EFSA Journal,
Vol. 15 nº 1 (2017) doi: 10.2903/j.efsa.2017.4680.
Abstract
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.
Keywords: health claims, food/constituent, substantiation, comprehensive
review, human pertinent data, application, guidance
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