Scientific opinion on the tolerable upper intake level for manganese

Following a request from the European Commission (EC), the EFSA Panel onNutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientificopinion on the tolerable upper intake level (UL) for manganese. Systematic reviewsof the literature of human and animal data were conducted to assess evidenceregarding excess manganese intake (including authorised manganese salts) andthe priority adverse health effect, i.e. manganese-induced neurotoxicity. Availablehuman and animal studies support neurotoxicity as a critical effect, however, dataare not sufficient and suitable to characterise a dose–response relationship andidentify a reference point for manganese-induced neurotoxicity. In the absenceof adequate data to establish an UL, estimated background dietary intakes (i.e.manganese intakes from natural dietary sources only) observed among high consumers (95th percentile) were used to provide an indication of the highest level of intake where there is reasonable confidence on the absence of adverse effects. A safe level of intake of 8 mg/day was established for adults ≥18years (including pregnant and lactating women) and ranged between 2 and 7 mg/day for other population groups. The application of the safe level of intake is more limited than an UL because the intake level at which the risk of adverse effects starts to increase is not defined

Scientific opinion on the tolerable upper intake level for manganese

Following a request from the European Commission (EC), the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the tolerable upper intake level (UL) for manganese. Systematic reviews of the literature of human and animal data were conducted to assess evidence regarding excess manganese intake (including authorised manganese salts) and the priority adverse health effect, i.e. manganese-induced neurotoxicity. Available human and animal studies support neurotoxicity as a critical effect, however, data are not sufficient and suitable to characterise a dose–response relationship and identify a reference point for manganese-induced neurotoxicity. In the absence of adequate data to establish an UL, estimated background dietary intakes (i.e. manganese intakes from natural dietary sources only) observed among high consumers (95th percentile) were used to provide an indication of the highest level of intake where there is reasonable confidence on the absence of adverse effects. A safe level of intake of 8 mg/day was established for adults ≥ 18 years (including pregnant and lactating women) and ranged between 2 and 7 mg/day for other population groups. The application of the safe level of intake is more limited than an UL because the intake level at which the risk of adverse effects starts to increase is not defined

Scientific opinion on the tolerable upper intake level for manganese

Funding Information: The Panel wishes to thank for their contribution to this output: the WG on Upper Levels: Peter Aggett, Brandy Beverly, Torsten Bohn, Julia Bornhorst, Marta Crous-Bou, Francesco Cubadda, Aymeric Dopter, Susan Fairweather-Tait, Rex FitzGerald, Susan Lanham New, Georg Lietz, Harry J McArdle, Anne Molloy, Giovanni Passeri, Kristina Pentieva, Marco Vinceti and Misha Vrolijk; hearing expert: Peter Willatts, individual scientific advisor (ISA) expert: Keyvin Darney and EFSA staff members: Constanza De Matteu Monteiro, Jean-Lou Dorne, Alessandra Giarola, Irene Muñoz Guajardo, Nena Karavasiloglou, Laura Ciccolallo, Roanne Marie Saad, Angeliki Sofroniou and Silvia Valtueña Martínez. The Panel also wishes to thank Carmen Peláez for her contribution as member of the NDA Panel until June 2023. The Panel acknowledges Thorhallur I Halldorsson, Bryndis Eva Birgisdottir, Anete Dudele, Jacob Juel Christensen and Birna Thorisdottir for the preparatory work as part of a procurement procedure. The Panel also wishes to acknowledge the contribution of all national institutions in European countries that provided consumption data for this scientific output. Publisher Copyright: © 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.Peer reviewe

Guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals

Vitamins and essential minerals are micronutrients that are required for the normal functioning of the human body. However, they may lead to adverse health effects if consumed in excess. A tolerable upper intake level (UL) is a science‐based reference value that supports policy‐makers and other relevant actors in managing the risks of excess nutrient intake. EFSA's principles for establishing ULs for vitamins and minerals were originally developed by the Scientific Committee on Food in 2000. This guidance from the EFSA Panel on Nutrition, Novel Foods and Food Allergens provides an updated framework for UL assessments. A draft was published in 2022 and underwent a 2‐year piloting period. The present document incorporates revisions based on the experience gained through its practical implementation. It covers aspects related to the planning of the risk assessment (problem formulation and definition of methods) and its implementation (evidence retrieval, appraisal, synthesis, integration, uncertainty analysis). As in the previous framework, the general principles developed for the risk assessment of chemicals in food are applied, i.e. hazard identification, hazard characterisation, intake assessment, risk characterisation. Specific to nutrients are their biochemical and physiological roles and the specific and selective mechanisms that maintain the systemic homeostasis and accumulation of the nutrient in the body. Such considerations must also be taken into account when conducting risk assessments of nutrients

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