8 May 2002
INITIAL ASSESSMENT REPORT
Full Report [ pdf 206kb ]
The Australia New Zealand Food Authority (ANZFA) is a bi-national statutory body responsible for developing draft food standards and draft variations of standards, to make recommendations to the Australia New Zealand Food Standards Council (ANZFSC) in relation to those drafts, and to review standards. ANZFSC may then decide to adopt the draft standards or draft variations of standards, which results in their incorporation into food laws of the Australian States and Territories, and New Zealand.
On 24 November 2000, ANZFSC adopted the Australia New Zealand Food Standards Code (known as Volume 2 of the Food Standards Code ) that will apply in both Australia and New Zealand. A two-year transitional period has been implemented at the conclusion of which Volume 2 of the Food Standards Code will be the sole code for both countries. In the interim, for the majority of the food standards, there is a system of dual standards operating in both Australia and New Zealand.
An application has been received from Hayashibara Company Ltd. on 4 October 2001 seeking to amend Standards A19/1.5.1 of the Food Standards Code to permit the use of trehalose as a novel food ingredient. This application is at the preliminary assessment stage as detailed in the section 13 of the Australia New Zealand Food Authority Act.
The application is seeking approval of trehalose as a novel food ingredient. Under the current food regulations, novel foods and novel food ingredients are required to undergo a pre-market safety assessment, as per Standard A19/1.5.1 - Novel Foods. The purpose of Standard A19/1.5.1 is to ensure that non-traditional foods, which have features or characteristics that may raise safety concerns will undergo a risk-based safety assessment before they are offered for retail for consumption in Australia or New Zealand.
Novel Foods is defined in the Standard as:
A non-traditional food or food ingredient for which there is insufficient knowledge in the broad community to enable safe use in the form or context in which it is presented, taking into account-
(a) the composition or structure of the product;
(b) levels of undesirable substances in the product;
(c) the potential for adverse effects in humans;
(d) traditional preparation and cooking methods; or
(d) patterns and levels of consumption of the product;
Trehalose is considered a novel food ingredient because it is a non-traditional food for which there is insufficient knowledge in the broad community to ensure safe use in the form in which it is presented. Thus, an assessment of its safety is required before it can be marketed.
The application received from Hayashibara Company Ltd. on 4 October 2001 is seeking to amend Standards A19/1.5.1 of the Food Standards Code to permit the use of trehalose as a novel food ingredient. The objective of this application is to determine whether the food regulations can be amended to approve the use of trehalose as a novel food ingredient.
Any amendment to the FSC needs to be consistent with the section 10 objectives of ANZFA Act. The three primary objectives of the Authority in developing food regulatory measures are:
(a) the protection of public health and safety;
(b) the provision of adequate information relating to food to enable consumers to make informed choices; and
(c) the prevention of misleading or deceptive conduct.
In developing and varying standards, ANZFA must also have regard to:
(a) the need for standards to be based on risk analysis using the best available scientific evidence;
(b) the promotion of consistency between domestic and international food standards;
(c) the desirability of an efficient and internationally competitive food industry; and
(d) the promtion of fair trading in food.
Full Report [ pdf 206kb ]