Open AccessScientific and technical guidance for the preparation and presentation of a health claim application (Revision 2)
Author(s) -
Turck Dominique,
Bresson JeanLouis,
Burlingame Barbara,
Dean Tara,
FairweatherTait Susan,
Hein Marina,
HirschErnst Karen Ildico,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
NeuhäuserBerthold Monika,
Nowicka Grażyna,
Pentieva Kristina,
Sanz Yolanda,
Sjödin Anders,
Stern Martin,
Tomé Daniel,
Van Loveren Henk,
Vinceti Marco,
Willatts Peter,
Martin Ambroise,
Strain John Joseph,
Heng Leng,
Valtueña Martínez Silvia,
Siani Alfonso
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.4680
Subject(s) - library science , presentation (obstetrics) , stern , medicine , history , computer science , radiology , ancient history
EFSA asked the Panel on Dietetic Products, Nutrition and Allergies ( NDA ) to update the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim published in 2011. Since then, the NDA Panel has gained considerable experience in the evaluation of health claims. Lessons learnt from these experiences have been translated into a new General scientific guidance for stakeholders on health claim applications (published in January 2016). In this context, it is noted the need to adapt the existing guidance to the new scientific and technical developments in this area. 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.