21 May 2003
FINAL ASSESSMENT REPORT
Full Report [ pdf 259kb ]
Executive Summary and Statement of Reasons
FSANZ received a paid application from Genencor International to amend the Australia New Zealand Food Standards Code (the Code) to approve the use of an enzyme,alpha-amylase derived from Bacillus stearothermophilus as a processing aid. The Application was received on 29 May 2002 and work commenced 9 July 2002.
Alpha-amylase is used as a food enzyme for the hydrolysis of starch in the starch, sugar and alcoholic 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 approved sources fo ralpha-amylases listed as processing aids in Standard 1.3.3 - Processing Aids. 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.
The purpose of this assessment is to determine whether it is appropriate to amend the Code to permit the use of alpha-amylase derived from Bacillus stearothermophilus as 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 till 2 October 2002. Three submissions were received with all supporting approval of the use of the enzyme - subject to an appropriate safety assessment as part of the Draft Assessment.
Public comment was sought on the Draft Assessment Report from 18 December 2002 till 12 February 2003. Two submissions were received, both of which supported the application.
The Final Assessment Report concludes that approval of the use ofalpha - amylase derived from Bacillus stearothermophilus as a processing aid is technologically justified and does not raise any public health and safety concerns.
Statement of Reasons
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 stearothermophilus as a processing aid is recommended for the following reasons.
- There are no public health and safety concerns associated with the use of this enzyme.
- The use of the alpha-amylase enzyme derived from Bacillus stearothermophilusis technologically justified since it has a role in food manufacturing, primarily with starch hydrolysis. This enzyme has greater thermostability and a different sugar profile.
- The source organism (Bacillus stearothermophilus) has a long history of safe use.
- The alpha-amylase enzyme has a history of safe use for many years in Australia and New Zealand.
- The enzyme alpha-amylase derived from Bacillus stearothermophilus complies with the specifications for enzyme preparations in Food Chemicals codex (4th Edition, 1996) and the Joint Expert Committee on Food Additives (JECFA) 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.
- The regulation impact assessment has concluded that the benefits of permitting use of the enzyme outweigh any costs associated with its use.
Full Report [ pdf 259kb ]