EFSA approves omega-3 kids’ eye health claim

The verdict on the dossier submitted by Mead Johnson Nutritionals in France comes a few months after the world’s number one DHA (docosahexaenoic acid) supplier, Maryland-based Martek Biosciences, earned a negative opinion from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA).

Mead’s article 14 children’s claim was partly rejected however as the US-headquartered company wanted the claim to relate to both DHA and ARA (arachidonic acid), but the NDA found the scientific data did not demonstrate ARA’s ability to benefit infant eye health.

The NDA therefore proposed the wording: “DHA contributes to the visual development of infants” ​as applicable for infants from birth to 12 months of age and to formula containing at least 0.3 per cent of total fatty acids comprised of DHA.

Mead’s dossier​

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The dossier contained 43 items including 12 randomised controlled trials (RCTs) on the effects of DHA supplementation (with or without ARA) on visual development among infants. The NDA found four of these to be “pertinent to substantiate the claimed effect.”​

Two of them demonstrated better visual outcomes through the first year of life for formulae supplemented with either DHA and DHA and ARA, then unsupplemented formulae.

The NDA stated: “The Panel considers that the consumption of infant formulae supplemented with DHA at around 0.36 per cent of total fatty acids from birth up to 12 months is associated with better visual function in term infants as compared to the consumption of unsupplemented formulae, even if a dose-response relationship has not been directly tested and not all the studies performed at the recommended dose reach the same conclusion.”​

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But it noted such fortified formulas were not better than breast milk and found the science backing ARA wanting. “The Panel considers that a role of ARA on visual development of term infants cannot be established on the basis of the data presented.”​

Mead was unavailable for comment at the time of publication.

The NDA’s opinion on Mead’s claim can be read here​.

Its opinion on Martek’s claim from September, 2008, can be read here​.

The European Union is attempting to formulate a centralised list under the nutrition and health claims regulation that is due for completion in January, 2010.