Preparatory work for the evaluation of the safety of preparations from the fruits of sweet and bitter fennel (Foeniculum vulgare Mill. and Foeniculum piperitum (Ucria) C.Presl) AUTORIDAD EUROPEA DE SEGURIDAD ALIMENTARIA: SUBVENCIONES/NOTICIAS/ADQUISCIONES

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 preparations from the fruits of sweet and bitter fennel (Foeniculum vulgare Mill. and Foeniculum piperitum (Ucria) C.Presl). Three subquestion were answered through systematic review methodology. Sub‐question 2 about the evidence for the extent to which the 1’‐hydroxylation pathway is activated or sulphoconjugation of 1’‐hydroxyestragole occurs at different levels of dietary exposure to estragole. Sub‐question 3 regarding the effect of the matrix (i.e. preparations from sweet and bitter fennel fruits) on the sulphoconjugation of 1’‐hydroxyestragole, on DNA adduct formation and on the carcinogenicity of estragole. Sub‐question 5 on the content of estragole in preparations from sweet or bitter fennel fruits; on s the content of estragole, methyleugenol and safrole in herbs and spices that contain these p‐allylalkoxybenzenes (e.g. aromatic herbs such as basil, spices such as nutmeg, etc.) and preparations from these herbs and spices in which the herb or the spice is one of the main ingredients (e.g. pesto); on the content of estragole, methyleugenol and safrole in compound foods, on the content of estragole, methyleugenol and safrole in food supplements. The search strategy was run on two databases, PubMed and Embase, 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 27, 9 and 132 papers were included for subquestion 2, bub‐question 3 and subquestion 5, respectively.