EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) found causality had not been demonstrated between the intake of Eye Q and the improvement of working memory in children of 6-12 years of age.
Working memory is defined as a person’s ability to process, maintain and manipulate small amounts of information and can be measured by established methods.
Eye Q is a combination of the n-3 polyunsaturated fatty acids (PUFAs), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), and the n-6 PUFA, GLA (gamma-linolenic acid).
Equazen, owned by Swiss company Vifor Pharma, has had three previous claims related to children’s brain, eye and development for Eye Q, under article 14 of the EU nutrition and health claims regulation, rejected and the subsequent negative opinions have been written into the EU legislature.
A spokesperson for Vifor Pharma told Nutraingredients.com that as this latest NDA opinion relates to prospective claims, it does not impact on current claims or marketing activity.
"As the EFSA process becomes more understood, the industry as a whole is gaining further knowledge. We shall analyze this opinion further and evaluate our position in relation to future submissions," she continued.
The spokeperson added that Vifor Pharma is dedicated to furthering scientific understanding of omega-3 and polyunsaturated fatty acids (PUFAs) with regard to supporting cognitive function and it is its intention to maintain this focus.
The Opinion
EFSA said the references identified by Vitro Pharma as being pertinent to the health claim included six human intervention studies, five of which were randomised, placebo-controlled studies, and one was an open label study, with all studies being performed on children and adolescents in the age range of the specified target group.
The NDA found that “three of the studies did not report any measures of working memory and therefore any measures pertinent to the health claim.”
In addition, they said, two of the studies reporting on measures related to working memory were conducted in children with either developmental coordination disorder (DCD) or showing severe symptoms of attention deficit hyperactivity disorder (ADHD).
The Panel said that no scientific conclusions could thus be drawn from these studies for the substantiation of the claimed effect.
In weighing the evidence, the Panel said that it took into consideration that one study undertaken in healthy children reported a statistically significant difference between the Eye Q and the control group in relation to verbal working memory.
However the NDA noted that “there were no data indicating a dose-response relationship between Eye Q consumption and working memory outcomes in healthy children, [and] that there were no other data (from experimental or observational studies) presented on this combination of fatty acids in the target population in order to corroborate these findings.”
The panel also said that the evidence provided did not establish a biologically plausible mechanism by which the combination of DHA, EPA, and GLA in Eye Q could exert the claimed effect in the target population.
It therefore concluded in both cases that causality had not been demonstrated.
The EFSA opinion can be found here.