Smoke flavouring application procedure
How to submit a dossier for scientific evaluation
At EFSA we assess the safety of any new smoke flavouring Ingredient added to foodstuffs to alter their flavour or odour before it can be placed on the EU market.
We also assess new proposed uses and modifications of the conditions of use or specification for smoke flavourings that have already undergone a full safety assessment and are authorised for use.
The administrative and scientific requirements of your application differ depending on which of these procedures you are applying for. In short, an application for a new smoke flavouring is more detailed while an application for renewal or modification requires 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
Getting started
EU legislation explains the overall process, the steps in the authorisation procedure, and subsequent marketing of the product.
Legislation
- Regulation EC 2065/2003 on smoke flavourings used or intended for use in or on foods
- Regulation EU 1321/2013 - establishes the Union List of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings
- EC practical guidance for applications - containing a check list, useful addresses, contact points and relevant documents (update in 2021)
For any question on the authorisation and the legislation, contact the SANTE-E2-FLAVOURINGS [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.
- Administrative guidance for the preparation of applications on smoke flavouring primary products (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 smoke flavouring application dossier. In brief, an application dossier should contain information on the identity of the smoke flavouring, its characterisation, conditions of use, proposed uses and its safety.
Scientific guidance
There is one scientific guidance document for smoke flavouring applications.
- Scientific Guidance for the preparation of applications on smoke flavourings primary products (published 2 March 2021)
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.
- Information for creating, submitting and managing study notifications is available in the EFSA Toolkit (see the user guide on pre-application ID and the user guide on notification of studies).
- Clarification on what studies to notify is available here.
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 that the scientific information you provide complies with the requirements described in the scientific guidance.
Specifying the toxicity The potential of a substance to cause harm to a living organism limits of your smoke flavouring is a necessary step in the scientific risk assessment. To do so, you should apply the benchmark dose (BMD) approach to your product.
We provide a tool to help you with this – the Benchmark Dose Modelling (BMDL) software, which is used to estimate the benchmark dose: a dose level, estimated from the dose-response relationship and associated with the benchmark dose response (BMR).
How does BMDL work? To understand it, please consult this manual document, which provides instructions and explanations for its use.
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 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 smoke flavouring application is complete when EFSA’s Panel on Food Additives and Flavourings (FAF) 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 food additive A substance deliberately added to foods or beverages for beneficial technological reasons (e.g. to preserve, flavour, colour or ensure a particular texture). Food additives are not normally consumed by themselves nor used as typical ingredients in food and for what purpose.
How to follow post-adoption
You can continue to follow your application on the ESFC.
If your smoke flavouring is authorised, it will be included in the list of authorised smoke flavourings, which will also specify the authorised conditions of its use.
- The EU Rules – European Commission
- The EU list of authorised smoke flavourings (primary products) – European Commission
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.