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

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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.

In: EFSA Journal, Vol. 15, No. 5, 04849, 05.2017.

Research output: Contribution to journalJournal article

Harvard

Hardy, A, Benford, D, Halldorsson, T, Jeger, MJ, Knutsen, HK, More, S, Naegeli, H, Noteborn, H, Ockleford, C, Ricci, A, Rychen, G, Schlatter, JR, Silano, V, Solecki, R, Turck, D, Bresson, J-L, Dusemund, B, Gundert-Remy, U, Kersting, M, Lambré, C, Penninks, A, Tritscher, A, Waalkens-Berendsen, I, Woutersen, R, Arcella, D, Court Marques, D, Dorne, J-L, Kass, GEN & Mortensen, A 2017, 'Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age', EFSA Journal, vol. 15, no. 5, 04849. https://doi.org/10.2903/j.efsa.2017.4849

APA

Hardy, A., Benford, D., Halldorsson, T., Jeger, M. J., Knutsen, H. K., More, S., Naegeli, H., Noteborn, H., Ockleford, C., Ricci, A., Rychen, G., Schlatter, J. R., Silano, V., Solecki, R., Turck, D., Bresson, J-L., Dusemund, B., Gundert-Remy, U., Kersting, M., ... Mortensen, A. (2017). Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age. EFSA Journal, 15(5), [04849]. https://doi.org/10.2903/j.efsa.2017.4849

Vancouver

Hardy A, Benford D, Halldorsson T, Jeger MJ, Knutsen HK, More S et al. Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age. EFSA Journal. 2017 May;15(5). 04849. https://doi.org/10.2903/j.efsa.2017.4849

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. / Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age. In: EFSA Journal. 2017 ; Vol. 15, No. 5.

Bibtex

@article{8f7661f136b342b99aa5cdd95e5fa793,
title = "Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age",
abstract = "Abstract 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.",
keywords = "infants, neonates, ADI, health-based guidance values, development",
author = "Anthony Hardy and Diane Benford and Thorhallur Halldorsson and Jeger, {Michael John} and Knutsen, {Helle Katrine} and Simon More and Hanspeter Naegeli and Hubert Noteborn and Colin Ockleford and Antonia Ricci and Guido Rychen and Schlatter, {Josef R} and Vittorio Silano and Roland Solecki and Dominique Turck and Jean-Louis Bresson and Birgit Dusemund and Ursula Gundert-Remy and Mathilde Kersting and Claude Lambr{\'e} and Andr{\'e} Penninks and Angelika Tritscher and Ine Waalkens-Berendsen and Ruud Woutersen and Davide Arcella and {Court Marques}, Daniele and Jean-Lou Dorne and Kass, {George EN} and Alicja Mortensen",
note = "doi: 10.2903/j.efsa.2017.4849",
year = "2017",
month = may
doi = "10.2903/j.efsa.2017.4849",
language = "English",
volume = "15",
journal = "EFSA Journal",
issn = "1831-4732",
publisher = "John Wiley & Sons, Ltd",
number = "5",

}

RIS

TY - JOUR

T1 - Guidance on the risk assessment of substances present in food intended for infants below 16 weeks of age

AU - Hardy, Anthony

AU - Benford, Diane

AU - Halldorsson, Thorhallur

AU - Jeger, Michael John

AU - Knutsen, Helle Katrine

AU - More, Simon

AU - Naegeli, Hanspeter

AU - Noteborn, Hubert

AU - Ockleford, Colin

AU - Ricci, Antonia

AU - Rychen, Guido

AU - Schlatter, Josef R

AU - Silano, Vittorio

AU - Solecki, Roland

AU - Turck, Dominique

AU - Bresson, Jean-Louis

AU - Dusemund, Birgit

AU - Gundert-Remy, Ursula

AU - Kersting, Mathilde

AU - Lambré, Claude

AU - Penninks, André

AU - Tritscher, Angelika

AU - Waalkens-Berendsen, Ine

AU - Woutersen, Ruud

AU - Arcella, Davide

AU - Court Marques, Daniele

AU - Dorne, Jean-Lou

AU - Kass, George EN

AU - Mortensen, Alicja

N1 - doi: 10.2903/j.efsa.2017.4849

PY - 2017/5

Y1 - 2017/5

N2 - Abstract 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.

AB - Abstract 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.

KW - infants

KW - neonates

KW - ADI

KW - health-based guidance values

KW - development

U2 - 10.2903/j.efsa.2017.4849

DO - 10.2903/j.efsa.2017.4849

M3 - Journal article

VL - 15

JO - EFSA Journal

JF - EFSA Journal

SN - 1831-4732

IS - 5

M1 - 04849

ER -