A501 - IAR - Exec summ

11/03

13 August 2003


INITIAL ASSESSMENT REPORT

DEADLINE FOR PUBLIC SUBMISSIONSto FSANZ in relation to this matter:

24 September 2003

(See 'Invitation for Public Submissions' for details)

Full report [ pdf 193kb ]

Executive Summary

FSANZ received an application on 12 May 2003, from Genencor International to amend Standard 1.3.3 - Processing Aids of theAustralia New Zealand Food Standards Code (the Code) to approve the use of a new enzyme, phospholipase A 2 (Enzyme Commission number EC number 3.1.1.4) sourced from Streptomyces violaceoruber, as a processing aid. The enzyme is not sourced from a genetically modified organism. Work commenced on this cost recovered application on 9 July 2003.

This Initial Assessment Report is not a detailed assessment of Application A501 but rather an assessment of whether the application should undergo further consideration. The report is based mainly on information provided by the applicant and has been written to assist in identifying the affected parties and to outline expected relevant issues to complete the assessment. The information needed to complete the assessment will include information received from public submissions.

Processing aids are required to undergo a pre-market safety assessment before approval for use in Australia and New Zealand. There is currently approval for the use of phospholipase A 2 derived from porcine pancreas in the Code. The objective of this assessment is to determine whether the Code should be amended to permit the use of phospholipase A 2 sourced from S. violaceoruber.

Phospholipase A 2 is used to hydrolyse lecithin to produce lysolecithin, which has improved emulsifying properties.

S. violaceoruberis the source of the enzyme and does not have a long history of safe use in the production of food enzymes. The applicant claims S. violaceoruberis non-pathogenic and non-toxigenic.

Phospholipase A 2 preparations meet both the current Food Chemical codex (FCC) specifications and JECFA compendium of specifications for food grade enzyme preparations.

This application has been assessed against the requirements of section 13 of the Food Standards Australia New Zealand Act 1991(the Act). Accordingly, it is recommended that this application be accepted and progressed to Draft Assessment subject to the payment of fees assessed pursuant to section 66 of the Act and the Food Standards Australia New Zealand Regulations 1994(the Regulations). Submissions are invited to assist in assessing this application, the proposed Regulatory options and the Report as a whole.

Full report [ pdf 193kb ]