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Submitting a regulated product authorisation application from 1 January 2021

Advice on the new authorisation procedure for a regulated food or animal feed product or process requiring pre-market approval in the UK.

Regulated products and processes 

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). We'll take over responsibility with Food Standards Scotland (FSS) 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 make an application for the authorisation of a regulated food or feed product or process, you’ll need to apply using our regulated products service.

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 our guidance for regulated product applicants.

After you submit your application, we will carry out initial checks to make sure it contains all the necessary information. We 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. We'll 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 by the end of the transition period, that authorisation will remain valid in the UK.

You will need to use our authorisation procedure to:

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

Ongoing applications

We are finalising procedures for the applications submitted to the EU before the end of the transition period for which the assessment process has not been completed. We will provide guidance in due course.