How to make a novel food application in the EU and Great Britain
A novel food application goes to the European Commission via ESFC, or to the FSA in Great Britain. Steps, dossier, timelines and costs explained.
In the EU, submit a novel food application to the European Commission through its E-Submission Food Chain (ESFC) platform. In Great Britain, apply to the Food Standards Agency (FSA) through its regulated products portal. The Commission usually asks EFSA to assess safety under Regulation (EU) 2015/2283.
A novel food is food not consumed to a significant degree in the EU before 15 May 1997 (European Commission). Regulation (EU) 2015/2283 has applied since 1 January 2018. It replaced the old novel foods regulation, (EC) No 258/97 (Commission legislation page).
Check whether the food is novel
Checking status is the food business operator's job. If you're unsure, consult the Member State where you first plan to sell the food, under Article 4 (Regulation (EU) 2015/2283, consolidated). The Commission publishes status consultation outcomes. Search the Union list, Implementing Regulation (EU) 2017/2470, before you draft a file for a food that may already be authorised (Union list).
Pick the route
There are two EU routes (EUR-Lex):
- A full application under Article 10, the standard route.
- A traditional food notification under Article 14, for eligible foods from a third country. Check the Article 3 definition first. Safe use means at least 25 years of continued use in the customary diet of a significant number of people in at least one third country.
For a traditional food notification, Member States and EFSA have 4 months after the Commission forwards a valid notification to raise reasoned safety objections. If nobody objects, the Commission authorises the food. If they do, you can apply under Article 16. EFSA then has 6 months from receipt of a valid application, and that period can be extended if it asks for more data. The Commission has 3 months from publication of the opinion to put a draft act to the committee (Commission authorisations page; EFSA traditional foods; EUR-Lex).
Notify studies and ask for advice early
Since 27 March 2021, every study you commission or carry out to support the application must be notified to EFSA through the Connect.EFSA portal before the study starts (EFSA novel food applications). The rule comes from the Transparency Regulation (EU) 2019/1381 (Commission legislation page). Read EFSA's administrative guidance on study-notification requirements before commissioning lab work. EFSA strongly recommends that you request pre-submission advice before the dossier is final (EFSA).
Build the dossier
Article 10(2) sets the minimum content (EUR-Lex):
- applicant name and address
- name and description of the novel food
- production process
- detailed composition
- scientific evidence that the food poses no safety risk
- analysis methods, where appropriate
- proposed conditions of use and labelling, or why they aren't needed
Implementing Regulation (EU) 2017/2469 sets the administrative and scientific requirements for applications, and (EU) 2017/2468 does the same for traditional foods (Commission legislation page).
For a dossier you submit now, use the EFSA novel food guidance that applies to applications from 1 February 2025 (Commission e-submission page). EFSA's administrative guidance was updated on 27 November 2025. A draft written against pre-February 2025 guidance needs a rebuild before you file.
EFSA's guidance always requires identity, production process, composition, specifications, proposed uses and use levels, and anticipated intake. History of use, absorption, distribution, metabolism and excretion (ADME), toxicology, nutrition and allergenicity are required unless you justify why new data aren't needed (EFSA guidance).
Make confidentiality and data protection requests in the application itself (Articles 23 and 26). Where granted, data protection prevents use of those data for another applicant's benefit for 5 years after authorisation. Traditional foods don't get this protection (Commission Q&A).
Submit the EU novel food application through ESFC
EU applications must go through the E-Submission Food Chain platform (Commission e-submission page). Do not send the dossier directly to EFSA. The Commission checks validity and, where the food may affect health, asks EFSA for an opinion (Commission authorisations page).
EFSA novel food application timeline
| Stage | Legal deadline |
|---|---|
| EFSA opinion (Article 11) | 9 months from receipt of a valid application, extended if EFSA requests more data |
| Commission draft act to the Standing Committee on Plants, Animals, Food and Feed (Article 12) | 7 months after the opinion is published |
When EFSA asks for more data, it stops the clock for the period set for your reply (EFSA). The extension is automatic unless the Commission objects within 8 working days. If you miss EFSA's deadline, it gives its opinion on the information it has. Extra data you send without being asked does not extend the clock (Articles 11 and 12). The Commission can also end the procedure at any stage (European Commission).
The 9 months exclude the validity check, clock stops and the committee vote, so a launch plan built on 9 plus 7 months will slip once a data request lands. An adopted act puts the food on the Union list (Union list).
Costs
"No fees will be charged for the submission and the scientific assessment of an application," EFSA says (EFSA webinar slides, October 2023). The FSA also charges no application fee. The real cost is the studies and the dossier.
The FSA route for novel foods in the UK
The novel foods regulation in Great Britain is assimilated Regulation 2015/2283, and an EU authorisation does not cover Great Britain today (FSA guidance). If you are unsure the food is novel, request a status decision through the regulated products application portal. Assimilated Regulation 2018/456 covers that request (FSA guidance). You use the same portal for the application and prepare the dossier with EFSA guidance. After validation, the FSA and Food Standards Scotland assess it with independent experts, then publish draft recommendations for consultation. Ministers in England, Scotland and Wales decide. Where granted, GB data protection lasts 5 years from authorisation (FSA flowchart).
A full application has no fixed timescale. Timing "will depend on how complex the application is" (GOV.UK). Traditional food notifications get a four-month review. Since 1 April 2025, a ministerial decision takes effect without a statutory instrument, and the authorisation is recorded in the FSA register (GOV.UK reforms). Northern Ireland follows the EU process (GOV.UK).
Before you commission studies for a GB-only file, read the planned UK-EU SPS agreement. It is intended for mid-2027, and it is still subject to negotiations. Under it, GB novel food authorisations would cease to apply, with their data protection and market exclusivity, and EU authorisations would apply instead (GOV.UK). The FSA guidance says a substantial number of applications already in the service are unlikely to reach a ministerial decision before then, and existing GB rules continue for now (GOV.UK). Build that risk into the project plan before lab work starts.
You can ask RegAffairs AI how to apply for novel food authorisation and get the answer with links to the regulation and EFSA guidance.