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Safety of bovine milk osteopontin as a novel food pursuant to Regulation (EU) 2015/2283

Dominique Turck, Jacqueline Castenmiller, Stefaan De Henauw (UGent) , Karen Ildico Hirsch-Ernst, John Kearney, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Carmen Pelaez, et al.
(2022) EFSA JOURNAL. 20(5).
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Abstract
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.
Keywords
Novel Foods, bovine milk osteopontin, whey protein, infants and young, children, infant formula, follow-on formula, SERUM OSTEOPONTIN, EXPRESSION, FORMULA, GROWTH, SITES

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MLA
Turck, Dominique, et al. “Safety of Bovine Milk Osteopontin as a Novel Food Pursuant to Regulation (EU) 2015/2283.” EFSA JOURNAL, vol. 20, no. 5, Wiley, 2022, doi:10.2903/j.efsa.2022.7137.
APA
Turck, D., Castenmiller, J., De Henauw, S., Hirsch-Ernst, K. I., Kearney, J., Maciuk, A., … Nutr Novel Foods Food A, E. P. (2022). Safety of bovine milk osteopontin as a novel food pursuant to Regulation (EU) 2015/2283. EFSA JOURNAL, 20(5). https://doi.org/10.2903/j.efsa.2022.7137
Chicago author-date
Turck, Dominique, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, John Kearney, Alexandre Maciuk, Inge Mangelsdorf, et al. 2022. “Safety of Bovine Milk Osteopontin as a Novel Food Pursuant to Regulation (EU) 2015/2283.” EFSA JOURNAL 20 (5). https://doi.org/10.2903/j.efsa.2022.7137.
Chicago author-date (all authors)
Turck, Dominique, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, John Kearney, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Miguel Prieto Maradona, Rosangela Marchelli, Monika Neuhauser-Berthold, Morten Poulsen, Josef Rudolf Schlatter, Henk van Loveren, Wolfgang Gelbmann, Helle Katrine Knutsen, and EFSA Panel Nutr Novel Foods Food A. 2022. “Safety of Bovine Milk Osteopontin as a Novel Food Pursuant to Regulation (EU) 2015/2283.” EFSA JOURNAL 20 (5). doi:10.2903/j.efsa.2022.7137.
Vancouver
1.
Turck D, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Kearney J, Maciuk A, et al. Safety of bovine milk osteopontin as a novel food pursuant to Regulation (EU) 2015/2283. EFSA JOURNAL. 2022;20(5).
IEEE
[1]
D. Turck et al., “Safety of bovine milk osteopontin as a novel food pursuant to Regulation (EU) 2015/2283,” EFSA JOURNAL, vol. 20, no. 5, 2022.
@article{01GWHK6MP0651G7V5SG6NDWQKS,
  abstract     = {{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.}},
  articleno    = {{e07137}},
  author       = {{Turck, Dominique and  Castenmiller, Jacqueline and De Henauw, Stefaan and  Hirsch-Ernst, Karen Ildico and  Kearney, John and  Maciuk, Alexandre and  Mangelsdorf, Inge and  McArdle, Harry J. and  Naska, Androniki and  Pelaez, Carmen and  Pentieva, Kristina and  Siani, Alfonso and  Thies, Frank and  Tsabouri, Sophia and  Vinceti, Marco and  Cubadda, Francesco and  Frenzel, Thomas and  Heinonen, Marina and  Maradona, Miguel Prieto and  Marchelli, Rosangela and  Neuhauser-Berthold, Monika and  Poulsen, Morten and  Schlatter, Josef Rudolf and  van Loveren, Henk and  Gelbmann, Wolfgang and  Knutsen, Helle Katrine and Nutr Novel Foods Food A, EFSA Panel}},
  issn         = {{1831-4732}},
  journal      = {{EFSA JOURNAL}},
  keywords     = {{Novel Foods,bovine milk osteopontin,whey protein,infants and young,children,infant formula,follow-on formula,SERUM OSTEOPONTIN,EXPRESSION,FORMULA,GROWTH,SITES}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{24}},
  publisher    = {{Wiley}},
  title        = {{Safety of bovine milk osteopontin as a novel food pursuant to Regulation (EU) 2015/2283}},
  url          = {{http://doi.org/10.2903/j.efsa.2022.7137}},
  volume       = {{20}},
  year         = {{2022}},
}
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