INITIAL ASSESSMENT REPORT
21 August 2002
An application has been received from Genencor International to amend theAustralia New Zealand Food Standards Code (Food Standards Code) to approve the use of an enzyme,alpha-amylase derived from Bacillus stearothermophilus (brand names G-zyme, G-995 and G-997) as a processing aid.
This Initial Assessment report is not an assessment of the application but rather that the application should be accepted for further consideration. The report is based on information provided by the applicant and has been written to assist in identifying the affected parties and to outline the expected relevant issues to complete the assessment. The information needed to complete the assessment will include information received from public submissions.
Alpha-amylase is used as a food enzyme for the hydrolysis of starch in the starch, sugar and alcohol beverage industries. Genencor's alpha-amylase is produced with the use of a non-genetically modified strain of Bacillus stearothermophilus.
Alpha-amylases have been approved and used for many years in food manufacture. There are currently a number of approvedalpha-amylases listed as processing aids in Standard 1.3.3 of the Food Standards Code. The applicant contends that this alpha-amylase derived from Bacillus stearothermophilus has advantages over other approved enzymes in that it has greater thermal stability, produces a different sugar profile and is not derived from genetically modified organisms.
If this application is approved FSANZ will amend Standard 1.3.3 - Processing Aids in the Australia New Zealand Food Standards Code, but not the relevant standard in theAustralian Food Standards Code because it is expected to be rescinded in Dec 2002.
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established an ADI of 'not specified' for alpha-amylase from Bacillus stearothermophilus at their thirty-seventh session.
The Food and Drug Administration of the United States (FDA) affirmed the generally recognised as safe (GRAS) status of the alpha-amylase derived from Bacillus stearothermophilus.
Public submissions are now invited on this Initial Assessment report. Comments are specifically requested on the safety of the enzyme and the technological justification of its use.