DRAFT ASSESSMENT REPORT
21 August 2002
The Australia New Zealand Food Authority (ANZFA - now Food Standards Australia New Zealand (FSANZ)) received an application from Novozymes A/S to amend the Australia New Zealand Food Standards Code to approve the use of the enzyme, glucose oxidase, as a processing aid under Standard A16 (Volume 1) and Standard 1.3.3 (Volume 2) of the Food Standards Code. The enzyme was produced using recombinant DNA techniques from the host bacterial strain, Aspergillus oryzae, and contains a donor gene coding for glucose oxidase from Aspergillus niger. There is already a permission in the Food Standards Code for glucose oxidase [1.1.3.4] sourced from Aspergillus niger.
The Application was received on 26 October 2001 and work was commenced on 12 December 2001.
A total of 4 submissions were received in response to the first round of public consultation at Initial Assessment - two were supportive and two were not supportive. The main issues raised in the submissions that were not supportive were (i) the labelling of processing aids obtained from genetically modified organisms (GMOs), (ii) lack of technological justification and (iii) the similarity to previous applications.
The scientific evaluations concluded that approval of the use of glucose oxidase from genetically modified host bacterial strain, Aspergillus oryzae, containing a donor gene coding for glucose oxidase from Aspergillus niger, is technologically justified and poses no significant risk to public health and safety. None of the section 10 objectives in the Food Standards Australia New Zealand Act 1991 (FSANZ Act) are compromised by the proposed change to the Food Standards Code. It is recommended that the draft variation should come into effect on the date of gazettal.
Approval for use will provide Australian manufacturers with a processing aid which is claimed to be more cost-effective and technologically efficient to manufacture and use.
FSANZ will now seek further input from the public during the second round of public consultation before Final Assessment.
Enzymes used in food preparations are regulated as processing aids under Standards A16 and 1.3.3 of the Food Standards Code and require pre-market safety assessment and approval before use. Glucose oxidase from genetically modified host bacterial strain, Aspergillus oryzae, containing a donor gene coding for glucose oxidase from Aspergillus niger, is currently not approved in Australia and New Zealand (under Standard A16 (Volume 1) and Standard 1.3.3 (Volume 2).
To determine whether to change the Food Standards Code can be changed to permit the use of glucose oxidase from genetically modified host bacterial strain, Aspergillus oryzae, containing a donor gene coding for glucose oxidase from Aspergillus niger.
Issues considered during assessment of the Application
A range of issues were considered during the assessment; namely, the safety and technological need for the processing aid.
FSANZ identified two options, namely:
1. Not to permit the use of glucose oxidase from genetically modified host bacterial strain, Aspergillus oryzae, containing a donor gene coding for glucose oxidase from Aspergillus niger; or
2. Permit the use of glucose oxidase from genetically modified host bacterial strain, Aspergillus oryzae, containing a donor gene coding for glucose oxidase from Aspergillus niger.
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Option 1, which supports status quo by not giving specific permission in the Food Standards Code for the use of this enzyme, has no perceived benefits to the stakeholders, government, consumers and industry.
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Option 2, which supports approval to allow an alternative safe source of glucose oxidase with no additional costs to government, industry or consumers, is the preferred option.
The Application was released for the first round of public consultation following Initial Assessment from 13 March 2002 until 24 April 2002.
FSANZ is seeking public comment in order to assist in assessing this application at Final Assessment. Comments that would be useful could cover:
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Safety of glucose oxidase of from genetically modified host bacterial strain, Aspergillus oryzae, containing a donor gene coding for glucose oxidase from Aspergillus niger.
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Technological need for of glucose oxidase from genetically modified host bacterial strain, Aspergillus oryzae, containing a donor gene coding for glucose oxidase from Aspergillus niger.
The Statement of Reasons explains the basis of the Authority's decision to adopt draft variations to Standard A16 of Volume 1 and Standard 1.3.3 of Volume 2 of the Food Standards Code. The variations concern the inclusion of a new source of the enzyme glucose oxidase for use as a processing aid in the food industry.
The Draft variation to the Food Standards Code is recommended because:
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The safety evaluation of the glucose oxidase produced by Aspergillus oryzae, containing a donor gene coding for glucose oxidase from Aspergillus niger found that, the source organism has a long history of safe use, the glucose oxidase gene is stably integrated into the host organisms, the enzyme preparation complies with the Joint Expert Committee on Food Additives (JECFA) specifications and there are no public health and safety concerns associated with the enzyme preparation.
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Use of glucose oxidase sourced from Aspergillus oryzae,that carries a gene coding for glucose oxidase isolated from Aspergillus niger is technologically justified.
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The proposed changes to Volume 1 and Volume 2 of the Food Standards Code are consistent with the section 10 objectives of the FSANZ Act.
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The Regulatory Impact Statement showed that for Aspergillus oryzae,carrying a gene coding for glucose oxidase isolated from Aspergillus niger, the benefits outweighed the costs in relation to the proposal to amend Standard 1.3.3 - Processing Aids. Approval would allow an alternative safe source of glucose oxidase with no additional costs to government, industry or consumers.
The Australia New Zealand Food Authority (ANZFA) to FSANZ transitional requirements for an application/proposal at preliminary (initial) stage provide that FSANZ is taken to have made an initial assessment of the Application. Any submissions received by ANZFA about an Application in response to a notice given under section 13A or 14 of the Australia New Zealand Food Authority Act 1991, are taken to be submissions made to FSANZ about the application/proposal in response to a notice under section 13A or 14 under the Food Standards Australia New Zealand Act 1991.