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Application A597 – Addition of Lutein to Formulated Supplementary Foods for Young Children – Draft Assessment Report

22 February 2008

Dear Sir/Madam

Thank you for the opportunity to comment on this application. The New Zealand Food Safety Authority’s (NZFSA) preferred regulatory option for A597 is; Option 1 – maintain the status quo by not amending the Code to permit the addition of lutein as an optional nutritive substance in Formulated Supplementary Foods for Young Children (FSFYC). NZFSA has the following comments to make on the Draft Assessment Report (DAR).

Regulation of Nutritive Substances

NZFSA does not support the approach FSANZ has taken to manage the potential addition of nutritive substances to FSFYC. In the absence of Ministerial Policy guidance, FSANZ’s approach, in accordance with its FSANZ Act s.18 statutory objectives, has been to undertake a safety assessment only. Therefore, we note that FSANZ has not undertaken an assessment of the potential benefit of the addition of lutein to FSFYC.

NZFSA is however of the view that, despite the absence of policy guidance, any substance classified as a ‘nutritive substance’ should be assessed for potential benefit. “Nutritive substance” is defined in Standard 1.1.1. This definition includes the phrase that the substance is “intentionally added to achieve a nutritional purpose”. NZFSA considers that FSANZ, in their assessment, should determine if a nutritive substance provides a ‘nutritional purpose’. Therefore, if there is insufficient scientific evidence to support the role of a substance in achieving this purpose, its addition as a nutritive substance should not be permitted.

Lack of Justification for the addition of lutein

Although this assessment focuses primarily on safety, lutein is being added for its potential benefit. NZFSA believes there is insufficient evidence to support the addition of lutein to FSFYC as it is only ‘postulated to function in the eye as an antioxidant and blue light filter’, and ‘it has been suggested that lutein and zeaxanthin can protect against oxidative damage to the retina’ yet the application acknowledges that ‘data is not available on the nutritional function of lutein specific to children of young ages’. The data presented are inadequate to support the addition of lutein to FSFYC for the purpose of eye health.

Proposed levels and claims

FSANZ’s preferred regulatory approach in the DAR is to permit the voluntary addition of lutein to FSFYC (maximum level of 100 micrograms/serve), and to require at least 30 micrograms/serve of lutein in FSFYC where a claim has been made on the presence of lutein. Should a content claim be permitted, NZFSA believes that the minimum level required for that claim, should be based on the level required to achieve the ‘nutritional purpose’. NZFSA is concerned that there was no consideration of a minimum effective level when setting a range for the addition of lutein to FSFYC, and questions how realistic it is to assume that FSFYC will likely contain close to the maximum permitted amount of lutein (100 micrograms/serve) if the claimable amount is only 30 micrograms/serve.

NZFSA is also concerned with how the minimum claimable amount of 30 micrograms/serve has been derived. This level ‘reflects approximately 10% of the mean dietary intake of 1 year olds in Australia’. The mean dietary intake has been extrapolated from constructed theoretical diets. In the absence of a reference value for lutein, we are unable to ascertain whether this level is meaningful.

Proposed draft variation to the FSC

The proposal to add section 6A Lutein to Standard 2.9.3 is confusing. Should the addition of lutein to FSFYC be permitted, NZFSA suggests the addition of a fourth clause to section 6 of Standard 2.9.3.

Yours sincerely