Vol. 144, No. 6 — March 17, 2010

Registration

SOR/2010-42 February 23, 2010

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1610 — Food Additives)

P.C. 2010-211 February 23, 2010

Her 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 (1610 — Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS
(1610 — FOOD ADDITIVES)

AMENDMENTS

1. The portion of item G.3 of Table V to section B.16.100 of the Food and Drug Regulations (see footnote 1) in column II is replaced by the following:

Item No.	Column II Permitted Source
G.3	Aspergillus niger var.; Aspergillus oryzae Mtl-72 (pHUda107)

2. Item I.1 of Table V to section B.16.100 of the Regulations is amended by adding the following in columns II to IV before the permitted source “Saccharomyces sp.”:

Item No.	Column II Permitted Source	Column III Permitted in or Upon	Column IV Maximum Level of Use
I.1	Aspergillus japonicus	Sucrose used in the production of fructooligosaccharides	Good Manufacturing Practice

3. Item P.7 of Table V to section B.16.100 of the Regulations is amended by adding the following in columns II to IV after the permitted source “ Bacillus subtilis B1-163 (pEB301)”:

Item No.	Column II Permitted Source	Column III Permitted in or Upon	Column IV Maximum Level of Use
P.7	Bacillus subtilis RB121 (pDG268)	(1) Brewers’ Mash	(1) Good Manufacturing Practice
		(2) Distillers’ Mash	(2) Good Manufacturing Practice
		(3) Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or maltose	(3) Good Manufacturing Practice

4. Item X.1 of Table V to section B.16.100 of the Regulations is replaced by the following:

Item No.	Column I Additive	Column II Permitted Source	Column III Permitted in or Upon	Column IV Maximum Level of Use
X.1	Xylanase	Aspergillus oryzae Fa 1–1 (pA2X1TI)	(1) Bread; Flour; Whole wheat flour	(1) Good Manufacturing Practice
			(2) Unstandardized bakery products	(2) Good Manufacturing Practice
		Aspergillus oryzae JaL 339 (pJaL537); Bacillus subtilis DIDK 0115 (pUB110 OIS2)	(1) Bread; Flour; Whole wheat flour	(1) Good Manufacturing Practice
			(2) Unstandardized bakery products	(2) Good Manufacturing Practice

COMING INTO FORCE

5. 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 submissions from industry requesting that the Regulations be amended to enable the use of enzymes produced from the following genetically modified or conventional sources of micro-organisms:

• Pullulanase produced from a genetically modified Bacillus subtilis micro-organism, Bacillus subtilis RB121 (pDG268), that carries the gene from Bacillus deramificans in starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or maltose, and in distillers’ and brewers’ mash at levels consistent with good manufacturing practices;
• Glucose oxidase produced from a genetically modified Aspergillus oryzae micro-organism, Aspergillus oryzae Mtl-72 (pHUda107), that carries the gene from Aspergillus niger in the production of bread, flour, whole wheat flour, unstandardized bakery products, soft drinks, and liquid whole egg, liquid egg-white (liquid albumen) and liquid yolk destined for drying, at levels consistent with good manufacturing practices;
• Invertase derived from a conventional strain of Aspergillus japonicus micro-organism in sucrose used in the production of fructooligosaccharides at levels consistent with good manufacturing practices;
• Xylanase produced from a Bacillus subtilis micro-organism, Bacillus subtilis DIDK 0115 (pUB110 OIS2) genetically modified to contain multiple copies of the gene from Bacillus subtilis coding for the xylanase enzyme in the production of bread, flour, whole wheat flour and unstandardized bakery products at levels consistent with good manufacturing practices;
• Xylanase produced from a genetically modified Aspergillus oryzae micro-organism, Aspergillus oryzae JaL 339 (pJaL 537) that carries the gene from Thermomyces lanuginosus in the production of bread, flour, whole wheat flour and unstandardized bakery products at levels consistent with good manufacturing practices.

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

These amendments benefit the consumers by allowing greater availability of quality food products in the marketplace while continuing to protect their health and safety. In addition, these amendments benefit industry by facilitating the manufacture of quality food products.

Description and rationale

These amendments to the Regulations enable the use of the enzymes pullulanase, glucose oxidase, invertase and xylanase produced from new genetically modified or conventional sources of micro-organisms, 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.

The only regulatory options available to address these submissions are for the Minister to recommend or not to the Governor in Council that the Regulations be amended to permit the uses described above for these food additives. Based on its safety and efficacy assessment, Health Canada is recommending to enable these uses.

Interim Marketing Authorizations (IMAs) were issued to permit the immediate use of these food additives as proposed in the submissions while the regulatory process was undertaken to amend the Regulations. They were published in the Government Notices section of the Canada Gazette, Part I, on

• December 20, 2003, for the enzyme pullulanase from Bacillus subtilis RB121 (pDG268) in the production of distillers’ and brewers’ mash and of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or maltose;
• June 17, 2006, for the enzyme glucose oxidase from Aspergillus oryzae Mtl-72 (pHUda107) in the production of bread, flour, whole wheat flour and unstandardized bakery products, soft drinks, and liquid whole egg, liquid egg-white (liquid albumen) and liquid yolk destined for drying;
• August 5, 2006, for the enzyme invertase from a conventional strain of Aspergillus japonicus in the production of fructooligosaccharides;
• September 9, 2006, for the enzyme xylanase from Bacillus subtilis DIDK 0115 (pUB110 OIS2) in the production of bread, flour, whole wheat flour and unstandardized bakery products;
• December 16, 2006, for the enzyme xylanase from Aspergillus oryzae JaL 339 (pJaL 537) in the production of bread, flour, whole wheat flour and unstandardized bakery products.

Consultation

These amendments permit the use of these food additives in foods for which there are compositional and health and safety standards set out in Divisions 13 (Grain and Bakery Products) and 22 (Poultry, poultry meat, their preparations and products) of the Regulations. Since these enzymes from various sources have a long history of safe use as permitted food additives in Canada in standardized bread, flour, whole wheat flour, and liquid whole egg, liquid egg-white (liquid albumen) and liquid yolk destined for drying, no additional amendments are required to those standards.

Health Canada has announced, through posting on its Web site, the publication in the Canada Gazette, Part I, of these IMAs and the proposed regulatory amendments. Since the publication of these IMAs in the Canada Gazette, Part I, between 2003 and 2006, 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, list of ingredients and perform on-site verification of the manufacture of the product. The frequency of inspection depends on the history of compliance of a particular product, the history of compliance of the manufacturer and the food safety risk.

Contact

John Salminen
Acting 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

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