Anxiofit‐1 and reduction of subthreshold and mild anxiety: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Abstract

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.

Anxiofit‐1 and reduction of subthreshold and mild anxiety: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

“…Background and Terms of Reference as provided by the requestor Regulation (EC) No 1924/2006 harmonises the provisions that relate to nutrition and health claims, and establishes rules governing the Community authorisation of health claims made on foods. As a rule, health claims are prohibited unless they comply with the general and specific requirements of this Regulation, are authorised in accordance with this Regulation, and are included in the lists of authorised claims provided for in Articles 13 and 14 thereof.…”

“…EFSA is requested to evaluate the scientific data submitted by the applicant in accordance with Article 16(3) of Regulation (EC) No 1924/2006. On the basis of that evaluation, EFSA will issue an opinion on the scientific substantiation of a health claim related to: Anxiofit-1 and reduction of subthreshold and mild anxiety.…”

“…The present opinion does not constitute, and cannot be construed as, an authorisation for the marketing of Anxiofit-1, a positive assessment of its safety, nor a decision on whether Anxiofit-1 is, or is not, classified as a foodstuff. It should be noted that such an assessment is not foreseen in the framework of Regulation (EC) No 1924/2006 It should also be highlighted that the scope, the proposed wording of the claim, and the conditions of use as proposed by the applicant may be subject to changes, pending the outcome of the authorisation procedure foreseen in Article 18(4) of Regulation (EC) No 1924/2006.…”

“…Health claim application on Anxiofit-1 and reduction of subthreshold and mild anxiety pursuant to Article 14 of Regulation (EC) No 1924/2006. Submitted by Anxiofit Ltd., 18 Nyul Street, Budapest, 1026 Hungary.…”