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?
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
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 E1 – Food information and composition, food waste, European Commission’s Directorate-General for Health and Food Safety (DG SANTE)
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. Does EFSA perform a safety assessment as part of its evaluation of health claims made on foods?
The Scientific Opinions of the EFSA NDA Panel relate solely to the scientific substantiation of health claims submitted for authorisation in the EU. They do not constitute an assessment of the safety of the food/constituent for which a health claim is made. The safety assessment of food/constituent might be required by legal frameworks other than the one for health claims.
6. 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.
7. 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’.
8. 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’.
9. 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.
10. Does EFSA authorise health 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, in the context of the decision making process foreseen in articles 23 and 25 of Regulation EC 1924/2006, on its authorisation, permission of use, and establishment of conditions of use. Therefore, any questions related to the authorisation of health 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). These bodies also deal with administrative or other authorisation-related issues, such as import requirements, information on specific brands or products, labelling of foods and food ingredients. The control and enforcement of the correct implementation of the authorised claims is responsibility of the competent authorities in each Member State.
11. What is a nutrition claim and what is EFSA’s role in assessing nutrition claims?
A nutrition claim states or suggests that a food has particular beneficial nutritional properties. Examples include “low fat”, “source of omega-3 fatty acids” or “high in fibre”.
On the basis of Article 8 of Regulation EC 1924/2006, nutrition claims are only permitted if they are listed in the Annex of that Regulation.
Unlike health claims, nutrition claims cannot be the subject of an application for authorisation.
12. What is the regulatory and procedural framework for novel foods?
Current rules are laid out in Regulation EC 258/1997 which harmonised the authorisation of novel foods and food ingredients in the European Union.
In November 2015, the European Parliament and the Council have agreed on new procedures for novel foods and traditional foods by adopting Regulation EU 2015/2283. The revised rules increase the efficiency of the authorisation process by creating a centralised authorisation system.
Under the new regulation an applicant who intends to place on the EU market a novel food submits an application to the European Commission. The Commission makes this application available to the Member States and may request EFSA for a scientific assessment. EFSA has nine months to adopt an opinion (Article 10).
A different procedure is available in the same Regulation EU 2015/2283 for applicants who intend to place on the EU market a traditional food from a third country. In this case, the applicant submits a notification to the European Commission (Article 14). The Commission forwards the notification to the Member States and to EFSA. Should either a Member State or EFSA raise any objection to the introduction of the traditional food, the applicant has the possibility to submit an application to the Commission addressing the safety objections raised (Article 16). The Commission will forward the application to EFSA who will issue an opinion within 6 months from receipt of the valid application (Article 17).
Taking into account the EFSA assessment, the Commission eventually puts forward a proposal on the authorisation of a novel food or traditional food.
The new rules under Regulation EU 2015/2283 apply as of 1 January 2018. In the meantime, rules as laid out in Regulation EC 258/1997 remain valid.
If you have any further questions related to the authorisation of novel and traditional foods, please contact: Unit E2 – Food processing, technologies and novel foods, European Commission’s Directorate-General for Health and Food Safety (DG SANTE).
13. Short cuts for applicants
- Applications for health claims: guidance for applicants
- Submission to competent authority of a Member State
- Contact regarding authorisation: Unit E1 – Nutrition, Food Composition and Information and Unit E2 Food processing, technologies and novel foods, European Commission’s Directorate-General for Health and Food Safety (DG SANTE)