EU Exit: Requirements for regulated product applications from 1 January 2021
Advice on the information that you'll need to submit as part of your regulated product authorisation application
Information you'll need to supply
When applying for authorisation of a regulated product in the UK, you will have to supply administrative, technical and safety information as part of your application.
The information you will need to supply will be the same as is currently required by the European Food Safety Authority (EFSA) and the European Commission (EC).
The requirements for each type of authorisation are set out in law and cover 3 areas.
The Food Standards Agency (FSA) will need to know:
- who is applying for the authorisation
- who is responsible for the product or process
- who they should contact if they have any questions
This may include details about which information you'd like the FSA to treat as confidential.
This is information the FSA will need to understand more about the product or the process and how it is intended to be used. This may also include data for the FSA risk management team to assess whether all the criteria for authorisation have been met.
You should provide scientific data and analysis in the form of a dossier. This will allow the FSA to carry out a thorough risk assessment, where appropriate, to ensure the product or process can be used safely.
There may be some occasions when the required information or studies may not be relevant for your application. In these circumstances you should provide clear justification for not submitting this information.
To help you develop your application, the FSA has listed on their website guidance from EFSA and the European Commission based on the different product types. This guidance will remain relevant as their approach is based on EU processes. It's important that you follow this guidance so that your application can be processed as efficiently as possible.
Where the links in this guidance are to EU regulations, these will become UK retained law, but you should follow the parts that relate to the development of dossiers and not the application process.
How long will my application take?
The law includes deadlines for key steps in the process. In most cases, applications will take a minimum of one year.
The quality of the dossier, and the information provided, will significantly affect the time needed for assessment and authorisation. The FSA encourage applicants to follow the guidance and provide as much information as possible to ensure they can process your request as efficiently as possible.
First published 23 September 2020