Application A438 Initial Exec Summary

NOVEL FOOD INGREDIENT / FOOD ADDITIVE

8 May 2002

Initial Assessment Report

DEADLINE FOR PUBLIC SUBMISSIONS to the Authority in relation to this matter: 19 June 2002
(See ' Invitation for Public Submissions ' for details)

Full Report [ pdf 211kb ]

INTRODUCTION

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 Wacker Chemie GmbH on 12 April 2001 seeking to amend Standards A19/1.5.1 of the Food Standards Code to permit the use of gamma-cyclodextrin ( gamma -cyclodextrin) 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 1991.

REGULATORY PROBLEM

The application is seeking approval of gamma -cyclodextrin as a novel food. Under the current food regulations, novel foods 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 that 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;

(d) traditional preparation and cooking methods; or

(d) patterns and levels of consumption of the product;

gamma -Cyclodextrin could be considered a novel food ingredient (for some of the uses proposed) 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. Its safety needs to be assessed before it can be marketed.

gamma -Cyclodextrin also has properties consistent with its consideration as a food additive (see later discussion). Food additives also require pre-market assessment under Standard 1.3.1- Food Additives.

OBJECTIVE

The initial application received from Wacker Chemie GmbH on 12 April 2001 was seeking to amend Standards A19/1.5.1 of the Food Standards Code to permit the use of gamma -cyclodextrin as a novel food ingredient. After consultations with ANZFA regarding its use as food additive, the applicant has agreed to amend the application title to include ' food additive ' . The objective of this application is to determine whether the food standards can be amended to approve the use of gamma -cyclodextrin as a novel food ingredient/food additive in a wide range of foods. Such an amendment to the FSC will need to be consistent with the section 10 objectives of ANZFA Act. The three primary objectives of the Authority are:

· the protection of public health and safety;

INTRODUCTION

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.

REGULATORY PROBLEM

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;

(d) traditional preparation and cooking methods; or

(d) patterns and levels of consumption of the product;

gamma - Cyclodextrin could be considered a novel food ingredient (for some of the uses proposed) 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. Its safety needs to be assessed before it can be marketed.

gamma - Cyclodextrin also has properties consistent with its consideration as a food additive (see later discussion). Food additives also require pre-market assessment under Standard 1.3.1- Food Additives.

OBJECTIVE

The initial application received from Wacker Chemie GmbH on 12 April 2001 was seeking to amend Standards A19/1.5.1 of the Food Standards Code to permit the use of gamma - cyclodextrin as a novel food ingredient. After consultations with ANZFA regarding its use as food additive, the applicant has agreed to amend the application title to include ' food additive '. The objective of this application is to determine whether the food standards can be amended to approve the use of gamma -cyclodextrin as a novel food ingredient/food additive in a wide range of foods. Such an amendment to the FSC will need to be consistent with the section 10 objectives of ANZFA Act. The three primary objectives of the Authority are:

· the protection of public health and safety;

· the provision of adequate information relating to food to enable consumers to make informed choices; and

· the prevention of misleading or deceptive conduct.

In developing and varying standards, ANZFA must also have regard to:

· the need for standards to be based on risk analysis using the best available scientific evidence;

· the promotion of consistency between domestic and international food standards;

· the desirability of an efficient and internationally competitive food industry; and

the promotion of fair trading in food.

the provision of adequate information relating to food to enable consumers to make informed choices; and