Genetically modified organisms (GMOs) application procedure
How to submit a dossier for scientific evaluation
At EFSA we assess the safety of any new GMO A genetically modified organism (GMO) is an organism which contains genetic material that has been deliberately altered and which does not occur naturally through breeding or selection before it can be placed on the EU market.
We also assess modifications of the terms of the authorisation and applications for renewal of authorisation for GMOs 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.
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
Getting started
EU legislation explains the overall process, the steps in the authorisation procedure, and subsequent marketing of the product.
Legislation
- Regulation EC 1829/2003 on genetically modified food and feed
- Regulation EU 503/2013 on applications for authorisation of genetically modified food and feed
- EC overview of authorisation process for genetically modified organisms
- Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms
For any question on the authorisation and the legislation, please contact the sante-consult-e3 [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 in the course of 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 instead interested in submission of notifications for the deliberate release into the environment of genetically modified organisms, please refer to:
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 genetically modified plants (updated on 27 November 2025)
- Administrative guidance for the preparation of renewal applications on genetically modified food and feed (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 GMO application dossier. In brief, an application dossier for genetically modified organisms needs to contain information on the molecular characterisation, the comparative analysis, the food/feed and environmental safety, and its dietary exposure.
Scientific guidance
There are different scientific guidance documents for each type of genetically modified organism An organism which contains genetic material that has been deliberately altered and which does not occur naturally through breeding or selection application. For every application, you need to consult both the main guidance and the different documents about specific requirements.
Genetically Modified Plants
Main guidance document:
- Guidance on risk assessment of food and feed from GM plants (published 24 May 2011)
There are other guidance documents designed to help you with your application.
Molecular characterisation and food/feed safety
Molecular characterisation:
- Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
- Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation
- Risk assessment considerations for RNAi-based genetically modified plants
Food and feed safety:
- Explanatory statement for the applicability of the Guidance of the EFSA Scientific Committee on conducting repeated-dose 90-day oral toxicity study in rodents on whole food/feed for GMO risk assessment
- Guidance on allergenicity assessment of genetically modified plants
- Human dietary exposure assessment to newly expressed proteins in GM foods
- Animal dietary exposure in the risk assessment of feed derived from genetically modified plants
Comparative assessment Required in law, an assessment designed to compare the safety of a genetically modified (GM) organism against its non-GM bred counterpart:
- Guidance on the selection of comparators
- Guidance on the agronomic and phenotypic characterisation of genetically modified plants
- Explanatory note on the selection of forage material suitable for the risk assessment of GM feed of plant origin
Environmental Risk Assessment
- Environmental risk assessment of GM plants
- Explanatory note on DNA sequency similarity searches in the context of the assessment of horizontal gene transfer from plants to microorganisms
Post Market Monitoring
Genetically Modified Microorganisms
Main guidance document:
There is one more guidance document designed to help you with your application.
Molecular characterisation
- Guidance on the characterisation of microorganisms used as feed additives or as production organisms
In addition, EFSA’s statement on whole genome The entire amount of genetic material found in the cells of living organisms sequences (WGS) is relevant is relevant when preparing the scientific information to include in a GM microorganism dossier:
Genetically Modified Animals
There are two guidance documents that can help you in preparing an application for genetically modified animals.
- Risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects
- Guidance on the environmental risk assessment of genetically modified animals
Other GM-related
There are four additional guidance documents that are relevant when preparing an application for a genetically modified organism.
- Risk assessment of GM plants used for non-food or non-feed purposes
- Guidance for renewal applications of genetically modified food and feed authorised under Regulation (EC) 1829/2003
- Guidance for the risk assessment of the presence at low level of GM plant material in imported food and feed
- Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post-market environmental monitoring reports on GMOs authorised in the EU market
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 you provide scientific information in line with the requirements described in the scientific guidance.
Selecting the field trial Test conducted on crops to establish how much pesticide remains after normal farming practices and for how long pesticides and their residues persist in the crops. The test results are used to inform rules about permitted amounts of pesticide residues in foodstuffs sites and evaluating their representativeness is a necessary step in the scientific risk assessment.
We provide two tools to help you do this - the macro-enabled workbook “weather soil sites macro”, which is a template proposed for the submission of the meteorological and soil data, and the workbook “sowing dates macro” which compares the sowing/harvesting dates field trials with the sowing/harvesting periods typical for each location.
For more information you can consult this page.
Another necessary step for the scientific risk assessment is estimating the human 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 genetically modified organism.
We provide four excel files to help you do this – each excel file contains consumption statistics for each relevant crop and all derived food commodities.
For more information you can consult this page.
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 GMO application is complete when EFSA’s Panel on Genetically Modified Organisms (GMO) 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 genetically modified organism and for what purpose.
How to follow post-adoption
You can continue follow your application on the ESFC.
If your GMO is authorised, it will be included in the register of authorised genetically modified organisms.
- The EU rules on GMOs- European Commission
- The EU Food and Feed Information Portal Database, a tool to consult the genetically modified organisms authorised for use in the EU, based on the Community Register of GMOs - 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.