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

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.

Effectiveness of bed bath methods for skin integrity, skin cleanliness and comfort enhancement in adults: A systematic review

“…Second, we recommend regarding outcome measures. As for skin integrity, most of the studies used the gold standards for skin barrier function measurements such as TEWL and SCH (Martini et al., 2018 ). In addition to this, we believe that measures will be easier to apply in clinical settings if more common clinical scores are used increasingly, such as skin dryness and lesions, as outcome measures.…”

“…We searched for articles published between January 2004-May 2020 because the most significant achievements in device development emerged from 2004 onwards. A new model of one of the most widely used devices to measure transepidermal water loss (TEWL), which is the gold standard in skin barrier function assessment (Martini et al, 2018), was launched that successfully eliminated some of the limitations of the previous model (Rosado et al 2005). Thus, the development of skin barrier function measurement tools from 2004 onwards has facilitated improved measurement reliability in bed bath research.…”

Role of berries in vascular function: a systematic review of human intervention studies

“…The main methods for vascular reactivity assessment are flow-mediated dilation (FMD) and peripheral arterial tonometry/reactive hyperaemia index (PAT/RHI). FMD is considered the gold standard non-invasive ultrasound technique, measuring vasodilation at the level of the brachial artery following a standard occlusion 11,12 . EndoPAT is a plethysmographic technique able to measure pressure changes in the finger tips caused by a 5 min occlusion of the brachial artery 13 .…”

Claimed effects, outcome variables and methods of measurement for health claims on foods related to the gastrointestinal tract proposed under regulation (EC) 1924/2006

“…In this scenario, a project focusing on the appropriateness of the OVs and MMs selected by the applicants has been developed, as described in previous manuscripts (Martini et al 2018a, Martini et al 2017a, Martini et al 2018b, Martini et al 2017b, with the aim to improve the quality of applications provided to EFSA. The present manuscript refers to the collection, collation and critical analysis of OVs and MMs related to gastrointestinal tract functions, excluding immune function, compliant with the Regulation 1924/2006.…”