Guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals:Draft for internal testing

Vitamins and essential minerals are micronutrients that are essential for the normal functioning of the human body. However, they may lead to adverse health effects if consumed in excess. The concept of a tolerable upper intake level (UL) is a science-based reference value, which was introduced to support policy-makers and other relevant actors in managing the risks of excess nutrient intake. EFSA\u2019s principles for establishing ULs for vitamins and minerals were originally developed by the Scientific Committee on Food in 2000. Since then, experience has been gained and the scientific field developed. This guidance from the EFSA Panel on Nutrition, Novel Foods and Food Allergens provides an updated framework to support EFSA\u2019s UL assessments. 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 (hazard identification, hazard characterisation, intake assessment, risk characterisation). Peculiar to nutrients are their biochemical and physiological roles and the specific and selective mechanisms that maintain the systemic homoeostasis and body burden of the nutrient. These must be considered when conducting a risk assessment of nutrients. This document constitutes a draft guidance that will be applied in EFSA\u2019s assessments during a 1-year pilot phase and be revised and complemented as necessary. Before finalisation of the guidance, a public consultation will be launched

Scientific opinion on the tolerable upper intake level for selenium

Following a request from the European Commission, 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 selenium. Systematic reviews of the literature were conducted to identify evidence regarding excess selenium intake and clinical effects and potential biomarkers of effect, risk of chronic diseases and impaired neuropsychological development in humans. Alopecia, as an early observable feature and a well‐established adverse effect of excess selenium exposure, is selected as the critical endpoint on which to base a UL for selenium. A lowest‐observed‐adverse‐effect‐level (LOAEL) of 330 μg/day is identified from a large randomised controlled trial in humans (the Selenium and Vitamin E Cancer Prevention Trial (SELECT)), to which an uncertainty factor of 1.3 is applied. A UL of 255 μg/day is established for adult men and women (including pregnant and lactating women). ULs for children are derived from the UL for adults using allometric scaling (body weight(0.75)). Based on available intake data, adult consumers are unlikely to exceed the UL, except for regular users of food supplements containing high daily doses of selenium or regular consumers of Brazil nuts. No risk has been reported with the current levels of selenium intake in European countries from food (excluding food supplements) in toddlers and children, and selenium intake arising from the natural content of foods does not raise reasons for concern. Selenium‐containing supplements in toddlers and children should be used with caution, based on individual needs

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

Tolerable upper intake level for dietary sugars

Following a request from five European Nordic countries, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was tasked to provide scientific advice on a tolerable upper intake level (UL) or a safe level of intake for dietary (total/added/free) sugars based on available data on chronic metabolic diseases, pregnancy‐related endpoints and dental caries. Specific sugar types (fructose) and sources of sugars were also addressed. The intake of dietary sugars is a well‐established hazard in relation to dental caries in humans. Based on a systematic review of the literature, prospective cohort studies do not support a positive relationship between the intake of dietary sugars, in isocaloric exchange with other macronutrients, and any of the chronic metabolic diseases or pregnancy‐related endpoints assessed. Based on randomised control trials on surrogate disease endpoints, there is evidence for a positive and causal relationship between the intake of added/free sugars and risk of some chronic metabolic diseases: The level of certainty is moderate for obesity and dyslipidaemia (> 50–75% probability), low for non‐alcoholic fatty liver disease and type 2 diabetes (> 15–50% probability) and very low for hypertension (0–15% probability). Health effects of added vs. free sugars could not be compared. A level of sugars intake at which the risk of dental caries/chronic metabolic diseases is not increased could not be identified over the range of observed intakes, and thus, a UL or a safe level of intake could not be set. Based on available data and related uncertainties, the intake of added and free sugars should be as low as possible in the context of a nutritionally adequate diet. Decreasing the intake of added and free sugars would decrease the intake of total sugars to a similar extent. This opinion can assist EU Member States in setting national goals/recommendations

Guidance on the preparation and presentation of thenotification and application for authorisation of traditionalfoods from third countries in the context of Regulation(EU) 2015/2283

Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Councilon Novel Foods, the European Commission requested EFSA to develop a scientific and technicalguidance for the preparation and presentation of notifications for traditional foods from third countries.This guidance presents a common format for the organisation of the information to be presented inorder to assist the applicant in the preparation of a well-structured dossier. The safety of a traditionalfood should be substantiated by reliable data on its composition, its experience of continued use andits proposed conditions of use. Besides, its normal consumption should not be nutritionallydisadvantageous. To that end, information is requested on the description, production process,composition, stability data, specifications, data from experience of continued use in a third country andon the proposed conditions of use of the traditional food for the EU market. The structure of thenotification dossier should follow the sections presented in this guidance. This guidance is alsointended to support applicants in provi ding the type and quality of information EU Member States andEFSA need for the assessments of traditional foods from third countries. The applic ation should becomprehensive and complete. The applicant should integrate the information on the compo sition andthe experience of continued use and provide a concise overall conside ration on how this substantiatesthe history of safe use of the traditional food and how this relates to the proposed conditions of usefor the EU. Where potential health hazards have been identified on the basis of the composition and/ordata from the experience of continu ed use, they should be discussed. On the basis of the informationprovided, EFSA will assess the safety related to the consumption of the traditional food under theproposed conditions of use

Guidance on the preparation and presentation of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283

Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of novel foods. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in preparing a well-structured application to demonstrate the safety of the novel food. The application should be comprehensive and complete. This guidance outlined the data needed for the safety assessments of novel foods. Requirements which should be covered in all applications relate to the description of the novel food, production process, compositional data, specification, proposed uses and use levels, and anticipated intake of the novel food. Further sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity should be considered by the applicant by default. If not covered in the application, this should be justified. The applicant should integrate the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they should be discussed in relation to the anticipated intakes of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use

Statement on the derivation of Health-Based Guidance Values (HBGVs) for regulated products that are also nutrients

This Statement presents a proposal for harmonising the establishment of Health-Based Guidance Values (HBGVs) for regulated products that are also nutrients. This is a recurrent issue for food additives and pesticides, and may occasionally occur for other regulated products. The Statement describes the specific considerations that should be followed for establishing the HBGVs during the assessment of a regulated product that is also a nutrient. It also addresses the elements to be considered in the intake assessment; and proposes a decision tree for ensuring a harmonised process for the risk characterisation of regulated products that are also nutrients. The Scientific Committee recommends the involvement of the relevant EFSA Panels and units, in order to ensure an integrated and harmonised approach for the hazard and risk characterisation of regulated products that are also nutrients, considering the intake from all relevant sources