- Print Friendly - Help

Application A609 – Addition of GOS, Long Chain Inulin to Infant Formula Products & Infant Food – Initial Assessment Report

22 February 2008

Dear Sir/Madam

Thank you for the opportunity to comment on this application. The New Zealand Food Safety Authority (NZFSA) has considered this Application at initial assessment in conjunction with P306 Addition of Inulin/ FOS and GOS to Food as requested by FSANZ, and therefore includes comments made in P306.

NZFSA has reviewed the safety assessment undertaken by FSANZ in P306 and agrees with FSANZ’s conclusion that infants fed solely on infant formula, older infants and toddlers fed follow-on formula, and infant foods and formulated supplementary foods for young children containing inulin-derived substances and/ or GOS (as defined by FSANZ) in any ratio, provided certain maximum levels are not exceeded, are unlikely to be at risk from these foods.

NZFSA therefore supports the recommendation that the addition of inulin-derived substances and GOS (as defined by FSANZ) to infant formula be permitted in the Australia New Zealand Food Standards Code (FSC), however subject to classification of inulin-derived substances and GOS as “nutritive substances”.

NZFSA considers that in order to provide regulatory clarity around the substances of concern in this Application and P306, NZFSA recommends that GOS and long chain inulin (as defined by FSANZ) are permitted as “nutritive substances” in Standard 2.9.1 and are added to the table to clause 7 until such time that the definition of “nutritive substance” and Standard 2.9.1 – Infant Formula Products are reviewed.

Therefore, NZFSA recommends that FSANZ review the following as a matter of priority:

i) the ‘nutritive substance’ definition; and

ii) Standard 2.9.1 – Infant Formula Products

NZFSA also considers that the terminology used, in this Application and P306, to describe these substances needs to be consistent with internationally accepted scientific definitions. NZFSA believes that the terminology proposed adds regulatory confusion; and therefore recommends that FSANZ considers terms that adequately reflect the composition of these substances.

In the DAR, FOS is referred to as those fructose polymers with β(2→1) fructosyl-fructose linkages, where the average Degree of Polymerisation (DP) is less than four; and oligofructose means those fructans with β(2→1) fructosyl-fructose linkages, where the average DP is less than ten but greater than or equal to four. However, in scientific literature the terms FOS and oligofructose have exactly the same meaning and can be used interchangeably ie. oligo means “few” whether it is used in “oligofructose” or “fructo-oligosaccharide”. Therefore NZFSA believes that the terms “FOS” and “oligofructose” should not be used to describe two substances that have different degrees of polymerisation.

Inulin is a generic term for a range of fructose polymers – fructans and fructooligosaccharides. This Proposal considers using the term long chain inulin to describe inulin that has a DP > 23. However this infers that only the long chains are being referred to and therefore inulin is not being considered.

In order to provide greater clarity around the nature of the substances, NZFSA recommends that FSANZ state the DP range that is being referred to. This will prevent confusion around the definition of substance with terms such as “long”. For example: inulin_>23 or inulin_≥10.

NZFSA does not wish to make further comment on this Application at initial assessment until the outcomes of P306 at Draft Assessment are documented. NZFSA will comment further at Draft Assessment on this Application.

Yours sincerely