Vol. 146, No. 12 — June 6, 2012

Registration

SOR/2012-103 May 17, 2012

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1599 — Food Additive)

P.C. 2012-638 May 17, 2012

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 (1599 — Food Additive).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1599 — FOOD ADDITIVE)

AMENDMENTS

1. The heading of Table X to section B.16.100 of the French version of the Food and Drug Regulations (see footnote 1) is replaced by the following:

ADDITIFS ALIMENTAIRES AUTORISÉS COMME RAJUSTEURS DU PH, SUBSTANCES À RÉACTION ACIDE ET AGENTS CORRECTEURS DE L’EAU

2. Table X to section B.16.100 of the Regulations is amended by adding the following after item C.1:

Item No.

Column I

Additive

Column II

Permitted in or Upon

Column III

Maximum Level of Use

C.1A

Calcium Acid Pyrophosphate

  1. (1) Baking powder


  2. (2) Unstandardized foods
  1. (1) Good Manufacturing Practice
  2. (2) Good Manufacturing Practice

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 permit the use of calcium acid pyrophosphate as an acid-reacting material in baking powder and in unstandardized foods at a maximum level of use consistent with good manufacturing practice. Calcium acid pyrophosphate as an acid-reacting material can be used in these foods to help achieve leavening and to adjust the acid-alkali balance (pH).

The evaluation of the available data supports the safety and efficacy of calcium acid pyrophosphate as an acid-reacting material in baking powder and unstandardized foods. Therefore, the Regulations are amended to permit the use of this new food additive 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. These amendments also permit the use of a new acid-reacting material in these foods which does not contain sodium.

Description and rationale

These amendments to the Regulations enable the use of a new food additive, calcium acid pyrophosphate, in baking powder and in unstandardized foods as an acid-reacting material. In addition, the Regulations are amended by replacing the title preceding Table X to section B.16.100 of the French version of the Regulations in order to correct an inconsistency in the terminology.

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.

Based on the safety and efficacy assessment, the Minister is recommending that the Regulations be amended to enable the use of this new food additive as described.

Consultation

These amendments permit the use of calcium acid pyrophosphate in baking powder, a food subject to a standard in Division 3 (Baking Powder) of the Regulations. Consequently, input regarding the use of calcium acid pyrophosphate in baking powder was sought from the Canadian Food Inspection Agency (CFIA), the Baking Association of Canada, the Association of Canadian Biscuit Manufacturers and the Canadian Snack Food Association. The CFIA and the Baking Association of Canada expressed support for these amendments. Health Canada has conducted a public consultation on this proposal to amend the Regulations through a posting on its Web site. The 75-day comment period started on November 3, 2011, and closed on January 16, 2012. Comments were received from one domestic industry association and one international association. Both comments indicated support for the regulatory amendments.

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, 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