Anxiofit-1 and reduction of subthreshold and mild anxiety: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
Anxiofit-1, Echinacea angustifolia, anxiety, health claims
First published in the EFSA Journal:
8 January 2016
10 December 2015
Following an application from Anxiofit Ltd. and ExtractumPharma Co Ltd., submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Hungary, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Anxiofit-1 and reduction of subthreshold and mild anxiety. The food, Anxiofit-1, Echinacea angustifolia root extract, standardised for the content of echinacoside (at least 3%) and the alkamide profile, which is the subject of the health claim, is sufficiently characterised. The Panel considers that reduction of subthreshold and mild anxiety is a beneficial physiological effect. Subthreshold and mild anxiety is a risk factor for anxiety and depressive disorders. One human intervention study with a small number of participants showed a decrease in anxiety scores under the conditions of use proposed by the applicant. Another small study, performed by the same research group with patients with diagnosed generalised anxiety disorder, also showed a decrease in anxiety in this population. However, the Panel notes that 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 Anxiofit-1 could exert the claimed effect. The Panel concludes that the scientific evidence is insufficient to establish a cause and effect relationship between the consumption of Anxiofit-1 and reduction of subthreshold and mild anxiety.
© European Food Safety Authority, 2016
Panel members at the time of adoption:
Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Daniel Tomé, Dominique Turck, Hendrik Van Loveren, Marco Vinceti and Peter Willatts.
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal 2016;14(1):4365 [13 pp.].
On request from:
Competent Authority of Hungary following an application by Anxiofit Ltd. and ExtractumPharma Co Ltd.