Scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim (revision 1)

The scientific and technical guidance of the EFSA Panel on Dietetic Products, Nutrition and Allergies for the preparation and presentation of an application for authorisation of a health claim 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 Article 14 (referring to children’s development and health, and to disease risk reduction claims), or 13(5) (which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data), or for the modification of an existing authorisation in accordance with Article 19 of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. 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.