Vol. 139, No. 25 — December 14, 2005

Registration
SOR/2005-394 November 28, 2005

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1225 — Food Additives)

P.C. 2005-2219 November 28, 2005

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, hereby makes the annexed Regulations Amending the Food and Drug Regulations (1225 — Food Additives).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1225 — FOOD ADDITIVES)

AMENDMENTS

1. (1) Item A.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 before the permitted source beginning with the words "Bacillus licheniformis;":

Item No.	Column II Permitted Source	Column III Permitted in or Upon	Column IV Maximum Level of Use
A.1	Aspergillus niger STz18-9 (pHUda7)	(1) Ale; Beer; Light beer; Malt liquor; Porter; Stout	(1) Good Manufacturing Practice
		(2) Distillers' Mash	(2) Good Manufacturing Practice
		(3) Starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), maltose	(3) Good Manufacturing Practice

(2) The portion of item A.1 of Table V to section B.16.100 of the Regulations in column II beginning with the words "Bacillus licheniformis" is replaced by the following:

Item No.	Column II Permitted Source
A.1	Bacillus amyloliquefaciens EBA 20 (pUBH2); Bacillus licheniformis; Bacillus licheniformis BML 592 (pAmyAmp); Bacillus licheniformis BML 730 (pAmyAmp); Bacillus licheniformis LA 57 (pDN1981); Bacillus licheniformis LAT8 (pLAT3); Bacillus licheniformis LiH 1159 (pLiH1108); Bacillus licheniformis LiH 1464 (pLiH1346); Bacillus licheniformis PL 1303 (pPL1117)

2. The portion of item A.2 of Table V to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted Source
A.2	Bacillus subtilis DN1413 (pDN1413); Bacillus subtilis LFA 63 (pLFA63)

3. Item G.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 "Rhizopus niveus var.":

Item No.	Column II Permitted Source	Column III Permitted in or Upon	Column IV Maximum Level of Use
G.1	Aspergillus niger STz18-9 (pHUda7)	(1) Ale; Beer; Light beer; Malt liquor; Porter; Stout	(1) Good Manufacturing Practice
		(2) Distillers' Mash	(2) Good Manufacturing Practice
		(3) Starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), maltose	(3) Good Manufacturing Practice

4. The portion of item G.4 of Table V to section B.16.100 of the Regulations in column II is replaced by the following:

Item No.	Column II Permitted Source
G.4	Bacillus coagulans var.; Streptomyces olivochromogenes var.; Actinoplanes missouriensis var.; Streptomyces olivaceus var.; Microbacterium arborescens NRRL B-11022; Streptomyces murinus DSM 3252; Streptomyces rubiginosus ATCC No. 21,175; Streptomyces rubiginosus SYC 5406 (pSYC5239)

5. Item P.3 of Table V to section B.16.100 of the Regulations is amended by adding the following in columns II to IV after subitem (7) in columns III and IV opposite the permitted source "Aspergillus niger var.; Rhizopus oryzae var.":

Item No.	Column II Permitted Source	Column III Permitted in or Upon	Column IV Maximum Level of Use
P.3	Aspergillus oryzae Km-1-1 (pA2PEI)	(1) Cider; Wine	(1) Good Manufacturing Practice
		(2) Single-strength fruit juices	(2) Good Manufacturing Practice
		(3) Unstandardized fruit and vegetable products	(3) Good Manufacturing Practice

6. Item P.7 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
P.7	Pullulanase	Bacillus acido-pullulyticus NCIB 11647; Bacillus licheniformis SE2-Pul-int211 (pUBCDEBR A11DNSI)	(1) Bread; Flour; Whole wheat flour	(1) Good Manufacturing Practice
			(2) Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, maltose	(2) Good Manufacturing Practice
			(3) Unstandardized bakery products	(3) Good Manufacturing Practice
		Bacillus licheniformis BMP 139 (pR11Amp)	(1) Bread; Flour; Whole wheat flour	(1) Good Manufacturing Practice
			(2) Brewers' Mash	(2) Good Manufacturing Practice
			(3) Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, maltose	(3) Good Manufacturing Practice
			(4) Unstandardized bakery products	(4) Good Manufacturing Practice
		Bacillus subtilis B1-163 (pEB301)	(1) Bread; Flour; Whole wheat flour	(1) Good Manufacturing Practice
			(2) Brewers' Mash	(2) Good Manufacturing Practice
			(3) Distillers' Mash	(3) Good Manufacturing Practice
			(4) Starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, maltose	(4) Good Manufacturing Practice
			(5) Unstandardized bakery products	(5) Good Manufacturing Practice

COMING INTO FORCE

7. 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.)

Description

Provision currently exists in the Food and Drug Regulations for the use of the enzymes alpha-amylase, glucoamylase, glucose isomerase, maltogenic amylase, pectinase and pullulanase in a wide variety of foods. The micro-organisms used to produce these enzymes are also regulated under Division 16 of Part B of these Regulations.

Health Canada has received submissions to permit the use of these enzymes produced from new genetically modified source micro-organisms, as indicated below:

- alpha-amylase and glucoamylase enzymes, produced by Aspergillus niger STz18-9 (pHUda7) genetically modified to contain multiple copies of the natural alpha-amylase and glucoamylase genes from Aspergillus niger, in the production of distillers' mash, ale, beer, light beer, malt liquor, porter, stout, and in starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup) and maltose;

- alpha-amylase enzyme, produced by Bacillus amyloliquefaciens EBA 20 (pUBH2) genetically modified to contain multiple copies of the natural alpha-amylase gene from Bacillus amyloliquefaciens, in the production of brewers' mash, distillers' mash, and in starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup) and maltose;

- alpha-amylase enzyme, which has high temperature and low pH stability, produced by Bacillus licheniformis BML 592 (pAmyAmp) genetically modified to contain the alpha-amylase gene obtained from the wild type Bacillus licheniformis modified by mutagenesis, in the production of brewers' mash, distillers' mash, and in starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup) and maltose;

- alpha-amylase enzyme, which has high temperature and low pH stability and a reduced calcium requirement, produced by Bacillus licheniformis BML 730 (pAmyAmp) genetically modified to contain the alpha-amylase gene obtained from the wild type Bacillus licheniformis modified by mutagenesis, in the production of brewers' mash, distillers' mash, and in starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup) and maltose;

- alpha-amylase enzyme, produced by Bacillus licheniformis LAT8 (pLAT3) genetically modified to contain multiple copies of the natural alpha-amylase gene from Bacillus licheniformis, in the production of brewers' mash, distillers' mash, and in starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup) and maltose;

- alpha-amylase enzyme, produced by Bacillus licheniformis LiH 1159 (pLiH1108) genetically modified to contain a hybrid Bacillus amyloliquefaciens and Bacillus licheniformis alpha-amylase gene, in the production of brewer's mash, distillers' mash, and in starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup) and maltose;

- alpha-amylase enzyme, produced by Bacillus licheniformis LiH 1464 (pLiH1346) genetically modified to contain the alpha-amylase gene from Bacillus stearothermophilus, in the production of brewers' mash, distillers' mash, and in starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup) and maltose;

- amylase (maltogenic) enzyme, produced by Bacillus subtilis LFA 63 (pLFA63) genetically modified to contain a maltogenic amylase gene from Bacillus stearothermophilus, in starch used in the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried glucose syrup), maltose, and in bakery products;

- glucose isomerase (wild type) enzyme, produced by Streptomyces rubiginosus SYC 5406 (pSYC5239) genetically modified to contain multiple copies of the natural glucose isomerase gene from Streptomyces rubiginosus, in the production of high fructose corn syrups;

- pectinase enzyme, produced by Aspergillus oryzae Km-1-1 (pA2PEI) genetically modified to contain the pectinase gene from Aspergillus aculeatus, in the production of cider, wine, single-strength fruit juices, and unstandardized fruit and vegetable products;

- pullulanase enzyme, produced by Bacillus licheniformis BMP 139 (pR11Amp) genetically modified to contain the pullulanase gene from Bacillus deramificans, in the production of brewers' mash, bread, flour, whole wheat flour, unstandardized bakery products, and starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, and maltose; and

- pullulanase enzyme, produced by Bacillus subtilis B1-163 (pEB301) genetically modified to contain the pullulanase gene from Bacillus naganoensis, in the production of brewers' mash, distillers's mash, bread, flour, whole wheat flour, unstandardized bakery products, and starch used in the production of dextrins, dextrose, glucose (glucose syrup), glucose solids (dried glucose syrup) or fructose syrups and solids, and maltose.

Evaluation of available data supports the safety and effectiveness of these food additives in these specific uses. These amendments to the Regulations permit the use of the above noted additives in the specified foods at levels consistent with good manufacturing practice.

Alternatives

Under the Food and Drug Regulations, provision for the use of new sources of food enzymes can only be accommodated by regulatory amendment. Maintaining the status quo was rejected as this would preclude the use of food additives which have been shown to be both safe and effective.

Benefits and Costs

These amendments will benefit the consumer by increasing the availability of quality products in the marketplace. These amendments will also provide industry with alternative sources for alpha-amylase, maltogenic amylase, glucoamylase, glucose isomerase, pectinase and pullulanase enzymes for use in a variety of foods, thus improving yield and productivity.

There is no anticipated increase in cost to government from the administration of these amendments to the Regulations. Furthermore, compliance costs incurred by manufacturers are not considered to be a factor as the use of these food additives by manufacturers is optional.

Consultation

Because of the proprietary nature of submissions which deal with food additives, consultation on proposed amendments are not conducted prior to pre-publication in the Canada Gazette, Part I.

Interim Marketing Authorizations (IMAs) were issued to permit the immediate use of these enzymes in the specified above applications while the regulatory process was undertaken to formally amend the Regulations. The IMAs were published in the Canada Gazette, Part I, as follows:

- on April 29, 2000, for alpha-amylase enzyme from Bacillus licheniformis LAT8 (pLAT3), pullulanase enzyme from Bacillus licheniformis BMP 139 (pR11Amp) and Bacillus subtilis B1-163 (pEB301), and glucose isomerase enzyme from Streptomyces rubiginosus SYC 5406 (pSYC5239);

- on June 10, 2000, for alpha-amylase enzyme from Bacillus amyloliquefaciens EBA 20 (pUBH2);

- on August 19, 2000, for alpha-amylase and glucoamylase enzymes from Aspergillus niger STz18-9 (pHUda7);

- on August 18, 2001, for alpha-amylase enzyme from Bacillus licheniformis BML 592 (pAmyAmp) and Bacillus licheniformis BML 730 (pAmyAmp);

- on November 17, 2001, for alpha-amylase enzyme from Bacillus licheniformis LiH 1464 (pLiH1346);

- on June 15, 2002, for alpha-amylase enzyme from Bacillus licheniformis LiH 1159 (pLiH1108);

- on June 21, 2003, for maltogenic amylase enzyme from Bacillus subtilis LFA63 (pLFA63); and

- on August 17, 2003, for pectinase enzyme from Aspergillus oryzae Km-1-1 (pA2PEI).

These IMAs will be revoked on the date on which these amendments come into force.

The proposed amendments were published in the Canada Gazette, Part I, on May 15, 2004. Interested parties were invited to provide comments on these amendments. No comments were received.

Compliance and Enforcement

Compliance will be monitored by ongoing domestic and import inspection programs conducted by the Canadian Food Inspection Agency.

Contact

Ronald Burke
Director
Bureau of Food Regulatory, International and Interagency Affairs
Health Canada
A.L. 0702C1
Ottawa, Ontario
K1A 0L2
Telephone: (613) 957-1828
FAX: (613) 941-3537
E-mail: sche-ann@hc-sc.gc.ca

Footnote a

S.C. 1999, c. 33, s. 347

Footnote 1

C.R.C., c. 870

NOTICE:
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