Extraction solvents authorisation guidance
Extraction solvents authorisation requirements and what you need to submit as part of your application.
Extraction solvents are used in food processing to help dissolve and separate parts of a food. For example certain extraction solvents can be used to remove caffeine in coffee and tea to help produce decaffeinated versions. The extraction solvent is removed before the resulting food or ingredient is used, but technically unavoidable residues or derivatives may remain. This is why it is important to ensure that extraction solvents are safe.
Extraction solvents need to be authorised before they can be placed on the market in Great Britain (GB). Only ‘permitted extraction solvents’, as defined in The Food Additives, Flavourings, Enzymes and Extraction Solvents Regulations 2013, can be used in the production of food and placed on the market.
The domestic legislation governing the use of extraction solvents in Scotland is The Food Additives, Flavourings, Enzymes and Extraction Solvents (Scotland) Regulations 2013.
To apply for an authorisation of a new extraction solvent in GB use our regulated products application service. This is where you will be asked to upload all the documents to support your application, which will form your dossier. There is no fee for the application.
There is no specific guidance for extraction solvents applications. However, you may find it helpful to follow the guidance for food additives as appropriate.
Your application should explain the technological need for the new extraction solvent, including the reason for setting a maximum residual level at a certain level. You also need to demonstrate that the new extraction solvent or its use would not be of safety concern.
If you submitted an extraction solvent application to the European Union (EU) before 1 January 2021 and the assessment process for this application has not been completed, you will need to re-submit your application to us, using our regulated products application service. When completing the application, you will be asked to provide your European Food Safety Authority (EFSA) question number.
If your product or process was authorised by the European Commission (EC) before 1 January 2021 and the necessary legislation is in place, that authorisation will remain valid in GB.
How long will my application take?
In most cases, applications will take at least a year.
The quality of the dossier, and the information provided, will significantly affect the time needed for assessment and authorisation. We encourage applicants to follow the guidance and provide as much information as possible to ensure we can process your request as efficiently as possible.
If you have any questions about the authorisation procedure or process, you can contact us at email@example.com
Apply for authorisation
You can now use our online service to make a regulated product application.
Published: 29 December 2020
Last updated: 22 June 2023