Health claim application procedure

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How to submit a dossier for scientific evaluation

At EFSA we assess the scientific basis (i.e. substantiation) of any new health claim Any practice (e.g. a statement or visual) used in food marketing to suggest that health benefits can be gained from consuming a given food, nutrient or ingredient before it can be made to consumers in commercial communications in the labelling, presentation or advertising of foods on the EU market.

We also assess proposed modifications of health claims that have already undergone a full assessment and are authorised.

Below you can follow our step-by-step guide to the application process. It includes four main phases: pre-submission, submission and validity check, scientific assessment, and post-adoption. You need to use different documents and tools during each phase to move the process forward.

A useful overview of the application process

Application procedure – Health Claims

This diagram gives you an overview of the process and indicates the tools you need to use at each stage. Each step is essential to move your application forward.

Check the diagram (PDF)

Getting started

EU legislation explains the overall process, the steps in the authorisation procedure, and subsequent commercial use of health claims made about food on the EU market.

Legislation

For any question on the authorisation and the legislation, please contact the sante-consult-e1 [at] ec.europa.eu (European Commission).

Please be aware that we are required by law to make the non-confidential version of your application publicly available during the application process and to hold a public consultation. Consult this page for information on how to request confidentiality for specific information in your application.

Scientific guidance documents tell you what scientific data and other information you need to include in your health claim application dossier. In brief, an application dossier needs to contain information on the type of health claim you wish to apply for, characterisation of the food/constituent, relevance of the claimed effect to human health, human efficacy How well something works in relation to predefined standards or expectations studies to support the claim, and on the claim’s biological plausibility.

Scientific guidance

There is a technical guidance document which provides information on how to prepare and submit your application, and a general scientific guidance document explaining the steps of the application procedure and data requirements, that applies to every type of health claim:

In addition, there are different scientific guidance documents to consult, based on what the health claim relates to:

N.B. We sometimes update our scientific guidance documents to take account of new science, tools and working practices. Please check that you use the latest version of these documents before applying!

We strive for a customer-oriented approach and provide a range of support services, which are available to you throughout the application process – from pre-submission to post-adoption:

  • Services to applicants – from pre-submission advice and responses to queries and clarification teleconferences at various stages of the application process.
  • SME support services – in addition to the services for all applicants, we offer a range of services dedicated to Small and Medium-sized Enterprises (SMEs) preparing and submitting applications, including fast-tracking of advice, support using IT tools, and teleconferences at various stages of the application process.
  • Frequently Asked Questions – to clarify any doubts about the applicable procedure.

1. Pre-submission

What do I need to do first? Register in our systems, request advice and notify studies.

You need to register on our platform to access our support and start getting ready to submit your application.

  • Connect.EFSA – this platform is where you obtain a pre-application identification number, notify the studies you plan to include in your submission, and access pre-submission advice along with tailored information. It also offers opportunities for further engagement in later phases. You can register by following this quick guide.

Notifying studies to EFSA - before they start

Studies submitted in support of an application that were commissioned or carried out after 27/03/2021 must be notified to EFSA using the Connect.EFSA portal, before the study starts.

Request general pre-submission advice

From the early stages of your application, we strongly recommend requesting pre-submission advice to clarify any doubts you may have regarding the requirements and content of your future application.

2. Submission and validity check

You need to register on another platform to prepare your application for submission.

  • E-submission Food Chain platform (ESFC) – this platform is where you submit your application dossier with all the required scientific evidence. It also allows you to interact with us as needed – for example to request deadline extensions or withdraw an application or monitor progress once the scientific assessment starts. You can register by creating an EU login.
  • Follow the steps described in the administrative guidance and ensure you provide scientific information in line with the requirements described in the scientific guidance.

The submission process takes place entirely online. Once you have created your application and uploaded all the required information and documents in the ESFC e-submission system, your application is ready for submission. The application is submitted to the competent authority of an EU Member State of your choice. You can consult the list of competent authorities at this link.

Once you’ve submitted your application, the Member State performs the validity check and requests for additional information in case is needed. Once the application is considered complete, it is forwarded to EFSA, where we check to ensure that no confidential data are disclosed and compliance with intellectual property rights, and share the outcome with the European Commission. We may contact you via the ESFC to request further information if anything is missing or incorrectly submitted. This may also include additional information needed in relation to confidentiality and sanitisation.

When the validity check is over and after EFSA’s check, the Member State proceeds with the validation of the application.

3. Scientific assessment

What happens after I’ve submitted a valid application? Monitor progress & provide additional information if requested.

After the application is validated, our scientists will assess your application. During this phase, we hold a public consultation on the non-confidential version of the application dossier through Connect.EFSA.

You can monitor the progress of your application using the ESFC. It is also visible on our Open.EFSA Portal, a publicly available platform where users can follow the life cycle of all our ongoing and completed scientific activities.

If your application has all the necessary information, the assessment should take 5 months.

Important: Sometimes during an assessment we require additional information from you. This can happen for different reasons, for example, the claimed effect is not clear or not well defined, or additional details are needed on the studies submitted. When this happens, we stop the clock to allow you time to provide the additional information.

The scientific assessment of your health claim application is complete when EFSA’s expert Nutrition, Novel Foods and Food Allergens (NDA) Panel adopts a scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment which describes their assessment and conclusions.

4. Post-adoption

What happens following adoption? Publication of a scientific opinion & possible authorisation by risk managers.

Publication follows adoption but usually takes a few weeks as we carry out editorial checks and adapt the document to the scientific publishing platform used for the EFSA Journal.

Once the scientific opinion is adopted, responsibility for your application switches from EFSA to the European Commission. The Commission, together with EU Member States, decides whether to authorise your health claim and for what purpose.

How to follow post-adoption

You can continue to follow your application on the ESFC.

If your health claim will be authorised, it will be included in the register of authorised health claims which will also specify the authorised conditions of use.

Application jargon explained

When you submit an application, you will find it useful to understand the jargon used to explain certain procedural aspects. These are explained in our administrative guidance. Some common examples follow:

“Notification of study”: the process of submitting a notification of the studies which will support your application. Studies must be notified in Connect.EFSA before they are conducted.

“Request for information”: when reviewing your application during the check carried out by EFSA, we might request information to complete your submission.

“Additional data request”: during the scientific assessment phase, EFSA may request additional information to complete the assessment of your application.

“Clock-stop”: term used when EFSA requests additional information during the scientific assessment phase. The deadline for delivering EFSA’s opinion is put on hold until you submit the requested information.