Claimed effects, outcome variables and methods of measurement for health claims proposed under Regulation (EC) 1924/2006 in the framework of bone health

Several foods or food components have been the object of application for authorization of health claims on bone health, pursuant to Regulation (EC) 1924/2006. For most of them, the European Food Safety Authority (EFSA) has issued negative opinions mainly for reasons pertaining to an insufficient substantiation of the claim, incluiding the choice of not appropriate outcome variables (OVs) and methods of measurement (MMs). The present manuscript refers to the collection, collation and critical analysis of OVs and MMs related to bone health compliant with the Regulation. The definition of the keywords, the PubMed search strategies and the creation of databases of references were performed to critically analyse the OVs and their MMs on the basis of the literature review. The assessment of each OV and related MM was defined according to its appropriatness in relation to the claimed effects proposed. The results obtained are relevant for the choice of the best OVs and MMs, to be used not only for the substantiation of health claims on bone health, but also in general research performed with different purposes. Moreover, the results can be used by EFSA during the update of guidance for the scientific requirements of health claims on bone health.