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.
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.
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.
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.
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
- The EC common authorisation procedure guidance provides a brief overview of the procedure
- Regulation (EC) 234/2011 (consolidated version) provides the general and specific data and information required for your application
- EFSA guidance for submission of food additive evaluations
- EFSA data requirements for the evaluation of food additive applications
- European Commission practical guidance for applicants on the submission of applications on food additives, food enzymes and food flavourings
- Regulation (EC) 562/2012 – food enzymes outlines the specific data required for risk assessment of food enzymes
- EFSA guidance on the submission of a dossier on food enzymes
Smoke flavourings are assessed through a separate authorisation procedure. These authorisations are applicant-specific.
- EFSA guidance on the submission of a dossier on smoke flavouring primary product
- Regulation (EU) 627/2006 – smoke products covers the quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products
There is no specific guidance on extraction solvents. However, you may find it helpful to follow the guidance for food additives as appropriate.
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 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
- 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
- EFSA guidelines on submission of a dossier for safety evaluation of a recycling process to produce recycled plastics intended to be used for manufacture of materials and articles in contact with food
Genetically modified organisms as food and feed
- Regulation (EC) 641/2004 – authorisation of new genetically modified food and feed
- Regulation (EC) 503/2013 – authorisation of genetically modified food and feed
- ESFA guidance for GMO applications
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.
There are two types of authorisation for novel foods which have slightly different requirements on the data to be submitted.
- Regulation (EC) 2017/2469 – administrative and scientific requirements for novel foods applications
- EFSA guidance on the preparation and presentation of an application for authorisation of a novel food
Traditional food notification
- Regulation (EC) 2017/2468 – administrative and scientific requirements concerning traditional foods from third countries
- EFSA guidance on the preparation and presentation of an application for authorisation of traditional foods from third countries
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.