Claimed effects, outcome variables and methods of measurement for health claims on foods proposed under Regulation (EC) 1924/2006 in the area of oral health

Objective Some of the requests of authorization to apply health claims in the context of oral health have received a negative scientific opinion from the European Food Safety Authority (EFSA). The main reasons refer 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 at collecting, collating and critically analysing the information in relation to claimed effects, OVs and MMs, in the area of oral health and compliant with Regulation (EC) 1924/2006. Methods Claimed effects, OVs and the related MMs were collected from EFSA guidance documents and from the scientific opinions on the substantiation of health claims under Articles 13.5 and 14. The collection, collation and critical analysis of the relevant scientific literature consisted in a definition of the keywords, PubMed search strategies and in the creation of databases of references. Results and conclusions 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 each specific claimed effect. Clinical significance The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for health claims related to oral health, as well as to the stakeholders for the identification of existing and design of novel randomized controlled trials aimed at substantiating such health claims.