A508 - IAR - Exec summ

11/03

13 August 2003

INITIAL ASSESSMENT REPORT

Executive Summary

Parmalat Australia Ltd has submitted an application to FSANZ seeking approval for the use of tall oil phytosterols [1] (TOPs) as a novel food ingredient in low-fat and no-fat liquid milk products under Standard 1.5.1 - Novel Foods-in the Australia New Zealand Food Standards Code (the Code). Standard 1.5.1 requires that novel foods undergo a safety assessment before being permitted in the food supply. If approved, the novel food is listed in the Table to the Standard and must comply with any special conditions of use also listed in the Table.

Prior consideration by FSANZ of the use of TOPs and phytosterol esters derived from vegetable oils as novel food ingredients resulted in permission for their use in one food type only, namely edible oil spreads and margarines, where the level of consumption is self-limiting. Further safety data and additional scientific information was deemed to be necessary to extend the permission for their use in a broader range of food products.

The applicant has supplied additional scientific information relevant to a safety assessment supporting the use of TOPs in milk products. This will be assessed by FSANZ in the draft assessment stage.

This Initial Assessment report is not an assessment of the merits of this application but rather is an appraisal of whether the application warrants further consideration according to criteria laid down in the Food Standards Australia New Zealand Act 1991(FSANZ Act). It is the conclusion of this assessment that, having regard to the requirements of section 13 of the FSANZ Act, this application should be accepted.

This report outlines the relevant issues necessary to proceed with assessment of the application and also provides the general community with relevant information supplied by the applicant to assist in identifying the issues and parties that may be affected by a decision.

Public submissions are invited on this Initial Assessment report. Comments are specifically sought on the public health and safety aspects of this application, and the costs and benefits to the food industry, consumers and Government in general. Should any submissions be received, those will be considered as part of the assessment process.

Full report [ pdf 187kb ]