EFSA has launched an open consultation on its draft scientific and technical guidance for the preparation and presentation of a health claim application.
This 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 (reflecting the relative strength of evidence which may be obtained from different types of studies) and the key issues which should be addressed in the application to substantiate the health claim.
In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and stakeholders, EFSA has launched a public consultation on the draft document developed by the NDA Panel of EFSA.
Deadline for comments: 12 September 2016.
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