Requirements for regulated product applications after Brexit

Advice on the information that you'll need to submit as part of your regulated product authorisation application, if the UK leaves the EU without a deal.
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Information you'll need to supply 

When applying for authorisation of a regulated product  in the UK, you will have to supply administrative, technical and safety information as part of your application.

The information you will need to supply will be the same as is currently required by the European Food Safety Authority (EFSA) and the European Commission (EC).

The requirements for each type of authorisation are set out in law and cover 3 areas.

Administrative information  

We’ll need to know:

  • who is applying for the authorisation
  • who is responsible for the product or process
  • who we should contact if we have any questions

This may include details about which information you’d like us to treat as confidential.

Technical information  

This is information we will need to understand more about the product or the process and how it is intended to be used. This may also include data for our risk management team to assess whether all the criteria for authorisation have been met.

Safety information  

You should provide scientific data and analysis in the form of a dossier. This will allow us to carry out a thorough risk assessment, where appropriate, to ensure the product or process can be used safely.

There may be some occasions when the required information or studies may not be relevant for your application. In these circumstances you should provide clear justification for not submitting this information.

General guidance 

To help you develop your application, we’ve listed below available guidance from EFSA and the European Commission based on the different product types. This guidance will remain relevant as our approach is based on EU processes.

It's important that you follow this guidance so that your application can be processed as efficiently as possible.

Where the links are to EU regulations, these will become UK retained law, but you should follow the parts that relate to the development of dossiers and not the application process.

Food improvement agents 

This covers food additives, flavourings, enzymes and extraction solvents. In the UK, the retained Regulation (EC) 1331/2008 outlines the authorisation procedure for these substances. EFSA and European Commission guidance on this is available to inform your application. 

General guidance for food improvement agents 

Food additives 

Food enzymes 

Flavourings 

Smoke flavourings 

Smoke flavourings are assessed through a separate authorisation procedure. These authorisations are applicant-specific. 

Extraction solvents 

There is no specific guidance on extraction solvents. However, you may find it helpful to follow the guidance for food additives as appropriate.

Feed authorisations 

The primary regulated animal feed products requiring authorisation are feed additives. In addition, you should submit applications for feed for particular nutritional uses (PARNUTS) and feed detoxification processes. We’ve listed guidance provided by EFSA on the information that needs to be submitted to support the assessment.

Feed additives 

Feed for particular nutritional uses (PARNUTS) 

No specific guidance available. The dossier should demonstrate that the specific composition of the feed fulfils the particular intended nutritional purpose and that it has no adverse effects.  

Feed (detoxification processes) 

No specific guidance. However, any dossier should demonstrate that the detoxification process meets the criteria established in Regulation (EC) 2015/786 – acceptability criteria for detoxification processes

Food contact materials 

Active/intelligent materials 

Plastic additives 

Recycled processes 

Genetically modified organisms as food and feed 

Irradiated foods 

For irradiated foods, a food irradiation licence is needed for the facility that will undertake the treatment. Further information on how you seek an authorisation of this type is detailed in Schedule 2 of The Food Irradiation (England) Regulations 2009

Novel foods 

There are two types of authorisation for novel foods which have slightly different requirements on the data to be submitted. 

Full application 

Traditional food notification 

How long will my application take? 

The law includes deadlines for key steps in the process. In most cases, applications will take a minimum of 1 year.  

The quality of the dossier, and the information provided, will significantly affect the time needed for assessment and authorisation. We encourage applicants to follow the guidance and provide as much information as possible to ensure we can process your request as efficiently as possible.