Affron® and increase in positive mood: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Pharmactive Biotech Products, S.L. submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to affron (R) and contributes to maintain a healthy mood. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is affron (R), an aqueous saffron extract with a content of the sum of crocins and safranal typically between 3.5% and 3.9%. The Panel notes that affron (R) is sufficiently characterised. The claimed effect proposed by the applicant is 'contributes to maintain a healthy mood'. The Panel notes that increase in positive mood is a beneficial physiological effect for individuals with low mood or anxiety. One human intervention study showed that consumption of affron (R) at a dose of 28 mg/day for 4 weeks improves mood in a population of adults with low mood. However, the results have not been replicated in other studies. The information supplied by the applicant did not provide evidence for a plausible mechanism by which affron (R) could exert the claimed effect. The Panel concludes that the evidence is insufficient to establish a cause and effect relationship between the consumption of affron (R) and increase in positive mood. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.