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

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Article
Panel on Dietetic Products, Nutrition and Allergies
Acknowledgements

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.

EFSA Journal
EFSA Journal 2010; 8(3):1516 [10 pp.].
doi
10.2903/j.efsa.2010.1516
Panel members at the time of adoption
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.
Contact
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
4 March 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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.

Keywords
Eye qTM, polyunsaturated fatty acids (PUFAs), eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), gamma-linolenic acid (GLA), working memory, children, health claims
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Number of Pages
10