GMO applications: frequently asked questions

EFSA provides scientific advice on the safety evaluation of genetically modified organisms (GMOs) and their use as food or feed and/or for cultivation. This includes GM plants, GM microorganisms and GM animals.

Frequently Asked Questions

1. I have submitted a GMO dossier for evaluation by EFSA. How can I check the status of my application?

All applications received and accepted by EFSA are given an application number and assigned an EFSA Question number (e.g. EFSA-Q-2009-12345) in the Register of Questions (ROQ) once the mandate is received from the European Commission. In the ROQ, applicants can monitor the status and progress of EFSA’s scientific work related to their applications. To find an application in the ROQ, click on the ‘Question’ option in the top menu of the ROQ, then in the ‘Question type’ field select ‘Application’ and select the relevant ‘Food sector area’ (there are four options for GMO applications). You can then search using key words or a Question number if you know it. After locating your application, the ‘Status’ column indicates the present stage of the evaluation. When a question is ‘Finished’, an opinion has been adopted by EFSA’s Panel on Genetically Modified Organisms (GMO) and is scheduled for publication within a few days. Once the opinion is published, it is available via the ‘View’ link. Further information: ROQ User Guide

While EFSA is undertaking its scientific evaluation, you can further monitor the progress of an application in the agendas and minutes of the three standing Working Groups of the Panel on Genetically Modified Organisms (Molecular Characterisation, Food and Feed and Environment) and of its plenary meetings.

2. I am not sure if my GMO requires authorisation. Who should I contact?

An overview of the authorisation process for GMOs can be found on the European Commission website. If you have any further questions related to the authorisation or renewal of authorisation of GMOs, please contact: Unit E1 – Biotechnology, European Commission’s Directorate-General for Health and Food Safety (DG SANTE), European Commission. EFSA’s topics on GMOs also contain relevant background information for GM plants, GM microorganisms and GM animals.

3. Is there an official list of all authorised GMOs?

The European Commission maintains a database – the EU register of genetically modified food and feed – which lists all authorised GM products established in accord with Regulation EC 1829/2003.

4. I am a new applicant. How do I prepare an application?

The application procedure is described in Regulation EC 1829/2003. In the first instance, applications should be submitted to the national competent authority of a Member State, which will forward your application to EFSA. The technical dossier of an application submitted under Regulation EC 1829/2003 must be compiled according to Commission Implementing Regulation EU No 503/2013 on applications for authorisation of genetically modified food and feed and to EFSA’s guidelines.

5. Are the requirements for applicants the same for all GMO evaluations?

No. The requirements for applicants differ depending on a number of factors, including a) whether the application concerns a GM micro-organism (GMM), a GM plant or a GM animal, b) whether the GMO contains a single event or stacked events, and c) on the type of species and the intended use of the GMO, determining the possible routes of exposure for humans, animals and the environment. All specific requirements for applicants can be found in the Commission Implementing Regulation EU No 503/2013 on applications for authorisation of genetically modified food and feed and in the relevant EFSA scientific guidance documents.

6. I am an applicant wanting to use data held in the European Food Consumption Database for an exposure assessment as part of my application. Where can I find these data?

EFSA provides summary statistics of human consumption data for food categories from certain crops of interest for GMO risk assessment. These data are designed to complement the exposure assessment in applications for authorisation of genetically modified plants. In using the data, it is strongly recommended that applicants follow the associated EFSA Guidance document. Both the available data and the associated Guidance document are accessible through the EFSA website.

7. What happens to my application when EFSA has received it?

Completeness check – Following receipt of an application, an acknowledgement letter is sent to the applicant and EFSA performs a check to verify its completeness. The completeness check is carried out within six weeks of receiving an official request by a Member State or the European Commission (in the case of an application for renewal) to perform the risk assessment for the GMO in question. EFSA verifies that the application submitted complies with Regulation EC 1829/2003 and EFSA’s administrative guidance (including the checklist for applicants). During this completeness check, the status of an application in EFSA’s Register of Questions (ROQ) is described as either ‘Registration not yet completed’ or ‘Under consideration’. Further information: ROQ User Guide

Incomplete applications – Applicants should make every effort to include all information, data and full study reports as requested in the respective guidance documents, when they first submit their application. If information is missing or incomplete, the applicant is asked to provide the missing information and the status bar in the ROQ reads ‘Waiting for full dossier’.

Valid applications – If the application is complete, it is considered valid and EFSA can start its scientific assessment, which is done by its Panel on Genetically Modified Organisms (GMO). The status in the ROQ then changes to ‘In progress’.

8. How does EFSA assess an application?

EFSA assesses an application according to the scientific guidance documents of EFSA’s Panel on Genetically Modified Organisms (GMO) and in line with Regulation EC 1829/2003 and Commission Implementing Regulation EU 503/2013. The guidance documents describe the data requirements for applicants as well as the principles and approaches used by the GMO Panel in the evaluation of the risk assessment. In addition to assessing all information provided by the applicant, the GMO Panel also takes into account relevant scientific literature, bio-safety research results and knowledge gained from previous GMO risk assessments carried out in Europe or elsewhere in the world.

9. How long does EFSA’s evaluation take?

EFSA’s Panel on Genetically Modified Organisms must endeavor to adopt an opinion within a six-month deadline from the point at which an applicant’s dossier is considered valid (i.e. after the completeness check. See also Question 7, above). This time limit can be extended during the evaluation process if EFSA requests additional information from the applicant. EFSA’s work ends with the publication of a scientific opinion and the status of the application in EFSA’s Register of Questions is described as ‘Finished’. The European Commission is then required to prepare a draft Regulation to grant market authorisation within three months of receipt of EFSA’s opinion. The decision about whether or not to adopt the draft Regulation is taken by the European Commission’s Standing Committee on Plants, Animals, Food and Feed.

10. Do I need to pay?

The only cost associated with the authorisation process for GMOs is the contribution requested by the European Union Reference Laboratory according to Article 32 of Regulation EC 1829/2003. Currently, EFSA does not charge a fee for its scientific evaluations. However, this practice is under review by the EU decision-makers.

11. Does EFSA authorise GMOs?

No. The authorisation of these materials is not within EFSA’s remit. In the European food safety system, scientific risk assessment (the responsibility of EFSA) is done independently from risk management, which includes market authorisation. EFSA’s scientific advice is available in the adopted scientific opinions of the Panel on Genetically Modified Organisms. The decision about whether or not to authorise the GMO is taken by the European Commission’s Standing Committee on Plants, Animals, Food and Feed.

If you require further information on the authorisation of GMOs, please contact: Unit E1 – Biotechnology, European Commission’s Directorate-General for Health and Food Safety (DG SANTE), European Commission.

12. Short cuts for applicants