A475 IAR Exec Summary

9 October 2002

INITIAL ASSESSMENT REPORT

Full Report [ pdf 174 kb ]

Executive Summary

An application has been received 8 August 2002, from Danisco A/S to amend Standard 1.3.3 of the Australia New Zealand Food Standards Code (Food Standards Code) to approve the use of an enzyme, hexose oxidase as a processing aid. The hexose oxidase is produced, using recombinant DNA techniques, from the host yeast Hansenula polymorpha which contains the donor gene coding for hexose oxidase from the algae Chondrus crispus.

This Initial Assessment report is not a detailed assessment of the application but rather an assessment that the application should be accepted for further consideration. The report is based mainly on information provided by the applicant and has been written to assist in identifying the affected parties and to outline expected relevant issues to complete the assessment. The information needed to complete the assessment will include information received from public submissions.

There is currently no approval for the use of hexose oxidase as a food enzyme in the Food Standards Code. If this application is successful FSANZ will add permission to use the enzyme hexose oxidase produced by Hansenula polymorpha,carrying the gene coding for hexose oxidase isolated from Chondrus crispus to the Table to clause 17 of Standard 1.3.3 - Processing Aids.

The objective of this assessment is to determine whether it is appropriate to amend the Food Standards Code to permit the use of hexose oxidase from the above source.

Hexose oxidase catalyses the oxidation of various mono and oligosaccharides to lactones and hydrogen peroxide. Its main application is in bread making to increase dough strength and bread volume. It acts in a similar way to glucose oxidase for this purpose however it is claimed to have added advantages. Other applications in the food industries are in cheese and tofu manufacture where it aids curd formation, limiting undesirable browning by limiting Maillard reactions in food and as an oxygen scavenger in dressings and sauces.

The enzyme is isolated from the red algae Chondrus crispus. However this source is not a suitable production organism since recoveries are low and not economic. The gene for the enzyme was therefore inserted into the host yeast Hansenula polymorpha from which the enzyme can be recovered in economic quantities using a submerged fermentation process.

The applicant claims that the gene, the vector and the host organism are all well characterised. The donor organism, Chondrus crispus, has a long history of safe use in food. The host organism, Hansenula polymorpha is non-toxigenic.

The hexose oxidase enzyme preparations comply with the specifications for food enzyme preparations in Food Chemicals codex, 4th Edition 1996, and also the Joint FAO/WHO Expert Committee on Food Additives (JECFA), in the Compendium of Food Additives Specifications, FAO Food and Nutrition Paper 52, Vol. 1, Annex 1 (1992), including relevant updates in addenda 1 to 9 (2001).

In the USA a GRAS (generally recognised as safe) expert panel has concluded that the enzyme is safe for food use as a processing aid. The enzyme is approved for use in baked goods (at a level up to 150 enzyme units/kg) in Denmark.

Full Report [ pdf 174 kb ]