Ashwagandha, also known as Withania somnifera, sleep berry preparations or Indian ginseng, is an adaptogenic plant belonging to the nightshade family. It is native to India and other parts of Asia and Africa and is increasingly used in traditional medicine.
Withania somnifera has gained popularity as a supplement due to its potential health benefits, especially in reducing stress and anxiety, as well as improving physical performance and cognitive function. Ashwagandha’s bioactive compounds, known as withanolides, are responsible for many of the medicinal properties attributed to the plant thanks to its anti-inflammatory, antioxidant and neuroprotective properties.
Despite its broad profile of health benefits, the use of ashwagandha is currently not regulated in a harmonized way at the European level and some countries are considering the assessment of its potential health risks for specific population groups more than others.
This September 2024, Germany published the opinion on ashwagandha warning against its use. The German Federal Institute for Risk Assessment (BfR) has for some time raised concerns about preparations and extracts from the root of Withania somnifera, recommending the entry of the plant into Annex III of Regulation (EC) 1925/2006 on the addition of vitamins, minerals and certain other substances to foods. This German opinion states that the advertised positive effects have not been scientifically proven and that the risks associated with the intake of these plant preparations have not yet been adequately investigated, therefore, according to the BfR itself, the currently available data are not sufficient to allow a final risk assessment and more precise statements on health risks.
It is a plant that often comes up in the Rapid Alert System for Food and Feed (RASFF) because of the different considerations for its use depending on the country, but the current studies are still insufficient for its evaluation by bodies such as EFSA and attribution of more precise official statements on health risks.
From Cía de Productos Naturales Lleó, we will remain attentive to any new developments in this regard.
