Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims on Foods Related to Vision Proposed Under Regulation (EC) 1924/2006

Daniela Martini,Giovanni Passeri,Carlo Pruneti,Marco Vitale,Chiara Cosentino,Daniela Galli,Beatrice Biasini,Marco Ventura,Riccardo Bonadonna,Alessandra Dei Cas,Giorgio Bedogni,Daniele Del Rio,Prisco Mirandola,Ivana Zavaroni,Augusto Innocenti,Donato Angelino

doi:10.3390/nu10020211

Abstract

Adequate 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.

Highlights

Proper vision development and setup are features with strong impacts on practically all aspects of an individual’s life
Regarding the methods of measurement (MMs), all the methods proposed for each outcome variables (OVs) in the scientific opinion and/or in the guidance document were included in the evaluation, unless the related OV was considered to be inappropriate per se, or for the specific claimed effect
Visual acuity (VA) commonly refers to clarity of vision and is the measure of the spatial resolution of the visual processing system. It mainly depends on how light is focused on the retina, the integrity of the retina and the interpretation of the cognitive brain, and it declines with age

Summary

Introduction

Proper vision development and setup are features with strong impacts on practically all aspects of an individual’s life. A recent review has shown that, in high income countries, as well as in in Eastern and Central Europe, blindness and mild and severe vision impairment (MSVI) decreased from 1990 to 2010 from 0.2 to 0.1% (3.314 million to 2.736 million people) and from 1.6 to 1.0% (25.362 million to 22.176 million), respectively [2]. Beyond diabetes, which is one of the biggest nutritional contributors to complete vision loss, a wide range of ocular defects have their origin either in nutritional deficiencies or excess. These conditions have been shown to respond favourably to nutritional components [6]

Methods

Results

Conclusion