Risk assessment regarding the use of Annona muricata in food supplements

The current risk assessment was performed in the context of the European Food Risk Assessment Fellowship Programme (EU‐FORA) supported by EFSA and was intended to evaluate possible health risks associated with the consumption of Annona muricata L. (Annonaceae) and derived food supplements. A. muricata grows as a tree and is native to the Caribbean and Central America. Preparations made from different plant parts of A. muricata (i.e. fruit, leaves, bark, roots) have been used as herbal medicine and are also marketed worldwide as over‐the‐counter food supplements that have been purported to support general health or to treat a wide range of health conditions, particularly cancer and parasitic infections. However, open questions remain regarding the safety of A. muricata‐based food supplements, since Annonaceae have been reported to contain potentially neurotoxic compounds, i.e. acetogenins. The assessment conducted within the present fellowship programme shows that substantial uncertainties exist regarding the safe use of A. muricata‐based supplements. The available data provide indications of neurotoxic potential of certain A. muricata preparations. The paucity of adequate studies, particularly related to long‐term use of A. muricata supplements, currently does not allow the establishment of a safe intake level. Within this technical report a workflow of the project is presented.