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Application A594 – Addition of Lutein as a Nutritive Substance to Infant Formula and Follow-on Formula – Draft Assessment Report

13 November 2007

Thank you for the opportunity to comment on this application. The New Zealand Food Safety Authority’s (NZFSA) preferred regulatory option for A594 is; Option 1 – maintain status quo by not amending the Code to permit the addition of lutein as an optional nutritive substance in infant formula and follow-on formula. The NZFSA has the following comments to make.

Justification for the addition of Lutein

The NZFSA believes there is insufficient justification for the addition of lutein to infant formula and follow-on formula. In the Draft Assessment Report (DAR) lutein is referred to as having ‘proposed protective functions in the eye as an antioxidant and blue light filter’ and it is hypothesised as having ‘possible protective and palliative roles against age-related macular degeneration’. We believe that this level of uncertainly is not a sufficient basis on which to permit the addition of a new substance to a food which may be consumed as the sole or principal source of nourishment by infants. The data presented are inadequate to support the addition of lutein to infant formula for the purpose of eye health. NZFSA considers that if lutein does have an important role in eye health it should be considered for mandatory addition to infant formula.

In addition, the DAR reports that lutein concentration levels are highest in colostrum with declining levels in mature human milk. We therefore believe there is even less justification for the inclusion of lutein in follow-on formula, particularly as levels in breast milk naturally decline and the commencement of follow-on formula would coincide with the introduction of complementary foods and exposure to other dietary sources of lutein.

Strength of evidence

NZFSA is concerned with the strength of the science presented in the DAR. We question the robustness and completeness of the data and do not think the scientific evidence is sufficient to support the addition of lutein. Most of the data presented in the Nutrition Assessment of the DAR has been conducted by the Applicant and this research has not been published nor is there any evidence of peer review. The NZFSA believes that there are insufficient baseline data on which to base the request to amend the Food Standards Code (FSC). Currently there are no population representative data that characterise the breast milk concentration of lutein in New Zealand and Australian women. In addition there are no serum lutein data for New Zealand or Australian breast-fed infants or formula fed infants. The DAR does not include any reproduction toxicology studies.

Proposed levels

The preferred regulatory approach in the DAR for A594 is to permit the voluntary addition of lutein at a maximum concentration of 250ug/L in infant formula and 500ug/L in follow-on formula, with a minimum declaration of 56ug/L required for labelling purposes. The proposed maximum levels are significantly higher that what is present in breast milk and there does not appear to be any sound justification for these proposed levels. The issue of bioavailability is not supported by any studies based on the proposed increased levels.

NZFSA is also concerned that there was no consideration of a minimum effective level when setting a range for the addition of lutein. In addition, as discussed in the Food Technology Report of the DAR, manufacturers will need to be aware of the instability of lutein and the associated losses that occur due to storage conditions and time. It would be interesting to know if this will result in ‘overdosing’ to account for these losses and what the impact would be on actual lutein levels.

NZFSA also understands that some infant formula (particularly those based on cows milk) may naturally contain lutein. We would be interested to know what the natural level of lutein in cows milk based infant formula products is and how this compares to the levels found in breast milk.

Health Claims

As FSANZ point out in section 9.2.2 of the DAR, the general prohibition on nutrition, health and related claims for nutrients and nutritive substances in infant formula products is proposed to be maintained under draft Standard 1.2.7. NZFSA strongly supports the prohibition of claims on infant formula products so that no marketing advantages can be sought by manufacturers. Permitting health claims could create a situation where some infant formula products are perceived as a ‘premium product’ and superior to breast milk, because of the addition of optional ingredients.

NZFSA does however seek comment from FSANZ as to whether Clause 20 of Standard 2.9.1 which ‘prohibits a reference to any nutrient or nutritive substance on the label of an infant formula products, except where the reference to a nutrient or nutritive substance is in the statement of ingredients or a nutrition information statement’ could be interpreted as a permission for allowing a statement such as ‘contains lutein’ on the label of an infant formula product?

NZFSA requests that the Final Assessment Report (FAR) clearly states that the addition of lutein (if permitted) cannot be claimed anywhere on the label, and that the only reference to the addition of lutein is in the ingredient list and the nutrition information panel.

Classification of Lutein as a nutritive substance

A594 requests permission for the optional addition of lutein as a nutritive substance to infant formula products. The FAR should explain how lutein (in relation to its proposed function) fits the current definition of nutritive substance. Of particular interest is the role of a nutritive substance in achieving a ‘nutritional purpose’. NZFSA would like FSANZ to provide more guidance around what is intended as a ‘nutritional purpose’ and whether it should differentiate substances added for a nutrition purpose from those which provide a perceived health benefit or support a physiological function. This has significant implications for not only infant formula but the wider food supply.

Standard 2.9.1 – Review

As stated in our pervious submission on the Initial Assessment Report (IAR) 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. Currently there is a lack of clear criteria around what should be permitted to be added to infant formula products. Such criteria would assist in assessing A594 and any future applications requesting the addition of new substances to infant formula products.

Yours sincerely