16 July 2003
PRELIMINARY FINAL ASSESSMENT REPORT
DEADLINE FOR PUBLIC SUBMISSIONSto FSANZ in relation to this matter:
13 August 2003
(See ‘Invitation for Public Submissions’ for details)
An Application (A452) has been received from Holland Sweetener Company seeking approval for a new intense sweetener, aspartame-acesulphame, under Standard 1.3.1 – Food Additives in the Australia New Zealand Food Standards Code (the Code). The product is known commercially as Twinsweet™.
Aspartame-acesulphame salt is a molecular combination of two already approved sweeteners, aspartame and acesulphame potassium (K). When in aqueous solution, either in food or in the mouth, it dissociates into an anion (acesulphame) and a cation (aspartame) that are identical to the two parent sweeteners, aspartame and acesulphame K.
Standard 1.3.1 - Food Additives requires that food additives undergo a pre-market risk assessment through an application to FSANZ before being offered for sale in Australia and New Zealand. Although aspartame-acesulphame breaks down readily into the two parent sweeteners, it is a chemically distinct compound when added to food and therefore must also undergo a pre-market safety assessment. However, the application was progressed under section 36 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) because it was considered to raise issues of minor significance or complexity only.
The Initial/Draft Assessment Report concluded that aspartame-acesulphame fulfils a specific technological purpose consistent with that of a food additive, in this case, an intense sweetener. Aspartame-acesulphame offers some technological advantages to manufacturers and, due to synergistic sweetness properties, also provides the potential to use lower amounts in certain foods to achieve a particular level of sweetness.
The safety of aspartame-acesulphame is based largely on the previous safety evaluations of the dissociated salts, aspartame and acesulphame K. As these have an established history of safe use, the use of aspartame-acesulphame raises no additional safety concerns. If approved, aspartame-acesulphame may only be used in foods where there is currently a permission to use both parent sweeteners, at a level equivalent to that of the limiting sweetener. In most cases, the limiting parent sweetener is acesulphame K, with the exception of brewed soft drink where aspartame is limiting.
The Authority received 6 submissions in response to the public consultation on the Initial/Draft Assessment Report. While all submissions supported the application, several submitters raised issues concerning the maximum permitted levels of use proposed in the draft variations to the Code. Following a review of these proposed variations, the maximum permitted level of use of aspartame-acesulphame has been increased, in line with current permissions (by weight) for acesulphame K or, in the case of brewed soft drink, aspartame. The revised maximum levels are consistent with the ADI for each parent sweetener, and with regulatory decisions of other countries including Canada, the United States and parts of the European Union. Other issues concerning the safety of the parent sweetener, aspartame, have been addressed in this report.
In view of these changes to the draft variations to the Code, the Authority has prepared this Preliminary Final Assessment Report and will conduct another round of public comment, allowing full consultation with all stakeholders. In addition, FSANZ has already written to relevant organisations to inform them of the proposed use of aspartame-acesulphame and advise on the expected labelling requirements for this product. Under proposed changes to Standard 1.2.3, a mandatory advisory statement to the effect that the product contains phenylalanine will be required when aspartame-acesulphame is used as a table top sweetener or as an ingredient in food, as is currently required when aspartame is used alone.
The regulatory impact analysis has concluded that the option to approve aspartame-acesulphame salt has advantages for consumers and for industry. There are no identified disadvantages to the approval of aspartame-acesulphame salt as an intense sweetener.
The draft variation to Standard 1.3.1 – Food Additives giving approval for the use of the aspartame-acesulphame salt is recommended for the following reasons:
- there are no public health and safety concerns associated with the use of aspartame-acesulphame salt under the proposed conditions of use;
- the use of the aspartame-acesulphame salt as an intense sweetener is technologically justified, and should lead to a small reduction in the levels of some intense sweeteners in specific foods;
- aspartame-acesulphame salt complies with the specifications in supplement 3 of the Fourth edition of Food Chemicals Codex;
- the proposed draft variations to theAustralia New ZealandFood Standards Codeare consistent with the section 10 objectives of the FSANZ Act; and
- the regulatory impact statement concluded that there are potential benefits for both consumers and industry in using aspartame-acesulphame which outweigh any perceived costs.
The proposed draft variations to the Code are at Attachment 1.
Full Report [ pdf 246kb ]