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Scientific Opinion on the substantiation of a health claim related to Eye qTM and working memory pursuant to Article 14 of Regulation (EC) No 1924/2006

EFSA Journal 2010; 8(3):1516[10 pp.]. doi:10.2903/j.efsa.2010.1516
  EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Panel Members Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen. Acknowledgment The Panel wishes to thank Astrid Schloerscheidt and the members of the Working Group on Claims for the preparation of this opinion: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: Vifor Pharma (Potters) Question number: EFSA-Q-2009-00485 Adopted: 11 February 2010 Published: 04 March 2010 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Following an application from Vifor Pharma (Potters) submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Eye qTM and working memory. Eye qTM is a combination of eicosapentaenoic acid, docosahexaenoic acid, and gamma-linolenic acid, and is sufficiently characterised regarding the content of these polyunsaturated fatty acids. The improvement of working memory is considered beneficial for children’s development and health. Six human intervention studies were identified by the applicant as being pertinent to the health claim, three of which did not report any measures of working memory. Two of the studies were conducted in children with either developmental coordination disorder or showing severe symptoms of attention deficit hyperactivity disorder. The sixth was a randomised, placebo-controlled intervention reporting a statistically significant difference between the Eye qTM and control group in relation to verbal working memory. There were no data indicating a dose-response relationship between Eye qTM consumption and working memory outcomes in healthy children. 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 the findings, and the evidence provided did not establish a biologically plausible mechanism by which the combination of docosahexaenoic acid, eicosapentaenoic acid, and gamma-linolenic acid in Eye qTM could exert the claimed effect in the target population. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the intake of Eye qTM and the improvement of working memory.

© European Food Safety Authority,2010

Summary

Following an application from Vifor Pharma (Potters) submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to: Eye qTM and working memory.

The scope of the application was proposed to fall under claims referring to children’s development and health.

The food which is the subject of the health claim is Eye qTM, a combination of the n-3 polyunsaturated fatty acids (PUFAs), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and the n-6 PUFA, gamma-linolenic acid (GLA). High-EPA oil is derived from sardines and pilchards from the southern ocean and Indian oceans. High-DHA oil is derived from South Pacific tuna. GLA is derived from evening primrose (Oenothera biennis) seed oil. Absorption of these PUFAs has been demonstrated in humans. The Panel considers that the food (i.e., Eye qTM) for which the claim is made is sufficiently characterised regarding the content of DHA, EPA and GLA.

The claimed effect is “help to improve working memory”. The target population is children 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. The Panel considers that improvement of working memory is beneficial for children’s development and health.

The references identified by the applicant 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. All studies were performed on children and adolescents in the age range of the specified target group.

Three of the studies did not report any measures of working memory and therefore any measures pertinent to the health claim. In addition, 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 considers that no scientific conclusions can be drawn from these studies for the substantiation of the claimed effect.

In a three-month randomised, double-blind, placebo-controlled clinical trial, a total of 241 primary school children aged 6-12 years were randomised to consume either Eye qTM or a control oil (olive oil) for three months, followed by three months in which all participants received the active treatment. The Panel notes that no conclusions can be drawn from the second three-month (non-controlled) phase of the study in relation to the claimed effect. Among the outcome measures considered in this study, only the Digit Span test is an appropriate measure of working memory. The Digit Span test measures only one aspect of what constitutes working memory (verbal working memory or what is commonly known as short-term retention), whereas other aspects of working memory such as the ability to update and manipulate information (processes attributed to the central executive part of working memory) were not tested. Differences between the treatment and placebo groups during the first three-month phase were assessed using t-tests for independent samples. Results showed a significant improvement in the Digit Span test in the treatment group as compared to placebo after the first three months of the study.

The evidence provided has not established a biologically plausible mechanism by which the combination of DHA, EPA, and GLA could exert the claimed effect in the target population.

In weighing the evidence, the Panel took into consideration that one study undertaken in healthy children reported a statistically significant difference between the Eye qTM and control group in relation to verbal working memory (also known as short-term retention), that there were no data indicating a dose-response relationship between Eye qTM consumption and working memory outcomes in healthy children, 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, and that the evidence provided did not establish a biologically plausible mechanism by which the combination of DHA, EPA, and GLA in Eye qTM could exert the claimed effect in the target population.

The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the intake of Eye qTM and the improvement of working memory.
 

Keywords

Eye qTM, polyunsaturated fatty acids (PUFAs), eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), gamma-linolenic acid (GLA), working memory, children, health claims