Guidance for applicants on health claims

EFSA engages regularly with stakeholders to explain the process followed by its Panel on Dietetic Products, Nutrition and Allergies (NDA) in the evaluation of health claims. The NDA Panel has been providing advice in this field since 2006 through guidance documents and by holding scientific meetings.

Applicants who wish to submit an application for authorisation of a health claim under Article 13.5 or 14 of Regulation (EC) No 1924/2006 or for modification of an existing authorisation should consult the NDA Panel guidance documents and complete the relevant application forms below.

Guidance documents:

Scientific and technical guidance

The scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim was adopted by the NDA Panel in 2007. It was subject to public consultation and was the subject of discussion at a technical meeting with EFSA’s Stakeholder Consultative Platform. The guidance was revised in May 2011 to simplify the presentation of an application (updated sections: Parts 1-4 and the Appendices).

General guidance

The general guidance covering the principles applied by the NDA Panel in the evaluation of health claims was adopted in March 2011. This document was also the subject of a public consultation and discussed at stakeholder meetings. A report on the outcome of the public consultation has been published.

Additional specific guidance

The NDA Panel is committed to providing further guidance on the substantiation of health claims in specific areas. In 2011 it adopted guidance on the scientific requirements for health claims related to gut and immune function, and those related to antioxidants, oxidative damage and cardiovascular health. In 2012 it has adopted guidance on the scientific requirements for health claims related to: appetite ratings, weight management and blood glucose concentrations; bone, joints, skin and oral health; physical performance; and functions of the nervous system, including psychological functions.

EFSA is in constant dialogue with stakeholders to further explain how it carries out its work and to provide applicants with more detailed information on the preparation of applications. The Authority has held public consultations on all the additional guidance documents.

Further information

List of competent authorities of the Member States within the framework of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (0.1 Mb)