Application A428 Final Assessment Report Exec Summary

8 May 2002

Final Assessment Report

Full Report [ pdf 423kb ]

EXECUTIVE SUMMARY

The Australia New Zealand Food Authority (ANZFA) received an Application (A428) on

13 March 2001, from Omega Tech Inc., to amend Standards A19 and 1.5.1 (the Novel Foods Standards) of the Food Standards Code to permit the use of dried marine micro-algae (Schizochytriumsp.) which is rich in the omega-3 long chain polyunsaturated fatty acid DHA (docosahexaenoic acid) as a novel food ingredient in a limited range of foods. The Applicant subsequently amended their Application on 28 August 2001 to include DHA- rich oil derived from the same species for use as a novel food ingredient in a limited range of foods. The Applicant has also requested in his 28 January 2002 communication that minor changes be made to the specification proposed in the Draft Assessment Report (Full Assessment - section 15) for the oil derived from the micro-algae. The changes proposed do not affect the safety of the oil. The earlier specification has narrow limits for some tests and proposed changes reflect the normal process operation capability more appropriately.

Under Standards A19 and 1.5.1 of the Food Standards code, novel food is defined as a sub-set of non-traditional food, as defined in the Standard. DHA-rich marine micro-algae (Schizochytriumsp.) and DHA-rich oil derived from Schizochytrium sp. are non-traditional foods because they do not have a history of significant human consumption by the broad community in Australia and New Zealand. They are considered to be novel foods for the purposes of the Standard because there is insufficient knowledge in the broad community to enable safe use of these foods in the form or context in which they are proposed to be presented.

Omega-3 long chain fatty acids, specifically, DHA have been identified as important dietary nutrients with specific roles in the developing foetus and pre-term infants. There are also recent reports that indicate that DHA, as one of the omega-3 fatty acids, may have an important role in cardiovascular health and beneficial effects on the immune system in the general population. DHA is also considered to be vital for the development and function of the brain and eyes.

ANZFA released a Draft Assessment Report in relation to this application on

12 December 2001, seeking public comment. The submission period ended on

6 February 2002. A total of five submissions were received.