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Scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance for the preparation and presentation of applications for authorisation of infant and/or follow‐on formula manufactured from prot...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2017
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010067/ https://www.ncbi.nlm.nih.gov/pubmed/32625485 http://dx.doi.org/10.2903/j.efsa.2017.4779 |
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| author | Turck, Dominique Bresson, Jean‐Louis Burlingame, Barbara Dean, Tara Fairweather‐Tait, Susan Heinonen, Marina Hirsch‐Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Neuhäuser‐Berthold, Monika Nowicka, Grażyna Pentieva, Kristina Sanz, Yolanda Sjödin, Anders Stern, Martin Tomé, Daniel Van Loveren, Henk Vinceti, Marco Willatts, Peter Fewtrell, Mary Przyrembel, Hildegard Titz, Ariane Valtueña Martínez, Silvia |
| author_facet | Turck, Dominique Bresson, Jean‐Louis Burlingame, Barbara Dean, Tara Fairweather‐Tait, Susan Heinonen, Marina Hirsch‐Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Neuhäuser‐Berthold, Monika Nowicka, Grażyna Pentieva, Kristina Sanz, Yolanda Sjödin, Anders Stern, Martin Tomé, Daniel Van Loveren, Henk Vinceti, Marco Willatts, Peter Fewtrell, Mary Przyrembel, Hildegard Titz, Ariane Valtueña Martínez, Silvia |
| collection | PubMed |
| description | Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance for the preparation and presentation of applications for authorisation of infant and/or follow‐on formula manufactured from protein hydrolysates. This guidance document addresses the information and data to be submitted to EFSA on infant and follow‐on formulae manufactured from protein hydrolysates with respect to the safety and suitability of the specific formula and/or the formula's efficacy in reducing the risk of developing allergy to milk proteins. The guidance will be further reviewed and updated with the experience gained from the evaluation of specific applications for authorisation, and in the light of future Community guidelines and legislation. The NDA Panel endorsed a draft of this scientific opinion on 14 December 2016 for public consultation. The draft document has been revised and updated according to the comments received, where appropriate. |
| format | Online Article Text |
| id | pubmed-7010067 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2017 |
| publisher | John Wiley and Sons Inc. |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-70100672020-07-02 Scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates Turck, Dominique Bresson, Jean‐Louis Burlingame, Barbara Dean, Tara Fairweather‐Tait, Susan Heinonen, Marina Hirsch‐Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Neuhäuser‐Berthold, Monika Nowicka, Grażyna Pentieva, Kristina Sanz, Yolanda Sjödin, Anders Stern, Martin Tomé, Daniel Van Loveren, Henk Vinceti, Marco Willatts, Peter Fewtrell, Mary Przyrembel, Hildegard Titz, Ariane Valtueña Martínez, Silvia EFSA J Scientific Opinion Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance for the preparation and presentation of applications for authorisation of infant and/or follow‐on formula manufactured from protein hydrolysates. This guidance document addresses the information and data to be submitted to EFSA on infant and follow‐on formulae manufactured from protein hydrolysates with respect to the safety and suitability of the specific formula and/or the formula's efficacy in reducing the risk of developing allergy to milk proteins. The guidance will be further reviewed and updated with the experience gained from the evaluation of specific applications for authorisation, and in the light of future Community guidelines and legislation. The NDA Panel endorsed a draft of this scientific opinion on 14 December 2016 for public consultation. The draft document has been revised and updated according to the comments received, where appropriate. John Wiley and Sons Inc. 2017-05-11 /pmc/articles/PMC7010067/ /pubmed/32625485 http://dx.doi.org/10.2903/j.efsa.2017.4779 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 Turck, Dominique Bresson, Jean‐Louis Burlingame, Barbara Dean, Tara Fairweather‐Tait, Susan Heinonen, Marina Hirsch‐Ernst, Karen Ildico Mangelsdorf, Inge McArdle, Harry J Naska, Androniki Neuhäuser‐Berthold, Monika Nowicka, Grażyna Pentieva, Kristina Sanz, Yolanda Sjödin, Anders Stern, Martin Tomé, Daniel Van Loveren, Henk Vinceti, Marco Willatts, Peter Fewtrell, Mary Przyrembel, Hildegard Titz, Ariane Valtueña Martínez, Silvia Scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates |
| title | Scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates |
| title_full | Scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates |
| title_fullStr | Scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates |
| title_full_unstemmed | Scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates |
| title_short | Scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates |
| title_sort | scientific and technical guidance for the preparation and presentation of an application for authorisation of an infant and/or follow‐on formula manufactured from protein hydrolysates |
| topic | Scientific Opinion |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010067/ https://www.ncbi.nlm.nih.gov/pubmed/32625485 http://dx.doi.org/10.2903/j.efsa.2017.4779 |
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