Preparatory work for the evaluation of the safety of plant preparations containing berberine

This report is the outcome of an EFSA procurement (OC/EFSA/MESE/2022/03 - SC11) reviewing relevant scientific information related to the evaluation of the safety in use of plant preparations containing Berberine. Three subquestion were answered through systematic review methodology. Sub‐question 2a was about the causal relationship between Berberine as single substance and the a priori identified adverse effect, subquestion 2b was about the causal relationship between intake of plant preparations and food containing Berberine and the a priori identified adverse effect. Subquestion 5a was about the content of Berberine in foods (including food supplements) and preparations of plant. Subquestions 2a,b were answered together with the same search string and screening process.

The search strategy was run on three databases, PubMed, Embase, and Cochrane (only for subquestions 2a,b and identified records were imported in Distiller SR software where the selection of relevant studies was carried out. Screening was carried out in parallel by two reviewers and conflicts were solved through consensus. At the end, 52 and 237 papers were included for subquestions 2a,b and subquestion 5a, respectively.