10/03
16 July 2003
INITIAL ASSESSMENT REPORT
Full Report [ pdf 177kb ]
DEADLINE FOR PUBLIC SUBMISSIONS to FSANZ in relation to this matter: 27 August 2003 (See 'Invitation for Public Submissions' for details) |
Executive Summary and Statement of Reasons
FSANZ received a paid application on 10 June 2003 from ADM Kao LLC, a joint venture business between the Archer Daniels Midland Company and the Koa Corporation to approve the use of diacylglycerol oil (DAG-oil) as a novel food under Standard 1.5.1 - Novel Foods of the Food Standards Code. Novel foods may not be sold as food or for use as food ingredients unless listed in the Table to clause 2 of Standard 1.5.1. In deciding whether to list a novel food in the table FSANZ conducts a safety assessment of the food. If approved, the novel food must comply with any special conditions of use also listed in the Table.
It is proposed by the applicant to use DAG-oil as edible oil and as an ingredient in various foods. For a food to be considered novel, it must first be considered to be a non-traditional food. A non-traditional food is a food which does not have a history of significant consumption by the broad community in Australia or New Zealand. DAG-oil consists of >80% diglycerides, while edible oil normally consists of triglycerides and only small amounts of diglycerides. Therefore, the broad community may be currently only exposed to low levels of diglycerides. This means that although there may be a history of human consumption of the main component of DAG-oil in the broad community in Australia and New Zealand, this consumption may not be significant. Hence, DAG-oil may be a non-traditional food.
DAG-oil may be a novel food because the composition of the product is markedly different to traditional oils. DAG-oil contains >80% diglycerides, 20% triacylglycerol, 5% monoacylglycerol and
This Initial Assessment report is an assessment of whether the application should be accepted for further consideration, according to criteria laid down in the FSANZ Act.
FSANZ accepts this application following initial assessment for the following reasons.
- The application seeks approval for the use of DAG-oil as a novel food.
- DAG-oil may be a non-traditional food as there is no history of human consumption of DAG-oil or its main component, diglycerides, at significant levels in Australia or New Zealand.
- DAG-oil may be a novel food because, due to the markedly different composition of DAG-oil compared with edible oils, FSANZ considers that there is insufficient knowledge in the broad community to enable safe use of DAG-oil in the form or context in which it is presented.
- Therefore, the application relates to a matter that warrants a variation to Standard 1.5.1, if further assessment supports such a variation.
- The application is not so similar to any previous application that it ought not be accepted.
- There is no basis for considering, at this stage of assessment, that the costs that would arise from a variation to Standard 1.5.1 to permit DAG-oil would outweigh the direct and indirect benefits to the community, Government or industry.
- There are no measures other than a variation to the Food Standards Code available to permit a novel food to be sold as food or for use as a food ingredient.
Accordingly, FSANZ now seeks public comment on matters relevant to this application for consideration in making a Draft Assessment. If approved by FSANZ and agreed by the Ministerial Council, an amendment to Standard 1.5.1 would allow the use of DAG-oil derived from vegetable oils as a novel food and novel food ingredient.
The purpose of this report is to provide relevant information supplied by the applicant, to assist in identifying the affected parties and to outline the relevant issues necessary to complete assessment of the application, now that it has been accepted. The information needed to complete the assessment will include information received from public submissions.
Full Report [ pdf 177kb ]