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A472 Draft Assessment Report 21 May 2003


21 May 2003


Full Assessment Report [ pdf 402kb ]

Executive Summary

Food Standards Australia New Zealand (FSANZ) received an Application from Aria Food Ingredients amba (Denmark) on 17 July 2002 seeking to amend Standard 1.5.1 of the Food Standards Code to permit the use of D-tagatose as a novel food ingredient. This application is at the draft assessment stage under section 15 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act). The work on this application was commenced on 08 August 2002.

Under the current food standards, novel foods are required to undergo a pre-market safety assessment, as per Standard 1.5.1 - Novel Foods. D-Tagatose can be considered a ‘sugar’ as defined in the Standard 2.8.1 in the Australia New Zealand Food Standard Code (the Code) and hence a food. It is also considered a non-traditional food because it has no history of significant human consumption in Australia or New Zealand. Its safety in the context in which it is presented has not yet been determined within the context of the Australian and New Zealand diet. For these reasons, D-tagatose is considered to be a novel food and is accordingly considered under Standard 1.5.1.

The objective of this assessment is to determine whether it is appropriate to amend the Code to permit the use of D-tagatose as a novel food. Such an amendment would need to be consistent with the section 10 objectives of the FSANZ Act.

A range of issues was considered during the assessment of the application. An analysis of the safety and nutritional impact of the use of D-tagatose indicate that there are no public health and safety concerns at the anticipated levels of dietary exposure. D-tagatose has technological properties similar to traditional sugars such as glucose and fructose and can be used as a reducing sugar as it caramelises at elevated temperatures. However, in contrast to traditional sugars, it is only partially absorbed by the body resulting in reduced energy value.

The only regulatory options identified were to approve or not approve the use of D-tagatose as a novel food.The regulatory impact analysis shows that benefits accrue to industry and Governments, in terms of enhanced market opportunities and trade (under Australia and New Zealand’s requirements under the World Trade Organization), respectively, and to consumers through potentially a greater choice of foods.

Three submissions were received during the consultation period. One submitter supported the proposal to amend the Food Standards Code to permit D-tagatose. One argued that D-tagatose is a traditional food and therefore should not be regulated, while another was undecided on whether permission should be given or not because of insufficient information in the Initial Assessment Report.

Full Assessment Report [ pdf 402kb ]


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