To apply for an authorisation of a GMO in GB:
- Use the regulated products application portal to complete the application. This is where you will be asked to upload all the documents to support your application, which will form your dossier.
- You should take into account the requirements in EU law as appropriate. The European Food Safety Authority (EFSA) has previously developed technical guidance on the requirements for application dossiers which is also applicable for dossiers submitted in GB. However, you should follow the parts that relate to the development of dossiers only and not the application process.
- As part of the application process, an evaluation of the analytical method supplied by the applicant must be undertaken by the reference laboratory. Regulation (EC) 1829/2003 establishes the reference laboratory and defines its tasks. At stage you should upload the documentation on the analytical method and any relevant information needed for the reference laboratory to undertake the evaluation of the method. If relevant, make reference to any evaluation which may have already been undertaken by the EU Reference Laboratory on the GMO in question.
- After receiving your application, we will contact you to agree and set out the process for payment of any fees due to be paid for the analytical assessment as laid down in the legislation. We will also provide details on how to send the three samples (and standards) where applicable to the reference laboratory.
Application requirements
In the “Uploads” folder within our application portal there are 3 subfolders:
1. Administrative dossier files
Applicants should upload letters and other correspondence related to the dossier.
2. Technical dossier files
Applicants should upload all technical files, including studies and data related to specific sections of the safety assessment to the corresponding sub-folder as detailed in the following:
Part 1 - General information
Part 2 - Scientific information
This folder contains the scientific information alongside a Table of Contents (TOC), the main text, studies and sequencing/bioinformatics files. It is divided into the following sub-folders for each section and applicants should provide the required data for each section in the corresponding sub-folder:
- Information relating to the recipient
- Molecular Characterisation (including sequencing files and bioinformatic analyses)
- Comparative Analysis
- Toxicology Assessment
- Allergenicity Assessment
- Nutritional Assessment
- Exposure assessment Anticipated intake extent of use
- Risk characterisation
- Post-Market monitoring PMM
- Environmental Risk Assessment
- Post-Market Environmental Monitoring Plan PMEM
- Additional information related to the safety
Applicants should upload any additional information useful for the assessment, also those relating to other regulators' assessments, including EFSA requests.
Part 3 – Cartagena protocol
Part 4 – Labelling proposal
Part 5 – Methods of detection, sampling and identification and reference material
Part 6 – Additional information to be provided for GM plants and/or food/feed containing or consisting of GM plants
Part 7 – Summary of applications
Part 8 – Administrative documents
3. Annexes files
This folder should contain:
- references
- appendices (not studies/not data files)
- any other files that do not fall within one of the named sections above