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08/03
19 March 2003
FINAL ASSESSMENT REPORT
Executive Summary
The Australia New Zealand Food Authority (ANZFA - now Food Standards Australia New Zealand (FSANZ)) received an application from Wacker Chemie GmbH on 12 April 2001 seeking to amend Standard 1.5.1 of the Australia New Zealand Food Standards codeto permit the use of gamma cyclodextrin ( g -cyclodextrin) as a novel food ingredient.
Work on this application was commenced on 25 March 2002, as per the FSANZ Work plan.
Under the current food standards, novel foods are required to undergo a pre-market safety assessment, Standard 1.5.1 - Novel Foods. While g -cyclodextrin has properties consistent with its use as either a food ingredient or a food additive under the provisions of the Australia New Zealand Food Standards code, it is more appropriate to regulate g -cyclodextrin as a food ingredient, albeit a novel food ingredient.
The objective of this assessment is to determine whether it is appropriate to amend the food regulations to permit the use of gamma -cyclodextrin as a novel food ingredient. Such an amendment would need to be consistent with the section 10 objectives of the FSANZ Act.
A range of issues was considered during the assessment of the application; namely, the safety and nutritional impact of the use of gamma -cyclodextrin. Other issues such as technological function and the level of dietary exposure were also addressed. gamma -Cyclodextrin serves a variety of functions in food applications including stabilisations of emulsions, elimination of undesirable molecules, solubilisation of ingredients and protection from oxidation. It also serves as a carrier of nutrients and vitamins.
The available safety studies on gamma -cyclodextrin indicate that there are no public health and safety concerns at the anticipated levels of dietary exposure. The estimated levels of dietary exposure are 3.6 g/ day for Australia and 4.1 g/day (0.06 g/kg bw/day) for New Zealand. gamma - Cyclodextrin consumption is not expected to affect the bioavailability of essential nutrients such as fat-soluble vitamins because of its rapid metabolism .
The only regulatory options identified were to approve or not approve the use of gamma -cyclodextrin as a novel food ingredient. The impact analysis shows that the approval of gamma -cyclodextrin satisfies the objectives of the assessment based on the outcome of the scientific risk assessment and the Regulatory Impact Statement (RIS). These issues included an assurance of the safety of gamma -cyclodextrin, the provision of benefits to industry and Governments, in terms of enhanced market opportunities and trade (under Australia and New Zealand's requirements under the World Trade Organization), respectively, and in addition, the benefits to consumers in regard to possible greater choice of foods.
One argued that g -cyclodextrin is a traditional food and therefore should not be regulated, while another supported its permission to be used as a food additive but not as a novel food. Two were undecided. During the second round, two submissions were received, one for and one against the amendment to theAustralia New Zealand Food Standards code.
Statement of Reasons
FSANZ recommends the approval of the use of gamma -cyclodextrin as a novel food ingredient in the listed food items for the following reasons:
- there is no evidence of any public health and safety concern associated with consumption of foods containing g -cyclodextrin and there are no significant nutritional concerns at proposed levels of use;
- the proposed change to the Australia New Zealand Food Standards code is consistent with the section 10 objectives of the FSANZ Act; and
- the Regulatory Impact Statement indicates that, for the preferred option, namely, to approve the use of g -cyclodextrin as a novel food ingredient, the benefits of the proposed amendment outweigh the costs.
The proposed drafting for amendments to Standard 1.5.1 is at Attachment 1 of the Draft Assessment Report.
The Australia New Zealand Food Authority (ANZFA) to FSANZ transitional requirements for an application/proposal at preliminary (initial) stage provide that FSANZ is taken to have made an initial assessment of the Application. Any submissions received by FSANZ about an Application in response to a notice given under section 13A or 14 of the FSANZ Act, are taken to be submissions made to FSANZ about the application/proposal in response to a notice under section 13A or 14 under the FSANZ Act.
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