Regulated products and processes

Outline of the authorisation process from 1 January 2021

Hemp oil is poured onto a spoon before falling into a bowl

Regulated products

Certain food and feed products, called regulated products, require authorisation before they can be sold in the UK. 

Food Standards Scotland (FSS) and the Food Standards Agency (FSA) carry out a risk analysis process for regulated products and provide advice to ministers, who decide whether the product can be placed on the market in Scotland, England and Wales.

New applications

On 1st April 2025 the legislation covering the market authorisation process in Great Britain (GB) for regulated products was amended which:  

  • removes requirements for the periodic renewal of authorisations for feed additives, smoke flavourings and food or feed containing, consisting of or produced from genetically modified organisms.
  • allows authorisations to come into effect following ministerial decision and then be published in an official register or list, rather than being prescribed by statutory instrument (SI). 

Our guidance was amended to take these changes into account. You may wish to refer to further information on the reforms and how they relate to specific product types.

Access the new regulated products application service

Regulated products on sale in Northern Ireland will continue to be subject to EU application and authorisation procedures, under the terms of the Northern Ireland Protocol.

As with current EU authorisation procedures, applications will undergo a risk assessment using established protocols. Risk assessments will be undertaken based on expert advice from independent technical experts, Scientific Advisory Committees, and Joint Expert Groups on a GB basis.

Get more information about the Scientific Advisory Committees and the Joint Expert Groups.

Based on the outputs of the risk assessment and analysis of other relevant evidence, FSS will provide risk management advice to Scottish Ministers for decision on authorisation in Scotland. FSA will be responsible for providing risk management advice to Ministers in England and Wales.

Authorisations will be completed via legislation.

Ongoing applications

Businesses that have submitted an application to the EU and have an interest in bringing the product to market in GB will need to submit a dossier through the regulated products application service. It would be helpful for us if you include your EFSA question number in your submission.

This applies to both new applications and re-authorisation applications.

Existing authorisations

For products and processes which have been authorised by the European Commission and where the necessary legislation is in place and applies by the end of the transition period, that authorisation will remain valid in the UK.

However, you will need to use the new regulated products application service to make changes to or renew an existing authorisation in GB.

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