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Scientific Opinion on the substantiation of a health claim related to “Femilub®” and maintenance of vaginal moisture pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Abstract

Following an application from Nutrilinks Sarl submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on a health claim related to “Femilub®” and maintenance of vaginal moisture. The food that is the subject of the health claim, “Femilub®”, which is a combination of macadamia oil, borage oil, perilla oil, d‑α‑tocopherol and biotin, is sufficiently characterised. The claimed effect, maintenance of vaginal moisture, is a beneficial physiological effect. No human intervention studies were provided from which conclusions could be drawn for the scientific substantiation of the claim. A cause and effect relationship has not been established between the consumption of “Femilub®” and maintenance of vaginal moisture.