Vol. 138, No. 20 — May 15, 2004

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

Statutory Authority

Food and Drugs Act

Sponsoring Department

Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

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. Therefore, it is proposed to amend the Regulations to 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 proposed amendments would benefit the consumer by increasing the availability of quality products in the marketplace. These proposed amendments would 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 proposed 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 would be optional.

Consultation

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

Interim Marketing Authorizations (IMAs) were issued to permit the immediate use of these enzymes in the previously specified 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;

— 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).

Compliance and enforcement

If these proposed amendments are adopted, compliance will be monitored by ongoing domestic and import inspection programs conducted by the Canadian Food Inspection Agency.

Contact

Mr. Ronald Burke, Director, Bureau of Food Regulatory, International and Interagency Affairs, Health Canada, Address Locator 0702C1, Ottawa, Ontario K1A 0L2, (613) 957-1828 (telephone), (613) 941-3537 (facsimile), sche-ann@hc-sc.gc.ca (electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1225 — Food Additives).

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Ronald Burke, Director, Bureau of Food Regulatory, International and Interagency Affairs, Department of Health, Building No. 7, Room 2395, Address Locator 0702C1, Tunney's Pasture, Ottawa, Ontario K1A 0L2 (tel.: (613) 957-1828; fax: (613) 941-3537; e-mail: sche-ann@hc-sc.gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

Ottawa, May 10, 2004

EILEEN BOYD
Assistant Clerk of the Privy Council

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;":

(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:

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:

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.":

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:

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.":

6. Item P.7 of Table V to section B.16.100 of the Regulations is replaced by the following:

COMING INTO FORCE

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

[20-1-o]

Footnote a

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

Footnote 1

C.R.C., c. 870

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with hypertext language (HTML). Its content is very similar except for the footnotes, the symbols and the tables.

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