Claimed effects, outcome variables and methods of measurement for health claims on foods proposed under European Community Regulation 1924/2006 in the area of appetite ratings and weight management

Abstract

All the requests for authorisation to bear health claims under Articles 13(5) and 14 in the context of appetite ratings and weight management have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of the insufficient substantiation of the claimed effects (CEs). This manuscript results from an investigation aimed to collect, collate and critically analyse the information related to outcome variables (OVs) and methods of measurement (MMs) in the context of appetite ratings and weight management compliant with Regulation 1924/2006. Based on the literature review, the appropriateness of OVs and MMs was evaluated for specific CEs. This work might help EFSA in the development of updated guidance addressed to stakeholders interested in bearing health claims in the area of weight management. Moreover, it could drive the applicants during the design of randomised controlled trials aimed to substantiate such claims.

Keywords:

• Health claim
• outcome variable
• method of measurement
• appetite
• body weight
• body composition

Acknowledgements

The present article, however, is under the sole responsibility of the authors. The positions and opinions presented in this article are those of the authors alone and do not necessarily represent the views/any official position or scientific works of EFSA. To know about EFSA guidance documents and other scientific outputs of EFSA, see http://www.efsa.europa.eu.

Disclosure statement

The authors report no conflicts of interest.

Additional information

Funding

European Food Safety Authority (EFSA)GP/EFSA/NUTRI//01European Food Safety AUthorityThis project has received financial support from the European Food Safety Authority (EFSA), Grant GP/EFSA/NUTRI/2014/01.