Open AccessGuidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources (Revision 1) 1
Author(s) -
Younes Maged,
Aggett Peter,
Aguilar Fernando,
Crebelli Riccardo,
Dusemund Birgit,
Filipič Metka,
Frutos Maria Jose,
Galtier Pierre,
GundertRemy Ursula,
Kuhnle Gunter Georg,
Lambré Claude,
Leblanc JeanCharles,
Lillegaard Inger Therese,
Moldeus Peter,
Mortensen Alicja,
Oskarsson Agneta,
Stankovic Ivan,
WaalkensBerendsen Ine,
Woutersen Rudolf Antonius,
Wright Matthew,
Di Domenico Alessandro,
FairweatherTait Susan,
McArdle Harry J,
Smeraldi Camilla,
Gott David
Publication year - 2021
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2021.6552
Subject(s) - nutrient , bioavailability , environmental science , risk assessment , biochemical engineering , risk analysis (engineering) , computer science , microbiology and biotechnology , business , engineering , biology , bioinformatics , ecology , computer security
Endorsement date 21 January 2021 Implementation date 27 March 2021This guidance describes the scientific data required to allow an evaluation of the safety of new substances that are proposed for use as sources of nutrients in food supplements, foods for the general population or foods for specific groups and an assessment of the bioavailability of the nutrient from the proposed source. This guidance describes the scientific data required to allow an evaluation of the safety of the source within the established framework for risk assessment of food additives and novel food ingredients and the bioavailability of the nutrient from this source. This document is arranged in five main sections: one on technical data aimed at characterising the proposed source and at identifying potential hazards resulting from its manufacture and stability in food; one on existing authorisations and evaluation, providing an overview of previous assessments on the proposed source and their conclusions; one on proposed uses and exposure assessment section, allowing an estimate of the dietary exposure to the source and the nutrient based on the proposed uses and use levels; one on toxicological data, describing approaches which can be used to identify (in conjunction with data on manufacture and composition) and to characterise hazards of the source and any relevant breakdown products; the final section on bioavailability focuses on determining the extent to which the nutrient from the proposed source is available for use by the body in comparison with one or more forms of the same nutrient that are already permitted for use on the positive lists. This guidance was adopted by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) on 16 May 2018. Upon request from EFSA, the present guidance has been revised to inform applicants of new provisions set out in Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain.