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Nutrients 2018, 10(1), 7; https://doi.org/10.3390/nu10010007

Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims Proposed Under European Community Regulation 1924/2006 in the Framework of Maintenance of Skin Function

1
The Laboratory of Phytochemicals in Physiology, Department of Food and Drug, University of Parma, 43125 Parma, Italy
2
Department of Medicine and Surgery, Section of Dermatology, University of Parma, 43125 Parma, Italy
3
Department of Medicine and Surgery, Division of Endocrinology, University of Parma, 43125 Parma, Italy
4
The Azienda Ospedaliera Universitaria of Parma, Division of Endocrinology, 43125 Parma, Italy
5
Clinical Epidemiology Unit, Liver Research Center, Basovizza, 34149 Trieste, Italy
6
Department of Food and Drug, University of Parma, 43125 Parma, Italy
7
Department of Medicine and Surgery, Clinical Psychology Unit, University of Parma, 43125 Parma, Italy
8
Department of Medicine and Surgery, University of Parma, Building Clinica Medica Generale, 43125 Parma, Italy
9
Laboratory of Probiogenomics, Department of Chemistry, Life Sciences and Environmental Sustainability, University of Parma, 43125 Parma, Italy
10
Department of Medicine and Surgery, Sport and Exercise Medicine Centre (SEM), University of Parma, 43125 Parma, Italy
Authors equally contributed to the study.
*
Author to whom correspondence should be addressed.
Received: 31 October 2017 / Revised: 16 December 2017 / Accepted: 19 December 2017 / Published: 22 December 2017
(This article belongs to the Special Issue Nutraceuticals and the Skin: Roles in Health and Disease)
View Full-Text   |   Download PDF [1163 KB, uploaded 22 December 2017]   |  

Abstract

Evidence suggests a protective role for several nutrients and foods in the maintenance of skin function. Nevertheless, all the requests for authorization to use health claims under Article 13(5) in the framework of maintenance of skin function presented to the European Food Safety Authority (EFSA) have received a negative opinion. Reasons for such failures are mainly due to an insufficient substantiation of the claimed effects, including the choice of inappropriate outcome variables (OVs) and methods of measurement (MMs). The present paper reports the results of an investigation aimed at collecting, collating and critically analyzing the information with relation to claimed effects (CEs), OVs and MMs related to skin health compliance with Regulation 1924/2006. CEs, OVs and MMs were collected from both the EFSA Guidance document and from the authorization requests of health claims under Article 13(5). The critical analysis of OVs and MMs was based on a literature review, and was aimed at defining their appropriateness (alone or in combination with others) in the context of a specific CE. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the claims. View Full-Text
Keywords: health claim; outcome variable; method of measurement; skin health health claim; outcome variable; method of measurement; skin health
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Martini, D.; Angelino, D.; Cortelazzi, C.; Zavaroni, I.; Bedogni, G.; Musci, M.; Pruneti, C.; Passeri, G.; Ventura, M.; Galli, D.; Mirandola, P.; Vitale, M.; Dei Cas, A.; Bonadonna, R.C.; Di Nuzzo, S.; De Felici, M.B.; Del Rio, D. Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims Proposed Under European Community Regulation 1924/2006 in the Framework of Maintenance of Skin Function. Nutrients 2018, 10, 7.

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