Vol. 146, No. 7 — March 28, 2012


SOR/2012-45 March 15, 2012


Regulations Amending the Food and Drug Regulations (1631 — Xylanase)

P.C. 2012-294 March 15, 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 (1631 — Xylanase).



1. Item X.1 of Table V to section B.16.100 of the Food and Drug Regulations (see footnote 1) is amended by adding the following in columns II to IV after the permitted source beginning with “ Aspergillus oryzae JaL 339”:

Item No.

Column II

Permitted Source

Column III

Permitted in or Upon

Column IV

Level of Use


Bacillus subtilis CF 307 (pJHPaprE-xynAss-BS3xylanase#1)

(1) Bread; Flour;
Whole wheat flour

(2) Unstandardized bakery products

(1) Good Manufacturing Practice

(2) Good Manufacturing Practice


2. 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 enable the use of the enzyme xylanase produced from a genetically modified Bacillus subtilis micro-organism, Bacillus subtilis CF 307 (pJHPaprE-xynAss-BS3xylanase#1), that carries the gene from another strain of Bacillus subtilis coding for this enzyme. This enzyme will be used in the production of bread, flour, whole wheat flour and unstandardized bakery products at maximum levels of use consistent with good manufacturing practices.

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

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. Xylanase improves the strength of the gluten network in dough and so improves the quality of the bread and other products made with the treated flour.

Description and rationale

These amendments to the Regulations enable the use of the enzyme xylanase produced from a new genetically modified micro-organism, as described above.

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. 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 to permit the use of xylanase in bread, flour, whole wheat flour and unstandardized bakery products remain valid.

The Minister has the option to recommend or not to the Governor in Council that the Regulations be amended to permit the uses described above for this food additive. Based on its safety and efficacy assessment and the history of safe use of xylanase in bread, flour, whole wheat flour and unstandardized bakery products since the issuance of the IMA, the Minister is recommending that amendments be made to enable these uses.


These amendments permit the use of xylanase derived from the source indicated above in bread, flour and whole wheat flour, foods for which standards are set out in Division 13 (Grain and Bakery Products) of the Regulations. Since this enzyme has a long history of safe use as a permitted food additive in Canada in standardized bread, flour and whole wheat flour, no input regarding the source was needed or sought. No amendments to these standards are required.

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, the Government has received no objections or safety concerns regarding these uses.

Implementation, enforcement and service standards

The Canadian Food Inspection Agency (“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.


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