A475 Exec SummaryDAR

08/03

19 March 2003

DRAFT ASSESSMENT REPORT

Full Report [ pdf 440kb ]

Executive Summary

FSANZ received an Application on 8 August 2002, from Danisco A/S to amend Standard 1.3.3 of the 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. The abbreviation HOX is used in this report to refer to the enzyme hexose oxidase sourced from Hansenula polymorpha, which contains the donor gene coding for hexose oxidase from the algae Chondrus crispus.

There is currently no approval for the use of hexose oxidase as a food enzyme in Australia and New Zealand. 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 produced from this source.

The only regulatory options considered were to approve or not approve this application. Approval of the use of this enzyme has advantages for food manufacturers by providing them with a new enzyme, which can perform a range of functions for their food manufacturing. There are no significant disadvantages to food manufacturers, consumers or government agencies.

Hexose oxidase catalyses the oxidation of various mono- and oligosaccharides to lactones and hydrogen peroxide. The enzyme's main application is in bread making to increase dough strength and bread volume. The enzyme acts in a similar way to glucose oxidase for this purpose, however it has added advantages, since it acts on a wider range of substrates. 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 during production of dressings and sauces. The Food Technology Report concludes that use of HOX is technologically justified.

The enzyme can be 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 gene, the vector and the host organism are all well characterised. The donor organism, Chondrus crispus (a seaweed commonly called Irish moss), has a long history of safe use in food. The host organism, Hansenula polymorpha is non-toxigenic and non-pathogenic.Hansenula polymorpha is used for the production of pharmaceutical products with two hepatitis B vaccines produced by recombinant techniques commercially available.

The safety assessment of HOX concluded that:

• the host organism and donor organisms are safe and demonstrate no evidence of toxicity and/or pathogenicity;
• the HOX gene is stably integrated into the host genome;
• the enzyme preparation complies with international specifications; and
• the enzyme preparation causes no mutagenic effects in in vitro studies and there were no acute or subchronic toxicity effects in animals studies.

The Safety Assessment Report concludes that HOX, used as a processing aid poses no significant public health and safety risk.

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.

Public comment on the Initial Assessment Report for this application was sought from 9 October till 20 November 2002. Four submissions were received . Three (Goodman Fielder, Australian Food and Grocery Council (AFGC) and Food Technology Association of Victoria) supported approval of the use of the enzyme - subject to an appropriate safety assessment as part of the Draft Assessment. The fourth submission, from the Western Australian Department of Health raised a number of issues, which have been addressed.

The Draft Assessment Report concludes that approval of the use of HOX as a food processing aid is technologically justified and poses no significant risk to public health and safety. FSANZ is now seeking public comment on this Draft Assessment to assist in the Final Assessment

Full Report [ pdf 440kb ]