A health claim application on saffron extract (Affron®) and positive mood: a negative opinion
EFSA has published a new scientific opinion on a health claim application related to a saffron extract (Affron®) and an increase in positive mood. Based on the data presented by the applicant (Pharmactive Biotech Products, S.L., Spain), EFSA concluded that evidences are insufficient to establish a cause and effect relationship between the consumption of the ingredient and the claimed effect.
Three clinical studies have been provided in the application, all assessing the effects of the saffron extract on mood, two in adults and one in adolescents. One study has not been considered as pertinent by EFSA, due to the consumption of antidepressant by the studied population. Moreover, no conclusions have been drawn from the adolescents study regarding the effects of the extract on mood.
Therefore, only one study was pertinent for the substantiation of the claimed effect. This study showed a significant effect of the extract (28 mg for 4 weeks) in adults with low mood. EFSA noted also the potential mechanism of action is not defined. Consequently, based on only one study, EFSA considered that evidence is insufficient to demonstrate the effects of the saffron extract on mood.
EFSA NDA Panel (EFSA Panel on Nutrition, Novel foods and Food allergens),Turck D, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Kearney J, Knutsen HK, Maciuk A, MangelsdorfI, McArdle HJ, Naska A, Pelaez C, Pentieva K, Thies F, Tsabouri S, Vinceti M, Bresson J-L and Siani A,2021. Scientific Opinion on the affron® and increase in positive mood: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924 /2006. EFSA Journal 2021;19(7):6669.