10 October 2001
05/02
DRAFT ASSESSMENT REPORT
(FULL ASSESSMENT - SECTION 15 OF THE ANZFA ACT)
Full Report [ pdf 64kb ]
EXECUTIVE SUMMARY
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The Australia New Zealand Food Authority (ANZFA) received an Application (A435) on 6 February 2001, from Novo Nordisk for the approval of a new source of the enzyme triacylglycerol lipase (EC 3.1.1.3), for use as a processing aid in the food industry. The Applicant seeks to include provision for lipase sourced from a strain of Aspergillus oryzae (A. oryzae), which carries the gene coding for a lipase isolated from Fusarium oxysporum.
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Four submissions were received in response to the public consultation- two supported the proposal, one disagreed and the other had no comments. The main issues raised in the submissions 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.
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The scientific evaluations concluded that the use of lipase produced in A. oryzae carrying the donor gene from Fusarium oxysporum, is technologically justified and poses no additional risk to public health and safety. None of section 10 objectives in the Australia New Zealand Food Authority Act 1991 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.
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The Regulatory Impact Statement concluded that the benefits outweighed the cost in relation to the proposal to amend Standard 1.3.3 - Processing Aids to permit lipase from the new source organismA. oryzae carrying the donor gene from Fusarium oxysporum.
Full Report [ pdf 64kb ]