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Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age

Following a request from the European Commission to EFSA, the EFSA Scientific Committee (SC) prepared a guidance for the risk assessment of substances present in food intended for infants below 16 weeks of age. In its approach to develop this guidance, the EFSA SC took into account, among others, (i...

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Autores principales: Hardy, Anthony, Benford, Diane, Halldorsson, Thorhallur, Jeger, Michael John, Knutsen, Helle Katrine, More, Simon, Naegeli, Hanspeter, Noteborn, Hubert, Ockleford, Colin, Ricci, Antonia, Rychen, Guido, Schlatter, Josef R, Silano, Vittorio, Solecki, Roland, Turck, Dominique, Bresson, Jean‐Louis, Dusemund, Birgit, Gundert‐Remy, Ursula, Kersting, Mathilde, Lambré, Claude, Penninks, André, Tritscher, Angelika, Waalkens‐Berendsen, Ine, Woutersen, Ruud, Arcella, Davide, Court Marques, Daniele, Dorne, Jean‐Lou, Kass, George EN, Mortensen, Alicja
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010120/
https://www.ncbi.nlm.nih.gov/pubmed/32625502
http://dx.doi.org/10.2903/j.efsa.2017.4849
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author Hardy, Anthony
Benford, Diane
Halldorsson, Thorhallur
Jeger, Michael John
Knutsen, Helle Katrine
More, Simon
Naegeli, Hanspeter
Noteborn, Hubert
Ockleford, Colin
Ricci, Antonia
Rychen, Guido
Schlatter, Josef R
Silano, Vittorio
Solecki, Roland
Turck, Dominique
Bresson, Jean‐Louis
Dusemund, Birgit
Gundert‐Remy, Ursula
Kersting, Mathilde
Lambré, Claude
Penninks, André
Tritscher, Angelika
Waalkens‐Berendsen, Ine
Woutersen, Ruud
Arcella, Davide
Court Marques, Daniele
Dorne, Jean‐Lou
Kass, George EN
Mortensen, Alicja
author_facet Hardy, Anthony
Benford, Diane
Halldorsson, Thorhallur
Jeger, Michael John
Knutsen, Helle Katrine
More, Simon
Naegeli, Hanspeter
Noteborn, Hubert
Ockleford, Colin
Ricci, Antonia
Rychen, Guido
Schlatter, Josef R
Silano, Vittorio
Solecki, Roland
Turck, Dominique
Bresson, Jean‐Louis
Dusemund, Birgit
Gundert‐Remy, Ursula
Kersting, Mathilde
Lambré, Claude
Penninks, André
Tritscher, Angelika
Waalkens‐Berendsen, Ine
Woutersen, Ruud
Arcella, Davide
Court Marques, Daniele
Dorne, Jean‐Lou
Kass, George EN
Mortensen, Alicja
collection PubMed
description Following a request from the European Commission to EFSA, the EFSA Scientific Committee (SC) prepared a guidance for the risk assessment of substances present in food intended for infants below 16 weeks of age. In its approach to develop this guidance, the EFSA SC took into account, among others, (i) an exposure assessment based on infant formula as the only source of nutrition; (ii) knowledge of organ development in human infants, including the development of the gut, metabolic and excretory capacities, the brain and brain barriers, the immune system, the endocrine and reproductive systems; (iii) the overall toxicological profile of the substance identified through the standard toxicological tests, including critical effects; (iv) the relevance for the human infant of the neonatal experimental animal models used. The EFSA SC notes that during the period from birth up to 16 weeks, infants are expected to be exclusively fed on breast milk and/or infant formula. The EFSA SC views this period as the time where health‐based guidance values for the general population do not apply without further considerations. High infant formula consumption per body weight is derived from 95th percentile consumption. The first weeks of life is the time of the highest relative consumption on a body weight basis. Therefore, when performing an exposure assessment, the EFSA SC proposes to use the high consumption value of 260 mL/kg bw per day. A decision tree approach is proposed that enables a risk assessment of substances present in food intended for infants below 16 weeks of age. The additional information needed when testing substances present in food for infants below 16 weeks of age and the approach to be taken for the risk assessment are on a case‐by‐case basis, depending on whether the substance is added intentionally to food and is systemically available.
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spelling pubmed-70101202020-07-02 Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age Hardy, Anthony Benford, Diane Halldorsson, Thorhallur Jeger, Michael John Knutsen, Helle Katrine More, Simon Naegeli, Hanspeter Noteborn, Hubert Ockleford, Colin Ricci, Antonia Rychen, Guido Schlatter, Josef R Silano, Vittorio Solecki, Roland Turck, Dominique Bresson, Jean‐Louis Dusemund, Birgit Gundert‐Remy, Ursula Kersting, Mathilde Lambré, Claude Penninks, André Tritscher, Angelika Waalkens‐Berendsen, Ine Woutersen, Ruud Arcella, Davide Court Marques, Daniele Dorne, Jean‐Lou Kass, George EN Mortensen, Alicja EFSA J Scientific Opinion Following a request from the European Commission to EFSA, the EFSA Scientific Committee (SC) prepared a guidance for the risk assessment of substances present in food intended for infants below 16 weeks of age. In its approach to develop this guidance, the EFSA SC took into account, among others, (i) an exposure assessment based on infant formula as the only source of nutrition; (ii) knowledge of organ development in human infants, including the development of the gut, metabolic and excretory capacities, the brain and brain barriers, the immune system, the endocrine and reproductive systems; (iii) the overall toxicological profile of the substance identified through the standard toxicological tests, including critical effects; (iv) the relevance for the human infant of the neonatal experimental animal models used. The EFSA SC notes that during the period from birth up to 16 weeks, infants are expected to be exclusively fed on breast milk and/or infant formula. The EFSA SC views this period as the time where health‐based guidance values for the general population do not apply without further considerations. High infant formula consumption per body weight is derived from 95th percentile consumption. The first weeks of life is the time of the highest relative consumption on a body weight basis. Therefore, when performing an exposure assessment, the EFSA SC proposes to use the high consumption value of 260 mL/kg bw per day. A decision tree approach is proposed that enables a risk assessment of substances present in food intended for infants below 16 weeks of age. The additional information needed when testing substances present in food for infants below 16 weeks of age and the approach to be taken for the risk assessment are on a case‐by‐case basis, depending on whether the substance is added intentionally to food and is systemically available. John Wiley and Sons Inc. 2017-05-31 /pmc/articles/PMC7010120/ /pubmed/32625502 http://dx.doi.org/10.2903/j.efsa.2017.4849 Text en © 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://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
Hardy, Anthony
Benford, Diane
Halldorsson, Thorhallur
Jeger, Michael John
Knutsen, Helle Katrine
More, Simon
Naegeli, Hanspeter
Noteborn, Hubert
Ockleford, Colin
Ricci, Antonia
Rychen, Guido
Schlatter, Josef R
Silano, Vittorio
Solecki, Roland
Turck, Dominique
Bresson, Jean‐Louis
Dusemund, Birgit
Gundert‐Remy, Ursula
Kersting, Mathilde
Lambré, Claude
Penninks, André
Tritscher, Angelika
Waalkens‐Berendsen, Ine
Woutersen, Ruud
Arcella, Davide
Court Marques, Daniele
Dorne, Jean‐Lou
Kass, George EN
Mortensen, Alicja
Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age
title Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age
title_full Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age
title_fullStr Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age
title_full_unstemmed Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age
title_short Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age
title_sort guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age
topic Scientific Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010120/
https://www.ncbi.nlm.nih.gov/pubmed/32625502
http://dx.doi.org/10.2903/j.efsa.2017.4849
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