- Print Friendly - Help

Application A594 and A597 – Lutein as a Nutritive Substance in Infant Formula and Addition of Lutein to Formulated Supplementary Foods for Young Children – Initial Assessment Reports

May 2007

Project Officer Application A594 and A597
Food Standards Australia New Zealand
PO Box 10559
WELLINGTON 6036

FS350-114-594

FS350-114-597

Dear Sir/Madam

Thank you for the opportunity to comment on these applications. The New Zealand Food Safety Authority (NZFSA) has the following comments to make.

A594 – Lutein as a Nutritive Substance in Infant Formula

Scope and intent of standard 2.9.1

The NZFSA prefers a conservative approach when considering issues arising from the regulation of infant formula. Infants are a vulnerable group of the population, for whom infant formula may be consumed as the sole or principal source of nourishment. NZFSA strongly supports the nutrition policy recommendations of the Ministry of Health (MoH) including the promotion of breastfeeding. The compositional requirements of infant formula should not exceed or provide additional benefits over breast milk.

The Initial Assessment Report (IAR) for A594 states that the application is based on the role of lutein in supporting eye health and aims to provide formula-fed infants with lutein at levels comparable to breast-fed infants.  This principle aligns with the intent of Standard 2.9.1 - for infant formula to match the composition of breast milk as closely as possible. We therefore consider that the Draft Assessment Report (DAR) needs to establish the content of lutein in breast milk, and its role in infant nutrition.  Once this is established, the efficacy of lutein from the marigold flower, compared with dietary sources, would need to be determined.

Determination of the safety of Lutein

The lutein contained in breast milk is derived from the maternal diet.  Lutein from the marigold flower should be subject to an appropriate safety evaluation that applies to infants.

While the assessment of lutein by JECFA is as a food additive and a nutrient supplement, the establishment of an ADI by JECFA normally does not apply to infants younger than 12 weeks. Accordingly, NZFSA believes a safety evaluation for lutein as a substance added to infant formula is needed. The DAR should consider what safety data is available and whether this is sufficient for infants, at the levels of use proposed to be added to infant formula. The safety assessment should also determine if there are any allergenicity issues.

Health claims

 As discussed in section 6.1.1 of the IAR, it is proposed that Standard 1.2.7 – Nutrition Health and Related Claims will prohibit claims on infant formula and follow-on formula that relate to the presence of any nutrient or nutritive substance. NZFSA supports this approach as any reference to the addition of lutein and eye health will not be permitted.  Clearly no marketing advantage can be sought by manufacturers if lutein were to be permitted to be added to infant formula. If permitted, the only reference to lutein would be in the ingredient list, and possibly the nutrition information panel.

Classification of Lutein as a nutritive substance

Clause 2 of Standard 1.1.1 defines nutritive substance as: ‘a substance not normally consumed as a food in itself and not normally used as an ingredient of food, but which, after extraction and/or refinement, or synthesis, is intentionally added to a food to achieve a nutritional purpose, and includes vitamins, minerals, amino acids, electrolytes and nucleotides’. It is our understanding that the applicant proposes to add lutein to ‘support eye health’. NZFSA seeks comment from FSANZ in the DAR as to whether it could be argued that adding a substance to infant formula to ‘support eye health’ is a physiological benefit rather than a nutritional purpose. If so, does lutein then fall outside the definition of ‘nutritive substance’, and how would any permission as a result of this application be handled in Standard 2.9.1?

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.

A597 – Addition of Lutein to Formulated Supplementary Foods for Young Children

As for infant formula, NZFSA believes lutein from the marigold flower should be subject to a safety assessment at the levels of use proposed.

The applicant states that ‘some of the richest sources of lutein are some of the least preferred foods of young children’. NZFSA does not believe this is justification for addressing poor dietary habits through the addition of nutritive substances to Formulated Supplementary Foods for Young Children (FSFYC).

NZFSA is still considering the issue of whether FSFYC with added lutein should be permitted to make nutrition content claims and/or health claims in relation to the presence of lutein. We will reserve our judgement on this until we are provided with further information in the DAR. NZFSA supports further discussion on the merits of specific labelling requirements of FSFYC with added nutritive substances or substances added to produce a physiological benefit.

Yours sincerely

Carole Inkster
Director
Joint Food Standards