Claimed effects, outcome variables and methods of measurement for health claims proposed under European Community Regulation 1924/2006 in the framework of protection against oxidative damage and cardiovascular health.

D Martini, S Rossi, B Biasini, I Zavaroni, G Bedogni, M Musci, C Pruneti, G Passeri, M Ventura, S Di Nuzzo, D Galli, P Mirandola, M Vitale, A Dei Cas, R C Bonadonna, D Del Rio

Journal: Nutrition, metabolism, and cardiovascular diseases : NMCD 2017;27(6):473-503

PMID: 28434807

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Abstract

BACKGROUND AND AIMS

The high number of negative opinions from the European Food Safety Authority (EFSA) to the requests for authorization of health claims is largely due to the design of human intervention studies, including the inappropriate choice of outcome variables (OVs) and of their methods of measurement (MMs). The present manuscript reports the results of an investigation aimed to collect, collate and critically analyse the information in relation to claimed effects, OVs and MMs, in the context of protection against oxidative damage and cardiovascular health compliant with Regulation 1924/2006.

METHODS AND RESULTS

Claimed effects, OVs and the related MMs were collected from EFSA Guidance documents and applications for authorization of health claims under Articles 13.5 and 14. The OVs and their MMs were evaluated only if the claimed effect was sufficiently defined and was considered beneficial by EFSA. The collection, collation and critical analysis of the relevant scientific literature consisted in the definition of the keywords, the PubMed search strategies and the creation of databases of references. The critical analysis of the OVs and their MMs was performed on the basis of the literature review and was aimed at defining the appropriateness of OVs and MMs in the context of the specific claimed effects.

CONCLUSIONS

The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for health claims, as well as to the stakeholders for the proper design of human intervention studies aimed to substantiate such health claims.

Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

Address: The Laboratory of Phytochemicals in Physiology, Department of Food and Drug, University of Parma, Parma, Italy.; Department of Medicine and Surgery, Division of Endocrinology, University of Parma, Italy; Azienda Ospedaliera Universitaria of Parma, Parma, Italy.; Clinical Epidemiology Unit, Liver Research Center, Basovizza, Trieste, Italy.; Department of Food and Drug, University of Parma, Parma, Italy.; Department of Medicine and Surgery, Clinical Psychology Unit, University of Parma, Medical School Building, Parma, Italy.; Department of Medicine and Surgery, Building Clinica Medica Generale, University of Parma, Parma, Italy.; Department of Chemistry, Life Sciences and Environmental Sustainability, Laboratory of Probiogenomics, University of Parma, Parma, Italy.; Department of Medicine and Surgery, Section of Dermatology, University of Parma, Parma, Italy.; Department of Medicine and Surgery, Sport and Exercise Medicine Centre (SEM), University of Parma, Parma, Italy.; The Laboratory of Phytochemicals in Physiology, Department of Food and Drug, University of Parma, Parma, Italy. Electronic address: [email protected].

DOI: 10.1016/j.numecd.2017.01.008