Traditional foods notification and application procedure

EU legislation explains the overall process, the steps in the authorisation procedure, and subsequent marketing of the product.

Legislation

• Regulation EU 2015/2283 on novel foods
• Regulation EU 2017/2468 on administrative and scientific requirements for traditional foods applications
• Regulation EU 2017/2470 on establishing the Union list of novel foods
• EC overview of the authorisation process for traditional foods

For any question on the authorisation process or the legislation, please contact the SANTE-NOVELFOODS [at] ec.europa.eu (Commission).

If you are unsure about the status of your product, being a traditional or a novel food, you can also consult the EU Novel Food Status Catalogue, which is regularly updated by the European Commission. The Catalogue is a non-exhaustive list and serves as orientation whether a product requires authorisation under the Novel Food Regulation. If you are still unsure about the status of your product, contact a EU competent authority as explained on the Commission website.

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

Administrative guidance

EFSA administrative guidance documents describe in detail all the different phases of the notification and application life-cycle, from pre-submission to the conclusion of the evaluation. They specify the administrative requirements for preparing and submitting a notification and, where needed, an application and provide practical tips and tools to support this process.

• Administrative guidance for the preparation of notifications and applications on traditional foods from third countries in the context of Regulation (EU) 2015/2283 (updated on 27 November 2025)

N.B. We regularly update our administrative guidance documents to take account of new working practices. Please check that you use the latest version of these documents before applying!

Scientific guidance documents tell you what scientific data and other information you need to include in your traditional food notification or application dossier. In brief, a notification dossier needs to contain information on the identity of the traditional food, its proposed conditions of use, its history of use in third countries, and on its dietary exposure For the purposes of risk assessment, measurement of the amount of a substance consumed by a person or animal in their diet that is intentionally added or unintentionally present (e.g. a nutrient, additive or pesticide) levels. When needed, the follow-up application should in addition address the safety objections raised while assessing the notification.

Scientific guidance

There is one scientific guidance document for traditional foods applications.

• Guidance on the scientific requirements for a notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 (published 30 September 2024)

In addition, EFSA published a statement on whole genome The entire amount of genetic material found in the cells of living organisms sequences (WGS) which may be relevant when preparing the scientific information to include in a traditional food dossier:

• EFSA statement on the requirements for WGS analysis of microorganisms intentionally used in the food chain

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 notification or 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 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.

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 risk 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.

Calculating the exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time and the intake levels of your traditional food is a key step in the scientific risk assessment. EFSA has developed two tools to help you do this, each with slightly different features. They work based on the information on the target population Section of the healthy population defined by a specified age range and gender. Because of their particular physiological status, pregnant and lactating women are specific target populations and the proposed uses and use levels that you provide.

The first tool, the Food Additives Intake Model (FAIM) helps you to calculate the maximum levels (concentrations) of anticipated and combined intake, and to estimate the consumer exposure to substances of safety concern. It is freely accessible on our R4EU platform, where instructions for use are provided. Registration is required.

The second tool, Dietary Exposure (DietEx), uses the same food consumption data as FAIM, but the information is categorised according to EFSA’s FoodEx2 food classification system. This provides more refined food categories compared to those in the FAIM tool, which uses broader food categories.

The DietEx tool is also freely accessible, however, via a different platform. You can find more information and instructions for use here. Registration is required.

Please keep in mind that you need to use only one of the two tools when preparing a notification for traditional foods.

When your traditional food is plant based, you should provide the levels at which the constituents are present in the respective part of the botanical A substance, used either as a food or a medicine, derived from plants, fungi, algae or lichens (or botanical preparation). EFSA has developed two tools to help you do this.

The EFSA Compendium of Botanicals provides information on naturally occurring substances that may be of concern for human health.

A second tool, the EFSA Chemical Hazard Database (OpenFoodTox), can help you identifying the possible substances of concern in a botanical material.

For specific cases, please refer to the scientific guidance document when using these tools.

The submission process takes place completely online. Once you have created your notification and uploaded all the required information and documents in the ESFC e-submission system, your notification is ready for submission.

Once you’ve submitted your notification, the European Commission may ask EFSA and the Member States to check that the notification is complete and suitable for starting the safety evaluation. We share the outcome with the European Commission. The Commission 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 application is considered suitable, the Commission is informed and proceeds with its validation.

Once the scientific report is published, responsibility for your notification switches from EFSA to the European Commission. If no safety objections were raised, the Commission, together with EU Member States, decide whether to authorise your traditional food and for what purpose.

If duly reasoned safety objections were raised by EFSA or a Member State during the safety evaluation of your notification, you can submit an application to address the safety objections. ESFC allows you to proceed with the submission of the application starting from the refused notification, without reinserting the information already provided. You will have still the possibility to request advice to EFSA before submission, and the obligation to notify any additional study, if performed to support the application.

Once the application is submitted, the European Commission checks your application and may request information before sending it to EFSA. At EFSA we do a suitability check and share the outcome with the European Commission. The Commission 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 application is considered suitable, the Commission is informed and proceeds with its validation.

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 risk assessments.

If your application has all the necessary information, the assessment should take 6 months.

Important: Sometimes during an assessment, we may require additional information from you. This can happen for different reasons, for example, the studies provided did not allow a clear-cut conclusion about a possible health effect, or the quality of the studies may not have been high enough for the results to be considered reliable. When this happens, we stop the clock to allow you time to provide the additional information.

The scientific assessment of your traditional food application is complete when EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) 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.

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 traditional food and for what purpose.