18 December 2002
DRAFT ASSESSMENT REPORT
Full Report [ pdf 372kb ]
EXECUTIVE SUMMARY
Food Standards Australia New Zealand (FSANZ) formerly known as the Australia New Zealand Food Authority (ANZFA) received an application from Hayashibara Company Ltd. on 4 October 2001 seeking to amend Standard A19 [1] -Novel Foods of Volume 1 of the Australian Food Standards Code to permit the use of trehalose as a novel food ingredient.
Trehalose is used in a number of countries as a food (USA, South Korea and Taiwan) or food additive (Japan). Trehalose was approved as a novel food in the European Union.
Under the current food regulations, novel foods and novel food ingredients are required to undergo a pre-market safety assessment, as per Standard 1.5.1 - Novel Foods. Trehalose is considered to be a novel food because the level of consumption in the proposed products is expected to be far greater than that normally consumed from current sources of trehalose in food. Therefore, under the proposed conditions of use, trehalose is considered to be a 'non-traditional' food and also a novel food because the safety of its use as proposed is unknown. A risk-based safety assessment must therefore be performed by FSANZ.
To determine whether the food regulations should be changed to permit the sale of trehalose as a novel food. Such an amendment needs to be consistent with the section 10 objectives of the FSANZ Act.
Technical properties of trehalose
Trehalose has a range of useful technological properties functions (eg reduced sweetener, stabiliser, cryoprotectant etc) and approval may provide food processors with the opportunity to develop innovative new processed foods and to improve the quality and increase the shelf-life of existing processed foods. Therefore, there are benefits for both industry and consumers in the approval of trehalose.
The main hazard from trehalose was gastro-intestinal symptoms. However, it was concluded that, provided consumers did not exceed a level of between 33-50g from a single exposure to trehalose in food, then no symptoms would be expected in the majority of the population. The level of 33g applies to the most sensitive individuals (Eastern populations).
Predicted mean trehalose exposure from consumption of foods containing both added and naturally occurring trehalose is 5.7 g/day for Australians (2 years and above) and 4.5 g/day in NZ (15 years and above), rising to 22.7 and 18.2 g/day respectively at the 95th percentile of exposure. Exposure is higher, in total and on a bodyweight basis, among children and teenagers, reflecting the contribution of ice cream, toppings and confectionery in these age groups. 95th percentile exposure among teenagers, the group with the highest exposure, is 33.8 and 33.7 g/day in Australia and New Zealand respectively.
The data supports the safety of trehalose at the level of intake that would be achieved by addition of trehalose to a range of foods at the maximum levels provided by the Applicant. Exposure for all ages for Australian and New Zealand populations is at or below the level (33-50g) at which minimal or no gastro-intestinal effects were observed in subjects, even at the 95th percentile (highest) exposure level. The highest potential exposure by age group (teenagers at the 95th percentile exposure level) was 34g/day for both Australia and New Zealand) consumers, which is still within the level at which minimal or no gastro-intestinal effects were observed.
Other issues raised in public submissions
No additional labelling statements for consumers were needed (other than general labelling requirements for ingredients of food) as it was considered that the potential to exceed a level in which gastro-intestinal effects had been reported was extremely unlikely.
Based on the dietary modelling, the level of consumption of trehalose is not expected to significantly alter the glycaemic load of the diet based on the reported carbohydrate intake in Australia and New Zealand.
FSANZ identified two options, namely:
Option 1. Not permit the use of trehalose.
Option 2. Permit the use of trehalose.
The impact analysis shows that option 2 satisfies the objectives based on the outcome of the scientific risk assessment and the Regulatory Impact Statement (RIS) taking into account matters raised following the public consultation period.
These matters included an assurance of the safety of trehalose, the provision of adequate labelling so as to give consumers informed choices for purchases of products containing trehalose, and the provision of benefits to industry and governments, in terms of enhanced market opportunities and trade.
FSANZ has consulted on the advantages and disadvantages to specific stakeholders should permission be granted for trehalose as a novel food and evaluated the costs and benefits to consumers, the Government and industry.
FSANZ recommends the approval of Application A453 for the following reasons:
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There is no public health and safety concern associated with consumption of trehalose as a novel food and there are no significant nutritional issues in the context of the total dietary exposure to trehalose.
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Trehalose can be used in a range of food products and provide a range of technological functions.
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The proposed changes to Volume 2 of the Food Standards Code are consistent with the section 10 objectives of the Food Standards Australia New Zealand Act 1991.
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The Regulatory Impact Statement indicates that, for the preferred option, namely, to approve the use of trehalose as a novel food, the benefits of the proposed amendment outweigh the costs.
It is recommended that trehalose be approved as a novel food, subject to its use according to the specifications for composition and purity.
The proposed drafting in Volume 2 of theFood Standards Codeis shown in Attachment 1.
[1] Standard A19 Volume 1 of the Australian Food Standards Code was replicated in Standard 1.5.1 of Volume 2 of the Australia New Zealand Food Standards Code.
Full Report [ pdf 372kb ]