15 January 2003
INITIAL ASSESSMENT REPORT
Full Report [ pdf 269kb ]
DEADLINE FOR PUBLIC SUBMISSIONS to the Authority in relation to this matter: 26 February 2003(See “Invitation for Public Submissions” for details)
Executive Summary
An Application was received from the Australasian Soft Drinks Association Ltd on 26 June 2002 for the development of a new standard in the Food Standards Code(FSC) for Formulated Beverages (FB), described as non-alcoholic water-based beverages containing claimable amounts of a wide range of vitamins and minerals. The vitamins and minerals were requested for addition to FB at levels currently above the permissions for most foods in the FSC. The statutory timeframe for this Application was suspended for 10 weeks as FSANZ sought more information from the Applicant.
The Applicant has requested the creation of a standard for FB as a means of correcting the situation where New Zealand manufacturers can produce these products under the New Zealand Dietary Supplements Regulations 1985 and sell them in Australia via theTrans-Tasman Mutual Recognition Arrangement, while the Australian industry has no such permissions. This Application has been identified as A470 and classified as complexity Category 5 in Group 3 on the FSANZ Workplan, with an initial amount paid by the Applicant to expedite its assessment.
Objectives
The specific objectives of Application A470 are to:
- protect public health and safety through appropriate regulation of FB;
- ensure that consumers can make informed choices about FB; and
- promote fair trade through the development of a consistent and equitable regulatory system for all sections of the FB industry.
Issues
Several issues have been identified as important in meeting the objectives of this Application, and in assessing the regulatory status of FB:
- The determination of product purpose and definition:
In assessing the purpose category for FB, these products can either be classified as general-purpose foods or as having a supplemental purpose similar to food-type dietary supplements (currently under review by Proposal P235) and formulated caffeinated beverages (as regulated by Standard 2.6.4 - Formulated Caffeinated Beverages) in the FSC. Determining which classification is appropriate for FB is fundamental to this Application, as it will determine the presentation of such products, the appropriate regulatory controls, and how FB should be defined.
- The use of consumption data in the assessment of FB:
Accurate data on consumption of FB will enable FSANZ to conduct a risk assessment that is specific to the consumption patterns of FB within the population. At present, the Applicant has provided New Zealand per capita information on the consumption of FB. Without more specific information however, FSANZ will adopt a highly conservative risk assessment during draft assessment of this Application.
- An appropriate composition of vitamins, minerals, and food additives:
The request by the Applicant for vitamin and mineral additions, and the use of specific food additives for FB raises the issue of the appropriateness and suitability of these substances in the context of risk.
Included within the discussions on composition are: the use of one-day quantities, the nutritional quality of the beverage vehicle, and the use of FB as ingredients in other foods. Discussions on these specific issues will influence the final regulations that are applied to FB. Consideration of medicinal herbs is being undertaken in related proposals, P235 - Food-type Dietary Supplements and P260 - Medicinal Herbs
- Labelling:
Labelling issues are a central consideration for this Application, the foremost being the issue of nutrition claims. The Applicant has requested the ability to claim the vitamin and mineral content of FB. With the requested higher level of vitamin and mineral content, such claims may be considered misleading without further consideration of the nutritional quality of the beverage vehicle. An extension of the claims issue is whether the use of percentage daily intake information such as percentage Recommended Dietary Intake (% RDI) is an appropriate labelling measure when such information may result in declaration of up to multiples of the RDI.
Other labelling issues discussed in this Report include the use of a mandatory statement advising the maximum one-day quantity of a formulated beverage, and whether a prescribed name is appropriate for the identification of FB.
Regulatory Options and Impact Analysis
There are two options for progressing Application A470 at Initial Assessment:
- Maintain the status quo, or
- Include regulations specific to FB in the Food Standards Code.
For each regulatory option, an impact analysis has been undertaken to assess the potential costs and benefits to various stakeholder groups associated with its implementation.
Conclusion
For both the Issues and Impact Analysis sections in this Report, a number of questions have been posed to facilitate consideration of this Application. Public comment is invited on these questions, the proposed regulatory options, and the Report as a whole.
Subject to further payment being received from the Applicant to continue this assessment, all responses received by FSANZ will be used to inform the next stage of this Application, including the conduct of any risk assessments and the development of any necessary drafting amendments to the FSC.