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Efficacy of an infant formula manufactured from a specific protein hydrolysate derived from whey protein isolate and concentrate produced by Societe des Produits Nestle S.A. in reducing the risk of developing atopic dermatitis

(2021) EFSA JOURNAL. 19(6).
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Abstract
The European Commission asked EFSA to evaluate the efficacy of an infant formula, containing a specific protein hydrolysate derived from whey protein isolate and concentrate and manufactured by Societe des Produits Nestle S.A., in reducing the risk of developing atopic dermatitis in infants with a family history of allergy. This was following the submission of a dossier by Societe des Produits Nestle S.A. to the European Commission, in the context of Regulation (EU) 2016/127. The protein hydrolysate from which the infant formula is produced is included in Annex I and II of Commission delegated Regulation (EU) 2016/127 as suitable protein source for the manufacture of infant and follow-on formulae. This opinion does not cover the assessment of the nutritional safety and suitability of the infant formula or the safety of the food enzymes used in the manufacture of the protein hydrolysate. The Panel considers that, in relation to the effect that is claimed, the infant formula under evaluation is not sufficiently characterised with respect to the molecular weight distribution of peptides. From the human intervention studies submitted, no conclusions could be drawn on the efficacy of the infant formula in reducing the risk of developing atopic dermatitis. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of the infant formula under evaluation and the reduction in the risk of developing atopic dermatitis in infants with a family history of allergy. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Keywords
protein hydrolysate, characterisation, formula, allergy, atopic, dermatitis, clinical trial, infants, NUTRITIONAL INTERVENTION, COWS MILK, ALLERGIC SYMPTOMS, PREVENTION, AGE, PROPHYLAXIS, PROGRAM, DIETARY, ASTHMA

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MLA
Castenmiller, Jacqueline, et al. “Efficacy of an Infant Formula Manufactured from a Specific Protein Hydrolysate Derived from Whey Protein Isolate and Concentrate Produced by Societe Des Produits Nestle S.A. in Reducing the Risk of Developing Atopic Dermatitis.” EFSA JOURNAL, vol. 19, no. 6, European Food Safety Authority-EFSA, 2021, doi:10.2903/j.efsa.2021.6603.
APA
Castenmiller, J., Hirsch-Ernst, K.-I., Kearney, J., Knutsen, H. K., Maciuk, A., Mangelsdorf, I., … De Henauw, S. (2021). Efficacy of an infant formula manufactured from a specific protein hydrolysate derived from whey protein isolate and concentrate produced by Societe des Produits Nestle S.A. in reducing the risk of developing atopic dermatitis. EFSA JOURNAL, 19(6). https://doi.org/10.2903/j.efsa.2021.6603
Chicago author-date
Castenmiller, Jacqueline, Karen-Ildico Hirsch-Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, et al. 2021. “Efficacy of an Infant Formula Manufactured from a Specific Protein Hydrolysate Derived from Whey Protein Isolate and Concentrate Produced by Societe Des Produits Nestle S.A. in Reducing the Risk of Developing Atopic Dermatitis.” EFSA JOURNAL 19 (6). https://doi.org/10.2903/j.efsa.2021.6603.
Chicago author-date (all authors)
Castenmiller, Jacqueline, Karen-Ildico Hirsch-Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Dominique Turck, Marco Vinceti, Rosangela Marchelli, Henk van Loveren, Celine Dumas, Ariane Titz, and Stefaan De Henauw. 2021. “Efficacy of an Infant Formula Manufactured from a Specific Protein Hydrolysate Derived from Whey Protein Isolate and Concentrate Produced by Societe Des Produits Nestle S.A. in Reducing the Risk of Developing Atopic Dermatitis.” EFSA JOURNAL 19 (6). doi:10.2903/j.efsa.2021.6603.
Vancouver
1.
Castenmiller J, Hirsch-Ernst K-I, Kearney J, Knutsen HK, Maciuk A, Mangelsdorf I, et al. Efficacy of an infant formula manufactured from a specific protein hydrolysate derived from whey protein isolate and concentrate produced by Societe des Produits Nestle S.A. in reducing the risk of developing atopic dermatitis. EFSA JOURNAL. 2021;19(6).
IEEE
[1]
J. Castenmiller et al., “Efficacy of an infant formula manufactured from a specific protein hydrolysate derived from whey protein isolate and concentrate produced by Societe des Produits Nestle S.A. in reducing the risk of developing atopic dermatitis,” EFSA JOURNAL, vol. 19, no. 6, 2021.
@article{01GW4DDQX9R5HYJFQN1EQJ394H,
  abstract     = {{The European Commission asked EFSA to evaluate the efficacy of an infant formula, containing a specific protein hydrolysate derived from whey protein isolate and concentrate and manufactured by Societe des Produits Nestle S.A., in reducing the risk of developing atopic dermatitis in infants with a family history of allergy. This was following the submission of a dossier by Societe des Produits Nestle S.A. to the European Commission, in the context of Regulation (EU) 2016/127. The protein hydrolysate from which the infant formula is produced is included in Annex I and II of Commission delegated Regulation (EU) 2016/127 as suitable protein source for the manufacture of infant and follow-on formulae. This opinion does not cover the assessment of the nutritional safety and suitability of the infant formula or the safety of the food enzymes used in the manufacture of the protein hydrolysate. The Panel considers that, in relation to the effect that is claimed, the infant formula under evaluation is not sufficiently characterised with respect to the molecular weight distribution of peptides. From the human intervention studies submitted, no conclusions could be drawn on the efficacy of the infant formula in reducing the risk of developing atopic dermatitis. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of the infant formula under evaluation and the reduction in the risk of developing atopic dermatitis in infants with a family history of allergy. (C) 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.}},
  articleno    = {{e06603}},
  author       = {{Castenmiller, Jacqueline and  Hirsch-Ernst, Karen-Ildico and  Kearney, John and  Knutsen, Helle Katrine 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  Turck, Dominique and  Vinceti, Marco and  Marchelli, Rosangela and  van Loveren, Henk and  Dumas, Celine and  Titz, Ariane and De Henauw, Stefaan}},
  issn         = {{1831-4732}},
  journal      = {{EFSA JOURNAL}},
  keywords     = {{protein hydrolysate,characterisation,formula,allergy,atopic,dermatitis,clinical trial,infants,NUTRITIONAL INTERVENTION,COWS MILK,ALLERGIC SYMPTOMS,PREVENTION,AGE,PROPHYLAXIS,PROGRAM,DIETARY,ASTHMA}},
  language     = {{eng}},
  number       = {{6}},
  pages        = {{16}},
  publisher    = {{European Food Safety Authority-EFSA}},
  title        = {{Efficacy of an infant formula manufactured from a specific protein hydrolysate derived from whey protein isolate and concentrate produced by Societe des Produits Nestle S.A. in reducing the risk of developing atopic dermatitis}},
  url          = {{http://doi.org/10.2903/j.efsa.2021.6603}},
  volume       = {{19}},
  year         = {{2021}},
}

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