Authorisation requirements and what you need to submit as part of your application
Enzymes are present in microorganisms, plants and animals and act as catalysts in various chemical reactions. This means that they increase the rate of the reactions. Because of this they can be useful in the production of food or certain food ingredients (i.e. flavourings), achieving increased yields or more efficient production processes.
Food enzymes are mainly used in:
The law on the common authorisation process for food additives, food enzymes and food flavourings in Regulation (EC) 1331/2008 and Regulation (EC) 234/2011 outline the authorisation procedure for these substances as regulated products. This requires the FSS to maintain a register of that accurately represents the authorisation status of these products as determined by the appropriate authority (ministers) in Scotland, England and Wales.
The domestic list for food enzymes is not yet established. Until the list is in place, enzymes may continue to be used in food if they meet the requirements of the following law:
However, if an enzyme use falls within the scope of food additives or novel food legislation it will need to be approved before it can be used, if it is not already permitted under the relevant legislation.
Once the list is established, new food enzymes will need to be authorised to be placed on the market in Great Britain (GB).
We will publish a call for applications setting the deadline for submission of food enzyme applications. After this date, all valid applications will be evaluated and considered for inclusion on the initial list.
We can accept applications before the call is published, however they may not be evaluated immediately.
To apply for an authorisation of a food enzyme in GB, use the regulated products application portal. 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.
Your enzyme authorisation application will need to consist of:
If you want some parts of the dossier to be treated as confidential, your application will need to include also:
The application requirements are set out in law:
Guidance on the submission of a dossier on food enzymes has also previously been developed by the European Food Safety Authority (EFSA). This guidance remains relevant as our approach is based on EU processes. You should follow the parts that relate to the development of dossiers only and not the application process.
If you have any questions about the authorisation procedure or process, please contact regulatedproducts@food.gov.uk.
You can now use our online service to make a regulated product application.
