How to apply
Applications are made via our online application portal, where you can upload all the required information. Once your application has been submitted you will receive an email with your case reference number and a secure link where you can view your application and case history.
General advice on submitting an application
When applying for a regulated product authorisation you will have to supply administrative, technical and safety information. This information will form your application dossier.
The dossier requirements and structure are specific to each product type. You must read and follow the detailed guidance for the regime your product falls under and submit the required data and information specified in the relevant guidance.
Some new products, particularly those produced by genetic modification, may require applications under more than one regime. If this might be relevant to your product, you are strongly advised to contact the FSA at regulatedproducts@food.gov.uk before starting an application.
FSS’ regime specific guidance links to parts of the technical guidance produced by EFSA where it remains relevant.
As detailed in FSS’ regime specific guidance, you should follow the parts of the EFSA guidance that relate to the development of dossiers only (not the application process).
What is needed for an application
An application consists of two parts:
1. Administrative information
We will need to know:
- who is applying for the authorisation.
- who is responsible for the product or process.
- who we should contact if we have any questions.
It is also helpful to know the application’s status in the EU, if it has been submitted there.
Applicants must provide up-to-date details to FSS for correspondence. Failure to do so may result in the application(s) being deemed invalid.
2. Technical and safety information
The dossier needs to contain all the information requested within the applicable regime regulations and guidance. Failure to submit all the necessary information may result in the application being delayed and/or deemed invalid or refused.
The application portal includes a checklist to ensure your dossier is complete when you submit it.
You should not submit your application until you have uploaded all supporting information to the online application portal.
We need this information to understand more about the product or process and how it is intended to be used. This will allow us to carry out a thorough risk analysis, where appropriate, to verify whether the product or process can be used safely to inform the decision on whether the application will be authorised.
You should include all relevant data, whether the results are supportive of the product or not, to demonstrate that you understand the risks and have identified how these can be managed. You should clearly list all the data provided and explain how it supports the application.
You should also tell us what information in the application you would like to be kept confidential, in line with the criteria set out in FSS’ regime-specific guidance. Copies of all references and a table of references should be provided, which should clearly indicate which files or parts of files are regarded as confidential and for which a data protection request has been made.
Please note, our working language is English. Dossiers can be accepted in English and Welsh. Any documents, including supporting documents such as annexes or references that are in other languages must be translated and the translation provided with the submission.