 
 WORLD TRADE  
ORGANIZATION   
G/SPS/N/CAN/206 
1 June 2004 
 (04-2315) 
Committee on Sanitary and Phytosanitary Measures Original:   English/ 
 French 
 
 
NOTIFICATION  
 
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 numbe r(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 Add itives) (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 Di vision 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 mu ltiple 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 c opies 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 temp erature and low pH stability, produced by 
Bacillus licheniformis BML 592 (pAmyAmp) genetically modified to contain the 
alpha-amylase gene obtaine d from the wild type Bacillus licheniformis modified by 
mutagenesis, in the production of brewers' m ash, distillers' mash, and in starch used in 
the production of dextrins, dextrose, glucose (glucose syrup) or glucose solids (dried 
glucose syrup) and maltose;  G/SPS/N/CAN/206 
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  — alpha-amylase enzyme, which has high temper ature 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 th e production of dextrins, dextrose, glucose 
(glucose syrup) or glucose solids (d ried 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 s upports the safety and effectiven ess 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 c onsistent with good 
manufacturing practice.   G/SPS/N/CAN/206 
 Page 3 
 
 
 7. Objective and rationale:  [ X ] food safety, [   ] animal health, [   ] plant protection, 
[  ] protect humans from animal/plant pest or  disease, [   ] protec t 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 (availabl e in English and French) 
10. Proposed date of adoption:   Normally within 5 to 8 mont hs 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 notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body:  
The electronic version of the regul atory text can be  downloaded at:  
http://canadagazette.gc.ca/partI/2004/20040515/pdf/g1-13820.pdf  
 
 