• Daniela Martini, Augusto Innocenti, Chiara Cosentino, Giorgio Bedogni, Donato Angelino, Beatrice Biasini, Ivana Zavaroni, Marco Ventura, Daniela Galli, Prisco Mirandola, Marco Vitale, Alessandra Dei Cas, Riccardo C Bonadonna, Giovanni Passeri, Carlo Pruneti, and Daniele Del Rio.
• The Laboratory of Phytochemicals in Physiology, Department of Food and Drug, University of Parma, 43125 Parma, Italy. daniela.martini@unipr.it.
• Nutrients. 2018 Feb 14; 10 (2).

AbstractAdequate visual function has a strong impact on the quality of life of people. Several foods and food components have been hypothesized to play a role in the maintenance of normal visual function and in the prevention of eye diseases. Some of these foods/food components have been the object of a request of authorization for use of health claims under Articles 13(5) or 14 of the Regulation (EC) 1924/2006. Most of these requests have received a negative opinion from the European Food Safety Authority (EFSA) due to the choice of inappropriate outcome variables (OVs) and/or methods of measurement (MMs) applied in the studies used to substantiate the claims. This manuscript refers to the collection, collation and critical analysis of OVs and MMs related to vision. Guidance document and requests for authorization of health claims were used to collect OVs and MMs related to vision. A literature review was performed to critically analyse OVs and MMs, with the aim of defining their appropriateness in the context of a specific claimed effect related to vision. The results highlight the importance of adequate choices of OVs and MMs for an effective substantiation of claims related to visual function.

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