Food enzyme application procedure
How to submit a dossier for scientific evaluation
At EFSA we assess the safety of any new food enzyme A protein which stimulates or hastens a specific reaction in the body; for example, digestive enzymes help to break down food into nutrients 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 food enzymes that have already undergone a full safety assessment and are among the authorised food enzymes.
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 enzyme is more detailed while a proposed new use 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 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings
- Regulation EC 1332/2008 on food enzymes – covers the EU list of approved food enzymes, labelling requirements and procedural aspects.
- EC practical guidance for applications containing a check list, useful addresses, contact points and relevant documents (updated in 2021)
For any question on the authorisation and the legislation, contact the SANTE-E2-ENZYMES [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 food improvement agents (food enzymes, food additives and food flavourings) (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 food enzyme application dossier. In brief, an application dossier needs to contain information on the identity of the enzyme, its characterisation and conditions of use, information about genetic modification (if applicable) and on the safety for animals, users and the environment.
Scientific guidance
There are two scientific guidance documents for food enzyme applications. They complement each other so you should consult them in parallel when preparing a dossier for your food enzyme.
- Scientific Guidance for the submission of dossiers on food enzymes (updated on 26 July 2023)
- Scientific Guidance for the submission of food manufacturing processes and technical data used in the exposure assessment of food enzymes (published on 25 July 2023)
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 is relevant when preparing the scientific information to include in a food enzyme 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 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 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.
Estimating 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) to your food enzyme is a necessary step in the scientific risk assessment.
We provide a tool to help you do this - the Food Enzyme Intake Model (FEIM) estimates chronic dietary exposure to food enzymes used in food manufacturing processes to produce food or food ingredients.
How does FEIM work? It is freely accessible on our R4EU platform where instructions for use are provided. Registration is required.
There are also some 40 FEIM Calculators, each designed to calculate dietary exposure from a specific manufacturing process.
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 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 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 food enzyme application is complete when EFSA’s expert Panel on Food Enzymes 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 enzyme and for what purpose.
How to follow post-adoption
You can continue to follow your application on the ESFC.
There is currently no EU list of authorised food enzymes. One will be established once the evaluations are finalised. For the time being, the placing on the market and the use of food enzymes and of food produced with food enzymes are subject to national legislation.
- The EU Rules on enzymes marketing – European Commission
- The EU lists and Applications – 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 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.