US firm Mead Johnson had an Article 14 health claim approved by EFSA (the European Food Safety Authority) for Enfamil Lipil in March 2009 that states: “DHA has a structural and functional role in the retina, and DHA intake contributes to the visual development of infants up to 12 months of age.”
Subsequently ratified by the EC Standing Committee on Food Chain and Animal Health, the claim now awaits European Council and Parliamentary approval, but is opposed by a trans-national MEP grouping that claims further scientific evidence is needed for claims relating to baby milk and increased public scrutiny.
Dossiers ‘cherry-pick’ research
Baby Milk Action group policy director, Patti Rundall OBE, is backing a the MEP-led veto of the claim, and told NutraIngredients.com that she disagreed with EFSA’s opinion, based on 12 randomised controlled trials submitted by Mead Johnson:
“The danger is that people think breast milk can come in cans, and there’s no evidence that DHA works in follow-on milks," she said, adding that Mead Johnson had submitted some evidence to EFSA on its effectiveness in infant formulae, although this stopped far short of proof.
Advertising of infant formula (for infants up to 6 months old) is currently banned in some EU states (although permitted across the union in baby care books under the relevant Directive) while health claims face a wholesale ban. Recent UK Food Standards Agency (FSA) guidance called upon manufacturers to “make it clear that follow-on formula is intended for babies over six months. This includes clearly representing the age of babies in the adverts.”
Claim only allowed on follow-on
Rundall said: “The claim as we interpret it – ‘makes babies’ eyes better’ – when used in follow-on is a way of getting round this restriction. Under European regulations, it’s illegal to make it on infant formulae, but when this is sold alongside follow-on in shops, it risks misleading parents.”
This was especially pressing, Rundall said, given that infant formulas are allowed to carry several nutrition claims such as 'contains DHA' and a disease risk reduction claim, "worse than a health claim in my view, because it spawned all the hypoallergenic claims based on questionable science".
As regards the Article 14 opinion in question, she added: "EFSA approved the formula on a 0-12 month basis, but failed to realise that follow-on only starts at 6 months, and there’s no conclusive, independent evidence that it works at this stage”
“I don’t want to hammer EFSA, they’ve generally done a good job within the confines of the law, but submitted dossiers like this cherry-pick research, and are not systematic enough – along the lines of a Cochrane Review.”
EU Parliament could veto health claim
Rundall said that Labour Party MEP Glenis Wilmot had secured the opportunity to present a report on the issue in the Environment, Food Safety and Public Health Committee in March, which if supported by a majority would then proceed to the EU Parliament vote on vetoing the Article 14 claim.
“We’re not overly confident that we’ll win this, but it isn’t simply a breast/bottle issue, it’s about parents getting true, proper information on products, which they aren’t getting now,” said Rundall.
“If safe forms of DHA are found – and some studies are emerging that it might even raise blood pressure in babies – then we’ll all for including it in all formulas, but only as an essential ingredient, and without health claims.”
Rundall also said the group does not dispute DHA’s ability to benefit the visual development of infants, but questioned its overall efficacy when delivered via a bottle.
“DHA works well as a co-factor in breast milk, various enzymes and the general environment make it work properly, but things are different when it’s added to a dead, inert powder,” she said.