Full Report [ pdf 234 kb | Word document 255kb ]
08/03
19 March 2003
FINAL ASSESSMENT REPORT
Executive Summary and Statement of Reasons
Food Standards Australia New Zealand (FSANZ) received an application from Genencor International to amend theFood Standards Code to approve the use of the enzyme transglucosidase sourced from Aspergillus niger(TG) as a processing aid.
The Application was received on 2 April 2002 and work commenced on 23 April 2002.
Standard 1.3.3 - Processing Aids of the Australia New Zealand Food Standards Codecurrently does not list this enzyme as approved from any source.
The objective of this assessment is to determine whether to amend the Code to permit the use of TG as a processing aid.
There are currently no other enzymes or chemical methods that can commercially produce isomalto-oligosaccharides (IMO) from high maltose syrups other than using TG. The Food Technology Report concluded that the use of the enzyme is technologically justified. The Safety Assessment Report concluded that the use of TG would pose no significant public health and safety risk. The source organism and the enzyme has a long history of safe use, while the enzyme preparation complies with FAO/WHO Joint Expert Committee on Food Additives (JECFA) specifications.
The only regulatory options considered were to approve or not approve this application. Approval of the use of TG has advantages to food manufacturers to be able to use TG to produce 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.
Public comment on the Initial Assessment Report was sought 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 outcome of the Draft Assessment Report. In one case, support was dependent on the safety assessment confirming the safety of the enzyme and in the two other cases support was dependent on more information on the use of IMO in food.
Public comment on the Draft Assessment Report was sought from 9 October to 20 November 2002. Two submissions were received, both supporting the Application. No other comments or issues were raised.
The Final Assessment Report concludes that approval of the use of TG as a food processing aid is technologically justified and poses no significant risk to public health and safety.
The Australia New Zealand Food Authority (ANZFA) to FSANZ transitional requirements for an application at Full (Draft) Assessment stage have been followed and no additional submissions have been received.
Statement of Reasons
The draft variation to Standard 1.3.3 - Processing Aids, thereby giving approval for the use of TG as a processing aid is recommended for the following reasons.
- There are no significant public health and safety concerns associated with the use of the enzyme preparation.
- The use of TG is technologically justified, being an enzyme that is able to produce a type of sugar syrup - IMO - from starch. IMO are suitable for use as a food ingredient in a range of products.
- The source organism (Aspergillus niger) has a long history of safe use.
- TG has a history of safe use in other countries.
- TG complies with the specifications in the Compendium of Food Additives Specifications, Vol. 1, Annex 1, and 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. FSANZ protects public health and safety by assessing the safety of the enzyme preparations for its use in food manufacture. The assessment is based on the best available scientific data.
- The benefits of using the enzyme outweigh any costs associated with its use.
Full Report [ pdf 234 kb | Word document 255kb ]