A492DARExecsumm

10/03

16 July 2003

DRAFT ASSESSMENT REPORT

Executive Summary and Statement of Reasons

FSANZ received an application on 14 February 2003, from Genencor International to amend Standard 1.3.3 - Processing Aids - of the Australia New Zealand Food Standards Code (the Code) to approve the use of a new enzyme, lysophospholipase (EC number 3.1.1.5). The application is being progressed as a Group 3 (cost-recovered) application. Lysophospholipase is sourced from Aspergillus niger which is the source organism for a number of approved enzymes within the Code.

Processing aids are required to undergo a pre-market safety assessment before approval for use in Australia and New Zealand. There is currently no approval for the use of lysophospholipase in the Code. The objective of this assessment is to determine whether it is appropriate to amend the Code to permit the use of lysophospholipase sourced from Aspergillus niger.

The main function that lysophospholipase has in food manufacturing is as a processing aid to improve the filterability and therefore process efficiencies during the production of glucose syrups and maltodextrins from the hydrolysis of wheat starch. Lysophospholipase reduces the concentration of phospholipids during processing, which otherwise cause slow filtration.

The safety assessment concluded that:

• the source organism, Aspergillus niger has a long history of safe use in the production of food enzymes, is the source for many approved enzymes in the Code, and is regarded as non-pathogenic and non-toxigenic;
• the enzyme preparation complies with international specifications;
• the enzyme causes no mutagenic effects in in vitro studies and there are no acute toxicity effects in animal studies; and
• a sub-chronic study in rats produced an ADI for lysophospholipase of 3 mg/kg bw per day.

Lysophospholipase is listed as Generally Recognized As Safe (GRAS) for use in food in the USA. France has approved the use of lysophospholipase as a food enzyme.

The only regulatory options considered were to approve or not approve the use of lysophospholipase sourced from Aspergillus niger as a processing aid. Approval of the application provides advantages to manufacturers of glucose syrups and maltodextrins by improving filtration rates so improving process efficiencies. There should be no added costs to government regulators or consumers.

Public comment on the Initial Assessment Report had been sought from 19 March 2003 till 30 April 2003. Three submissions were received; two submissions supported the application, while one deferred comments until after the Draft Assessment Report.

The Draft Assessment Report concludes that approval of lysophospholipase sourced from Aspergillus niger 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 lysophospholipase sourced from Aspergillus niger as a processing aid is recommended for the following reasons.

• Use of the enzyme does not raise any public health and safety concerns.
• Use of the enzyme is technologically justified since it has a role in improving filtration rates and hence process efficiencies in the process of hydrolysing wheat starch to produce caloric sweeteners such as glucose syrups and maltodextrins.
• The source organism, Aspergillus niger has a long history of safe use in the production of food enzymes, is the source for many approved enzymes in the Code, and is regarded as non-pathogenic and non-toxigenic.
• The proposed draft variation to the Code is consistent with the section 10 objectives of the FSANZ Act. FSANZ has addressed the protection of public health and safety by undertaking a safety assessment of the enzyme and using the best available scientific data.
• 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 275kb ]