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.
- Authorisation procedure
- General guidance
- Food additives
- Food enzymes
- Flavourings
- Smoke flavourings
- Extraction solvents
Genetically modified organisms as food and feed
Food improvement agents
This covers food additives, flavourings, enzymes and extraction solvents.
- EFSA guidance for submission of food additive evaluations
- EFSA data requirements for the evaluation of food additive applications
- EC practical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings
- Commission Implementing Regulation (EU) 562/2012
- EFSA guidance on the submission of a dossier on food enzymes
- EFSA guidance on the submission of a dossier on smoke flavouring primary product
- Commission Regulation (EC) 627/2006
- 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 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
- EFSA guidance on the submission of a dossier for safety evaluation of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food
- EU guidance on active and intelligent materials and articles intended to come into contact with food
- EFSA administrative guidance for the preparation of applications for the safety assessment of substances to be used in plastic food contact materials
- EU guidelines on plastic materials and articles intended to come into contact with food
Genetically modified organisms as food and feed
- Commission Regulation (EC) 641/2004
- Commission Implementing Regulation (EU) 503/2013
- EFSA guidance for GMO applications
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
Post EU Exit
Changes to the regulatory and business environment.
Regulated products and processes
Outline of the authorisation process from 1 January 2021.
