Safety, bioavailability and suitability of lutein for the particular nutritional use by infants and young children[1] - Scientific Opinion of the Panel on Dietetic Products, Nutrition and Allergies

No abstract available

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver a scientific opinion on the safety, bioavailability and suitability of lutein for the particular nutritional use by infants and young children. If the substance under evaluation is considered to be suitable for the particular nutritional use by infants and young children, the European Food Safety Authority is asked to advise on any condition for use that might be necessary.

Lutein is a naturally occurring xanthophyll and oxycarotenoid. Carotenoids are primarily synthesised by photosynthetic plants and micro-organisms and lutein is one of the most abundant. It occurs with the isomeric xanthophyll, zeaxanthin, in many foods, particularly vegetables and fruits. Animals are unable to synthesise carotenoids, and in humans, lutein may be considered as a marker of vegetable intake.

This application refers to a “purified lutein” obtained by saponification from an oleoresin extracted with hexane from dried marigold flower (Tagetes erecta) petals. The process does not involve a chemical synthesis. The commercial ingredient “FloraGLO® Lutein 20 % liquid in safflower oil” is made of “purified lutein” suspended in edible triglyceride oil and contains at least 20 % lutein and 0.8 % zeaxanthin. This ingredient is combined with the other formula components according to standard manufacturing procedures for powder or liquid products.

The applicant proposes to add lutein to infant and follow-on formulae on the grounds that lutein may have special importance to the eye of infants and young children. The applicant further suggests that early lutein intakes may entail benefits for the eye in later life.

The applicant indicates that lutein is currently not added deliberately to infant and follow-on formulae. This would account for higher plasma and eye lutein concentrations in breast-fed than in formula-fed infants. The applicant proposes to add 250 to 300 microgram/l lutein to infant formulae. This level was chosen according to published data on lutein content in breast milk and on bioavailability of lutein in infant formulae.

The applicant proposes to add 500 microgram/l lutein to follow-on formulae. This level was chosen so that the intake of such a formula could make a significant contribution to the diet of older infants and young children whose consumption of fruits and vegetables may be poor.

The Panel considers that the information provided in the dossier does not raise concerns about the safety of lutein in infant formulae at the levels achieved through the natural content of ingredients nor at the level of use (concentration of added lutein 250µg/l) proposed by the applicant for infant formulae with a low natural lutein content (about 20 µg/l or lower).

Based on the studies provided, the Panel concludes that lutein from Flora GLO® is bio-available in infant formulae. No data are provided for follow-on formulae, but it may be assumed that the bioavailability is not different from that of infant formulae.

The Panel notes that no requirement, nutritional reference value or dietary recommendation has been established for lutein. The Panel considers that the available data do not demonstrate that lutein addition to infant formulae and follow-on formulae offers any immediate or long-term benefit on eye function and development.