Guidance on scientific principles and data requirements for the safety and relative bioavailability assessment of new micronutrient sources

Following the adoption of Regulation (EU) No 1169/2011 on food information toconsumers, the European Commission requested EFSA to update its ‘Guidance onsafety evaluation of sources of nutrients and bioavailability of the nutrient from thesources’ regarding the scientific principles and data requirements for the scientificassessment of all new forms of micronutrients and to derive a conversion factorfor new micronutrient sources or forms of micronutrients to be authorised for ad-dition to foods, including food supplements. This guidance outlines the scientificprinciples that the NDA Panel will consider for the assessment of the safety andthe quantification of the relative bioavailability of new sources of micronutrients,which applicants are requested to consider when preparing their applications. Italso outlines the data requirements for dossiers. Applicants should integrate thedata presented in different sections to provide their overall considerations on howthe information provided supports the safety of the new micronutrient source andthe quantification of its relative bioavailability compared to a reference sourceunder the proposed conditions of use. As preparatory work for the developmentof this guidance, EFSA launched an Expert Survey and held an online workshop on9th March 2023 inviting scientific input from stakeholders and scientific experts,the report of which is now available online in the EFSA's webpage