Protocol: Risk Assessment For Peri- And Post-Menopausal Women Taking Food Supplements Containing Isolated Isoflavones

This mandate was allocated to the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) and to this end a Working Group was set up to draft the scientific opinion, as requested by the German Bundesinstitut für Risikobewertung (BfR). The Working Group engaged in discussion with the requestor to further clarify the interpretation of the Terms of Reference. Additionally, in the context of the ongoing EFSA Prometheus (PROMoting METHods for Evidence Use in Science) project (EFSA, 2015) aimed at further enhancing the methodological rigour, transparency and openness of EFSA scientific assessments, this risk assessment was chosen as a case-study to test the importance of performing the assessment in two steps, i.e. planning and implementing phase. For the planning phase of the risk assessment, the current protocol was developed with the aim of performing a priori the whole process of problem formulation and defining beforehand the strategy for gathering the data, the criteria for selecting and appraising the evidence and for the synthesis of the results. The experience gained with this specific risk assessment will be used as guidance for further refinement of the Methodological Framework developed in the Prometheus project. The outcome of the protocol was used by the ANS Panel to complete its scientific opinion on the Risk Assessment for peri‐ and post‐menopausal women taking food supplements containing isolated isoflavones. This protocol was published as an Annex to the scientific opinion: https://efsa.onlinelibrary.wiley.com/doi/abs/10.2903/j.efsa.2015.4246
EU; eng; pdf; Camilla.Smeraldi@efsa.europa.eu