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Proposal P306 – Addition of Inulin/FOS and GOS to Food – Draft Assessment Report

22 February 2008

Dear Sir/Madam

Thank you for the opportunity to comment on this proposal. The New Zealand Food Safety Authority (NZFSA) has the following comments to make on the Draft Assessment Report (DAR).

NZFSA has reviewed the safety assessment undertaken by FSANZ as part of Proposal 306 and the scientific evidence cited which supports it. On that basis NZFSA 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, are unlikely to be at risk from these foods, provided certain maximum levels are not exceeded.

NZFSA therefore supports the recommendation that the addition of inulin-derived substances and GOS to infant formula products be permitted in the Australia New Zealand Food Standards Code (FSC); however NZFSA does not support the interim approach taken by FSANZ that “does not adopt a position either way on the status of inulin-derived substances and GOS when added to special purpose foods for infants and young children.”

NZFSA supports the purpose of P306 in that it aims to provide clarity and regulatory certainty to regulators and the food industry; however it questions the extent to which the preferred approach set out in P306 will meet those objectives concerning substances which appear to be of a “nutritive” character.

NZFSA does not agree that the interim approach will “provide clarity for enforcement agencies in Australia and New Zealand”, as is claimed at p44 of P306. To the contrary, while this Proposal, when implemented, will provide an interim solution for the inclusion of these particular substances, as defined by FSANZ, the underlying issues that have generated “polarity of views”, and which FSANZ notes, “undermine an efficient and competitive food industry”, remain unresolved, and will remain so until any changes that may flow from FSANZ’s proposed reviews of “nutritive substances”, and Standard 2.9.1 have come into force.

NZFSA has previously called for a review of the “nutritive substances” definition and Standard 2.9.1. We note below comments made in our submission of May 2007, concerning the proposed addition of lutein to infant formula and to formulated supplementary foods for young children (A594 and A597):

Standard 2.9.1 - Review

“There appears to be an increasing number of Applications received, and likely to be received by FSANZ, seeking approval to vary the Australia New Zealand Food Standards Code to allow the addition of new substances to infant formula. While nutritive substances are listed, the regulatory status of other ingredients is sometimes less clear. NZFSA believes that it is timely for FSANZ to consider a Proposal to look more broadly at Standard 2.9.1 – Infant Formula Products, and in particular the compositional requirements. “

In order to provide regulatory clarity around the substances of concern in this Proposal, NZFSA recommends that inulin-derived substances and GOS (as defined by FSANZ) are permitted as “nutritive substances” in Standard 2.9.1 and are added to the Table to clause 7 until any changes are implemented following the review of the “nutritive substance” definition and Standard 2.9.1 – Infant Formula Products.

NZFSA submits that until such time as the definition of “nutritive substance” and the handling of these in the food supply is clarified, no change should be made to the existing “nutritive substance” definition in Standard 1.1.1.

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

• the ‘nutritive substance’ definition; and

• Standard 2.9.1 – Infant Formula Products

The balance of this submission sets out NZFSA’s concerns in more detail, as well as providing more detailed comments on the preferred approach and issues with the proposed terminology. NZFSA considers that the terminology used to describe these substances needs to be consistent with internationally accepted definitions.

Preferred Approaches

While NZFSA supports in principle the inclusion of inulin-derived substances and GOS in infant formula products, NZFSA does not support the preferred regulatory approach proposed by FSANZ, in terms of proposed amendments to Standards 1.1.1, 2.9.1, 2.9.2 and 2.9.3 Division 4.

NZFSA has a number of comments to make relating to each preferred approach presented by FSANZ in the DAR. These are outlined below:

1. Amend Standard 1.1.1 to state that the inulin-derived substances and FOS are taken not to be nutritive substances;

Do not agree. NZFSA considers that the status of inulin derived substances and FOS in the general food supply cannot be determined until such time that the definition of “nutritive substance” and the handling of these in the food supply is clarified; therefore no change should be made to Standard 1.1.1. at the present time.

2. Amend Standard 2.9.1 to permit the voluntary addition of inulin-derived substances to infant formula products up to a total maximum of 110 mg/100 kJ (0.3 g/100 mL), or GOS up to a total maximum of 290 mg/100 kJ (0.8 g/100 mL), or a combination of inulin-derived substances and GOS up to a total maximum of 290 mg/100 kJ (0.8 g/100 mL) where inulin-derived substances do not exceed 110 mg/100 kJ (0.3 g/100 mL);

Agree, subject to classification of inulin-derived substances and GOS as “nutritive substances”. NZFSA agrees with the above approach to permit the voluntary addition of inulin-derived substances to infant formula products in Standard 2.9.1. However NZFSA recommends that inulin-derived substances and GOS (as defined by FSANZ) are listed as “nutritive substances” in Standard 2.9.1, and therefore 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.

There are a number of inconsistencies evident throughout the DAR regarding the proposed status of inulin-derived substances and GOS in Standard 2.9.1.

a. FSANZ states in 8.3.2.2: that “FSANZ is proposing that where inulin-derived substances and GOS are added voluntarily to infant formula products, a mandatory declaration of these substances will be required, as for energy, protein, fat and carbohydrate, and permitted vitamins and minerals and other nutritive substances”.

This suggests that inulin-derived substances and GOS are nutritive substances and should be classified as such. On the contrary, omission of inulin-derived substances and GOS from the “nutritive substance” table in Standard 2.9.1 indicates that these substances are not “nutritive substances”.

b. In 8.3.2.2, in regard to Standard 2.9.1 the DAR states that “FSANZ is proposing to insert a new sub clause to clause 20. The intention of the sub clause is to clarify that…inulin derived substances and GOS are taken to be a nutrient. The proposed amendment to clause 20 would therefore permit… inulin derived substances and GOS only in the statement of ingredients or in a nutrition information statement”.

Including inulin-derived substances in the Nutrition Information Panel suggests that they are nutrients or “nutritive substances”.

c. Standard 2.9.1 requires that a nutritive substance must not be added to infant formula product unless expressly permitted, therefore requiring a pre-market safety assessment. The DAR includes the safety assessment required to determine whether or not inulin-derived substances and GOS can be added to infant formula.

By undertaking this safety assessment, FSANZ is acknowledging that these substances are “‘nutritive substances”.

All of these inconsistencies could be readily addressed by listing inulin-derived substances and GOS as nutritive substances in Standard 2.9.1 - Infant Formula Products.

3. Amend Standards 2.9.2 and 2.9.3 Division 4 to permit the voluntary addition of inulin-derived substances and GOS, alone or in combination, to infant foods and formulated supplementary foods for young children up to a total maximum of 0.8 g/100 g and 1.6 g/serve (0.8 g/100 mL), respectively.

Agree. NZFSA agrees with the above approach to permit the voluntary addition of inulin-derived substances and GOS (as defined by FSANZ) to infant formula products in Standard 2.9.2 and Standard 2.9.3.

Use of terminology – inconsistent with literature

NZFSA believes that the terminology proposed in this Proposal is inconsistent with scientific literature and adds regulatory confusion; and therefore recommends that FSANZ consider 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. This should be reflected in the Draft Variation at Attachment 1 to the DAR.

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. This should be reflected in the Draft Variation at Attachment 1 to the DAR.

Yours sincerely