Vol. 146, No. 12 — June 6, 2012


SOR/2012-106 May 17, 2012


Regulations Amending the Food and Drug Regulations (1640 — Food Additives)

P.C. 2012-641 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 (1640 — Food Additives).



1. Table IV to section B.16.100 of the Food and Drug Regulations (see footnote 1) is replaced by the following after item A.1:

Item No.

Column I


Column II

Permitted in or Upon

Column III

Maximum Level of Use


Acacia Gum modified with octenyl succinic anhydride (OSA)

  1. (1) French dressing; Icings; Salad dressing; Unstandardized dressings; Unstandardized sauces
  2. (2) Unstandardized beverages
  3. (3) Unstandardized flavouring preparations

(1) 1%

(2) 0.1%

(3) 0.05%

2. The portion of item O.1 of Table XIII to section B.16.100 of the Regulations in column I is replaced by the following:

Item No.

Column I



Octenyl Succinic Anhydride (OSA)


3. These Regulations come into force on the day on which they are registered.


(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 octenyl succinic anhydride (OSA) modified acacia gum as an emulsifying agent in a variety of food products such as unstandardized beverages, salad dressing, sauces and icings at various levels of use. Emulsifying agents are used in these types of food products in order to keep mixtures of immiscible fluids (emulsions) well dispersed.

Evaluation of available data supports the safety and effectiveness of this food additive in unstandardized beverages at a maximum level of use of 0.1%; in French dressing, salad dressing, unstandardized dressings, unstandardized sauces and icings at a maximum level of use of 1%; and in unstandardized flavouring preparations at a maximum level of use of 0.05%. Therefore, the Regulations are amended to permit such uses for this food additive. These amendments list this food additive as Acacia Gum modified with octenyl succinic anhydride (OSA).

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 to the Regulations enable the use of this food additive as described above.

There is no anticipated increase in the 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 food additive as described above.


These amendments permit the use of Acacia Gum modified with octenyl succinic anhydride (OSA) in various products, including French dressing and salad dressing, for which standards are set out in Division 7 of the Regulations. Consequently, input regarding these uses was sought from the Canadian Food Inspection Agency (“the CFIA”) and the Food Processors of Canada. These organizations expressed their support for the proposed 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. Health Canada received one comment in support of these 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 and list of ingredients, and perform on-site verification of the manufacture of the product. The frequency of inspection depends on the history of compliance in relation to the manufacturing of a particular type of product, the compliance history of the manufacturer and the food safety risk.


Barbara Lee
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