Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on bovine milk osteopontin (bmOPN) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF concerns OPN derived from bovine whey. The NF is i...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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John Wiley and Sons Inc.
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9074041/ https://www.ncbi.nlm.nih.gov/pubmed/35572202 http://dx.doi.org/10.2903/j.efsa.2022.7137 |
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author | Turck, Dominique Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Kearney, John Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pelaez, Carmen Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Cubadda, Francesco Frenzel, Thomas Heinonen, Marina Maradona, Miguel Prieto Marchelli, Rosangela Neuhäuser‐Berthold, Monika Poulsen, Morten Schlatter, Josef Rudolf van Loveren, Henk Gelbmann, Wolfgang Knutsen, Helle Katrine |
author_facet | Turck, Dominique Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Kearney, John Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pelaez, Carmen Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Cubadda, Francesco Frenzel, Thomas Heinonen, Marina Maradona, Miguel Prieto Marchelli, Rosangela Neuhäuser‐Berthold, Monika Poulsen, Morten Schlatter, Josef Rudolf van Loveren, Henk Gelbmann, Wolfgang Knutsen, Helle Katrine |
collection | PubMed |
description | Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on bovine milk osteopontin (bmOPN) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF concerns OPN derived from bovine whey. The NF is intended to be used at a maximum use level of 151 mg/L, in infant formula (IF), follow‐on formula (FoF) and ready‐to‐eat dairy‐based meals for children up to 35 months of age. As compared to the concentrations naturally present in cow’s milk and concentrations found in IF on the market reported in the literature, the proposed use level of the NF represents an about 10‐fold higher concentration of bmOPN. The intended use levels of the NF would provide bmOPN at a concentration within the range of human milk (hm) OPN. In a 6‐month study, 14, 72 and 140 mg bmOPN/L in reconstituted (as consumed) IF were given to 279 infants in order to study possible effects on frequency and severity of adverse events, and growth, formula intake and stool consistency. Despite that a number of inconsistencies and limitations were noted in the study report, the Panel considers that the results obtained from this study do not raise safety concerns. Considering the source of the NF, that neither the toxicological studies nor the provided infant study do raise safety concerns, and the low bmOPN plasma levels in infants resulting from the consumption of the NF, the Panel considers that the margin of exposure (i.e. 36) between the NOAEL of the subchronic toxicity study (1,200 mg/kg bw per day) and the highest P95 estimate for infants (33.4 mg/kg bw per day) is sufficient. The Panel concludes that the NF is safe under the proposed conditions of use. |
format | Online Article Text |
id | pubmed-9074041 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-90740412022-05-13 Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283 Turck, Dominique Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Kearney, John Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pelaez, Carmen Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Cubadda, Francesco Frenzel, Thomas Heinonen, Marina Maradona, Miguel Prieto Marchelli, Rosangela Neuhäuser‐Berthold, Monika Poulsen, Morten Schlatter, Josef Rudolf van Loveren, Henk Gelbmann, Wolfgang Knutsen, Helle Katrine EFSA J Scientific Opinion Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on bovine milk osteopontin (bmOPN) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF concerns OPN derived from bovine whey. The NF is intended to be used at a maximum use level of 151 mg/L, in infant formula (IF), follow‐on formula (FoF) and ready‐to‐eat dairy‐based meals for children up to 35 months of age. As compared to the concentrations naturally present in cow’s milk and concentrations found in IF on the market reported in the literature, the proposed use level of the NF represents an about 10‐fold higher concentration of bmOPN. The intended use levels of the NF would provide bmOPN at a concentration within the range of human milk (hm) OPN. In a 6‐month study, 14, 72 and 140 mg bmOPN/L in reconstituted (as consumed) IF were given to 279 infants in order to study possible effects on frequency and severity of adverse events, and growth, formula intake and stool consistency. Despite that a number of inconsistencies and limitations were noted in the study report, the Panel considers that the results obtained from this study do not raise safety concerns. Considering the source of the NF, that neither the toxicological studies nor the provided infant study do raise safety concerns, and the low bmOPN plasma levels in infants resulting from the consumption of the NF, the Panel considers that the margin of exposure (i.e. 36) between the NOAEL of the subchronic toxicity study (1,200 mg/kg bw per day) and the highest P95 estimate for infants (33.4 mg/kg bw per day) is sufficient. The Panel concludes that the NF is safe under the proposed conditions of use. John Wiley and Sons Inc. 2022-05-06 /pmc/articles/PMC9074041/ /pubmed/35572202 http://dx.doi.org/10.2903/j.efsa.2022.7137 Text en © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the 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 Turck, Dominique Castenmiller, Jacqueline De Henauw, Stefaan Hirsch‐Ernst, Karen Ildico Kearney, John Maciuk, Alexandre Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Pelaez, Carmen Pentieva, Kristina Siani, Alfonso Thies, Frank Tsabouri, Sophia Vinceti, Marco Cubadda, Francesco Frenzel, Thomas Heinonen, Marina Maradona, Miguel Prieto Marchelli, Rosangela Neuhäuser‐Berthold, Monika Poulsen, Morten Schlatter, Josef Rudolf van Loveren, Henk Gelbmann, Wolfgang Knutsen, Helle Katrine Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283 |
title | Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283 |
title_full | Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283 |
title_fullStr | Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283 |
title_full_unstemmed | Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283 |
title_short | Safety of bovine milk osteopontin as a Novel food pursuant to Regulation (EU) 2015/2283 |
title_sort | safety of bovine milk osteopontin as a novel food pursuant to regulation (eu) 2015/2283 |
topic | Scientific Opinion |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9074041/ https://www.ncbi.nlm.nih.gov/pubmed/35572202 http://dx.doi.org/10.2903/j.efsa.2022.7137 |
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