• Business guidance

Guidance for regulated products applicants

Content: Business guidance

Published by:

  • Food Standards Scotland

Before you start

Before you begin the application process, please consider if you need to apply for a regulated product market authorisation. This page explains the application requirements and will help you to work out if you need to make an application.  

You will need to apply for a regulated product authorisation if you wish to place one of the following product types on the market in GB. Follow the links for specific FSS guidance according to each product type (‘regime’). These pages also link to the relevant guidance and regulations applicable to each regime:

In addition, if you wish to apply for an authorisation of a cannabidiol (CBD) product you can find more information in our CBD guidance.

If you wish to apply for an authorisation of a cell-cultivated product (CCP) you can find more information in our CCP guidance.

Existing authorisations 

If your product or process was authorised by the European Commission (EC) before 1st January 2021 and the necessary legislation applies, that authorisation remains valid in GB.

Placing your product on the Northern Ireland market

Applicants wishing to place regulated products (excluding feed additives) on the Northern Ireland market continue to follow the EU authorisation process. However, regulated products authorised in GB may also be placed on the Northern Ireland market, provided they are eligible for, and are moved through, the Northern Ireland Retail Movement Scheme (NIRMS). Feed additives are ineligible to be moved through NIRMS. Feed additives placed on the Northern Ireland market are assessed by EFSA. If there is any difference in approach, this is managed through the relevant provisional Common Frameworks.

Did you find this helpful? We would love to hear from you.
Thank you for your feedback!