Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2): (Guidance)
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Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2) : (Guidance). / EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA).
In: E F S A Journal, Vol. 15, No. 1, 4680, 31.01.2017.Research output: Contribution to journal › Journal article › Commissioned
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TY - JOUR
T1 - Scientific and technical guidance for the preparation and presentation of a health claim application (Revision 2)
T2 - (Guidance)
AU - Sjödin, Anders Mikael
AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
N1 - EFSA 2017 4680
PY - 2017/1/31
Y1 - 2017/1/31
N2 - 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 ofinformation 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.
AB - 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 ofinformation 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.
KW - Faculty of Science
KW - Health claims
KW - Food/constituent
KW - Substantiation
KW - Comprehensive review
KW - Human pertinent data
KW - Application
KW - Guidance
U2 - 10.2903/j.efsa.2017.4680
DO - 10.2903/j.efsa.2017.4680
M3 - Journal article
VL - 15
JO - E F S A Journal
JF - E F S A Journal
SN - 1831-4732
IS - 1
M1 - 4680
ER -
ID: 188400208