Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms: (Scientific Oplinion)

TY - JOUR

T1 - Guidance on the scientific requirements for health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms

T2 - (Scientific Oplinion)

AU - Sjödin, Anders Mikael

AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

N1 - EFSA 2016 4369

PY - 2016/1/1

Y1 - 2016/1/1

N2 - The European Food Safety Authority (EFSA) has asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to gut and immune function published in 2011. Since then, the NDA Panel has completed the evaluation of Article 13.1 claims except for claims put on hold by the European Commission, and has evaluated additional health claim applications submitted pursuant to Articles 13.5 and 14, which are in the area covered by this guidance. In addition, the NDA Panel has developed the general scientific guidance for stakeholders for health claims applications which addresses general issues that are common to all health claims. This guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms. Examples of claims evaluated favourably by the Panel will be used to provide guidance to applicants on the scientific requirements for the substantiation of health claims in specific areas, whereas examples of claims evaluated unfavourably by the Panel will be used to illustrate the shortcomings that prevented the substantiation of these claims. The general document represents the views of the NDA Panel based on the experience gained to date with theevaluation of health claims, and it may be further updated, as appropriate, in the light of experiences gained from the evaluation of additional health claim applications.

AB - The European Food Safety Authority (EFSA) has asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to gut and immune function published in 2011. Since then, the NDA Panel has completed the evaluation of Article 13.1 claims except for claims put on hold by the European Commission, and has evaluated additional health claim applications submitted pursuant to Articles 13.5 and 14, which are in the area covered by this guidance. In addition, the NDA Panel has developed the general scientific guidance for stakeholders for health claims applications which addresses general issues that are common to all health claims. This guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to the immune system, the gastrointestinal tract and defence against pathogenic microorganisms. Examples of claims evaluated favourably by the Panel will be used to provide guidance to applicants on the scientific requirements for the substantiation of health claims in specific areas, whereas examples of claims evaluated unfavourably by the Panel will be used to illustrate the shortcomings that prevented the substantiation of these claims. The general document represents the views of the NDA Panel based on the experience gained to date with theevaluation of health claims, and it may be further updated, as appropriate, in the light of experiences gained from the evaluation of additional health claim applications.

KW - Faculty of Science

KW - Health claims

KW - Immune system

KW - Gastrointestinal tract

KW - Pathogens

KW - Microorganisms

KW - Applications

KW - Guidance

U2 - 10.2903/j.efsa.2016.4369

DO - 10.2903/j.efsa.2016.4369

M3 - Journal article

SN - 1831-4732

VL - 14

JO - E F S A Journal

JF - E F S A Journal

IS - 1

M1 - 4369

ER -