INQUIRY REPORT AND REGULATORY IMPACT STATEMENT

PERMISSION FOR USE OF NEOTAME

EXECUTIVE SUMMARY

ANZFA received an application on 14 December 1999 from Food Liaison Ltd to amend theFood Standards Codeso as to permit the use of Neotame as an intense sweetener and flavour enhancer by amending Standard A8 - Artificial Sweetening Substances and Standard A6 Flavourings and Flavour enhancers.
Neotame is a dipeptide methyl ester derivative with a sweetness potency 7000-13000 times that of sugar. The applicant claims that Neotame has a clean, sweet taste with no undesirable taste characteristics and exhibits functionality and stability in a wide range of beverages and foods.
Eleven submissions were received in response to the Preliminary Assessment (section 14 notice under theAustralia New Zealand Food Authority Act 1991). Seven of these supported the application while the other four did not support the application and expressed concern that the toxicological evaluation was based upon studies provided by the applicant.
A further 18 submissions were received following Full Assessment, of which, 4 did not support the application. Supporting submissions highlighted the technological benefits for approval of Neotame, in particular, the smaller quantities and lower concentrations needed for food applications, compared to other intense sweeteners. Non-supporting submissions again raised concerns over public health and safety, in particular, specific aspects of the toxicological data provided by the applicant. However, these points had been addressed at Full Assessment and in addition, were revisited in ANZFA' s review of the toxicology report at Inquiry.
The scientific evaluations indicated that there are no public health and safety concerns with the use of Neotame as an intense sweetener and flavour enhancer at the levels proposed for use for the general population and its use is technologically justified.

Neotame can be generally permitted in Volume 1 and 2 of Standard 1.3.1 (Schedule 2) of theFood Standards Code.

The proposed changes at Inquiry are to Volume 1 (Standard A1, A11 and 1.3.1) and Volume 2 (Standard 1.2.4, 1.3.1 and 1.3.4) of theFood Standards Code.The proposed changes are consistent with ANZFA' s section 10 objectives. The requested changes should be implemented and come into force on gazettal.
The Regulatory Impact Statement supports the requested amendments and concludes that the preferred option is Option 2 - amend Volume 1 (Standard A1 and 1.3.1) and Volume 2 (Standard 1.2.4 and 1.3.1) of theFood Standards Codeto permit the use of Neotame as an intense sweetener and flavour enhancer, and provide a specification for Neotame in Volume 1 (Standard A11) and Volume 2 (Standard 1.3.4) of theFood Standards Code.

OBJECTIVES AND BACKGROUND OF THE APPLICATION

The Authority had before it an Application (A406) received from Food Liaison Ltd on 14 December 1999 seeking a variation to the list of approved artificial sweetening substances in Standard A8 - Artificial Sweetening Substances, and a variation to the list of permitted flavour enhancers in Standard A6 - Flavourings and Flavour enhancers, to include Neotame.

As indicated at Full Assessment, a scientific evaluation of Neotame indicated that there were no public health and safety concerns with the use of Neotame as an intense sweetener and flavour enhancer at the levels proposed for use for the general population, and that its use is technologically justified. Consequently this Application will, if successful, require an amendment to Volume 1 (Standard A1, A11 and 1.3.1) and Volume 2 (Standard 1.2.4, 1.3.1 and 1.3.4) of theFood Standards Code,rather than Volume 1 (Standard A6 and A8) on the basis that Neotame posed no health and safety concerns and could consequently be approved as a general additive into Volume 1 and 2.

The applicant claims that Neotame has a clean, sweet taste with no undesirable taste characteristics and exhibits functionality and stability in a wide range of beverages and foods. Neotame can be used alone or blended with other sweeteners. Permission has been requested for Neotame to be used broadly as a sweetener in food, as Neotame has exhibited greater stability in baked goods and dairy foods compared to some other intense sweeteners such as aspartame.

Neotame is a dipeptide methyl ester derivative with a sweetness potency 7000-13000 times that of sugar. This will result in smaller quantities and lower concentrations of Neotame being used for food applications compared to other intense sweeteners. Neotame is not metabolised to phenylalanine. Therefore, no special labelling provisions that apply to other intense sweeteners will be needed to alert consumers with phenylketonuria, since the food product will not contain phenylalanine. However, general additive labelling requirements are still required for foods containing Neotame.

A406 - Inquiry Report and Regulatory Impact Statement

Part A: Executive Summary, Objectives and Background, Relevant Changes, Proposed changes, Public Consulation - Summary of Submissions, Scientific Assessment
[ PDF format 115 kb ]

Part B: Attachment 1 - Variations to Volume 1 and Volume 2 of the Australia New Zealand Food Standards Code; Attachment 2 - Statement of Reasons
[ PDF format 95 kb ]

Part C: Attachment 3 - Safety Assessment Report
[ PDF format 467 kb ]

Part D: Attachment 4 - Food Technology Report; Attachment 5 - Revised Dietary Exposure Assessment Report; Attachment 6 - Public Comment REceived at Inquiry
[ PDF format 100 kb ]

A406 - Inquiry Report and Regulatory Impact Statement
[ Full Report PDF format 663 kb ]