• Business guidance

Guidance for regulated products applicants

Content: Business guidance

Published by:

  • Food Standards Scotland

The application process

Once you’ve established that the product you wish to market is a regulated product that is not already authorised in GB, you must review the information on this page and the guidance specific to your regime before you submit your application to ensure you have all the required information.  

This information is needed so that our risk assessors can assess whether the product or process is safe and to inform the decision on whether the application will be authorised.  

The registers of regulated products lists the regulated products permitted for use in GB and provides references to their terms of authorisation.

Important:

The quality of the dossier, and the information provided, will significantly affect the time needed for analysis and authorisation. We encourage applicants to follow the guidance and provide all the required information to ensure we can process your application as efficiently as possible. Incomplete applications are likely to be delayed and/or deemed invalid or refused.

For an overview of the authorisation process, please refer to our regulated product process flowchart.  

For most regulated product types, once products or processes are authorised, they are listed in online registers which also set out how they can be used.

The registers for the following products or processes have not yet been established:

  • food enzymes
  • food contact materials - recycled processes 
  • food contact materials - active and intelligent materials

Until the registers are in place, these products may be placed on the market if they meet requirements of:

  • the  General Food Law
  • the relevant general criteria in the food enzyme and food contact material legislation. 

Please note: Authorisations are not generally issued for composite foods. The authorisation requirement relates to a particular substance (for example, 2’-fucosyllactose as a novel food) rather than to a composite product containing a regulated product as an ingredient (for example, a flavoured drink containing the novel food 2’-fucosyllactose).  Applications for authorisations must be prepared accordingly.

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