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A453 Final Assessment Exec Summary

21 May 2003

FINAL ASSESSMENT REPORT

Full Report [ pdf 453kb ]

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 AustralianFood Standards Codeto permit the use of trehalose as a novel food ingredient.

Trehalose is a disaccharide consisting of 2 glucose units and is produced by a multi-step enzymatic process. Trehalose can be found at low levels in certain foods (brewers and bakers yeast, bread, beer and wine, honey and mushrooms). Trehalose exhibits the same technological properties as sucrose with a relative sweetness of 40-45% of that of sucrose.

Trehalose is used in a number of countries as a food (USA, South Korea and Taiwan) or food additive (Japan). Trehalose has approval as a novel food in the European Union.

Regulatory Problem

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.

Objective

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 (e.g. 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.

Hazard assessment

There was no evidence of toxicity in a broad range of studies in both animals and humans. 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 (Asian populations).

Dietary exposure

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 and 18 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 34 g/day in both Australia and New Zealand.

Risk assessment

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.

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.

Impact analysis of regulatory options

The only options identified were to permit or not permit the use of trehalose. The impact analysis shows that the first option (to permit trehalose as a novel food) 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.

Consultation

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.

Statement of Reasons

FSANZ recommends the approval of Application A453 for the following reasons:

  • There are no public health and safety concerns associated with consumption of trehalose to food at the proposed levels.
  • Trehalose provides a range of technological functions in a range of food products.
  • The proposed changes to theAustralia New ZealandFood Standards Codeare consistent with the section 10 objectives of theFood Standards Australia New Zealand Act 1991.
  • 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.

Recommendation

It is recommended that trehalose be approved as a novel food, without any conditions of use.

The proposed drafting to the Australia New Zealand Food Standards Code (the Code) is shown in Attachment 1.

Full report [ pdf 453kb ]


[1] Standard A19 Volume 1 of theAustralian Food Standards Codewas replicated in Standard 1.5.1 of Volume 2 of theAustralia New Zealand Food Standards Code.

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