GSPSNCAN206 PAGE 3 WORLD TRADE ORGANIZATION GSPSNCAN206 1 JUNE

World Trade

Organization

G/SPS/N/CAN/206

1 June 2004

(04-2315)

Committee on Sanitary and Phytosanitary Measures

Original: English/
French

1.

Member to Agreement notifying: CANADA

If applicable, name of local government involved:

2.

Agency responsible: Department of Health

3.

Products covered (provide tariff item number(s) as specified in national schedules deposited with the WTO; ICS numbers should be provided in addition, where applicable): Food additives (ICS: 67.220.20)

4.

Regions or countries likely to be affected, to the extent relevant or practicable: Not stated

5.

Title, language and number of pages of the notified document: Proposed Amendment to the Food and Drug Regulations (1225 - Food Additives) (available in English and French, pages 1588-1594)

6.

Description of content: 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.

7.

Objective and rationale: [ X ] food safety, [   ] animal health, [   ] plant protection, [  ] protect humans from animal/plant pest or disease, [   ] protect territory from other damage from pests

8.

International standard, guideline or recommendation:

[   ] Codex Alimentarius Commission, [   ] World Organization for Animal Health (OIE), [   ] International Plant Protection Convention, [ X ] None

If an international standard, guideline or recommendation exists, give the appropriate reference and briefly identify deviations:

9.

Relevant documents and language(s) in which these are available: Canada Gazette, Part I, 15 May 2004 (available in English and French)

10.

Proposed date of adoption: Normally within 5 to 8 months of publication in the Canada Gazette, Part I.

11.

Proposed date of entry into force: On the date the measure is adopted.

12.

Final date for comments: 29 July 2004

Agency or authority designated to handle comments: [   ] National notification authority, [ X ] National enquiry point, or address, fax number and E-mail address (if available) of other body:

13.

Texts available from: [   ] National notification authority, [ X ] National enquiry point, or address, fax number and E-mail address (if available) of other body:

The electronic version of the regulatory text can be downloaded at: http://canadagazette.gc.ca/partI/2004/20040515/pdf/g1-13820.pdf