Nutrition and health claim applications

EFSA is responsible for verifying the scientific substantiation of health claims submitted for authorisation in the EU. This evaluation serves as a basis for the European Commission and Member States to decide whether to authorise the claims.

Frequently Asked Questions

1. I have submitted a health claim for evaluation by EFSA. How can I check the status of my application?
2. I am not sure if my claim requires authorisation. Who should I contact?
3. Is there an official list of all authorised health claims?
4. I am a new applicant. How do I prepare an application?
5. Are the requirements the same for all health claim evaluations?
6. What happens to my application when EFSA has received it?
7. How long does EFSA’s evaluation take?
8. Do I need to pay?
9. Does EFSA authorise health claims?
10. Short cuts for applicants

1.  I have submitted a health claim for evaluation by EFSA. How can I check the status of my application?

   All applications received by EFSA are given an Application Number and an EFSA Question Number (e.g. EFSA-Q-2009-12345) and are listed in the EFSA Register of Questions (ROQ), which describes the status and progress of EFSA’s scientific work. To find an application, click on the Question option in the top menu of the ROQ, then in the Question type field select ‘Application’ and select the relevant Food sector area (e.g. ‘Health claim Art. 14’). You can then search using key words or a Question Number if you know it. After locating your application, the ‘Status’ column indicates the present stage of the evaluation. When a question is ‘Finished’, an opinion has been adopted by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) and is scheduled for publication within a few days. When the opinion is published, it is available via the ‘View’ link. Further information: ROQ User Guide

   While EFSA is undertaking its evaluation, you can further monitor the progress of an application in the agendas and minutes of the Working Groups of the NDA Panel and of its plenary meetings .

2.  I am not sure if my claim requires authorisation. Who should I contact?

   If you have any questions related to whether a health claim requires authorisation or whether a specific claim is authorised for use, please contact the national competent authority of a Member State. If you have any further questions related to the authorisation of health claim, please contact: Unit E4 – Nutrition, Food Composition and Information, Directorate-General for Health and Consumers (DG SANCO), European Commission.

3.  Is there an official list of all authorised health claims?

   The European Commission has established and updates regularly a Union Register of nutrition and health claims which contains information on the status of all applications for which a decision on their authorisation or otherwise has been taken.

4.  I am a new applicant. How do I prepare an application?

   Applicants who wish to submit an application for authorisation of a health claim under Articles 13.5 or 14 of Regulation EC 1924/2006 or for modification of an existing authorisation should consult the guidance documents and complete the relevant application forms . Applications should be submitted to the national competent authority of a Member State. The competent authority passes the application and any supplementary information supplied by the applicant to EFSA, which carries out the scientific evaluation.

5.  Are the requirements the same for all health claim evaluations?

   Yes, but there are different types of health claim.

   ‘Function’ claims – this category, dealt with under Article 13 of Regulation EC 1924/2006, includes claims referring to the role of a nutrient or other substance in the growth, development and functions of the body, to psychological and behavioural functions, and to slimming or weight control. See more on Article 13.1 and Article 13.5 health claims and related guidances for applicants.

   Reduction of disease risk and child development or health – these claims are dealt with under Article 14 of Regulation 1924/2006. Reduction of disease risk claims are claims which refer to a significant reduction of a risk factor in the development of a human disease, such as: “Plant sterols have been shown to reduce cholesterol levels, a risk factor in the development of coronary heart disease.” See more on Article 14 health claims and related guidances for applicants.

6.  What happens to my application when EFSA has received it?

   Completeness check – Following receipt of a dossier, an acknowledgement letter is sent to the applicant and EFSA verifies that the dossier is complete. During this completeness check, the status of an application in EFSA’s Register of Questions (ROQ) is described as ‘Registration not yet completed’.

   Incomplete applications – Applicants should make every effort to include all information, data and full study reports as requested in the respective guidance documents, when they first submit their application. If information is missing or incomplete, EFSA will ask the applicant to provide the missing information and the status bar in the ROQ reads ‘Registration not yet completed’.

   Valid applications – If the application is complete, it is considered valid and EFSA’s Panel on Dietetic Products, Nutrition and Allergies can start its scientific assessment. The status of the question in the ROQ reads ‘in progress’.

7.  How long does EFSA’s evaluation take?

   The Panel on Dietetic Products, Nutrition and Allergies must endeavour to deliver its opinion within five months of the application being deemed complete and valid. This time limit may be extended during the evaluation process if EFSA requests the applicant to clarify certain aspects of the application or to provide additional information during the evaluation process. EFSA’s work ends with the publication of a scientific opinion and the status of the application in EFSA’s Register of Questions is described as ‘Finished’.

8.  Do I need to pay?

   No. Currently, EFSA does not charge a fee for its scientific evaluations. However, this practice is under review by the EU decision-makers.

9.  Does EFSA authorise claims?

   No. EFSA’s role is to evaluate the scientific basis for the claim. It passes on its evaluation to the European Commission in the form of a scientific opinion. It is up to the European Commission and the Member States to decide on the authorisation of the claim. Therefore, any questions related to the authorisation of claims or the permission of use of claims on the European market should be directed to one of the competent authorities of a Member State or the European Commission (see Question 2, above).

10.  Short cuts for applicants

    • Applications for health claims: guidance for applicants

    • Submission to competent authority of a Member State

    • Contact regarding scientific evaluation of regulated products: EFSA’s Applications helpdesk

    • Contact regarding authorisation: European Commission’s Directorate-General for Health and Consumers

Ask a question about applications

I have carefully checked both the administrative guidance and the technical guidance documents and I still have a question related to my application – what should I do?