Food allergen labelling exemption application procedure

How to submit a dossier for scientific evaluation

The EU has established labelling rules for certain substances or products causing allergies or intolerances, when used in the production of foodstuffs.

At EFSA we assess requests for an exemption from the mandatory labelling of products derived from known food allergens.

Below you can follow our step-by-step guide to the application process. It includes four main phases: pre-submission, submission and completeness check, 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 – Exemption from labelling of Food Allergens

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, 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.

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.

There is no specific administrative guidance document for applications for exemption from labelling of food allergens. You can get familiar with the general principles of the application procedure by consulting the general administrative guidance for all applications for regulated products.

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 application dossier. In brief, an application dossier needs to contain information on the food allergen A normally harmless substance, such as an ingredient in a foodstuff, that causes an (immediate) allergic reaction in a susceptible person-derived product and its characteristics, its conditions of use and 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 data, and information on its residual allergenicity The ability to trigger an abnormal immune response that leads to an allergic reaction in a person under the proposed conditions of use.

Scientific guidance

There is one scientific guidance document for applications for an exemption from labelling of food allergen-derived products.

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 completeness 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.

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.

Once you’ve submitted your application, at EFSA we do a completeness check. 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 completeness check is over, we proceed with the validation of the application.

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 up to 12 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 application is complete when EFSA’s 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 the exemption from labelling of the food allergen-derived product.

How to follow post-adoption

You can continue to follow your application on the ESFC.

Substances or products that are causing allergies or intolerances are listed in Annex II of Regulation EU 1169/2011.

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 completeness 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.