Guidance for Regulated Products Applicants

Information about the authorisation of regulated products or processes in the UK.

Last updated 7 December

You will need to supply administrative, technical and safety information as part of your application for authorisation of a regulated product or process in the UK.

This is the same as is currently required by the European Food Safety Authority (EFSA) and the European Commission (EC).

We have listed below the available guidance from EFSA and the European Commission for the individual regulated products and processes. This guidance remains relevant to UK applications as our approach is based on EU processes.

Food improvement agents

Feed authorisations

Genetically modified organisms as food and feed

Irradiated foods

Novel foods

Food improvement agents

This covers food additives, flavourings, enzymes and extraction solvents.

Authorisation procedure:

General guidance:

Food additives:        

Food enzymes:

Flavourings:

Smoke flavourings:

Extraction solvents

  • There is no specific guidance on extraction solvents but it may be helpful to follow the guidance on food additives as appropriate.

Feed authorisations

Feed additives:

Feed for particular nutritional uses (PARNUTS):

  • No specific guidance available however 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 (dotixification processes):

  • No specific guidance however the dossier should demonstrate that the detoxification process meets the criteria established in Commission Regulation (EU) 2015/786

Food contact materials

Active/intelligent materials:

Plastic additives:

Recycled processes:

Genetically modified organisms as food and feed

Irradiated foods

A food irradiation licence is need for the facility that will undertake the treatment. Further information is detailed in Schedule 2 of The Food Irradiation (Scotland) Regulations 2009.

Novel foods

Full application:

Traditional food notification:

More on this topic

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Regulated products and processes

Outline of the authorisation process from 1 January 2021

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