permit the extended use of caramel in cream cheese spread with (naming the added ingredients) at a maximum level of use of 1.5%. These amendments reduce the regulatory burden to both government and industry.
These amendments benefit consumers by allowing greater availability of food products in the marketplace 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 caramel, a food additive already listed in Table III to section B.16.100 of the Regulations, as a colouring agent in cream cheese spread with (naming the added ingredients).
There is no anticipated increase in cost to government from the administration of these amendments to the Regulations. The use of food additives is optional and therefore a manufacturer choosing to use a food additive in its products voluntarily assumes the costs associated with its use and compliance with the Regulations.
An Interim Marketing Authorization (“IMA”) was issued to permit the immediate use of this food additive 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 February 14, 2009, for the use of caramel as a colouring agent in chocolate-flavoured cream cheese spread at a maximum level of use of 1.5%. The IMA expired on February 14, 2011. Health Canada confirms that the results of the pre-market safety assessment that was conducted prior to the issuance of the IMA that permitted caramel in cream cheese spread with (naming the added ingredients) 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 described above for this food additive. Based on the additive’s safety and efficacy assessment and the history of safe use since the issuance of the IMA, the Minister is recommending to enable the use of caramel in cream cheese spread with (naming the added ingredients).
These amendments permit the use of caramel in cream cheese spread with (naming the added ingredients), a food subject to a standard in Division 8 (Dairy Products) of the Regulations. Consequently, input regarding the proposed use of caramel was sought from the Dairy Processors Association of Canada and the Canadian Food Inspection Agency (“CFIA”). These organizations have expressed their support for these amendments.
Health Canada has announced, through posting on its Web site, the publication in the Canada Gazette, Part Ⅰ, of this IMA and the proposed regulatory amendments. 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. Since the publication of this IMA in the Canada Gazette, Part Ⅰ, on February 14, 2009, the Government has received no objections or safety concerns regarding this use.
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.
Bureau of Chemical Safety
251 Sir Frederick Banting Driveway
Address Locator: 2203B
S.C. 2005, c. 42, s. 2
R.S., c. F-27
C.R.C., c. 870