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Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3)
[Table: see text] Upon request from the European Commission, the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim initially published in 2007 and subsequently revised in 2011 and 2016 has been updated. This guidance document...
Formato: | Online Artículo Texto |
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Lenguaje: | English |
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John Wiley and Sons Inc.
2021
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996105/ https://www.ncbi.nlm.nih.gov/pubmed/33791038 http://dx.doi.org/10.2903/j.efsa.2021.6554 |
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collection | PubMed |
description | [Table: see text] Upon request from the European Commission, the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim initially published in 2007 and subsequently revised in 2011 and 2016 has been updated. This guidance document presents a common format for the organisation of information for the preparation of a well‐structured application for authorisation of health claims which fall under Articles 13(5), 14, and 19 of Regulation (EC) No 1924/2006. This guidance outlines: the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, and the key issues which should be addressed in the application to substantiate the health claim. This guidance has been revised in 2020 to inform applicants of new provisions in the pre‐submission phase and in the application procedure set out in Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain, that are applicable to all applications submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021. |
format | Online Article Text |
id | pubmed-7996105 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-79961052021-03-30 Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3) EFSA J Guidance [Table: see text] Upon request from the European Commission, the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim initially published in 2007 and subsequently revised in 2011 and 2016 has been updated. This guidance document presents a common format for the organisation of information for the preparation of a well‐structured application for authorisation of health claims which fall under Articles 13(5), 14, and 19 of Regulation (EC) No 1924/2006. This guidance outlines: the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, and the key issues which should be addressed in the application to substantiate the health claim. This guidance has been revised in 2020 to inform applicants of new provisions in the pre‐submission phase and in the application procedure set out in Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain, that are applicable to all applications submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021. John Wiley and Sons Inc. 2021-03-26 /pmc/articles/PMC7996105/ /pubmed/33791038 http://dx.doi.org/10.2903/j.efsa.2021.6554 Text en © 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the http://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 | Guidance Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3) |
title | Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3)
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title_full | Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3)
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title_fullStr | Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3)
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title_full_unstemmed | Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3)
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title_short | Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 3)
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title_sort | scientific and technical guidance for the preparation and presentation of a health claim application (revision 3) |
topic | Guidance |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996105/ https://www.ncbi.nlm.nih.gov/pubmed/33791038 http://dx.doi.org/10.2903/j.efsa.2021.6554 |
work_keys_str_mv | AT scientificandtechnicalguidanceforthepreparationandpresentationofahealthclaimapplicationrevision3 |