Novel food application procedure

How to submit a dossier for scientific evaluation

At EFSA we assess the safety of any new novel food Foodstuff or food ingredient that was not used for human consumption to a significant degree within the European Union before 15 May 1997 before it can be placed on the EU market.

We also assess modifications of the authorisation for novel foods that have already undergone a full safety assessment and are authorised for use.

The administrative and scientific requirements of your application differ depending which of these procedures you need to apply for. In short, an application for a new novel food is more detailed while an application for modification may require less scientific information.

Below you can follow our step-by-step guide to the application process. It includes four main phases: pre-submission, submission, risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation, 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 – Novel Foods

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 marketing of the product.

Legislation

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

If you are unsure about the status of your product, being a novel food or not, you can 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 on 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.

If you are using an enzyme in the manufacturing process of your novel food, the enzyme should either be authorised, under assessment by EFSA or already assessed with a positive outcome. If none of these applies, please consult the European Commission for information on how to proceed.

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.

If you are still unsure about the status of your product, the authorisation process or the legislation, please check the Commission website or contact the Commission directly. (link to website and to email address.)

Administrative guidance

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

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 novel food application dossier.

Scientific guidance

There is one scientific guidance document for novel foods applications.

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

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

2. Submission and suitability 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 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 novel 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 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) (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 an application for authorisation of novel foods.

Please refer to the scientific guidance documents when using these tools.

The submission process takes place completely 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.

Once you’ve submitted your application, 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.

3. Risk 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 risk assessments.

If your application has all the necessary information, the assessment should take 9 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 novel 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.

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 novel food and for what purpose.

How to follow post-adoption

You can continue to follow your application on the ESFC.

If your novel food is authorised, it will be included in the list of authorised novel foods which will also specify the authorised conditions of its 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 checking the suitability of your application, EFSA might request missing information to complete your submission.

“Additional data request”: during the risk 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 risk assessment phase. The deadline for delivering EFSA’s opinion is put on hold until you submit the requested information.