LAUSR

Abstract The rejection of many putative health claims in Europe is assumed to have negatively affected functional food innovation. This study analysed the influence of Article 13.1 health claims review procedure on the perception of functional food innovation. The analysis of all scientific opinions related to antioxidants and a subsequent qualitative review of five scientific dossiers reveals that the evaluation by the European Food Safety Authority was not conducted consistently, as the Authority did not follow their own procedure. Several submitted scientific dossiers however also contain studies unrelated to the proposed health claim. By not following their own procedure, the European Food Safety Authority has created uncertainty regarding health claim evaluations. This uncertainty presents a risk for food companies and impacts future investments for research and development of new functional food products. Although published guidance documents have partially clarified the evaluation process, further standardisation and clarification will benefit functional food innovation.