18 December 2002
DRAFT ASSESSMENT REPORT
Full Report [ pdf 290kb ]
Executive Summary and Statement of Reasons
An Application has been received from Genencor International to amend the Australia New Zealand Food Standards Code (the Code) to approve the use of an enzyme,alpha-amylase derived fromBacillus stearothermophilus(brand names G-zyme, G-995 and G-997) as a processing aid. The Application was received on 29 May 2002 and work commenced on 9 July 2002.
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 Code.
If this Application is approved Standard 1.3.3 - Processing Aids in the Australia New Zealand Food Standards Code(Volume 2) will be amended. The relevant standard in the Australian Food Standards Code(Volume 1) will not be amended because Volume 1 is expected to be repealed in December 2002.
The purpose of this assessment is to determine whether to amend the Code to permit the use of alpha-amylase derived from Bacillus stearothermophilusas a processing aid.
The only regulatory options considered were to approve or not approve this application. Approval of the use of this enzyme has advantages for food manufacturers by providing a different source of the alpha-amylase enzyme; one, which has greater thermal stability and produces a different sugar profile. There are no significant disadvantages to food manufacturers, consumers or government agencies.
Public comment on the Initial Assessment Report for this application was sought from 21 August until 2 October 2002. Three submissions were received. All supported approval of the use of the enzyme - subject to an appropriate safety assessment as part of the Draft Assessment.
FSANZ is now seeking public comment on this Draft Assessment to assist in the Final Assessment. Comments on the following points would be useful:
-
Technological justification;
-
Safety considerations; and
-
Interest from industry in using the enzyme in food manufacture.
The draft variation to Standard 1.3.3 - Processing Aids of the Code, thereby giving approval for the use of alpha-amylase derived from Bacillus stearothermophilusas a processing aid is recommended for the following reasons:
-
There are no public health and safety concerns associated with the use of the enzyme preparation.
-
The use of thealpha-amylase enzyme is technologically justified since it has a role in food manufacturing, primarily with starch hydrolysis. The enzyme fromBacillus stearothermophilushas greater thermostability, results in a different sugar profile and promotes cost competition to other enzyme suppliers.
-
The source organism (Bacillus stearothermophilus) has a long history of safe use.
-
Thealpha-amylase enzyme has a history of safe use for many years in Australia and New Zealand.
-
The enzyme preparations ofalpha-amylase derived fromBacillus stearothermophiluscomplies with the specifications in Food Chemicals codex (4th Edition, 1996) and the Compendium of Food Additives Specifications, Vol. 1, Annex 1, FAO 1992, (updated in Addendum 9, 2001).
-
The proposed draft variation to the Code is consistent with the section 10 objectives of the FSANZ Act. FSANZ protects public health and safety by assessing the safety of the enzyme preparation to its use in the food supply. The assessment is based on the best available scientific data. It will allow food manufacturers to have a range of enzyme supplies so encouraging an efficient and internationally competitive industry.
-
The benefits of using the enzyme for food manufacturers outweigh any costs associated with its use.
Full Report [ pdf 290kb ]