A466 DAR Exec Summary

9 October 2002

DRAFT ASSESSMENT REPORT

Full Report [ pdf 212 kb ]

Executive Summary and Statement of Reasons

Food Standards Australia and New Zealand (FSANZ) received an application from Genencor International to amend the Food Standards Code to approve the use of the enzyme transglucosidase (TG) sourced from Aspergillus niger as a processing aid.

The Application was received on 2 April 2002 and work commenced on 23 April 2002.

There is currently no approval for the use of TG as a processing aid in Standard A16 of the Australian Food Standards Code (Volume 1) and Standard 1.3.3 of the Australia New Zealand Food Standards Code (Volume 2). Because Volume 1 is expected to be repealed in December 2002 when Volume 2 will become the sole food regulatory code for Australia and New Zealand, it has been decided to only amend Volume 2 and not Volume 1. 'Food Standards Code' will be used to refer only to the Volume 2 for the rest of this report.

The objective of this assessment is to determine whether to amend the Food Standards Code to permit the use of the enzyme transglucosidase sourced from Aspergillus niger as a processing aid.

The regulatory options considered are to:

1. Not approve, or
2. Approve

this Application.

Option 2 has advantages to food manufacturers to be able to use the enzyme TG to produce isomalto-oligosaccharides (IMO) and to other food manufacturers that can source locally produced IMO for use in their products. There are no significant disadvantages to food manufacturers, consumers or government agencies.

The Initial Assessment went out for a round of public comment (from 8 May to 19 June 2002). There were 4 submissions received which all supported the application. However three submissions did have qualifications depending on the Draft Assessment Report. In one case providing the safety assessment confirmed the safety of the enzyme and in two cases requiring more information on the use of IMO (which are produced by the action of the enzyme) in food.

FSANZ is now seeking public comment on this Draft Assessment to assist in the Final Assessment. Comments that will be useful would include:

  • Technological justification;

  • Safety considerations; and

  • Interest from industry in using the enzyme to produce IMO and using IMO in food products.

Statement of Reasons

The draft variation to Standard 1.3.3 - Processing Aids of the Food Standards Code , thereby giving approval for the use of the transglucosidase sourced from Aspergillus niger as a processing aid is recommended for the following reasons:

  • There are no public health and safety concerns associated with the use of the enzyme preparation.

  • The use of the transglucosidase enzyme is technologically justified.

  • The source organism (Aspergillus niger) has a long history of safe use.

  • The transglucosidase enzyme has a history of safe use in other countries.

  • Transglucosidase derived from Aspergillus niger complies with the specifications in the Compendium of Food Additives Specifications, Vol. 1, Annex 1, FAO 1992, specifications (updated in Addendum 9, 2001).

  • The proposed draft variation to the Food Standards Code is consistent with the section 10 objectives of the FSANZ Act.

  • The benefits of using the enzyme for food manufacturers outweigh any costs associated with its use.

The Australia New Zealand Food Authority (ANZFA) to FSANZ transitional requirements for an application at preliminary (initial) stage provide that FSANZ is taken to have made an initial assessment of the Application. Any submissions received by ANZFA about an Application in response to a notice given under section 13A or 14 of the Australia New Zealand Food Authority Act 1991, are taken to be submissions made to FSANZ about the application/proposal in response to a notice under section 13A or 14 under the Food Standards Australia New Zealand Act 1991.

Full Report [ pdf 212 kb ]