A491 - IAR - Exec summary

11/03

13 August 2003

INITIAL ASSESSMENT REPORT

Full report [ pdf 236kb ]

Food Standards Australia New Zealand (FSANZ) received an Application from Matsutani Chemical industry Co Ltd on 17 January 2003 seeking to amend Standard 1.2.8 - Nutrition Information Requirements of the Australia New Zealand Food Standards Code (the Code) to recognise resistant maltodextrin (RMD) as a dietary fibre and to include a specific method of analysis for dietary fibre in foods containing RMD. This Application has been accepted on the FSANZ workplan as number A491.

Regulatory problem

Standard 1.2.8 - Nutrition Information Requirements defines dietary fibre and prescribes methods of analysis to determine both the total dietary fibre and specifically named fibre content of food. This Standard does not permit a nutrition information statement to recognise RMD in the calculation of total dietary fibre content.

Objective

The specific objectives of A491 are to:

• protect public health and safety through appropriate regulation of RMD, including safety considerations on the addition of RMD to foods; and
  
  
• ensure that consumers can make informed choices about the dietary fibre content of foods containing RMD.

Issues

Several issues have been identified as important in meeting the objectives of this Application, and in assessing the regulatory status of RMD:

• Classification of Resistant Maltodextrin as dietary fibre

Consideration of whether RMD should be considered as dietary fibre is fundamental to the assessment of this Application, as it will determine the most appropriate regulatory approach.

• Criteria for determination of physiological effect (of dietary fibre)

The development of quantified criteria for the determination of physiological effect is paramount to determining if a substance should be considered dietary fibre.

• Method of analysis

The method of analysis, 'AOAC Official Method 2001.03 - Total Dietary Fibre in Foods Containing Resistant Maltodextrin' , is an extension of the AOAC 985.29 method currently prescribed in Standard 1.2.8. Of relevance to this issue is a determination of not only the appropriateness of including AOAC 2001.03 in Standard 1.2.8, but also how it applies to the analysis of various dietary fibre components.

• Safety of RMD

FSANZ has identified several safety concerns regarding the use of RMD in foods. A safety assessment will be conducted during the Draft Assessment of A491 based on available information. The safety assessment will consider:

• the altered chemical structure of the product compared to traditional maltodextrin,
  
  
• the potential for high levels of consumption of the product, and
  
  
• the physiological effects of a poorly digested fibre on the gastrointestinal tract.
  
  
  
• Nutrition issues

The Applicant has highlighted the potential nutritional benefits of RMD, in that it does not form viscous solutions associated with other forms of soluble dietary fibre, and thus the consumption of RMD containing food will not compromise nutritional intake.

• Dietary issues

RMD can be used in a wide variety of foods at concentrations ranging from 0.2 -30%. If AOAC 2001.03 is accepted as a method of analysis, it is likely that the number of food products presenting as a source of dietary fibre will increase in Australia and New Zealand, and nutrition education may need to account for different sources of dietary fibre.

Regulatory options and impact analysis

Two options are being considered for progressing A491 at Initial Assessment:

1. Maintain the status quo by not including a new method of analysis for dietary fibre in Standard 1.2.8; or
   
   
2. Include specific regulation for the method of analysis of RMD in Standard 1.2.8 and implement any appropriate risk management strategies subject to a safety assessment to be conducted at Draft Assessment.

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 and recommendation

This Application has been assessed against the requirements of Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act). Accordingly it is recommended that this Application should be accepted and progressed to Draft Assessment subject to payment of fees assessed pursuant to Section 66 of the Act and the Regulations.

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.

Full report [ pdf 236kb ]