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Statement on the safety of synthetic l‐ergothioneine as a novel food – supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a supplementary dietary exposure and safety assessment of synthetic l‐ergothioneine for those groups of the population which had been excluded by the applicant in...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010164/ https://www.ncbi.nlm.nih.gov/pubmed/32625352 http://dx.doi.org/10.2903/j.efsa.2017.5060 |
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author | Turck, Dominique Bresson, Jean‐Louis Burlingame, Barbara Dean, Tara Fairweather‐Tait, Susan Heinonen, Marina Hirsch‐Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Neuhäuser‐Berthold, Monika Nowicka, Grażyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjödin, Anders Stern, Martin Tomé, Daniel Vinceti, Marco Willatts, Peter Engel, Karl‐Heinz Marchelli, Rosangela Pöting, Annette Poulsen, Morten Schlatter, Josef Rudolf Ackerl, Reinhard van Loveren, Henk |
author_facet | Turck, Dominique Bresson, Jean‐Louis Burlingame, Barbara Dean, Tara Fairweather‐Tait, Susan Heinonen, Marina Hirsch‐Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Neuhäuser‐Berthold, Monika Nowicka, Grażyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjödin, Anders Stern, Martin Tomé, Daniel Vinceti, Marco Willatts, Peter Engel, Karl‐Heinz Marchelli, Rosangela Pöting, Annette Poulsen, Morten Schlatter, Josef Rudolf Ackerl, Reinhard van Loveren, Henk |
collection | PubMed |
description | Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a supplementary dietary exposure and safety assessment of synthetic l‐ergothioneine for those groups of the population which had been excluded by the applicant in the original application, i.e. infants and young children (i.e. toddlers), pregnant and breastfeeding women. Thus, intake estimates were calculated for these population groups and the following maximum anticipated daily intakes of l‐ergothioneine from the NF, in addition to the background diet, were calculated: 2.82 mg/kg body weight (bw) per day for infants, 3.39 mg/kg bw per day for toddlers and 1.31 mg/kg bw per day for adults including pregnant and breastfeeding women. The Panel considers that based on the overall toxicological data the no‐observed‐adverse‐effect level (NOAEL) of 800 mg/kg bw per day as established in the original assessment also pertains to pregnant and breastfeeding women as well as to young children (i.e. toddlers) and infants. The corresponding margins of exposure (i.e. the ratio between the NOAEL and the maximum anticipated daily intakes) are 284 for infants, 236 for young children and 610 for pregnant and breastfeeding women. These margins of exposure are considered sufficient. The Panel concludes that the novel food, synthetic l‐ergothioneine, is safe under the proposed uses and use levels for infants, young children (i.e. toddlers) and pregnant and breastfeeding women. |
format | Online Article Text |
id | pubmed-7010164 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-70101642020-07-02 Statement on the safety of synthetic l‐ergothioneine as a novel food – supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women Turck, Dominique Bresson, Jean‐Louis Burlingame, Barbara Dean, Tara Fairweather‐Tait, Susan Heinonen, Marina Hirsch‐Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Neuhäuser‐Berthold, Monika Nowicka, Grażyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjödin, Anders Stern, Martin Tomé, Daniel Vinceti, Marco Willatts, Peter Engel, Karl‐Heinz Marchelli, Rosangela Pöting, Annette Poulsen, Morten Schlatter, Josef Rudolf Ackerl, Reinhard van Loveren, Henk EFSA J Scientific Opinion Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a supplementary dietary exposure and safety assessment of synthetic l‐ergothioneine for those groups of the population which had been excluded by the applicant in the original application, i.e. infants and young children (i.e. toddlers), pregnant and breastfeeding women. Thus, intake estimates were calculated for these population groups and the following maximum anticipated daily intakes of l‐ergothioneine from the NF, in addition to the background diet, were calculated: 2.82 mg/kg body weight (bw) per day for infants, 3.39 mg/kg bw per day for toddlers and 1.31 mg/kg bw per day for adults including pregnant and breastfeeding women. The Panel considers that based on the overall toxicological data the no‐observed‐adverse‐effect level (NOAEL) of 800 mg/kg bw per day as established in the original assessment also pertains to pregnant and breastfeeding women as well as to young children (i.e. toddlers) and infants. The corresponding margins of exposure (i.e. the ratio between the NOAEL and the maximum anticipated daily intakes) are 284 for infants, 236 for young children and 610 for pregnant and breastfeeding women. These margins of exposure are considered sufficient. The Panel concludes that the novel food, synthetic l‐ergothioneine, is safe under the proposed uses and use levels for infants, young children (i.e. toddlers) and pregnant and breastfeeding women. John Wiley and Sons Inc. 2017-11-13 /pmc/articles/PMC7010164/ /pubmed/32625352 http://dx.doi.org/10.2903/j.efsa.2017.5060 Text en © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. |
spellingShingle | Scientific Opinion Turck, Dominique Bresson, Jean‐Louis Burlingame, Barbara Dean, Tara Fairweather‐Tait, Susan Heinonen, Marina Hirsch‐Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Neuhäuser‐Berthold, Monika Nowicka, Grażyna Pentieva, Kristina Sanz, Yolanda Siani, Alfonso Sjödin, Anders Stern, Martin Tomé, Daniel Vinceti, Marco Willatts, Peter Engel, Karl‐Heinz Marchelli, Rosangela Pöting, Annette Poulsen, Morten Schlatter, Josef Rudolf Ackerl, Reinhard van Loveren, Henk Statement on the safety of synthetic l‐ergothioneine as a novel food – supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women |
title | Statement on the safety of synthetic l‐ergothioneine as a novel food – supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women |
title_full | Statement on the safety of synthetic l‐ergothioneine as a novel food – supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women |
title_fullStr | Statement on the safety of synthetic l‐ergothioneine as a novel food – supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women |
title_full_unstemmed | Statement on the safety of synthetic l‐ergothioneine as a novel food – supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women |
title_short | Statement on the safety of synthetic l‐ergothioneine as a novel food – supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women |
title_sort | statement on the safety of synthetic l‐ergothioneine as a novel food – supplementary dietary exposure and safety assessment for infants and young children, pregnant and breastfeeding women |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010164/ https://www.ncbi.nlm.nih.gov/pubmed/32625352 http://dx.doi.org/10.2903/j.efsa.2017.5060 |
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