The article 14 claim linked “follow-on formulae with fixed combination of short-chain galacto-oligosaccharides (GOS), acidified milk, nucleotides and beta-palmitate” and intestinal ailments for infants between the age of six and 12 months no longer being breast-fed.
Plada said its product could aid “minor intestinal ailments” such as colic, constipation and digestive symptoms, but EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) concluded causality had not been demonstrated and so rejected the claim.
The NDA found only one of 18 submitted studies (one unpublished) employed the specific formula in question. This double-blind, randomised, placebo-controlled trial featured 58 newborn babies observed for 135 days.
While rates of abdominal distension, cramps, gas production, diarrhoea and constipation were lower in the study group, statistical analysis of the differences was not performed, the NDA noted, and therefore cast the “study as having limited relevance for the proposed claim.”
It noted, in addition to using other formulas, most of the other studies were performed on an infant population of under six months and hence were not relevant to the target population.
The rejection comes despite the fact Milan-based Plada had been asked by EFSA in May, 2008, to provide unspecified additional information, which it did in September.
Plada nor its owner, Heinz, were available for comment at the time of publication.
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. To date EFSA has published around 50 opinions of a list containing more than 4000 claims.
Article 13.5 claims relate to proprietary science as opposed to article 13.1 claims which are more generic and article 14 claims which related to children’s and disease reduction. To date most of EFSA’s opinions have been drawn from the article 14 list.
To view the NDA’s opinion click here.