News article

Brexit: Submitting a regulated product authorisation application

23 September 2019


The new procedure for regulated food, animal feed and process authorisation in the event of a no-deal Brexit

The FSA have issued advice on the new authorisation procedure for a regulated food or animal feed product or process requiring pre-market approval in the UK if it leaves the EU without a deal.

Regulated products and processes 
After Brexit, certain regulated food and feed products will require authorisation before they can be sold in the UK. This authorisation will be required for the following regulated product types:

  • extraction solvents
  • feed additives
  • feed for particular nutritional uses (PARNUTS)
  • feed (detoxification processes)
  • flavourings
  • food contact materials (active/intelligent materials)
  • food contact materials (plastic additives)
  • food contact materials (recycled processes)
  • food additives
  • food enzymes
  • genetically modified organisms as food and feed
  • irradiated food
  • novel foods (full application)
  • novel foods (traditional food notification)
  • smoke flavourings

Currently, authorisations for these products and processes are provided by the European Commission (EC) following a risk assessment by the European Food Safety Authority (EFSA). If the UK leaves the EU without a deal, the FSA will take over responsibility for carrying out this risk assessment and providing advice to ministers, who will decide whether an authorisation is appropriate.

New regulated products authorisation
If you’re planning to place a new regulated food or feed product or process on the market after Brexit, you’ll need to apply for regulated product authorisation.

To minimise disruption, our risk assessment will be based on the process developed by EFSA. For more details on what you’ll need to supply with your application, read guidance for regulated product applicants.

After you submit your application, The FSA will carry out initial checks to make sure it contains all the necessary information. It will then carry out an assessment to decide if the product or process is safe for the UK market.

Based on this, we’ll make a recommendation to ministers who will decide on whether the product should be authorised. If so, this will be done via legislation.

The timing for this depends on the complexity of the application and the specific regime which, in some cases, establishes deadlines in legislation. The FSA will keep in touch throughout the process to clarify any elements of the application or to seek additional information if needed.

Existing authorisations
If your product or process has been authorised by the European Commission and the necessary legislation is in place and applies at the time the UK leaves the EU, that authorisation will remain valid in the UK after Brexit.

You will need to use our authorisation procedure to:

  • make changes to an existing authorisation
  • renew an existing authorisation

Ongoing applications
The FSA are finalising procedures for the applications submitted to the EU before exit for which assessment process has not been completed. It will provide guidance in due course.