18 December 2002
FINAL ASSESSMENT REPORT
Full Report [ pdf229kb ]
Executive Summary
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 - Food Standards Code) and Standard 1.3.3 (Volume 2 - Australia New Zealand Food Standards Code).The enzyme was produced from a new source 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. The Australia New Zealand Food Authority (ANZFA) to FSANZ transitional requirements for an application at Full Assessment (Draft) stage have been followed. The Authority has not been notified of any ministerial Council policy guidelines relevant to this application.
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. One late submission was received from New Zealand Ministry of Health.
Three submissions were received during the second round of public consultation at Draft Assessment- all three were supportive.
Only two regulatory options were considered: to approve or not approve the new source of the enzyme, glucose oxidase. The option to approve the new source of the enzyme was considered appropriate because the donor and host organisms, and the new enzyme were demonstrated to be safe, and the enzyme is technologically justified.
The Statement of Reasons forms the basis for the Authority's decision to adopt draft variations to 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 Authority agreed to adopt the draft variation to the Food Standards Code because:
- 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 donor and the source organisms have 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.
- Use of glucose oxidase sourced from Aspergillus oryzae, that carries a gene coding for glucose oxidase isolated from Aspergillus niger is technologically justified.
- The proposed change to Volume 2 of theFood Standards Codeis consistent with the section 10 objectives of the FSANZ Act.
- The Regulatory Impact Statement showed that forAspergillus oryzae, carrying a gene coding for glu cose oxidase isolated fromAspergillus 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.
Full Report [ pdf229kb ]