• Business guidance

Guidance for regulated products applicants

Content: Business guidance

Published by:

  • Food Standards Scotland

The authorisation process

In assessing your application, we will take into account assimilated law and the guidance previously developed by the European Food Safety Authority (EFSA), as outlined in the regime-specific guidance pages.  

Once you have submitted your application, we will carry out initial checks to make sure it contains all the necessary information. FSS and the Food Standards Agency (FSA) will then carry out an analysis to decide if the product or process is safe to be placed on the market in GB. This may involve risk analysis by one of our Joint Expert Groups and/or Scientific Advisory Committees and a consideration of other legitimate factors (for example, risks to the environment). These will be combined to form an evidence package.

Based on this evidence, we will consider possible risk management options and make a recommendation to ministers. There will be an opportunity to comment on the application by taking part in a consultation during the risk management process. The decision on authorisation is made by the respective Minister in Scotland, England and Wales, with the Minister in Northern Ireland kept informed.

If a decision is taken to support an authorisation the relevant register will be updated to reflect the change.

The timing of the full risk analysis process will depend on how complex the application is and on the type of product. For some products, the deadlines are set in legislation. 

Ongoing applications to the European Union (EU)

If you submitted your application to the EU before 1st January 2021 and the analysis process has not been completed, you will need to submit your application to us using our application portal. Please include your EFSA question number in your submission. 

We may take into account the published EFSA opinion and the outcome of any risk management discussions at the end of the transition period (31st December 2020), but in some cases we may still need to carry out a full risk analysis and consider risk management options.

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