9 October 2002
DRAFT ASSESSMENT REPORT
Full Report [ pdf 352 kb ]
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 Food Standards Code to permit the use of gamma-cyclodextrin (gamma-cyclodextrin) as a novel food ingredient.
The work was commenced on 25 March 2002.
Regulatory Problem
Under the current food standards, both food additives and novel foods are required to undergo a pre-market safety assessment, as per Standard 1.3.1 - Food Additives or Standard 1.5.1 - Novel Foods. Gamma-Cyclodextrin has properties consistent with its use as either a food ingredient or a food additive. Under the provisions of the Food Standards Code, however, it is more appropriate to regulate gamma-cyclodextrin as a food ingredient, albeit a novel food ingredient.
Gamma-Cyclodextrin is considered a novel food ingredient because it is a non-traditional food for which there is no knowledge in the broad community to ensure safe use in the Australian or New Zealand diet.
To determine whether it is appropriate to amend the Food Standards Code 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.
Issues considered during assessment of the Application
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 food ingredient when used as a carrier of nutrients and vitamins.
The available safety studies on gamma-cyclodextrin indicate that there are no public health and safety concerns. The estimated levels of dietary exposure are 3.6 g/ day (0.07 g/kg bw/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.
Optionsand Impact Analysis
FSANZ identified two options, namely:
Option 1. Not permit the use of gamma-cyclodextrin as a novel food ingredient.
Option 2. Permit the use of gamma-cyclodextrin as a novel food ingredient.
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 all issues considered above. 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.
Consultation
Six submissions were received during the consultation period. Two submitters supported the proposal to amend the Food Standards Code to permit gamma-cyclodextrin. One argued that gamma-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 on whether permission should be given or not because of insufficient information in the Initial Assessment Report.
Statement of Reasons
FSANZ recommends the approval of the use of gamma-cyclodextrin as a novel food ingredient for the following reasons:
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there is no evidence of any public health and safety concern associated with consumption of foods containing gamma-cyclodextrin and there are no significant nutritional concerns at proposed levels of use;
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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 Act1991; and
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the Regulatory Impact Statement indicates that, for the preferred option, namely, to approve the use of gamma-cyclodextrin as a novel food ingredient, the benefits of the proposed amendment outweigh the costs.
The proposed drafting for amendment 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 Australia New Zealand Food Authority Act 1991, 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.
Full Report [ pdf 352 kb ]